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In Title 5 of the Code of Federal Regulations, Parts 1 to 699, revised as of January 1, 2017, on page 464, in Part 532, Subpart B, Appendix C, under MINNESOTA, Minneapolis-St. Paul,
National Credit Union Administration (NCUA).
Final rule.
The NCUA Board (“Board”) is issuing this final rule to amend its regulations regarding the treatment by the Board, as liquidating agent or conservator (“liquidating agent” or “conservator,” respectively) of a federally insured credit union (“FICU”), of financial assets transferred by the credit union in connection with a securitization or a participation. The final rule replaces NCUA's current safe harbor for financial assets transferred in connection with securitizations and participations in which the financial assets were transferred in compliance with the existing regulation, and defines the conditions for safe harbor protection for securitizations and participations for which transfers of financial assets would be made after the effective date of this rule.
The effective date for this rule is July 31, 2017.
John Nilles, Senior Capital Markets Specialist, Office of Examination and Insurance, at (703) 518–1174; or John H. Brolin, Senior Staff Attorney, Office of General Counsel, at (703) 518–6438; National Credit Union Administration, 1775 Duke Street, Alexandria, VA 22314.
In 2000, when it adopted a regulation codified at 12 CFR 709.10,
In 2009, the Financial Accounting Standards Board (“FASB”) finalized modifications to GAAP through Statement of Financial Accounting Standards No. 166, (now codified in FASB Accounting Standards Codification (ASC) Topic 860, Transfers and Servicing) and Statement of Financial Accounting Standards No. 167 (now codified in FASB ASC Topic 810, Consolidation) (together, the “2009 GAAP Modifications”). The 2009 GAAP Modifications made changes that affect whether a special purpose entity (“SPE”) must be consolidated for financial reporting purposes, thereby subjecting many SPEs to GAAP consolidation requirements. These accounting changes could require a FICU to consolidate an issuing entity to which financial assets have been transferred for securitization on to its balance sheet for financial reporting purposes primarily because an affiliate of the FICU retains control over the financial assets. Given the 2009 GAAP Modifications, legal and accounting treatment of a transaction may no longer be aligned. As a result, the safe harbor provision of the 2000 Rule may not apply to a transfer in connection with a securitization that does not qualify for off balance sheet accounting treatment.
FASB ASC Topic 860 also affects the treatment of participation interests transferred by a FICU, in that it defines participating interests as pari-passu, pro-rata interests in financial assets, and subjects the sale of a participation interest to the same conditions as the sale of financial assets. FASB ASC Topic 860 provides that transfers of
In 2005, Congress enacted Section 207(c)(13)(C)
In response to the changes outlined above, on June 26, 2014, the Board issued a notice of proposed rulemaking (Proposal) to revise the agency's safe harbor provisions.
The Proposal sought to address concerns of securitization investors and loan participants regarding the impact of the 2009 GAAP Modifications on the eligibility of transfers of financial assets for safe harbor protection by clarifying the position of the conservator or liquidating agent under established law. Under section 207(c)(12) of the FCU Act, the conservator or liquidating agent cannot use its statutory power to repudiate or disaffirm contracts to avoid a legally enforceable and perfected security interest in transferred financial assets “except where such an interest is taken in contemplation of the credit union's insolvency or with the intent to hinder, delay or defraud the credit union or the creditors of such credit union.”
In addition, the Proposal stated that, if the conservator or liquidating agent decides to repudiate the securitization transaction, the payment of repudiation damages in an amount equal to the par value of the outstanding obligations on the date of liquidation will discharge the lien on the securitization assets.
Following issuance of NCUA's Proposal, the FDIC issued two additional rules revising its securitization safe harbor rule to (1) be consistent with regulations required under Section 15G of the Securities and Exchange Act, 15 U.S.C. 78a
NCUA received seven comments on the Proposal to continue the safe harbor for financial assets transferred in connection with securitizations and participations in which the financial assets transferred in connection with the securitization. All the commenters supported the Proposal, stating that investors would have no interest in pursuing securitizations without the safe harbor protections. Two commenters, however, did question the proposed limit of six tranches in a securitization. One commenter also questioned the proposed limits on external credit enhancements. These comments are discussed in more detail below. Based on the rationale previously set forth, the commenters overwhelming support, and for the reasons explained in more detail below, the Board has decided to finalize the Proposal with only the slight modification mentioned above to § 709.10(b)(5)(i).
Consistent with the Proposal, this final rule replaces current § 709.10 of NCUA's regulations. Section 709.10(a) of the rule sets forth definitions of terms used in the rule. It retains many of the definitions used in the current § 709.10(a), but modifies or adds definitions to the extent necessary to accurately reflect current industry practice in securitizations. Pursuant to these definitions, the safe harbor does not apply to certain government sponsored enterprises (“Specified GSEs”), affiliates of certain such enterprises, or any entity established or guaranteed by those GSEs. In addition, the rule is not intended to apply to the Government National Mortgage Association (“Ginnie Mae”) or Ginnie Mae-guaranteed securitizations. When Ginnie Mae guarantees a security, the mortgages backing the security are assigned to Ginnie Mae, an entity owned entirely by the United States government. Ginnie Mae's statute contains broad authority to enforce its contract with the lender/issuer and its ownership rights in the mortgages backing Ginnie Mae-guaranteed
Section 709.10(b) of this final rule imposes conditions to the availability of the safe harbor for transfers of financial assets to an issuing entity in connection with a securitization. These conditions make a clear distinction between the conditions imposed on residential mortgage-backed securities (RMBS) from those imposed on securitizations for other asset classes. In the context of a conservatorship or liquidation, the conditions applicable to all securitizations will improve overall transparency and clarity through disclosure and documentation requirements, along with ensuring effective incentives for prudent lending by requiring that the payment of principal and interest be based primarily on the performance of the financial assets and by requiring retention of a share of the credit risk in the securitized loans.
The conditions applicable to RMBS are more detailed and include additional capital structure, disclosure, documentation and compensation requirements, as well as a requirement for the establishment of a reserve fund. These requirements are intended to address the factors that caused significant losses in RMBS securitization structures as demonstrated in the 2007–2008 financial crisis. Confidence can be restored in RMBS markets only through greater transparency and other structures that support sustainable mortgage origination practices and require increased disclosures. These standards respond to investor demands for greater transparency and alignment of the interests of parties to the securitization. In addition, they are generally consistent with industry efforts, while taking into account legislative and regulatory initiatives.
The benefits of this final rule should be available only to securitizations that are readily understood by the market, increase liquidity of the financial assets, and reduce consumer costs. Consistent with the Security and Exchange Commission's (“SEC's”) Regulation AB, the documents governing the securitization must provide financial asset level disclosure as appropriate to the securitized financial assets for any re-securitizations (securitizations supported by other securitization obligations). These disclosures must include full disclosure of the obligations, including the structure and the assets supporting each of the underlying securitization obligations, and not just the obligations that are transferred in the re-securitization. This requirement applies to all re-securitizations, including static re-securitizations as well as managed collateralized debt obligations.
For RMBS only, the Proposal limited the capital structure of the securitization to six or fewer tranches to discourage complex and opaque structures. The most senior tranche could include time-based sequential pay or planned amortization and companion sub-tranches, which are not viewed as separate tranches for the purpose of the six tranche requirement. This condition would not have prevented an issuer from creating the economic equivalent of multiple tranches by re-securitizing one or more tranches, so long as they meet the conditions set forth in the rule, including adequate disclosure in connection with the re-securitization. In addition, RMBS could not include leveraged tranches that introduced market risks (such as leveraged super senior tranches). Although the financial assets transferred into an RMBS would have been permitted to benefit from asset level credit support, such as guarantees (including guarantees provided by governmental agencies, private companies, or government-sponsored enterprises), co-signers, or insurance, the RMBS could not benefit from external credit support at the issuing entity or pool level. The Proposal intended that guarantees permitted at the asset level include guarantees of payment or collection, but not credit default swaps or similar items. The temporary payment of principal and interest, however, could be supported by liquidity facilities. These conditions were designed to limit both the complexity and the leverage of an RMBS and therefore the systemic risks introduced by them in the market. In addition, the Proposal provided that the securitization obligations could be enhanced by credit support or guarantees provided by Specified GSEs. However, as noted in the discussion on the definitions in the Proposal, a securitization that was wholly guaranteed by a Specified GSE would not have been subject to the rule and thus would not have been eligible for the safe harbor.
Two commenters expressed concern that codifying a limit of six credit tranches in a securitization may have the unintended consequence of limiting a FCU's ability to access the market or issuing a securitization at the best possible price. The commenter recommended that, because there is no empirical evidence that structures with more than six tranches create materially more risk than those with less than six, the Board should eliminate this requirement from the safe harbor. In addition, one commenter urged elimination of the prohibition on external credit enhancements for RMBS.
The Board disagrees with the commenter's recommendations. As previously stated, the rule was intentionally modeled on § 360.6 of the FDIC's regulations to encourage a market for securitization participants and help assure investors. The limiting language in § 709.10(b)(1)(ii)(A) and (B) of the Proposal is nearly identical
For all securitizations, disclosure serves as an effective tool for increasing the demand for high quality financial assets and thereby establishing incentives for robust financial asset underwriting and origination practices. Consistent with the Proposal, this final rule increases transparency in securitizations by enabling investors to decide whether to invest in a securitization based on full information with respect to the quality of the asset pool and thereby provide additional liquidity only for sustainable origination practices.
The data must enable investors to analyze the credit quality for the specific asset classes that are being securitized. The documents governing securitizations must, at a minimum, require disclosure for all issuances to include the types of information required under current Regulation AB or any successor disclosure requirements with the level of specificity that applies to public issuances, even if the obligations are issued in a private placement or are not otherwise required to be registered.
The documents governing securitizations that qualify under the rule must require disclosure of the structure of the securitization and the credit and payment performance of the obligations, including the relevant capital or tranche structure and any liquidity facilities and credit enhancements. The disclosure must be required to include the priority of payments and any specific subordination features, as well as any waterfall triggers or priority of payment reversal features. The disclosure at issuance must include the representations and warranties made with respect to the financial assets and the remedies for breach of such representations and warranties, including any relevant timeline for cure or repurchase of financial assets, and policies governing delinquencies, servicer advances, loss mitigation and write offs of financial assets. The documents must also require that periodic reports provided to investors include the credit performance of the obligations and financial assets, including periodic and cumulative financial asset performance data, modification data, substitution and removal of financial assets, servicer advances, losses that were allocated to each tranche and remaining balance of financial assets supporting each tranche as well as the percentage coverage for each tranche in relation to the securitization as a whole. Where appropriate for the type of financial assets included in the pool, reports must also include asset level information that may be relevant to investors (
The securitization documents must also require disclosure to investors of the nature and amount of compensation paid to any mortgage or other broker, the servicer(s), rating agency or third-party advisor, and the originator or sponsor, and the extent to which any risk of loss on the underlying financial assets is retained by any of them for such securitization. The documents must require disclosure of changes to this information while obligations are outstanding. This disclosure should enable investors to assess potential conflicts of interests and how the compensation structure affects the quality of the assets securitized or the securitization as a whole.
For RMBS, consistent with the Proposal, this final rule requires the sponsor to disclose loan level data as to the financial assets securing the mortgage loans, such as loan type, loan structure, maturity, interest rate and location of property. Sponsors of securitizations of residential mortgages will be required to affirm compliance in all material respects with applicable statutory and regulatory standards for origination of mortgage loans. None of the disclosure conditions should be construed as requiring the disclosure of personally identifiable information of obligors or information that would violate applicable privacy laws. The rule requires sponsors to disclose a third-party due diligence report on compliance with standards and representations and warranties made about the financial assets.
Finally, this final rule, consistent with the Proposal, specifies that the securitization documents require disclosure by servicers of any ownership interest of the servicer or any affiliate of the servicer in other whole loans secured by the same real property that secures a loan included in the financial asset pool. This provision does not require disclosure of interests held by servicers or their affiliates in the securitization securities. This provision is intended to give investors information to evaluate potential servicer conflicts of interest that might impede the servicer's actions to maximize value for the benefit of investors.
For all securitizations, this final rule, consistent with the Proposal, requires operative agreements to use available standardized documentation for each available asset class. It is not possible to define in advance when use of standardized documentation will be appropriate, but when there is general market use of a form of documentation for a particular asset class, or where a trade group has formulated standardized documentation generally accepted by the industry, such documentation must be used.
Consistent with the Proposal, the rule also requires that securitization documents define the contractual rights and responsibilities of the parties, including but not limited to representations and warranties, ongoing disclosure requirements and any measures to avoid conflicts of interest. The documents are required to provide authority for the parties to fulfill their rights and responsibilities under the securitization contracts.
Consistent with the Proposal, additional conditions apply to RMBS to address a significant issue that has been demonstrated in the mortgage crisis by requiring that servicers have authority to mitigate losses on mortgage loans consistent with maximizing net present value of the mortgages. Therefore, for RMBS, contractual provisions in the servicing agreement must provide servicers with authority to modify loans to address reasonably foreseeable defaults and to take other action to maximize the value and minimize losses on the securitized financial assets. The documents must require servicers to apply industry best practices related to asset management and servicing.
The RMBS documents may not give control of servicing discretion to a particular class of investors. The documents must require that the servicer act for the benefit of all investors rather than for the benefit of any particular class of investors. Consistent with the forgoing, the documents must require the servicer to commence action to mitigate losses no later than ninety days after an asset first becomes delinquent unless all delinquencies on such an asset have been cured. A servicer must be required to maintain sufficient records of its actions to permit appropriate review of its actions.
In January 2013, the Consumer Financial Protection Bureau (“CFPB”) adopted mortgage loan servicing requirements that became effective on
In response to this change, the Board is now making minor amendments in this final rule to clarify that the 90-day loss mitigation requirement does not conflict with the foreclosure commencement delays mandated by the CFPB under Regulation X. In particular, § 709.10(b)(3)(ii)(A) retains the original language proposed, but now includes additional language stating that the loss mitigation action requirement thereunder “will not be deemed to require that the documents include any provision concerning loss mitigation that requires any action that may conflict with the requirements of Regulation X. . . .”
In addition, NCUA believes that a prolonged period of servicer advances in a market downturn misaligns servicer incentives with those of the RMBS investors. Servicing advances also serve to aggravate liquidity concerns, exposing the market to greater systemic risk. Occasional advances for late payments, however, are beneficial to ensure that investors are paid in a timely manner. To that end, consistent with the Proposal, the servicing agreement for RMBS must not require the primary servicer to advance delinquent payments of principal and interest by borrowers for more than three payment periods unless financing or reimbursement facilities to fund or reimburse the primary servicers are available. However, such facilities shall not be dependent for repayment on foreclosure proceeds.
Consistent with the Proposal, the compensation requirements of this final rule apply only to RMBS. Due to the demonstrated issues in the compensation incentives in RMBS, the rule seeks to realign compensation to parties involved in the rating and servicing of residential mortgage securitizations.
The securitization documents are required to provide that any fees payable credit rating agencies or similar third-party evaluation companies must be payable in part over the five-year period after the initial issuance of the obligations based on the performance of surveillance services and the performance of the financial assets, with no more than 60% of the total estimated compensation due at closing. Thus, payments to rating agencies must be based on the actual performance of the financial assets, not their ratings.
A second area of concern is aligning incentives for proper servicing of the mortgage loans. Therefore, the documents must require that compensation to servicers must include incentives for servicing, including payment for loan restructuring or other loss mitigation activities, which maximizes the net present value of the financial assets in the RMBS.
As discussed above and consistent with the Proposal, this final rule imposes conditions addressing origination and retention requirements for all securitizations to provide further incentives for quality origination practices. Because the regulations required under Section 15G of the Securities Exchange Act, 15 U.S.C. 78a
The Board continues to believe that requiring the sponsor to retain an economic interest in the credit risk relating to each credit tranche or in a representative sample of financial assets will help ensure quality origination practices. A risk retention requirement that did not cover all types of exposure would not be sufficient to create an incentive for quality underwriting at all levels of the securitization. The recent economic crisis made clear that, if quality underwriting is to be assured, it will require true risk retention by sponsors, and that the existence of representations and warranties or regulatory standards for underwriting will not alone be sufficient.
Consistent with the Proposal, § 709.10(c) of this final rule includes general conditions for securitizations and the transfer of financial assets. These conditions also include requirements that are consistent with good financial institution practices.
The transaction should be an arms-length, bona fide securitization transaction and the documents must limit sales to credit union service organizations in which the sponsor credit union has an interest (other than a wholly-owned credit union service organization consolidated for accounting and capital purposes with the credit union), and insiders of the sponsor. The securitization agreements must be in writing, approved by the board of directors of the credit union or its loan committee (as reflected in the minutes of a meeting of the board of directors or committee), and have been, continuously, from the time of execution, in the official record of the credit union. The securitization must have been entered into in the ordinary course of business, not in contemplation of insolvency and with no intent to hinder, delay or defraud the credit union or its creditors.
The rule applies only to transfers made for adequate consideration. The transfer and/or security interest need to be properly perfected under the Uniform Commercial Code (UCC) or applicable state law. NCUA anticipates that it will be difficult to determine whether a transfer complying with the rule is a sale or a security interest, and therefore expects that a security interest will be properly perfected under the UCC, either directly or as a backup.
The governing documents must require that the sponsor separately identify in its financial asset data bases the financial assets transferred into a securitization and maintain an electronic or paper copy of the closing documents in a readily accessible form, and that the sponsor maintain a current list of all of its outstanding securitizations and issuing entities, and the most recent SEC Form 10–K or other
In addition, the rule requires that the transfer of financial assets and the duties of the sponsor as transferor be evidenced by an agreement separate from the agreement governing the sponsor's duties, if any, as servicer, custodian, paying agent, credit support provider or in any capacity other than transferor.
Consistent with the Proposal, § 709.10(d)(1) of the rule continues the safe harbor provision that was provided by the 2000 Rule with respect to participations so long as the participation satisfies the conditions for sale accounting treatment set forth by generally accepted accounting principles. In addition, last-in first-out participations are specifically included in the safe harbor, provided that they satisfy requirements for sale accounting treatment other than the pari-passu, proportionate interest requirement that is not satisfied solely as a result of the last-in first-out structure.
Consistent with the Proposal, § 709.10(d)(2) of the Rule addresses transfers of financial assets made in connection with a securitization for which transfers of financial assets are made after the effective date of this rule or securitizations from a master trust or revolving trust established after the date of adoption of this rule, that (in each case) satisfy the conditions for sale accounting treatment under GAAP in effect for reporting periods after November 15, 2009. For such securitizations, NCUA as conservator or liquidating agent will not, in the exercise of its statutory authority to disaffirm or repudiate contracts, reclaim, recover, or recharacterize as property of the institution or the liquidation estate any such transferred financial assets, provided that such securitizations comply with the conditions set forth in paragraphs (b) and (c) of the rule.
Consistent with the Proposal, § 709.10(d)(3) of the Rule addresses transfers of financial assets in connection with a securitization for which transfers of financial assets were made after the effective date of this rule or securitizations from a master trust or revolving trust established after the date of adoption of the rule, that (in each case) satisfy the conditions set forth in paragraphs (b) and (c), but where the transfer does not satisfy the conditions for sale accounting treatment under GAAP in effect for reporting periods after November 15, 2009.
Consistent with the Proposal, § 709.10(d)(3)(i) provides that if the conservator or liquidating agent is in monetary default due to its failure to pay or apply collections from the financial assets received by it in accordance with the securitization documents, and remains in monetary default for ten business days after actual delivery of a written notice to the conservator or liquidating agent requesting exercise of contractual rights because of such default, the conservator or liquidating agent consents to the exercise of such contractual rights, including any rights to obtain possession of the financial assets or the exercise of self-help remedies as a secured creditor, provided that no involvement of the conservator or liquidating agent is required, other than consents, waivers or the execution of transfer documents reasonably requested in the ordinary course of business in order facilitate the exercise of such contractual rights. This paragraph also provides that the consent to the exercise of such contractual rights shall serve as full satisfaction for all amounts due.
Consistent with the Proposal, § 709.10(d)(3)(ii) provides that, if the conservator or liquidating agent gives a written notice of repudiation of the securitization agreement pursuant to which assets were transferred and does not pay the damages due by reason of such repudiation within ten business days following the effective date of the notice, the conservator or liquidating agent consents to the exercise of any contractual rights, including any rights to obtain possession of the financial assets or the exercise of self-help remedies as a secured creditor, provided that no involvement of the conservator or liquidating agent is required other than consents, waivers or the execution of transfer documents reasonably requested in the ordinary course of business in order facilitate the exercise of such contractual rights. Paragraph 3(d)(ii) also provides that the damages due for these purposes shall be an amount equal to the par value of the obligations outstanding on the date of liquidation less any payments of principal received by the investors through the date of repudiation, plus unpaid, accrued interest through the date of repudiation to the extent actually received through payments on the financial assets received through the date of repudiation, and that upon receipt of such payment all liens on the financial assets created pursuant to the securitization documents shall be released.
In computing amounts payable as repudiation damages, consistent with the FCU Act, the conservator or liquidating agent will not give effect to any provisions of the securitization documents increasing the amount payable based on the appointment of as the conservator or liquidating agent.
Consistent with the Proposal, § 709.10(e) provides that prior to repudiation or, in the case of monetary default, prior to the effectiveness of the consent referred to in § 709.10(d)(3)(i), the conservator or liquidating agent consents to the making of, or if acting as servicer agrees to make, required payments to the investors during the stay period imposed by 12 U.S.C. 1787(c)(13)(C). The rule also provides that the conservator or liquidating agent consents to any servicing activity required in furtherance of the securitization (subject to its rights to repudiate the servicing agreements), in connection with securitizations that meet the conditions set forth in paragraphs (b) and (c) of § 709.10 of the rule.
Consistent with the Proposal, § 709.10(f) requires that any party requesting consent pursuant to paragraph (d)(3), provide notice to the conservator or liquidating agent, together with a statement of the basis upon which the request is made, together with copies of all documentation supporting the request. This includes a copy of the applicable agreements (such as the transfer agreement and the security agreement) and of any applicable notices under the agreements.
Consistent with the Proposal, § 709.10(g) provides that the conservator or liquidating agent will not seek to avoid an otherwise legally enforceable agreement that is executed by a FICU in connection with a securitization solely because the agreement does not meet the “contemporaneous” requirement of 12 U.S.C. 1787(b)(9) and 1788(a)(3).
Consistent with the Proposal, § 709.10(h) of the rule provides that the consents set forth in the rule will not act to waive or relinquish any rights granted to NCUA, the conservator, or the liquidating agent, in any capacity, pursuant to any other applicable law or any agreement or contract except as specifically set forth in the rule, and nothing contained in the section will alter the claims priority of the securitized obligations.
Consistent with the Proposal, § 709.10(i) provides that except as specifically set forth in the rule, the rule does not authorize, and shall not be construed as authorizing the attachment of any involuntary lien upon the property of the conservator or liquidating agent. The rule should not be construed as waiving, limiting or otherwise affecting the rights or powers of NCUA, the conservator, or the liquidating agent to take any action or to exercise any power not specifically mentioned, including but not limited to any rights, powers or remedies of the conservator or the liquidating agent regarding transfers taken in contemplation of the FICU's insolvency or with the intent to hinder, delay or defraud the FICU, or the creditors of such FICU, or that is a fraudulent transfer under applicable law.
The right to consent under 12 U.S.C. 1787(c)(13)(C) may not be assigned or transferred to any purchaser of property from a conservator or liquidating agent, other than to a conservator or bridge credit union. The rule can be repealed by NCUA upon 30 days' notice provided in the
The Regulatory Flexibility Act requires NCUA to prepare an analysis of any significant economic impact any proposed regulation may have on a substantial number of small entities (primarily those under $100 million in assets).
The Paperwork Reduction Act of 1995 (PRA) applies to rulemakings in which an agency by rule creates a new paperwork burden on regulated entities or increases an existing burden.
Executive Order 13132 encourages independent regulatory agencies to
NCUA has determined that this rule will not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, 1999, Public Law 105–277, 112 Stat. 2681 (1998).
The Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121) (SBREFA) provides generally for congressional review of agency rules. A reporting requirement is triggered in instances where NCUA issues a final rule as defined by Section 551 of the Administrative Procedure Act.
Credit unions, Liquidations.
For the reasons discussed above, the National Credit Union Administration amends 12 CFR part 709 as follows:
12 U.S.C. 1757, 1766, 1767, 1786(h), 1787, 1789, 1789a.
(a)
(1) The Federal National Mortgage Association and any affiliate thereof;
(2) Federal Home Loan Mortgage Corporation and any affiliate thereof;
(3) The Government National Mortgage Association; and
(4) Any Federal or State sponsored mortgage finance agency.
(1) The conveyance of a financial asset or financial assets to an issuing entity; or
(2) The creation of a security interest in such asset or assets for the benefit of the issuing entity.
(b)
(1)
(i)
(B) The documents creating the securitization must require that payment of principal and interest on the securitization obligation will be primarily based on the performance of financial assets that are transferred to the issuing entity and, except for interest rate or currency mismatches between the financial assets and the obligations, will not be contingent on market or credit events that are independent of such financial assets. The securitization may not be an unfunded securitization or a synthetic transaction.
(ii)
(B) The credit quality of the obligations cannot be enhanced at the issuing entity or pool level through external credit support or guarantees. However, the credit quality of the obligations may be enhanced by credit support or guarantees provided by Specified GSEs and the temporary payment of principal and/or interest may be supported by liquidity facilities, including facilities designed to permit the temporary payment of interest following appointment of the NCUA Board as conservator or liquidating agent. Individual financial assets transferred into a securitization may be guaranteed, insured, or otherwise benefit from credit support at the loan level through mortgage and similar insurance or guarantees, including by private companies, agencies or other governmental entities, or government-sponsored enterprises, and/or through co-signers or other guarantees.
(2)
(i)
(B) The documents must require that, on or prior to issuance of obligations, the structure of the securitization and the credit and payment performance of the obligations will be disclosed, including the capital or tranche structure, the priority of payments, and specific subordination features; representations and warranties made with respect to the financial assets, the remedies for, and the time permitted for cure of any breach of representations and warranties, including the repurchase of financial assets, if applicable; liquidity facilities and any credit enhancements permitted by this rule, any waterfall triggers, or priority of payment reversal features; and policies governing delinquencies, servicer advances, loss mitigation, and write-offs of financial assets.
(C) The documents must require that while obligations are outstanding, the issuing entity will provide to investors information with respect to the credit performance of the obligations and the financial assets, including periodic and cumulative financial asset performance data, delinquency and modification data for the financial assets, substitutions and removal of financial assets, servicer advances, as well as losses that were allocated to such tranche and remaining balance of financial assets supporting such tranche, if applicable, and the percentage of each tranche in relation to the securitization as a whole.
(D) In connection with the issuance of obligations, the documents must disclose the nature and amount of compensation paid to the originator, sponsor, rating agency or third-party advisor, any mortgage or other broker, and the servicer(s), and the extent to which any risk of loss on the underlying assets is retained by any of them for such securitization be disclosed. The securitization documents must require the issuer to provide to investors while obligations are outstanding any changes to such information and the amount and nature of payments of any deferred compensation or similar arrangements to any of the parties.
(ii)
(B) Prior to issuance of obligations, sponsors must affirm compliance in all material respects with applicable statutory and regulatory standards for the underwriting and origination of residential mortgage loans. Sponsors must disclose a third-party due diligence report on compliance with such standards and the representations and warranties made with respect to the financial assets.
(C) The documents must require that prior to issuance of obligations and while obligations are outstanding, servicers will disclose any ownership interest by the servicer or an affiliate of the servicer in other whole loans secured by the same real property that secures a loan included in the financial asset pool. The ownership of an obligation, as defined in this regulation, does not constitute an ownership interest requiring disclosure.
(3)
(i)
(ii)
(B) The servicing agreement may not require a primary servicer to advance delinquent payments of principal and interest for more than three payment periods, unless financing or reimbursement facilities are available, which may include, but are not limited to, the obligations of the master servicer or issuing entity to fund or reimburse the primary servicer, or alternative reimbursement facilities. Such “financing or reimbursement facilities” under this paragraph may not be dependent for repayment on foreclosure proceeds.
(4)
(i) The documents must require that any fees or other compensation for services payable to credit rating agencies or similar third-party evaluation companies are payable, in part, over the five-year period after the first issuance of the obligations based on the performance of surveillance services and the performance of the financial assets, with no more than sixty percent of the total estimated compensation due at closing; and
(ii) The documents must provide that compensation to servicers will include incentives for servicing, including payment for loan restructuring or other loss mitigation activities, which maximizes the net present value of the financial assets. Such incentives may include payments for specific services, and actual expenses, to maximize the net present value or a structure of incentive fees to maximize the net present value, or any combination of the foregoing that provides such incentives.
(5)
(ii)
(B) The documents must include a representation that the assets were originated in all material respects in compliance with statutory, regulatory, and originator underwriting standards in effect at the time of origination. The documents must include a representation that the mortgages included in the securitization were underwritten at the fully indexed rate, based upon the borrowers' ability to repay the mortgage according to its terms, and rely on documented income and comply with all existing all laws, rules, regulations, and guidance governing the underwriting of residential mortgages by federally insured credit unions.
(c)
(2) The securitization agreements are in writing, approved by the board of directors of the credit union or its loan committee (as reflected in the minutes of a meeting of the board of directors or committee), and have been, continuously, from the time of execution in the official record of the credit union;
(3) The securitization was entered into in the ordinary course of business, not in contemplation of insolvency and with no intent to hinder, delay, or defraud the credit union or its creditors;
(4) The transfer was made for adequate consideration;
(5) The transfer and/or security interest was properly perfected under the UCC or applicable state law;
(6) The transfer and duties of the sponsor as transferor must be evidenced in a separate agreement from its duties, if any, as servicer, custodian, paying agent, credit support provider, or in any capacity other than the transferor; and
(7) The documents must require that the sponsor separately identify in its financial asset data bases the financial assets transferred into any securitization and maintain (i) an electronic or paper copy of the closing documents for each securitization in a readily accessible form, (ii) a current list of all of its outstanding securitizations and the respective issuing entities, and (iii) the most recent Securities and Exchange Commission Form 10-K, if applicable, or other periodic financial report for each securitization and issuing entity. The documents must provide that to the extent serving as servicer, custodian, or paying agent for the securitization, the sponsor may not comingle amounts received with respect to the financial assets with its own assets except for the time, not to exceed two business days, necessary to clear any payments received. The documents must require that the sponsor will make these records
(d)
(2)
(3)
(i)
(ii)
(iii)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
National Credit Union Administration (NCUA).
Final rule.
On January 23, 2017, the NCUA Board (Board) published an interim final rule amending its regulations to adjust the maximum amount of each civil monetary penalty (CMP) within its jurisdiction to account for inflation. This action, including the amount of the adjustments, is required under the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 and the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. This rule finalizes those amendments.
Effective June 30, 2017.
Ian Marenna, Senior Trial Attorney, at 1775 Duke Street, Alexandria, VA 22314, or telephone: (703) 518–6540.
The Debt Collection Improvement Act of 1996
On January 23, 2017, in compliance with the 2015 amendments, the Board published the annual inflation adjustments for 2017 in an interim final rule with a request for comments in the
The interim final rule became effective on January 23, 2017. The Board received no comments on the rule. Accordingly, this final rule confirms the adjustments made in the interim final rule without change.
Section III of the Supplementary Information in the January 2017 interim final rule sets forth the Board's analyses under the Administrative Procedure Act, the Regulatory Flexibility Act, the Paperwork Reduction Act of 1995, the Small Business Regulatory Enforcement Fairness Act (SBREFA), Executive Order 13132, and the Treasury and General Government Appropriations Act.
National Credit Union Administration (NCUA).
Final rule.
The NCUA Board (Board) is finalizing its interim final rule amending its Freedom of Information Act (FOIA) regulation. The FOIA Improvement Act of 2016 amended the FOIA and required agencies to review their FOIA regulations and issue certain amendments by December 27, 2016. The amendments included revised procedures for disclosing records under the FOIA, assessing fees, and notifying requestors of options for resolving disputes through the NCUA FOIA Public Liaison and the Office of Government Information Services (OGIS) within the National Archives and Records Administration. The interim final rule became effective on December 22, 2016. This rulemaking finalizes the interim rule with minor edits for consistency and clarification.
Effective June 30, 2017.
Regina Metz, Senior Staff Attorney, or Linda Dent, Associate General Counsel, Administrative Law Section, Office of General Counsel, at 1775 Duke Street, Alexandria, Virginia 22314–3428, or telephone: (703) 518–6540.
On December 22, 2016, NCUA published an interim final rule
The interim final rule revised procedures for the disclosure of records, including procedures for engaging in dispute resolution through the FOIA Public Liaison and the OGIS. The revisions were necessary to comply with amendments to the FOIA Improvement Act of 2016. NCUA is issuing this rulemaking to finalize the interim rule with minor wording changes for consistency and clarification.
NCUA received two comments on the interim final rule. One was from a trade organization and one was from an institute. One comment was fully supportive of the Act, noting that the interim rule met all the technical statutory requirements. The comment, however, also urged the NCUA to exceed the requirements and continue to adopt a presumption of openness. NCUA's longstanding FOIA practices include a presumption of openness which will continue under the final rule.
In addition, the commenter believes the NCUA should post every FOIA response to its Web site. The FOIA and the interim final rule, in section 792.03(c), already provide that NCUA must post on its Web site records released in response to a FOIA request that are either: Likely to be the subject of subsequent requests because of the nature of their subject matter; or records that have been requested three or more times. NCUA generally exceeds these requirements, posting on its FOIA page records requested more than once and considering each record requested for possible routine Web site posting. As every record requested, however, is not of interest to the general public, NCUA is adopting this section in the final rule without change.
The other commenter requested that NCUA revise its definition of “representative of the news media” in § 792.20 to be consistent with the FOIA at 5 U.S.C. 552(a)(4)(A)(ii) and also to consider additional technical matters. As a change to this definition and the other issue raised were not included in the interim final rule, NCUA will address this in an upcoming technical amendment rule. The final rule does contain minor changes to wording for consistency and clarification.
In accordance with the requirements of the Paperwork Reduction Act (PRA) of 1995,
This category is limited to those disclosures that require persons to provide or display only facts necessary to identify themselves. For example, they entail no burden other than that necessary to identify the respondent, the date, the respondent's address, and the nature of the instrument. “Nature of the instrument” refers to a respondent's request for materials, such as publications or other information from an agency. To facilitate such requests for information from an agency, an agency may ask requesters to describe the material or information sought in detail sufficient to describe the individual desires.
The final rule implements the FOIA Improvement Act of 2016 by amending the agency's FOIA regulations. Because the only paperwork burden in this final rule relates to activities that are not considered to be information collections, NCUA has determined that this rule is exempt from the requirements of the PRA.
The Regulatory Flexibility Act requires NCUA to prepare an analysis to describe any significant economic impact a rule may have on a substantial number of small credit unions (those under $100 million in assets). This final rule does not impose any requirements on federally insured credit unions. Therefore, it will not have a significant economic impact on a substantial number of small credit unions and a regulatory flexibility analysis is not required. Because this final rule would affect few, if any, small entities, the Board certifies that the final rule will
Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on state and local interests. In adherence to fundamental federalism principles, NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order. The final rule would not have substantial direct effects on the states, on the connection between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. NCUA has determined that this final rule does not constitute a policy that has federalism implications for purposes of the executive order.
NCUA has determined that this final rule would not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act of 1999.
The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) provides generally for congressional review of agency rules. A reporting requirement is triggered in instances where the Board issues a final rule as defined by Section 551 of the APA. The Board submitted the rule to the Office of Management and Budget. It determined the rule is not a “major rule” within the meaning of the relevant sections of SBREFA.
Administrative practice and procedure, Credit unions, Freedom of Information, Information, Privacy, Records, System of records.
For the reasons stated above, the National Credit Union Administration adopts the interim rule published December 22, 2016, at 81 FR 93792, as final with the following changes:
5 U.S.C. 301, 552, 552a, 552b; 12 U.S.C. 1752a(d), 1766, 1789, 1795f; E.O. 12600, 52 FR 23781, 3 CFR, 1987 Comp., p.235; E.O. 13526, 75 FR 707, 2009 Comp. p.298.
Except for records that are exempt from public disclosure under FOIA as amended (5 U.S.C. 552) or are promptly published and copies are available for purchase, NCUA routinely makes the following five types of records available for you to inspect and copy and in an electronic format:
(d) Copies of all records, regardless of form or format, which have been released after March 31, 1997, in response to a FOIA request and which, because of the nature of their subject matter, NCUA determines have been or are likely to become the subject of subsequent requests; or records that have been requested three (3) or more times; and
NCUA maintains current indices providing identifying information for the public for any matter referred to in § 792.02, issued, adopted, or promulgated after July 4, 1967. The listing of material in an index is for the convenience of possible users and does not constitute a determination that all of the items listed will be disclosed. NCUA has determined that publication of the indices is unnecessary and impractical. You may obtain copies of indices by making a request to the NCUA, Office of General Counsel, 1775 Duke Street, Alexandria, VA 22314–2387, Attn: FOIA Officer or as indicated on the NCUA Web site at
(c) Popular FOIA Index: Records released in response to a FOIA request, that NCUA determines are likely to be the subject of subsequent requests because of the nature of their subject matter, or records that have been requested three (3) or more times. The Popular FOIA Index is available on the NCUA Web site.
(e) Upon a determination by the appropriate Information Center to comply with your initial request for records, the records will be made promptly available to you. NCUA will also advise you of the right to seek assistance from the FOIA Public Liaison. If we notify you of a denial of your request, we will include the reason for the denial. NCUA will also advise you of the right to utilize dispute resolution services offered by the FOIA Public Liaison and the Office of Government Information Services.
(a) * * *
(5) Inter-agency or intra-agency memoranda or letters which would not be available by law to a private party in litigation with NCUA. This exemption preserves the existing freedom of NCUA officials and employees to engage in full and frank written or taped communications with each other and with officials and employees of other agencies. It includes, but is not limited to, inter-agency and intra-agency reports, memoranda, letters, correspondence, work papers, and minutes of meetings, as well as staff papers prepared for use within NCUA or in concert with other governmental agencies. In applying this exemption, the NCUA will not withhold records based on the deliberative process privilege if the records were created 25 years or more before the date on which the records were requested.
(b) * * *
(2) Such alternative time period as mutually agreed by you and the Information Office, when NCUA notifies
(c) If NCUA sends you an extension notice, it will also advise you that you can either limit the scope of your request so that it can be processed within the statutory time limit or agree to an alternative time frame for processing your request. In such cases, NCUA will make available its FOIA Public Liaison and notify you of the right to seek dispute resolution services from the Office of Government Information Services.
(a) If NCUA does not comply with the time limits under § 792.15, or as extended under § 792.16, you do not have to pay search fees; requesters qualifying for free search fees will not have to pay duplication fees. However, if NCUA has extended the time limits under § 792.16 and must review more than 5,000 pages to respond to the request, NCUA may charge you search fees (or for requesters qualifying for free search fees, duplication fees), if NCUA has discussed with you via written mail, electronic mail, or telephone (or made not less than 3 good-faith attempts to do so) how you could effectively limit the scope of the request.
(b) You can seek assistance from the FOIA Public Liaison or dispute resolution services from the Office of Government Information Services. You also can file suit against NCUA because you will be deemed to have exhausted your administrative remedies if NCUA fails to comply with the time limit provisions of this subpart. If NCUA can show that exceptional circumstances exist and that it is exercising due diligence in responding to your request, the court may retain jurisdiction and allow NCUA to complete its review of the records. You may have to pay search or duplication fees if a court has determined that exceptional circumstances exist and has extended the time limits for NCUA's response by a court order. In determining whether exceptional circumstances exist, the court may consider your refusal to modify the scope of your request or arrange an alternative time frame for processing after being given the opportunity to do so by NCUA, when it notifies you of the existence of unusual circumstances as set forth in § 792.16.
If you are not satisfied with NCUA's response to your request, you can seek dispute resolution services from the FOIA Public Liaison and the Office of Government Information Services, and you can file an administrative appeal. Your appeal must be in writing and must be filed within 90 days from receipt of the initial determination (in cases of denials of the entire request or denials of a fee waiver or reduction), or from receipt of any records being made available pursuant to the initial determination (in cases of partial denials). In the response to your initial request, the Freedom of Information Act Officer or the Inspector General (or designee), will notify you that you may appeal any adverse determination to the Office of General Counsel. The General Counsel, or designee, as set forth in this paragraph, will:
Bureau of Consumer Financial Protection.
Policy guidance.
The Consumer Financial Protection Bureau (Bureau) is issuing policy guidance on its supervisory and enforcement priorities regarding early compliance with the final rule it issued in August 2016 (2016 Mortgage Servicing Final Rule) amending certain of the Bureau's mortgage servicing rules.
The Bureau released this Policy Guidance on its Web site on June 27, 2017.
Joel L. Singerman, Counsel, or Laura A. Johnson, Senior Counsel, Office of Regulations, at 202–435–7700.
On August 4, 2016, the Bureau issued the 2016 Mortgage Servicing Final Rule clarifying, revising, or amending certain of the Bureau's mortgage servicing rules.
The Bureau understands industry's concerns and believes that, in the context of the 2016 Mortgage Servicing Final Rule, servicers and consumers are likely to benefit if servicers have the weekend immediately before each of the effective dates to update and test their systems. The Bureau does not, therefore, intend to take supervisory or enforcement action for violations of existing Regulation X or Regulation Z resulting from a servicer's compliance with the 2016 Mortgage Servicing Final Rule occurring up to three days before the applicable effective dates. For these purposes, “up to three days before the applicable effective dates” means, for the amendments that will take effect on Thursday, October 19, 2017, the period of Monday, October 16, through Wednesday, October 18, 2017; and, for the amendments that will take effect on Thursday, April 19, 2018, the period of Monday, April 16, through Wednesday, April 18, 2018.
This Policy Guidance is a non-binding general statement of policy articulating considerations relevant to the Bureau's exercise of its supervisory and enforcement authority. It is therefore exempt from notice and comment rulemaking requirements under the Administrative Procedure Act pursuant to 5 U.S.C. 553(b). Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis. 5 U.S.C. 603(a), 604(a). The Bureau has determined that this Policy Guidance does not impose any new or revise any existing recordkeeping, reporting, or disclosure requirements on covered entities or members of the public that would be collections of information requiring OMB approval under the Paperwork Reduction Act, 44 U.S.C. 3501,
U.S. Customs and Border Protection, Department of Homeland Security.
Final rule.
This document adopts as a final rule, with changes, the amendments proposed to the U.S. Customs and Border Protection (CBP) regulations concerning the customs broker's examination provisions. Specifically, this rule transitions the examination to a computer automated customs broker examination, adjusts the dates of the examination to account for the fiscal year transition period and payment schedule requirements, and increases the examination fee to cover the cost of delivering the exam.
Effective July 31, 2017.
Julia Peterson, Chief, Broker Management Branch, Office of Trade, U.S. Customs and Border Protection, (202) 863–6601,
Section 641 of the Tariff Act of 1930, as amended (19 U.S.C. 1641), provides, among other things, that a person (an individual, corporation, association, or partnership) must hold a valid customs broker's license and permit in order to transact customs business on behalf of others, sets forth standards for the issuance of a broker's license and permit, and provides for disciplinary action against brokers that have engaged in specific infractions. This section also provides that an examination may be conducted to assess an applicant's qualifications for a license.
The regulations issued under the authority of section 641 are set forth in title 19 of the Code of Federal Regulations, part 111 (19 CFR part 111). Part 111 sets forth the regulations regarding, among other things, the licensing of, and granting of permits to, persons desiring to transact customs business as customs brokers. These regulations also include the qualifications required of applicants and the procedures for applying for licenses and permits, including examination procedures and requirements.
Currently, a customs broker's examination consists of a paper test booklet and a scannable answer sheet which is administered by the Office of Personnel Management (OPM). CBP supplements OPM's resources by providing CBP officials to proctor the examination and space to conduct the examination. There is a $200 fee to take the examination. This fee, which has not changed since 2000, currently does not cover the administrative costs of the paper-based examination as the costs of administering the examination have increased. At the same time that CBP is looking to update its fee to reflect the costs of administering the exam, OPM has informed CBP that it will no longer administer the paper-based examination and it is shifting all the examinations it administers to an electronic format.
On September 14, 2016, CBP published a document in the
Eight comments were received in response to the notice of proposed rulemaking.
The selection of an examination location depends on the information in the application. Applicants select their business port when they register for the customs broker's examination; CBP assigns the applicants to the exam locations closest to their selected port. With the examination location notification, CBP will provide the applicant with contingency plans for system failures, power outages, and other site-related breakdowns or emergencies. The examination sites themselves will offer ample room for hard copies of reference material, and the guidance on
The electronic examination itself will allow applicants to skip answers, to return to skipped or completed answers, and to change their answers during the examination period. After the broker's examination development team completes its testing of the electronic examination, CBP will provide a link to a sample practice examination so that applicants can familiarize themselves with the format and how to navigate within the examination. The guidance CBP will provide on
Accordingly, after review of the comments and further consideration, CBP has decided to adopt as final, with the changes discussed above, and grammatical corrections, the proposed rule published in the
Executive Orders 12866 (“Regulatory Planning and Review”) and 13563 (“Improving Regulation and Regulatory Review”) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”) directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”
The Office of Management and Budget (OMB) has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, OMB has not reviewed it. As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771.
Customs brokers are private individuals and/or business entities (partnerships, associations or corporations) that are regulated and empowered by CBP to assist importers and exporters in meeting federal requirements governing imports and exports. Customs brokers have an enormous responsibility to their clients and to CBP that requires them to properly prepare importation and exportation documentation, file these documents timely and accurately, classify and value goods properly, pay duties and fees, and safeguard their clients' information.
CBP currently licenses brokers who meet a certain set criteria. One criterion is that each prospective broker must first pass a broker license exam. CBP's current paper-based examination method will soon no longer be available and so CBP is shifting to an all-electronic exam. The all-electronic exam has benefits to both CBP and the trade, such as a faster processing time, which lets examinees know their results more quickly and efficiently, and a significant reduction in administrative duties for CBP employees. However, administering this new electronic exam is also more expensive. Additionally, the current $200 fee does not cover the costs of the current paper exam. CBP is therefore increasing the examination fee from $200 to $390 in order to fully cover all of CBP's costs of administering the broker examination.
CBP is also changing the date of the semi-annual customs broker exam from the first Monday in October and April to the fourth Wednesday in October and April for easier administration.
It is CBP's responsibility to ensure that only qualified individuals and business entities can perform customs business on another party's behalf. The first step in meeting the eligibility requirements for a customs broker license requires an individual to pass the customs broker license examination. Currently paper-based, the customs broker examination is an open-book examination consisting of 80 multiple-choice questions.
An individual currently must meet the following criteria in order to be eligible to take the customs broker examination:
• Be a U.S. citizen at least 18 years of age;
• Not be an employee of the U.S. federal government; and
• Pay a $200 examination fee.
The customs broker examination is offered semi-annually, in April and October, and an examinee has four and a half (4.5) hours to complete it. Based on prior year exams from 2004 to 2013, CBP estimates that there will be approximately 2,600 examinees per year, or 1,300 examinees per session. Currently the broker exam is given at 50 testing locations around the country. CBP anticipates that changing the exam format from paper-based to electronic would result in no change in the number of testing locations in the country; the only change would be the type of testing location. The exam is currently administered at hotels and ports throughout the country. In the future, the exam will instead be held at privately operated formal testing locations.
Beginning in October 2017, the current paper testing option will no longer be available and the broker examination will be fully electronic. Despite the higher costs of an electronic exam, it has many favorable features which would benefit both CBP and the examinees, including shorter wait times for examinees to get their test results and a reduction in the time CBP staff
As discussed above, CBP currently charges a $200 fee for the customs broker license examination. This fee is used to offset the costs associated with providing the services necessary to operate the customs broker license examination. Based on a recently completed fee study entitled, “Customs Broker License Examination Fee Study,” CBP has determined that these fees are no longer sufficient to cover its costs.
CBP has determined that the fee of $390 is necessary to recover the costs associated with administering the customs broker license examination once the exam is made electronic. The customs broker examination is an established service provided by CBP that already requires a fee payment. Absent this rule, CBP would be operating the exam at a loss and this fee is intended to offset that loss. As such, a change in the fee is not a net cost to society, but rather a transfer payment from test takers to the government.
As discussed above, CBP is increasing the customs broker license examination fee from $200 to $390. The broker exam fee was last changed in 2000 when it was reduced from $300 to the current fee of $200. The lower cost paper-based examination that is currently being administered is being replaced by an all-electronic exam in an effort to fully modernize the customs broker testing procedure. This fee increase will allow CBP to fully recover all of its costs, including those to provide a fully electronic version of the customs broker examination beginning in October 2017. As discussed above, the fee increase is neither a cost nor a benefit of this rule since the broker exam fee is already an established fee. Thus, the fee increase is considered a transfer payment. As stated above, in order to inform stakeholders of all potential effects of the final rule, CBP has analyzed the distributional effects of the final rule in section “5. Distributional Impact.”
In addition to increasing the examination fee, CBP is changing the date the examination is given from the first Monday in October and April to the fourth Wednesday in October and April. Administering the examination on the first Monday in October is administratively difficult because it is too close to the conclusion of the Federal Government's fiscal year at the end of September. With this rule's changes, CBP and the examinees will benefit through greater predictability in years where federal budgets are uncertain.
Under the final rule, the customs broker license examination fee will increase from $200 to $390 in order for CBP to fully recover all of its costs to administer the broker examination. As noted above, these costs are increasing due to a shift in the administration of the exam that will go into effect beginning with the October 2017 exam.
The customs broker license examination fee will cost individuals an additional $190 when they register to take the customs broker license examination. As discussed above, CBP estimates that there will be 2,600 examinees per year (1,300 per session) who will take the customs broker license examination. Using this estimate and the additional cost that each examinee will incur, CBP estimates that the fee increase will result in a transfer payment to the government of approximately $494,000 per year (2,600 examinees per year * $190 proposed fee increase = $494,000).
This section examines the impact of the rule on small entities as required by the Regulatory Flexibility Act (5 U.S.C. 601
The final rule will apply to all prospective brokers who take the broker exam. The fee is paid by the individual taking the broker exam and individuals are not considered small entities under the Regulatory Flexibility Act. However, some of these individuals are sole proprietors or may be reimbursed for this expense by their brokerage, so we consider the impact on these entities. The U.S. Census Bureau categorizes customs brokers (as well as freight forwarders and marine shipping agents) under the North American Industry Classification (NAICS) code 488510. As shown in Exhibit 1 below, approximately 96 percent of business entities in this NAICS code are small. As this rule will affect any prospective broker or his/her employer, regardless of its size, this rule has an impact on a substantial number of small entities.
The direct impact of this rule on each individual customs broker examinee, or his/her employer, is the fee increase of $190. To assess whether this is a significant impact, we examine the annual revenue for customs brokers. The U.S. Census Bureau categorizes customs brokers under the NAICS code 488510. In addition to customs brokers, this NAICS code also includes freight
This document is being issued in accordance with 19 CFR 0.2(a), which provides that the authority of the Secretary of the Treasury with respect to CBP regulations that are not related to customs revenue functions was transferred to the Secretary of Homeland Security pursuant to section 403(l) of the Homeland Security Act of 2002. Accordingly, this final rule to amend such regulations may be signed by the Secretary of Homeland Security (or his delegate).
Administrative practice and procedure, Brokers, Customs duties and inspection, Penalties, Reporting and recordkeeping requirements.
For the reasons given above, part 111 of title 19 of the Code of Federal Regulations (19 CFR part 111) is amended as set forth below:
19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States), 1624, 1641.
Section 111.3 also issued under 19 U.S.C. 1484, 1498;
Section 111.96 also issued under 19 U.S.C. 58c, 31 U.S.C. 9701.
The revisions read as follows:
(b)
(c)
(d)
(f)
Internal Revenue Service (IRS), Treasury.
Correcting amendment.
This document contains corrections to final and temporary regulations (TD 9808), which were published in the
Nancy Lee, (202) 317–6942 (not a toll-free number).
The final and temporary regulations that are the subject of these corrections are §§ 1.1441–0, 1.1441–1, 1.1441–1T, 1.1441–3, 1.1441–4, 1.6045–1, and 1.6049–5, promulgated under sections 1441, 6045, 6049, and 7805 of the Internal Revenue Code. These regulations affect persons making payments of U.S. source income to foreign persons and persons making payments to certain U.S. persons subject to reporting and backup withholding.
As published, the final regulations contain a number of items that need to be corrected or clarified. Several portions of TD 9808 could not be incorporated due to inaccurate amendatory instructions. Most of the correcting amendments to TD 9808 are needed to clarify or correct the results of these inaccurate amendatory instructions. The correcting amendments also include the addition, deletion, or modification of regulatory language to clarify the relevant provisions to meet their intended purposes, specifically to make a conforming change to the entry in the table of contents (§ 1.1441–0) for § 1.1441–1(e)(4)(ix); to correct typographical errors in §§ 1.1441–1(e)(4)(ix)(D), 1.1441–1T(c)(3)(ii), and 1.1441–3(d)(1); to clarify that allowances for electronic signatures in § 1.1441–1T(e)(4)(i)(B) and use of third party repository in § 1.1441–1T(e)(4)(iv)(E) are limited to Forms W–8; to remove an obsolete cross-reference
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments:
26 U.S.C. 7805 * * *
The addition and revisions read as follows:
(e) * * *
(4) * * *
(viii) * * *
(C) Reliance on a prior version of a withholding certificate.
(ix) Certificates to be furnished to withholding agent for each obligation unless exception applies.
(5) * * *
(v) * * *
(A) In general.
(f) Effective/applicability date.
(2) Lack of documentation for past years.
The addition and revisions read as follows:
(b) * * *
(7) * * *
(ii) * * *
(B) [Reserved]. For further guidance, see § 1.1441–1T(b)(7)(ii)(B).
(e) * * *
(3) * * *
(iv) * * *
(B)
(C)
(
(
(
(
(
(
(
(
(
(
(
(
This example illustrates the principles of paragraph (e)(3)(iv)(C) of this section. WA makes a withholdable payment of U.S. source dividends to NQI, a nonqualified intermediary. NQI provides WA with a valid intermediary withholding certificate under paragraph (e)(3)(iii) of this section that includes NQI's certification of its status for chapter 4 purposes as a participating FFI. NQI provides a withholding statement on which NQI allocates 20% of the payment to a chapter 4 withholding rate pool of recalcitrant account holders of NQI for purposes of chapter 4 and allocates 80% of the payment equally to A and B, individuals that are account holders of NQI. NQI also provides WA with valid beneficial owner withholding certificates from A and B establishing their status as foreign persons entitled to a 15% rate of withholding under an applicable income tax treaty. Because NQI has certified its status as a participating FFI, withholding under chapter 4 is not required with respect to NQI. See § 1.1471–2(a)(4). Based on the documentation NQI provided to WA with respect to A and B, WA can reliably associate
(4) * * *
(ii) * * *
(B) * * *
(
(ix) * * *
(D) * * * See § 1.1471–3(c)(9)(v) for a similar reliance rule that applies for purposes of chapter 4.
(5) * * *
(ii)
(A) A foreign financial institution that is a participating FFI (including a reporting Model 2 FFI), a registered deemed-compliant FFI (including a reporting Model 1 FFI), an FFI treated as a deemed-compliant FFI under an applicable IGA that is subject to due diligence and reporting requirements with respect to its U.S. accounts similar to those applicable to a registered deemed-compliant FFI under § 1.1471–5(f)(1), excluding a U.S. branch of any of the foregoing entities, or any other category of FFI identified in a qualified intermediary withholding agreement as eligible to act as a qualified intermediary;
(B) A foreign branch or office of a U.S. financial institution or a foreign branch or office of a U.S. clearing organization that is either a reporting Model 1 FFI or agrees to the reporting requirements applicable to a participating FFI with respect to its U.S. accounts;
(D) Any other person acceptable to the IRS.
(iii)
(B)
(iv)
(v)
(B)
(
(
(
(
(C)
(
(
(
(
The following example illustrates the application of paragraph (e)(5)(v)(C) of this section for a qualified intermediary providing chapter 4 withholding rate pools on an FFI withholding statement provided to a withholding agent. WA makes a payment of U.S. source interest that is a withholdable payment to QI, a qualified intermediary that is an FFI and a non-U.S. payor (as defined in § 1.6049–5(c)(5)), and A and B are account holders of QI (as defined under § 1.1471–5(a)) and are both U.S. non-exempt recipients (as defined in paragraph (c)(21) of this section). Ten percent of the payment is attributable to both A and B. A has provided WA with a Form W–9, but B has not provided WA with a Form W–9. QI assumes primary withholding responsibility under chapters 3 and 4 with respect to the payment, 80 percent of which is allocable to foreign payees who are account holders other than A and B. As a participating FFI, QI is required to report with respect to its U.S. accounts under § 1.1471–4(d) (as incorporated into its qualified intermediary agreement). Provided that QI reports A's account as a U.S. account under the requirements referenced in the preceding sentence, QI is not required to provide WA with a Form W–9 from A and may instead include A in a chapter 4 withholding rate pool of U.S. payees, allocating 10% of the payment to this pool. See § 1.6049–4(c)(4)(iii) concerning when reporting under section 6049 for a payment of interest is not required when an FFI that is a non-U.S. payor reports an account holder receiving the payment under its chapter 4 requirements. With respect to B, the interest payment is subject to backup withholding under section 3406. Because B is a recalcitrant account holder of QI for withholdable payments and because QI assumes primary chapter 4 withholding responsibility, however, QI may include the portion of the payment allocated to B with the remaining 80% of the payment for which QI assumes primary withholding responsibility. WA can reliably associate the full amount of the payment based on the withholding statement and does so regardless of whether WA knows B is a U.S. non-exempt recipient that is receiving a portion of the payment. See § 31.3406(g)–1(e) (providing exemption to backup withholding when withholding was applied under chapter 4).
(f)
(2)
(3)
(4) [Reserved]. For further guidance, see § 1.1441–1T(f)(4).
(a) through (b)(7)(ii)(A) [Reserved]. For further guidance, see § 1.1441–1(a) through (b)(7)(ii)(A).
(B)
(b)(7)(iii) through (c)(2)(i) [Reserved]. For further guidance, see § 1.1441–1(b)(7)(iii) through (c)(2)(i).
(ii)
(c)(3) through (c)(3)(i) [Reserved]. For further guidance, see § 1.1441–1(c)(3) through (c)(3)(i).
(ii)
(c)(4) through (c)(38)(i) [Reserved]. For further guidance, see § 1.1441–1(c)(4) through (c)(38)(i).
(ii)
(c)(39) through (e)(2)(ii)(A) [Reserved]. For further guidance, see § 1.1441–1(c)(39) through (e)(2)(ii)(A).
(B)
(e)(3) through (e)(3)(iv)(C)(
(
(
(
(
(
(e)(3)(iv)(C)(
(B)
(e)(4)(ii) through (e)(4)(ii)(A)(
(
(e)(4)(ii)(B) through (e)(4)(iv)(B)(
(C)
(D) [Reserved]. For further guidance, see § 1.1441–1(e)(4)(iv)(D).
(E)
A, a foreign corporation, completes a Form W–8BEN–E and a Form W–8ECI and uploads the forms to X, a third party repository (X is an entity that maintains withholding certificates on an electronic data aggregation site). WA, a withholding agent, enters into a contract with A under which it will make payments to A of U.S. source FDAP that are not effectively connected with A's conduct of a trade or business in the United States. X is not an agent of WA or A. Prior to receiving a payment, A sends WA an email with a link that authorizes WA to access A's Form W–8BEN–E on X's system. The link does not authorize WA to access A's Form W–8ECI. X's system meets the requirements of a third party repository, and WA can treat the Form W–8BEN–E as furnished by A.
The facts are the same as
FP is a foreign partnership that is acting on behalf of its partners, A and B, who are both foreign individuals. FP completes a Form W–8IMY and uploads it to X, a third party repository. FP also uploads Forms W–8BEN from both A and B and a valid withholding statement allocating 50% of the payment to A and 50% to B. WA is a withholding agent that makes payments to FP as an intermediary for A and B. FP sends WA an email with a link to its Form W–8IMY on X's system. The link also provides WA access to FP's withholding statement and A's and B's Forms W–8BEN. FP also has processes in place that ensure it will provide a new withholding statement or withholding certificate to X's repository in the event of a change in the information previously provided that affects the validity of the withholding statement and that ensure it will update WA if there is a new withholding statement. X's system meets the requirements of a third party repository, and WA can treat the Form W–8IMY (and withholding statement) as furnished by FP. In addition, because FP is acting as an agent of A and B, the beneficial owners, WA can treat the Forms W–8BEN for A and B as furnished by A and B.
(e)(4)(v) through (f)(3) [Reserved]. For further guidance, see § 1.1441–1(e)(4)(v) through (f)(3).
(4)
(g)
(m) * * *
(2) * * *
(ii)
(B) Notwithstanding paragraph (m)(2)(i) of this section, if the property referenced by an option (that is, the property underlying the option) is a debt instrument that is issued by a non-U.S. person or that provides for one or more payments denominated in, or determined by reference to, a currency other than the U.S. dollar, paragraph (m) of this section applies to the option if it is granted or acquired on or after January 1, 2016.
(n) * * *
(12) * * *
(ii)
(c) * * *
(1)
(A) An account maintained at an office or branch of a bank or other financial institution located outside the United States; or
(B) An obligation as defined in § 1.6049–4(f)(3) (other than an account described in paragraph (c)(1)(i)(A) of this section), contract, or other instrument with respect to which the payor is either engaged in business as a broker or dealer in securities or a financial institution (as defined in § 1.1471–5(e)) that engages in significant activities at an office or branch located outside the United States. For purposes of the preceding sentence, an office or branch of such payor shall be considered to engage in significant activities with respect to an obligation when it participates materially and actively in negotiating the obligation under the principles described in § 1.864–4(c)(5)(iii) (substituting the term “obligation” for the term “stock or security”).
(ii) A payor may rely on documentary evidence if the payor has established procedures to obtain, review, and maintain documentary evidence sufficient to establish the identity of the payee and the status of that person as a foreign person; and the payor obtains, reviews, and maintains such documentary evidence in accordance with those procedures. A payor maintains the documents reviewed for purposes of this paragraph (c)(1) by retaining an original, certified copy, or photocopy (including a microfiche, electronic scan, or similar means of electronic storage) of the documents reviewed for as long as it may be relevant to the determination of the payor's obligation to report under § 1.6049–4 and this section and noting in its records the date on which the document was received and reviewed. Documentary evidence furnished for a payment of an amount subject to withholding under chapter 3 of the Code or that is a chapter 4 reportable amount under § 1.1474–1(d)(2) must contain all of the information that is necessary to complete a Form 1042–S for that payment. See §§ 1.1471–3(c) and 1.1471–4(c) for additional documentation requirements to identify a payee or account holder for chapter 4 purposes that may apply in addition to the requirements under paragraph (c) of this section.
(iii) Even if an account or obligation (as defined in § 1.6049–4(f)(3)) is not maintained outside the United States (maintained in the United States), a payor may rely on documentary evidence associated with a withholding certificate described in § 1.1441–1(e)(3)(iii) with respect to the persons for whom an entity acting as an intermediary collects the payment. A payor may also rely on documentary evidence associated with a flow-through withholding certificate for payments treated as made to foreign partners of a nonwithholding foreign partnership, as defined in § 1.1441–1(c)(28), the foreign beneficiaries of a foreign simple trust, as defined in § 1.1441–1(c)(24), or foreign owners of a foreign grantor trust, as defined in § 1.1441–1(c)(26), even though the partnership or trust account is an obligation maintained in the United States.
(iv) For accounts opened on or after July 1, 2014, and before January 1, 2015, and for obligations entered into on or after July 1, 2014, and before January 1, 2015, a payor may continue to apply the rules of § 1.6049–5(c)(1) and (c)(4) as in effect and contained in 26 CFR part 1 revised April 1, 2013, rather than this paragraph (c)(1) and paragraph (c)(4) of this section. A payor that applies the rules of § 1.6049–5(c)(1) and (c)(4) as in effect and contained in 26 CFR part 1 revised April 1, 2013, to an account or obligation must also apply § 1.1441–6(c)(2) (to the extent applicable) and § 1.6049–5(e) both as in effect and contained in 26 CFR part 1 revised April, 2013, with respect to the account or obligation.
(2)
(3)
(4)
(i)
(ii)
(iii)
Internal Revenue Service (IRS), Treasury.
Correcting amendments.
This document contains corrections to final and temporary regulations (TD 9809) that were published in the
These corrections are effective June 30, 2017 and are applicable beginning January 6, 2017.
Kamela Nelan at (202) 317–6942 (not a toll-free number).
The final and temporary regulations (TD 9809) that are the subject of this correction are under sections 1471 through 1474 of the Internal Revenue Code.
As published, the final and temporary regulations (TD 9809) contain errors which may prove to be misleading and need to be clarified. Some portions of TD 9809 could not be incorporated due to inaccurate amendatory instructions. Several of the correcting amendments to TD 9809 are needed to clarify or correct the results of inaccurate amendatory instructions. These correcting amendments also include the addition, deletion, or modification of regulatory language to clarify the relevant provisions to meet their intended purposes or for consistency with other related provisions of these regulations. The addition of final regulatory language includes language that was inadvertently removed in a prior amendment to the final regulations.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments:
26 U.S.C. 7805 * * *
(b) * * *
(99) * * * An address that is provided subject to instructions to hold all mail to that address must be accompanied by certain documentary evidence described in § 1.1441–1(c)(38)(ii). * * *
(a) * * *
(2) * * *
(i) * * * Further, a withholding agent is not required to withhold on a payment that it can reliably associate with documentation indicating that the payee is a U.S. branch treated as a U.S. person (as defined in § 1.1471–1(b)(135)) or is a U.S. branch of an FFI that is not treated as a U.S. person but that applies the rules described in § 1.1471–4(d)(2)(iii)(C). * * *
(b) * * *
(3)
(d) * * *
(3) * * *
(ii) * * *
(E) Such other information as is otherwise required to be reported under this paragraph (d)(3) or in the form described in paragraph (d)(3)(v) of this section and its accompanying instructions.
(7)
(d) * * *
(2) * * *
(ii) * * *
(G)
(f) * * *
(1) * * *
(i) * * *
(F) * * *
(
(
(2) * * *
(iii) * * *
(C) Twenty or fewer individuals own all of the debt and equity interests in the FFI (disregarding debt interests owned by U.S. financial institutions, participating FFIs, registered deemed-compliant FFIs, and certified deemed-compliant FFIs and equity interests owned by an entity if that entity owns 100 percent of the equity interests in the FFI and is itself a sponsored FFI under this paragraph (f)(2)(iii)).
The revisions and addition read as follows:
(d) * * *
(4) * * *
(i) * * *
(C) * * *
(
(
(ii) * * *
(C)
(iii)
(B)
Internal Revenue Service (IRS), Treasury.
Final regulations and removal of temporary regulations.
This document contains final regulations that allow the Commissioner of Internal Revenue to adopt a streamlined application process that eligible organizations may use to apply for recognition of tax-exempt status under section 501(c)(3) of the Internal Revenue Code (Code). The final regulations affect organizations seeking recognition of tax-exempt status under section 501(c)(3).
Peter A. Holiat at (202) 317–5800 (not a toll-free number).
Since 1969, section 508 of the Code has required an organization seeking tax-exempt status under section 501(c)(3), as a condition of its
On July 2, 2014, final and temporary regulations (TD 9674) authorizing the Commissioner to adopt a streamlined application process that eligible organizations may use to apply for recognition of tax-exempt status under section 501(c)(3) were published in the
Also on July 2, 2014, a notice of proposed rulemaking (REG–110948–14) cross-referencing the temporary regulations and soliciting public comments and requests for a hearing was published in the
The Treasury Department and the IRS have considered how the process of meeting the notice requirement of section 508 in seeking recognition of tax-exempt status may be made more efficient for certain smaller organizations. The IRS developed Form 1023–EZ to provide a simplified application form that relies more heavily on attestations by the organization that it meets the section 501(c)(3) organizational and operational requirements, which are explained in the accompanying form instructions. The new form was made available for use by eligible small organizations in July 2014, following the issuance of the temporary regulations and a revenue procedure describing the streamlined application process. The streamlined application process generally allows eligible small organizations to receive IRS determinations of tax-exempt status more quickly and allows the IRS to focus resources on more complex exemption applications and on compliance programs. This Treasury decision adopts the 2014 proposed regulations by amending §§ 1.501(a)–1, 1.501(c)(3)–1, and 1.508–1 to authorize the continued use of the IRS' streamlined process by eligible organizations to meet the notice requirements of section 508.
Specifically, this Treasury decision amends §§ 1.501(a)–1 and 1.501(c)(3)–1, as in effect before July 2, 2014, to authorize the Treasury Department and the IRS to modify, by applicable regulations or other guidance published in the Internal Revenue Bulletin, the requirement that an organization applying for section 501(c)(3) tax-exempt status provide a detailed statement of its proposed activities. This document also amends the § 1.501(a)–1 provisions relating to the Commissioner's ability to revoke a determination because of a change in the law or regulations, or for other good cause, to reference the Commissioner's authority to retroactively revoke a determination under section 7805(b). No substantive change is intended by this amendment. This Treasury decision also amends the requirement in § 1.501(a)–1(b)(3) that an organization claiming to be exempted from filing annual returns file a statement supporting its claim with and as a part of its application. As amended, § 1.501(a)–1(b)(3) allows an organization to file the statement either in its application, or in a manner prescribed in guidance published in the Internal Revenue Bulletin.
In addition, this document amends § 1.508–1 to provide that eligible organizations may use Form 1023–EZ to notify the Commissioner of their applications for tax-exempt status under section 501(c)(3). This Treasury decision also amends §§ 1.501(a)–1 and 1.508–1 to state that the office to which applications should be submitted will be published in the Internal Revenue Bulletin or instructions to the Form 1023 or Form 1023–EZ.
Finally, this Treasury decision incorporates minor revisions within the portions of §§ 1.501(a)–1, 1.501(c)(3)–1, and 1.508–1 that are otherwise being amended. In § 1.501(a)–1(a)(2), the reference to “internal revenue district” is removed because such reference has been made obsolete by the enactment of the Internal Revenue Service Restructuring and Reform Act of 1998, Public Law 105–206, 112 Stat. 685. References to a district director in §§ 1.501(a)–1, 1.501(c)(3)–1, and 1.508–1 are also modified as appropriate, as those positions no longer exist within the IRS. Similarly, references to obsolete due dates for filing notices described in section 508 and related transition relief provisions that are no longer relevant have been removed from §§ 1.508–1(a)(2)(i) and (b)(2)(iv). In addition, § 1.508–1(b)(2)(v) has been revised to remove a reference to the instructions for Form 4653, which is no longer in use.
The temporary regulations have applied since July 1, 2014, and this Treasury decision adopts the proposed regulations that cross-referenced the text of those temporary regulations without substantive change. Thus, the final regulations apply on and after July 1, 2014.
Rev. Proc. 2017–5 is published in the Internal Revenue Bulletin and is available from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402, or by visiting the IRS Web site at
Certain IRS regulations, including these, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. It is hereby certified that this rule will not have a significant economic impact on a substantial number of small entities. Although this rule may affect a substantial number of eligible small entities that choose to use Form 1023–EZ to apply for recognition of tax-exempt status under section 501(c)(3), the Form 1023–EZ streamlines the application process, thereby reducing the economic impact on these entities. This rule merely permits use of the streamlined form of application available to satisfy the notice requirements under section 508(a). Therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to section 7805(f), the temporary and proposed regulations preceding these final regulations were submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business and no comments were received.
The principal author of these regulations is Peter A. Holiat of the Office of Associate Chief Counsel (Tax Exempt and Government Entities). However, other personnel from the Treasury Department and the IRS participated in their development.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is amended as follows:
26 U.S.C. 7805 * * *
(a) * * *
(2) An organization, other than an employees' trust described in section 401(a), is not exempt from tax merely because it is not organized and operated for profit. In order to establish its exemption, it is necessary that every such organization claiming exemption file an application form as set forth below with the appropriate office as designated by the Commissioner in guidance published in the Internal Revenue Bulletin, forms, or instructions to the applicable forms. Subject only to the Commissioner's inherent power to revoke rulings, including with retroactive effect as permitted under section 7805(b), because of a change in the law or regulations or for other good cause, an organization that has been determined by the Commissioner (or previously by a district director) to be exempt under section 501(a) or the corresponding provision of prior law may rely upon such determination so long as there are no substantial changes in the organization's character, purposes, or methods of operation. An organization that has been determined to be exempt under the provisions of the Internal Revenue Code of 1939 or prior law is not required to secure a new determination of exemption merely because of the enactment of the Internal Revenue Code of 1954 unless affected by substantive changes in law made by such Code.
(b)
(i) Mutual insurance companies shall submit copies of the policies or certificates of membership issued by them.
(ii) In the case of title holding companies described in section 501(c)(2), if the organization for which title is held has not been specifically notified in writing by the Internal Revenue Service that it is held to be exempt under section 501(a), the title holding company shall submit the information indicated herein as necessary for a determination of the status of the organization for which title is held.
(iii) An organization described in section 501(c)(3) shall submit with, and as a part of, an application filed after July 26, 1959, a detailed statement of its proposed activities.
(3) An organization claiming to be specifically exempted by section 6033(a) from filing annual returns shall submit with and as a part of its application (or in such other manner as is prescribed in guidance published in the Internal Revenue Bulletin) a statement of all the facts on which it bases its claim.
(f)
(b) * * *
(1) * * *
(v) Unless otherwise prescribed by applicable regulations or other guidance published in the Internal Revenue Bulletin, an organization must, in order to establish its exemption, submit a detailed statement of its proposed activities with and as a part of its application for exemption (see § 1.501(a)–1(b)).
(6)
(h)
(a) * * *
(2)
(ii) Although the information required by either Form 1023 or Form 1023–EZ must be submitted to satisfy the notice required by this section, the failure to supply, within the required time, all of the information required to complete such form is not alone sufficient to deny exemption from the date of organization to the date such complete information for such form is submitted by the organization. If the information that is submitted within the required time is incomplete, and the organization supplies the necessary additional information requested by the Commissioner within the additional time period allowed, the original notice will be considered timely.
(b) * * *
(2) * * *
(iv) Any organization filing notice under this paragraph (b)(2)(iv) shall file its notice by submitting a properly completed and executed Form 1023 (or, if applicable, Form 1023–EZ) and providing information that it is not a private foundation. The organization shall also submit all information required by the regulations under section 170 or 509 (whichever is applicable) necessary to establish recognition of its classification as an organization described in section 509(a)(1), (2), (3), or (4). The notice required by this paragraph (b)(2)(iv) should be filed with the appropriate office as designated by the Commissioner in guidance published in the Internal Revenue Bulletin, forms, or instructions to the applicable forms.
(v) An extension of time for the filing of a notice under this paragraph (b)(2) may be granted by the office with which the notice is filed upon timely request by the organization, if the organization demonstrates that additional time is required.
(c)
Internal Revenue Service (IRS), Treasury.
Final and temporary regulations; correction.
This document contains a correction to final and temporary regulations (TD 9809) that were published in the
This correction is effective June 30, 2017 and is applicable beginning January 6, 2017.
Kamela Nelan at (202) 317–6942 (not a toll-free number).
The final and temporary regulations (TD 9809) that are subject of this correction are under sections 1471 through 1474 of the Internal Revenue Code.
As published, the final and temporary regulations (TD 9809) contain an error that proves to be misleading and is in need of clarification.
Accordingly, the final and temporary regulations (TD 9809) that are the subject of FR Doc. 2016–31601 are corrected as follows:
26 U.S.C. 7805 * * *.”
Office of Justice Programs.
Final rule; correcting amendments.
The Office of Juvenile Justice and Delinquency Prevention (“OJJDP”) of the Office of Justice Programs (“OJP”) published in the
Gregory Thompson, Senior Advisor, Office of Juvenile Justice and Delinquency Prevention, at 202–307–5911.
The OJJDP Formula Grant Program is authorized by the Juvenile Justice and Delinquency Prevention Act (“JJDPA”), which authorizes OJJDP to provide an annual grant to each State to improve its juvenile justice system and to support juvenile delinquency prevention programs. The partial Final Rule that OJJDP published on January 17, and which took effect on March 21, 2017, amends the implementing regulations for the Formula Grant Program found at 28 CFR part 31. In particular, § 31.303(f)(5) amends States' reporting requirements in several aspects. This technical correction simply corrects inaccurate references to sections of the Act cited in the partial Final Rule.
This technical correction has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review,” section 1(b), The Principles of Regulation, and Executive Order 13563, “Improving Regulation and Regulatory Review,” section 1, General Principles of Regulation. This technical correction is limited to amending the citations to sections of the Act and, therefore, is not a “regulation” or “rule” as defined by that Executive Order.
This technical correction to the partial Final Rule will not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, “Federalism,” OJP has determined that this technical correction does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.
This technical correction to the partial Final Rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, “Civil Justice Reform.”
This technical correction simply corrects citations to sections of the Act in the partial Final Rule published on January 17, 2017 and, accordingly, OJP finds it unnecessary to publish this technical correction for public notice and comment.
OJP, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), has reviewed this technical correction and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities because it simply makes a technical correction to the partial Final Rule published on January 17, 2017. Further, a Regulatory Flexibility analysis is not required for this technical correction because OJP was not required to publish a general notice of proposed rulemaking for this matter.
This technical correction is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 804. This technical correction will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.
This technical correction was not preceded by a published notice of proposed rulemaking; will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year; will not significantly or uniquely affect small governments; and does not contain significant intergovernmental mandates. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531–1535.
This technical correction does not impose any new reporting or recordkeeping requirements under the Paperwork Reduction Act, 44 U.S.C. 3501–3521.
Authority and Issuance.
42 U.S.C. 5611(b); 42 U.S.C. 5631–5633.
Coast Guard, DHS.
Final rule.
The Coast Guard will establish a permanent special local regulation on Lake Superior within Chequamegon Bay for the annual Washburn Board Across the Bay racing event. This annual event historically occurs within the last 2 weeks of July and lasts for 1 day. This action is necessary to safeguard the participants and spectators on the water in a portion of Chequamegon Bay between Washburn, WI and Ashland, WI. This regulation would functionally restrict all vessel speeds while within a designated no-wake zone, unless otherwise specifically authorized by the Captain of the Port (COTP) Duluth or a designated representative. The area forming the subject of this permanent special local regulation is described below.
This rule is effective July 31, 2017.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this rulemaking, call or email Lieutenant Junior Grade John Mack, Waterways management, MSU Duluth, Coast Guard; telephone 218–725–3818, email
COTP Captain of the Port, Duluth
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
§ Section
U.S.C. United States Code
On March 30, 2017 the Coast Guard published an NPRM in the
As noted above, we received no comments on our NPRM published on March 30, 2017. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM. This rule will create a permanent special local regulation in Chequamegon Bay for the annual Washburn Board Across the Bay racing event that historically takes place in the third or fourth week of July. The no-wake zone will be enforced on all vessels entering into 100 yards of either side of an imaginary line beginning in Washburn, WI at position 46°36′52″ N., 090°54′24″ W.; thence southwest to position 46°38′44″ N., 090°54′50″ W.; thence southeast to position 46°37′02″ N., 090°50′20″ W.; and ending southwest at position 46°36′12″ N., 090°51′51″ W. All vessels transiting through the no-wake zone will be required to travel at an appropriate rate of speed that does not create a wake except as may be permitted by the COTP or a designated representative. The precise times and date of enforcement for this special local regulation will be determined annually.
The COTP, Duluth, will use all appropriate means to notify the public when the special local regulation in this rule will be enforced. Such means may include publication in the
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders and we discuss First Amendment rights of protestors.
E.O.s 12866 (“Regulatory Planning and Review”) and 13563 (“Improving Regulation and Regulatory Review”) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health and safety effects, distributive impacts, and equity. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”), directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”
The Office of Management and Budget (OMB) has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget (OMB) has not reviewed it.
As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).
This regulatory action determination is based on the size, location, duration, and time-of-year of the Special Local Regulation. Vessel traffic will be able to safely transit through the no-wake zone which will be 200 yards wide and will impact only a small designated area of Lake Superior in Chequamegon Bay between Washburn, WI and Ashland, WI during a time of year when commercial vessel traffic is normally low. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF–FM marine channel 16.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601–612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and
While some owners or operators of vessels intending to transit through the no-wake zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule will have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531–1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023–01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321–4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a no-wake zone being enforced for no more than 5 hours along a prescribed route between Washburn & Ashland, Wisconsin. Normally such actions are categorically excluded from further review under paragraph 34(h) of Figure 2–1 of Commandant Instruction M16475.lD. A preliminary Record of Environmental Consideration and Categorical Exclusion Determination are available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:
33 U.S.C. 1233
(a)
(b)
(c)
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Northern Santa Fe Railroad Company (BNSF) Railroad Swing Span Drawbridge 12A across Swinomish Channel, mile 8.4,
This deviation is effective from 7 a.m. on July 1, 2017 to 6 p.m. on November 30, 2017.
The docket for this deviation, [USCG–2017–0470] is available at
If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206–220–7282, email
BNSF (bridge owner) has requested the BNSF Railroad Swing Span Drawbridge 12 be allowed to close the span, and need not open to marine traffic to facilitate fender replacements. The BNSF Railroad Swing Span Drawbridge 12A crosses the Swinomish channel, mile 8.4, near Whitmarsh, WA. The swing span provides 8 feet of vertical clearance in the closed-to-navigation position, and 100 feet of horizontal clearance in the open-to-navigation position. The span provides unlimited vertical clearance in the open-to-navigation position. Vertical and horizontal clearances are referenced to mean high-water elevation.
The closures of the BNSF Railroad Swing Span Drawbridge for the fender replacements will depend on the tidal status of the river, which means that work (and closure), will occur on different times on different days. The specific times of the bridge closures will be published in the weekly Coast Guard Local Notice to Mariners. BNSF work requires the swing span to be in the closed-to-navigation position when the ebb tide height reaches plus three feet above Mean Tide Level, and open the span when the flood tide height reaches plus three feet above Mean Tide Level. The deviation period allows the subject bridge to be in the closed-to-navigation position from 6 a.m. on July 1, 2017 to 6 p.m. on November 30, 2017, when the river is a plus three foot ebb tide, and open the bridge span on a plus three foot flood tide Monday through Saturday. However, if the project gets delayed, work on Sundays will be required.
The swing span at various times will only be able to open to 97 percent. This reduces the horizontal navigation clearance by five feet—from 100 feet to 95 feet. The five feet of horizontal clearance is needed to position work barges at various locations to replace fenders.
During the dates and times of the deviation, the drawbridge will not be able to operate according to the normal operating schedule. This drawbridge normally operates in accordance with 33 CFR 117.5. The subject bridge is normally maintained in the open-to-navigation position. The bridge shall operate in accordance to 33 CFR 117.5 at all other times. Waterway usage on the Swinomish Channel includes commercial tugs and barges, U.S. Coast Guard vessels, and large to small pleasure craft. The Coast Guard provided notice of this deviation to local mariners via the Local Notice Mariners and emails. One objection was submitted to the Coast Guard, and requested bridge closure times be posted in the Local Notice to Mariners. As stated herein, specific times will be published in the weekly Local Notice to Mariners.
Vessels will not be able to pass through the swing span via the marked navigation channel during the closure times. Working barges will be positioned in the channel at the bridge during the closed-to-navigation periods preventing safe passage. An alternate route is via the southern Swinomish Channel using Skagit Bay. The bridge will not be able to open for vessels responding to emergencies during the stated closure times. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the SR 175 Bridge that carries the SR 175 across the Lewis Creek Channel, mile 0.0, at Chincoteague, VA. The deviation is necessary to facilitate the Annual Pony Run. This deviation allows the bridge to remain in the closed-to-navigation position.
The deviation is effective from 7 a.m. on Wednesday July 26, 2017, through 5 p.m. on Thursday July 27, 2017.
The docket for this deviation, [USCG–2017–0365] is available at
If you have questions on this temporary deviation, call or email Mr. Michael Thorogood, Bridge Administration Branch Fifth District, Coast Guard, telephone 757–398–6557, email
The Virginia Department of Transportation, owner and operator of the SR 175 Bridge that carries the SR 175 Bridge across the Lewis Creek Channel, mile 0.0, at Chincoteague, VA, has requested a temporary deviation from the current operating regulations to ensure the safety of the increased volumes of spectators that will be attending Annual Pony Run on Wednesday July 26, 2017, and Thursday July 27, 2017. This bridge is a bascule span drawbridge with a vertical clearance of 15 feet above mean high water in the closed position and unlimited vertical clearance in the open position. The current operating regulation is set out in 33 CFR 117.5. Under this temporary deviation, the bridge will be maintained in the closed-to-navigation position from 7 a.m. to 5 p.m. on Wednesday July 26, 2017 and Thursday July 27, 2017.
The Lewis Creek Channel is used by recreational vessels. The Coast Guard has carefully considered the nature and volume of vessel traffic on the waterway in publishing this temporary deviation.
Vessels able to pass through the bridge in the closed-to-navigation position may do so at any time. The bridge will be able to open for emergencies and there is no immediate alternative route for vessels unable to pass through the bridge in the closed position. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce five safety zones for annual firework displays in the Captain of the Port, Puget Sound Zone during the dates and times noted under
The regulations in 33 CFR 165.1332 will be enforced for the five safety zones listed under
If you have questions about this notice of enforcement, call or email Petty Officer Zachary Spence, Sector Puget Sound Waterways Management, Coast Guard; telephone 206–217–6051,
The Coast Guard will enforce regulations for the following five safety zones established for Annual Fireworks Displays within the Captain of the Port, Puget Sound Area of Responsibility in 33 CFR 165.1332 during the dates and times noted in the table below.
The following safety zones will be enforced from 5 p.m. on July 4, 2017, through 1 a.m. on July 5, 2017:
The special requirements listed in 33 CFR 165.1332(b) apply to the activation and enforcement of these safety zones. All vessel operators who desire to enter the safety zone must obtain permission from the Captain of the Port or their Designated Representative by contacting the Coast Guard Sector Puget Sound Joint Harbor Operations Center (JHOC) on VHF Ch 13 or Ch 16 or via telephone at (206) 217–6002.
The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.
This notice of enforcement is issued under authority of 33 CFR 165.1332 and 5 U.S.C. 552(a). In addition to the publication of this document in the
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the annual City of Richmond Fourth of July Fireworks Display in the Captain of the Port, San Francisco area of responsibility during the dates and times noted below. This action is necessary to protect life and property of the maritime public from the hazards associated with the fireworks display. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM).
The regulations in 33 CFR 165.1191, Table 1, Item number 9, will be enforced from 8 a.m. on July 1, 2017 to 10 p.m. on July 3, 2017.
If you have questions on this notice, call or email Lieutenant Junior Grade Christina Ramirez, U.S. Coast Guard Sector San Francisco; telephone (415) 399–2001 or email at
The Coast Guard will enforce a 100 foot safety zone around the fireworks barge during the loading, transit, and arrival of the fireworks barge from the loading location to the display location and until the start of the fireworks display. From 8 a.m. on July 1, 2017 until 5 p.m. on July 3, 2017, the fireworks barge will be loading pyrotechnics from Pier 50 in San Francisco, CA. The fireworks barge will remain at the loading location until its transit to the display location. From 6 p.m. to 8:30 p.m. on July 3, 2017, the loaded fireworks barge will transit from Pier 50 to the launch site in Richmond Marina in approximate position 37°54′40″ N., 122°21′05″ W. (NAD 83) where it will remain until the conclusion of the fireworks display. Upon the commencement of the 20-minute fireworks display, scheduled to begin at 9:30 p.m. on July 3, 2017, the safety zone will increase in size and encompass the navigable waters around and under the fireworks barge within a radius 560 feet in Richmond Marina in approximate position 37°54′40″ N., 122°21′05″ W. (NAD 83) for the Fourth of July Fireworks, City of Richmond in 33 CFR 165.1191, Table 1, Item number 9. This safety zone will be in effect from 8 a.m. on July 1, 2017 until 10 p.m. on July 3, 2017.
Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone during all applicable effective dates and times, unless authorized to do so by the PATCOM. Additionally, each person who receives notice of a lawful order or direction issued by an official patrol vessel shall obey the order or direction. The PATCOM is empowered to forbid entry into and control the regulated area. The PATCOM shall be designated by the Commander, Coast Guard Sector San Francisco. The PATCOM may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so. This notice is issued under authority of 33 CFR 165.1191 and 5 U.S.C. 552(a). In addition to this notice in the
If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce a safety zone regulation for an annual fireworks event on the Delaware River, Philadelphia, PA from 9:30 p.m. to 11:30 p.m. on June 30, 2017 and July 1, 2017. Enforcement of this safety zone is necessary and intended to ensure safety of life on navigable waters immediately prior to, during, and immediately after these fireworks events. During the enforcement periods, no vessel may transit this regulated area without approval from the Captain of the Port or a designated representative.
The regulations in 33 CFR 165.506 will be enforced from 9:30 p.m. to 11:30 p.m. on June 30, 2017 and July 1, 2017, for the safety zone listed in the Table to § 165.506, line (a.)(16).
If you have questions about this notice of enforcement, you may call or email MST2 Amanda Boone, Sector Delaware Bay Waterways Management Division, U.S. Coast Guard; telephone 215–271–4889, email
From 9:30 p.m. to 11:30 p.m. on June 30, 2017 and July 1, 2017, the Coast Guard will enforce the safety zone regulation listed in the Table to 33 CFR 165.506 (a.)(16) that takes place on the Delaware River, Philadelphia, PA. This action is being taken to enhance the safety of life on navigable waterways during the fireworks display.
Coast Guard regulations for recurring firework events in Captain of the Port Delaware Bay Zone, are published in § 165.506, Safety Zones; Fireworks Displays within the Fifth Coast Guard District, which specifies the location of the regulated area for this safety zone as all waters of Delaware River, adjacent to Penns Landing, Philadelphia, PA, bounded from shoreline to shoreline, bounded on the south by a line running east to west from points along the shoreline at latitude 39°56′31.2″ N., longitude 075°08′28.1″ W.; thence west to latitude 39°56′29.1″ N., longitude 075°07′56.5″ W., and bounded on the north where the Benjamin Franklin Bridge crosses the Delaware River.
As specified in § 165.506, during the enforcement period, no vessel or person may enter, transit through, anchor in, or remain within the regulated area unless authorized by the Captain of the Port Delaware Bay or a designated representative. If permission is granted, all persons and vessels shall comply with the instructions of the COTP, designated representative or Patrol Commander.
This notice of enforcement is issued under authority of 33 CFR 165.506 and 33 U.S.C. 1233. The Coast Guard will provide the maritime community with advanced notice of enforcement of regulation by Broadcast Notice to Mariners (BNM), Local Notice to Mariners and on-scene actual notice by designated representative. In the event Captain of the Port Delaware Bay determines that it's not necessary to enforce the regulated area for the entire duration of the enforcement period, a BNM will be issued to authorize general permission to enter the regulated area.
Coast Guard, DHS.
Notice of enforcement of regulations.
The Coast Guard will enforce several recurring safety zones on navigable waterways within Sector Ohio Valley. This regulatory action is necessary to provide for the safety of life and protection of vessels from the hazards associated with fireworks displays, festivals, and events. During the enforcement period, entry into these safety zones is prohibited unless
The regulations in 33 CFR 165.801, Table 1, will be enforced for the safety zones within Sector Ohio Valley as identified in
If you have questions about this notice of enforcement, call or email Petty Officer James Robinson, Sector Ohio Valley, U.S. Coast Guard; telephone 502–779–5347, email
The Coast Guard will enforce the safety zones in 33 CFR 165.801, Table 1, lines 13, 17, 19, 21, 22, 23, 24, 25, 26, 27, 29, 50, and 69 as follows:
Line 13, Riverview Park Independence Festival, from 9:30 p.m. through 11 p.m. on July 1, 2017; Line 17, Louisville Bats Firework Show, from 9 p.m. through 11 p.m. on July 4, 2017; Line 19, All American 4th of July, from 9 p.m. through 10 p.m. on July 4, 2017; Line 21, Spirit of Freedom Fireworks, from 9 p.m. through 9:30 p.m. on July 4, 2017; Line 22, Lighting up the Cumberlands Fireworks, from 9 p.m. through 9:30 p.m. on July 1, 2017; Line 23, Knoxville July 4th Fireworks, from 9:40 p.m. through 10:10 p.m. on July 4, 2017; Line 24, Music City July 4th, from 9 p.m. through 9:30 p.m. on July 4, 2017; Line 25, Grand Harbor Marina July 4th Celebration, from 10 p.m. through 10:20 p.m. on July 1, 2017; Line 26, City of Bellevue, KY/Bellevue Beach Park Concert Fireworks, from 9 p.m. through 11 p.m. on July 08, 2017; Line 27, Cincinnati Bell, WEBN, and Proctor Riverfest, from 12 p.m. to 10 p.m. on September 3, 2017; Line 29, City of Point Pleasant/Point Pleasant Sternwheel Fireworks, from 9:30 p.m. through 10 p.m. on July 1, 2017; Line 50, Evansville Freedom Celebration, from 9:45 p.m. through 10:15 p.m. on July 4, 2017; and Line 69, Newburgh Fireworks Display, from 9:45 p.m. through 10:10 p.m. on July 1, 2017. The regulations for the Coast Guard Sector Ohio Valley Annual and Recurring Safety Zones, § 165.801, Table 1, specifies the locations of these safety zones. As specified in § 165.23, during the enforcement period, no vessel may transit these safety zones without approval from the Captain of the Port Ohio Valley (COTP) or a designated representative. Sector Ohio Valley may be contacted on VHF–FM radio channel 16 or phone at 1–800–253–7465.
This notice of enforcement is issued under authority of 33 CFR 165.801 and 5 U.S.C. 552(a). In addition to this notice in the
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the City of Pittsburg Fourth of July Fireworks display, in the Captain of the Port, San Francisco area of responsibility during the dates and times noted below. This action is necessary to protect life and property of the maritime public from the hazards associated with the fireworks display. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM).
The regulations in 33 CFR 165.1191, Table 1, Item number 13 will be enforced from 9:30 p.m. to 10 p.m. on July 4, 2017.
If you have questions on this notice of enforcement, call or email Lieutenant Junior Grade Christina Ramirez, U.S. Coast Guard Sector San Francisco; telephone (415) 399–2001 or email at
The Coast Guard will enforce the safety zone established in 33 CFR 165.1191, Table 1, Item number 13 on July 4, 2017. Upon commencement of the 20 minute fireworks display, scheduled to begin at 9:30 p.m. on July 4, 2017, the safety zone will encompass the navigable waters surrounding the land based launch site on the Pittsburg Marina Pier in approximate position 38°02′32″ N., 121°53′19″ W. (NAD 83). Upon the conclusion of the fireworks display the safety zone shall terminate. This safety zone will be in effect from 9:30 p.m. to 10 p.m. on July 4, 2017.
Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone during all applicable effective dates and times, unless authorized to do so by the PATCOM. Additionally, each person who receives notice of a lawful order or direction issued by an official patrol vessel shall obey the order or direction. The PATCOM is empowered to forbid entry into and control the regulated area. The PATCOM shall be designated by the Commander, Coast Guard Sector San Francisco. The PATCOM may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so.
This notice of enforcement is issued under authority of 33 CFR 165.1191 and 5 U.S.C. 552(a). In addition to this notification in the
If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notification, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the annual Execpro Services Fourth of July Fireworks Display in the Captain of the Port, San Francisco area of responsibility during the dates and times noted below. This action is necessary to protect life and property of the maritime public from the
The regulations in 33 CFR 165.1191, Table 1, Item number 28, will be enforced from 6 a.m. on July 1, 2017 to 10:30 p.m. on July 3, 2017.
If you have questions on this notice of enforcement, call or email Lieutenant Junior Grade Christina Ramirez, U.S. Coast Guard Sector San Francisco; telephone (415) 399–2001 or email at
The Coast Guard will enforce a 100 foot safety zone around the fireworks barge during the loading, transit, and arrival of the fireworks barge from the loading location to the display location and until the start of the fireworks display. From 6 a.m. on July 1, 2017 until 8 a.m. on July 1, 2017, the fireworks barge will be loading pyrotechnics Obexers Marina in Homewood, CA. The fireworks barge will remain at the loading location until its transit to the display location. From approximately 8 a.m. to 10 a.m. on July 1, 2017, the loaded fireworks barge will transit from Obexers Marina to the launch site off-shore from Incline Village, NV in approximate position 39°13′54″ N., 119°56′25″ W. (NAD 83) where it will remain until the conclusion of the fireworks display. Upon the commencement of the 24-minute fireworks display, scheduled to begin at 9:30 p.m. on July 3, 2017, the safety zone will increase in size and encompass the navigable waters around and under the fireworks barge within a radius 1,000 feet, off-shore from Incline Village, NV, in approximate position 39°13′54″ N., 119°56′25″ W. (NAD 83) for the Execpro Services Fourth of July Fireworks in 33 CFR 165.1191, Table 1, Item number 28. This safety zone will be in effect from 6 a.m. on July 1, 2017 until 10:30 p.m. on July 3, 2017.
Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone during all applicable effective dates and times, unless authorized to do so by the PATCOM.
Additionally, each person who receives notice of a lawful order or direction issued by an official patrol vessel shall obey the order or direction. The PATCOM is empowered to forbid entry into and control the regulated area. The PATCOM shall be designated by the Commander, Coast Guard Sector San Francisco. The PATCOM may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so.
This notice of enforcement is issued under authority of 33 CFR 165.1191 and 5 U.S.C. 552 (a). In addition to this notification in the
If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone in support of the environmental and salvage response operation to the sunken barge Vengeance in the San Francisco Bay, east of Yerba Buena Island and north of the Oakland Outer Harbor Entrance Channel near Oakland, CA. All vessel traffic is prohibited from transiting the area to allow safe response operations to be conducted. All vessels are prohibited from entering into, transiting through, or remaining in the safety zone without permission of the Captain of the Port or their designated representative.
This rule is effective without actual notice from June 30, 2017 until July 31, 2017. For the purposes of enforcement, actual notice will be used from June 1, 2017 until June 30, 2017.
Documents mentioned in this preamble are part of docket USCG–2017–0310. To view these documents go to
If you have questions on this rule, call or email Lieutenant Marcia Medina, U.S. Coast Guard Sector San Francisco; telephone (415) 399–7443 or email at
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.”
We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM. Publishing an NPRM would be impractical due to the emergent nature of the environmental and salvage response to be conducted on the barge Vengeance.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The legal basis for the proposed rule is 33 U.S.C 1231; 50 U.S.C. 191; 33 CFR 1.05–1, 6.04–1, 6.04–6, 160.5; Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish safety zones.
The sunken barge Vengeance creates a significant underwater hazard to navigation to vessels transiting the San Francisco Bay. The response operations are complex in nature and involve
The Coast Guard or a designated representative will enforce a safety zone in navigable waters of the San Francisco Bay, east of Yerba Buena Island and north of Oakland Outer Harbor Entrance Channel within the following points: 37°48.549′ N. 122°20.891′ W., 37°48.498′ N. 122°21.134′ W., 37°48.346′ N. 122°21.068′ W., and 37°48.461′ N. 122°20.782′ W. (NAD 83).
This safety zone is effective from June 1, 2017 through on July 31, 2017 or as announced via Broadcast Notice to Mariners.
The effect of the temporary safety zone will be to restrict navigation in the vicinity of the sunken barge Vengeance until the environmental and salvage response operations are complete. Except for persons or vessels authorized by the Captain of the Port or a designated representative, no vessel may enter or remain in the restricted area. These regulations are needed to keep vessels safely outside of the response zone until environmental and salvage response operations are complete.
We developed this rule after considering numerous statutes and Executive order related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
E.O.s 12866 (“Regulatory Planning and Review”) and 13563 (“Improving Regulation and Regulatory Review”) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health and safety effects, distributive impacts, and equity. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”), directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”
The Office of Management and Budget (OMB) has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget (OMB) has not reviewed it.
As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).
We expect the economic impact of this rule will not rise to the level of necessitating a full Regulatory Evaluation. The safety zone is limited in duration, and is limited to a narrowly tailored geographic area. In addition, although this rule restricts access to the waters encompassed by the safety zone, the effect of this rule will not be significant because it is outside of the Oakland Outer Harbor Entrance Channel and will be notified via public Broadcast Notice to Mariners to ensure the safety zone will result in minimum impact. The entities most likely to be affected are waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601–612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This rule may affect the following entities, some of which may be small entities: Owners and operators of waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities and sightseeing, if these facilities or vessels are in the vicinity of the safety zone at times when this zone is being enforced. This rule will not have a significant economic impact on a substantial number of small entities for the following reasons: (i) This rule will encompass only a small portion of the waterway for a limited period of time, (ii) vessel traffic can transit safely around the safety zone, and (iii) the maritime public will be advised in advance of this safety zone via Broadcast Notice to Mariners.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1–888–REG–FAIR (1–888–734–3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531–1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023–01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321–4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone of limited size and duration. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2–1 of the Commandant Instruction. A Record of Environmental Consideration for categorically excluded actions is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, and Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(d)
(2) The safety zone is closed to all vessel traffic, except as may be permitted by the COTP or a designated representative.
(3) Vessel operators desiring to enter or operate within the safety zone must contact the COTP or a designated representative to obtain permission to do so. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP or a designated representative. Persons and vessels may request permission to enter the safety zone through the 24-hour Command Center at telephone (415) 399–3547 or on VHF channel 16.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is amending a temporary safety zone on the Housatonic River near Milford and Stratford, CT. Amending the safety zone is necessary to protect personnel, vessels, and the marine environment from potential hazards created by the United Illuminating Company Housatonic River Crossing Project. This regulation prohibits entry of vessels or people into the safety zone unless authorized by the Captain of the Port Sector Long Island Sound. The safety zone will only be enforced during cable pulling operations or other instances which may create a hazard to navigation.
This rule is effective without actual notice from June 30, 2017 through August 31, 2017. For the purposes of enforcement, actual notice will be used from June 12, 2017 through June 30, 2017.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, contact Petty Officer Katherine Linnick, Prevention Department, U.S. Coast Guard Sector Long Island Sound,
This rulemaking amends a temporary safety zone for certain waters of the Housatonic River near Milford and Stratford, CT. Corresponding regulatory history is discussed below.
On August 25, 2016, United Illuminating Company notified the Coast Guard that it would conduct a project involving the installation of new transmission conductors over the Housatonic River near Stratford and Milford, CT. On March 14, 2017, the Coast Guard published a NPRM entitled, “Safety Zone; United Illuminating Company Housatonic River Crossing Project; Housatonic River; Milford and Stratford, CT” in the
On May 22, 2017, the Coast Guard published a TFR entitled, “Safety Zone; United Illuminating Company Housatonic River Crossing Project; Housatonic River; Milford and Stratford, CT” in the
On May 10, 2017, United Illuminating Company notified the Coast Guard that due to foul weather it was behind schedule and was unable to complete phase one as described in the above-mentioned TFR. The project is now scheduled to begin on June 12, 2017 and be completed by August 31, 2017. Due to fluctuations in the project's schedule, the safety zone is being amended to permit enforcement of the safety zone during re-scheduled cable installation operations or other instances which may cause a hazard to navigation. The COTP Long Island Sound (LIS) has determined that the potential hazards associated with the cable installation project could be a safety concern for anyone within the work area. The work area is between the eastern and western shores of the Housatonic River. The southern boundary of the work zone begins at the Metro-North Rail Bridge and extends north approximately 525 feet upstream.
The Coast Guard is amending § 165.T01–0825 without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM with respect to this rule because doing so would be impracticable and contrary to the public interest. The late finalization of project details after weather delays did not give the Coast Guard enough time to publish an NPRM, take public comments regarding the amendments to § 165.T01–0825, and issue a new final rule before the rescheduled cable crossing operation is set to begin. It would be impracticable and contrary to the public interest to delay promulgating the amendments to this rule as it is necessary to protect the safety of the public and waterway users.
Under 5 U.S.C. 553(d)(3), and for the same reasons stated in the preceding paragraph, the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The legal basis for this temporary rule is 33 U.S.C. 1231. The COTP LIS has determined that potential hazards associated with the river cable crossing project starting on June 12, 2017 and continuing through August 31, 2017 will be a safety concern for anyone within the work zone. This rule is needed to protect people and vessels within the safety zone while the cable crossing project is completed.
This rule amends the temporary safety zone in § 165.T01–0825. The safety zone will cover all navigable waters of the Housatonic River near Milford and Stratford, CT contained within the following area: Beginning at a point on land in position at 41°12′17″ N., 073°06′40″ W. near the Governor John Davis Lodge Turnpike (I–95) Bridge; then northeast across the Housatonic River to a point on land in position at 41°12′20″ N., 073°06′29″ W. near the Governor John Davis Lodge Turnpike (I–95) Bridge; then northwest along the shoreline to a point on land in position at 41°12′25″ N., 073°06′31″ W.; then southwest across the Housatonic River to a point on land in position at 41°12′22″ N., 073°06′43″ W.; then southeast along the shoreline back to point of origin (NAD 83). All positions are approximate. The duration of the zone is intended to ensure the safety of people and vessels in these navigable waters during any instance that necessitates a temporary closure of the Housatonic River at the work site. The safety zone will only be enforced during cable installation operations or other instances, when they cause a hazard to navigation. During enforcement periods, no vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.
The Coast Guard will notify the public and local mariners of this safety zone through appropriate means, which may include, but are not limited to, publication in the
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the size, location, and duration of the safety zone which will affect a small, designated area of the Housatonic River for less than one hour
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601–612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit this regulated area may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator. Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1–888–REG–FAIR (1–888–734–3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531–1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023–01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321–4370f), and have made a determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This temporary rule involves a safety zone enforced for less than one hour at a time that would prohibit entry within the work zone during cable installation. It also may be enforced temporarily during the cable installation project if necessitated by an emergency, such as equipment falling from the towers into the Housatonic River. Normally such actions are categorically excluded from further review under paragraph 34(g) of Figure 2–1 of Commandant Instruction M16475.lD. A Record of Environmental Consideration (REC) is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(d)
(2) In accordance with the general regulations in § 165.23, entry into or movement within this zone is prohibited unless authorized by the COTP Long Island Sound.
(3) Operators of vessels desiring to enter or operate within the safety zone should contact the COTP Long Island Sound at 203–468–4401 (Sector Long Island Sound Command Center) or the designated representative via VHF channel 16 to obtain permission to do so. Request to enter or operate in the safety zone must be made 24 hours in advanced of the planned undertaking.
(4) Mariners are requested to proceed with caution after passing arrangements have been made. Mariners are requested to cooperate with the United Illuminating Company work vessels for the safety of all concerned. The United Illuminating Company work vessels will be monitoring VHF channels 13 and 16. Mariners are requested to proceed with extreme caution and operate at their slowest safe speed as to not cause a wake.
(5) Any vessel given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP Long Island Sound, or the designated on-scene representative.
(6) Upon being hailed by a U.S. Coast Guard vessel by siren, radio, flashing light or other means, the operator of the vessel shall proceed as directed.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the Fourth of July Fireworks Display, Tahoe City, CA in the Captain of the Port, San Francisco area of responsibility during the dates and times noted below. This action is necessary to protect life and property of the maritime public from the hazards associated with the fireworks display. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM).
The regulations in 33 CFR 165.1191, Table 1, Item number 15, will be enforced from 7 a.m. to 10:30 p.m. on July 4, 2017.
If you have questions on this notice, call or email Lieutenant Junior Grade Christina Ramirez, Sector San Francisco Waterways Safety Division, U.S. Coast Guard; telephone 415–399–2001, email
The Coast Guard will enforce a safety zone in navigable waters around and under the fireworks barge within a radius of 100 feet during the loading, transit, and arrival of the fireworks barge to the display location and until the start of the fireworks display. From 7 a.m. until 10 a.m. on July 4, 2017, the fireworks barge will be loading pyrotechnics at the Kings Beach Boat Ramp, in Kings Beach, CA. From approximately 10 a.m. to noon on July 4, 2017, the loaded fireworks barge will transit from the Kings Beach Boat Ramp to the launch site off of Commons Beach in Tahoe City, CA in approximate position 39°10′03″ N., 120°08′09″ W. (NAD 83) where it will remain until the commencement of the fireworks display. Upon the commencement of the 20 minute fireworks display, scheduled to begin at approximately 9:30 p.m. on July 4, 2017, the safety zone will increase in size to encompass the navigable waters around and under the fireworks barge within a radius 1,000 feet in approximate position 39°10′03″ N., 120°08′09″ W. (NAD 83) for the Fourth of July Fireworks, Tahoe City, CA in 33 CFR 165.1191, Table 1, Item number 15. This safety zone will be in effect from 7 a.m. until 10:30 p.m. on July 4, 2017. Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone during all applicable effective dates and times, unless authorized to do so by the PATCOM. Additionally, each person who receives notice of a lawful order or direction issued by an official patrol vessel shall obey the order or direction. The PATCOM is empowered to forbid entry into and control the regulated area. The PATCOM shall be designated by the Commander, Coast Guard Sector San Francisco. The PATCOM may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so.
This notice is issued under authority of 33 CFR 165.1191 and 5 U.S.C. 552(a). In addition to this notice in the
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the Fourth of July Fireworks display in the City of Martinez in the Captain of the Port, San Francisco area of responsibility during the dates and times noted below. This action is necessary to protect life and property of the maritime public from the hazards associated with the fireworks display. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM).
The regulations in 33 CFR 165.1191, Table 1, Item number 11 will be enforced from 9:30 p.m. to 10 p.m. on July 4, 2017.
If you have questions on this notice of enforcement, call or email Lieutenant Junior Grade Christina Ramirez, U.S. Coast Guard Sector San Francisco; telephone (415) 399–2001 or email at
The Coast Guard will enforce the safety zone established in 33 CFR 165.1191, Table 1, Item number 11 on July 4, 2017. Upon commencement of the 20 minute fireworks display, scheduled to begin at 9:30 p.m. on July 4, 2017, the safety zone will encompass the navigable waters surrounding the land based launch site at Waterfront Park near Martinez, CA within a radius of 560 feet in approximate position 38°01′32″ N., 122°08′24″ W. (NAD 83) for the Fourth of July Fireworks, City of Martinez in 33 CFR 165.1191, Table 1, Item number 11. Upon the conclusion of the fireworks display the safety zone shall terminate. This safety zone will be in effect from 9:30 p.m. to approximately 10 p.m. on July 4, 2017.
Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone during all applicable effective dates and times, unless authorized to do so by the PATCOM. Additionally, each person who receives notice of a lawful order or direction issued by an official patrol vessel shall obey the order or direction. The PATCOM is empowered to forbid entry into and control the regulated area. The PATCOM shall be designated by the Commander, Coast Guard Sector San Francisco. The PATCOM may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so.
This notice of enforcement is issued under authority of 33 CFR 165.1191 and 5 U.S.C. 552(a). In addition to this notification in the
If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notification, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the Red, White, and Tahoe Blue Fireworks display in the Captain of the Port, San Francisco area of responsibility during the dates and times noted below. This action is necessary to protect life and property of the maritime public from the hazards associated with the fireworks display. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM).
The regulations in 33 CFR 165.1191, Table 1, Item number 19, will be enforced without actual notice from June 30, 2017, until July 4, 2017. For the purposes of enforcement, actual notice will be used from June 28, 2017 through June 30, 2017.
If you have questions on this notice, call or email Lieutenant Junior Grade Christina Ramirez, Sector San Francisco Waterways Safety Division, U.S. Coast Guard; telephone 415–399–2001, email
The Coast Guard will enforce a safety zone in navigable waters around and under the fireworks barges within a radius of 100 feet during the loading of the fireworks barges at the display location and until the start of the fireworks display. From 12:20 p.m. on June 28, 2017 until 5 p.m. on July 4, 2017 the fireworks barges will be loaded in the vicinity of Incline Beach, near Incline Village, NV at approximate position 39°14′13″ N., 119°57′01″ W. (NAD 83) where they will remain until the commencement of the fireworks display. Upon the commencement of the 35-minute fireworks display, scheduled to start at approximately 9:30 p.m. on July 4, 2017, the safety zone will increase in size to encompass the navigable waters around and under the fireworks barges within a radius of 1,000 feet at approximate position 39°14′13″ N., 119°57′01″ W. (NAD 83) for the Red, White, and Tahoe Blue Fireworks, Incline Village, NV in 33 CFR 165.1191, Table 1, Item number 19. This safety zone will be in effect from 12:20 p.m. on June 28, 2017 until 10:30 p.m. on July 4, 2017.
Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone during all applicable effective dates and times, unless authorized to do so by the PATCOM. Additionally, each person who receives notice of a lawful order or direction issued by an official patrol vessel shall obey the order or direction. The PATCOM is empowered to forbid entry into and control the regulated area. The PATCOM shall be designated by the Commander, Coast Guard Sector San Francisco. The PATCOM may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so.
This document is issued under authority of 33 CFR 165.1191 and 5 U.S.C. 552(a). In addition to this notice in the
If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the Independence Day Fireworks, Kings Beach, CA in the Captain of the Port, San Francisco area of responsibility during the dates and times noted below. This action is necessary to protect life and property of the maritime public from the hazards associated with the fireworks display. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM).
The regulations in 33 CFR 165.1191, Table 1, number 17, will be enforced from 7 a.m. through 10:30 p.m. on July 3, 2017.
If you have questions on this notice of enforcement, call or email Lieutenant Junior Grade Christina Ramirez, Sector San Francisco Waterways Safety Division, U.S. Coast Guard; telephone 415–399–2001, email
The Coast Guard will enforce a safety zone in navigable waters around and under the fireworks barge within a radius of 100 feet during the loading, transit, and until the start of the fireworks display. From 7 a.m. until 9 a.m. on July 3, 2017, the fireworks barge will be loading pyrotechnics at the Kings Beach Boat Ramp in Kings Beach, CA. From approximately 9 a.m. to 10 a.m. on July 3, 2017, the loaded barge will be towed from the Kings Beach Boat Ramp to the display location off of Kings Beach, CA in approximate position 39°13′59″ N., 120°01′37″ W. (NAD 83) where it will remain until the conclusion of the fireworks display. Upon the commencement of the 15 minute fireworks display, scheduled to begin at 9:30 p.m. on July 3, 2017, the safety zone will increase in size to encompass the navigable waters around and under the fireworks barge within a radius 1,000 feet in approximate position 39°13′59″ N., 120°01′37″ W. (NAD 83) for the Independence Day Fireworks, Kings Beach, CA in 33 CFR 165.1191, Table 1, Item number 17. This safety zone will be in effect from 7 a.m. until 10:30 p.m. on July 3, 2017.
Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone during all applicable effective dates and times, unless authorized to do so by the PATCOM. Additionally, each person who receives notice of a lawful order or direction issued by an official patrol vessel shall obey the order or direction. The PATCOM is empowered to forbid entry into and control the regulated area. The PATCOM shall be designated by the Commander, Coast Guard Sector San Francisco. The PATCOM may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so.
This notice of enforcement is issued under authority of 33 CFR 165.1191 and 5 U.S.C. 552(a). In addition to this notification in the
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the Delta Independence Day Celebration Fireworks in the Captain of the Port, San Francisco area of responsibility during the dates and times noted below. This action is necessary to protect life and property of the maritime public from the hazards associated with the fireworks display. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM).
The regulations in 33 CFR 165.1191, Table 1, Item number 14 will be enforced from 8 a.m. to 10:30 p.m. July 4, 2017.
If you have questions on this notice, call or email Lieutenant Junior Grade Christina Ramirez, U.S. Coast Guard Sector San Francisco; telephone (415) 399–2001 or email at
The Coast Guard will enforce a 100 foot safety zone around the fireworks barge during the loading, transit, and arrival of the fireworks barge to the display location and until the start of the fireworks display. From 8 a.m. until 9 a.m. on July 4, 2017, the fireworks barge will be loading off of Dutra Corporation Yard in Rio Vista, CA. From approximately 9 a.m. to 2 p.m. on July 4, 2017 the loaded barge will transit from Dutra Corporation Yard to the launch site near Venice Island, CA in approximate position 38°03′21″ N., 121°32′03″ W. (NAD83). The fireworks barge will remain at launch site until the commencement of the fireworks display. Upon the commencement of the 20-minute fireworks display, scheduled to begin at approximately 9:30 p.m. on July 4, 2017, the safety zone will increase in size and encompass the navigable waters around and under the fireworks barge within a radius 1,000 feet in approximate position 38°03′21″
Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone during all applicable effective dates and times, unless authorized to do so by the PATCOM. Additionally, each person who receives notice of a lawful order or direction issued by an official patrol vessel shall obey the order or direction. The PATCOM is empowered to forbid entry into and control the regulated area. The PATCOM shall be designated by the Commander, Coast Guard Sector San Francisco. The PATCOM may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so.
This notice is issued under authority of 33 CFR 165.1191 and 5 U.S.C. 552(a). In addition to this notice in the
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for certain waters of the Severn River. This action is necessary to provide for the safety of life on the navigable waters of Sherwood Forest near Annapolis, MD, during a fireworks display on July 3, 2017. This action will prohibit persons and vessels from entering the safety zone unless authorized by the Captain of the Port Maryland-National Capital Region or a designated representative.
This rule is effective from 8 p.m. on July 3, 2017, until 10:30 p.m. on July 7, 2017.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this rulemaking, call or email Mr. Ronald Houck, Sector Maryland-National Capital Region Waterways Management Division, U.S. Coast Guard; telephone 410–576–2674, email
On December 29, 2016, the Sherwood Forest Club, Inc. of Sherwood Forest, MD notified the Coast Guard that from 9:15 p.m. to 10 p.m. on July 3, 2017, it will be conducting a fireworks display launched from the end of the Sherwood Forest Club main pier located adjacent to the Severn River, approximately 200 yards east of Brewer Pond in Sherwood Forest, MD. In the event of inclement weather, the fireworks display will be scheduled for July 7, 2017. In response, on April 6, 2017, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Special Local Regulations and Safety Zones; Recurring Marine Events and Fireworks Displays Within the Fifth Coast Guard District” (82 FR 16746). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this fireworks display. During the comment period that ended May 8, 2017, we received two comments. While the Coast Guard has made the determination to issue a temporary final rule concerning this year's fireworks display, USCG still plans to issue a final rule in the future to cover this recurring event in future years.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP has determined that potential hazards associated with the fireworks to be used in this July 3, 2017 display will be a safety concern for anyone on the Severn River near the end of the Sherwood Forest Club main pier. The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters in the safety zone before, during, and after the scheduled event.
As noted above, we received two comments on our NPRM published April 6, 2017. Both comments addressed issues not related to this rulemaking. Therefore, there are no changes in the regulatory text of this rule from the proposed rule in the NPRM based on the comments received.
Details of the event were provided to the Coast Guard on May 15, 2017, that allowed the COTP to reassess the potential hazards associated with the fireworks to be used in this July 3, 2017 display. The area of the safety zone at the fireworks discharge site located at end of the Sherwood Forest Club main pier, listed in the Table to 33 CFR 165.506 under Coast Guard Sector Maryland-National Capital Region—COTP Zone as No. (b.)27, is reduced from a 200 yards radius to a 150 yards radius. As a result, there is one change in the regulatory text of this rule from the proposed rule in the NPRM. The safety zone will be reduced in size from 200 yards from the center point located at 39°01′54.0″ N., longitude 076°32′41.8″ W. to a 150 yard radius.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory
This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact a small designated area of the Severn River for 2
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601–612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), we want to assist small entities in understanding this rule. If the rule might affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531–1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023–01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321–4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting approximately 2
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 19133 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; Pub. L. 107–295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(1) All persons are required to comply with the general regulations governing safety zones found in § 165.23.
(2) Entry into or remaining in this safety zone is prohibited unless authorized by the Coast Guard Captain of the Port Maryland-National Capital Region. All vessels underway within this safety zone at the time it is implemented shall depart the safety zone.
(3) Persons desiring to transit the area of the safety zone must first obtain authorization from the Captain of the Port Maryland-National Capital Region or designated representative. To request permission to enter or transit the regulated area, the Captain of the Port Maryland-National Capital Region or designated representatives can be contacted at telephone number 410–576–2693 or on Marine Band Radio VHF–FM channel 16 (156.8 MHz). The Coast Guard vessels enforcing this section can be contacted on Marine Band Radio VHF–FM channel 16 (156.8 MHz). Upon being hailed by a U.S. Coast Guard vessel, or other Federal, State, or local agency vessel, by siren, radio, flashing light or other means, the operator of a vessel shall proceed as directed. If permission is granted to enter the safety zone, all persons and vessels must comply with the instructions of the Captain of the Port Maryland-National Capital Region or designated representative and proceed as directed while in the zone.
(4)
(d)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for navigable waters within Apra Outer Harbor, Guam. The safety zone will encompass a U.S. Navy underwater detonation (UNDET) exercise. The Coast Guard believes this safety zone regulation is necessary to protect the public and exercise participants within the affected area from possible safety hazards associated with the exercise. This safety zone will impact a small designated area of navigable waters in Apra Harbor for 8 hours or less. With the exception of exercise participants, entry of vessels or persons into the zone is prohibited unless specifically authorized by the Captain of the Port Guam.
This rule is effective from 8 a.m. through 4 p.m. on July 13th, 2017.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Petty Officer Robin Branch, Sector Guam, U.S. Coast Guard; telephone (671) 355–4835, email
After the Coast Guard analyzed the scope and potential impacts associated with a temporary safety zone being established, the Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to public interest. To delay implementation of the safety zone past the exercise date of July 13th, 2017 to publish and seek public comment is impracticable as it would unavoidably prevent the Coast Guard from ensuring the safety of the public and exercise participants from potential hazards associated with the exercise. It is for the same reason good cause exists under the public interest exception to the required public comment period. It is in the public's interest the safety zone be established prior to notice and comment to ensure the safety zone is in place for the UNDET exercise on July 13th, 2017.
For the same reasons as noted above, we are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Guam concurs with the U.S. Navy that potential hazards associated with the UNDET exercise on July 13th, 2017 may be a safety concern for anyone within a 700-yard radius above and below the surface in the area of the operation. This rule is needed to protect the public, exercise participants and vessels in the navigable waters within the safety zone during the exercise. Mariners and divers
This rule establishes a safety zone from 8 a.m. through 4 p.m. on July 13th, 2017. The safety zone will cover all navigable waters within 700-yards above and below the surface of the water around the UNDET exercise. The duration of the zone is intended to protect the public, exercise participants and vessels in navigable waters during the exercise. No vessel or person, with the exception of exercise participants, will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.
We developed this rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location and duration of the safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact a small designated area of waters in the outer harbor for 8 hours or less. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF–FM marine channel 16 about the zone. Further, the rule allows vessels and persons to seek permission to enter the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601–612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104–121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1–888–REG–FAIR (1–888–734–3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O 13132.
Also, this rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531–1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023–01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321–4370f), and have determined that the establishment of a safety zone is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting up to eight hours that will prohibit entry within 700-yards above and below the surface of the UNDET exercise. It is categorically excluded from further review under paragraph 34(g) of Figure 2–1 of the Commandant Instruction. A Record of Environmental Consideration (REC) supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine Safety, Navigation (water), Reporting and record-keeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05–1(g), 6.04–1, 6.04–6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(d)
(e)
(f)
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the Fourth of July Fireworks display in the Captain of the Port, San Francisco area of responsibility during the dates and times noted below. This action is necessary to protect the life and property of the maritime public from the hazards associated with the fireworks display. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM).
The regulations in 33 CFR 165.1191, Table 1, Item number 16 will be enforced from 7 a.m. through 10:30 p.m. on July 4, 2017.
If you have questions on this notice of enforcement, call or email Lieutenant Junior Grade Christina Ramirez, U.S. Coast Guard Sector San Francisco; telephone (415) 399–2001 or email at
The Coast Guard will enforce a safety zone in navigable waters around and under a fireworks barge within a radius of 100 feet during the loading of the fireworks barge and until the start of the fireworks display. From 7 a.m. until 8 a.m. on July 4, 2017, the fireworks barge will be loading pyrotechnics at the launch site in Glenbrook Bay in approximate position 39°05′18″ N., 119°56′34″ W. (NAD 83). The fireworks barge will remain at the launch site in Glenbrook Bay in approximate position 39°05′18″ N., 119°56′34″ W. (NAD 83) until the commencement of the fireworks display. Upon the commencement of the 20 minute fireworks display, scheduled to begin at approximately 9:30 p.m. on July 4, 2017, the safety zone will increase in size and encompass the navigable waters around and under the fireworks barge within a radius 1,000 feet in approximate position 39°05′18″ N., 119°56′34″ W. (NAD 83). Upon the conclusion of the fireworks display the safety zone shall terminate. This safety zone will be in effect from 7 a.m. until approximately 10:30 p.m. on July 4, 2017.
Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone during all applicable effective dates and times, unless authorized to do so by the PATCOM. Additionally, each person who receives notice of a lawful order or direction issued by an official patrol vessel shall obey the order or direction. The PATCOM is empowered to forbid entry into and control the regulated area. The PATCOM shall be designated by the Commander, Coast Guard Sector San Francisco. The PATCOM may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so.
This notice of enforcement is issued under authority of 33 CFR 165.1191 and 5 U.S.C. 552(a). In addition to this notification in the
If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notification, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone regulations for the Tacoma Freedom Fair Air Show on Commencement Bay from 1:30 p.m. July 4, 2017, until 12:30 a.m. on July 5, 2017. This action is necessary to ensure the safety of the public from inherent dangers associated with these annual aerial displays. During the enforcement period, no person or vessel may enter or transit this safety zone unless authorized by the Captain of the Port or her designated representative.
The regulations in 33 CFR 165.1305 will be enforced from 1:30 p.m. July 4, 2017, until 12:30 a.m. on July 5, 2017.
If you have questions on this notice of enforcement, call or email Petty Officer Zachary Spence, Sector Puget Sound Waterways Management Division, Coast Guard; telephone (206) 217–6051, email
The Coast Guard will enforce the safety zone in 33 CFR 165.1305 from 1:30 p.m. July 4, 2017 until 12:30 a.m. July 5, 2017 unless canceled sooner by the Captain of the Port Puget Sound. It is necessary to start the safety zone 30 minutes sooner since the Tacoma Freedom Fair Air Show will begin at 1:30 p.m. instead of 2 p.m. This action is being taken to provide for the safety of life on navigable waterways during the air show.
The safety zone resembles a rectangle protruding from the shoreline along Ruston Way and will be marked by the event sponsor. The specific coordinates of the safety zone location is listed in 33 CFR 165.1305.
As specified in § 165.1305(c), during the enforcement period, no vessel may transit this regulated area without approval from the Captain of the Port Sector Puget Sound (COTP) or a COTP designated representative. The Captain of the Port may be assisted by other federal, state and local law enforcement agencies in enforcing this regulation.
This notice of enforcement is issued under authority of 33 CFR 165.1305 and 5 U.S.C. 552 (a). In addition to this notice of enforcement in the
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the Fourth of July Fireworks, City of Sausalito in the Captain of the Port, San Francisco area of responsibility during the dates and times noted below. This action is necessary to protect life and property of the maritime public from the hazards associated with the fireworks display. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM).
The regulations in 33 CFR 165.1191, Table 1, Item number 10 will be enforced from 9 a.m. to 10 p.m. on July 4, 2017.
If you have questions on this notice, call or email Lieutenant Junior Grade Christina Ramirez, U.S. Coast Guard Sector San Francisco; telephone (415) 399–2001 or email at
The Coast Guard will enforce a safety zone extending around and under the fireworks barge within a radius of 100 feet during the loading, transit, and arrival of the fireworks barge to the display location until the start of the fireworks display.
From 9 a.m. until 3 p.m. on July 4, 2017, the fireworks barge will be loading pyrotechnics off of Pier 50 in San Francisco, CA. The fireworks barge will remain at the pier until its transit to the display location. From 6:30 p.m. to 8 p.m. on July 4, 2017 the loaded fireworks barge will transit from Pier 50 to the launch site near Sausalito, CA in approximate position 37°51′31″ N., 122°28′28″ W. (NAD83) where it will remain until the conclusion of the scheduled fireworks display.
Upon the commencement of the fireworks display at approximately 9:15 p.m. on July 4, 2017, the safety zone will increase in size and encompass the navigable waters around and under the fireworks barge within a radius of 1,000 feet in approximate position 37°51′31″ N., 122°28′28″ W. (NAD83) for the Fourth of July Fireworks, City of Sausalito in 33 CFR 165.1191, Table 1, Item number 10. This safety zone will be in effect from 9 a.m. to 10 p.m. on July 4, 2017.
Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone during all applicable effective dates and times, unless authorized to do so by the PATCOM. Additionally, each person who receives notice of a lawful order or direction issued by an official patrol vessel shall obey the order or direction. The PATCOM is empowered to forbid entry into and control the regulated area. The PATCOM shall be designated by the Commander, Coast Guard Sector San Francisco. The PATCOM may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so.
This notice is issued under authority of 33 CFR 165.1191 and 5 U.S.C. 552(a). In addition to this notice in the
If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.
Office of Special Education and Rehabilitative Services, Department of Education.
Final regulations.
The Secretary of Education (Secretary) amends the regulations implementing Parts B and C of the Individuals with Disabilities Education Act (IDEA). These conforming changes are needed to implement statutory amendments made to the IDEA by the Every Student Succeeds Act (ESSA), enacted on December 10, 2015. These regulations remove and revise IDEA definitions based on changes made to the definitions in the Elementary and Secondary Education Act of 1965 (ESEA), as amended by the ESSA, and also update several State eligibility requirements to reflect amendments to the IDEA made by the ESSA. They also update relevant cross-references in the IDEA regulations to sections of the ESEA to reflect changes made by the ESSA. These regulations also include several technical corrections to previously published IDEA Part B regulations.
These final regulations are effective June 30, 2017.
Mary Louise Dirrigl, U.S. Department of Education, 550 12th Street SW., Potomac Center Plaza, Room 5156, Washington, DC 20202–2641. Telephone: (202) 245–7324 or by email:
• Revise the definition of the term “charter school” in § 300.7 to update the statutory reference to the ESEA's amended definition of that term.
• Remove the definition of the term “core academic subjects” in § 300.10, the definition of “highly qualified special education teachers” in § 300.18, and the definition of “scientifically based research” in §§ 300.35 and 303.32 because these terms have been removed from the ESEA.
• Revise the term “Limited English proficient” in § 300.27 to reflect the revisions to the term “English learner” in section 8101 of the ESEA.
• Revise § 300.102(a)(3)(iv) to incorporate the definition of “regular high school diploma” in section 8101(43) of the ESEA.
• Move the qualification requirements for special education teachers from § 300.18(b)(1) and (2) to § 300.156(c).
• Revise § 300.160(c) to reflect amendments made to the IDEA by the ESSA that clarify that guidelines and alternate assessments to measure academic progress under title I of the ESEA apply only to children with disabilities who are students with the most significant cognitive disabilities, whose achievement is measured against alternate academic achievement standards if a State has adopted such standards as permitted under section 1111(b)(1)(E) of the ESEA.
• Revise paragraph (b)(4)(xi) of § 300.704 (State-level activities), regarding the provision of technical assistance to schools and local educational agencies (LEAs) implementing comprehensive support and improvement activities or targeted support and improvement activities under section 1111(d) of the ESEA on the basis of consistent underperformance of the disaggregated subgroup of children with disabilities, to include direct student services described in section 1003A(c)(3) of the ESEA to children with disabilities.
We are revising the definition of “charter school” in § 300.7 by removing the phrase “section 5210(1)” and replacing it with “section 4310(2).” We are revising the authority citation for § 300.7 by removing “20 U.S.C. 7221i(1)” and replacing it with “20 U.S.C. 7221i(2).”
We are removing the definition of “core academic subjects” in § 300.10 and reserving § 300.10. This change is consistent with section 9215(ss)(1)(A) of the ESSA, which eliminated section 602(4) of the IDEA.
Consistent with section 9215(ss)(1)(B) of the ESSA, we are revising the definition of “excess cost” in § 300.16. Specifically, we are revising the cross-reference to the ESEA in § 300.16(a)(3) to read “under part A of title III of the ESEA.”
We are removing the definition of “highly qualified special education teachers” in § 300.18, consistent with section 9214(d)(1) of the ESSA, which eliminated section 602(10) of the IDEA, and we are reserving § 300.18. Consequently, we are removing the references to § 300.18 in §§ 300.138(a)(1) and 300.146(b) and adding a reference to § 300.156(c) in § 300.138(a)(1), as explained below. Based on the amendments made to the IDEA by section 9214(d)(2)(A) of the ESSA, as discussed in Subpart B, we are moving § 300.18(b)(1) and (2), regarding qualifications for special education teachers, to § 300.156(c). Consistent with changes made by section 9214(d)(2)(B) and (C) to section 612(a)(14)(D) and (E) of the IDEA, we are also removing references to the term “highly qualified” in § 300.156(d) and (e) and replacing them with references to personnel “who meet the applicable requirements described in paragraph (c) of this section.”
Consistent with section 9215(ss)(1)(C) of the ESSA, which amended section 602(18) of the IDEA, we are revising the definition of “Limited English proficient” in § 300.27 to adopt the meaning given to the term “English learner” in section 8101 of the ESEA.
Consistent with section 8002(1) of the ESEA, we are removing the definition of “scientifically based research” in § 300.35 because this definition has been removed from the ESEA. Section 300.35 is reserved. However, we are retaining references to “scientifically based research” in §§ 300.604(a)(1)(ii) and 300.704(b)(4)(xi), because these references were retained in sections 616(e)(1)(A)(ii) and 611(e)(2)(C)(xi), respectively.
We are revising the following cross-references to definitions:
• The cross-reference to the definition of “special education” in § 300.105(a)(1) is changed from § 300.36 to § 300.39, and from § 300.38 to § 300.39 in § 300.115(b)(1).
• The cross-reference to the definition of “supplementary aids and services” in § 300.105(a)(3) is changed from § 300.38 to § 300.42, and from § 300.41 to § 300.42 in § 300.154(b)(1)(i).
• The cross-reference to the definition of “transition services” in § 300.154(b)(1)(i) is changed from § 300.42 to § 300.43.
We are revising § 300.102(a)(3)(iv) to incorporate the definition of “regular high school diploma” currently included in section 8101(43) of the ESEA. The term means the standard high school diploma awarded to the preponderance of students in the State that is fully aligned with State standards, or a higher diploma, except that a regular high school diploma shall not be aligned to the alternate academic achievement standards described in section 1111(b)(1)(E) of the ESEA. A regular high school diploma does not include a recognized equivalent of a diploma, such as a general equivalency diploma, certificate of completion, certificate of attendance, or similar lesser credential. We are making this conforming change to ensure that “regular high school diploma” has the same meaning under the IDEA and the ESEA, and the definition is consistently applied under both programs. We are also updating the authority citation to reflect this change.
Consistent with section 9214(d)(2)(A) of the ESSA, we are revising § 300.156(c) by removing the language indicating that each person employed as a public school special education teacher in the State must be highly qualified by the deadline established in section 1119(a)(2) of the ESEA. In its place at § 300.156(c), we are adding language from the current definition of “highly qualified” in § 300.18(b)(1). The revisions are needed to clarify that the IDEA, as amended by the ESSA, retains the same requirements as in current § 300.18(b)(1) governing the qualifications of special education teachers. Additionally, consistent with section 9214(d)(2)(A) of the ESSA, we are retaining the requirements in current § 300.18(b)(2), regarding participation in an alternate route to certification as a special educator. The retention of these requirements is consistent with amendments to section 612(a)(14)(C)(i) of the IDEA, which require that an alternate route to certification as a special educator meets the minimum requirements described in 34 CFR 200.56(a)(2)(ii), as such section was in effect on November 28, 2008. Because 34 CFR 200.56(a)(2)(ii), as in effect on November 28, 2008, included the language in current § 300.18(b)(2), we are moving the language in current § 300.18(b)(2) to new § 300.156(c)(2). Additionally, consistent with amendments to section 612(a)(14)(D) and (E) of the IDEA made by section 9214(d)(2)(B) and (C) of the ESSA, we are removing references to “highly qualified” in paragraphs (d) and (e) of § 300.156 and replacing them with references to personnel “who meet the applicable requirements described in paragraph (c) of this section.”
Consistent with section 9215(ss)(3)(A) of the ESSA, which amended section 612(a)(15) of the IDEA (Performance goals and indicators), we are making the following changes to § 300.157. Consistent with section 9215(ss)(3)(A)(i) of the ESSA, which amended section 612(a)(15)(A)(ii) of the IDEA, we are replacing § 300.157(a)(2) in its entirety with the language “Are the same as the State's long-term goals and measurements of interim progress for children with disabilities under section 1111(c)(4)(A)(i) of the ESEA.” Consistent with amendments to section 612(a)(15)(B) made by section 9215(ss)(3)(A)(ii) of the ESSA, we are also revising § 300.157(b) by replacing the language “including measurable annual objectives for progress by children with disabilities under section 1111(b)(2)(C)(v)(II)” with “including measurements of interim progress for children with disabilities under section 1111(c)(4)(A)(i).”
We are making a number of amendments to §§ 300.160(c) through (f) to address amendments made by section 9215(ss)(3)(B) of the ESSA to section 612(a)(16)(C)(ii) of the IDEA, as well as changes made by the ESSA to section 1111(b)(2)(D) of the ESEA, which affect current (d), (e), and (f) of § 300.160. We are changing the title of § 300.160(c) from “Alternate Assessments” to “Alternate Assessments Aligned with Alternate Academic Achievement Standards for Students with the Most Significant Cognitive Disabilities.” We are adding the phrase “children with disabilities who are students with the most significant cognitive disabilities” in § 300.160(c)(1) with respect to State guidelines for participation in alternate assessments, because section 9215(ss)(3)(B) of the ESSA clarifies that the State guidelines referred to in section 612(a)(16)(C)(i) of the IDEA apply only to participation of children with disabilities who are students with the most significant cognitive disabilities in alternate assessments aligned with alternate academic achievement standards as permitted under section 1111(b)(1)(E) of the ESEA, if those children cannot take regular assessments, even with accommodations as indicated in their respective individualized education programs (IEPs).
Consistent with section 9215(ss)(3)(B) of the ESSA, which amended section 612(a)(16)(C)(ii) of the IDEA, we are also reorganizing § 300.160(c)(2) for greater clarity and to ensure consistency with 34 CFR 200.6(c) of the regulations for title I, part A of the ESEA. These changes will clarify that if a State has adopted alternate academic achievement standards as permitted under section 1111(b)(1)(E) of the ESEA and 34 CFR 200.1(d) of the regulations for title I, part A of the ESEA, the State must conduct alternate assessments that measure the achievement of children with disabilities who are students with the most significant cognitive disabilities against those standards. Consistent with amendments made to section 612(a)(16)(C)(ii) of the IDEA by section 9215(ss)(3)(B) of the ESSA, we are replacing the phrase “the State's challenging academic content standards and challenging student academic achievement standards” with “challenging State academic content standards under section 1111(b)(1) of the ESEA and alternate academic achievement standards under section 1111(b)(1)(E) of the ESEA.” Accordingly, § 300.160(c)(2)(iii) is removed, because the statutory amendments that form the basis for the above regulatory changes clarify that in assessing the academic progress of children with disabilities under title I, part A of the ESEA, the only alternate assessments permitted under the IDEA and title I of the ESEA are alternate assessments aligned with alternate academic achievement standards for children with disabilities who are students with the most significant cognitive disabilities under section 1111(b)(2)(D) of the ESEA. We are amending § 300.160(c)(3) by adding a reference to section 1111(b)(1)(E)(ii) of the ESEA and changing the title I, part A regulatory reference to § 200.6(c)(6) to reinforce that States are prohibited from adopting modified academic achievement standards or any other alternate academic achievement standards that do not meet the requirements in section 1111(b)(1)(E) of the ESEA for any students with disabilities under section 602(3) of the IDEA.
Consistent with section 1111(b)(2)(D)(i)(II) of the ESEA, and 34
Consistent with section 612(a)(16)(C) of the IDEA and section 1111(b)(1)(E)(ii) of the ESEA, we are revising § 300.160(f) to make clear that school year 2016–2017 is the last school year for which States may report on the participation and performance of children with disabilities taking alternate assessments based on grade-level achievement standards. We are also correcting an inadvertent error in § 300.160(f)(3), regarding participation in assessments, that was included in the August 21, 2015 regulations governing title I, part A of the ESEA. See Improving the Academic Achievement of the Disadvantaged; Assistance to States for the Education of Children With Disabilities. 80 FR 50773. We are replacing school years prior to “2015–2016” with school years prior to “2016–2017.” This correction clarifies that school year 2015–2016, not school year 2014–2015, was the last school year in which States were permitted to administer alternate assessments based on modified academic achievement standards. We have also removed the words “if any” from § 300.160(f)(4), because the only alternate assessments that States may conduct to assess academic progress under title I of the ESEA are alternate assessments aligned with alternate academic achievement standards for students with the most significant cognitive disabilities. We are also changing the words “based on” to “aligned with” in paragraphs (f)(3) and (4) of § 300.160 to be consistent with the language used elsewhere in § 300.160(c) referring to alternate assessments conducted under this section.
Consistent with section 9215(ss)(4) of the ESSA, which amended section 613(a)(3) of the IDEA, we are revising § 300.207, regarding personnel development, by removing the reference to “section 2122 of the ESEA” and replacing it with “section 2102(b) of the ESEA.”
Evaluations and Reevaluations
Consistent with section 9215(ss)(5) of the ESSA, which amended section 614(b)(5)(A) of the IDEA, we are revising § 300.306(b)(1)(i), regarding determination of eligibility, by inserting the phrase “as such section was in effect on the day before the date of enactment of the Every Student Succeeds Act (December 9, 2015)” after “ESEA.” Development of IEP
We are correcting an inadvertent error in § 300.324(d)(2)(ii) (Children with disabilities in adult prisons) by changing the least restrictive environment reference from § 300.112 to § 300.114.
Consistent with section 9215(ss)(2)(A) and (B) of the ESSA, which amended section 611(e)(2)(C) and (e)(3)(C)(ii)(I)(bb) of the IDEA, we are making the following revisions. We are revising § 300.704(b)(4) (Other State-level activities) as follows:
• Removing “section 6111 of the ESEA” from paragraph (x) and replacing it with “section 1201 of the ESEA.”
• Revising paragraph (xi) regarding the provision of technical assistance to schools and LEAs by removing “including supplemental educational services as defined in section 1116(e) of the ESEA to children with disabilities, in schools or LEAs identified for improvement under section 1116 of the ESEA on the sole basis of the assessment results of the disaggregated subgroup of children with disabilities” and replacing it with “including direct student services described in section 1003A(c)(3) of the ESEA to children with disabilities, to schools or LEAs implementing comprehensive support and improvement activities or targeted support and improvement activities under section 1111(d) of the ESEA on the basis of consistent underperformance of the disaggregated subgroup of children with disabilities.”
• Replacing the phrase “to meet or exceed the objectives established by the State under section 1111(b)(2)(G) of the ESEA” with “based on the challenging academic standards described in section 1111(b)(1) of the ESEA.”
• Finally, we are revising § 300.704(c)(3)(i)(A)(
Consistent with section 8002(1) of the ESEA, we are removing the definition of
Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—
(1) Have an annual effect on the economy of $100 million or more or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities in a material way (also referred to as an “economically significant” rule);
(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.
This final regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.
Under Executive Order 13771, for each new regulation that the Department proposes for notice and comment or otherwise promulgates that is a significant regulatory action under Executive Order 12866, it must identify two deregulatory actions. For Fiscal Year 2017, any new incremental costs associated with a new regulation must be fully offset by the elimination of existing costs through deregulatory actions. The final regulations are not a significant regulatory action. Therefore, the requirements of Executive Order 13771 do not apply.
We have also reviewed these regulations under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—
(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);
(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;
(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);
(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and
(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.
Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”
We are issuing these final regulations only upon a reasoned determination that their benefits will justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the analysis that follows, the Department believes that these final regulations are consistent with the principles in Executive Order 13563.
We also have determined that this regulatory action would not unduly interfere with State, local, and Tribal governments in the exercise of their governmental functions.
Under Executive Order 12866, we have assessed the potential costs and benefits of this regulatory action and have determined that these regulations will not impose additional costs to States and LEAs or to the Federal government. These regulations do not impose additional costs or administrative burdens because States will be in the process of developing and revising their regulations implementing title I of the ESEA to conform with the changes made by the ESSA. We believe any additional costs imposed on States by these final regulations will be negligible, primarily because they reflect technical changes which do not impose additional burden. Moreover, we believe any costs will be significantly outweighed by the potential benefits of ensuring consistency among the implementation of the IDEA and ESSA requirements for children with disabilities.
Under the Administrative Procedure Act (APA) (5 U.S.C. 553), the Department generally offers interested parties the opportunity to comment on proposed regulations. However, the APA provides that an agency is not required to conduct notice- and-comment rulemaking when the agency, for good cause, finds that notice and public comment thereon are impracticable, unnecessary, or contrary to the public interest (5 U.S.C. 553(b)(B)). There is good cause to waive rulemaking here as unnecessary.
Rulemaking is “unnecessary” in those situations in which “the administrative rule is a routine determination, insignificant in nature and impact, and inconsequential to the industry and to the public.”
The APA also generally requires that regulations be published at least 30 days before their effective date, unless the agency has good cause to implement its regulations sooner (5 U.S.C. 553(d)(3)). Again, because these final regulations include only conforming changes and technical corrections, there is good
These regulations do not contain any information collection requirements.
This program is subject to the requirements of Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance. This document provides early notification of the Department's specific plans and actions for this program.
Based on our review, we have determined that these final regulations do not require transmission of information that any other agency or authority of the United States gathers or makes available.
Administrative practice and procedure, Education of individuals with disabilities, Elementary and secondary education, Equal educational opportunity, Grant programs—education, Privacy, Private schools, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, the Secretary amends parts 300 and 303 of title 34 of the Code of Federal Regulations as follows:
20 U.S.C. 1221e–3, 1406, 1411–1419, and 3474, unless otherwise noted.
(a)* * *
(3)* * *
(iv) As used in paragraphs (a)(3)(i) through (iii) of this section, the term
20 U.S.C. 1412(a)(1)(B)–(C) and 7801(43).
The revision reads as follows:
(c)
(i) Has obtained full State certification as a special education teacher (including certification obtained through an alternate route to certification as a special educator, if such alternate route meets minimum requirements described in 34 CFR 200.56(a)(2)(ii) as such section was in effect on November 28, 2008), or passed the State special education teacher licensing examination, and holds a license to teach in the State as a special education teacher, except that when used with respect to any teacher teaching in a public charter school, the teacher must meet the certification or licensing requirements, if any, set forth in the State's public charter school law;
(ii) Has not had special education certification or licensure requirements waived on an emergency, temporary, or provisional basis; and
(iii) Holds at least a bachelor's degree.
(2) A teacher will be considered to meet the standard in paragraph (c)(1)(i) of this section if that teacher is participating in an alternate route to special education certification program under which—
(i) The teacher—
(A) Receives high-quality professional development that is sustained, intensive, and classroom-focused in order to have a positive and lasting impact on classroom instruction, before and while teaching;
(B) Participates in a program of intensive supervision that consists of structured guidance and regular ongoing support for teachers or a teacher mentoring program;
(C) Assumes functions as a teacher only for a specified period of time not to exceed three years; and
(D) Demonstrates satisfactory progress toward full certification as prescribed by the State; and
(ii) The State ensures, through its certification and licensure process, that the provisions in paragraph (c)(2)(i) of this section are met.
The revision reads as follows:
(a) * * *
(2) Are the same as the State's long-term goals and measurements of interim progress for children with disabilities under section 1111(c)(4)(A)(i) of the ESEA.
(c)
(2) For assessing the academic progress of children with disabilities who are students with the most significant cognitive disabilities under title I of the ESEA, the alternate assessments and guidelines in paragraph (c)(1) of this section must—
(i) Be aligned with the challenging State academic content standards under section 1111(b)(1) of the ESEA and alternate academic achievement standards under section 1111(b)(1)(E) of the ESEA; and
(ii) Measure the achievement of children with disabilities who are students with the most significant cognitive disabilities against those standards.
(3) Consistent with section 1111(b)(1)(E)(ii) of the ESEA and 34 CFR 200.6(c)(6), a State may not adopt modified academic achievement standards or any other alternate academic achievement standards that do not meet the requirements in section 1111(b)(1)(E) of the ESEA for any children with disabilities under section 602(3) of the IDEA.
(d)
(1) Provide to IEP teams a clear explanation of the differences between assessments based on grade-level academic achievement standards and those based on alternate academic achievement standards, including any effects of State and local policies on a student's education resulting from taking an alternate assessment aligned with alternate academic achievement standards, such as how participation in such assessments may delay or otherwise affect the student from completing the requirements for a regular high school diploma; and
(2) Not preclude a student with the most significant cognitive disabilities who takes an alternate assessment aligned with alternate academic achievement standards from attempting to complete the requirements for a regular high school diploma.
(e)
(f)
(1) The number of children with disabilities participating in regular assessments, and the number of those children who were provided accommodations (that did not result in an invalid score) in order to participate in those assessments.
(2) The number of children with disabilities, if any, participating in alternate assessments based on grade-level academic achievement standards in school years prior to 2017–2018.
(3) The number of children with disabilities, if any, participating in alternate assessments aligned with modified academic achievement standards in school years prior to 2016–2017.
(4) The number of children with disabilities who are students with the most significant cognitive disabilities participating in alternate assessments aligned with alternate academic achievement standards.
(5) Compared with the achievement of all children, including children with disabilities, the performance results of children with disabilities on regular
(i) The number of children participating in those assessments is sufficient to yield statistically reliable information; and
(ii) Reporting that information will not reveal personally identifiable information about an individual student on those assessments.
The revision reads as follows:
(b) * * *
(4) * * *
(xi) To provide technical assistance to schools and LEAs, and direct services, including direct student services described in section 1003A(c)(3) of the ESEA, to children with disabilities, in schools or LEAs implementing comprehensive support and improvement activities or targeted support and improvement activities under section 1111(d) of the ESEA on the basis of consistent underperformance of the disaggregated subgroup of children with disabilities, including providing professional development to special and regular education teachers who teach children with disabilities, based on scientifically based research to improve educational instruction, in order to improve academic achievement based on the challenging academic standards described in section 1111(b)(1) of the ESEA.
20 U.S.C. 1431 through 1444, unless otherwise noted.
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is taking direct final action to approve revisions to the Great Basin Unified Air Pollution Control District (GBUAPCD) and the Town of Mammoth Lakes portion of the California State Implementation Plan (SIP). These revisions concern emissions of particulate matter (PM) from wood burning devices and road dust in the Town of Mammoth Lakes. We are approving local rules that regulate these emission sources under the Clean Air Act (CAA or the Act).
This rule is effective on August 29, 2017 without further notice, unless the EPA receives adverse comments by July 31, 2017. If we receive such comments, we will publish a timely withdrawal in the
Submit your comments, identified by Docket ID No. EPA–R09–OAR–2016–0409 at
Christine Vineyard, EPA Region IX, (415) 947–4125,
Throughout this document, “we,” “us,” and “our” refer to the EPA.
Table 1 lists the rules addressed by this action with the dates that they were adopted by the local agencies and submitted by the California Air Resources Board (CARB).
On December 11, 2014, the EPA determined that the submittal for GBUAPCD Rule 431 and Town of Mammoth Lakes Municipal Code Chapter 8.30 met the completeness criteria in 40 CFR part 51 Appendix V,
We approved earlier versions of Rule 431 and Municipal Code Chapter 8.30 into the SIP on October 31, 2007 (72 FR 61526) and June 24, 1996 (61 FR 32341), respectively. The GBUAPCD and Town of Mammoth Lakes adopted revisions to the SIP-approved rules on May 5, 2014 and May 7, 2014 respectively, and CARB submitted them to us on November 6, 2014.
PM, including PM equal to or less than 10 microns in diameter (PM
SIP rules must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), and must not modify certain SIP control requirements in nonattainment areas without ensuring equivalent or greater emissions reductions (see CAA section 193).
On October 5, 2015 (80 FR 60049), the EPA redesignated the Mammoth Lakes Planning Area to attainment of the 24-hour PM
Guidance and policy documents that we use to evaluate enforceability, revision/relaxation and rule stringency requirements for the applicable criteria pollutants include the following:
We believe these rules are consistent with the relevant policy and guidance regarding enforceability and SIP relaxations. The District is not including for SIP approval Rule 431 paragraphs M and N regarding fees and penalties, and similar provisions in Municipal Code Chapter 8.30, paragraphs 8.30.110 and 8.30.120. These paragraphs could lead to confusion with respect to similar federal requirements. The TSD has more information on our evaluation.
The TSD describes additional rule revisions that we recommend for the next time the local agencies modify the rules.
As authorized in section 110(k)(3) of the Act, the EPA is fully approving the submitted rules because we believe they fulfill all relevant requirements.
Please note that if the EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, the EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the GBUAPCD Rule 431 (except paragraphs M and N) and Town of Mammoth Lakes Chapter 8.30 (except paragraphs 8.30.110 and 8.30.120), described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents available through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 29, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the Proposed Rules section of today's
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements.
Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(c) * * *
(228) * * *
(i) * * *
(A) * * *
(
(
(350) * * *
(i) * * *
(A) * * *
(
(457) * * *
(i) * * *
(I) Great Basin Unified Air Pollution Control District.
(
(
This document was received for publication by the Office of the Federal Register on June 20, 2017.
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) Region 8 is publishing a direct final notice of Partial Deletion of the property currently owned by Tallgrass Energy Partners, LP, (formerly owned by KM Upstream LLC and hereinafter referred to as the former KMI
This partial deletion pertains to the former KMI Property. EPA is proposing to delete the entire former KMI Property from the NPL, including the groundwater (OU1) and the soil/former source area (OU2). The remaining areas and media of the Site for both OU1 and OU2 containing the volatile halogenated organic chemicals (VHOs) source soils and plume, which are attributable to the Dow Chemical Company/Dowell Schlumberger, Inc. (DOW/DSI) facility, will remain on the NPL and are not being considered for deletion as part of this action. However, this partial deletion does not preclude future actions under Superfund.
This direct final rule is effective August 29, 2017 unless EPA receives adverse comments by July 31, 2017. If adverse comments are received, EPA will publish a timely withdrawal of the direct final partial deletion in the
Submit your comments, identified by Docket ID No. EPA–HQ–SFUND–1990–0011, by one of the following methods:
•
•
•
•
Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.
Andrew Schmidt, Remedial Project Manager, 8EPR–SR, U.S. Environmental Protection Agency, Region 8, 1595 Wynkoop Street, Denver, CO 80202–1129, (303) 312–6283, email:
EPA Region 8 is publishing this direct final notice of Partial Deletion for the former KMI Property of the Mystery Bridge Road/U.S. Highway 20 Superfund Site (Site) from the National Priorities List (NPL). The former KMI Property includes areas of soil and groundwater formerly impacted by benzene, toluene, ethylbenzene, and total xylenes (collectively known as BTEX) contamination. A map and surveyed boundaries of the former KMI Property are included in the docket and at the information repositories listed above. The NPL constitutes Appendix B of 40 CFR part 300, which is the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), which EPA promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) of 1980, as amended. EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). This partial deletion of the Mystery Bridge Road/U.S. Highway 20 Superfund Site is proposed in accordance with 40 CFR 300.425(e) and is consistent with the Notice of Policy Change: Partial Deletion of Sites Listed on the NPL, 60 FR 55466 (Nov. 1, 1995). As described in § 300.425(e)(3) of the NCP, a portion of a site deleted from the NPL remains eligible for Fund-financed remedial action if future conditions warrant such actions.
Because EPA considers this action to be non-controversial and routine, this action will be effective August 29, 2017 unless EPA receives adverse comments
Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses the Mystery Bridge Road/U.S. Highway 20 Superfund Site and demonstrates how portions of the Site proposed for deletion meet the deletion criteria. Section V discusses EPA's action to partially delete the Site from the NPL unless adverse comments are received during the public comment period.
The NCP establishes the criteria that EPA uses to delete sites from the NPL. In accordance with 40 CFR Section 300.425(e), sites may be deleted from the NPL where no further response is appropriate. In making such a determination pursuant to 40 CFR 300.425(e), EPA will consider, in consultation with the state, whether any of the following criteria have been met:
i. Responsible parties or other persons have implemented all appropriate response actions required;
ii. All appropriate Fund-financed responses under CERCLA have been implemented, and no further response action by responsible parties is appropriate; or
iii. The remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, the taking of remedial measures is not appropriate.
Pursuant to CERCLA section 121(c) and the NCP, EPA conducts five-year reviews to ensure the continued protectiveness of remedial actions where hazardous substances, pollutants, or contaminants remain at a site above levels that allow for unlimited use and unrestricted exposure. EPA conducts such five-year reviews even if a site is deleted from the NPL. EPA may initiate further action to ensure continued protectiveness at a deleted site if new information becomes available that indicates it is appropriate. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system.
The following procedures apply to the deletion of the former KMI Property of the Site:
1. EPA has consulted with the State of Wyoming prior to developing this direct final Notice of Partial Deletion and the Notice of Intent for Partial Deletion co-published in the “Proposed Rules” section of the
2. EPA has provided the State 30 working days for review of this notice and the parallel Notice of Intent for Partial Deletion prior to their publication today. The State, through the Wyoming Department of Environmental Quality (WDEQ), has concurred on the partial deletion of the Site from the NPL.
3. Concurrent with the publication of this direct final Notice of Partial Deletion, a notice of the availability of the parallel Notice of Intent for Partial Deletion is being published in a major local newspaper, the Casper Star Tribune. The newspaper notice announces the 30-day public comment period concerning the Notice of Intent for Partial Deletion of the Site from the NPL.
4. The EPA placed copies of documents supporting the partial deletion in the deletion docket and made these items available for public inspection and copying at the Site information repositories identified above.
5. If adverse comments are received within the 30-day public comment period on this partial deletion action, EPA will publish a timely notice of withdrawal of this direct final Notice of Partial Deletion before its effective date and will prepare a response to comments and continue with the deletion process on the basis of the Notice of Intent for Partial Deletion and the comments already received.
Deletion of a portion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a portion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for further response actions, should future conditions warrant such actions.
The following information provides EPA's rationale for deleting the former KMI Property from the Mystery Bridge Road/U.S. Highway 20 Superfund Site.
The Mystery Bridge Road/U.S. Highway 20 Superfund Site (Site), EPA ID No. WYD981546005, is located in Natrona County, Wyoming northeast of Casper, Wyoming and one mile east of Evansville. The Site is bordered on the north by the North Platte River, on the west by the Sinclair Refinery (formerly known as the Little America Refining Company or LARCO), on the south by U.S. Highway 20 and on the east by Mystery Bridge Road. The northern two thirds of the Site contain residential housing units built primarily between 1973 and 1983. The former KN Energy (KN) facility, now owned by Tallgrass Energy Partners, LP, formerly owned by KM Upstream LLC and referred to in this Notice of Partial Deletion as the former KMI Property, and the adjacent Dow Chemical Company and Dowell-Schlumberger, Inc (DOW/DSI) facilities comprise the southern third of the Site. Site investigations, initiated due to resident complaints of poor water and air quality, were completed in 1986 and 1987 and identified a BTEX plume originating from the former KMI Property and a volatile halogenated organic chemicals (VHOs) plume originating from the DOW/DSI property, moving northeast towards the North Platte River. The Site was proposed for listing on the National Priorities List June 24, 1988 (53 FR 23996, 23749–24010 (June 24, 1988)), and was listed on the National Priorities List on August 30, 1990 (55 FR 35508, 35419–35554 (August 30, 1990)). Potential releases at the Sinclair Refinery (formerly LARCO) facility are currently being addressed under a RCRA 3008(h) order.
KM Upstream LLC and its predecessors have operated a natural gas fractionation, compression, cleaning, odorizing, and transmission plant at the Site since 1965. During the plant start-up, an underground pipe burst, injecting 5,000 to 10,000 gallons of absorption oil into the subsurface. Also, initially, an earthen flare pit was used to collect spent material generated by the facility. Absorption oil, emulsions, anti-foulants, and anti-corrosive agents, crude oil condensate, liquids accumulated in the flare stack, potassium hydroxide treated waste, and lubrication oils and blowdown materials from plant equipment were all possibly collected in
The DOW/DSI facility has conducted oil and gas production enhancement services for the oil and gas industry since the 1950's. Contamination originating from the DOW/DSI facility is believed to have come from the truck wash water disposal system (believed to have contained chlorinated solvents) and the toluene storage area on the northern end of the facility.
EPA is the lead agency for the Site, and WDEQ is the support agency. Pursuant to the 1991 Consent Decree, KN, its successor Kinder Morgan Inc. (KMI), and DOW/DSI have jointly conducted and funded the remediation work at the Site. The former KMI Property is in continued operation as mid-stream gas processing facility.
The Site was divided into two media-specific operable units (OUs). OU1 refers to the groundwater at the Site and OU2 refers to the source areas in the soil at the Site.
Numerous studies and remedial investigations conducted within the Site have addressed the former KMI Property. In December 1987, KN and DOW/DSI entered into Administrative Orders on Consent (AOCs) to perform removal actions at their respective facilities. Based on the findings of the initial investigation, each PRP was required to prepare an Engineering Evaluation/Cost Analysis (EE/CA) of its property to document the extent and nature of the contaminants present and to support proposals of expedited removal actions. The AOC also required the two PRPs to perform a Remedial Investigation/Feasibility Study (RI/FS) of the Brookhurst Subdivision site. The Mystery Bridge/U.S. Hwy 20 Superfund site includes the former KMI Property, the DOW/DSI property, several adjacent industrial properties, the Burlington Northern right-of-way and the Subdivision. The Brookhurst Subdivision RI/FS was submitted in June 1990 and concluded that two groundwater plumes originated from the industrial area, one from the DOW/DSI property containing VHOs and one from the former KMI Property contaminated with BTEX and suggested that the two plumes were not commingled.
In early 1988, Phase I and Phase II Environmental Site Assessments were performed on the former KMI Property, focusing on the area around the flare pit. Based on the free product findings, a Phase III Environmental Site Assessment, including a soil vapor survey, was conducted in mid-1988 to identify the extent of impacts. The EPA developed site-specific soil action levels (SALs) in 1988 for the former KMI Property that were based on toxicity data current at the time including:
In March 1989, the KN EE/CA was submitted to the EPA.
On July 14, 1989 the EPA signed an action memorandum, choosing the suggested response strategy outlined by the EE/CA. In November 1989, KN started the OU1 response actions, coupling a groundwater pump and treat system with a soil vapor extraction system, to remove BTEX contaminants in three phases: Soil vapor, floating product, and dissolved in groundwater. In September 1990, EPA issued a Record of Decision (ROD) dividing the Site into two operable units: OU1, groundwater contaminant plumes, and OU2, contaminated soils which represent a source for the groundwater contamination. The 1990 ROD selected a remedial action for OU1, the groundwater, and deferred selection of the remedial action for OU2. The OU1 ROD set out the following remedial action objectives (RAOs) for the BTEX contamination:
(1) Prevent ingestion of water containing benzene, toluene, ethylbenzene, or xylene at concentrations that either (a) exceed MCLs or proposed MCLs, or (b) Present a total carcinogenic risk range greater than 1 × 10
(2) Restore the alluvial aquifer to concentrations that both (a) meet the MCLs or proposed MCLs for benzene, toluene, ethylbezene, and xylene, and (b) Present a total carcinogenic risk range less than 1 × 10
The applicable MCLs for BTEX were the National Primary Drinking Water Regulations (40 CFR 141.61):
An institutional control to restrict the groundwater use was also included in the OU1 ROD. In October 1991, a Consent Decree, where parties agreed to implement the OU1 remedy, was signed between EPA, KN and DOW/DSI.
The KN OU1 remediation system operated from November 1989 to August 1996 and involved a pump-and-treat system, where the effluent was sent through an air stripper and a soil vapor extraction system. The clean effluent from the air stripper was returned to the subsurface. A groundwater monitoring plan (GWP) was developed in 1993 and specified that quarterly post-remedial action (RA) monitoring would begin after the remediation system was discontinued and 12 months of groundwater sampling results were below the MCLs.
KMI assumed responsibility for KN's portion of the Site when KMI purchased KN in 1999. After a minimum of eight quarterly post-RA sampling events were conducted where the 90 percent one-tailed upper confidence limit (UCL90) concentrations for benzene, ethylbenzene, toluene, and total xylenes were below the MCLs for each chemical, compliance with the RAOs for the BTEX groundwater plume was achieved. It was confirmed that the OU1 RAOs were achieved in 2010 and the results were recorded in the September 30, 2010 OU2 ROD.
KN, KMI, and DOW each conducted work at the Site under an Administrative Order on Consent that addressed the contaminated soils on their respective properties. The OU2 ROD served to document that this previous work was completed and that this work cleaned up the DOW/DSI property and the KMI Property to levels safe for industrial use. Contaminants have been left above levels that allow for unlimited use and unrestricted exposure and it is acknowledged that land uses around these properties are transitioning from rural to residential and commercial. The OU2 ROD concluded that ICs were necessary for future protectiveness. Specifically for the former KMI Property, the RAOs specified in the OU2 ROD include:
• Restricting the use of the KMI Property to industrial uses.
• Controlling the handling of excavated soils on the KMI Property.
The OU2 RAOs have been achieved through institutional controls placed on the former KMI Property and implemented through restrictive covenants within the deed transferring the KMI Property from KMI to KM
No operation and maintenance is required at the former KMI Property in addition to maintaining institutional controls.
Because the remedial action implemented for the former KMI Property results in contaminants remaining on site above concentrations that allow for unlimited use and unrestricted exposure, continued five-year reviews will be necessary to ensure that the remedy is protective of human health and the environment. The Fourth Five-Year Review for the Site, noted that the pump and treat remedy, as selected in the ROD, was shutdown prior to meeting cleanup levels at the site. Proper documentation for the shutdown, and Agency approval was identified for the decision to turn of the pump and treat system, and can be found in the deletion docket.
Public participation activities have been satisfied as required in CERCLA section 113(k), 42 U.S.C. 9613(k) and CERCLA section 117, 42 U.S.C. 9617. Documents in the partial deletion docket, which the EPA relied on for the partial deletion from the NPL, are available to the public in the information repositories, and a notice of availability of the Intent for Partial Deletion has been published in the Casper Star Tribune to satisfy public participation procedures required by 40 CFR 300.425(e)(4).
For the former KMI Property of both OU1 and OU2, EPA and the WDEQ have determined that the responsible parties completed all appropriate response actions required by the OU1 and OU2 Records of Decision and the 1991 Consent Decree. Additionally, institutional controls are in place that will limit property use to industrial purposes only and will control the handling of excavated soils and restrict ground water use to sampling only without further approval from EPA or the State. EPA has consulted with the State on the proposed partial deletion of the former KMI Property from OU1 and OU2 from the NPL prior to developing this notice of Partial Deletion.
Pursuant to CERCLA section 121(c) and the NCP, EPA will conduct the next five-year review by September 2019 to ensure the continued protectiveness of remedial actions where hazardous substances, pollutants, or contaminants remain at a site above levels that allow for unlimited use and unrestricted exposure.
The EPA, with the concurrence of the State of Wyoming through WDEQ, has determined that all appropriate response actions under CERCLA, other than maintenance of institutional controls and five-year reviews, have been completed. Therefore, EPA is deleting the former KMI Property, including the groundwater from OU1 and the soils/source area from OU2 of the Mystery Bridge Road/U.S. Highway 20 Superfund Site from the NPL.
Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication. This action will be effective August 29, 2017 unless EPA receives adverse comments by July 31, 2017. If adverse comments are received within the 30-day public comment period, EPA will publish a timely withdrawal of this direct final notice of partial deletion before the effective date of the partial deletion and it will not take effect. EPA will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to partially delete and the comments already received. There will be no additional opportunity to comment.
Environmental protection, Air pollution control, Chemicals, Hazardous waste, Hazardous substances, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply.
For the reasons set out in this document, 40 CFR part 300 is amended as follows:
33 U.S.C. 1321(c)(2); 42 U.S.C. 9601–9657; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923; 3 CFR, 1987 Comp., p. 193.
Federal Communications Commission.
Announcement of effective date.
In this document, the Federal Communications Commission (Commission) announces that the Office of Management and Budget (OMB) has approved the information collection requirements associated with the FCC 15–80, Updating Part 1 Competitive Bidding Rules, published on September 18, 2015. This document is consistent with FCC 15–80, which stated that the Commission would publish a document in the
FCC 15–80 and the changes to FCC Form 603 and FCC Form 608 published at 80 FR 56764 will become effective on June 30, 2017.
Cathy Williams by email at
This document announces that on June 8, 2017, OMB approved the information collection requirements, OMB Control Numbers 3060–0800 and 3060–1058, for changes to the FCC Forms 603 and 608.
As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that on June 8, 2017, OMB approved changes to FCC Form 603 and FCC Form 608. In doing so, OMB approved changes to the information collection requirements of OMB Control Numbers 3060–0800 and 3060–1058. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Numbers are 3060–0800 and 3060–1058.
The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104–13, October 1, 1995, and 44 U.S.C. 3507.
The total annual reporting burdens and costs for the respondents are as follows:
The purpose of this form is to obtain information sufficient to identify the parties to the proposed assignment or transfer, establish the parties' basic eligibility and qualifications, classify the filing, and determine the nature of the proposed service. Various technical schedules are required along with the main form applicable to Auctioned Services, Partitioning and Disaggregation, Undefined Geographical Area Partitioning, Notification of Consummation or Request for Extension of Time for Consummation.
The data collected on FCC Form 603 includes the FCC Registration Number (FRN), which serves as a “common link” for all filings an entity has with the FCC. The Debt Collection Improvement Act of 1996 requires entities filing with the Commission use an FRN.
The OMB approved revisions to the previously approved collection of information under OMB Control Number 3060–0800 to permit the collection of the additional information for Commission licenses and permits, pursuant to the rules and information collection requirements adopted by the Commission in the Part 1 R&O and the Mobile Spectrum Holdings R&O. As part of the collection, the Commission is seeking approval for the information collection and recordkeeping requirements associated with FCC Form 603.
In addition, OMB approved various other, non-substantive editorial/consistency edits and updates to FCC Form 603 that corrected inconsistent capitalization of words and other typographical errors, and better align the text on the form with the text in the Commission rules both generally and in connection with recent non-substantive, organizational amendments to the Commission's rules. Also, in certain circumstances, the Commission requires the applicant to provide copies of their agreements. The Commission did not anticipate that these revisions will impact the collection filing burden. OMB therefore approved the FCC revision of its currently approved information collection on FCC Form 603 to revise FCC Form 603 accordingly.
The OMB approved revisions to the previously approved collection of information under OMB Control Number 3060–1058 to permit the collection of the additional information for Commission licenses and permits, pursuant to the rules and information collection requirements adopted by the Commission in the Part 1 R&O and the Mobile Spectrum Holdings R&O. As part of the collection, the Commission is seeking approval for the information collection and recordkeeping requirements associated with FCC Form 608.
In addition, OMB approved various other, non-substantive editorial/consistency edits and updates to FCC Form 608 that corrected inconsistent capitalization of words and other typographical errors, and better align the text on the form with the text in the Commission rules both generally and in connection with recent non-substantive, organizational amendments to the Commission's rules. Also, in certain circumstances, the Commission requires the applicant to provide copies of their agreements. The Commission did not anticipate that these revisions will impact the collection filing burden. OMB therefore approved the FCC revision of its currently approved information collection on FCC Form 608 to revise FCC Form 608 accordingly.
Federal Communications Commission.
Final rule.
In this document, the Federal Communications Commission (Commission) describes the information that must be provided in periodic progress reports (FCC Form 2100—Schedule 387 (Transition Progress Report)) by full power and Class A television stations that are not eligible to receive payment of relocation expenses from the TV Broadcast Relocation Fund in connection with their being assigned to a new channel through the Incentive Auction.
Effective June 30, 2017.
Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.
Joyce Bernstein,
This is a summary of the Commission's document, DA 17–484, MB Docket No. 16–306, GN Docket No. 12–268, adopted and released May 18, 2017. The complete text of this document is available for inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY–A257, Washington, DC 20554. The complete text of this document is also available for download at
The Incentive Auction Task Force and Media Bureau (collectively, the Commission) previously determined that stations that are eligible for reimbursement from the TV Broadcast Relocation Fund in connection with their being assigned to a new channel through the Incentive Auction must file reports showing how the disbursed funds have been spent and what portion of the stations' construction in complete, and sought comment on whether non-reimbursable stations should also file reports to show what portion of the stations' construction is complete. These Transition Progress Reports will help the Commission, broadcasters, those involved in construction of broadcast facilities, other interested parties, and the public to monitor the construction of stations.
The Commission announces that each full power and Class A television station that will be changing channels during the post-incentive auction transition and is not eligible for reimbursement of its relocation costs from the TV Broadcast Relocation Fund established by the Middle Class Tax Relief and Job Creation Act of 2012 must follow the same progress reporting requirements as reimbursable stations and periodically file an FCC Form 2100—Schedule 387 (Transition Progress Report) that is attached as Appendix A to the Public Notice DA 17–34. The appendix is available at
Some commenters proposed changes to questions in the Transition Progress Report Form adopted for reimbursable stations and certain filing procedures, which the Commission treated as requests for reconsideration and declined to adopt. The Commission declined to incorporate the response of “unknown at this time” into the form for each question, to change the wording of a question dealing with auxiliary antenna systems, to require a more detailed level of reporting with respect to a number of questions, to require reports to be filed on a less frequent basis, or to allow group owners to file a single report for all of their stations.
The Commission will send a copy of the document, DA 17–484, in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act,
As required by the Regulatory Flexibility Act of 1980, as amended (“RFA”), an Initial Regulatory Flexibility Analysis (“IRFA”) was incorporated in the
The Commission has estimated the number of licensed commercial television stations to be 1,384. Of this total, 1,264 stations (or about 91 percent) had revenues of $38.5 million or less, according to Commission staff review of the BIA Kelsey Inc. Media Access Pro Television Database (BIA) on February 24, 2017, and therefore these licensees qualify as small entities under the SBA definition. In addition, the Commission has estimated the number of licensed noncommercial educational (NCE) television stations to be 394. Notwithstanding, the Commission does not compile and otherwise does not have access to information on the revenue of NCE stations that would permit it to determine how many such stations would qualify as small entities.
We note, however, that in assessing whether a business concern qualifies as small under the above definition, business (control) affiliations must be included. Our estimate, therefore, likely overstates the number of small entities that might be affected by our action, because the revenue figure on which it is based does not include or aggregate revenues from affiliated companies. In addition, an element of the definition of “small business” is that the entity not be dominant in its field of operation. We are unable at this time to define or quantify the criteria that would establish whether a specific television station is dominant in its field of operation. Accordingly, the estimate of small businesses to which rules may apply does not exclude any television station from the definition of a small business on this basis and is therefore possibly over-inclusive to that extent.
The reporting requirement adopted in the Public Notice will allow the Commission, broadcasters (including those filing the Reports), and other interested parties to more closely monitor the status of construction during the transition, and focus resources on ensuring successful completion of the transition by all reassigned stations and continuity of over-the-air television service. In addition, the burdens of the reporting requirements are minimal and we believe the benefits of the reporting requirements, which will facilitate the successful post-incentive auction transition, outweigh any burdens associated with compliance.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
NMFS issues regulations to implement Amendment 36 to the Fishery Management Plan (FMP) for the Snapper-Grouper Fishery of the South Atlantic Region as prepared and submitted by the South Atlantic Fishery Management Council (Council). This final rule modifies the FMP framework procedures to allow spawning special management zones (SMZs) to be established or modified through the framework process; establishes spawning SMZs off North Carolina, South Carolina, and Florida; establishes transit and anchoring provisions in the spawning SMZs; and establishes a sunset provision for most of the spawning SMZs. This final rule also moves the boundary of the existing Charleston Deep Artificial Reef Marine Protected Area (MPA). The purpose of this final rule is to protect spawning snapper-grouper species and the habitat where they spawn, and to reduce bycatch and bycatch mortality for snapper-grouper species, including speckled hind and warsaw grouper.
This final rule is effective July 31, 2017.
Electronic copies of Amendment 36 may be obtained from
Frank Helies, NMFS Southeast Regional Office, telephone: 727–824–5305, or email:
The snapper-grouper fishery in the South Atlantic region is managed under the FMP and includes speckled hind and warsaw grouper, along with other snapper-grouper species. The FMP was prepared by the Council and is implemented by NMFS through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).
On January 4, 2017, NMFS published a notice of availability of Amendment 36 and requested public comment (82 FR 810). On January 18, 2017, NMFS published the proposed rule to implement Amendment 36 and requested public comment (82 FR 5512). The proposed rule and Amendment 36 outline the rationale for the actions contained in this final rule. A summary of the actions implemented by Amendment 36 and this final rule is provided below.
This final rule modifies the FMP framework procedures to allow spawning SMZs to be established or modified through the framework process; establishes spawning SMZs off North Carolina, South Carolina, and Florida; establishes transit and anchoring provisions in the spawning SMZs; establishes a sunset provision for
The current FMP contains framework procedures to allow the Council to modify certain management measures, such as annual catch limits and other management measures, via an expedited process (see 50 CFR 622.194; 56 FR 56016, October 31, 1991). In Amendment 36 and this final rule, the Council has included changes to spawning SMZs, such as boundary modifications and the establishment or removal of spawning SMZs, under the framework process. For example, this final rule allows the Council to remove a spawning SMZ if monitoring efforts do not document evidence of spawning snapper-grouper species within the boundary. The revisions to the FMP framework procedures also allow the Council to remove the 10-year sunset provision for a spawning SMZ if monitoring efforts document snapper-grouper species' spawning inside a spawning SMZ. The Council decided that changing spawning SMZs through an expedited process can have beneficial biological and socio-economic impacts, especially if the changes respond to newer information, such as spawning locations for snapper-grouper species. The Council concluded that the framework process will allow adequate time for the public to comment on any proposed change related to a spawning SMZ.
The Council is establishing five snapper-grouper spawning SMZs in the South Atlantic off North Carolina, South Carolina, and Florida. This final rule prohibits fishing for or harvest of snapper-grouper species year-round in the spawning SMZs. The final rule establishes other restrictions in the spawning SMZs, including transiting with snapper-grouper species on board and anchoring.
The spawning SMZ off North Carolina is called South Cape Lookout (5.1 sq mi; 13.2 sq km). The final rule establishes three spawning SMZs off South Carolina that are called Devil's Hole/Georgetown Hole (3.03 sq mi; 7.8 sq km), Area 51 (approximately 3 sq mi; 7.8 sq km), and Area 53 (approximately 3 sq mi; 7.8 sq km). The spawning SMZ off the east coast of the Florida Keys is called Warsaw Hole/50 Fathom Hole (3.64 sq mi; 9.4 sq km).
Another purpose of spawning SMZs is to reduce bycatch and bycatch mortality of snapper-grouper species, including speckled hind and warsaw grouper. Currently, retention of speckled hind and warsaw grouper is prohibited in Federal waters in the South Atlantic. Prohibiting the targeting or harvest of snapper-grouper species in specified areas where these species are known to occur and possibly spawn is expected to reduce encounters with these deep-water species and provide protection for reproduction. The Council concluded that protecting snapper-grouper species within the spawning SMZs could enhance the opportunity for these species to reproduce and introduce more eggs and larvae into the environment.
This final rule allows fishing vessels to transit through the spawning SMZs with snapper-grouper species on board only when fishing gear is properly stowed. “Properly stowed” means that trawl or try nets and the attached doors must be out of the water, but are not be required to be on deck or secured below deck. Terminal gear (hook, leader, sinker, flasher, or bait) used with automatic reels, bandit gear, buoy gear, handline, or rod and reel would have to be disconnected and stowed separately from such fishing gear and sinkers would have to be disconnected from down riggers and stowed separately. Except under the limited condition to possess snapper-grouper species while transiting a spawning SMZ with fishing gear properly stowed, vessels in the spawning SMZs are prohibited from fishing for, harvesting, or possessing snapper-grouper species year-round in these areas. Except for the Area 51 and Area 53 Spawning SMZs off South Carolina, persons on board a fishing vessel are not allowed to anchor, use an anchor or chain, or use a grapple and chain while in spawning SMZs. Fishermen continue to be allowed to troll for pelagic species such as dolphin, tuna, and billfish in spawning SMZs.
This final rule implements a 10-year sunset provision for the establishment of the spawning SMZs, except for the Area 51 and Area 53 Spawning SMZs, which will remain in effect indefinitely. Therefore, except for Areas 51 and 53, the spawning SMZs and their associated management measures are effective for 10 years following the implementation of this final rule for Amendment 36. For the spawning SMZs and management measures subject to the sunset provision to extend beyond 10 years, the Council would need to take further action. The Council will regularly evaluate all of the spawning SMZs over the 10-year period.
This final rule moves the existing Charleston Deep Artificial Reef MPA 1.4 mi (2.3 km) northwest to match the boundary of the U.S. Army Corps of Engineers' permitted artificial reef area at that location. This final rule does not change the size of the existing MPA. The Council originally designated the current area as an artificial reef site in Amendment 14 to the FMP (74 FR 1621, January 13, 2009). The State of South Carolina has worked with the U.S. Army Corps of Engineers to modify the boundary of this site to include material recently sunk by the state in the area and requested that the Council shift their boundary of the existing Charleston Deep Artificial Reef MPA to match the new boundary of the U.S. Army Corps of Engineers' permitted artificial reef area.
In addition to the management measures that this final rule implements, Amendment 36 includes an action to modify the SMZ procedures in the FMP to allow for the designation of spawning SMZs. The Council will be able to designate important spawning areas as spawning SMZs to provide additional protection to some existing Essential Fish Habitat-Habitat Areas of Particular Concern for snapper-grouper species. The Council concluded that designating areas as spawning SMZs is important to protect snapper-grouper species and habitat where snapper-grouper species spawn. Additionally, the Council concluded that designating the spawning SMZ sites through this final rule, and subsequent changes to regulations, would enhance reproduction for snapper-grouper species and thus increase the number of eggs and larvae that are produced by the species.
NMFS received a total of 101 comments on the notice of availability and proposed rule for Amendment 36. The commenters included commercial, private recreational, and charter vessel fishing entities, as well as recreational divers, non-governmental organizations, and individuals from the general public. Comments both supported additional protections for spawning fish through
NMFS disagrees that spatial closures are not a viable management option for protecting spawning snapper-grouper species. Areas closed to protect known spawning locations of fish species have been shown to provide positive biological and socio-economic benefits. The spawning SMZs implemented by this final rule are expected to result in additional protections for spawning snapper-grouper, while potentially providing positive economic effects by increasing future stock size and sustainability. Should monitoring efforts highlight the need for the adjustment of an area or the removal of a spawning SMZ if spawning snapper-grouper species are not documented in the area, this final rule will allow the Council to modify spawning SMZs. If the Council does not take any subsequent action to modify or renew the spawning SMZs, most of the spawning SMZs would expire automatically after the 10-year sunset provision in this final rule.
NMFS acknowledges that there may be short-term negative social and economic impacts from the spawning SMZ being implemented for Warsaw Hole. The Council considered these economic impacts but determined that the enhanced reproduction for snapper-grouper species and, subsequently, the increased the number of eggs and larvae that are produced as a result of this added protection, would be expected to result in long-term indirect economic benefits to commercial and recreational fishermen. In the end, the Council concluded that the 3.6-square mile area for the Warsaw Hole Spawning SMZ best meets the objectives of Amendment 36 by creating positive impacts, while balancing both short and long-term social and economic impacts.
The Regional Administrator for the NMFS Southeast Region has determined that this final rule is consistent with Amendment 36, the FMP, the Magnuson-Stevens Act, and other applicable laws.
This final rule has been determined to be not significant for purposes of Executive Order 12866.
The Magnuson-Stevens Act provides the statutory basis for this rule. No duplicative, overlapping, or conflicting Federal rules have been identified. In addition, no new reporting, record-keeping, or other compliance requirements are introduced by this final rule.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this rule would not have a significant economic impact on a substantial number of small entities. The factual basis for this determination was published in the proposed rule and is not repeated here. Public comments relating to socio-economic implications and potential impacts on small businesses are addressed in the responses to Comments 2, 3, and 4 in the Comments and Responses section of this final rule. No comments were received regarding the certification and NMFS has not received any new information that would affect its determination. As a result, a final regulatory flexibility analysis was not required and none was prepared.
In this final rule, NMFS makes one change to the coordinates table for the Devil's Hole/Georgetown Hole Spawning SMZ. In the proposed rule, the coordinate points for this spawning SMZ were listed in a counter-clockwise order when plotted on a map or chart. The points for all other coordinate tables of the spawning SMZs in the proposed rule were listed in a clockwise order. This final rule revises the order of the coordinates for the Devil's Hole/Georgetown Hole Spawning SMZ to list them in a clockwise order, to be consistent with the other spawning SMZs in this final rule.
Fisheries, Fishing, Marine protected area, South Atlantic, Special management zone.
For the reasons set out in the preamble, 50 CFR part 622 is amended as follows:
16 U.S.C. 1801
(a) * * *
(1) * * *
(i) * * *
(D) * * *
(2)
(ii)
(iii)
(iv)
(v)
(vi)
(vii) For the purpose of paragraph (a)(2)(i) of this section, transit means direct, non-stop progression through the spawning SMZ. Fishing gear appropriately stowed means—
(A) A longline may be left on the drum if all gangions and hooks are disconnected and stowed below deck. Hooks cannot be baited. All buoys must be disconnected from the gear; however, buoys may remain on deck.
(B) Trawl doors and nets must be out of the water, but the doors are not required to be on deck or secured on or below deck.
(C) A gillnet, stab net, or trammel net must be left on the drum. Any additional such nets not attached to the drum must be stowed below deck.
(D) Terminal gear (
(E) A crustacean trap, golden crab trap, or sea bass pot cannot be baited. All buoys must be disconnected from the gear; however, buoys may remain on deck.
(a) Biomass levels, age-structured analyses, target dates for rebuilding overfished species, MSY (or proxy), OY, ABC, TAC, quotas (including a quota of zero), annual catch limits (ACLs), annual catch targets (ACTs), AMs, maximum fishing mortality threshold (MFMT), minimum stock size threshold (MSST), trip limits, bag limits, size limits, gear restrictions (ranging from regulation to complete prohibition), seasonal or area closures, fishing year, rebuilding plans, definitions of essential fish habitat, essential fish habitat, essential fish habitat HAPCs or Coral HAPCs, restrictions on gear and fishing activities applicable in essential fish habitat and essential fish habitat HAPCs, and establish or modify spawning SMZs.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
NMFS issues this rule to implement annual management measures and harvest specifications to establish the allowable catch levels (
Effective July 1, 2017 through June 30, 2018.
Joshua Lindsay, West Coast Region, NMFS, (562) 980–4034,
NMFS manages the Pacific sardine fishery in the U.S. EEZ off the Pacific coast (California, Oregon, and Washington) in accordance with the CPS FMP. Annual specifications published in the
The FMP and its implementing regulations require NMFS to set these annual catch levels for the Pacific sardine fishery based on the annual specification framework and control
1.
2.
3.
4.
As described above, the Pacific sardine HG control rule, the primary mechanism for setting the annual directed commercial fishery quota, includes a CUTOFF parameter, which has been set as a biomass level of 150,000 mt. This amount is subtracted from the annual biomass estimate before calculating the applicable HG for the fishing year. Since this year's biomass estimate is below that value, the formula results in an HG of zero, and no Pacific sardine are available for the primary commercial directed fishery during the 2017–2018 fishing season.
At the April 2017 Pacific Fishery Management Council (Council) meeting, the Council's Science and Statistical Committee (SSC) approved, and the Council adopted, the “Assessment of the Pacific Sardine Resource in 2017 for U.S. Management in 2017–2018,” which was prepared by NMFS Southwest Fisheries Science Center. The resulting Pacific sardine biomass estimate of 86,586 mt is the best available science for setting harvest specifications. Based on recommendations from its SSC and other advisory bodies, the Council recommended, and NMFS is implementing, an OFL of 16,957 mt, an ABC of 15,497 mt, and a prohibition on Pacific sardine catch, unless it is harvested as part of either the live bait or tribal fishery or incidental to other fisheries for the 2017–2018 Pacific sardine fishing year. As additional management measures, the Council also recommended, and NMFS is implementing through this action, an ACL of 8,000 mt and that the incidental catch of Pacific sardine in other CPS fisheries be managed with the following automatic inseason actions to reduce the potential for both targeting and discard of Pacific sardine:
• An incidental per landing by weight allowance of 40 percent Pacific sardine in non-treaty CPS fisheries until a total of 2,000 mt of Pacific sardine are landed.
• When 2,000 mt are landed, the incidental per landing allowance will be reduced to 20 percent until a total of 5,000 mt of Pacific sardine have been landed.
• When 5,000 mt have been landed, the incidental per landing allowance will be reduced to 10 percent for the remainder of the 2017–2018 fishing year.
Pacific sardine is known to comingle with other CPS stocks; thus, these incidental allowances are established to allow for the continued prosecution of these other important CPS fisheries and reduce the potential discard of sardine. Additionally, an incidental per landing allowance is allowed in non-CPS fisheries: Up to 2 mt may be landed per trip.
The NMFS West Coast Regional Administrator will publish a notice in the
As explained in the proposed rule, the Quinault Indian Nation requested a set-aside for tribal harvest of 800 mt (the same amount that was requested and approved for 2016–2017). NMFS considered this request and, per this action, 800 mt of the 2017–2018 ACL are being set aside for tribal harvest.
Detailed information on the fishery and the stock assessment are found in the report “Assessment of the Pacific Sardine Resource in 2017 for U.S. Management in 2017–2018” (see
On May 30, 2017, NMFS published a proposed rule for this action and solicited public comments (82 FR 24656), with a public comment period that ended on June 14, 2017. NMFS received one comment letter—explained below—during the comment period. After consideration of the public comment, no changes were made from the proposed rule. For further background information on this action please refer to the preamble of the proposed rule. NMFS summarizes and responds below to the comment letter below.
In addition to commenting on the proposed rule, the bulk of the comment described various scientific papers and requested reconsideration of various aspects of sardine management including the Minimum Stock Size Threshold value as well as aspects of the harvest guideline control rule, including but not limited to the existing CUTOFF parameter and the DISTRIBUTION parameter. (These parameters, as well as other changes to the sardine harvest control rule and management are set in the CPS Plan and are beyond the scope of this rulemaking; therefore, they will not be addressed below.)
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Fishery Conservation and Management Act, the NMFS West Coast Regional Administrator, with the concurrence of the Assistant Administrator, has determined that this final rule is consistent with the CPS FMP, other provisions of the Magnuson-Stevens Fishery Conservation and Management Act, and other applicable laws.
NMFS finds good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effectiveness for the establishment of these final harvest specifications for the 2017–2018 Pacific sardine fishing season. In accordance with the FMP, this rule was recommended by the Council at its meeting in April 2017, the contents of which were based on the best available new scientific information on the population status of Pacific sardine that became available at that time. Making these final specifications effective on July 1, 2017, is necessary for the conservation and management of the Pacific sardine resource. The FMP requires a prohibition on directed fishing for Pacific sardine for the 2017–2018 fishing year because the sardine biomass is below the CUTOFF. The purpose of the CUTOFF in the FMP—and prohibiting directed fishing when the biomass drops below this level—is to protect the stock when biomass is low and provide a buffer of spawning stock that is protected from fishing and available for use in rebuilding the stock. A delay in the effectiveness of this rule for a full 30 days would not allow the implementation of this prohibition prior to the expiration of the closure of the directed fishery on July 1, 2017, which was imposed under the 2016–2017 annual specifications.
Delaying the effective date of this rule beyond July 1 would be contrary to the public interest because reducing Pacific sardine biomass beyond the limits set out in this action could decrease the sustainability of the Pacific sardine, as well as cause future harvest limits to be even lower under the harvest control rule, thereby reducing future profits of the fishery.
These final specifications are exempt from review under Executive Order 12866.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required and none was prepared.
This action does not contain a collection-of-information requirement for purposes of the Paper Reduction Act.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final specifications.
NMFS specifies an annual catch limit (ACL) of 306,000 lb for Deep 7 bottomfish in the main Hawaiian Islands (MHI) for the 2017–18 fishing year, which will begin on September 1, 2017, and end on August 31, 2018. If NMFS projects that the fishery will reach the ACL, NMFS would close the commercial and non-commercial fisheries for MHI Deep 7 bottomfish for the remainder of the fishing year as an accountability measure (AM). The ACL and AM support the long-term sustainability of Hawaii bottomfish.
The final specifications are effective from July 31, 2017, through August 31, 2018.
Copies of the Fishery Ecosystem Plan for the Hawaiian Archipelago are available from the Western Pacific Fishery Management Council (Council), 1164 Bishop St., Suite 1400, Honolulu, HI 96813, tel. 808–522–8220, fax 808–522–8226, or
Sarah Ellgen, NMFS PIR Sustainable Fisheries, 808–725–5173.
Through this action, NMFS is specifying an ACL of 306,000 lb of Deep 7 bottomfish in the MHI for the 2017–18 fishing year. The fishing year begins September 1, 2017, and ends on August 31, 2018. The Council recommended this ACL, based on the best available scientific, commercial, and other information, taking into account the associated risk of overfishing. The ACL of 306,000 lb for 2017–18 is 12,000 lb less than the ACL that NMFS specified for 2016–17 (82 FR 5429, January 18, 2017).
The MHI Management Subarea is the portion of U.S. Exclusive Economic Zone around the Hawaiian Archipelago east of 161°20′ W. The Deep 7 bottomfish are onaga (
NMFS will monitor the fishery and, if we project that the fishery will reach the ACL before August 31, 2018, we would, as an AM authorized in 50 CFR 665.4(f), close the non-commercial and commercial fisheries for Deep 7 bottomfish in Federal waters through August 31, 2018. During a fishery closure for Deep 7 bottomfish, no person may fish for, possess, or sell any of these fish in the MHI Management Subarea.
You may review additional background information on this action in the preamble to the proposed specifications (82 FR 24092; May 25, 2017); we do not repeat that information here.
The comment period for the proposed specifications ended on June 9, 2017. NMFS did not receive any comments.
There are no changes in the final specifications from the proposed specifications.
The Regional Administrator, NMFS PIR, determined that this action is necessary for the conservation and management of MHI Deep 7 bottomfish, and that it is consistent with the Magnuson-Stevens Act and other applicable laws.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed specification stage that this action would not have a significant economic impact on a substantial number of small entities. NMFS published the factual basis for the certification in the proposed specifications, and does not repeat it here. NMFS did not receive comments regarding this certification. As a result, a final regulatory flexibility analysis is not required, and one was not prepared.
This action is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Request for information (“RFI”).
The U.S. Department of Energy (“DOE”) is initiating a data collection process through this request for information to consider whether to amend DOE's test procedures for consumer refrigerators, refrigerator-freezers, and freezers. To inform interested parties and to facilitate this process, DOE has gathered data, identifying several issues associated with the currently applicable test procedures on which DOE is interested in receiving comment. The issues outlined in this document mainly concern testing products with newly-available features, the inclusion of automatic icemaker energy use, built-in product test configuration, any issues with the current test procedure that need to be addressed, and any additional topics that may inform DOE's decisions in a future test procedure rulemaking, including methods to reduce regulatory burden while ensuring the procedure's accuracy. DOE welcomes written comments from the public on any subject within the scope of this document (including topics not raised in this request for information).
Written comments and information are requested and will be accepted on or before July 31, 2017.
Interested persons are encouraged to submit comments using the Federal eRulemaking Portal at
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No telefacsimilies (faxes) will be accepted. For detailed instructions on submitting comments and additional information on the rulemaking process, see section III of this document.
The docket Web page can be found at
Dr. Stephanie Johnson, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE–5B, 1000 Independence Avenue SW., Washington, DC, 20585–0121. Telephone: (202) 287–1943. Email:
Mr. Michael Kido, U.S. Department of Energy, Office of the General Counsel, GC–33, 1000 Independence Avenue SW., Washington, DC 20585–0121. Telephone: (202) 586–8145. Email:
For further information on how to submit a comment, review other public comments and the docket, or participate in the public meeting, contact the Appliance and Equipment Standards Program staff at (202) 586–6636 or by email:
Consumer refrigerators, refrigerator-freezers, and freezers are included in the list of “covered products” for which DOE is authorized to establish and amend energy conservation standards and test procedures. (42 U.S.C. 6292(a)(1)) DOE's test procedures for consumer refrigerators, refrigerator-freezers, and freezers are prescribed at title 10 of the Code of Federal Regulations (“CFR”) part 430, subpart B, appendices A and B (“Appendices A and B”). The following sections discuss DOE's authority to establish and amend test procedures for consumer refrigerators, refrigerator-freezers, and freezers, as well as relevant background information regarding DOE's consideration of test procedures for these products.
The Energy Policy and Conservation Act of 1975 (“EPCA” or “the Act”),
Under EPCA, DOE's energy conservation program consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. Relevant provisions of the Act specifically include definitions (42 U.S.C. 6291), energy conservation standards (42 U.S.C. 6295), test procedures (42 U.S.C. 6293), labeling provisions (42 U.S.C. 6294), and the authority to require information and reports from manufacturers (42 U.S.C. 6296).
Federal energy efficiency requirements for covered products established under EPCA generally supersede State laws and regulations concerning energy conservation testing, labeling, and standards. (See 42 U.S.C. 6297) DOE may, however, grant waivers of Federal preemption for particular State laws or regulations, in accordance with the procedures and other provisions of EPCA. (42 U.S.C. 6316(b)(2)(D))
The Federal testing requirements consist of test procedures that manufacturers of covered products must use as the basis for: (1) Certifying to DOE that their products comply with the applicable energy conservation standards adopted pursuant to EPCA (42 U.S.C. 6295(s)), and (2) making representations about the efficiency of those consumer products (42 U.S.C. 6293(c)). Similarly, DOE must use these test procedures to determine whether the products comply with relevant standards promulgated under EPCA. (42 U.S.C. 6295(s))
Under 42 U.S.C. 6293, EPCA sets forth the criteria and procedures DOE must follow when prescribing or amending test procedures for covered products. EPCA requires that any test procedures prescribed or amended under this section be reasonably designed to produce test results which measure energy efficiency, energy use or estimated annual operating cost of a covered product during a representative average use cycle or period of use and not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3))
In addition, if DOE determines that a test procedure amendment is warranted, it must publish proposed test procedures and offer the public an opportunity to present oral and written comments on them. (42 U.S.C. 6293(b)(2))
EPCA also requires that, at least once every 7 years, DOE evaluate test procedures for each type of covered product, including consumer refrigerators, refrigerator-freezers, and freezers, to determine whether amended test procedures would more accurately or fully comply with the requirements for the test procedures to not be unduly burdensome to conduct and be reasonably designed to produce test results that reflect energy efficiency, energy use, and estimated operating costs during a representative average use cycle. (42 U.S.C. 6293(b)(1)(A)) If amended test procedures are appropriate, DOE must publish a final rule to incorporate the amendments. If DOE determines that test procedure revisions are not appropriate, DOE must publish its determination not to amend the test procedures. DOE is publishing this RFI to collect data and information to inform a potential test procedure rulemaking to satisfy the 7-year review requirement specified in EPCA, which requires that DOE publish, by April 21, 2021, either a final rule amending the test procedures or a determination that amended test procedures are not required. (42 U.S.C. 6293(b)(1)(A))
DOE's current test procedures for refrigerators, refrigerator-freezers, and freezers are the result of numerous evolutionary steps taken since DOE initially established its test procedures for these products in a final rule published in the
On August 31, 1989, DOE amended the test procedure further when it published a final rule establishing test procedures for variable-defrost control refrigeration products, dual-compressor refrigerator-freezers, and freezers equipped with “quick-freeze” (54 FR 36238).
DOE amended the test procedures again on March 7, 2003, by modifying the test period used for products equipped with long-time automatic defrost or variable defrost (68 FR 10957).
On December 16, 2010, DOE made its most recent significant modifications to the test procedures when it published a final and interim final rule establishing the test procedures in Appendices A and B (75 FR 78810). That rule established a number of comprehensive changes to help improve the measurement of energy consumption of refrigerators, refrigerator-freezers, and freezers. These changes included, among other things: (1) Adjusting the standardized compartment temperatures and volume-adjustment factors, (2) adding new methods for measuring compartment volumes, (3) modifying the long-time automatic defrost test procedure to measure all energy use associated with the defrost function, and (4) adding test procedures for products with a single compressor and multiple evaporators with separate active defrost cycles. Lastly, the interim final rule addressed icemaking energy use by including a fixed energy use adder for those products equipped with an automatic icemaker. Using available data submitted by the industry, this value was set at 84 kilowatt-hours (kWh) per year.
On July 10, 2013, DOE proposed further amending the consumer refrigerator and refrigerator-freezer test procedure to address products with multiple compressors and to allow an alternative method for measuring and calculating energy consumption for refrigerator-freezers and refrigerators with freezer compartments, (78 FR 41610, “2013 NOPR”). DOE also proposed to amend certain aspects of the consumer refrigerator, refrigerator-freezer, and freezer test procedures to ensure better accuracy and repeatability. Additionally, DOE solicited comment on a proposed automatic icemaker test procedure and on whether built-in
On April 21, 2014, DOE published a final rule for the refrigerator, refrigerator-freezer, and freezer test procedures (the “2014 final rule”), (79 FR 22320). The amendments enacted by the 2014 final rule addressed products with multiple compressors and established an alternative method for measuring and calculating energy consumption for refrigerator-freezers and refrigerators with freezer compartments. The 2014 final rule also amended certain aspects of the test procedures to improve test accuracy and repeatability. To allow time to review comments and data received during the comment period extension, DOE did not address automatic ice making energy use or built-in testing configuration in the 2014 final rule.
On July 18, 2016, DOE published a final rule that established coverage and test procedures for a variety of refrigeration products collectively described as “miscellaneous refrigeration products” (“MREFs”), (81 FR 46768). Included within this category are refrigeration products that include one or more compartments that maintain higher temperatures than typical refrigerator compartments, such as wine chillers and beverage coolers. Additionally, the final rule amended Appendices A and B to include provisions for testing MREFs and to improve the clarity of certain existing test requirements.
In the following sections, DOE has identified a variety of issues on which it seeks input to aid in the development of the technical and economic analyses regarding whether amended test procedures for consumer refrigerators, refrigerator-freezers, and freezers may be warranted. Specifically, DOE is requesting comment on any opportunities to streamline and simplify testing requirements for refrigerators, refrigerator-freezers, and freezers.
Additionally, DOE welcomes comments on other issues relevant to the conduct of this rulemaking that may not specifically be identified in this document. In particular, DOE notes that under E.O. 13771, executive branch agencies such as DOE are directed to manage the costs associated with the imposition of expenditures required to comply with Federal regulations. See 82 FR 9339 (Feb. 3, 2017) (E.O. 13771 “Reducing Regulation and Controlling Regulatory Costs”). Pursuant to that executive order, DOE encourages the public to provide input on measures DOE could take to lower the cost of its regulations applicable to consumer refrigerators, refrigerator-freezers, and freezers consistent with the requirements of EPCA.
DOE's test procedures for refrigerators, refrigerator-freezers, and freezers are intended to represent operation in typical room conditions with door openings by testing at an elevated ambient temperature with no door openings. 10 CFR 430.23(a)(7). The increased thermal load from the elevated ambient temperature is intended to represent the thermal load that would be associated with both door openings as cool cabinet air mixes with warmer ambient air and the loading of warmer items in the cabinet.
DOE is aware of certain products available on the market that incorporate a door-in-door design. This feature allows the consumer to access items loaded in the door shelves without opening an interior door that encloses the inner cabinet. This feature prevents the majority of the cool cabinet air from escaping to the room and being replaced by warmer ambient air, as would be the case during a typical total door opening.
Because the DOE test procedure requires testing with the cabinet doors remaining closed, it would not reflect the potential energy savings associated with door-in-door features during typical consumer operation with door openings.
DOE requests comment on test methods for products with door-in-door designs that will yield accurate and repeatable results. Specifically, DOE seeks information on whether an alternate test method is appropriate or whether potential energy savings may be addressed with a calculation approach. DOE also seeks information regarding what steps, if any, manufacturers are taking to account for the energy use characteristics of products that use door-in-door designs. Further, DOE requests data, if any, on consumer use of the door-in-door feature, including how often the outer door is used in comparison to a total door opening, and the corresponding energy impacts of each type of door opening.
Many refrigerators, refrigerator-freezers, and freezers currently available on the market include user control panels or displays located on the front of the product. These features, which can control the products' function and provide additional user features, such as television or internet access, operate with many different control schemes, including activation by proximity sensors.
The DOE test procedure, by referencing AHAM's 2008 version of “Energy and Internal Volume of Refrigerating Appliances” (HRF–1–2008), requires testing with customer-accessible features, not required for normal operation, which are electrically powered, manually initiated, and manually terminated, set at their lowest energy usage positions when adjustment is provided.
However, by testing in this manner (
Similarly, many products incorporating these more advanced user interfaces include internet connections to allow for additional functions. The product controls may consume different amounts of energy depending on whether the internet connection is enabled or disabled, and if enabled, whether it is connected to a network. DOE requests information (such as survey data) on whether consumers typically use an internet connection, when available, for refrigerators, refrigerator-freezers, and freezers. DOE also requests information on the potential energy impacts of the refrigeration products equipped with a connected configuration, and on the appropriate energy-related settings to use for testing.
In 2010, DOE initiated a test procedure rulemaking to help address a
In January 2012, AHAM provided DOE with a draft test procedure that could be used to measure automatic icemaker energy usage. (AHAM Refrigerator, Refrigerator-Freezer and Freezer Ice Making Energy Test Procedure, Revision 1.0—12/14/11, No. 4)
A number of interested parties supported the development and adoption of a test procedure that measures the energy use of automatic icemaking. These commenters cited a number of reasons to justify a laboratory-based icemaker energy test procedure, including: (1) A direct laboratory test is more accurate and representative of actual icemaking energy use, and (2) the fixed adder approach would not reward improvements in icemaking efficiency or provide incentives to reduce icemaker energy consumption. (BSH Home Appliances Corporation, No. 21 at p. 1;
Other interested parties supported the adder approach, noting the significant test burden associated with the proposed icemaking test procedure and the limited opportunities to reduce icemaking energy consumption. (AHAM, No. 37 at p. 2–5; GE Appliances, No. 40 at p. 5; Sub-Zero Group, Inc., No. 36 at p. 2) Further, DOE received data indicating that consumers likely use less ice than assumed in calculating the 84 kWh/year adder. Interested parties commented that the updated consumer use data supported an adder as low as 28 kWh/year. (AHAM, No. 37 at pp. 2–6; GE Appliances, No. 40 at pp. 2–4; Northwest Energy Efficiency Alliance and Northwest Power & Conservation Council, No. 41 at p. 2)
DOE welcomes additional feedback from interested parties on the most appropriate approach to account for icemaker energy use. DOE also requests any more recent consumer use data, if available, regarding ice consumption and automatic icemaker usage in consumer refrigerator-freezers and freezers. DOE also seeks input regarding whether retention of the current fixed adder approach should continue or whether an actual test procedure should replace it at this time. If DOE were to adopt a test procedure that measures icemaker energy use, DOE seeks input on which one to use, for example, the test proposed in the 2013 NOPR, and what specific technical issues it needs to consider if it were to propose such a rule for adoption. To this end, DOE is also interested in what impacts, if any, the adoption of an icemaking energy measurement test procedure would have on the measured energy use of a given product when compared to the fixed energy value adder approach used in the current test procedure.
DOE is also aware of consumer products available on the market that use two automatic icemakers. Typically, these products are refrigerator-freezers with bottom-mounted freezers, with an icemaker in the freezer compartment and another contained in the through-the-door ice service in the fresh food compartment. The fresh food icemaker serves more frequent through-the-door ice service, while the freezer icemaker serves as an in-freezer storage container for infrequent bulk ice use.
DOE requests information on whether products with multiple automatic icemakers should be tested differently than the more typical single automatic icemaker models—and if so, how. DOE seeks consumer use data for these products to inform whether a different energy use adder or test procedure would be appropriate for these dual-icemaker products.
In the 2013 NOPR, DOE presented data indicating that testing in a built-in enclosure may affect energy consumption for certain configurations of built-in products. Specifically, those products that reject condenser heat at the back of the unit showed a potential increase in energy use when tested in an enclosure. DOE observed no significant change in energy use associated with the test configuration for those products that reject heat from the front of the unit. DOE requested comment on the appropriate test configuration for built-in refrigerators, refrigerator-freezers, and freezers, (78 FR 46149–46150). Similar to the icemaking test issue, DOE provided additional time to comment on the built-in testing issue prior to the 2014 final rule, but did not address the issue in that rule.
In the rulemaking leading to the 2014 final rule, DOE received multiple comments. Some commenters supported testing built-in products in an enclosure, as this would represent how the products are used in the field. (Joint Commenters, No. 42 at pp. 5–6; Northwest Energy Efficiency Alliance and Northwest Power & Conservation Council, No. 41 at p. 4) Others opposed the enclosure approach, noting the significant increase in test burden with little or no corresponding change in
DOE continues to seek comment on the built-in testing issue, including consumer installation, test burden, and energy impacts. Among the issues of interest to DOE include whether testing a product in its built-in condition would generally be more representative of energy consumption of a product during its average use cycle or period of use and, if so, the extent to which testing in this condition would be expected to affect the measured energy use of these products, if any. DOE requests information on whether testing all built-in products in an enclosure is appropriate, or whether testing in an enclosure would affect the test results only for certain built-in product configurations, such as those that exhaust condenser heat from the rear of the product. DOE is also interested in detailed information on whether there would be a significant additional test burden resulting from a requirement that specifies these products be tested in a built-in condition—and if so, the nature and extent of that burden. Additionally, DOE is interested in whether alternative methods of assessing the energy consumption of built-in products during their average use cycle or period of use, such as through a calculation or adder approach, are feasible—and if so, what likely degree of accuracy could be obtained if such methods were used in lieu of testing in a built-in condition.
As discussed in section II.A.2 of this document, Appendices A and B incorporate by reference portions of HRF–1–2008 for testing requirements. Section 5.5.5.5 of HRF–1–2008 includes figures specifying thermocouple placement for a number of example fresh food and freezer compartment configurations. HRF–1–2008 also notes that in situations where the interior of a cabinet does not conform to the configurations shown in the example figures, measurements must be taken at locations chosen to represent approximately the entire cabinet.
HRF–1–2008 provides a specific thermocouple location diagram for freezer compartments in refrigerator-freezers (type 6 in Figure 5–2). However, the diagram for this configuration is based on an upright, front-opening freezer compartment, and does not explicitly address drawer-type freezer compartments. Based on its experience testing these products at third-party test laboratories, DOE understands there may be confusion over which thermocouple layout is appropriate for drawer-type freezer compartments in refrigerator-freezers. DOE believes that sensor layout type 6 is appropriate for testing drawer freezer compartments in refrigerator-freezers. DOE requests feedback on whether this sensor layout or, alternatively, a different thermocouple configuration set forth in HRF–1–2008 or elsewhere, is appropriate for testing drawer freezer compartments.
As discussed in the recent MREF test procedure final rule, DOE's test procedures in Appendices A and B frequently use the term “compartment” despite that term not being defined. While DOE considered the need for clarifying that term, it did not define it in that final rule. See 81 FR 46779.
DOE is aware of only one specific definition for “compartment” in finalized international or industry test procedures—specifically, Australian/New Zealand testing standard AS/NZS 4474.1–2007. This procedure define a compartment as “an enclosed space within a refrigerating appliance, which is directly accessible through one or more external doors. A compartment may contain one or more sub-compartments and one or more convenience features.” AS/NZS 4474.1–2007 further defines a “sub-compartment” as “a permanent enclosed space within a compartment or sub-compartment which is designated as being a different type of food storage space (
However, DOE notes that the AS/NZS 4474.1–2007 approach is not fully consistent with all of the uses of the term “compartment” currently found in the DOE test procedures. In some cases, the term denotes all of the space within a refrigeration product that operates within a designated temperature range. In other cases, the term refers to specific enclosed spaces that operate within a designated temperature range. For example, Appendix A, section 5.1.3 uses the term in both ways, referring to individual fresh food compartment temperatures and volumes to calculate the overall fresh food compartment temperature.
DOE requests information on whether the clarity of Appendices A and B would be improved by defining the term “compartment” and using the term consistently throughout the test procedures. If DOE were to define the term “compartment,” DOE seeks comment on what that definition should be—and whether a definition such as the one included in AS/NZS 4474.1–2007 would be sufficient to clearly define this term.
DOE also notes that while Appendix A defines “cooler compartment,” it does not directly define related terms such as “fresh food compartment” or “freezer compartment”—although these definitions are in HFR–1–2008, which is incorporated by reference into Appendices A and B. 10 CFR 430.3. DOE requests comment on whether it should directly define these terms in Appendix A—and if so, how?
DOE also welcomes feedback on the definitions of “refrigerators,” “refrigerator-freezers,” and “freezers” in 10 CFR 430.2. These definitions were most recently amended in DOE's final rule establishing coverage and test procedures for MREFs, (81 FR 46768). Prior to that final rule, DOE published a supplemental noticed of proposed determination (“SNOPD”) in which it proposed to amend these definitions. In that SNOPD, DOE noted that the refrigerator and refrigerator-freezer product definitions described a freezer compartment as a compartment designed for the freezing and storage of food at temperatures below 8 °F which may be adjusted by the user to a temperature of 0 °F or below, and proposed to amend the definitions to refer to a compartment capable of maintaining compartment temperatures of 0 °F or below, (81 FR 11454, 11460, March 4, 2016). However, because interested parties commented that the proposed amendments may affect the scope of the existing refrigerator, refrigerator-freezer, and freezer definitions (AHAM, MREF Coverage No. 24 at pp. 2–3;
The proposed amendments would have resolved an inconsistency between the definitions and the standardized compartment temperature specified in the test procedure. Specifically, while the 8 °F threshold for freezer compartments in the definitions for refrigerators and refrigerator-freezers is consistent with the fresh food compartment and freezer compartment definitions included in HRF–1–2008, Appendix A requires that freezer compartments in refrigerator-freezers be tested to a standardized compartment temperature of 0 °F. Under the existing requirements, a product would meet the refrigerator-freezer definition but would not receive an energy use rating under Appendix A if the freezer compartment is capable of achieving a temperature below 8 °F but above 0 °F.
DOE requests feedback on whether it should address this potential definitional and testing issue, and if so, how. DOE also seeks information on how to best harmonize the refrigerator and refrigerator-freezer definitions with any potential updates to the fresh food and freezer compartment definitions.
As discussed in section II.A.2 of this document, the DOE test procedures incorporate by reference certain sections of the AHAM industry standard HRF–1–2008. DOE references HRF–1–2008 for definitions, installation and operating conditions, temperature measurements, and volume measurements. In August 2016, AHAM released an updated version of the HRF–1 standard, HRF–1–2016. Based on review of the newer standard, DOE notes that the majority of the updates from the 2008 standard are clarifications or other revisions that harmonize with DOE's test procedures. Accordingly, DOE does not expect that updating its references to HRF–1–2016 would substantively affect the test procedures in Appendices A and B.
DOE requests feedback on whether its test procedures should incorporate by reference certain sections of the most current version of HRF–1, HRF–1–2016, rather than HRF–1–2008. DOE also requests whether any of the revisions between HRF–1–2008 and HRF–1–2016 would substantively affect the requirements currently incorporated by reference in Appendices A and B—and if so, how?
In addition to the issues identified earlier in this document, DOE welcomes comment on any other aspect of the existing test procedures for refrigerators, refrigerator-freezers, and freezers not already addressed by the specific areas identified in this document. DOE particularly seeks information that would improve the repeatability, reproducibility, and consumer representativeness of the test procedures. DOE also requests information that would help DOE create a procedure that would limit manufacturer test burden through streamlining or simplifying testing requirements. Comments regarding repeatability and reproducibility are also welcome.
DOE also requests feedback on any potential amendments to the existing test procedure that could be considered to address impacts on manufacturers, including small businesses. Regarding the Federal test method, DOE seeks comment on the degree to which the DOE test procedure should consider and be harmonized with the most recent relevant industry standards for consumer refrigerators, freezers, and refrigerator-freezers and whether there are any changes to the Federal test method that would provide additional benefits to the public.
Additionally, DOE requests comment on whether the existing test procedures limit manufacturer's ability to provide additional features to consumers on refrigerators, refrigerator-freezers, and freezers. DOE particularly seeks information on how the test procedures could be amended to reduce the cost of these new or additional features and make it more likely that such features are included on consumer refrigerators, freezers, and refrigerator-freezers.
DOE invites all interested parties to submit in writing by July 31, 2017, comments and information on matters addressed in this notice and on other matters relevant to DOE's consideration of amended test procedures for refrigerators, refrigerator-freezers, and freezers. After the close of the comment period, DOE will begin collecting data, conducting analyses, and reviewing the public comments, as needed. These actions will be taken to aid in the development of a test procedure NOPR for refrigerators, refrigerator-freezers, and freezers if DOE determines that amended test procedures may be appropriate for these products.
Submitting comments via
However, your contact information will be publicly viewable if you include it in the comment or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. Persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.
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DOE processes submissions made through
Submitting comments via email, hand delivery, or mail. Comments and documents submitted via email, hand delivery, or mail also will be posted to
Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via mail or hand delivery, please provide all items on a CD, if feasible. It is not necessary to submit printed copies. No facsimiles (faxes) will be accepted.
Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, written in English and free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.
Campaign form letters. Please submit campaign form letters by the originating organization in batches of between 50 to 500 form letters per PDF or as one form letter with a list of supporters' names compiled into one or more PDFs. This reduces comment processing and posting time.
Confidential Business Information. According to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email, postal mail, or hand delivery two well-marked copies: one copy of the document marked confidential including all the information believed to be confidential, and one copy of the document marked “non-confidential” with the information believed to be confidential deleted. Submit these documents via email or on a CD, if feasible. DOE will make its own determination about the confidential status of the information and treat it according to its determination.
Factors of interest to DOE when evaluating requests to treat submitted information as confidential include (1) a description of the items, (2) whether and why such items are customarily treated as confidential within the industry, (3) whether the information is generally known by or available from other sources, (4) whether the information has previously been made available to others without obligation concerning its confidentiality, (5) an explanation of the competitive injury to the submitting person which would result from public disclosure, (6) when such information might lose its confidential character due to the passage of time, and (7) why disclosure of the information would be contrary to the public interest.
It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).
DOE considers public participation to be a very important part of the process for developing test procedures and energy conservation standards. DOE actively encourages the participation and interaction of the public during the comment period in each stage of the rulemaking process. Interactions with and between members of the public provide a balanced discussion of the issues and assist DOE in the rulemaking process. Anyone who wishes to be added to the DOE mailing list to receive future notices and information about this rulemaking should contact Appliance and Equipment Standards Program staff at (202) 586–6636 or via email at
Federal Aviation Administration (FAA), DOT.
Supplemental notice of proposed rulemaking (SNPRM); reopening of comment period.
We are revising an earlier proposal for an airworthiness directive (AD) for certain 328 Support Services GmbH Model 328–100 and Model 328–300 airplanes. This action revises the notice of proposed rulemaking (NPRM) by expanding the applicability and making certain inspections repetitive. We are proposing this AD to address the unsafe condition on these products. Since these actions impose an additional burden over those proposed in the NPRM, we are reopening the comment period to allow the public the chance to comment on these proposed changes.
The comment period for the NPRM published in the
We must receive comments on this SNPRM by August 14, 2017.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
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For service information identified in this SNPRM, contact 328 Support Services GmbH, Global Support Center, P.O. Box 1252, D–82231 Wessling, Federal Republic of Germany; telephone +49 8153 88111 6666; fax +49 8153 88111 6565; email
You may examine the AD docket on the Internet at
Todd Thompson, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057–3356; telephone 425–227–1175; fax 425–227–1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We issued an NPRM to amend 14 CFR part 39 by adding an AD that would apply to certain 328 Support Services GmbH Model 328–100 and Model 328–300 airplanes. The NPRM published in the
Since we issued the NPRM, we have determined that repetitive inspections are necessary to address the unsafe condition and that additional airplanes are affected by the unsafe condition and must be added to the applicability.
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2017–0016, dated January 31, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition on all 328 Support Services GmbH Model 328–100 and Model 328–300 airplanes. The MCAI states:
Occurrences of broken bonding wires of the fuel line clamps have been reported on Dornier 328–100 and Dornier 328–300 aeroplanes equipped with fuel line clamps Part Number (P/N) 14C02–10A, or P/N 14C02–12A, or P/N 14C02–16A. The affected fuel line clamps have been installed in accordance with the instructions of Dornier 328 Service Bulletin (SB) SB–328–28–490 or SB–328J–28–241, as applicable, to reduce occurrences of fuel line chafing.
The results of the investigation did not identify design deficiency or production failure of the fuel line clamps. It is assumed that the chafing and breaking of the bonding wires are caused either by excessive vibration, misalignment, excessive installation tolerances or mistakes on installation or a combination thereof.
This condition, if not detected and corrected, could lead to the loss of bonding function and, in combination with a lightning strike, create a source of ignition in a fuel tank, possibly resulting in a fire or explosion and consequent loss of the aeroplane.
To address the unsafe condition, 328 Support Services issued Alert SB (ASB) ASB–328–28–041 (for Dornier 328–100) and ASB–328J–28–018 (for Dornier 328–300), providing inspection instructions.
Consequently, EASA issued AD 2016–0169 [which corresponds to the NPRM] to require a one-time inspection of the fuel line clamps and, depending on findings, replacement. That [EASA] AD also required the reporting off all inspection results to the design approval holder.
Since that [EASA] AD was issued, it was determined that repetitive inspections are necessary and 328 Support Services revised the applicable ASBs accordingly.
For the reason described above, this [EASA] AD retains the requirements of EASA AD 2016–0169, which is superseded, and requires repetitive inspections of all Hydraflow fuel line clamps [
You may examine the MCAI in the AD docket on the Internet at
328 Support Services has issued Alert Service Bulletin ASB–328J–28–018, Revision 2, dated December 12, 2016; and Alert Service Bulletin ASB–328–28–041, Revision 2, dated December 12, 2016. The service information describes procedures for a general visual inspection of all Hydraflow fuel line clamps for worn and missing bonding wires; a general visual inspection of the jet pump outlet, connection part, and fuel lines for chafing marks; a measurement of the depth of the chafing marks, and replacement of affected parts. These documents are distinct since they apply to different airplane models. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We gave the public the opportunity to participate in developing this proposed AD. We considered the comments received.
Two commenters, Patrick Brady and Christoph Thallmayr, requested that we revise the proposed AD to refer to the latest 328 Support Services Service Bulletins. The commenters stated that updated versions of the service information specify repetitive inspections at intervals of 2,500 flight hours. The commenters further noted that EASA issued an updated AD, which references the latest service information. Patrick Brady noted that the repetitive inspections could be scheduled with recurring “5A” inspections to ensure no additional downtime is needed.
We agree with the request. We have revised this AD to refer to the updated service information and MCAI.
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of these same type designs.
Certain changes described above expand the scope of the NPRM. As a result, we have determined that it is necessary to reopen the comment period to provide additional opportunity for the public to comment on this SNPRM.
We estimate that this SNPRM affects 25 airplanes of U.S. registry
We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary replacements that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft that might need these replacements.
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this proposed AD is 2120–0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave SW., Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES–200.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by August 14, 2017.
None.
This AD applies to 328 Support Services GmbH (Type Certificate Previously Held by AvCraft Aerospace GmbH; Fairchild Dornier GmbH; Dornier Luftfahrt GmbH) airplanes, certificated in any category, as identified in paragraphs (c)(1) and (c)(2) of this AD.
(1) Model 328–100 airplanes, all serial numbers.
(2) Model 328–300 airplanes, all serial numbers.
Air Transport Association (ATA) of America Code 28, Fuel.
This AD was prompted by reports of broken bonding wires of certain fuel line clamps. We are issuing this AD to prevent the loss of bonding function, which, in combination with a lightning strike, could create a source of ignition in a fuel tank, possibly resulting in a fire or explosion and consequent loss of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 6 months after the effective date of this AD, do a general visual inspection of all Hydraflow fuel line clamps for worn and missing bonding wires; do a general visual
(1) 328 Support Services GmbH Alert Service Bulletin ASB–328–28–041, Revision 2, dated December 12, 2016 (for Model 328–100 airplanes).
(2) 328 Support Services GmbH Alert Service Bulletin ASB–328J–28–018, Revision 2, dated December 12, 2016 (for Model 328–300 airplanes).
(1) If any worn or missing bonding wires are found during any inspection required by paragraph (g) of this AD, before further flight, replace all affected clamps, in accordance with the Accomplishment Instructions of the service information specified in paragraph (g)(1) or (g)(2) of this AD, as applicable.
(2) If, during any inspection required by paragraph (g) of this AD, any chafing depth is found that is more than the replacement limits specified in the Accomplishment Instructions of the service information specified in paragraph (g)(1) or (g)(2) of this AD, as applicable, before further flight, replace all affected parts, in accordance with the Accomplishment Instructions of the service information specified in paragraph (g)(1) or (g)(2) of this AD, as applicable.
At the applicable time specified in paragraph (i)(1) or (i)(2) of this AD, report the inspection results, positive or negative, to 328 Support Services, GmbH, Global Support Center, P.O. Box 1252, D–82231 Wessling, Federal Republic of Germany; fax +49 8153 88111 6565; email
(1) If the inspection was done on or after the effective date of this AD: Submit the report within 30 days after the inspection.
(2) If the inspection was done before the effective date of this AD: Submit the report within 30 days after the effective date of this AD.
This paragraph provides credit for the initial inspection, parts replacement, and initial report required by paragraphs (g), (h), and (i) of this AD, if those actions were performed before the effective date of this AD using the service information specified in paragraphs (j)(1) through (j)(4) of this AD.
(1) 328 Support Services GmbH Alert Service Bulletin ASB–328–28–041, dated June 14, 2016.
(2) 328 Support Services GmbH Alert Service Bulletin ASB–328–041, Revision 1, dated October 13, 2016.
(3) 328 Support Services GmbH Alert Service Bulletin ASB–328J–28–018, dated June 3, 2016.
(4) 328 Support Services GmbH Alert Service Bulletin ASB–328J–28–018, Revision 1, dated October 13, 2016.
Replacement of clamps as required by paragraph (h) of this AD does not constitute terminating action for the repetitive inspections required by paragraph (g) of this AD for that airplane.
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2017–0016, dated January 31, 2017, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For more information about this AD, contact Todd Thompson, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057–3356; telephone 425–227–1175; fax 425–227–1149.
(3) For service information identified in this AD, contact 328 Support Services GmbH, Global Support Center, P.O. Box 1252, D–82231 Wessling, Federal Republic of Germany; telephone +49 8153 88111 6666; fax +49 8153 88111 6565; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Airbus Model A310 series airplanes. This proposed AD was prompted by a revision of certain airworthiness limitation items (ALI) documents, which require more restrictive maintenance requirements and airworthiness limitations. This proposed AD would require revising the maintenance or inspection program to incorporate the maintenance requirements and airworthiness limitations. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by August 14, 2017.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
You may examine the AD docket on the Internet at
Dan Rodina, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057–3356; telephone 425–227–2125; fax 425–227–1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2016–0217, dated November 2, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A310 series airplanes. The MCAI states:
The airworthiness limitations for Airbus A310 aeroplanes, which are approved by EASA, are currently defined and published in the Airbus A310 Airworthiness Limitations Section (ALS) document(s). These instructions have been identified as mandatory actions for continued airworthiness.
Failure to accomplish these instructions could result in an unsafe condition.
EASA previously issued [EASA] AD 2014–0124 (later revised) [which includes actions for Airbus A310 series airplanes; those actions are included in FAA AD 2013–13–13, Amendment 39–17501 (79 FR 48957, August 19, 2014) (“AD 2013–13–13”)], to require the actions as specified in Airbus A310 Airworthiness Limitation Item (ALI) Document at issue 08.
Since EASA AD 2014–0124R1 was issued, Airbus replaced ALI Document issue 08 with A310 ALS Part 2 Revision 01 and then published the A310 ALS Part 2 Variation 1.1 and Variation 1.2, to introduce more restrictive maintenance requirements and/or airworthiness limitations.
For the reason described above, this [EASA] AD retains part of the requirements of EASA AD 2014–0124R1, which will be superseded, and requires accomplishment of the actions specified in Airbus A310 ALS Part 2 Revision 01, ALS Part 2 Variation 1.1 and ALS Part 2 Variation 1.2 (hereafter collectively referred to as `the ALS' in this [EASA] AD). The remaining requirements of EASA AD 2014–0124R1 are retained in [EASA] AD 2016–0218, applicable to A300–600 aeroplanes, published at the same time as this [EASA] AD.
This NPRM would not supersede AD 2013–13–13. Rather, we have determined that a stand-alone AD would be more appropriate to address the changes in the MCAI. This NPRM would require revising the maintenance or inspection program to incorporate the maintenance requirements and airworthiness limitations. Accomplishment of the proposed actions would then terminate all requirements of AD 2013–13–13.
You may examine the MCAI in the AD docket on the Internet at
We reviewed the following service information:
• Airbus A310 Airworthiness Limitations Section (ALS), Part 2, “Damage Tolerant Airworthiness Limitation Items (DT—ALI),” Revision 01, dated August 7, 2015.
• Airbus A310 Airworthiness Limitations Section (ALS), Part 2, “Damage Tolerant Airworthiness Limitation Items (DT—ALI),” Variation 1.1, dated January 25, 2016.
• Airbus A310 Airworthiness Limitations Section (ALS), Part 2, “Damage Tolerant Airworthiness Limitation Items (DT—ALI),” Variation 1.2, dated July 22, 2016.
The service information describes airworthiness limitations applicable to the DT—ALIs. These documents are distinct because they contain different tasks at different revision levels. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
This AD requires revisions to certain operator maintenance documents to include new actions (
We estimate that this proposed AD affects 8 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by August 14, 2017.
This AD affects AD 2013–13–13, Amendment 39–17501 (79 FR 48957, August 19, 2014) (“AD 2013–13–13”).
This AD applies to all Airbus Model A310–203, –204, –221, –222, –304, –322, –324, and –325 airplanes, certificated in any category, all manufacturer serial numbers.
Air Transport Association (ATA) of America Code 05.
This AD was prompted by a revision of certain airworthiness limitation items (ALI) documents, which require more restrictive maintenance requirements and airworthiness limitations. We are issuing this AD to prevent fatigue cracking, damage, or corrosion in principal structural elements, which could result in reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 3 months after the effective date of this AD, revise the maintenance or inspection program, as applicable, to incorporate the information specified in paragraphs (g)(1), (g)(2), and (g)(3) of this AD. The initial compliance times for doing the tasks is at the time specified in the service information identified in paragraphs (g)(1), (g)(2), and (g)(3) of this AD, or within 3 months after the effective date of this AD, whichever occurs later.
(1) Airbus A310 Airworthiness Limitations Section (ALS), Part 2, “Damage Tolerant Airworthiness Limitation Items (DT—ALI),” Revision 01, dated August 7, 2015.
(2) Airbus A310 Airworthiness Limitations Section (ALS), Part 2, “Damage Tolerant Airworthiness Limitation Items (DT—ALI),” Variation 1.1, dated January 25, 2016.
(3) Airbus A310 Airworthiness Limitations Section (ALS), Part 2, “Damage Tolerant Airworthiness Limitation Items (DT–ALI),” Variation 1.2, dated July 22, 2016.
After the maintenance or inspection program has been revised as required by paragraph (g) of this AD, no alternative actions (
Accomplishing the actions required by this AD terminates all requirements of AD 2013–13–13 for that airplane only.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2016–0217, dated November 2, 2016, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For more information about this AD, contact Dan Rodina, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057–3356; telephone 425–227–2125; fax 425–227–1149.
(3) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all The Boeing Company Model 737–100, –200, –200C, –300, –400, and –500 series airplanes. This proposed AD was prompted by reports of fatigue cracking in the frame outboard chord and in the radius of the auxiliary chord at a certain area. This proposed AD would require inspections to detect this cracking, and corrective action if necessary. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by August 14, 2017.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110–SK57, Seal Beach, CA 90740; telephone 562–797–1717; Internet
You may examine the AD docket on the Internet at
Alan Pohl, Aerospace Engineer, Airframe Branch, ANM–120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, Washington 98057–3356; phone: (425) 917–6450; fax: (425) 917–6590; email:
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We have received reports indicating that fatigue cracking was found in the frame outboard chord at BS 727 and in the radius of the auxiliary chord at BS 727 and S–18A on certain airplanes. Cracks in the outboard chord were found on airplanes having between 20,000 and 85,000 flight cycles, and between 27,000 and 74,000 flight hours. Cracks in the radius of the auxiliary chord were found on airplanes having between 46,000 and 85,000 flight cycles, and between 41,000 and 64,000 flight hours. The cracks were caused by fatigue, and, for certain airplanes, the fretting of adjacent parts contributed to the initiation of the fatigue damage. This condition, if not corrected, could result in reduced structural integrity of the outboard chord and consequent rapid decompression of the airplane.
On October 16, 2012, we issued AD 2012–23–04, Amendment 39–17260 (77 FR 69747, November 21, 2012) (“AD 2012–23–04”), applicable to all The Boeing Company Model 737–100, –200, –200C, –300, –400, and –500 series airplanes. That AD requires various inspections for cracks in the outboard chord of the frame at BS 727. That AD also requires inspections for cracks in the BS 727 frame outboard chord and the radius of the auxiliary chord, for certain airplanes. That AD was prompted by several reports of fatigue cracking in the frame outboard chord at BS 727 and in the radius of the auxiliary chord. The actions required by that AD are intended to detect and correct fatigue cracking of the outboard and auxiliary chords, which could result in reduced structural integrity of the outboard chord and consequent rapid decompression of the airplane.
Since issuance of AD 2012–23–04, the FAA has found discrepancies in the requirements of that AD, as follows:
• The optional terminating action specified in paragraph (r) of AD 2012–23–04 allows terminating action if the preventive modification is installed. However, Boeing Alert Service Bulletin 737–53A1166, Revision 2, dated May 25, 2006, allows terminating action only if both the BS 727 outboard chord is replaced and the preventive modification is installed. Consequently, for airplanes having line numbers 1 through 999 inclusive on which the preventive modification may have been installed, the outboard chord may not have been replaced. Additionally, paragraph (r)(2) of AD 2012–23–04 specifies replacing only a cracked outboard chord; however, the intent was to require replacement of the outboard chord whether it was cracked or not. In light of these factors, there could be cracking in the auxiliary chord combined with cracking in the outboard chord. This cracking could progress undetected and result in the identified unsafe condition.
• Boeing Alert Service Bulletin 737–53A1166, Revision 2, dated May 25, 2006, contains instructions to determine whether the modification should be classified as interim or permanent; a one-time inspection is specified after the interim modification is done. The instructions specified in the previous service information did not contain this stipulation during installation of the preventive modification. Therefore, the modification could have resulted in edge margins in the frame outboard chord that would have been classified as interim had the modification been done in accordance with Boeing Alert Service Bulletin 737–53A1166, Revision 2, dated May 25, 2006. Since neither Boeing Alert Service Bulletin 737–53A1166, Revision 2, dated May 25, 2006, nor AD 2012–23–04 contained instructions to measure edge margins, it is possible that an edge margin condition exists, so the one-time follow-on inspection must be done.
• Paragraph (r) of AD 2012–23–04 terminates the one-time inspection specified in Part 8 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737–53A1166, Revision 2, dated May 25, 2006, for airplanes that have the interim preventive modification installed. This inspection is referenced in paragraph (o) of AD 2012–23–04, and should not have been terminated. Paragraph (o) of AD 2012–23–04 was incorrectly included in the list of paragraphs with inspections that are terminated after accomplishing paragraph (r) of that AD.
Therefore, since the discrepancies described previously provide inadvertent relief to operators, we find it necessary to issue additional, new AD rulemaking to provide additional inspection requirements. We have confirmed that the requirements of this AD correct those discrepancies and do not conflict with other requirements of AD 2012–23–04.
We reviewed Boeing Alert Service Bulletin 737–53A1166, Revision 2, dated May 25, 2006. The service information describes procedures for inspections for cracks of the BS 727 frame outboard chord and in the radius of the auxiliary chord, and repair or replacement if necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of these same type designs.
This proposed AD would require accomplishing the actions specified in the service information described previously.
This AD corrects discrepancies in the requirements for certain airplanes identified in AD 2012–23–04. The FAA has considered that fact in determining whether to issue a new AD action or to supersede AD 2012–23–04. We have determined that a less burdensome approach is to issue a separate AD action applicable to the airplanes on which the discrepancies could have occurred. This proposed AD would not supersede AD 2012–23–04, and compliance with the requirements must continue for airplanes listed in the applicability of AD 2012–23–04. This proposed AD is a separate AD action, applicable only to the airplanes identified in paragraph (c) of this AD.
We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary repairs that would be required based on the results of the inspections. We have no way of determining the number of aircraft that might need these repairs:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by August 14, 2017.
None.
This AD applies to all The Boeing Company Model 737–100, –200, –200C, –300, –400, and –500 series airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by reports of fatigue cracking in the frame outboard chord and in the radius of the auxiliary chord at body station (BS) 727 and stringer (S) 18A. We are issuing this AD to detect and correct fatigue cracking of the outboard and auxiliary chords, which could result in reduced structural integrity of the outboard chord and consequent rapid decompression of the airplane.
Comply with this AD within the compliance times specified, unless already done.
For airplanes identified in paragraph (h) of this AD: Within 4,500 flight cycles or 24 months after the effective date of this AD, whichever occurs first, do internal detailed and High Frequency Eddy Current (HFEC) inspections to detect cracks in the auxiliary chord radius, in accordance with Part 1 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737–53A1166, Revision 2, dated May 25, 2006. If any crack is found during any inspection required by this paragraph, before further flight, repair using a method approved in accordance with the procedures specified in paragraph (l) of this AD. Repeat the inspections thereafter at intervals not to exceed 15,000 flight cycles. Replacement of the outboard chord of the frame at BS 727 concurrently with the installation of the preventive modification of the outboard chord in accordance with Part 6 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737–53A1166, Revision 2, dated May 25, 2006, terminates the repetitive inspections required by this paragraph.
The actions specified in paragraph (g) of this AD are required for airplanes that meet the criteria of paragraphs (h)(1), (h)(2), (h)(3), and (h)(4) of this AD.
(1) Model 737–100, –200, and –200C series airplanes, line numbers 1 through 999 inclusive.
(2) Airplanes identified as Groups 1, 2, and 3 in Boeing Alert Service Bulletin 737–53A1166, Revision 2, dated May 25, 2006.
(3) Airplanes on which a preventive modification has been installed in accordance with the method specified in paragraph (h)(3)(i), (h)(3)(ii), or (h)(3)(iii) of this AD.
(i) Part 6 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737–53A1166, Revision 2, dated May 25, 2006.
(ii) Part II of the Accomplishment Instructions of Boeing Alert Service Bulletin 737–53A1166, Revision 1, dated May 25, 1995.
(iii) Part II of the Accomplishment Instructions of Boeing Alert Service Bulletin 737–53A1166, dated June 30, 1994.
(4) Airplanes on which the outboard chord has not been replaced in accordance with the method specified in paragraph (h)(4)(i), (h)(4)(ii), or (h)(4)(iii) of this AD.
(i) Part 3 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737–53A1166, Revision 2, dated May 25, 2006.
(ii) Part I of the Accomplishment Instructions of Boeing Alert Service Bulletin 737–53A1166, Revision 1, dated May 25, 1995.
(iii) Part I of the Accomplishment Instructions of Boeing Alert Service Bulletin 737–53A1166, dated June 30, 1994.
For Model 737–100, –200, and –200C series airplanes having line numbers 1 through 999 inclusive, identified as Groups 1 through 3 in Boeing Alert Service Bulletin 737–53A1166, Revision 2, dated May 25, 2006, on which the preventive modification has been installed in accordance with Boeing Alert Service Bulletin 737–53A1166, dated June 30, 1994; or Boeing Alert Service Bulletin 737–53A1166, Revision 1, dated May 25, 1995: Within 60,000 flight cycles after accomplishing the preventive modification, determine if the modification is classified as interim or permanent by using the edge margin measurement and repair classification specified in Part 6 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737–53A1166, Revision 2, dated May 25, 2006. In lieu of measuring on the airplane, a review of engineering documentation may be used to classify the modification if the engineering documentation was completed at the time of the modification and has the edge margins recorded.
(1) If the modification is classified as permanent, no further action is required by paragraph (i) of this AD.
(2) If the modification is classified as interim: Within 60,000 flight cycles after accomplishment of the interim modification of the outboard chord of the frame at BS 727 at S–18A, but no earlier than 50,000 flight cycles after accomplishment of the modification, do a one-time follow-on open-hole eddy current inspection to detect cracks
For airplanes having line numbers 1 through 3132 inclusive, on which an interim modification of the BS 727 outboard chord as defined in Part 6 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737–53A1166, Revision 2, dated May 25, 2006, has been accomplished: Within 60,000 flight cycles after accomplishment of the interim modification of the outboard chord of the frame at BS 727 at S–18A, but no earlier than 50,000 flight cycles after accomplishment of the modification, do a one-time follow-on open-hole eddy current inspection to detect cracks in the modified chord, in accordance with Part 8 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737–53A1166, Revision 2, dated May 25, 2006. If any crack is found during the inspection required by this paragraph, before further flight, repair in accordance with Part 3 or Part 4, as applicable, of the Accomplishment Instructions of Boeing Alert Service Bulletin 737–53A1166, Revision 2, dated May 25, 2006; except, where the repairs cannot be installed using the procedures identified in this service bulletin, repair before further flight using a method approved in accordance with the procedures specified in paragraph (l) of this AD.
Access and restoration procedures specified in the Accomplishment Instructions of Boeing Alert Service Bulletin 737–53A1166, Revision 2, dated May 25, 2006, are not required by this AD. Operators may do those actions following their approved maintenance procedures.
(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (m)(1) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(1) For more information about this AD, contact Alan Pohl, Aerospace Engineer, Airframe Branch, ANM–120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, Washington 98057–3356; phone: (425) 917–6450; fax: (425) 917–6590; email:
(2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110–SK57, Seal Beach, CA 90740; telephone 562–797–1717; Internet
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Airbus Model A330–200 Freighter, –200, and –300 series airplanes; and Airbus Model A340–200, –300, –500, and –600 series airplanes. This proposed AD was prompted by a report that the trimmable horizontal stabilizer actuator (THSA) might not function as intended after failure of the primary load path. This proposed AD would require repetitive detailed visual inspections for discrepancies of the THSA upper attachments and no-back housing. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by August 14, 2017.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
You may examine the AD docket on the Internet at
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057–3356; telephone 425–227–1138; fax 425–227–1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2017–0044, dated March 9, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A330–200 Freighter, –200 and –300 series airplanes; and Airbus Model A340–200, –300, –500, and –600 series airplanes. The MCAI states:
The Trimmable Horizontal Stabilizer Actuator (THSA), as installed on A330 and A340 aeroplanes, was initially designed to stall when engaging on the upper secondary load path (SLP) after primary load path (PLP) failure. Such stall triggers system monitoring detection. New mission profile analysis revealed that in some cases, the THSA could be operated while engaged on the upper SLP without stalling [
This condition, if not detected and corrected, could lead to THSA upper attachment failure and consequent disconnection of the THSA from the aeroplane structure, possibly resulting in loss of control of the aeroplane.
For the reasons described above, this [EASA] AD requires repetitive detailed [visual] inspections (DET) of the upper THSA attachments parts and the PLP and SLP fuselage attachment points, and, depending on findings (which include, but are not limited to, failure of the primary load path), accomplishment of applicable [additional inspections for discrepancies and] corrective action(s).
The additional inspections include a detailed visual inspection for discrepancies of the upper attachment fitting of the airplane and a detailed visual inspection for discrepancies of the removed THSA. Corrective actions include repair and replacement of the THSA. You may examine the MCAI in the AD docket on the Internet at
We reviewed the following Airbus service information:
• Airbus Service Bulletin A330–27–3218, Revision 01, dated December 5, 2016.
• Airbus Service Bulletin A340–27–4203, Revision 01 dated December 5, 2016.
• Airbus Service Bulletin A340–27–5067, Revision 01 dated December 5, 2016.
The service information describes procedures for detailed visual inspections for discrepancies of the THSA upper attachments and no-back housing, additional inspections for discrepancies, and corrective actions. These documents are distinct since they apply to different airplane models. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of these same type designs.
We estimate that this proposed AD affects 102 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary replacements that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft that might need this replacement.
We have received no definitive data that would enable us to provide cost estimates for other on-condition actions specified in this proposed AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by August 14, 2017.
None.
This AD applies to Airbus Model A330–201, –202, –203, –223, –223F, –243, –243F, –301, –302, –303, –321, –322, –323, –341, –342 and –343 airplanes; and Airbus Model A340–211, –212, –213, –311, –312, –313, –541, and –642 airplanes; certificated in any category, all manufacturer's serial numbers.
Air Transport Association (ATA) of America Code 27, Flight Controls.
This AD was prompted by a report that the trimmable horizontal stabilizer actuator (THSA) might not function as intended after failure of the primary load path. We are issuing this AD to detect and correct discrepancies of the THSA upper attachments and no-back housing, which could lead to THSA upper attachment failure and consequent disconnection of the THSA from the airplane structure, possibly resulting in loss of control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Before exceeding the Threshold in Table 1 to paragraph (g) of this AD, as applicable, or within 3 months after the effective date of this AD, whichever occurs later; and thereafter at intervals not to exceed the inspection interval values defined in Table 1 to paragraph (g) of this AD; accomplish a detailed visual inspection for discrepancies of the trimmable horizontal stabilizer actuator (THSA) upper attachments and no-back housing, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330–27–3218, Revision 01, A340–27–4203, Revision 01, or A340–27–5067, Revision 01, all dated December 5, 2016, as applicable. Where the “Threshold” column of table 1 to paragraph (g) of this AD specifies compliance times in “FH” (flight hours) or “FC” (flight cycles), those compliance times are flight hours or flight cycles since the first flight of the airplane, or since the last accomplishment of Airbus Model A330 or A340 Maintenance Review Board Report task 27.40.00/07, or since the last detailed visual inspection of the THSA done in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330–27–3218, A340–27–4203, or A340–27–5067, all dated July 1, 2016, as applicable.
(1) If, during any inspection required by paragraph (g) of this AD, any discrepancy identified in the Accomplishment Instructions of Airbus Service Bulletin A330–27–3218, Revision 01, A340–27–4203, Revision 01, or A340–27–5067, Revision 01, all dated December 5, 2016, as applicable, is detected, before further flight, remove the THSA, and accomplish a detailed visual inspection for discrepancies of the upper attachment fitting of the airplane and a detailed visual inspection for discrepancies of the removed THSA, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330–27–3218, Revision 01, A340–27–4203, Revision 01, or A340–27–5067, Revision 01, all dated December 5, 2016, as applicable. As an alternative to the removed THSA inspections required by this paragraph, before further flight, replace the THSA with a serviceable part (as defined in paragraph (i) of this AD).
(2) If, during any inspection of the upper attachment fitting of the airplane required by paragraph (h)(1) of this AD, any discrepancy identified in the Accomplishment Instructions of Airbus Service Bulletin A330–27–3218, Revision 01, A340–27–4203, Revision 01, or A340–27–5067, Revision 01, all dated December 5, 2016, as applicable, is detected, before further flight, repair using a method approved in accordance with the procedures specified in paragraph (k)(2) of this AD.
(3) If, during any inspection of the removed THSA required by paragraph (h)(1) of this AD, no discrepancy specified in the Accomplishment Instructions of Airbus Service Bulletin A330–27–3218, Revision 01, A340–27–4203, Revision 01, or A340–27–5067, Revision 01, all dated December 5, 2016, as applicable, is detected, before further flight, reinstall the THSA, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330–27–3218, Revision 01, A340–27–4203,
(4) If, during any inspection of the removed THSA required by paragraph (h)(1) of this AD, any discrepancy specified in the Accomplishment Instructions of Airbus Service Bulletin A330–27–3218, Revision 01, A340–27–4203, Revision 01, or A340–27–5067, Revision 01, all dated December 5, 2016, as applicable, is detected, before further flight, replace the THSA with a serviceable part (as defined in paragraph (i) of this AD), in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330–27–3218, Revision 01, A340–27–4203, Revision 01, or A340–27–5067, Revision 01, all dated December 5, 2016, as applicable.
For the purpose of this AD, a serviceable THSA is a part that has accumulated less than 4,000 FH or 1,000 FC (for Airbus Model A330, A340–200, or A340–300 airplanes) or 4,000 FH or 800 FC (for Airbus Model A340–500 or A340–600 airplanes), whichever occurs first since the first flight of the airplane, or since the last overhaul of the THSA, or since the last detailed visual inspection of the THSA in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330–27–3218, Revision 01, A340–27–4203, Revision 01, or A340–27–5067, Revision 01, all dated December 5, 2016, as applicable.
This paragraph provides credit for actions required by paragraphs (g), (h)(1), (h)(3), and (h)(4) of this AD, if those actions were performed before the effective date of this AD using the service information specified in paragraph (j)(1), (j)(2), or (j)(3) of this AD.
(1) Airbus Service Bulletin A330–27–3218, Revision 00, dated July 1, 2016.
(2) Airbus Service Bulletin A340–27–4203, Revision 00, dated July 1, 2016.
(3) Airbus Service Bulletin A340–27–5067, Revision 00, dated July, 1 2016.
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2017–044, dated March 9, 2017, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For more information about this AD, contact Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057–3356; telephone 425–227–1138; fax 425–227–1149.
(3) For service information identified in this AD, contact Airbus SAS, Airworthiness Office–EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of waiver.
This notice concerns three petitions for waiver submitted to the FAA by Rocket Lab USA Inc. (RL) for the Flight Termination Receiver (FTR) Qualification by Similarity (QBS): A petition to waive the requirement that a component may be qualified based on similarity to a component that has already been qualified for use only if the environments encountered by the previously qualified component during its qualification or flight history were equal or more severe than the Rocket Lab qualification environments; a petition to waive the Electromagnetic Interference and Compatibility (EMI/EMC) on the same units; and a petition to waive the requirement that the same manufacturer must produce the qualified and the unqualified component in the same location using identical tools and manufacturing processes. The FAA grants these three petitions.
Issued in Washington, DC, on May 15, 2017.
For technical questions concerning this waiver, contact Michael Wiktowy, Licensing Program Lead, Commercial Space Transportation—Licensing and Evaluation Division, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267–7287; email:
RL submitted a petition to the FAA's Office of Commercial Space Transportation (AST) requesting relief from regulatory requirements for a launch license for flight of Electron test flight missions from Mahia, New Zealand. Specifically, RL requested relief from 14 CFR E417.7(f)(2) and (5), Qualification Testing and Analysis by Similarity for the Flight Termination Receiver. For Qualification, the Flight Termination Receiver is required to meet Table E417.19–2, which states with note (5): “The same three sample components must undergo each test designated with an X. For a test designated with a quantity of less than three, each sample component tested must be one of the original three sample components.” For Qualification Testing and Analysis by Similarity, Part 417 Appendix E section 417.7(f) provides the requirements a launch operator must satisfy in order to qualify or re-qualify a flight termination system component's design through qualification by similarity to tests performed on identical or similar hardware. Section E417.7(f)(2) states that to qualify component “A” based on similarity to
The FAA licenses the launch of a launch vehicle and reentry of a reentry vehicle under authority granted to the Secretary of Transportation in the Commercial Space Launch Act of 1984, as amended and re-codified by 51 U.S.C. Subtitle V, chapter 509 (Chapter 509), and delegated to the FAA Administrator and the Associate Administrator for Commercial Space Transportation, who exercises licensing authority under Chapter 509.
RL is a private commercial space flight company. RL seeks to lower the cost and increase the frequency of access to space for small payloads, potentially expanding the opportunity for space services and research. RL's petition for waiver addresses all upcoming Electron test flights that RL plans to launch from the Mahia Peninsula, New Zealand. The Electron launch is the first planned test flight from the privately-owned Rocket Lab Launch Complex at Mahia Peninsula in Hawkes Bay, New Zealand. The launch location is capable of hosting launches to the northeast, east, and south. The area within 20 NM surrounding the launch site is extremely remote, and has a low population density. The launch flight corridor will have minimal impact on air and marine traffic.
Chapter 509 allows the FAA to waive a license requirement if the waiver (1) will not jeopardize public health and safety, safety of property; (2) will not jeopardize national security and foreign policy interests of the United States; and (3) will be in the public interest. See 51 U.S.C. 50905(b)(3) (2011); 14 CFR 404.5(b) (2011).
Section E417.7(f)(2) requires a launch operator wishing to qualify a component's design through qualification by similarity to tests performed on identical or similar hardware to demonstrate that the environments encountered by the component during its qualification or flight history were equal to or more severe than the qualification environments required for a component that has already been qualified for use. Section E417.7(f)(5) requires a launch operator qualifying a component's design as discussed above to demonstrate that the same manufacturer produced both the qualified component and the component the launch operator wishes to qualify in the same location using identical tools and manufacturing processes. For reasons described below, the FAA waives the requirements in section E417.7(f)(2) and (5) to allow RL to use components in its flight termination system that were qualified by similarity to more than one qualified component.
In deciding whether or not to issue a waiver, the FAA had to analyze whether the waiver: (1) Would jeopardize public health and safety or safety of property; (2) would jeopardize national security and foreign policy interests of the United States; and (3) was in the public interest. See 51 U.S.C. 50905(b)(3); 14 CFR 404.5(b).
Part 417 contains requirements for qualification and acceptance testing of flight termination system components based on the approach used at the federal launch ranges. At federal launch ranges, flight termination system components are tested according to federal range-approved test procedures and requirements. Verification methods include test, analysis, and inspection. As an alternative to testing, components of an FTS are sometimes qualified by similarity. A component that has been qualified through testing for one launch vehicle may be approved for use on a different launch vehicle if it can be shown that the environments in which it must operate on the second vehicle are no harsher than those of the first. Also, with limited additional testing, the component may be qualified for a more severe environment. Although RL did not complete each of the qualification by similarity requirements for its flight termination receiver as required by the regulations, the failsafe design of the Electron's flight termination system combined with the remoteness of the operating area allow the FAA to find that RL's activities will not jeopardize public health and safety and safety of property.
RL procured the Electron launch vehicle's flight termination receiver from Vendor A, who performed several qualification and delta qualification tests. A delta qualification test extends the tested environments to cover specific tests or levels that were not previously covered. RL submitted a Qualification by Similarity Analysis Report to the FAA, referencing three previous groups of similar flight termination receiver qualification and delta qualification tests performed by Vendor A. Group 1 was subjected to most of the qualification testing required by 14 CFR Table E417.19–2, with three exceptions: (a) Group 1 did not satisfy 14 CFR E417.7(f)(2) because the random vibration qualification environment encountered by Group 1 was not equal to or more severe than the random vibration qualification environment required for the Electron flight termination receivers, falling below for approximately 3.5% over the required 20 Hz to 2000 Hz test band; (b) Group 1 was not subjected to EMI/EMC testing; and (c) Group 1 did not meet the requirements of 14 CFR E417.7(f)(5) because it was not produced in the same manufacturing location using identical tools and manufacturing processes as the Rocket Lab Electron flight termination receivers. Group 1's deficiencies were mitigated by two subsequent delta qualification tests on 2 groups (referred to herein as Group 2 and Group 3) of similar receivers. Group 2 satisfied Electron's required random vibration qualification test levels for the entire required test band, and Group 2 was manufactured in the same location using identical tools and manufacturing processes as Electron flight termination receivers. Group 3 successfully passed EMI/EMC qualification testing.
Group 1 also did not meet the requirements of 14 CFR E417.7(f)(5) because Group 1 was not produced in the same manufacturing location using identical tools and manufacturing processes as Group 2 and Electron flight termination receivers. Vendor A originally outsourced one of the flight termination receiver's printed circuit boards to another supplier. In late 2013, Vendor A upgraded its internal equipment and process, and assembled the printed circuit boards in-house. Group 1 and Group 3 were manufactured and qualification tested before this change in equipment and process, whereas Group 2 and Electron's flight termination receivers were assembled after the change. To verify that the equipment and process change did not invalidate previous qualification and delta qualification testing, Vendor
The FAA waives the requirements of E417.7(f)(2) and (5) because the Electron has implemented a failsafe flight safety system design that would terminate thrust to the vehicle should both flight termination receivers fail or communication was lost with the ground station, and RL's operating area is remote enough that were it to experience a catastrophic failure, it would not jeopardize public health and safety and safety of property. The Electron test flight missions would occur from the isolated Mahia Peninsula in New Zealand. The area within 20 NM of Mahia Peninsula has a very low population density. The Electron flight corridor is over the broad ocean area with minimal impact on air and marine traffic. Consequence analysis showed that less than 1 in 100,000 casualties would be expected if the worst foreseeable vehicle response mode (
The FAA has identified no national security or foreign policy implications associated with granting this waiver.
The waiver is consistent with the public interest goals of Chapter 509 and the National Space Transportation Policy. Three of the public policy goals of Chapter 509 are: (1) To promote economic growth and entrepreneurial activity through use of the space environment; (2) to encourage the United States private sector to provide launch and reentry vehicles and associated services; and (3) to facilitate the strengthening and expansion of the United States space transportation infrastructure to support the full range of United States space-related activities. See 51 U.S.C. 50901(b)(1), (2), (4).
RL seeks to lower the cost and increase the frequency of access to space for small payloads, potentially expanding the opportunity for space services and research. These activities will help to make the U.S. launch industry more competitive internationally. The National Space Transportation Policy states that strengthening U.S. competitiveness in the international launch market and improving the cost effectiveness of U.S. space transportation services are in the public interest:
Maintaining an assured capability to meet United States Government needs, while also taking the necessary steps to strengthen U.S. competitiveness in the international commercial launch market, is important to ensuring that U.S. space transportation capabilities will be reliable, robust, safe, and affordable in the future. Among other steps, improving the cost effectiveness of U.S. space transportation services could help achieve this goal by allowing the United States Government to invest a greater share of its resources in other needs such as facilities modernization, technology advancement, scientific discovery, and national security. Further, a healthier, more competitive U.S. space transportation industry would facilitate new markets, encourage new industries, create high technology jobs, lead to greater economic growth and security, and would further the Nation's leadership role in space.
More specifically, Rocket Lab will be carrying onboard the Electron launch vehicle on its inaugural launch a flight test experiment for NASA Kennedy Space Center which will improve public risk mitigation capabilities from an errant launch vehicle. This component is designed and manufactured by NASA KSC and is part of the independent safety system which will be installed on the launch vehicles. This safety system will be capable of determining if the flight of the launch vehicle will pose an unacceptable increased risk to the public based on mission rules designed for its unique vehicle and flight characteristics and programmed into the safety system and terminate the flight of such launch vehicle. This type of capability is in public interest because this safety system will allow for improved protection of the public from mishaps resulting from flight of errant launch vehicles.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to modify the operating regulation that governs the DELAIR Memorial Railroad Bridge across the Delaware River, mile 104.6, at Pennsauken Township, NJ. This proposed regulation will allow the bridge to be remotely operated from the Conrail South Jersey dispatch center in Mount Laurel, NJ, instead of being operated by an on-site bridge tender. This regulation will not change the operating schedule of the bridge.
Comments and related material must reach the Coast Guard on or before August 18, 2017.
You may submit comments identified by docket number USCG–2016–0257 using Federal eRulemaking Portal at
See the “Public Participation and Request for Comments” portion of the
If you have questions on this proposed rule, call or email Mr. Hal R. Pitts, Fifth Coast Guard District (dpb); telephone (757) 398–6222, email
The DELAIR Memorial Railroad Bridge across the Delaware River, mile 104.6, at Pennsauken Township, NJ, owned and operated by Conrail Shared Assets, has a vertical clearance of 49 feet above mean high water in the closed-to-navigation position. There is a daily average of 28 New Jersey Transit trains and eight Conrail freight trains that cross the bridge and a daily average of three bridge openings that allow one or more vessels to transit through the bridge during each opening. The bridge is normally maintained in the closed position due to the average daily number of trains crossing the bridge. The operating schedule is published in 33 CFR 117.716. This current operating schedule has been in effect since 1984 and will not change with the implementation of remote operation of the bridge. However, within this proposed operating schedule, § 117.716 will be restructured from its current configuration to clearly distinguish the remote operation of the DELAIR Memorial Railroad Bridge. This proposed operating regulation allows the bridge to be operated remotely from the bridge owner's South Jersey dispatch center in Mount Laurel, NJ.
The Delaware River is used by a variety of vessels, including deep draft commercial vessels, tug and barge traffic, recreational vessels, and public vessels, including military vessels of various sizes. The three-year average number of bridge openings and maximum number of bridge openings by month and overall for 2013 through 2015, as drawn from the data contained in the bridge tender logs, is presented below.
The bridge owner and the maritime community have been working together since 2013 in an effort to incorporate sensors and other technologies into the bridge and the Conrail South Jersey dispatch center to allow for the safe and effective remote operation of the bridge.
On April 12, 2017, the Coast Guard published a temporary deviation entitled “Drawbridge Operation Regulation; Delaware River, Pennsauken Township, NJ” in the
This proposed operating regulation will allow the bridge to be operated remotely from the bridge owner's South Jersey dispatch center in Mount Laurel, NJ. The remote operation system will include eight camera views (four marine and four rail), two forward-looking infrared equipped camera views (marine), marine radar, a dedicated telephone line for bridge operations, radio telephone on VHF–FM channels 13 and 16, and an automated identification system (AIS) transmitter to provide bridge status. The AIS transmitter has been installed on the New Jersey side of the bridge at the bridge and land intersection in approximate position 39°58′50.52″ N. (39.9807), 75°03′58.75″ W. (−75.06632). The AIS transmitter is assigned maritime mobile service identity (MMSI) number 993663001 and will provide the status of the bridge (open/closed/inoperative) via the name transmitted by the private aids to navigation as DELAIR BRG–OPEN (fully open and locked position, channel light green), DELAIR BRG–CLOSED (other than fully open, not inoperative), or DELAIR BRG–INOP (other than fully open, inoperative). The AIS transmitter will transmit the bridge status every two minutes and upon a change in the bridge status.
The remote operation system is designed to provide equal or greater capabilities compared to the on-site bridge tender in visibility of the waterway and bridge and in signals (communications) via sound and visual signals and radio telephone (voice) via VHF–FM channels 13 and 16. The remote operation system also incorporates real-time bridge status via AIS signal to aid mariners in voyage planning and navigational decision-making, a dedicated telephone line (856) 231–2301 for bridge operations, and push-to-talk (PTT) capability on VHF–FM channel 13.
The signals for the remote operation center or on-site bridge tender to respond to a sound signal for a bridge opening will include: (1) When the draw can be opened immediately—a sound signal of one prolonged blast followed by one short blast and illumination of a fixed white light not more than 30 seconds after the requesting signal, and (2) when the draw cannot be opened immediately—five short blasts sounded in rapid succession and illumination of a fixed red light not more 30 seconds after the vessel's opening signal. The signals for the remote operation center or on-site
Vessels that require an opening shall continue to request an opening via the methods defined in 33 CFR 117.15(b) through (d) (sound or visual signals or radio telephone (VHF–FM) voice communications), via telephone at (856) 231–2301, or via push-to-talk (PTT) on VHF–FM channel 13. Vessels may push the PTT button five times while on VHF–FM channel 13 to request an opening.
The remote operation system will be considered in a failed condition and qualified personnel will return and operate the bridge within 60 minutes if any of the following conditions are found: (1) The remote operation system becomes incapable of safely and effectively operating the bridge from the remote operation center, (2) visibility of the waterway or bridge is degraded to less than equal that of an on-site bridge tender (all eight camera views are required), (3) signals (communications) via sound or visual signals or radio telephone (voice) via VHF–FM channels 13 or 16 become inoperative, or (4) AIS becomes inoperative.
We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on these statutes and Executive Orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
The determination that this NPRM is not a significant regulatory action is based on the findings that: (1) Vessels will continue to transit the bridge in accordance with 33 CFR 117.716, (2) the remote operation system is designed to provide equal or greater capabilities compared to the on-site bridge tender, and (3) the bridge owner will be capable of restoring on-site operation of the bridge within 60 minutes if the remote operation system fails.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601–612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. There are no known adverse impacts to any entities related to this proposed rule, given no aspects of the remote operating system for the bridge will create any burdens on any entity as described in section IV.A above. The incorporation of the automated identification system (AIS) capability into the remote operation system is expected to aid mariners who have AIS capability or access to computer-based AIS data in safely navigating through the bridge by providing real-time bridge status.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520.).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (Act) (2 U.S.C. 1531–1538) requires federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a state, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule will not result in such an expenditure, we do discuss the effects of this proposed rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland Security Management Directive 023–01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321–4370f), and have made a preliminary determination that this action is one of a category of
A preliminary Record of Environmental Consideration and a Memorandum for the Record are not required for this rule. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential to effective rulemaking and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this notice of proposed rulemaking and all public comments are in our online docket at
Bridges.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05–1; and Department of Homeland Security Delegation No. 0170.1.
(a) The following apply to all drawbridges across the Delaware River:
(1) The draws of railroad bridges need not be opened when there is a train in the bridge block approaching the bridge with the intention of crossing or within five minutes of the known time of the passage of a scheduled passenger train.
(2) The opening of a bridge may not be delayed more than five minutes for a highway bridge or 10 minutes for a railroad bridge after the signal to open is given.
(3) The owners of drawbridges shall provide and keep in good legible condition two board gages painted white with black figures not less than six inches high to indicate the vertical clearance under the closed draw at all stages of the tide. The gages shall be so placed on the bridge that they are plainly visible to operators of vessels approaching the bridge either up or downstream.
(b) The draw of the Conrail Memorial Railroad Bridge, mile 104.6, at Pennsauken Township, NJ shall be operated as follows:
(1) The bridge will be remotely operated from the Conrail South Jersey dispatch center in Mount Laurel, NJ unless the remote operation system is in a failed condition.
(2) An AIS transmitter has been installed on the New Jersey side of the bridge at the bridge and land intersection in approximate position 39°58′50.52″ N. (39.9807), 75°03′58.75″ (-75.06632). The AIS transmitter is assigned maritime mobile service identity (MMSI) number 993663001. The status of the bridge (open/closed/inoperative) will be provided via the name transmitted by the AIS private aids to navigation as DELAIR BRG–OPEN (fully open and locked position, channel light green), DELAIR BRG–CLOSED (other than fully open, not inoperative), or DELAIR BRG–INOP (other than fully open, inoperative). The AIS transmitter will transmit the bridge status every two minutes and upon a change in the bridge status.
(3) The remote operation system will be considered in a failed condition and qualified personnel will return and operate the bridge within 60 minutes if any of the following conditions are found:
(i) The remote operation system becomes incapable of safely and effectively operating the bridge from the remote operation center; or
(ii) Visibility of the waterway or bridge is degraded to less than equal that of an on-site bridge tender; or
(iii) Signals (communications) via sound or visual signals or radio telephone (voice) via VHF–FM channels 13 or 16 become inoperative; or
(iv) AIS becomes inoperative.
(4) Vessels that require an opening shall continue to request an opening via the methods defined in § 117.15(b) through (d) (sound or visual signals or radio telephone (VHF–FM) voice communications), via telephone at (856) 231–2301, or via push-to-talk (PTT) on VHF–FM channel 13. Vessels may push the PTT button five times while on VHF–FM channel 13 to request an opening.
(5) The signals for the remote operation center or on-site bridge tender to respond to a sound signal for a bridge opening include:
(i) When the draw can be opened immediately—a sound signal of one prolonged blast followed by one short blast and illumination of a fixed white light not more than 30 seconds after the requesting signal; or
(ii) When the draw cannot be opened immediately—five short blasts sounded in rapid succession and illumination of a fixed red light not more 30 seconds after the vessel's opening signal.
(6) The signals for the remote operation center or on-site bridge tender to respond to a visual signal for a bridge opening include:
(i) When the draw can be opened immediately—illumination of a fixed white light not more than 30 seconds after the requesting signal; or
(ii) When the draw cannot be opened immediately—illumination of a fixed red light not more 30 seconds after the vessel's opening signal.
(7) The fixed white light will remain illuminated until the bridge reaches the fully open position. The fixed white and red lights will be positioned on the east (New Jersey) bridge abutment adjacent to the navigation span.
U.S. Copyright Office, Library of Congress.
Notice of inquiry and request for petitions.
The United States Copyright Office is initiating the seventh triennial rulemaking proceeding under the Digital Millennium Copyright Act (“DMCA”), concerning possible temporary exemptions to the DMCA's prohibition against circumvention of technological measures that control access to copyrighted works. In this proceeding, the Copyright Office is establishing a new, streamlined procedure for the renewal of exemptions that were granted during the sixth triennial rulemaking. If renewed, those current exemptions would remain in force for an additional three-year period (October 2018—October 2021). Members of the public seeking the renewal of current exemptions should submit petitions as described below; parties opposing such renewal will then have the opportunity to file comments in response. The Office is also accepting petitions for
Written petitions for renewal of current exemptions must be received no later than 11:59 p.m. Eastern Time on July 31, 2017. Written comments in response to any petitions for renewal must be received no later than 11:59 p.m. Eastern Time on September 13, 2017. Written petitions for new exemptions must be received no later than 11:59 p.m. Eastern Time on September 13, 2017.
Written petitions for renewal of current exemptions must be completed using the form provided on the Office's Web site at
Regan A. Smith, Deputy General Counsel, by email at
The Digital Millennium Copyright Act (“DMCA”)
These protections, codified in section 1201 of title 17, United States Code, as envisioned by Congress, seek to balance the interests of copyright owners and users, including the personal interests of consumers, in the digital environment.
At the same time, section 1201 contains a number of discrete, statutory exemptions to these prohibitions, to avoid curtailing legitimate activities such as security testing, law enforcement activities, or the protection of personally identifying information.
In order for a temporary exemption from the prohibition on circumvention to be granted through the triennial rulemaking, it must be established that “persons who are users of a copyrighted work are, or are likely to be in the succeeding 3-year period, adversely affected by the prohibition . . . in their ability to make noninfringing uses under [title 17] of a particular class of copyrighted works.”
The rulemaking process for the seventh triennial proceeding will be generally similar to the process introduced in the sixth proceeding. The primary change from the last rulemaking is the addition of a new streamlined procedure through which members of the public may petition for current temporary exemptions that were granted during the sixth triennial rulemaking to remain in force for an additional three-year period (October 2018–October 2021).
With this notice of inquiry, the Copyright Office is initiating the petition phase of the rulemaking, calling for the public to submit petitions both to renew current exemptions, as well as any comments in support of or opposition to such petitions, and to propose new exemptions. This two-track petition process is described below. After the close of the petition phase, the Office will publish a notice of proposed rulemaking (“NPRM”) to initiate the next phase of the rulemaking process, as described below.
Video tutorials explaining section 1201 in general and the rulemaking process can be found on the Office's 1201 rulemaking Web page at
The Copyright Office recently published a comprehensive study of section 1201, including the process for adopting temporary exemptions. As part of the study, the Office solicited comments from the public and held roundtable discussions on whether the Office should adjust the rulemaking procedure to streamline the process for recommending readoption of previously adopted exemptions to the Librarian.
During the course of the study, a broad consensus of stakeholders requested that the Copyright Office change this approach and take steps within its regulatory authority to streamline the process for recommending the renewal of previously adopted exemptions to the Librarian.
Adopting an approach of
While the study concluded that the Office has some regulatory flexibility as to how it could implement a streamlined process for evaluating exemption renewals, it announced that the Office intended to implement such a process for this seventh triennial rulemaking proceeding. As promised in the study, below the Office provides further details regarding the streamlined process.
Those seeking readoption of a current exemption, granted during the sixth rulemaking, may petition for renewal by submitting the Copyright Office's required fillable form, available on the Office's Web site at
The petition form has four components:
For the attestation to be trustworthy and reliable, it is important that the petitioner make it based on his or her own personal knowledge and experience. This requirement should not be burdensome, as a broad range of individuals have a sufficient level of knowledge and experience. For example, a blind individual having difficulty finding and purchasing e-books with appropriate assistive technologies would have such personal knowledge and experience to make the declaration with regard to the assistive technology exemption; so would a relevant employee or volunteer at an organization like the American Foundation for the Blind, which advocates for the blind, visually impaired, and print disabled, is familiar with the needs of the community, and is well-versed specifically in the e-book accessibility issue. It would be improper, however, for a general member of the public to petition for renewal if he or she knows nothing more about matters concerning e-book accessibility other than what he or she might have read in a brief newspaper article, or simply opposes the use of digital rights management tools as a matter of general principle.
The declaration also requires affirmation that, to the best of the petitioner's knowledge, there has not been any material change in the facts, law, or other circumstances set forth in the prior rulemaking record (available at
Any interested party may respond to a petition to renew a current exemption by submitting comments. While the primary purpose of these comments is to allow for opposition to renewing the exemption, comments in support of renewal are also permitted. Although no form is being provided for such comments, the first page of any responsive comments must clearly identify which exemption's readoption is being supported or opposed. While participants may comment on more than one exemption, a single submission may not address more than one exemption. For example, a party that wishes to oppose the renewal of both the wireless device unlocking exemption and the jailbreaking exemption must file separate comments for each.
Opposition to a renewal petition must be meaningful, such that, from the evidence provided, it would be reasonable for the Register to conclude that the prior rulemaking record and any further information provided in the renewal petition are insufficient to support recommending renewal of an exemption. For example, a change in case law might affect whether a particular use is noninfringing, new technological developments might affect the availability for use of copyrighted works, or new business models might affect the market for or value of copyrighted works. Such evidence could cause the Office to conclude that the prior evidentiary record is too stale to rely upon for an assessment affecting the subsequent three-year period. The Office may also consider whether opposition is meaningful only as to part of a current exemption.
Unsupported conclusory opinion and speculation will not be enough for the Register to refuse to recommend renewing an exemption she would have otherwise recommended in the absence of any opposition, or subject consideration of this exemption to the more comprehensive rulemaking procedure.
Those seeking to engage in activities not currently permitted by an existing exemption, including activities that expand upon a current exemption, may propose a new exemption by filing a petition using the Copyright Office's required fillable form, available on the Office's Web site at
The petition form has two components:
To be clear, petitioners need not propose precise regulatory language or fully define the contours of an exemption class in the petition. A short, plain statement describing the nature of the activities the petitioners wish to engage in will be sufficient. Although there is no page limit, the Office anticipates that petitioners will be able to adequately describe in plain terms the relevant information in a few sentences. The Office's petition form includes examples of what it regards as a sufficient description of a requested exemption.
Nor does the Office intend for petitioners to deliver the complete legal and evidentiary basis for their proposals in the petition, and specifically requests that petitioners not do so. Rather, the sole purpose of the petition is to provide the Office with basic information about the uses of copyrighted works that are adversely affected by the prohibition on circumvention. The Office will then use that information to itself formulate categories of potential exemptions, and group similar proposals into those categories, for purposes of the next, more substantive, phase of the rulemaking beginning with the publication of the NPRM.
Indeed, as during the last rulemaking, even the NPRM will not “put forward precise regulatory language for the proposed classes, because any specific language for exemptions that the Register ultimately recommends to the Librarian will necessarily depend on the full record developed during this rulemaking.”
Following receipt of all petitions, as well as comments on petitions for renewal, the Office will evaluate the material received and will issue an NPRM addressing all of the potential exemptions to be considered in the seventh rulemaking.
The NPRM will set forth which exemptions the Register will recommend for readoption, along with proposed regulatory language. The NPRM will also identify any exemptions the Register has declined to recommend for renewal under the streamlined process, after considering any opposition received. Those exemptions will instead be subject to the more comprehensive rulemaking procedure in order to build out the administrative record. The Register will not at the NPRM stage make a final determination to reject recommendation of any exemption that meets the threshold requirements of section 1201(a).
For current exemptions for which renewal was sought but which were not recommended for readoption through the streamlined process and all new exemptions, including proposals to expand current exemptions, the NPRM will group them appropriately, describe them, and initiate at least three rounds of public comment. As with the sixth rulemaking, the Office plans to
As noted in the Office's study, however, the Office intends to issue the NPRM at an earlier point than during the sixth rulemaking proceeding, to give all parties sufficient time to participate in the process. Publishing the NPRM earlier should better accommodate the academic calendar and allow for greater law student participation during the more substantive comment and public hearing phases of the proceeding—something many commenters suggested during the study.
Postal Regulatory Commission.
Notice of proposed rulemaking.
The Commission is noticing a recent filing requesting that the Commission initiate an informal rulemaking proceeding to consider changes to an analytical method for use in periodic reporting (Proposal Three). This document informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202–789–6820.
On June 22, 2017, the Postal Service filed a petition pursuant to 39 CFR 3050.11 requesting the Commission to initiate an informal rulemaking proceeding to consider proposed changes to an analytical method related to periodic reports.
The Commission establishes Docket No. RM2017–7 for consideration of matters raised by the Petition. More information on the Petition may be accessed via the Commission's Web site at
1. The Commission establishes Docket No. RM2017–7 for consideration of the matters raised by the Petition of the United States Postal Service Requesting
2. Comments by interested persons in this proceeding are due no later than August 16, 2017.
3. Pursuant to 39 U.S.C. 505, the Commission appoints Lyudmila Y. Bzhilyanskaya to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this docket.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve revisions to the Great Basin Unified Air Pollution Control District (GBUAPCD) and the Town of Mammoth Lakes portion of the California State Implementation Plan (SIP). These revisions concern particulate matter (PM) emissions from wood burning devices and road dust in the Town of Mammoth Lakes. We are proposing to approve local rules to regulate these emission sources under the Clean Air Act (CAA or the Act).
Any comments on this proposal must arrive by July 31, 2017.
Submit your comments, identified by Docket ID No. EPA–R09–OAR–2016–0409 at
Christine Vineyard, EPA Region IX, (415) 947–4125,
Throughout this document, “we,” “us” and “our” refer to the EPA. This proposal addresses the following local rules:
• GBUAPCD Rule 431, Particulate Matter (except paragraphs M and N).
• Town of Mammoth Lakes Municipal Code Chapter 8.30, Particulate Emissions Regulations (except paragraphs 8.30.110 and 8.30.120).
In the Rules and Regulations section of this
We do not plan to open a second comment period, so anyone interested in commenting should do so at this time. If we do not receive adverse comments, no further activity is planned. For further information, please see the direct final action.
This document was received for publication by the Office of the Federal Register on June 20, 2017.
Environmental Protection Agency (EPA).
Proposed rule; notice of intent.
The Environmental Protection Agency (EPA) Region 8 is issuing a notice of Intent to Partially Delete the property currently owned by Tallgrass Energy Partners, LP (formerly owned by KM Upstream LLC and hereinafter referred to as the former KMI Property), on the Mystery Bridge Road/U.S. Highway 20 Site (Site) from the National Priorities List (NPL). The Site is located in Natrona County, northeast of Casper, Wyoming. EPA requests public comment on this proposed action. The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution and Contingency Plan (NCP). The EPA and the State of Wyoming, through the Wyoming Department of Environmental Quality (WDEQ), have determined that all appropriate response actions, other than maintenance of institutional controls and five-year reviews, have been completed for the former KMI source area and the resultant groundwater contamination. However, this deletion does not preclude future actions under Superfund.
This partial deletion pertains to the former KMI Property of OU1 and OU2 formerly containing the benzene, toluene, ethylbenzene, and total xylenes (collectively known as BTEX) groundwater plume and source soils, respectively. The remaining area and media of both OU1 and OU2 containing the volatile halogenated organic chemicals (VHOs) source soils and
Comments concerning this action must be received by July 31, 2017.
Submit your comments, identified by Docket ID no. EPA–HQ–SFUND–1910–0011, by one of the following methods:
•
•
•
•
Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.
All documents in the docket are listed in the
Andrew Schmidt, Remedial Project Manager, 8EPR–SR, U.S. Environmental Protection Agency, Region 8, 1595 Wynkoop Street, Denver, CO 80202–1129, (303) 312–6283,
In the “Rules and Regulations” section of the
For additional information, see the direct final notice of Partial Deletion, located in the Rules section of this
Environmental protection, Air pollution control, Chemicals, Hazardous waste, Hazardous substances, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply.
The authority citation for Part 300 is continues to read as follows:
33 U.S.C. 1321(c)(2); 42 U.S.C. 9601–9657; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923; 3 CFR, 1987 Comp., p. 193.
Federal Communications Commission.
Petition for Reconsideration.
A Petition for Reconsideration (Petition) has been filed in the Commission's rulemaking proceeding by Lee G. Petro, on behalf of The Wright Petitioners.
Oppositions to the Petition must be filed on or before July 17, 2017. Replies to an opposition must be filed on or before July 25, 2017.
Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.
Melissa Conway, Mobility Division, Wireless Telecommunications Bureau,
This is a summary of the Commission's document, Report No. 3079, released June 22, 2017. The full text of the Petition is available for viewing and copying at the FCC Reference Information Center, 445 12th Street SW., Room CY–A257, Washington, DC 20554. It also may be accessed online via the Commission's Electronic Comment Filing System at:
Federal Communications Commission.
Proposed rule.
In this document, the Federal Communications Commission (Commission) proposes to revise its rules governing the Emergency Alert System (EAS) to incorporate a new event code, “BLU”, for Blue Alerts. Adding this event code would allow alert originators to issue an alert whenever a law enforcement officer is injured or killed, missing in connection with their official duties, or if there is an imminent and credible threat to cause death or serious injury to law enforcement officers.
Comments are due on or before July 31, 2017 and reply comments are due on or before August 29, 2017.
You may submit comments, identified by PS Docket No. 15–94, by any of the following methods:
For detailed instructions for submitting comments and additional information on the rulemaking process, see the
Gregory Cooke, Deputy Division Chief, Policy and Licensing Division, Public Safety and Homeland Security Bureau, at (202) 418–2351, or by email at
This is a summary of the Commission's Notice of Proposed Rulemaking (
Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS).
All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW., Room TW–A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of
Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.
U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW., Washington DC 20554.
1. In this
2.
3.
4. Blue Alerts may be initiated by a law enforcement agency having primary jurisdiction over the incident. The Blue Alert Guidelines provide three criteria for Blue Alert issuance, any one of which should be met before a Blue Alert is issued. First, an alert may be issued when “the agency confirms that a law enforcement officer has been killed, seriously injured, or attacked and with indications of death or serious injury.” Second, an alert may be issued in the event of a “threat to cause death or serious injury to a law enforcement officer.” Under this criterion, the agency initiating the Blue Alert should confirm that the threat is “imminent and credible,” and, to the extent the threat arises from the acts of a suspect, such suspect, “at the time of receipt of the threat,” should be “wanted by a law enforcement agency.” Third, where a law enforcement officer is reported missing, an agency may issue a Blue Alert if it concludes that “the law enforcement officer is missing in connection with the officer's official duties” and that “there is an indication of serious injury to or death of the law enforcement officer.” With respect to each of these three scenarios, the agency should not issue the Blue Alert unless “any suspect involved has not been apprehended” and “there is sufficient descriptive information of the suspect, including any vehicle and license tag information.” The Blue Alert Act also provides that an alert should be issued only in those areas most likely to result in the apprehension of the suspect, and that an alert should be suspended once the suspect is apprehended.
5. Additionally, the National Blue Alert Coordinator is charged with cooperating with the Chairman of the FCC to carry out the Blue Alert Act. In its 2017 Report to Congress, the COPS Office noted that it has complied with this directive by establishing a point of contact with the FCC, and by commencing outreach efforts to pursue a dedicated EAS event code.
6. We propose to revise the Commission's EAS rules to add a new “Blue Alert” event code to the EAS and thus “promote compatible and integrated Blue Alert plans throughout the United States” as called for in the Blue Alert Act. Several developments support taking this action today. The Blue Alert Act was adopted to help the states provide effective alerts to the public and law enforcement when police and other law enforcement officers are killed or in danger. In order to ensure that these state plans are compatible and integrated throughout the United States as envisioned by the Blue Alert Act, the Blue Alert Coordinator has made a series of recommendations to Congress. Among them, the Blue Alert Coordinator identified the need for a dedicated EAS event code for Blue Alerts and noted the alignment of the EAS with the implementation of the Blue Alert Act. We propose that by adopting a dedicated EAS event code to deliver Blue Alerts, our rules can help facilitate the delivery of Blue Alerts to the public in a uniform and consistent manner that promotes the compatible and integrated Blue Alert plans contemplated by the Blue Alert Act. We seek comment on this proposal below.
7. We propose to amend Section 11.31(e) of the EAS rules to add a new “BLU” event code to the codes contained within the EAS Protocol. Consistent with the guidance issued by the National Blue Alert Coordinator, we anticipate this code would be used by alert originators to disseminate information related to (1) the serious injury or death of a law enforcement officer in the line of duty, (2) an officer who is missing in connection with their official duties, or (3) an imminent and credible threat that an individual intends to cause serious injury to, or kill, a law enforcement officer. We also propose that such alerts would be confined to those areas most likely to facilitate capture of the suspect, and would be suspended when the suspect is apprehended. As with other non-Presidential alerts, carriage of Blue Alerts and use of the Blue Alert event code would be voluntary. We seek comment on this proposal.
8.
9. We seek comment on whether the current system could accommodate Blue Alerts as effectively as it does these other types of alerts. Are there constraints that would impede the ability of the EAS to contain the information required under the Blue Alert Guidelines? For example, EAS alerts are subject to a two-minute time limit. Can the information required by the Blue Alert Guidelines be communicated within a two-minute time frame? We note that EAS alerts delivered over the IPAWS can contain detailed text files, non-English alerts, or other content-rich data that is not available to EAS alerts delivered via the broadcast-based daisy chain. Do Blue Alerts contain extra text files or other data-rich content that would benefit from IPAWS' capabilities? Would it have a negative impact on the value of an EAS Blue Alert that such data-rich content may not be delivered to all EAS Participants, depending on whether they receive the alert through IPAWS or through the broadcast-based daisy chain?
10. Further, EAS Alerts are limited to the geographic contours and service areas of broadcasters and cable service providers. In light of this, are EAS alerts suited to deliver Blue Alerts in a targeted geographic manner, consistent with the Blue Alert Act, which provides that Blue Alerts, to the maximum extent practicable, “be limited to the geographic areas most likely to facilitate the apprehension of the suspect involved or which the suspect could reasonably reach, which should not be limited to state lines”? Can EAS Participants distribute Blue Alerts to such smaller, more narrowly targeted geographic areas? We note that, in the future, if ATSC 3.0 DTV is approved by the Commission as proposed in the
11.
12. As of November 2016, 27 states have implemented Blue Alert plans. We observe that states' implementation of Blue Alert plans vary. For example, Montana and Florida utilize the “Law Enforcement Emergency” (LEW) EAS event code to transmit Blue Alerts, whereas Washington is creating its own “Blue Alert System” for voluntary cooperation between law enforcement, and radio, television, cable, and satellite systems. To what extent do current state guidelines for delivering a Blue Alert differ from the Blue Alert Guidelines? Would a dedicated EAS event code help ensure that both Blue Alerts and related outreach are undertaken in a consistent manner nationally? We seek comment on the distribution methods states currently employ to deliver Blue Alerts. To the extent states use different distribution methods to deliver Blue Alerts, do these various distribution methods detract from the effectiveness of Blue Alerts? We seek comment on the experience of any states that have adopted Blue Alerts as part of their statewide alerting systems. We seek comment on whether the adoption of a dedicated EAS Blue Alert event code would encourage EAS Participants to deliver Blue Alerts.
13. We additionally ask whether availability of a dedicated Blue Alert EAS event code would promote the adoption of additional Blue Alert systems throughout the nation. According to the COPS Office, a dedicated EAS event code would “facilitate and streamline the adoption of new Blue Alert plans throughout the nation and would help to integrate existing plans into a coordinated national framework.” As the National Blue Alert Coordinator noted in its 2016 Report to Congress, a majority of states and territories do not yet have Blue Alert systems. Would facilitating law enforcement agencies' ability to utilize existing EAS distribution networks alleviate much of the burden associated with designing and implementing Blue Alert systems and plans? Would the implementation of a dedicated Blue Alert EAS code encourage states that do not have Blue Alert plans to adopt, in whole or in part, existing procedures of states that have implemented Blue Alert plans? Has the lack of a dedicated Blue Alert EAS event code impeded adoption of Blue Alert plans? Further, would utilizing the nationwide EAS architecture help integrate existing plans into a coordinated national framework? In this regard, would integrating state Blue Alert plans into the EAS help individual states work together when suspects or threats cross state borders, as envisioned by the Blue Alert Act?
14. Alternately, we seek comment on whether existing event codes are sufficient to convey Blue Alert information. According to the COPS Office, there is a lack of urgency associated with existing event codes, which do not “suggest immediate action on the part of broadcasters.” As noted above, at least two states utilize the “Law Enforcement Warning” (LEW) EAS code to transmit Blue Alerts. The COPS Office observes, however, that the LEW event code is used for events such as road closures and notifying drivers of hazardous road conditions and is not an effective means to transmit Blue Alerts. We seek comment on this observation. Is the use of LEW effective to provide information to help protect law enforcement officials? For what purposes is LEW otherwise used? Does utilizing an existing EAS code for a Blue Alert detract from the existing code's ability to serve its intended purpose? Without adoption of a Blue Alert code, would law enforcement agencies be hampered by being forced to use codes that do not directly apply to the situation, nor convey the necessary information? Further, would the use of existing EAS event codes to broadcast a Blue Alert create confusion? Do other event codes contain instructions that might confuse the public or direct the public to take unsafe actions in response to the underlying situation? For example, in the 2016
15.
16. In this regard, we seek comment on what actions states have taken to educate the public on Blue Alerts and appropriate responses to Blue Alerts. For example, we note that the Blue Alert Foundation has prepared model Public Service Announcements (PSAs) for use by states to educate the public about Blue Alerts. Have states adopted these PSAs or other types of outreach to educate the public about Blue Alerts and appropriate responses to them? How often have Blue Alerts been activated and through what means or media have they been issued? How has the public reacted to Blue Alerts? In the past, the Commission has noted its concern that over-alerting or alerting to unaffected areas can lead to alert fatigue. Has public response indicated that is the case in connection with Blue Alerts? We encourage commenters to provide examples of all available public responses to Blue Alerts that have been delivered since the adoption of the Blue Alert Act and DOJ's Blue Alert Guidelines.
17.
18. With regard to EAS Participants, we note that in the NWS proceeding the Commission allowed EAS Participants to implement the new event codes on a voluntary basis. The Commission further noted that it has taken this approach when it has adopted other new EAS event codes in the past, and that the record did not reflect any basis to take a different approach. We therefore propose to take a similar approach here and would allow EAS Participants to upgrade their equipment (whether through new equipment that is programmed to contain the code or through implementing a software upgrade to install the code into equipment already in place) on a voluntary basis until such time as their equipment is replaced. We seek comment on our proposal. If commenters disagree with our analysis or proposed timeline, they should specify alternatives and the specific technical bases for such alternatives.
19.
20. Would the adoption of a dedicated EAS event code help ensure that Blue Alerts issued over WEA are swiftly processed and delivered to the public? If we were to adopt a dedicated Blue Alert EAS event code, and the alert originator were to select “BLU” as the event code type, could this automatically prepopulate the WEA message—thereby saving critical seconds—with uniform language that might be applicable to all Blue Alerts (such as by automatically including alert message text saying “This is a Blue Alert for [area]”)? We assume that WEA Blue Alerts would be classified as either an Imminent Threat Alert or the newly adopted Public Safety Message, depending on the circumstances. We seek comment on this assumption, and ask whether alert initiators, Participating CMRS providers, or other WEA stakeholders believe it would be helpful to receive additional guidance or direction regarding how Blue Alerts should be classified for purposes of WEA. Are there other reasons adopting a dedicated EAS Blue Alert event code would facilitate or otherwise affect the delivery of Blue Alerts to the public over WEA?
21.
22. In the background section of this
23. We seek comment on whether introducing a dedicated EAS event code
24. We seek comment on the benefits of a dedicated EAS Blue Alert code with respect to potentially providing an additional path of communication to others who may be best positioned to provide assistance, including off-duty public safety officials and the media. EAS Blue Alerts also could quickly provide the media with information that they can disseminate to the public. In this regard, could EAS Blue Alerts lower the amount of time that police forces devote to alerting the media, allowing more time for personnel to devote to responding to the emergency? We seek comment on this category of benefits and cost reductions.
25. We also seek comment on the costs of the proposed event code. In the
26. We believe $3.5 million represents a conservative estimate because it assumes all 28,508 broadcasters and cable companies will spend the maximum of one hour downloading and installing a Blue Alert specific software update. We note that, as of July 30, 2016, EAS Participants were required to have equipment in place that would be capable, at the minimum, of being upgraded by software to accommodate EAS modifications like what we propose here. We also believe that the actual cost imposed will fall far below the $3.5 million cost ceiling, because it is premised on the assumption that downloading the software updates will take one hour, whereas Sage estimated in the
27. The COPS Office observes that a dedicated event code would convey the necessary sense of urgency and galvanize the public awareness necessary to protect law enforcement and the public from dangerous offenders, avoid utilizing existing codes which are used for mundane informational purposes, facilitate the adoption of new Blue Alert plans and integrate existing plans into a cohesive framework, and serve as a central and organizing element for Blue Alert plans nationally. We acknowledge DOJ's guidance and expertise as to the potential benefits of Blue Alerts, and combine that with our own analysis to support the tentative conclusion that the benefits of the proposed event code will outweigh its costs. We seek comment on this tentative conclusion.
28. Finally, are there costs or benefits that should be considered that are not captured in the above discussion? Are there alternative or additional approaches that could increase benefits and/or reduce costs? We seek comment on whether there are alternative or additional measures that the Commission could take to improve the introduction of Blue Alerts over the EAS, in order to promote the important public policy objective of protecting our nation's law enforcement officials.
29. As required by the Regulatory Flexibility Act of 1980, as amended (RFA) the Commission has prepared this present Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in this
30. In this
31. Authority for the actions proposed in this
32. The RFA directs agencies to provide a description of and, where feasible, an estimate of, the number of small entities that may be affected by the rules adopted herein. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA). Below, we describe and estimate the number of small entity licensees that may be affected by the adopted rules.
33.
34.
35. According to Commission staff review of the BIA Publications, Inc. Master Access Radio Analyzer Database as of June 2, 2016, about 11,386 (or about 99.9 percent) of 11,395 commercial radio stations had revenues of $38.5 million or less and thus qualify as small entities under the SBA definition. The Commission has estimated the number of licensed commercial radio stations to be 11,415. We note that the Commission also has estimated the number of licensed NCE radio stations to be 4,101. Nevertheless, the Commission does not compile and otherwise does not have access to information on the revenue of NCE stations that would permit it to determine how many such stations would qualify as small entities.
36. We also note that in assessing whether a business entity qualifies as small under the above definition, business control affiliations must be included. The Commission's estimate therefore likely overstates the number of small entities that might be affected by its action, because the revenue figure on which it is based does not include or aggregate revenues from affiliated companies. In addition, to be determined a “small business,” an entity may not be dominant in its field of operation. We further note, that it is difficult at times to assess these criteria in the context of media entities, and the estimate of small businesses to which these rules may apply does not exclude any radio station from the definition of a small business on these basis; thus, our estimate of small businesses may be over-inclusive.
37.
38.
39. The Commission has estimated the number of licensed commercial television stations to be 1,384. Of this total, 1,264 stations (or about 91 percent) had revenues of $38.5 million or less, according to Commission staff review of the BIA Kelsey Inc. Media Access Pro Television Database (BIA) on February 24, 2017, and, therefore, these licensees qualify as small entities under the SBA definition. In addition, the Commission has estimated the number of licensed noncommercial educational (NCE) television stations to be 394. Notwithstanding, the Commission does not compile and otherwise does not have access to information on the revenue of NCE stations that would permit it to determine how many such stations would qualify as small entities.
40. We note, however, that in assessing whether a business concern qualifies as “small” under the above definition, business (control) affiliations must be included. Our estimate, therefore, likely overstates the number of small entities that might be affected by our action, because the revenue figure on which it is based does not include or aggregate revenues from affiliated companies. In addition, another element of the definition of “small business” requires that an entity not be dominant in its field of operation. We are unable at this time to define or quantify the criteria that would establish whether a specific television broadcast station is dominant in its field of operation. Accordingly, the estimate of small businesses to which rules may apply does not exclude any television station from the definition of a small business on this basis and therefore is possibly over-inclusive.
41.
42.
43.
44.
45.
46.
47.
48.
49.
50.
51. In 2009, the Commission conducted Auction 86, the sale of 78 licenses in the BRS areas. The Commission offered three levels of bidding credits: (i) A bidder with attributed average annual gross revenues that exceed $15 million and do not exceed $40 million for the preceding three years (small business) received a 15 percent discount on its winning bid; (ii) a bidder with attributed average annual gross revenues that exceed $3 million and do not exceed $15 million for the preceding three years (very small business) received a 25 percent discount on its winning bid; and (iii) a bidder with attributed average annual gross revenues that do not exceed $3 million for the preceding three years (entrepreneur) received a 35 percent discount on its winning bid. Auction 86 concluded in 2009 with the sale of 61 licenses. Of the ten winning bidders, two bidders that claimed small business status won 4 licenses; one bidder that claimed very small business status won three licenses; and two bidders that claimed entrepreneur status won six licenses.
52.
53.
54.
55.
56.
57. None.
58. The RFA requires an agency to describe any significant, specifically small business alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): “(1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) and exemption from coverage of the rule, or any part thereof, for small entities.”
59. The rule changes contemplated by the
60. None.
61. The proceeding this
62. As required by the Regulatory Flexibility Act of 1980, the Commission has prepared an Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on small entities of the policies and rules addressed in this document. The IRFA is set forth in Appendix B. Written public comments are requested in the IRFA. These comments must be filed in accordance with the same filing deadlines as comments filed in response to this
63. This document does not contain proposed information collection(s) subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104–13. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107–198.
64. Accordingly,
65.
Emergency Alert System.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 11 as follows:
47 U.S.C. 151, 154 (i) and (o), 303(r), 544(g) and 606.
(e) * * *
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104–13. Comments are required regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by July 31, 2017 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Office of the Secretary, USDA.
Notice.
The Office of the Secretary of the Department of Agriculture (the Secretary) announces the establishment of the Fiscal Year (FY) 2018 (October 1, 2017–September 30, 2018) in-quota aggregate quantity of raw cane sugar at 1,117,195 metric tons raw value (MTRV), and the establishment of the FY 2018 in-quota aggregate quantity of certain sugars, syrups, and molasses (also referred to as refined sugar) at 182,000 MTRV.
Souleymane Diaby, Import Policies and Export Reporting Division, Foreign Agricultural Service, Department of Agriculture, 1400 Independence Avenue SW., AgStop 1021, Washington, DC 20250–1021; by telephone (202) 720–2916; by fax (202) 720–0876; or by email
The provisions of paragraph (a)(i) of the Additional U.S. Note 5, Chapter 17 in the U.S. Harmonized Tariff Schedule (HTS) authorize the Secretary to establish the in-quota tariff-rate quota (TRQ) amounts (expressed in terms of raw value) for imports of raw cane sugar and certain sugars, syrups, and molasses that may be entered under the subheadings of the HTS subject to the lower tier of duties during each fiscal year. The Office of the U.S. Trade Representative (USTR) is responsible for the allocation of these quantities among supplying countries and areas.
Section 359(k) of the Agricultural Adjustment Act of 1938, as amended, requires that at the beginning of the quota year the Secretary of Agriculture establish the TRQs for raw cane sugar and refined sugars at the minimum levels necessary to comply with obligations under international trade agreements, with the exception of specialty sugar.
Notice is hereby given that I have determined, in accordance with paragraph (a)(i) of the Additional U.S. Note 5, Chapter 17 in the HTS and section 359(k) of the 1938 Act, that an aggregate quantity of up to 1,117,195 MTRV of raw cane sugar may be entered or withdrawn from warehouse for consumption during FY 2018. This is the minimum amount to which the United States is committed under the WTO Uruguay Round Agreements. I have further determined that an aggregate quantity of 182,000 MTRV of sugars, syrups, and molasses may be entered or withdrawn from warehouse for consumption during FY 2018. This quantity includes the minimum amount to which the United States is committed under the WTO Uruguay Round Agreements, 22,000 MTRV, of which 20,344 MTRV is established for any sugars, syrups and molasses, and 1,656 MTRV is reserved for specialty sugar. An additional amount of 160,000 MTRV is added to the specialty sugar TRQ for a total of 161,656 MTRV.
Because the specialty sugar TRQ is first-come, first-served, tranches are needed to allow for orderly marketing throughout the year. The FY 2018 specialty sugar TRQ will be opened in five tranches. The first tranche, totaling 1,656 MTRV, will open October 2, 2017. All specialty sugars are eligible for entry under this tranche. The second tranche will open on October 18, 2017, and be equal to 48,000 MTRV. The third tranche of 48,000 MTRV will open on January 23, 2018. The fourth and fifth tranches of 32,000 MTRV each will open on April 17, 2018, and July 17, 2018, respectively. The second, third, fourth, and fifth tranches will be reserved for organic sugar and other specialty sugars not currently produced commercially in the United States or reasonably available from domestic sources.
* Conversion factor: 1 metric ton = 1.10231125 short tons.
Animal and Plant Health Inspection Service, USDA.
Notice of availability.
We are advising the public that we are proposing to recognize Japan as being free of highly pathogenic avian influenza and Newcastle disease. This proposed recognition is based on a risk evaluation we have prepared in connection with this action, which we are making available for review and comment.
We will consider all comments that we receive on or before July 31, 2017.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
Dr. Kelly Rhodes, Senior Staff Veterinarian, Regionalization Evaluation Services, National Import Export Services, VS, APHIS, USDA, 4700 River Road, Unit 38, Riverdale, MD 20737–1231;
The regulations in 9 CFR part 94 (referred to below as the regulations) govern the importation of certain animals and animal products into the United States in order to prevent the introduction of various animal diseases, including highly pathogenic avian
In accordance with § 94.6(a)(1)(i) the Animal and Plant Health Inspection Service (APHIS) maintains a list of regions in which Newcastle disease is not considered to exist. Paragraph (a)(1)(ii) states that APHIS will add a region to this list after it conducts an evaluation of the region and finds that Newcastle disease is not likely to be present in its commercial bird or poultry populations.
In accordance with § 94.6(a)(2)(i), APHIS maintains a list of regions in which HPAI is considered to exist. Paragraph (a)(2)(ii) states that APHIS will remove a region from this list only after it conducts an evaluation of the region and finds that HPAI is not likely to be present in its commercial bird or poultry populations.
The regulations in 9 CFR part 92, § 92.2 contain requirements for requesting the recognition of the animal health status of a region (as well as for the approval of the export of a particular type of animal or animal product to the United States from a foreign region). If, after review and evaluation of the information submitted in support of the request, APHIS believes the request can be safely granted, APHIS will make its evaluation available for public comment through a document published in the
The Government of Japan has requested that APHIS evaluate the HPAI and Newcastle disease status of the country. In response to Japan's request, we have prepared an evaluation, titled “APHIS Evaluation of the Highly Pathogenic Avian Influenza and Newcastle Disease Status of Japan” (May 2017). Based on this evaluation, we have determined that Japan is free of both HPAI and Newcastle disease. APHIS has also determined that the surveillance, prevention, and control measures implemented by Japan are sufficient to minimize the likelihood of introducing HPAI and Newcastle disease into the United States via imports of species or products susceptible to these diseases. Our determination supports adding Japan to the Web-based list of regions in which Newcastle disease is not considered to exist and removing Japan from the Web-based list of regions in which HPAI is considered to exist.
Therefore, in accordance with § 92.2(e), we are announcing the availability of our risk evaluation of the HPAI and Newcastle disease status of Japan for public review and comment. We are also announcing the availability of an environmental assessment (EA) which has been prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
Information submitted in support of Japan's request is available by contacting the person listed under
After reviewing any comments we receive, we will announce our decision regarding the disease status of Japan with respect to HPAI and Newcastle disease in a subsequent notice.
7 U.S.C. 450, 7701–7772, 7781–7786, and 8301–8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
Animal and Plant Health Inspection Service, USDA.
Revision to and extension of approval of an information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the importation of animals and poultry, animal and poultry products, certain animal embryos, semen, and zoological animals.
We will consider all comments that we receive on or before August 29, 2017.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
For information on the importation of animals and poultry, animal and poultry products, certain animal embryos, and zoological animals, contact Dr. Bettina Helm, Senior Staff Veterinarian, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737; (301) 851–3300. For copies of more detailed information on the information collection, contact
Among other things, APHIS' Veterinary Services is responsible for preventing the introduction of foreign or certain other communicable animal diseases into the United States and for rapidly identifying, containing, eradicating, or otherwise mitigating such diseases when feasible. In connection with this mission, APHIS collects information from individuals, businesses, and farms that are involved with importation of animals or poultry, animal or poultry products, or animal germplasm (semen, ooycysts, and embryos, including eggs for hatching) into the United States, as well as from foreign countries and States to support these imports. Some of the information collection activities include agreements, permits, application and space reservation requests, inspections, registers, declarations of importation, requests for hearings, daily logs, additional requirements, application for permits, export health certificates, letters, written notices, daily record of horse activities, written requests, opportunities to present views, reporting, applications for approval of facilities, certifications, arrival notices, on-hold shipment notifications, reports, affidavits, animal identification, written plans, checklists, specimen submissions, emergency action notifications, refusal of entry and order to dispose of fish, premises information, recordkeeping, and application of seals.
In addition, APHIS opens U.S. markets to animal commodities by receiving and evaluating information collection activities, such as requests for recognition of the animal health status of a region, applications for recognition of the animal health status of a region, applications for recognition of a region as historically free of a disease, requests for additional information about the region, appeal classification of animal health status, and written recommendation implementation from foreign animal health authorities seeking to engage in the regionalization process.
The information collection requirements above are currently approved by the Office of Management and Budget (OMB) under OMB control numbers 0579–0040 (Importation of Animals and Poultry, Animal and Poultry Products, Certain Animal Embryos, Semen, and Zoological Animals), 0579–0165 (Importation of Horses, Ruminants, Swine, and Dogs; Inspection and Treatment for Screwworm), 0579–0224 (Tuberculosis Testing of Imported Cattle from Mexico), 0579–0301 (Spring Viremia of Carp; Import Restrictions on Certain Live Fish, Fertilized Eggs, and Gametes), and 0579–0425 (Cattle Fever Tick; Importation Requirements for Ruminants from Mexico). After OMB approves this combined information collection package (0579–0040), APHIS will retire OMB control numbers 0579–0165, 0579–0224, 0579–0301, and 0579–0425.
We are asking OMB to approve our use of these information collection activities, as described, for an additional 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies;
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Alaska Advisory Committee (Committee) to the Commission will be held at 2:00 p.m. (Alaska Time) Thursday, July 6, 2017. The purpose of the meeting is for the Committee to receive orientation from Commission staff and discussion regarding the status of the Committee project on voting rights.
The meeting will be held on Thursday, July 6, 2017, at 2:00 p.m. AKDT.
Ana Victoria Fortes (DFO) at
This meeting is available to the public through the following toll-free call-in number: 888–724–9513, conference ID number: 7347511. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1–800–977–8339 and providing the Service with the conference call number and conference ID number.
Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894–0508, or emailed Ana Victoria Fortes at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
Please click on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site,
First Responder Network Authority, National Telecommunications and Information Administration, U.S. Department of Commerce.
Notice of availability of a final programmatic environmental impact statement.
The First Responder Network Authority (“FirstNet”) announces the availability of the Final Programmatic Environmental Impact Statement for the Non-Contiguous Region (“Final PEIS”). The Final PEIS evaluates the potential environmental impacts of the proposed nationwide public safety broadband network in the Non-Contiguous Region (Alaska, Hawaii, American Samoa, Guam, the Northern Mariana Islands, Puerto Rico, and the U.S. Virgin Islands).
The Final PEIS is available for download from
For more information on the Final PEIS, contact Amanda Goebel Pereira, NEPA Coordinator, First Responder Network Authority, National Telecommunications and Information Administration, U.S. Department of Commerce, 12201 Sunrise Valley Drive, M/S 243, Reston, VA 20192.
The Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112–96, Title VI, 126 Stat. 256 (codified at 47 U.S.C. 1401
The National Environmental Policy Act of 1969 (42 U.S.C. 4321–4347) (“NEPA”) requires federal agencies to undertake an assessment of environmental effects of their proposed actions prior to making a final decision and implementing the action. NEPA requirements apply to any federal project, decision, or action that may have a significant impact on the quality of the human environment. NEPA also establishes the Council on Environmental Quality (“CEQ”), which issued regulations implementing the procedural provisions of NEPA (see 40 CFR parts 1500–1508). Among other considerations, CEQ regulations at 40 CFR 1508.28 recommend the use of
Due to the geographic scope of FirstNet (all 50 states, the District of Columbia, and five territories) and the diversity of ecosystems potentially traversed by the project, FirstNet has elected to prepare five regional PEISs. The five PEISs are divided into the East, Central, West, South, and Non-Contiguous Regions. The Non-Contiguous Region consists of Alaska, Hawaii, American Samoa, Guam, the Northern Mariana Islands, Puerto Rico, and the U.S. Virgin Islands. The Final PEIS analyzes potential impacts of the deployment and operation of the NPSBN on the natural and human environment in the Non-Contiguous
Now that this PEIS has been completed and once a Record of Decision (ROD) has been signed, the proposed FirstNet projects can begin to submit the site-specific environmental documentation to determine if the proposed project has been adequately evaluated in the PEIS or whether it instead warrants a Categorical Exclusion, an Environmental Assessment, or an Environmental Impact Statement.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On March 3, 2017, the Department of Commerce (the Department) published the preliminary results of the administrative review of the antidumping duty order on stainless steel bar (SSB) from Spain. The period of review (POR) is March 1, 2015, through February 29, 2016. The review covers one producer/exporter of the subject merchandise, Gerdau Aceros Especiales Europa, S.L. (Gerdau).
Effective June 30, 2017.
Ryan Mullen or Ian Hamilton, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482–5260 or (202) 482–4798, respectively.
The merchandise covered by the order is SSB products. The merchandise subject to this order is currently classified under the following Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 7222.10.00, 7222.11.00, 7222.19.00, 7222.20.00, and 7222.30.00. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the order is dispositive.
All issues raised in the case and rebuttal briefs by parties to this administrative review are addressed in the Issues and Decision Memorandum.
Based on a review of the record and comments received from interested parties, we have not made changes to the
We determine that, for the period of March 1, 2015, through February 29, 2016, the following weighted-average dumping margin exists:
The Department shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.
In accordance with the Department's “automatic assessment” practice, for entries of subject merchandise during the POR produced by Gerdau for which it did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.
We intend to issue instructions to CBP 15 days after the publication date of the final results of this review.
The following cash deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for Gerdau will be the rate established in the final results of this administrative review; (2) for merchandise exported by producers or exporters not covered in this administrative review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation, but the producer is, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the producer of the subject merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 25.77 percent, the all-others rate established in the investigation.
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement
This notice also serves as a reminder to parties subject to administrative protective orders (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(h).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) is postponing the deadline for issuing the final determination in the less-than-fair-value (LTFV) investigation of certain hardwood plywood products (hardwood plywood) from the People's Republic of China (PRC) until November 6, 2017, and is extending the provisional measures from a four-month period to a period of not more than six months.
Effective June 30, 2017.
Ryan Mullen or Amanda Brings, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482–5260 or (202) 482–3927, respectively.
On December 8, 2016, the Department of Commerce (the Department) initiated a LTFV investigation of imports of hardwood plywood from the PRC.
Section 735(a)(2) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.210(b)(2) provide that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative preliminary determination, a request for such postponement is made by the exporters or producers who account for a significant proportion of exports of the subject merchandise, or in the event of a negative preliminary determination, a request for such postponement is made by the petitioners. Further, 19 CFR 351.210(e)(2) requires that such postponement requests by exporters be accompanied by a request for extension of provisional measures from a four-month period to a period of not more than six months, in accordance with section 733(d) of the Act.
On June 14, 2017, Linyi Chengen Import And Export Co., Ltd. and Shandong Dongfang Bayley Wood Co., Ltd., the mandatory respondents in this investigation, requested that the Department fully extend the deadline for the final determination, and extend the application of the provisional measures from a four-month period to a period of not more than six months.
In accordance with section 735(a)(2)(A) of the Act and 19 CFR 351.210(b)(2)(ii), because: (1) The preliminary determination was affirmative; (2) the request was made by the exporters and producers who account for a significant proportion of exports of the subject merchandise; and (3) no compelling reasons for denial exist, the Department is postponing the final determination until no later than 135 days after the date of the publication of the
This notice is issued and published pursuant to 19 CFR 351.210(g).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of the Commerce (the Department) and the International Trade Commission (the ITC) have determined that revocation of the antidumping duty (AD) orders on
June 30, 2017.
Jacqueline Arrowsmith, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482–5255.
On December 30, 1992, the Department of Commerce (the Department) published the antidumping duty orders on welded ASTM A–312 stainless steel pipe (WSSP) from South Korea and Taiwan. On November 1, 2016, the Department published a notice of initiation of its fourth five-year (sunset) reviews of the antidumping duty orders on welded ASTM A–312 stainless steel pipe from South Korea and Taiwan.
As a result of these sunset reviews, the Department determined that revocation of the AD orders on WSSP from South Korea and Taiwan would likely lead to continuation or recurrence of dumping, and therefore, notified the U.S. International Trade Commission (ITC) of the magnitude of the margins likely to prevail should these orders be revoked.
On May 17, 2017, the ITC published its determination that revocation of the AD orders on WSSP from South Korea and Taiwan would likely lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time, pursuant to section 751(C) of the Act.
The merchandise subject to the antidumping duty orders is welded austenitic stainless steel pipe that meets the standards and specifications set forth by the American Society for Testing and Materials (ASTM) for the welded form of chromium-nickel pipe designated ASTM A–312. The merchandise covered by the scope of the orders also includes austenitic welded stainless steel pipes made according to the standards of other nations which are comparable to ASTM A–312.
WSSP is produced by forming stainless steel flat-rolled products into a tubular configuration and welding along the seam. WSSP is a commodity product generally used as a conduit to transmit liquids or gases. Major applications for steel pipe include, but are not limited to, digester lines, blow lines, pharmaceutical lines, petrochemical stock lines, brewery process and transport lines, general food processing lines, automotive paint lines, and paper process machines. Imports of WSSP are currently classifiable under the following Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 7306.40.5005, 7306.40.5015, 7306.40.5040, 7306.40.5062, 7306.40.5064, and 7306.40.5085.
As a result of the determinations by the Department and the ITC that revocation of the antidumping duty orders would likely lead to continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act, the Department hereby orders the continuation of the antidumping duty orders on welded ASTM A–312 stainless steel pipe from South Korea and Taiwan.
U.S. Customs and Border Protection will continue to collect antidumping duty cash deposits at the rates in effect at the time of entry for all imports of subject merchandise. The effective date of the continuation of these orders will be the date of publication in the
These sunset reviews and this notice are in accordance with section 751(c) of the Act and published pursuant to section 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Effective June 22, 2017.
Paul Stolz at (202) 482–4474 (Belgium); Stephanie Moore at (202) 482–3692 (Colombia); and George McMahon at (202) 482–1167 (Thailand), AD/CVD Operations, Enforcement and Compliance, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230.
On June 2, 2017, the Department of Commerce (the Department) received antidumping duty (AD) petitions (the Petitions) concerning imports of citric acid and certain citrate salts (citric acid) from Belgium, Colombia, and Thailand, filed in proper form on behalf of Archer Daniels Midland Company (ADM); Cargill Incorporated (Cargill); and Tate & Lyle Ingredients America LLC (Tate & Lyle) (collectively, the petitioners).
On June 7, 12, 14, and 16, 2017, the Department requested additional information and clarification of certain areas of the Petitions.
In accordance with section 732(b) of the Tariff Act of 1930, as amended (the Act), the petitioners allege that imports of citric acid and certain citrate salts from Belgium, Colombia, and Thailand, are being, or are likely to be, sold in the United States at less than fair value within the meaning of section 731 of the Act, and that such imports are materially injuring, or threatening material injury to, an industry in the United States. Also, consistent with section 732(b)(1) of the Act, the Petitions are accompanied by information reasonably available to the petitioners supporting their allegations.
The Department finds that the petitioners filed these Petitions on behalf of the domestic industry because the petitioners are interested parties as defined in section 771(9)(C) of the Act. The Department also finds that the petitioners demonstrated sufficient industry support with respect to the initiation of the AD investigations that the petitioners are requesting.
Because the Petitions were filed on June 2, 2017, the period of investigation (POI) for each investigation is April 1, 2016, through March 31, 2017.
The product covered by these investigations is citric acid and certain citrate salts from Belgium, Colombia, and Thailand. For a full description of the scope of these investigations,
During our review of the Petitions, the Department issued questions to, and received responses from, the petitioners pertaining to the proposed scope to ensure that the scope language in the Petitions would be an accurate reflection of the products for which the domestic industry is seeking relief.
As discussed in the preamble to the Department's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage (scope). The Department will consider all comments received from parties and, if necessary, will consult with parties prior to the issuance of the preliminary determinations. If scope comments include factual information (
The Department requests that any factual information the parties consider relevant to the scope of the investigations be submitted during this time period. However, if a party subsequently believes that additional factual information pertaining to the scope of the investigations may be relevant, the party may contact the Department and request permission to submit the additional information. As stated above, all such comments must be filed on the records of each of the concurrent AD and CVD investigations.
All submissions to the Department must be filed electronically using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS).
The Department will provide interested parties an opportunity to comment on the appropriate physical characteristics of citric acid to be reported in response to the Department's AD questionnaires. This information will be used to identify the key physical characteristics of the merchandise under consideration in order to report the relevant costs of production accurately as well as to develop appropriate product-comparison criteria.
Interested parties may provide any information or comments that they feel are relevant to the development of an accurate list of physical characteristics. Specifically, they may provide comments as to which characteristics are appropriate to use as: (1) General product characteristics and (2) product-comparison criteria. We note that it is not always appropriate to use all product characteristics as product-comparison criteria. We base product-comparison criteria on meaningful commercial differences among products. In other words, although there may be some physical product characteristics utilized by manufacturers to describe citric acid, it may be that only a select few product characteristics take into account commercially meaningful physical characteristics. In addition, interested parties may comment on the order in which the physical characteristics should be used in matching products. Generally, the Department attempts to list the most important physical characteristics first and the least important characteristics last.
In order to consider the suggestions of interested parties in developing and issuing the AD questionnaires, all product characteristics comments must be filed by 5:00 p.m. ET on July 12, 2017, which is 20 calendar days from the signature date of this notice. Any rebuttal comments, must be filed by 5:00 p.m. ET on July 24, 2017. All comments and submissions to the Department must be filed electronically using ACCESS, as explained above, on the records of the Belgium, Colombia, and Thailand less-than-fair-value investigations.
Section 732(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 732(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 732(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, the Department shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”
Section 771(4)(A) of the Act defines the “industry” as the producers, as a whole, of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs the Department to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both the Department and the ITC must apply the same statutory definition regarding the domestic like product,
Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (
With regard to the domestic like product, the petitioners do not offer a definition of the domestic like product distinct from the scope of the investigations. Based on our analysis of the information submitted on the record, we have determined that citric acid, as defined in the scope, constitutes a single domestic like product and we have analyzed industry support in terms of that domestic like product.
In determining whether the petitioners have standing under section 732(c)(4)(A) of the Act, we considered the industry support data contained in the Petitions with reference to the domestic like product as defined in the “Scope of the Investigations,” in the Appendix to this notice. To establish industry support, the petitioners provided their own production of the domestic like product in 2016.
Our review of the data provided in the Petitions, the General Issues Supplement, and other information readily available to the Department indicates that the petitioners have established industry support for the Petitions.
The Department finds that the petitioners filed the Petitions on behalf of the domestic industry because they are interested parties as defined in section 771(9)(C) of the Act and they have demonstrated sufficient industry support with respect to the AD investigations that they are requesting that the Department initiate.
The petitioners allege that the U.S. industry producing the domestic like product is being materially injured, or is threatened with material injury, by reason of the imports of the subject merchandise sold at less than normal value (NV). In addition, the petitioners allege that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.
The petitioners contend that the industry's injured condition is illustrated by reduced market share; underselling and price suppression or depression; lost sales and revenues; adverse impact on the domestic industry's production, capacity utilization, and U.S. shipments; and declines in financial performance.
The following is a description of the allegations of sales at less than fair value upon which the Department based its decision to initiate investigations of imports of citric acid from Belgium, Colombia and Thailand. The sources of data for the deductions and adjustments relating to U.S. price and NV are discussed in greater detail in the country-specific initiation checklists.
For Belgium, Colombia, and Thailand, the petitioners based export price (EP) on two methodologies: (1) POI average unit values (AUVs), and (2) transaction-specific AUVs for shipments of citric acid from the three countries. The first uses official U.S. import statistics to determine the AUV of imports of citric acid under the relevant Harmonized Tariff Schedule of the United States (HTSUS) subheading during the POI. The second involves matching individual shipments of goods identified in the U.S. Customs and Border Protection's (CBP's) Automated Manifest System (AMS) to individual entries of citric acid in the official U.S. import statistics for specific months and specific ports.
For Belgium, Colombia, and Thailand, the petitioners provided home market price information obtained through market research for citric acid produced in, and offered for sale in, each of these countries.
For Belgium and Thailand, the petitioners provided information indicating that sales of citric acid in the home market were made at prices below the cost of production (COP) and, as a result, calculated NV based on constructed value (CV).
Pursuant to section 773(b)(3) of the Act, COP consists of the cost of manufacturing (COM); selling, general and administrative (SG&A) expenses; financial expenses; and packing expenses.
For Belgium, the petitioners calculated COM during the POI, adjusted for known differences based on information available to the petitioners.
Because certain home market prices fell below COP, pursuant to sections 773(a)(4), 773(b), and 773(e) of the Act, as noted above, the petitioners calculated NVs based on CV.
For Thailand, the petitioners calculated COM using the same surrogate as was used for Belgium during the POI, adjusted for known differences based on information available to the petitioners.
Because certain home market prices fell below COP, pursuant to sections 773(a)(4), 773(b), and 773(e) of the Act, as noted above, the petitioners also calculated NV based on CV.
Based on the data provided by the petitioners, there is reason to believe that imports of citric acid from Belgium, Colombia, and Thailand are being, or are likely to be, sold in the United States at less than fair value. Based on comparisons of EP to NV, in accordance with sections 772 and 773(a) of the Act, the estimated dumping margin(s) for citric acid are as follows: 41.18 to 49.46 percent for Colombia,
Based upon the examination of the AD Petitions, we find that the Petitions meet the requirements of section 732 of the Act. Therefore, we are initiating AD investigations to determine whether imports of citric acid from Belgium, Colombia, and Thailand are being, or are likely to be, sold in the United States at less than fair value. In accordance with section 733(b)(1)(A) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determinations no later than 140 days after the date of this initiation.
Based on information from independent sources, the petitioners identified one company in Belgium, one company in Colombia, and four companies in Thailand, as producers/exporters of citric acid.
Although the Department normally relies on the number of producers/exporters identified in the petition and/or import data from CBP to determine whether to select a limited number of producers/exporters for individual examination in AD investigations, the Petitions identified only one company as a producer/exporter of citric acid in Belgium, Citrique Belge,
Comments for the above-referenced investigations must be filed electronically using ACCESS. An electronically-filed document must be received successfully in its entirety by 5:00 p.m. ET by the dates noted above. We intend to finalize our decision regarding respondent selection within 20 days of publication of this notice.
In accordance with section 732(b)(3)(A) of the Act and 19 CFR 351.202(f), copies of the public version of the Petitions have been provided to the governments of Belgium, Colombia, and Thailand via ACCESS. To the extent practicable, we will attempt to provide a copy of the public version of the Petitions to each exporter (as named in the Petitions), consistent with 19 CFR 351.203(c)(2).
We will notify the ITC of our initiation, as required by section 732(d) of the Act.
The ITC will preliminarily determine, within 45 days after the date on which the Petitions were filed, whether there is a reasonable indication that imports of citric acid from Belgium, Colombia, and/or Thailand are materially injuring or threatening material injury to a U.S. industry.
Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by the Department; and (v) evidence other than factual information described in (i)–(iv). Any party, when submitting factual information, must specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. Time limits for the submission of factual information are addressed in 19 CFR 351.301, which provides specific time limits based on the type of factual information being submitted. Parties should review the regulations prior to
Parties may request an extension of time limits before the expiration of a time limit established under Part 351, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Review
Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, the Department published
This notice is issued and published pursuant to section 777(i) of the Act and 19 CFR 351.203(c).
The merchandise covered by these investigations includes all grades and granulation sizes of citric acid, sodium citrate, and potassium citrate in their unblended forms, whether dry or in solution, and regardless of packaging type. The scope also includes blends of citric acid, sodium citrate, and potassium citrate; as well as blends with other ingredients, such as sugar, where the unblended form(s) of citric acid, sodium citrate, and potassium citrate constitute 40 percent or more, by weight, of the blend.
The scope also includes all forms of crude calcium citrate, including dicalcium citrate monohydrate, and tricalcium citrate tetrahydrate, which are intermediate products in the production of citric acid, sodium citrate, and potassium citrate.
The scope includes the hydrous and anhydrous forms of citric acid, the dihydrate and anhydrous forms of sodium citrate, otherwise known as citric acid sodium salt, and the monohydrate and monopotassium forms of potassium citrate. Sodium citrate also includes both trisodium citrate and monosodium citrate which are also known as citric acid trisodium salt and citric acid monosodium salt, respectively.
The scope does not include calcium citrate that satisfies the standards set forth in the United States Pharmacopeia and has been mixed with a functional excipient, such as dextrose or starch, where the excipient constitutes at least 2 percent, by weight, of the product.
Citric acid and sodium citrate are classifiable under 2918.14.0000 and 2918.15.1000 of the Harmonized Tariff Schedule of the United States (HTSUS), respectively. Potassium citrate and crude calcium citrate are classifiable under 2918.15.5000 and, if included in a mixture or blend, 3824.99.9295 of the HTSUS. Blends that include citric acid, sodium citrate, and potassium citrate are classifiable under 3824.99.9295 of the HTSUS. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily determines that certain softwood lumber products (softwood lumber) from Canada is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is October 1, 2015, through September 30, 2016.
Effective June 30, 2017.
Stephen Bailey or Thomas Martin, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482–0193 or (202) 482–3936, respectively.
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on December 22, 2016.
The product covered by this investigation is softwood lumber from Canada. For a complete description of the scope of this investigation,
In accordance with the preamble to the Department's regulations,
On May 15, 2017, the petitioner alleged that certain particular market situations exist within the Canadian lumber industry.
Specifically, regarding bioenergy programs, the petitioner alleges that the GOC has increased the demand for lumber byproducts by encouraging the development of energy from biomass, including wood chips from lumber. Regarding electricity, the petitioner alleges that the GOC has instituted certain energy initiatives that allow sawmills and consumers of lumber byproducts to either reduce or offset their electricity costs. The petitioner alleges these actions have decreased the electricity costs associated with producing lumber and lumber byproducts, which, in turn, distorts the COP of lumber producers. For stumpage, the petitioner alleges that lumber producers are able to obtain a steady supply of subsidized logs, which then enables them to meet the increased demand for byproducts.
The Department finds that the petitioner's presentation and discussion of the bioenergy, electricity and stumpage programs promoted by the GOC, substantiates the petitioner's allegations that such interventions and subsidies may have distorted the byproduct market and consequently the COP of lumber producers. The Department intends to further investigate and analyze the alleged distortions to COP raised by the petitioner in its PMS allegation. We intend to issue a schedule to provide deadlines for interested parties to submit further factual information related to the PMS allegation. We also intend to issue a supplemental questionnaire to all interested parties to obtain additional information to aid us in the analysis of the petitioner's PMS allegation. For further discussion of this matter, refer to the PMS Allegation Memorandum.
The Department is conducting this investigation in accordance with section 731 of the Act. The Department has calculated export prices in accordance with section 772(a) of the Act. Constructed export prices have been calculated in accordance with section 772(b) of the Act. Normal value (NV) is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying the preliminary determination,
As explained above, on April 13, 2017, the Department preliminarily determined that critical circumstances exist for all-others and do not exist for Canfor, Resolute, Tolko, and West Fraser. For a full description of the methodology and results of the Department's critical circumstances analysis,
Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination the Department shall determine an
In this investigation, the Department calculated estimated weighted-average dumping margins for Canfor, Resolute, Tolko, and West Fraser, none of which are zero,
The Department preliminarily determines that the following estimated weighted-average dumping margins exist:
In accordance with section 733(d)(2) of the Act, the Department will direct CBP to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Section 733(e)(2) of the Act provides that, given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the later of (a) the date which is 90 days before the date on which the suspension of liquidation was first ordered, or (b) the date on which notice of initiation of the investigation was published. As discussed in
The Department intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
As provided in section 782(i)(1) of the Act, the Department intends to verify the information relied upon in making its final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation, unless the Secretary alters the time limit. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
In accordance with section 733(f) of the Act, the Department intends to notify the International Trade Commission (ITC) of its preliminary affirmative determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.
We intend to issue and publish this notice in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
The merchandise covered by this investigation is softwood lumber, siding, flooring and certain other coniferous wood (softwood lumber products). The scope includes:
• Coniferous wood, sawn, or chipped lengthwise, sliced or peeled, whether or not planed, whether or not sanded, or whether or not finger-jointed, of an actual thickness exceeding six millimeters.
• Coniferous wood siding, flooring, and other coniferous wood (other than moldings and dowel rods), including strips and friezes for parquet flooring, that is continuously shaped (including, but not limited to, tongued, grooved, rebated, chamfered, V-jointed, beaded, molded, rounded) along any of its edges, ends, or faces, whether or not planed, whether or not sanded, or whether or not end-jointed.
• Coniferous drilled and notched lumber and angle cut lumber.
• Coniferous lumber stacked on edge and fastened together with nails, whether or not with plywood sheathing.
• Components or parts of semi-finished or unassembled finished products made from subject merchandise that would otherwise meet the definition of the scope above.
Softwood lumber product imports are generally entered under Chapter 44 of the Harmonized Tariff Schedule of the United States (HTSUS).
Subject merchandise as described above might be identified on entry documentation as stringers, square cut box-spring-frame components, fence pickets, truss components, pallet components, flooring, and door and window frame parts. Items so identified might be entered under the following ten-digit HTSUS subheadings in Chapter 44: 4415.20.40.00; 4415.20.80.00; 4418.99.90.05; 4418.99.90.20; 4418.99.90.40; 4418.99.90.95; 4421.91.70.40; and 4421.91.97.80.
Although these HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of these investigations is dispositive.
The scope of the order excludes the following items:
U.S.-origin lumber shipped to Canada for processing and imported into the United States is excluded from the scope of the investigations if the processing occurring in Canada is limited to one or more of the following: (1) Kiln drying; (2) planing to create smooth-to-size board; or (3) sanding.
Box-spring frame kits are excluded if they contain the following wooden pieces—two side rails, two end (or top) rails and varying numbers of slats. The side rails and the end rails must be radius-cut at both ends. The kits must be individually packaged and must contain the exact number of wooden components needed to make a particular box spring frame, with no further processing required. None of the components exceeds 1″ in actual thickness or 83″ in length.
Radius-cut box-spring-frame components, not exceeding 1″ in actual thickness or 83″ in length, ready for assembly without further processing are excluded. The radius cuts must be present on both ends of the boards and must be substantially cut so as to completely round one corner.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Effective June 22, 2017.
John Conniff at (202) 482–1009, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230.
On June 2, 2017, the Department of Commerce (the Department) received a countervailing duty (CVD) petition concerning imports of citric acid and
On June 7, and June 12, 2017, the Department requested additional information and clarification of certain areas of the Petition.
In accordance with section 702(b)(1) of the Tariff Act of 1930, as amended (the Act), the petitioners allege that imports of citric acid from Thailand received countervailable subsidies from Thai government authorities within the meaning of sections 701 and 771(5) of the Act, and that such imports are materially injuring, or threatening material injury to, an industry in the United States. Also, consistent with section 702(b)(1) of the Act, for those alleged programs on which we are initiating a CVD investigation, the Petition alleged the elements of a subsidy and provided information reasonably available to the petitioners supporting the allegations.
The Department finds that the petitioners filed the Petition on behalf of the domestic industry because the petitioners are interested parties as defined in section 771(9)(C) of the Act. The Department also finds that the petitioners demonstrated sufficient industry support with respect to the initiation of the CVD investigation that the petitioners are requesting.
Because the Petition was filed on June 2, 2017, the period of investigation (POI) is January 1, 2016, through December 31, 2016.
The product covered by this investigation is citric acid and certain citrate salts from Thailand. For a full description of the scope of this investigation,
During our review of the Petition, the Department issues questions to, and received responses from, the petitioners pertaining to the proposed scope to ensure that the scope language in the Petition would be an accurate reflection of the products for which the domestic industry is seeking relief.
As discussed in the preamble to the Department's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage (scope). The Department will consider all comments received from parties and, if necessary, will consult with parties prior to the issuance of the preliminary determinations. If scope comments include factual information (
The Department requests that any factual information the parties consider relevant to the scope of this investigation be submitted during this time period. However, if a party subsequently believes that additional factual information pertaining to the scope of the investigation may be relevant, the party may contact the Department and request permission to submit the additional information. As stated above, all such comments must be filed on the records of this investigation and each of the concurrent AD investigations.
All submissions to the Department must be filed electronically using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS).
Pursuant to section 702(b)(4)(A)(i) of the Act, the Department notified representatives of the Royal Thai Government (RTG) of the receipt of the Petition. Also, in accordance with section 702(b)(4)(A)(ii) of the Act, the Department provided representatives of the RTG with an opportunity for consultations with respect to the Petition. Consultations with the RTG were held at the Department's main building on June 14, 2017. The invitation letter and the memorandum regarding these consultations are on file electronically
Section 702(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 702(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) at least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 702(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic
Section 771(4)(A) of the Act defines the “industry” as the producers, as a whole, of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs the Department to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both the Department and the ITC must apply the same statutory definition regarding the domestic like product,
Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (
With regard to the domestic like product, the petitioners do not offer a definition of the domestic like product distinct from the scope of the investigation. Based on our analysis of the information submitted on the record, we have determined that citric acid, as defined in the scope, constitutes a single domestic like product and we have analyzed industry support in terms of that domestic like product.
In determining whether the petitioners have standing under section 702(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in the Appendix to this notice. To establish industry support, the petitioners provided their own production of the domestic like product in 2016.
Our review of the data provided in the Petition, the General Issues Supplement, and other information readily available to the Department indicates that the petitioners have established industry support for the Petition.
The Department finds that the petitioners filed the Petition on behalf of the domestic industry because they are interested parties as defined in section 771(9)(C) of the Act, and they have demonstrated sufficient industry support with respect to the CVD investigation they are requesting the Department to initiate.
Because Thailand is a “Subsidies Agreement Country” within the meaning of section 701(b) of the Act, section 701(a)(2) of the Act applies to this investigation. Accordingly, the ITC must determine whether imports of the subject merchandise from Thailand materially injure, or threaten material injury to, a U.S. industry.
The petitioners allege that imports of the subject merchandise are benefitting from countervailable subsidies and that such imports are causing, or threaten to cause, material injury to the U.S. industry producing the domestic like product. In addition, the petitioners allege that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.
The petitioners contend that the industry's injured condition is illustrated by reduced market share; underselling and price suppression or depression; lost sales and revenues; adverse impact on the domestic industry's production, capacity utilization, and U.S. shipments; and declines in financial performance.
Section 702(b)(1) of the Act requires the Department to initiate a CVD investigation whenever an interested party files a CVD petition on behalf of an industry that: (1) Alleges the elements necessary for an imposition of a duty under section 701(a) of the Act; and (2) is accompanied by information reasonably available to the petitioners supporting the allegations.
The petitioners allege that producers/exporters of citric acid in Thailand benefit from countervailable subsidies bestowed by their government. The Department examined the Petition and finds that it complies with the requirements of section 702(b)(1) of the Act. Therefore, in accordance with section 702(b)(1) of the Act, we are initiating this CVD investigation to determine whether manufacturers, producers, and/or exporters of citric acid in Thailand receive countervailable subsidies from Thai government authorities.
Under the Trade Preferences Extension Act of 2015, numerous amendments to the AD and CVD law were made.
Based on our review of the Petition, we find that there is sufficient information to initiate a CVD investigation on all nine alleged programs. For a full discussion of the basis for our decision to initiate on each program,
In accordance with section 703(b)(1) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 65 days after the date of this initiation.
Based on information from independent sources, the petitioners identified four companies in Thailand as producers/exporters of citric acid.
Comments must be filed electronically using ACCESS. An electronically-filed document must be received successfully, in its entirety, by ACCESS no later than 5:00 p.m. ET on the date noted above. We intend to finalize our decision regarding respondent selection within 20 days of publication of this notice.
In accordance with section 702(b)(4)(A)(i) of the Act and 19 CFR 351.202(f), a copy of the public version of the Petition has been provided to the RTG
We will notify the ITC of our initiation, as required by section 702(d) of the Act.
The ITC will preliminarily determine, within 45 days after the date on which the Petition was filed, whether there is a reasonable indication that imports of citric acid from Thailand are materially injuring, or threatening material injury to, a U.S. industry.
Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by the Department; and (v) evidence other than factual information described in (i)–(iv). Any party, when submitting factual information, must specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. Time limits for the submission of factual information are addressed in 19 CFR 351.301, which provides specific time limits based on the type of factual information being submitted. Parties should review the regulations prior to submitting factual information in this investigation.
Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Review
Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, the Department published
This notice is issued and published pursuant to sections 702 and 777(i) of the Act.
The merchandise covered by this investigation includes all grades and granulation sizes of citric acid, sodium citrate, and potassium citrate in their unblended forms, whether dry or in solution, and regardless of packaging type. The scope also includes blends of citric acid, sodium citrate, and potassium citrate; as well as blends with other ingredients, such as sugar, where the unblended form(s) of citric acid, sodium citrate, and potassium citrate constitute 40 percent or more, by weight, of the blend.
The scope also includes all forms of crude calcium citrate, including dicalcium citrate monohydrate, and tricalcium citrate tetrahydrate, which are intermediate products in the production of citric acid, sodium citrate, and potassium citrate.
The scope includes the hydrous and anhydrous forms of citric acid, the dihydrate and anhydrous forms of sodium citrate, otherwise known as citric acid sodium salt, and the monohydrate and monopotassium forms of potassium citrate. Sodium citrate also includes both trisodium citrate and monosodium citrate which are also known as citric acid trisodium salt and citric acid monosodium salt, respectively.
The scope does not include calcium citrate that satisfies the standards set forth in the United States Pharmacopeia and has been mixed with a functional excipient, such as dextrose or starch, where the excipient constitutes at least 2 percent, by weight, of the product.
Citric acid and sodium citrate are classifiable under 2918.14.0000 and 2918.15.1000 of the Harmonized Tariff Schedule of the United States (HTSUS), respectively. Potassium citrate and crude calcium citrate are classifiable under 2918.15.5000 and, if included in a mixture or blend, 3824.99.9295 of the HTSUS. Blends that include citric acid, sodium citrate, and potassium citrate are classifiable under 3824.99.9295 of the HTSUS. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) is notifying the public that the Court of International Trade's (CIT's or the Court's) final judgment in this case is not in harmony with the Department's final results of review and is, therefore, amending the final dumping duty margin for one reviewed company.
John Drury, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482–0195.
On December 10, 2001, the Department published an amended final determination of sales at less than fair value, and an antidumping duty order, on honey from the People's Republic of China (PRC).
On January 20, 2003, the Department initiated an administrative review of the antidumping duty order on honey from the PRC covering the period February 10, 2001, through November 30, 2002.
On May 5, 2004, the Department published the
Zhejiang challenged the
At the same time that Zhejiang challenged the Department's
On August 3, 2015, the CIT remanded this case to the Department. Specifically, the Court: (1) Granted the Department's request for a voluntary remand to reconsider the issues related to the surrogate value for raw honey; (2) remanded the issue of the selection of the appropriate financial statements; and (3) requested that the Department recalculate Zhejiang's dumping margin to reflect the different POR resulting from the decision in
The Department released a draft redetermination on December 31, 2015, and invited comments from parties.
On June 1, 2017, the CIT sustained the Department's Final Redetermination in its entirety.
In its decision in
Because there is now a final court decision, the Department amends the
In the event the Court's ruling is not appealed, or if appealed and upheld by the CAFC, the Department will instruct CBP to assess antidumping duties on entries of the subject merchandise exported by Zhejiang using the revised assessment rate calculated by the Department in the
This notice is issued and published in accordance with sections 516A(e)(1), 751(a)(1), and 777(i)(1) of the Act.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability; extension of comment period.
On May 31, 2017, we, NMFS, published a notice of availability to revise the Recovery Plan Preparation and Implementation Priorities and Recovery Plans contained in the 1990 Listing and Recovery Priority Guidelines. We opened a public comment period that lasted through June 30, 2017. We received several requests to extend the public comment period. Thus, we are extending the period through August 28, 2017.
Comments on the proposed revision must be received by close of business on August 28, 2017.
You may submit comments on this document, identified by NOAA–NMFS–2017–0020 by either of the following methods:
•
•
Section 4(f) of the Endangered Species Act (ESA) (16 U.S.C. 1533(f)) requires the Secretary to develop recovery plans for all species listed pursuant to the ESA, unless he/she finds that such a plan will not promote the recovery of the species. Section 4(h) of the ESA requires the Secretary to establish a system for developing and implementing, on a priority basis, recovery plans under Section 4(f). We finalized guidance for prioritizing recovery plan development and implementation on June 15, 1990 (55 FR 24296). However, through our application of the Recovery Plan Preparation and Implementation Priorities and Recovery Plans (see parts `B' and `C' 55 FR 24296; June 15, 1990), we have determined that the guidelines contain vague definitions and lack sufficient detail regarding factors that should be considered when evaluating threats and recovery potential. For these reasons, we published, on May 31, 2017 (82 FR 24944), proposed revisions to the Recovery Plan Preparation and Implementation Priorities and Recovery Plan parts of the 1990 Listing and Recovery Priority Guidelines. We solicited comments on the proposed revision to be submitted by June 30, 2017. On June 14 and June 16, 2017, we received requests to extend the public comment period by an additional 30 days and 90 days, respectively. Thus, we are extending the public comment period through August 28, 2017. Previously submitted comments do not need to be resubmitted.
16 U.S.C. 1531
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of initiation of 5-year review; request for information.
NMFS announces a 5-year review of the North Pacific right whale (
To allow us adequate time to conduct this review, we must receive your information no later than July 31, 2017. However, we will continue to accept new information about any listed species at any time.
You may submit comments on this document, identified by NOAA–NMFS–2017–0046, by either of the following methods:
•
•
Verena Gill, NMFS Alaska Region, (907) 271–1937,
Section 4(c)(2)(A) of the ESA requires that we conduct a review of listed species at least once every five years. The regulations in 50 CFR 424.21 require that we publish a notice in the
16 U.S.C. 1531
Under 44 U.S.C. 3506(e) and 13 U.S.C. Section 9, the U.S. Census Bureau is seeking comments on revisions to the confidentiality pledge it provides to its respondents under Title 13, United States Code, Section 9. These revisions are required by the passage and implementation of provisions of the Federal Cybersecurity Enhancement Act of 2015 (6 U.S.C. 1501 note), which require the Secretary of Homeland Security to provide Federal civilian agencies' information technology systems with cybersecurity protection for their Internet traffic. More details on this announcement are presented in the
On December 18, 2015, Congress passed the Federal Cybersecurity Enhancement Act of 2015 (the Act) (6 U.S.C. 1501 note). The Act requires the Department of Homeland Security to deploy for use by other agencies a program with the “capability to detect cybersecurity risks in network traffic transiting or traveling to or from an agency information system.”
In response to the passage of the Act, the Census Bureau considered whether it should revise its confidentially pledge. The Census Bureau's Center for Survey Measurement (CSM) joined the interagency Statistical Community of Practice and Engagement (SCOPE) Confidentiality Pledge Revision Subcommittee, which developed and evaluated the revision to the confidentiality pledge language. SCOPE and CSM conducted remote and in-person cognitive testing of the potential revised confidentiality pledge. The Census Bureau based its revised confidentiality pledge on the results of these tests. The revised confidentiality pledge utilizes the language the Census Bureau determined would best communicate the essential information to respondents while not negatively affecting response rates. The following is the revised statistical confidentiality pledge for the Census Bureau's data collections:
On December 23, 2016, the Census Bureau requested comments on the revised confidentiality pledge. During the public comment period, the Census Bureau received two comments from the Asian Americans Advancing Justice (AAJC) and American-Arab Anti-Discrimination Committee (ADC).
In response to the Census Bureau's revised confidentiality pledge, AAJC and the ADC provided comments and suggestions to the Census Bureau. These comments and suggestions, along with the Census Bureau's responses are below.
1. The AAJC and the ADC both expressed concerns about the effect of the revised confidentiality pledge on the accuracy of the results of the Census Bureau's survey.
2. The “ADC has serious concerns on the ability of [DHS] to . . . access . . . people's personal information on the server.”
EINSTEIN also provides greater protection for the Census Bureau's information and information systems than would otherwise exist. EINSTEIN enables DHS to detect cyber threat indicators traveling or transiting to or from one agency's information system, and to share those indicators with other agencies, thereby making all agencies' information systems more secure. The necessity of providing DHS limited access to such information—information which DHS can only use for cybersecurity purposes—is not only required by the Federal Cybersecurity Enhancement Act, but has a net positive impact of the security of information respondents provide to the Census Bureau.
3. The ADC is concerned that “there is a lack of safeguards in place on who has access to information through EINSTEIN.”
To reiterate, the information at issue is not a respondent's personal information, rather, it is cyber threat information. E3A does not provide DHS with access to a respondent's personal information. E3A does not currently decrypt respondent information or scan data at rest on Census Bureau information systems.
4. The ADC is concerned that the revised confidentiality pledge “raises flags on improper use of such information.”
5. The AAJC suggests that the protections contained in Title 13 and the Confidential Information Protection and Statistical Efficiency Act (CIPSEA), both of which limit the use and disclosure of information collected, should control the information at issue.
6. The AAJC suggests that either the Census Bureau employees “perform Einstein 3A functions for Census Bureau internet traffic” or that “DHS employees monitoring Census Bureau internet traffic under Einstein 3A take the current Title 13 confidentiality pledge.”
In addition to the safeguards contained in the Act, the Census Bureau works with DHS to safeguard respondent information. These additional safeguards cover the collection, retention, use, and disclosure of information. The safeguards also include notification and reporting requirements that would apply in the unlikely event that any unauthorized access, use, or dissemination of any Census Bureau information would occur.
Comments are invited on the necessity and efficacy of the Census Bureau's revised confidentiality pledge above. Comments submitted in response to this notice will become a matter of public record. Comments should be sent within 30 days of publication of this notice to
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of change of schedule for SEDAR 56 South Atlantic Black Sea Bass Assessment Webinars.
The SEDAR 56 assessment of the South Atlantic stock of black seabass will consist of a series webinars. Due to changes to the schedule for the stock assessment, webinars scheduled for Thursday, July 20, 2017 and Wednesday, August 16, 2017 have been cancelled. See
This notice serves to cancel the previously scheduled July 20, 2017 and August 16, 2017 webinars.
Julia Byrd, SEDAR Coordinator, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone: (843) 571–4366; email:
The original notice published in the
The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions, have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. The product of the SEDAR webinar series will be a report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses, and describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, Highly Migratory Species Management Division, and Southeast Fisheries Science Center. Participants include: Data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and non-governmental organizations (NGOs); international experts; and staff of Councils, Commissions, and state and federal agencies.
During its June 2017 meeting, the South Atlantic Fishery Management
National Telecommunications and Information Administration, U.S. Department of Commerce.
Notice of open meeting.
The National Telecommunications and Information Administration (NTIA) will convene a virtual meeting of a multistakeholder process on Internet of Things Security Upgradability and Patching on July 18, 2017. This is the fourth in a series of meetings. For information on prior meetings, see Web site address below.
The virtual meeting will be held on July 18, 2017, from 2:00 p.m. to 4:30 p.m., Eastern Time. See
This is a virtual meeting. NTIA will post links to online content and dial-in information on the multistakeholder process Web site at
Allan Friedman, National Telecommunications and Information Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Room 4725, Washington, DC 20230; telephone: (202) 482–4281; email:
In a separate but related matter in April 2016, NTIA, the Department's Internet Policy Task Force, and its Digital Economy Leadership Team sought comments on the benefits, challenges, and potential roles for the government in fostering the advancement of the Internet of Things.”
After reviewing these comments, NTIA announced that the next multistakeholder process on cybersecurity would be on IoT security upgradability and patching.
The matter of patching vulnerable systems is now an accepted part of cybersecurity.
To help realize the full innovative potential of IoT, users need reasonable assurance that connected devices, embedded systems, and their applications will be secure. A key part of that security is the mitigation of potential security vulnerabilities in IoT devices or applications through patching and security upgrades.
The ultimate objective of the multistakeholder process is to foster a market offering more devices and systems that support security upgrades through increased consumer awareness and understanding. Enabling a thriving market for patchable IoT requires common definitions so that manufacturers and solution providers
Stakeholders have identified four distinct work streams that could help foster better security across the ecosystem, and focused their efforts in four working groups addressing both technical and policy issues.
National Telecommunications and Information Administration, U.S. Department of Commerce.
Notice of Open Meeting.
The National Telecommunications and Information Administration (NTIA), through the BroadbandUSA program, will hold a Technical Assistance Workshop to share information and help communities build their broadband capacity and utilization. The workshop will present in-depth sessions on planning and funding broadband infrastructure projects. The session on planning will explore effective business and partnership models. The session on funding will explore available funding options and models, including federal funding.
The Technical Assistance Workshop will be held on August 21, 2017, from 8:30 a.m. to 12:30 p.m., Central Daylight Time.
The meeting will be held in Des Moines, Iowa at the Des Moines Public Library, 1000 Grand Avenue, Des Moines, IA 50309.
Giselle Sanders, National Telecommunications and Information Administration, U.S. Department of Commerce, Room 4889, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482–7971; email:
NTIA's BroadbandUSA program provides expert advice and field-proven tools for assessing broadband adoption, planning new infrastructure, and engaging a wide range of partners in broadband projects. BroadbandUSA convenes workshops on a regular basis to bring stakeholders together to discuss ways to improve broadband policies, share best practices, and connect communities to other federal agencies and funding sources for the purpose of expanding broadband infrastructure and adoption throughout America's communities. The Des Moines workshop will explore two specific topics for broadband infrastructure: Planning and funding.
The Des Moines workshop will feature subject matter experts from NTIA's BroadbandUSA broadband program. The first session will explore key elements required for planning successful broadband projects. The second session will explore funding models, including federal programs that fund broadband infrastructure projects.
The Des Moines workshop will be open to the public. Pre-registration is requested, and space is limited. NTIA will ask registrants to provide their first and last names and email addresses for both registration purposes and to receive any updates on the workshop. If capacity for the meeting is reached, NTIA will maintain a waiting list and will inform those on the waiting list if space becomes available. Meeting updates, changes in the agenda, if any, and relevant documents will also be available on NTIA's Web site at
The public meeting is physically accessible to people with disabilities. Individuals requiring accommodations, such as language interpretation or other ancillary aids, are asked to notify Giselle Sanders at the contact information listed above at least five (5) business days before the meeting.
National Telecommunications and Information Administration, U.S. Department of Commerce.
Notice of Open Meeting.
This notice announces a public meeting of the Commerce Spectrum Management Advisory Committee (Committee). The Committee provides advice to the Assistant Secretary of Commerce for Communications and Information and
The meeting will be held on August 15, 2017, from 8:00 a.m. to 11:00 a.m., Mountain Daylight Time (MDT).
The meeting will be held at the Renaissance Boulder Flatiron Hotel, 500 Flatiron Boulevard, Broomfield, CO 80021. Public comments may be mailed to Commerce Spectrum Management Advisory Committee, National Telecommunications and Information Administration, 1401 Constitution Avenue NW., Room 4600, Washington, DC 20230 or emailed to
David J. Reed, Designated Federal Officer, at (202) 482–5955 or
United States Patent and Trademark Office, Commerce.
Notice and request for nominations for the Patent and Trademark Public Advisory Committees.
On November 29, 1999, the President signed into law the Patent and Trademark Office Efficiency Act (the “Act”), Public Law 106–113, which, among other things, established two Public Advisory Committees to review the policies, goals, performance, budget and user fees of the United States Patent and Trademark Office (USPTO) with respect to patents, in the case of the Patent Public Advisory Committee, and with respect to trademarks, in the case of the Trademark Public Advisory Committee, and to advise the Director on these matters. The America Invents Act Technical Corrections Act made several amendments to the 1999 Act, including the requirement that the terms of the USPTO Public Advisory Committee members be realigned by 2014, so that December 1 be used as the start and end date, with terms staggered so that each year three existing terms expire and three new terms begin on December 1. Through this Notice, the USPTO is requesting nominations for up to three (3) members of the Patent Public Advisory Committee, and for up to three (3) members of the Trademark Public Advisory Committee, for terms of three years that begin on December 1, 2017.
Nominations must be postmarked or electronically transmitted on or before July 25, 2017.
Persons wishing to submit nominations should send the nominee's resumé by postal mail to Brendan McCommas, Acting Chief of Staff, Office of the Under Secretary of Commerce for Intellectual Property and Director of the
Brendan McCommas, Acting Chief of Staff, Office of the Under Secretary of Commerce for Intellectual Property and Director of the USPTO, at (571) 272–8600.
The Advisory Committees' duties include:
• Review and advise the Under Secretary of Commerce for Intellectual Property and Director of the USPTO on matters relating to policies, goals, performance, budget, and user fees of the USPTO relating to patents and trademarks, respectively; and
• Within 60 days after the end of each fiscal year: (1) Prepare an annual report on matters listed above; (2) transmit the report to the Secretary of Commerce, the President, and the Committees on the Judiciary of the Senate and the House of Representatives; and (3) publish the report in the Official Gazette of the USPTO.
The Public Advisory Committees are each composed of nine (9) voting members who are appointed by the Secretary of Commerce (the “Secretary”) and serve at the pleasure of the Secretary for three-year terms. Members are eligible for reappointment for a second consecutive three-year term. The Public Advisory Committee members must be citizens of the United States and are chosen to represent the interests of diverse users of the United States Patent and Trademark Office with respect to patents, in the case of the Patent Public Advisory Committee, and with respect to trademarks, in the case of the Trademark Public Advisory Committee. Members must represent small and large entity applicants located in the United States in proportion to the number of applications filed by such applicants. The Committees must include individuals with “substantial background and achievement in finance, management, labor relations, science, technology, and office automation.” 35 U.S.C. 5(b)(3). Each of the Public Advisory Committees also includes three (3) non-voting members representing each labor organization recognized by the USPTO. Administration policy discourages the appointment of federally registered lobbyists to agency advisory boards and commissions (Lobbyists on Agency Boards and Commissions,
Each newly appointed member of the Patent and Trademark Public Advisory Committees will serve for a three-year term that begins on December 1, 2017, and ends on December 1, 2020. As required by the 1999 Act, members of the Patent and Trademark Public Advisory Committees will receive compensation for each day (including travel time) while the member is attending meetings or engaged in the business of that Advisory Committee. The enabling statute states that members are to be compensated at the daily equivalent of the annual rate of basic pay in effect for level III of the Executive Schedule under section 5314 of Title 5, United States Code. Committee members are compensated on an hourly basis, calculated at the daily rate. While away from home or regular place of business, each member shall be allowed travel expenses, including per diem in lieu of subsistence, as authorized by Section 5703 of Title 5, United States Code.
Public Advisory Committee Members are Special Government Employees within the meaning of Section 202 of Title 18, United States Code. The following additional information includes several, but not all, of the ethics rules that apply to members, and assumes that members are not engaged in Public Advisory Committee business more than 60 days during any period of 365 consecutive days.
• Each member will be required to file a confidential financial disclosure form within thirty (30) days of appointment. 5 CFR 2634.202(c), 2634.204, 2634.903, and 2634.904(b).
• Each member will be subject to many of the public integrity laws, including criminal bars against representing a party in a particular matter that came before the member's committee and that involved at least one specific party. 18 U.S.C. 205(c);
• Representation of foreign interests may also raise issues. 35 U.S.C. 5(a)(1) and 18 U.S.C. 219.
Meetings of each Advisory Committee will take place at the call of the respective Committee Chair to consider an agenda set by that Chair. Meetings may be conducted in person, telephonically, on-line through the Internet, or by other appropriate means. The meetings of each Advisory Committee will be open to the public except each Advisory Committee may, by majority vote, meet in executive session when considering personnel, privileged, or other confidential information. Nominees must have the ability to participate in Committee business through the Internet.
Proposed extension of a continuing information collection; comment request.
The United States Patent and Trademark Office (USPTO), as required by the Paperwork Reduction Act of 1995, invites comments on a proposed extension of an existing collection: 0651–0075 (International Design Applications (Hague Agreement)).
Written comments must be submitted on or before August 29, 2017.
You may submit comments by any of the following methods:
Requests for additional information should be directed to Rafael Bacares, Senior Legal Advisor, Office of Patent Legal Administration, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313–1450; by telephone at 571–272–3276; or by email at
The Patent Law Treaties Implementation Act of 2012 (PLTIA) amends the patent laws to implement the provisions of the Geneva Act of the Hague Agreement Concerning International Registration of Industrial Designs (hereinafter “Hague Agreement”) in title 1, and the Patent Law Treaty (PLT) in title 2. The Hague Agreement is an international agreement that enables an applicant to file a single international design application which may have the effect of an application for protection for the design(s) in countries and/or intergovernmental organizations that are Parties to the Hague Agreement (the “Contracting Parties”) designated in the application. The United States is a Contracting Party to the Hague Agreement, which took effect with respect to the United States on May 13, 2015. The Hague Agreement is administered by the International Bureau (IB) of World Intellectual Property Organization (WIPO) located in Geneva, Switzerland.
Thus, under the Hague Agreement, a U.S. applicant could file an international design application in English “indirectly” through the U.S. Patent and Trademark Office (“USPTO”), which will forward the application to the IB or “directly” with the IB. The industrial design or designs will be eligible for protection in all the Contracting Parties designated by the applicant.
The IB ascertains whether the international design application complies with formal requirements, registers the international design in the International register, and publishes the international registration in the International Designs Bulletin. The international registration contains all of the data of the international application, any reproduction of the industrial design, date of the international registration, number of the international registration, and relevant class of the International Classification.
The IB will provide a copy of the publication of the international registration to each Contracting party designated by the applicant. A designated Contracting Party may perform a substantive examination of the design application. The USPTO will perform a substantive examination for patentability of the international design application, as in the case of regular U.S. design applications.
The Hague Agreement enables applicants from a Contracting Party to obtain protection of their designs with minimal formality and expense. Additionally, under the Hague Agreement, the international registration can be centrally maintained by the IB. For example, through the IB, applicants can record changes of their representatives or changes in ownership, and renew their international registration.
Most of the items in this collection can be submitted electronically through EFS-Web. The items can also be submitted by mail.
There are no maintenance, operation, capital start-up, or recordkeeping costs associated with this collection. However, this collection does have annual (non-hour) costs in the form of postage costs and filing fees.
Although the USPTO prefers that the items in this collection be submitted electronically, the items may be submitted by mail through the United States Postal Service (USPS). The USPTO estimates that the average cost for a paper submission will be $5.95 and that 62 submissions will be mailed to the USPTO per year.
This collection also contains an annual (non-hour) cost burden in the way of filing fees. The total estimated filing costs for this collection is $423,876 detailed in Table 3 below.
The USPTO estimates that the total annual (non-hour) respondent cost burden for this collection in the forms of postage costs and filing fees is estimated to be approximately be $424,245.90 per year ($368.90 in postage costs and $423,876 in filing fees).
Comments submitted in response to this notice will be summarized and/or included in the USPTO's request for OMB approval. All comments will become a matter of public record.
Comments are invited on:
(a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b) The accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(d) Ways to minimize the burden of the collection of information on respondents,
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed Additions to and Deletion from the Procurement List.
The Committee is proposing to add products and services to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes a service previously furnished by such agency.
Committee for Purchase From People Who Are Blind or Severely Disabled, 401 S. Clark Street, Suite 715, Arlington, Virginia 22202–4149.
Amy B. Jensen, Telephone: (703) 603–7740, Fax: (703) 603–0655, or email
This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51–2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the products and services listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.
The following products and services are proposed for addition to the Procurement List for production by the nonprofit agencies listed.
The following service is proposed for deletion from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to and Deletions from the Procurement List.
This action adds products and services to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products and services from the Procurement List previously furnished by such agencies.
Effective Date: 7/30/2017.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia, 22202–4149.
Amy B. Jensen, Telephone: (703) 603–7740, Fax: (703) 603–0655, or email
On 5/26/2017 (82 FR 24308–24309), 6/2/2017 (82FR 25602), and 6/16/2017 (82 FR 27698), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed additions to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the products and services and impact of the additions on the current or most recent contractors, the Committee has determined that the products and services listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501–8506 and 41 CFR 51–2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the products and services to the Government.
2. The action will result in authorizing small entities to furnish the products and services to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501–8506) in connection with the products and services proposed for addition to the Procurement List.
Accordingly, the following products and services are added to the Procurement List:
The following information is applicable to all products listed above.
On 5/19/2017 (82 FR 22972) and 5/26/2017 (82 FR 24308–24309), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List.
After consideration of the relevant matter presented, the Committee has determined that the product(s) and/or service(s) listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501–8506 and 41 CFR 51–2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may result in authorizing small entities to furnish the products and services to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501–8506) in connection with the products and services deleted from the Procurement List.
Accordingly, the following products and services are deleted from the Procurement List:
Office of the Secretary of Defense, Department of Defense.
Notice of updated TRICARE Young Adult Premiums for Calendar Year 2018.
This notice provides the updated TRICARE Young Adult program premiums for Calendar Year (CY) 2018.
The CY 2018 rates contained in this notice are effective for services on or after January 1, 2018.
Defense Health Agency, TRICARE Health Plan, 7700 Arlington Boulevard, Suite 5101, Falls Church, Virginia 22042–5101.
Mr. Mark A. Ellis, (703) 681–0039.
The final rule published in the
The Defense Health Agency has updated the monthly premiums for CY 2018 as shown below:
The above premiums are effective for services rendered on or after January 1, 2018.
Department of Defense.
Notice of Federal Advisory Committee meeting.
The Defense Science Board (DSB) 2017 Summer Study Task Force on Countering Anti-access Systems with Longer Range and Standoff Capabilities (“the Long Range Effects 2017 Summer Study Task Force”) will meet in closed session on Thursday, July 13, 2017 from 7:55 a.m. to 4:00 p.m. and Friday, July 14, 2017 from 8:00 a.m. to 4:00 p.m. at Strategic Analysis Inc., The Executive Conference Center, 4075 Wilson Boulevard, 3rd Floor, Arlington, VA 22203.
Thursday, July 13, 2017 from 7:55 a.m. to 4:00 p.m. and Friday, July 14, 2017 from 8:00 a.m. to 4:00 p.m.
Strategic Analysis Inc., The Executive Conference Center, 4075 Wilson Boulevard, 3rd Floor, Arlington, VA 22203.
Defense Science Board Designated Federal Officer (DFO) Ms. Karen D.H. Saunders, (703) 571–0079 (Voice), (703) 697–1860 (Facsimile),
Due to circumstances beyond the control of the Designated Federal Officer and the Department of Defense, the Defense Science Board was unable to provide public notification concerning its meeting on July 13 through 14, 2017, of the Defense Science Board 2017 Summer Study Task Force on Countering Anti-access Systems with Longer Range and Standoff Capabilities, as required by 41 CFR 102–3.150(a). Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102–3.150(b), waives the 15-calendar day notification requirement.
This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102–3.150.
The mission of the DSB is to provide independent advice and recommendations on matters relating to the Department of Defense's (DoD) scientific and technical enterprise. The objective of the Long Range Effects 2017 Summer Study Task Force is to explore new defense systems and technologies that will enable cost effective power projection that relies on the use of longer stand-off distances than current capabilities. System components may be deployed on manned or unmanned platforms with a range of potential autonomous capabilities. Use of cost reducing technology and advanced production practices from defense and commercial industry may be a major part of the strategy for deploying adequate numbers of weapons. This two-day session will focus on coalescing all the information from briefings presented during the January, February, March, April, and May meetings of the Long Range Effects 2017 Summer Study Task Force. The four panels (Architecture; Intelligence, Surveillance, and Reconnaissance; Basing, Delivery, and Weapons; and Command, Control, Communications, and Cyber) will meet simultaneously to discuss topics and analyze data in support of the study. Day Two will close with discussion of the four panels' work.
In accordance with section 10(d) of the FACA and 41 CFR 102–3.155, the DoD has determined that the Long Range Effects 2017 Summer Study Task
In accordance with section 10(a)(3) of the FACA and 41 CFR 102–3.105(j) and 102–3.140, interested persons may submit a written statement for consideration by the Long Range Effects 2017 Summer Study Task Force members at any time regarding its mission or in response to the stated agenda of a planned meeting. Individuals submitting a written statement must submit their statement to the DSB's DFO—Ms. Karen D.H. Saunders, Executive Director, Defense Science Board, 3140 Defense Pentagon, Room 3B888A, Washington, DC 20301, via email at
Department of the Navy, DoD.
Notice.
Pursuant to the National Environmental Policy Act (NEPA) of 1969 and regulations implemented by the Council on Environmental Quality, the Department of the Navy (DoN) has prepared and filed with the U.S. Environmental Protection Agency a Draft Environmental Impact Statement (EIS)/Overseas EIS (OEIS) for public release on June 30, 2017, to evaluate the potential environmental effects from training and testing activities conducted within the Navy's Atlantic Fleet Training and Testing (AFTT) Study Area.
The Study Area is in the western Atlantic Ocean and encompasses the waters along the east coast of North America, the Gulf of Mexico, portions of the Caribbean Sea, Navy pierside locations and port transit channels, waters near civilian ports, and inland waters (
The National Marine Fisheries Service (NMFS) is a Cooperating Agency for the EIS/OEIS.
With the filing of the Draft EIS/OEIS, the DoN is initiating a 60-day public comment period and has scheduled five public meetings to receive oral and written comments on the Draft EIS/OEIS. This notice announces the dates and locations of the public meetings for this Draft EIS/OEIS and provides supplementary information about the environmental planning effort.
The public meetings will be held between 4 p.m. and 8 p.m. on the following dates and at the following locations:
1. Wednesday, July 19, 2017, Hotel Providence, 139 Mathewson Street, Providence, RI 02903.
2. Tuesday, July 25, 2017, UNC Institute of Marine Sciences, 3431 Arendell Street, Morehead City, NC 28557.
3. Wednesday, July 26, 2017, Nauticus, 1 Waterside Drive, Norfolk, VA 23510.
4. Tuesday, August 1, 2017, Prime F. Osborn III Convention Center, 1000 Water Street, Jacksonville, FL 32204.
5. Thursday, August 3, 2017, Gulf Coast State College Conference Center, 5230 W. Highway 98, Panama City, FL 32401.
Attendees will be able to submit comments in writing or orally using a voice recorder at the public meetings. Equal weight will be given to oral and written statements. Comments may also be submitted by U.S. postal mail or electronically via the project Web site provided below. Written comments may be submitted by mail to Naval Facilities Engineering Command Atlantic, Attn: Code EV22KP (AFTT EIS Project Managers), 6506 Hampton Boulevard, Norfolk, VA 23508–1278 and through the project Web site; all written comments must be post marked or received by August 29, 2017. All statements, oral or written, submitted during the public review period will become part of the public record on the Draft EIS/OEIS and will be considered in preparation of the Final EIS/OEIS.
Public meeting details will also be announced in local newspapers and on the project Web site:
Naval Facilities Engineering Command Atlantic, Attn: Code EV22KP (AFTT EIS Project Managers), 6506 Hampton Boulevard, Norfolk, VA 23508–1278.
A Notice of Intent (NOI) to prepare this DEIS/OEIS was published in the
The DoN's Proposed Action is to conduct military readiness training activities, and research, development, testing, and evaluation activities in the AFTT Study Area. These military readiness activities include the use of active sonar and explosives within existing range complexes and testing ranges and additional areas located in the Atlantic Ocean along the eastern coast of North America, in portions of the Caribbean Sea, the Gulf of Mexico, at Navy pierside locations and port transit channels, near civilian ports, and in bays, harbors, and inland waterways (
Potential direct, indirect, cumulative, short-term, long-term, irreversible, and irretrievable impacts to the environment from two action alternatives and a No Action Alternative are evaluated in the Draft EIS/OEIS. Resources evaluated include air quality, sediments and water quality, vegetation, invertebrates, marine habitats, fish, marine mammals, sea turtles and other marine reptiles, birds and bats, cultural resources, socioeconomic resources, and public health and safety.
Based on the results of the analysis, the Navy has requested from NMFS a Letter of Authorization (LOA) in accordance with the MMPA to authorize the incidental take of marine mammals that may result from the implementation of the activities analyzed in the AFTT Draft EIS/OEIS. In accordance with Section 7 of the Endangered Species Act, the Navy is consulting with NMFS and U.S. Fish and Wildlife Service (USFWS) for potential impacts to federally listed species. The Navy will complete all required consultations and comply with other applicable laws and regulations.
The Draft EIS/OEIS addresses mitigation measures designed to help reduce or avoid potential impacts to marine resources, including new mitigation measures that include expanded geographic mitigation areas, and updates to procedural mitigation measures. In addition, the Draft EIS/OEIS addresses marine species monitoring efforts designed to track compliance with authorizations and to investigate the effectiveness of mitigation measures implemented as part of the Proposed Action. The proposed mitigation measures, including new mitigation measures, would be implemented under either alternative in order to maximize the mitigation benefits to the environment.
Mitigation measures are being coordinated through the consultation and permitting processes. The DoN will also consider public comments on proposed mitigation measures described in this Draft EIS/OEIS.
Notice of the availability of the draft EIS/OEIS was distributed to federal, state, and local agencies, elected officials, and other interested individuals and organizations. Copies of the Draft EIS/OEIS are available for public review at the following libraries:
1. Anne Arundel County Public Library, 5 Harry S. Truman Parkway, Annapolis, MD 21401.
2. Bay County Public Library, 898 West 11th Street, Panama City, FL 32401.
3. Ben May Main Library, 701 Government Street, Mobile, AL 36602.
4. Boston Public Library, Central Library, 700 Boylston Street, Boston, MA 02116.
5. Camden County Public Library, 1410 Highway 40 E, Kingsland, GA 31548.
6. Carteret County Public Library, 1702 Live Oak Street, Suite 100, Beaufort, NC 28516.
7. Charleston County Public Library, Main Library, 68 Calhoun Street, Charleston, SC 29401.
8. Corpus Christi Public Library, La Retama Central Library, 805 Comanche, Corpus Christi, TX 78401.
9. East Bank Regional Library, 4747 West Napoleon Avenue, Metairie, LA 70001.
10. Dare County Library, Manteo, 700 Highway 64/264, Manteo, NC 27954.
11. Havelock-Craven County Public Library, 301 Cunningham Boulevard, Havelock, NC 28532.
12. Jacksonville Public Library, 303 North Laura Street, Jacksonville, FL 32202.
13. Dare County Library, Kill Devil Hills, 400 Mustian Street, Kill Devil Hills, NC 27948.
14. Houston Public Library, 500 McKinney Street, Houston, TX 77002.
15. New Hanover County Public Library, 201 Chestnut Street, Wilmington, NC 28401.
16. New Orleans Public Library, Main Library, 219 Loyola Avenue, New Orleans, LA 70112.
17. Onslow County Public Library, 58 Doris Avenue East, Jacksonville, NC 28540.
18. Pascagoula Public Library, 3214 Pascagoula Street, Pascagoula, MS 39567.
19. West Florida Public Library, Pensacola Library, 239 North Spring Street, Pensacola, FL 32502.
20. Portland Public Library, 5 Monument Square, Portland, ME 04101.
21. Providence Public Library, 150 Empire Street, Providence, RI 02903.
22. Public Library of New London, 63 Huntington Street, New London, CT 06320.
23. Slover Memorial Main Library, 235 East Plume Street, Norfolk, VA 23510.
24. Walton County Library, Coastal Branch Library, 437 Greenway Trail, Santa Rosa Beach, FL 32459.
25. Webb Memorial Library and Civic Center, 812 Evans Street, Morehead City, NC 28557.
26. West Florida Public Library, Southwest Branch, 12248 Gulf Beach Highway, Pensacola, FL 32507.
27. Mandel Public Library of West Palm Beach, 411 Clematis Street, West Palm Beach, FL 33401.
Copies of the AFTT Draft EIS/OEIS are available for electronic viewing at
42 U.S.C. 4332, E.O. 12114, and 40 CFR 1500–1508.
Department of Education.
Notice of the re-establishment of a computer matching program.
This document provides notice of the re-establishment of a computer matching program between the Department of Education (ED) and the Defense Manpower Data Center (DMDC) of the U.S. Department of Defense (DoD).
We must receive your comments on or before July 31, 2017.
The re-established matching program will be effective on the latest of the following three dates: (A) August 1,
The matching program will continue for 18 months after the effective date and may be extended for an additional 12 months thereafter, if the conditions specified in 5 U.S.C. 552a(o)(2)(D) have been met.
Submit your comments through the Federal eRulemaking Portal or via postal mail, commercial delivery, or hand delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.
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Ms. Marya Dennis, Management and Program Analyst, U.S. Department of Education, Federal Student Aid, Union Center Plaza, 830 First Street NE., Washington, DC 20002–5345. Telephone: (202) 377–3385.
If you use a telecommunications device for the deaf or a text telephone, call the Federal Relay Service, toll free, at 1–800–877–8339.
We provide this notice in accordance with 5 U.S.C. 552a (commonly known as the Privacy Act of 1974, as amended); Office of Management and Budget (OMB) Final Guidance Interpreting the Provisions of Public Law 100–503, the Computer Matching and Privacy Protection Act of 1988, 54 FR 25818 (June 19, 1989); and OMB Circular A–108, 81 FR 94424 (December 23, 2016),
Under sections 420R and 473(b) of the Higher Education Act of 1965, as amended (HEA) (20 U.S.C. 1070h and 20 U.S.C. 1087mm(b)), the Secretary of Defense must provide the Secretary of Education with information to identify the children of military personnel who have died as a result of their military service in Iraq or Afghanistan after September 11, 2001, to determine if the child is eligible for increased amounts of title IV, HEA program assistance. DoD and ED have determined that matching data contained in the DoD DMDC system and the Defense Enrollment Eligibility Reporting System (DEERS) against ED's Federal Student Aid Application File (18–11–01) is the only practical method that the agencies can use to meet the statutory requirements of the HEA.
The prior Computer Matching Agreement (CMA) was published in the
Sections 420R and 473(b) of the HEA (20 U.S.C. 1070h and 20 U.S.C. 1087mm(b)) and 5 U.S.C. 552a.
This matching program identifies children whose parent or guardian was a member of the Armed Forces of the United States and died as a result of performing military service in Iraq or Afghanistan after September 11, 2001. These children (referred to as qualifying students) may be eligible for a greater amount of title IV, HEA program assistance. A qualifying student must have been age 24 or younger at the time of the parent's or guardian's death, or, if older than 24, enrolled part-time or full-time in an institution of higher education at the time of the parent's or guardian's death. Beginning July 1, 2010, students who are otherwise qualified children of deceased U.S. military who meet the requirements of section 420R of the HEA (20 U.S.C. 1070h) may also be eligible for higher amounts of title IV, HEA program assistance.
The individuals whose records are included in this matching program are dependents of service personnel who died as a result of performing their military service in Iraq or Afghanistan after September 11, 2001, which records are located in the DoD DMDC and DEERS systems, and all students who complete a Free Application for Federal Student Aid.
DoD data include the individual's first and last name, Social Security number (SSN), date of birth, and the parent's or guardian's date of death for each qualifying dependent record. ED uses the SSN, date of birth, and the first two letters of an applicant's last name to match with the Federal Student Aid Application File.
You may also access documents of the Department published in the
Department of Energy (DOE).
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the
Thursday, July 20, 2017, 6:00 p.m.
Barkley Centre, 111 Memorial Drive, Paducah, Kentucky 42001.
Jennifer Woodard, Deputy Designated Federal Officer, Department of Energy Paducah Site Office, Post Office Box 1410, MS–103, Paducah, Kentucky 42001, (270) 441–6825.
Department of Energy.
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Savannah River Site. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the
Applied Research Center, 301 Gateway Drive, Aiken, SC 29803.
Susan Clizbe, Office of External Affairs, Department of Energy, Savannah River Operations Office, P.O. Box A, Aiken, SC 29802; Phone: (803) 952–8281.
Environmental Protection Agency.
Notice of meeting.
Pursuant to the provisions of the Federal Advisory Committee Act, Public Law 92–463, notice is hereby given that the next meeting of the Children's Health Protection Advisory Committee (CHPAC) will be held July 18 and 19 at the Holiday Inn Capitol, 550 C Street SW., Washington, DC 20024. The CHPAC advises the Environmental Protection Agency on science, regulations, and other issues relating to children's environmental health.
July 18 and 19 at Holiday Inn Capitol in Washington, DC.
550 C Street SW., Washington, DC, 20024.
Martha Berger, Office of Children's Health Protection, USEPA, MC 1107T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 564–2191 or berger.
The meetings of the CHPAC are open to the public. An agenda will be posted to
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
The U.S. Department of Agriculture's Forest Service (USFS) has adopted the Federal Energy Regulatory Commission's FEIS #20170113, filed with EPA 06/22/2017. The USFS was a cooperating agency for this project.
Therefore, re-circulation of the document is not necessary under Section 1506.3(c) of the CEQ Regulations.
The U.S. Department of Agriculture's Forest Service (USFS) has adopted the U.S. Department of the Interior's Bureau of Land Management's FEIS #20160278, filed with EPA 11/18/2016. The USFS was a cooperating agency for this project. Therefore, re-circulation of this document is not necessary under Section 1506.3(c) of the CEQ Regulations.
Revision to FR Notice Published01/13/2012; Officially Withdrawn per request of the U.S. Forest Service.
Revision to FR Notice Published06/23/2017; Officially Withdrawn per request of the Bureau Land Management.
Environmental Protection Agency (EPA).
Notice.
This notice announces EPA's approval of the State of Idaho's request to revise its National Primary Drinking Water Regulations Implementation EPA-authorized program to allow electronic reporting.
EPA's approval is effective July 31, 2017 for the State of Idaho's National Primary Drinking Water Regulations Implementation program, if no timely request for a public hearing is received and accepted by the Agency.
Karen Seeh, U.S. Environmental Protection Agency, Office of Environmental Information, Mail Stop 2823T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 566–1175,
On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the
On May 5, 2017, the Idaho Department of Environmental Quality (IDEQ) submitted an application titled Compliance Monitoring Data Portal for revision to its EPA-approved drinking water program under title 40 CFR to allow new electronic reporting. EPA reviewed IDEQ's request to revise its EPA-authorized program and, based on this review, EPA determined that the application met the standards for approval of authorized program revision set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve Idaho's request to revise its Part 142—National Primary Drinking Water Regulations Implementation program to allow electronic reporting under 40 CFR part 141 is being published in the
IDEQ was notified of EPA's determination to approve its application with respect to the authorized program listed above.
Also, in today's notice, EPA is informing interested persons that they may request a public hearing on EPA's action to approve the State of Idaho's request to revise its authorized public water system program under 40 CFR part 142, in accordance with 40 CFR 3.1000(f). Requests for a hearing must be submitted to EPA within 30 days of publication of today's
(1) The name, address and telephone number of the individual, organization or other entity requesting a hearing;
(2) a brief statement of the requesting person's interest in EPA's determination, a brief explanation as to why EPA should hold a hearing, and any other information that the requesting person wants EPA to consider when determining whether to grant the request;
(3) the signature of the individual making the request, or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity.
In the event a hearing is requested and granted, EPA will provide notice of the hearing in the
Federal Communications Commission.
Notice.
In this document, the Commission announces and provides an agenda for the second meeting of Broadband Deployment Advisory Committee (BDAC).
Thursday, July 20, 2017, 9:30 a.m.
Federal Communications Commission, 445 12th Street SW., Room TW–C305, Washington, DC 20554.
Brian Hurley, Designated Federal Officer (DFO), at (202) 418–2220 or
This meeting is open to members of the general public. The FCC will accommodate as many participants as possible; however, admittance will be limited to seating availability. The Commission will also provide audio and/or video coverage of the meeting over the Internet from the FCC's Web page at
Open captioning will be provided for this event. Other reasonable accommodations for people with
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than July 28, 2017.
1.
The companies listed in this notice have applied to the Board for approval, pursuant to the Home Owners' Loan Act (12 U.S.C. 1461
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the HOLA (12 U.S.C. 1467a(e)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 10(c)(4)(B) of the HOLA (12 U.S.C. 1467a(c)(4)(B)). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than July 28, 2017.
1.
In connection with this proposal, Charter Financial will retain ownership of its savings association subsidiary, CharterBank, West Point, Georgia, and thereby engage in operating a savings association, pursuant to section 225.28(b)(4)(ii). Finally, Charter Financial will revert to savings and loan holding company status after the merger of Resurgens Bank with and into CharterBank.
The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570 or send an email to
Positive Health Check Evaluation Trial—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
HIV transmission continues to be an urgent public health challenge in the United States. According to the Centers for Disease Control and Prevention (CDC), approximately 1.2 million people are living with HIV, with close to 50,000 new cases each year. Antiretroviral therapy (ART) suppresses the plasma HIV viral load (VL) and people living with HIV (PLWH) who are treated with ART—compared with those who are not—have enhanced clinical outcomes and a substantially reduced risk of transmitting HIV sexually, through drug sharing, or from mother to child. However, it is estimated that only 30% of people who are infected with HIV in the United States have an undetectable HIV VL. To enhance HIV prevention efforts, implementable, effective, scalable interventions are needed that focus on enhancing prevention and care to improve the health of and reduce HIV transmission risk among PLWH. The Positive Health Check (PHC) intervention is based on earlier computer-based interventions that were proven efficacious for HIV prevention.
The PHC intervention approach is innovative in multiple ways. First, it uses an interactive video doctor to deliver tailored messages that meet specific patient needs related to ART initiation, adherence, sexual risk reduction, engagement in care, mother-to-child transmission, and drug use. Second, this intervention is designed specifically to support improved health outcomes by providing useful behavior-change tips for patients to practice between clinic visits. These tips are generated by the tool and selected by the patient and populated on a handout that is delivered to the patient upon completing the PHC intervention. The handout has no patient-identifying information. Third, PHC supports patient-provider communication by also generating a set of questions that patients may select to ask their provider. These PHC behavior-change tips and questions are populated on a Patient Handout to guide patients' conversations with their providers and if desired, patients may choose to share their handout with their provider. As such, PHC supports the interactions between patients and their providers during their clinical encounter and is intended to improve communication. Finally, the PHC intervention has been designed from the onset for wide-scale dissemination. This web-based intervention can be easily updated and is accessible on multiple mobile devices and platforms. This approach makes PHC an important intervention strategy to improve public health in communities that have a high incidence of HIV infection.
The PHC Evaluation Trial has four primary aims: (1.) Implement a randomized trial to test the effectiveness of the PHC intervention for improving clinical health outcomes, specifically viral load and retention in care; (2.) Conduct a feasibility assessment to determine strategies to facilitate implementation and integration of PHC into the workflow of HIV primary care clinics; (3.) Collect and document data on the cost of PHC intervention implementation; and (4.) Document the standard of care at each participating clinic. The awardee of this cooperative agreement—Research Triangle International (RTI)—has subcontracted with four clinical sites to implement the trial (Atlanta VA Medical Center (Atlanta, GA), Hillsborough County Health Department (Tampa, FL), Rutgers Infectious Disease Clinic (Newark, NJ) and Crescent Care (New Orleans, LA). The four clinical sites) are well suited for this work, given the high rates of patients with elevated viral loads.
During the 36-month study period, 1,010 patients will be enrolled into the trial (505 intervention arm and 505 control arm) across the four clinics to evaluate the effectiveness of the PHC intervention. Upon enrollment, participants will be asked their date of diagnosis. To assess the effectiveness of the PHC intervention (Aim 1), patients randomized to the intervention arm will provide their responses to the patient tailoring questions embedded within the intervention and all enrolled patients will consent to have their de-identified clinical values be made available via passive data collection via the electronic medical record (EMR). In addition to the main trial, three to five key staff at each clinic site will be selected to participate in the PHC feasibility assessment (Aim 2) which includes an online survey and qualitative interviews. Clinic staff will provide data on the cost of implementing the PHC intervention (Aim 3). Finally, the medical director of each clinic will collect data on their clinic's standard of care (Aim 4).
OMB approval is requested for three years. Participation in this study is voluntary. The total estimated annualized burden hours are 419.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice announces the April 7, 2017 posting of a funding opportunity for Round Two of the Zika Health Care Services Program which provides up to $6.45 million to support prevention activities and treatment services for health conditions related to the Zika virus for entities that meet the eligibility requirements of the Zika Health Care Services Program, but that did not receive an award under the Round One Funding Opportunity. The Round Two Funding Opportunity provides two application due dates, May 8, 2017 and July 10, 2017. Entities eligible to apply for this funding opportunity are states, territories, tribes or tribal organizations, with active or local transmission of the Zika virus, as confirmed by the Centers for Disease Control and Prevention (CDC).
The project period of performance for the Cooperative Agreement will be 36 months from the date of award.
Elizabeth Garbarczyk, 410–786–0426.
The Zika Response and Preparedness Act (Pub. L. 114–223) provides $387,000,000 in funding to prevent, prepare for, and respond to the Zika virus. Of the funds appropriated by Public Law (Pub. L.) 114–223, Congress designated $75 million to support states, territories, tribes, or tribal organizations with active or local transmission cases of the Zika virus, as confirmed by the Centers for Disease Control and Prevention (CDC), to reimburse the costs of health care for health conditions related to the Zika virus not covered by private insurance. No less than $60 million of this funding is for territories with the highest rates of Zika transmission.
The Zika Health Care Services Program funding opportunities solicit single source emergency applications for a cooperative agreement aimed at supporting prevention activities and treatment services for women (including pregnant women), children, and men adversely or potentially impacted by the Zika virus.
On January 18, 2017, CMS issued $66.1 million in awards to eligible entities that applied for Round One of the Zika Health Care Services Program (American Samoa, Puerto Rico, U.S. Virgin Islands, and Florida). The Round One Funding Opportunity sought to issue funds to areas of greatest need, while maintaining additional funds to prevent, detect, and respond to future Zika outbreaks.
In accordance with the Zika Response and Preparedness Act (Pub. L. 114–223), entities eligible to apply for this funding opportunity include states, territories, tribes or tribal organizations with active or local transmission of the Zika virus, as confirmed by the Centers for Disease Control and Prevention (CDC). Recipients who previously received a Notice of Award under Round One of the Zika Health Care Services Program, Funding Opportunity Number CMS–1Q1–17–001, are not eligible to apply. As of the first application due date, May 8, 2017, the CDC reports that Texas is the only new area with laboratory-confirmed active or local transmission of the Zika virus; and therefore, this is the only state currently eligible to receive funding as authorized under the legislation.
This funding opportunity has been structured to ensure a comprehensive response to Zika as quickly as possible. Accordingly, the single-source emergency funding opportunity is solely available to the state health department in Texas, based on its ability to quickly and efficiently expand its existing Zika response efforts and to further determine the most effective use and dissemination of funds in its respective jurisdictions. The health department in Texas is uniquely positioned to meet the goals of the emergency cooperative agreement based on its capacity, partnerships, resources, prior experience, and ability to begin implementing the project immediately. Immediate implementation is critical to successfully addressing this rapidly spreading public health threat. The budget and project period under the specific funding opportunity will be 36 months. The total amount of federal funds available in Round Two, for both the May 8, 2017 and July 10, 2017 due dates, is up to $6.45 million. The Texas Department of State Health Services submitted their application, and was the only entity eligible for an award as of the May 8, 2017 application due date. The proposed award amount is $1,800,000.
The second application due date for the Round Two Funding Opportunity is July 10, 2017. Eligibility for the second Round Two application due date is based on the state, territory, tribe, or tribal organization meeting all of the following criteria:
• Has active or local transmission cases of the Zika virus, as confirmed by the CDC.
• Did not receive an award in Round One.
• Has not received a response to an application submitted by the first application due date (May 8, 2017).
This notice establishes funding opportunities for health departments in areas with laboratory-confirmed active or local Zika virus transmission. The funding opportunity application process constitutes an information collection request. Specifically, this notice
Centers for Medicare & Medicaid Services, Department of Health and Human Services.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions:
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786–1326.
William Parham at (410) 786–4669.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
1.
Under the current 11th QIO Statement of Work (SOW), two organizations are providing services as BFCC QIOs across all of the United States. The QIO evaluation criteria have been revised to reflect this national regionalization and it is important for CMS to understand the impact on beneficiaries from this reorganization. The information will be used to evaluate the success of each QIO in meeting its contractual requirements and to understand the experience of Medicare beneficiaries and/or their representative with QIO contract mandated work.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice of meeting.
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (“Committee”) will be held on Wednesday, August 30, 2017. This meeting will specifically focus on obtaining the MEDCAC's recommendations regarding the appraisal of the state of evidence for health outcomes in the Medicare population for surgical and endoscopic procedures for weight loss. This meeting is open to the public in accordance with the Federal Advisory Committee Act.
Maria Ellis, Executive Secretary for MEDCAC, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Coverage and Analysis Group, S3–02–01, 7500 Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone (410–786–0309) or via email at
MEDCAC, formerly known as the Medicare Coverage Advisory Committee (MCAC), is advisory in nature, with all final coverage decisions resting with CMS. MEDCAC is used to supplement CMS' internal expertise. Accordingly, the advice rendered by the MEDCAC is most useful when it results from a process of full scientific inquiry and thoughtful discussion, in an open forum, with careful framing of recommendations and clear identification of the basis of those recommendations. MEDCAC members are valued for their background, education, and expertise in a wide variety of scientific, clinical, and other related fields. (For more information on MCAC, see the MEDCAC Charter (
This notice announces the Wednesday, August 30, 2017, public meeting of the Committee. During this meeting, the Committee will discuss recommendations regarding the appraisal of the state of evidence for health outcomes in the Medicare population for surgical and endoscopic procedures for weight loss. Background information about this topic, including panel materials, is available at
The Committee will deliberate openly on the topics under consideration. Interested persons may observe the deliberations, but the Committee will not hear further comments during this time except at the request of the chairperson. The Committee will also allow a 15-minute unscheduled open public session for any attendee to address issues specific to the topics
CMS' Coverage and Analysis Group is coordinating meeting registration. While there is no registration fee, individuals must register to attend. You may register online at
This meeting will be held in a federal government building; therefore, federal security measures are applicable. The Real ID Act, enacted in 2005, establishes minimum standards for the issuance of state-issued driver's licenses and identification (ID) cards. It prohibits Federal agencies from accepting an official driver's license or ID card from a state unless the Department of Homeland Security determines that the state meets these standards. Beginning October 2015, photo IDs (such as a valid driver's license) issued by a state or territory not in compliance with the Real ID Act will not be accepted as identification to enter Federal buildings. Visitors from these states/territories will need to provide alternative proof of identification (such as a valid passport) to gain entrance into CMS buildings. The current list of states from which a Federal agency may accept driver's licenses for an official purpose is found at
• Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel.
• Inspection of vehicle's interior and exterior (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection.
• Inspection, via metal detector or other applicable means, of all persons entering the building. We note that all items brought into CMS, whether personal or for the purpose of presentation or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for presentation or to support a presentation.
All visitors must be escorted in areas other than the lower and first floor levels in the Central Building.
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).
5 U.S.C. App. 2, section 10(a).
The data collected will inform State/Tribal/Federal policy decisions, program management, and responses to Congressional and Departmental inquiries. Specifically, the data are used for short/long-term budget projections, trend analysis, child and family service reviews, and to target areas for improved technical assistance. The data will provide information about foster care placements, adoptive parents, length of time in care, delays in termination of parental rights and placement for adoption.
In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. Chap 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington DC 20201. Attn: ACF Reports Clearance Officer. Email address:
The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an injectable treatment for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the U.S. Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized injectable treatment. The Authorization follows the April 11, 2017, determination by the Department of Health and Human Services (HHS) Secretary that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves nerve agents or certain insecticides (organophosphorus and/or carbamate). On the basis of such determination, the HHS Secretary declared on April 11, 2017, that circumstances exist justifying the authorization of emergency use of injectable treatments for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
The Authorization is effective as of April 11, 2017.
Submit written requests for single copies of the EUA to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorization may be sent. See the
Carmen Maher, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993–0002, 301–796–8510.
Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) as amended by the Project BioShield Act of 2004 (Pub. L. 108–276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113–5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help assure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives.
Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces of attack with a biological, chemical, radiological, or nuclear agent or agents; (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or (4) the identification of a material threat by the Secretary of Homeland Security under section 319F–2 of the Public Health Service (PHS) Act (42 U.S.C. 247d–6b) sufficient to affect national security or the health and security of U.S. citizens living abroad.
Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the
No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act. Because the statute is self-executing, regulations or guidance are not required for FDA to implement the EUA authority.
On April 11, 2017, under section 564(b)(1)(C) of the FD&C Act, the Secretary of HHS determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves nerve agents or certain insecticides (organophosphorus and/or carbamate). On April 11, 2017, under section 564(b)(1) of the FD&C Act, and on the basis of such determination, the Secretary of HHS declared that circumstances exist justifying the authorization of emergency use of injectable treatments for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning, subject to the terms of any authorization issued under section 564 of the FD&C Act. Notice of the determination and declaration of the Secretary was published in the
An electronic version of this document and the full text of the Authorization are available on the Internet at
Having concluded that the criteria for issuance of the Authorization under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of an injectable treatment for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning subject to the terms of the Authorization. The Authorization in its entirety (not including the authorized versions of the fact sheets and other written materials) follows and provides an explanation of the reasons for its issuance, as required by section 564(h)(1) of the FD&C Act.
In notice document 2017–10818 appearing on pages 24351 through 24356 in the issue of Friday, May 26, make the following correction:
On page 24351, in the third column, under the
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Roche Molecular Systems, Inc. for the
The Authorization is revoked as of March 13, 2017.
Submit written requests for single copies of the revocation to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the revocation may be sent. See the
Carmen Maher, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993–0002, 301–796–8510 (this is not a toll free number).
Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) as amended by the Project BioShield Act of 2004 (Pub. L. 108–276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113–5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. On August 26, 2016, FDA issued an EUA to Roche Molecular Systems, Inc. for the
On March 10, 2017, Roche Molecular Systems, Inc. requested, and on March 13, 2017, FDA revoked, the EUA for the
An electronic version of this document and the full text of the revocation are available on the Internet at
Having concluded that the criteria for revocation of the Authorization under section 564(g) of the FD&C Act are met, FDA has revoked the EUA for Roche Molecular Systems, Inc.'s
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for in vitro diagnostic devices for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Nanobiosym Diagnostics, Inc. and DiaSorin Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.
The Authorization for Nanobiosym Diagnostics, Inc. is effective as of March 20, 2017; the Authorization for DiaSorin Inc. is effective as of April 5, 2017.
Submit written requests for single copies of the EUAs to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorizations may be sent. See the
Carmen Maher, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993–0002, 301–796–8510 (this is not a toll free number).
Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) as amended by the Project BioShield Act of 2004 (Pub L. 108–276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub L. 113–5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help assure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives.
Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces of attack with a biological, chemical, radiological, or nuclear agent or agents; (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or (4) the identification of a material threat by the Secretary of Homeland Security under section 319F–2 of the Public Health Service (PHS) Act (42 U.S.C. 247d–6b) sufficient to affect national security or the health and security of U.S. citizens living abroad.
Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the
No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act. Because the statute is self-executing, regulations or guidance are not required for FDA to implement the EUA authority.
On February 26, 2016, the Secretary of HHS determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On February 26, 2016, under section 564(b)(1) of the FD&C Act, and on the basis of such determination, the Secretary of HHS declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under section 564 of the FD&C Act. Notice of the determination and declaration of the Secretary was published in the
An electronic version of this document and the full text of the Authorizations are available on the Internet at
Having concluded that the criteria for issuance of the Authorizations under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of two in vitro diagnostic devices for detection of Zika virus subject to the terms of the Authorizations. The Authorizations in their entirety (not including the authorized versions of the fact sheets and other written materials) follow and provide an explanation of the reasons for issuance, as required by section 564(h)(1) of the FD&C Act:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the National Advisory Neurological Disorders and Stroke Council.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to Public Law 92–463, notice is hereby given that the Substance Abuse and Mental Health Services Administration, (SAMHSA) Center for Mental Health Services (CMHS) National Advisory Council (NAC) will meet on July 27, 2017, from 3:00 p.m. to 4:00 p.m. (EDT) in a closed teleconference meeting.
The meeting will include discussion and evaluation of grant applications reviewed by SAMHSA's Initial Review Groups, and involves an examination of confidential financial and business information as well as personal information concerning the applicants. Therefore, the meeting will be closed to the public as determined by the Acting Deputy Assistant Secretary for Mental Health and Substance Use, in accordance with Title 5 U.S.C. 552b(c)(4) and (6) and Title 5 U.S.C. App. 2, 10(d).
Meeting information and a roster of Council members may be obtained either by accessing the SAMHSA Council Web site at
Coast Guard, Department of Homeland Security.
Request for applications.
The Coast Guard seeks applications for membership on the National Boating Safety Advisory Council. This Council advises the Coast Guard on recreational boating safety regulations and other major boating safety matters.
Completed applications should reach the Coast Guard on or before August 29, 2017.
Applicants should send a cover letter expressing interest in an appointment to the National Boating Safety Advisory Council and specifying which membership category the applicant is applying under, along with a resume detailing the applicant's boating experience via one of the following methods:
• By email:
• By mail: Commandant (CG–BSX–2)/NBSAC,
Mr. Jeff Ludwig, Alternate Designated Federal Officer of the National Boating Safety Advisory Council; telephone 202–372–1061 or email at
The National Boating Safety Advisory Council is a Federal advisory committee which operates under the provisions of Federal Advisory Committee Act, (Title 5 U.S.C., Appendix). It was established under the authority of 46 United States Code 13110 and advises the Coast Guard on boating safety regulations and other major boating safety matters. The Council usually meets at least twice each year at a location selected by the Coast Guard. It may also meet for extraordinary purposes. Subcommittees or working groups may also meet to consider specific issues.
Each member serves for a term of three years. Members may be considered to serve a maximum of two consecutive full terms. All members serve at their own expense and receive no salary, or other compensation from the Federal Government. The exception to this policy is when attending National Boating Safety Advisory Council meetings; members may be reimbursed for travel expenses and provided per diem in accordance with Federal Travel Regulations.
We will consider applications for the following seven positions that will be vacant on January 1, 2018:
• Three representatives of State officials responsible for State boating safety programs;
• Two representatives of recreational boat and associated equipment manufacturers; and
• Two representatives of national recreational boating organizations or the general public.
If you are selected as a member from the general public, you will be appointed and serve as a Special Government Employee as defined in section 202(a) of Title 18, United States Code. Applicants for appointment as a Special Government Employee, applicants are required to complete a Confidential Financial Disclosure Report (OGE Form 450). The Coast Guard may not release the reports or the information in them to the public except under an order issued by a Federal court or as otherwise provided under the Privacy Act (5 U.S.C. 552a). Only the Designated Coast Guard Ethics Official or his or her designee may release a Confidential Financial Disclosure Report. Applicants can obtain this form by going to the Web site of the Office of Government Ethics (
Registered lobbyists are not eligible to serve on federal advisory committees in an individual capacity. See “Revised Guidance on Appointment of Lobbyists to Federal Advisory Committees, Boards and Commissions” (79 FR 47482, August 13, 2014). The position we list for a member from the general public would be someone appointed in their capacity and would be designated as a Special Government Employee as defined in section 202(a) of Title 18, U.S.C. Registered lobbyists are lobbyist as defined in 2 U.S.C. 1602 who are required by 2 U.S.C. 1603 to register
Applicants are considered for membership on the basis of their particular expertise, knowledge, and experience in recreational boating safety. In addition to recreational boating safety experience, the Coast Guard is particularly interested in applicants who also have experience developing and implementing national media outreach campaigns designed to influence the decision-making of targeted audiences. The vacancies announced in this notice apply to membership positions that become vacant on January 1, 2018. Appointments for the 2017 vacancies remain pending, and applications received in response to this notice may also be used to fill the seven positions which became vacant on January 1, 2017. Applicants for the 2017 vacancies announced in the
To be eligible, applicants should have experience in one of the categories listed in the
The Department of Homeland Security does not discriminate in selection of Council members on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability and genetic information, age, membership in an employee organization, or other non-merit factor. The Department of Homeland Security strives to achieve a widely diverse candidate pool for all of its recruitment actions.
If you are interested in applying to become a member of the Council, send your cover letter and resume to Mr. Jeff Ludwig, Alternate Designated Federal Officer of the National Boating Safety Advisory Council via one of the transmittal methods in the
U.S. Customs and Border Protection, Department of Homeland Security.
Delay of effective date.
On August 30, 2016, U.S. Customs and Border Protection (CBP) published a notice in the
Questions related to this notice may be emailed to
On August 30, 2016, U.S. Customs and Border Protection (CBP) published a notice in the
This notice announces that the effective date announced in the June 8, 2017
U.S. Customs and Border Protection, Department of Homeland Security.
Delay of effective date.
This notice announces that the effective date for the modifications to the National Customs Automation Program (NCAP) tests regarding Reconciliation, Post-Summary Corrections (PSC), and Periodic Monthly Statements (PMS) is delayed until further notice. U.S. Customs and Border Protection (CBP) announced these modifications in notices previously published in the
The effective date for the modifications to the reconciliation, PSC, and PMS NCAP tests is delayed until further notice. CBP will publish a notice in the
Comments concerning the reconciliation test program may be submitted at any time during the test via email, with a subject line identifier reading, “Comment on Reconciliation test”, to
Comments concerning the PSC and PMS test programs may be submitted
On December 12, 2016, U.S. Customs and Border Protection (CBP) published a notice entitled “Modification of the National Customs Automation Program Test Regarding Reconciliation and Transition of the Test from the Automated Commercial System to the Automated Commercial Environment” in the
This notice announces that the effective date for the modifications to the reconciliation test and for mandatory filing of reconciliation entries in ACE has been delayed until further notice.
On December 12, 2016, CBP published a notice in the
This notice announces that the effective date for the modifications to the PSC and PMS tests has been delayed until further notice.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Kansas (FEMA–4319–DR), dated June 16, 2017, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646–2833.
The notice of a major disaster declaration for the State of Kansas is hereby amended to include the following area among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of June 16, 2017.
Stanton County for snow assistance under the Public Assistance program for any continuous 48-hour period during or proximate to the incident period (already designated for Public Assistance).
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency (FEMA), DHS.
Notice of new information collection; request for comments.
The Federal Emergency Management Agency (FEMA), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on a new information collection to replace a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the collection of Individual Assistance customer satisfaction survey responses and information for assessment and improvement of the delivery of disaster assistance to individuals and households.
Comments must be submitted on or before August 29, 2017.
To avoid duplicate submissions to the docket, please use only one of the following means to submit comments:
(1)
(2)
All submissions received must include the agency name and Docket ID. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at
Jessica Guillory, Statistician, Customer Survey & Analysis Section, Recovery Directorate, FEMA at
This collection is in accordance with Executive Orders 12862 and 13571 requiring all Federal agencies to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. The Government Performance and Results Act (GPRA) (Pub. L. 103–62, 107 Stat. 285) requires agencies to set missions and goals and measure performance against them. In addition, the GPRA Modernization Act of 2010 (Pub. L. 111–352, 124 Stat. 3866) requires quarterly performance assessments of government programs for the purposes of assessing agency performance and improvement. FEMA will fulfill these requirements by collecting customer satisfaction program information through surveys of the Recovery Directorate's external customers.
Comments may be submitted as indicated in the
U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the
Comments are encouraged and will be accepted for 60 days until August 29, 2017.
All submissions received must include the OMB Control Number 1615–0038 in the body of the letter, the agency name and Docket ID USCIS–2009–0008. To avoid duplicate submissions, please use only
(1)
(2)
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW.,
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(1)
(2)
(3)
(4)
(5)
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U.S. Citizenship and Immigration Services, Department of Homeland Security.
30-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The purpose of this notice is to allow an additional 30 days for public comments.
The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until July 31, 2017. This process is conducted in accordance with 5 CFR 1320.10.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be directed to the OMB USCIS Desk Officer via email at
You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make. For additional information please read the Privacy Act notice that is available via the link in the footer of
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW., Washington, DC 20529–2140, Telephone number (202) 272–8377 (This is not a toll-free number; comments are not accepted via telephone message.). Please note contact
The information collection notice was previously published in the
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(1)
(2)
(3)
(4)
Form I–864A is a contract between the sponsor and the sponsor's household members. It is only required if the sponsor used the income of his or her household members to reach the required 125 percent of the Federal poverty guidelines. The contract holds these household members jointly and severally liable for the support of the sponsored immigrant. The information collection required on Form I–864A is necessary for public benefit agencies to enforce the Affidavit of Support in the event the sponsor used income of his or her household members to reach the required income level and the public benefit agencies are requesting reimbursement from the sponsor.
USCIS uses Form I–864EZ in exactly the same way as Form I–864; however, less information is collected from the sponsors as less information is needed from those who qualify in order to make a thorough adjudication.
USCIS uses Form I–864W to determine whether the intending immigrant meets the criteria for exemption of section 213A requirements. This form collects the immigrant's basic information, such as name and address, the reason for the exemption, and accompanying documentation in support of the immigrant's claim that they are not subject to section 213A.
(5)
(6)
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Fish and Wildlife Service, Interior.
Notice.
We, the U.S. Fish and Wildlife Service, have received an application from the Louisiana Department of Wildlife and Fisheries for an enhancement of survival permit (permit) pursuant to the Endangered Species Act of 1973. The permit application includes a proposed programmatic candidate conservation agreement with assurances (CCAA) for the Louisiana pinesnake. The term of the agreement would be 99 years. If approved, the CCAA would allow the applicant to enter into conservation management agreements with eligible non-Federal landowners throughout Bienville, Beauregard, Jackson, Natchitoches, Rapides, Sabine, Vernon, Winn, Grant, and Allen Parishes, Louisiana, and to issue certificates of inclusion to enrollees. We invite public comments on these documents.
We must receive any written comments at our Regional Office (see
To request further information, review documents, or submit written comments, please use the following methods and specify that your information request or comments are in reference to the “Programmatic CCAA for the Louisiana Pinesnake.”
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Mr. Michael Harris, At-Risk Species Coordinator, at the Regional Office (see
We have received an application from the Louisiana Department of Wildlife and Fisheries for an enhancement of survival permit (permit) pursuant to the Endangered Species Act of 1973 (Act). The permit application includes a proposed programmatic candidate conservation agreement with assurances (CCAA) for the Louisiana pinesnake (
Under a CCAA, participating property owners voluntarily undertake management activities on their properties to enhance, restore, or maintain habitat benefiting species that may warrant listing under the Act. CCAAs encourage private and other non-Federal property owners to implement conservation efforts for candidate and at-risk species by assuring them that they will not be subjected to increased property use restrictions should the species become listed as “threatened” or “endangered” under the Act in the future. Application requirements and issuance criteria for CCAAs are found in 50 CFR 17.22(d) and 17.32(d).
The CCAA describes conservation measures designed to protect and enhance habitat for the benefit of the Louisiana pinesnake (covered species) on private or non-Federal public lands enrolled under the agreement. Enrolled landowners who implement these measures would receive assurances against take liability if the covered species were to be federally listed in the future. Conservation land use practices would vary according to the needs of a particular enrolled landowner. Typical measures include the use of prescribed fire, thinning of forests, and restoration of open-canopied pine (including longleaf pine). The CCAA also contemplates that other conservation measures may be developed in the future.
We specifically request information, views, and opinions from the public via this notice on our proposed Federal action, including our determination that the CCAA, including its proposed conservation measures, would have minor or negligible effects on the covered species. Therefore, we have determined that the incidental take permit for this project is “low effect” and qualifies for categorical exclusion under the National Environmental Policy Act (NEPA), as provided by 43 CFR 46.205 and 43 CFR 46.210. A low-effect project involves (1) minor or negligible effects on federally listed or candidate species or their habitats, and (2) minor or negligible effects on other environmental values or resources. Further, we specifically solicit information regarding the adequacy of the CCAA per 50 CFR parts 13 and 17.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The CCAA covers eligible lands in Bienville, Beauregard, Jackson, Natchitoches, Rapides, Sabine, Vernon, Winn, Grant, and Allen Parishes, Louisiana.
We will evaluate the application for enhancement of survival permit through candidate conservation agreement with assurances, including the CCAA, and any comments we receive to determine whether the application meets the requirements of section 10(a)(1)(A) of the Act and of applicable implementing regulations. We will also evaluate whether the section 10(a)(1)(A) enhancement of survival permit would comply with section 7 of the Act by conducting an intra-Service section 7 consultation. If we determine that the requirements are met, we will issue a permit under section 10(a)(1)(A) of the Act to the applicant in accordance with the applicable regulatory requirements. We will not make our final decision until after the end of the 30-day comment period and will fully consider all comments received during the comment period.
We provide this notice under section 10 of the Act (16 U.S.C. 1531
Fish and Wildlife Service, Interior.
Notice of receipt of permit application; request for comments.
We, the U.S. Fish and Wildlife Service, have received an application from Betteravia Farms, LLC, for an incidental take permit under the Endangered Species Act of 1973, as amended. The permit would authorize take of the federally endangered California tiger salamander (Santa Barbara distinct population segment) incidental to otherwise lawful activities associated with the Curletti Farm Employee Housing Project Habitat Conservation Plan. We invite public comment.
Written comments should be received on or before July 31, 2017.
You may download a copy of the draft habitat conservation plan and draft low-effect screening form and environmental action statement on the internet at
Rachel Henry, Fish and Wildlife Biologist, at the above address or by calling (805) 644–1766.
We, the U.S. Fish and Wildlife Service (Service), have received an application from Betteravia Farms, LLC (applicant), for an incidental take permit under the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
The Santa Barbara distinct population segment of the California tiger salamander was listed by the Service as endangered on January 19, 2000 (65 FR 3096). Section 9 of the Act (16 U.S.C. 1531
The applicants have applied for a permit for incidental take of the California tiger salamander. The potential taking would occur as a result of activities associated with the construction of the farm labor camp in suitable habitat for the covered species.
The Service has made a preliminary determination that issuance of the permit is neither a major Federal action that will significantly affect the quality of the human environment within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4321
If you wish to comment on the permit application, plan, and associated documents, you may submit comments by any one of the methods in
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public view, we cannot guarantee that we will be able to do so.
We provide this notice under section 10 of the Act (16 U.S.C. 1531
Fish and Wildlife Service, Interior.
Notice of initiation of reviews; request for information.
We, the U.S. Fish and Wildlife Service (Service), are initiating 5-year status reviews of 23 species under the Endangered Species Act of 1973, as amended (Act). We conduct these reviews to ensure that the classification of species as threatened or endangered on the Lists of Endangered and Threatened Wildlife and Plants is accurate. A 5-year review is an assessment of the best scientific and commercial data available at the time of the review. Therefore, we are requesting submission of information that has become available since the last review of each of these species.
To allow us adequate time to conduct these reviews, we must receive your comments or information on or before August 29, 2017. However, we
For instructions on how to submit information and review information we receive on these species, see “Request for New Information.”
For species-specific information, see “Request for New Information.”
Under the Act (16 U.S.C. 1531
This notice announces our active review of 22 species that are currently listed as endangered:
This notice also announces our active review of 1 species that is currently listed as threatened:
A 5-year review considers the best scientific and commercial data that have become available since the current listing determination or most recent status review of each species, such as:
A. Species biology, including but not limited to population trends, distribution, abundance, demographics, and genetics;
B. Habitat conditions, including but not limited to amount, distribution, and suitability;
C. Conservation measures that have been implemented to benefit the species;
D. Threat status and trends (see five factors under heading “How Do We Determine Whether a Species Is Endangered or Threatened?”); and
E. Other new information, data, or corrections, including but not limited to taxonomic or nomenclatural changes, identification of erroneous information contained in the List, and improved analytical methods.
New information will be considered in the 5-year review and ongoing recovery programs for the species.
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C.
Section 4(a)(1) of the Act establishes that we determine whether a species is endangered or threatened based on one or more of the following five factors:
A. The present or threatened destruction, modification, or curtailment of its habitat or range;
B. Overutilization for commercial, recreational, scientific, or educational purposes;
C. Disease or predation;
D. The inadequacy of existing regulatory mechanisms; or
E. Other natural or manmade factors affecting its continued existence.
To do any of the following, contact the person associated with the species you are interested in below:
A. To get more information on a species;
B. To submit information on a species; or
C. To review information we receive, which will be available for public inspection by appointment, during normal business hours, at the listed addresses.
• Florida panther: South Florida Ecological Services Field Office, U.S. Fish and Wildlife Service, 12085 State Road 29 S, Immokalee, FL 34142; fax 772–562–4288. For information on these species, contact David Shindle at the ES Field Office (by phone at 239–657–8013, or by email at
• Puerto Rican broad-winged hawk and Puerto Rican nightjar: Caribbean Ecological Services Field Office, U.S. Fish and Wildlife Service, Road 301, Km. 5.1, P.O. Box 491, Boqueron, PR 00622; fax 787–851–7440. For information on these species, contact Jose Cruz-Burgos at the ES Field Office (by phone at 787–851–7297, ext.218 or by email at
• Ozark Cavefish: Arkansas Ecological Services Field Office, U.S. Fish and Wildlife Service, 110 South Amity Road, Suite 300, Conway, Arkansas 72032; fax 501–513–4480. For information on these species, contact Tommy Inebnit at the ES Field Office (by phone at 501–513–4483 or by email at
• Cumberland darter: Kentucky Ecological Services Field Office, U.S. Fish and Wildlife Service, 330 West Broadway, Frankfort, Kentucky 40601 fax 502–695–1024. For information on these species, contact Dr. Michael Floyd at the ES Field Office (by phone at 502–695–0468 ext. 102 or by email at
• Rush darter and Vermilion darter: Mississippi Ecological Services Field Office, U.S. Fish and Wildlife Service, U.S. Fish and Wildlife Service, 6578 Dogwood View Parkway, Jackson, MS 39213; fax 601–965–4340. For information on these species, contact Daniel Drennen at the ES Field Office
• Pygmy madtom: Tennessee Ecological Services Field Office, U.S. Fish and Wildlife Service, U.S. Fish and Wildlife Service, 446 Neal Street, Cookeville, TN 38501; fax 931–528–7075. For information on these species, contact Warren Stiles at the ES Field Office (by phone at 931–525–4977 or by email at
• Cumberland bean and Ring pink: Kentucky Ecological Services Field Office (see contact information above). For information on these species, contact Leroy Koch at the ES Field Office (by phone at 502–695–0468 ext. 106 or by email at
• Anthony's riversnail: Tennessee Ecological Services Field Office (see contact information above). For information on these species, contact Stephanie Chance at the ES Field Office (by phone at 931–528–6481 ext. 211 or by email at
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We request any new information concerning the status of any of these 23 species. See “What Information Do We Consider In Our Review?” heading for specific criteria. Information submitted should be supported by documentation such as maps, bibliographic references, methods used to gather and analyze the data, and/or copies of any pertinent publications, reports, or letters by knowledgeable sources.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that the entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
We publish this document under the authority of the Endangered Species Act (16 U.S.C. 1531
Fish and Wildlife Service, Interior.
Notice of availability; request for comments.
We, the U.S. Fish and Wildlife Service (Service), announce the availability of our Mexican Wolf (
1. July 18, 2017 (6:00 p.m. to 9:00 p.m.): Flagstaff, Arizona.
2. July 19, 2017 (6:00 p.m. to 9:00 p.m.): Pinetop, Arizona.
3. July 20, 2017 (6:00 p.m. to 9:00 p.m.): Truth or Consequences, New Mexico.
4. July 22, 2017 (2:00 p.m. to 5:00 p.m.): Albuquerque, New Mexico.
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Sherry Barrett, Mexican Wolf Recovery Coordinator, 505–346–2525.
A primary goal of our endangered species program and the Act (16 U.S.C. 1531
The Service has revised its approach to recovery planning; the revised process is called Recovery Planning and Implementation (RPI) (USFWS 09/21/2016). RPI is intended to reduce the time needed to develop and implement recovery plans, increase recovery plan relevancy over a longer timeframe, and add flexibility to recovery plans so they can be adjusted to new information or circumstances. Under RPI, a recovery plan will include statutorily required elements (measurable criteria, site-specific management actions, and estimates of time and costs), along with a concise introduction and our strategy for how we plan to achieve species recovery. The RPI recovery plan is supported by a separate Species Status Assessment (SSA), or in some cases, a species Biological Report, which provides the background information and threat assessment, which are key to recovery plan development. The essential component to flexible implementation under RPI is producing a separate working document called the Recovery Implementation Strategy (implementation strategy). The implementation strategy steps down from the more general description of actions described in the recovery plan to detail the near-term, specific activities needed to implement the recovery plan. The implementation strategy will be adaptable by being able to incorporate new information without having to concurrently revise the recovery plan, unless changes to statutory elements are required. The Mexican wolf implementation strategy document will be developed with partners at a later date. The Mexican Wolf Draft Recovery Plan, First Revision, represents one of the first products developed using RPI.
In addition to the recovery plan and implementation strategy, we have completed a biological report describing the Mexican wolf's current status. The biological report supports the recovery plan by providing the background, life-history, and threat assessment information. The biological report was independently peer-reviewed by scientists outside of the Service and is available at
The Mexican wolf was originally listed as an endangered subspecies on April 28, 1976 (41 FR 17736), but was subsumed into the listing for the gray wolf in the coterminous United States and Mexico in 1978 (43 FR 9607, March 9, 1978). The Mexican wolf is currently listed as an endangered subspecies throughout its range without critical habitat (80 FR 2488, January 16, 2015). The Mexican wolf is also listed as endangered by the Secretaría de Medio Ambiente y Recursos Naturales, or Federal Ministry of the Environment and Natural Resource (SEMARNAT 2010) in Mexico. Mexican wolves in Arizona and New Mexico are protected under State wildlife statutes as the gray wolf. In Arizona, the gray wolf is on the Arizona Game and Fish Department's list of “Species of Greatest Conservation Need.” In New Mexico, the gray wolf is listed as endangered.
In the United States, current Mexican wolf range includes portions of Arizona and New Mexico in an area designated as the Mexican Wolf Experimental Population Area (MWEPA) under the Act, section 10(j) (U.S. Fish and Wildlife Service 2016). The Service began releasing Mexican wolves from captivity into the MWEPA in 1998, marking the first Mexican wolf reintroduction since their extirpation in the late 1970s. As of 2016, there is a single population of at least 113 Mexican wolves in the MWEPA (U.S. Fish and Wildlife Service 2017). In Mexico, the current Mexican wolf range includes the northern portion of the Sierra Madre Occidental in the state of Chihuahua (López González 2017, pers. comm.). After Mexican wolves were extirpated from Mexico in the late 1970s to early 1980s, Mexico began reintroducing the subspecies from captivity back into the wild in 2011. In Mexico, as of April 2017, approximately 28 wolves inhabit the northern portion of the Sierra Madre Occidental Mountains in the state of Chihuahua (Garcia Chavez et al. 2017).
In addition to the wild populations, a Mexican wolf captive population is managed under the Mexican Wolf Species Survival Plan (SSP), administered by the Association of Zoos and Aquariums. The SSP is a binational captive-breeding program with the primary purpose of producing Mexican wolves for reintroduction in the United States and Mexico and conducting public education and research. The captive population is the sole source of Mexican wolves available to reestablish the species in the wild and is, therefore, an essential component of the Mexican wolf recovery effort.
The Mexican wolf is at risk of extinction in the wild primarily because of gunshot-related mortality, inbreeding, loss of heterozygosity, loss of adaptive potential, small population size, and the cumulative effects of the aforementioned threats (80 FR 2488, January 16, 2015). As a result of predator control and eradication efforts in the 20th century, the number of Mexican wolves declined rapidly (Mech and Boitani 2003), but with the capture of the last remaining Mexican wolves in the wild in Mexico, and subsequent addition of several wolves already in captivity, the United States and Mexico established a binational captive-breeding program with seven unrelated “founders.” As a result of this small number of founders, Mexican wolves face the aforementioned genetic challenges (U.S. Fish and Wildlife Service 2014).
The overall strategy for recovering the Mexican wolf focuses on improving the two populations' resilience (
Under this strategy, Mexican wolves will be managed to achieve an average population size, with an upper population size management boundary applied to the MWEPA that would allow all forms of management to ensure that population growth does not continue unchecked. The population in Mexico will not be managed with an upper boundary. Another key component of the strategy includes working with Federal, State, Tribal, and local partners, and the public, to improve Mexican wolf tolerance on the landscape.
The Act, section 4(f), requires us to provide public notice and an opportunity for public review and comment during recovery plan development. Our policy is to also request peer review of recovery plans (59 FR 34270, July 1, 1994). We will summarize and respond to the issues the public and peer reviewers raise and make our responses available to the public. Substantive comments may or may not result in changes to the recovery plan; comments regarding recovery plan implementation will be forwarded as appropriate to Federal or other entities so that they can be taken into account during the course of implementing recovery actions. Pursuant to a court order, this recovery plan must be finalized by November 30, 2017.
We invite written comments on the draft recovery plan. In particular, we are interested in comments on the recovery strategy, recovery criteria, recovery actions, and the cost estimates associated with implementing the recommended recovery actions.
We make reference throughout the draft recovery plan to locations where more detailed information can be found. Information on the Mexican wolf's life-history needs, threats, current status and future projections, survey guidelines, and conservation efforts to date are detailed in a variety of separate documents, including the biological report the Service developed. These documents can be found at
Before we approve our final recovery plan, we will consider all comments we receive by the date specified in
If you submit information via
Comments and materials we receive will be available, by appointment, for public inspection during normal business hours at our office (see
A complete list of all references cited herein is available at
We developed our draft recovery plan under the authority of the Act, section 4(f), 16 U.S.C. 1533(f). We publish this notice under section 4(f) Endangered Species Act of 1973, as amended (16 U.S.C. 1531
National Park Service, Interior.
Notice.
The U.S. Department of the Interior, National Park Service, Hubbell Trading Post National Historic Site, has completed an inventory of human remains, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the human remains and any present-day Indian Tribes or Native Hawaiian organizations. Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to Hubbell Trading Post National Historic Site. If no additional requestors come forward, transfer of control of the human remains to the Indian Tribes or Native Hawaiian organizations stated in this notice may proceed.
Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Hubbell Trading Post National Historic Site at the address in this notice by July 31, 2017.
Lloyd Masayumptewa, Superintendent, Hubbell Trading Post National Historic Site,
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of the U.S. Department of the Interior, National Park Service, Hubbell Trading
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the Superintendent, Hubbell Trading Post National Historic Site.
A detailed assessment of the human remains was made by Hubbell Trading Post National Historic Site professional staff in consultation with representatives of the Fort Sill Apache Tribe of Oklahoma; Hopi Tribe of Arizona; Jicarilla Apache Nation, New Mexico; Navajo Nation, Arizona, New Mexico & Utah; Pueblo of Laguna, New Mexico; and Ute Mountain Ute Tribe (previously listed as the Ute Mountain Tribe of the Ute Mountain Reservation, Colorado, New Mexico & Utah) (hereafter referred to as “The Consulted Tribes”).
The following tribes were contacted but did not participate in the face-to-face consultation meetings: Apache Tribe of Oklahoma; Fort McDowell Yavapai Nation, Arizona; Kaibab Band of Paiute Indians of the Kaibab Indian Reservation, Arizona; Mescalero Apache Tribe of the Mescalero Reservation, New Mexico; Pueblo of Acoma, New Mexico; Pueblo of Jemez, New Mexico; Pueblo of Nambe, New Mexico; Pueblo of Pojoaque, New Mexico; Pueblo of San Ildefonso, New Mexico; Pueblo of Tesuque, New Mexico; San Carlos Apache Tribe of the San Carlos Reservation, Arizona; Southern Ute Indian Tribe of the Southern Ute Reservation, Colorado; White Mountain Apache Tribe of the Fort Apache Reservation, Arizona; and Zuni Tribe of the Zuni Reservation, New Mexico (hereafter referred to as “The Invited Tribes”).
At an unknown date, human remains representing, at minimum, one individual were removed from an unknown location. The human remains were donated by the Hubbell family to the National Park Service in approximately 1967, and are believed to have been displayed in the Trading Post Rug Room by Roman Hubbell. The human remains consist of one human skull of indeterminate age and sex. No known individual was identified. No associated funerary objects are present.
Pursuant to 43 CFR 10.16, the Secretary of the Interior may make a recommendation for a transfer of control of culturally unidentifiable human remains. In December 2016, Hubbell Trading Post National Historic Site requested that the Secretary, through the Native American Graves Protection and Repatriation Review Committee, recommend the proposed transfer of control of the culturally unidentifiable Native American human remains in this notice to the Hopi Tribe of Arizona and Navajo Nation, Arizona, New Mexico & Utah. The Review Committee, acting pursuant to its responsibility under 25 U.S.C. 3006(c)(5), considered the request at its March 2017 meeting and recommended to the Secretary that the proposed transfer of control proceed. An April 2017 letter on behalf of the Secretary of the Interior from the National Park Service Associate Director for Cultural Resources, Partnerships, and Science transmitted the Secretary's independent review and concurrence with the Review Committee that:
• None of The Consulted Tribes or The Invited Tribes objected to the proposed transfer of control, and
• Hubbell Trading Post National Historic Site may proceed with the agreed-upon transfer of control of the culturally unidentifiable human remains to the Hopi Tribe of Arizona and the Navajo Nation, Arizona, New Mexico & Utah.
Transfer of control is contingent on the publication of a Notice of Inventory Completion in the
Officials of Hubbell Trading Post National Historical Site have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice are Native American, based on osteological analysis.
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), a relationship of shared group identity cannot be reasonably traced between the Native American human remains and any present-day Indian tribe.
• Pursuant to 43 CFR 10.16, the disposition of the human remains will be to the Hopi Tribe of Arizona and the Navajo Nation, Arizona, New Mexico & Utah.
Representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Lloyd Masayumptewa, Superintendent, Hubbell Trading Post National Historic Site,
Hubbell Trading Post National Historic Site is responsible for notifying The Consulted Tribes and The Invited Tribes that this notice has been published.
National Park Service, Interior.
Notice.
Oberlin College has completed an inventory of human remains in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to Oberlin College. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Oberlin College at the address in this notice by July 31, 2017.
Dr. Amy V. Margaris, Oberlin College NAGPRA Compliance Officer, Department of Anthropology,
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of Oberlin College, Oberlin, OH. The human remains were removed from Onondaga County, NY.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by Oberlin College professional staff in consultation with representatives of the Onondaga Nation.
At an unknown date, human remains representing, at minimum, one individual were removed from an unknown site in Baldwinsville, Onondaga County, NY. In 1886, the Oberlin College Museum received human remains described as “Skull of Onondaga Indian” acquired from an “Ancient Burial Place, Baldwinsville, NY.” S.M. Dunbar is listed as the donor. The human remains were retained by Oberlin College after the museum's closure in the 1950s and are now in the care of the Oberlin College Department of Anthropology. The human remains consist of one probable female, approximately 18–35 years old. “Onondaga” is written in black ink on the human remains. No known individuals were identified. No associated funerary objects are present.
Osteological examination identifies these human remains as representing an individual of Native American ancestry. Their geographic affiliation with the territory of the Onondaga Nation is documented through collection evidence, oral history, and scholarly sources. During consultation, the Onondaga Nation's NAGPRA contact, Tony Gonyea, identified Baldwinsville as located in the heart of the traditional area of the Onondaga Nation. Archeological data demonstrate the Onondaga Nation's continued occupation of the Baldwinsville area since at least the Late Woodland period.
Officials of Oberlin College have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and the Onondaga Nation.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Dr. Amy V. Margaris, Oberlin College NAGPRA Compliance Officer, Department of Anthropology, 305 King Building, 10 North Professor Street, Oberlin, OH 44074 telephone (440) 775–5173, email
Oberlin College is responsible for notifying the Onondaga Nation that this notice has been published.
National Park Service, Interior.
Notice.
The Human Remains Repository, Department of Anthropology, University of Wyoming, has completed an inventory of human remains, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the human remains and any present-day Indian Tribes or Native Hawaiian organizations. Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the Human Remains Repository, Department of Anthropology, University of Wyoming. If no additional requestors come forward, transfer of control of the human remains to the Indian Tribes or Native Hawaiian organizations stated in this notice may proceed.
Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the Human Remains Repository, Department of Anthropology, University of Wyoming, at the address in this notice by July 31, 2017.
Dr. Rick L. Weathermon, Curator, Human Remains Repository, Department 3431, Anthropology, 1000 East University Avenue, University of Wyoming, Laramie, WY 82071, telephone (307) 314–2035, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of the Human Remains Repository, Department of Anthropology, University of Wyoming, Laramie, WY. The human remains were removed from an unknown location in Hamilton County, TX.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3) and 43 CFR 10.11(d). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Human Remains Repository, Department of Anthropology, University of Wyoming, professional staff in consultation with representatives of the Tonkawa Tribe of Indians of Oklahoma. The following Indian Tribes were invited to consult but did not participate in consultation: Apache Tribe of Oklahoma; Comanche Nation, Oklahoma; Jicarilla Apache Nation, New Mexico; Kiowa Indian Tribe of Oklahoma; Mescalero Apache
At some time in the 1920s, human remains representing, at minimum, one individual were removed from an unknown location in Hamilton County, TX. The fragmentary human remains were given to the Anna Miller Museum in Newcastle, WY, in 1969 and then transferred to the University of Wyoming Anthropology Department Human Remains Repository (Record HR202) in 1993. The human remains represent a single adult male. No known individual was identified. No associated funerary objects are present.
At the time of the excavation and removal of these human remains, the land from which the human remains were removed was not the tribal land of any Indian tribe or Native Hawaiian organization. In January of 2017, the Human Remains Repository, Department of Anthropology, University of Wyoming, initiated consultation with all Indian tribes who are recognized as aboriginal to the area from which these Native American human remains were removed. These tribes are the Comanche Nation, Oklahoma, and the Kiowa Indian Tribe of Oklahoma. None of these Indian tribes responded to the invitation nor agreed to accept control of the human remains. In May of 2017, the Human Remains Repository, Department of Anthropology, University of Wyoming, agreed to transfer control of the human remains to the Tonkawa Tribe of Indians of Oklahoma.
Officials of the Human Remains Repository, Department of Anthropology, University of Wyoming, have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice are reasonably believed to be Native American based on museum notes and characteristic features of the cranial fragments.
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), a relationship of shared group identity cannot be reasonably traced between the Native American human remains and any present-day Indian Tribe.
• Pursuant to 43 CFR 10.11(c)(2)(i), the disposition of the human remains may be to the Tonkawa Tribe of Indians of Oklahoma.
Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Dr. Rick L. Weathermon, Curator, Human Remains Repository, Department 3431, Anthropology, 1000 East University Avenue, University of Wyoming, Laramie, WY 82071, telephone (307) 314–2035, email
The Human Remains Repository, Department of Anthropology, University of Wyoming, is responsible for notifying the Apache Tribe of Oklahoma; Comanche Nation, Oklahoma; Jicarilla Apache Nation, New Mexico; Kiowa Indian Tribe of Oklahoma; Mescalero Apache Tribe of the Mescalero Reservation, New Mexico; San Carlos Apache Tribe of the San Carlos Reservation, Arizona; Tonkawa Tribe of Indians of Oklahoma; Tonto Apache Tribe of Arizona; and White Mountain Apache Tribe of the Fort Apache Reservation, Arizona, that this notice has been published.
National Park Service, Interior.
Notice.
The Texas State University, Center for Archaeological Studies and Department of Anthropology, has completed an inventory of human remains, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the human remains and any present-day Indian Tribes or Native Hawaiian organizations. Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the Texas State University, Center for Archaeological Studies and Department of Anthropology. If no additional requestors come forward, the human remains may be reinterred.
Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the Texas State University, Center for Archaeological Studies and Department of Anthropology, at the address in this notice by July 31, 2017.
Todd M. Ahlman, Center for Archaeological Studies, Texas State University, 601 University Drive, San Marcos, TX 78666, telephone (512) 245–2724, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of the Texas State University, Department of Anthropology, San Marcos, TX. The human remains were removed from Hays County, TX.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Texas State University, Center for Archaeological Studies and Department of Anthropology, professional staff in consultation with representatives of the Absentee-Shawnee Tribe of Indians of Oklahoma; Alabama-Coushatta Tribe of Texas (previously listed as the Alabama-Coushatta Tribes of Texas); Apache Tribe of Oklahoma; Caddo Nation of Oklahoma; Cherokee Nation; Comanche Nation, Oklahoma; Coushatta Tribe of Louisiana; Delaware Nation, Oklahoma; Iowa Tribe of Oklahoma; Jicarilla Apache Nation, New Mexico; Kialegee Tribal Town; Kickapoo Traditional
In February of 1983, human remains representing, at minimum, two individuals were removed from site 41HY161 in Hays County, TX. The human remains were initially discovered in the fall of 1982 during construction and maintenance of the Texas State University campus. Osteological analysis was conducted by a biological anthropologist from the Southwest Texas State University Department of Sociology and Anthropology (now Texas State University Department of Anthropology), who determined by the context and appearance of the remains that they are most likely of prehistoric Native American ancestry. The human remains from the first burial were very fragmentary. Age and sex could not be determined. The human remains from the second burial were determined to be those of an adult female. No known individuals were identified. No associated funerary objects are present.
In February of 2008 and April of 2009, human remains representing, at minimum, four individuals were removed from site 40HY163 in Hays County, TX. The human remains were discovered during a construction project for expansion of the City of San Marcos' Wonder World Drive and later excavated by Texas State University's Center for Archaeological Studies. Osteological analysis was conducted Kyra Stull, M.A. and Dr. Michelle Hamilton of the Department of Anthropology at Texas State University, who determined them to be of prehistoric Native American ancestry. The human remains consist of one adult male, two adult females, and one possible adult female. No known individuals were identified. No associated funerary objects are present.
Pursuant to 43 CFR 10.16, the Secretary of the Interior may recommend that culturally unidentifiable human remains with no “tribal land” or “aboriginal land” provenience be reinterred under State or other law. In January 2017, the Texas State University, Center for Archaeological Studies and Department of Anthropology, requested that the Secretary, through the Native American Graves Protection and Repatriation Review Committee, recommend the proposed re-interment of the culturally unidentifiable Native American human remains in this notice, according to State or other law. The Review Committee, acting pursuant to its responsibility under 25 U.S.C. 3006(c)(5), considered the request at its March 2017 meeting and recommended to the Secretary that the proposed re-interment proceed. An April 2017 letter on behalf of the Secretary of Interior from the National Park Service Associate Director for Cultural Resources, Partnerships, and Science transmitted the Secretary's independent review and concurrence with the Review Committee that:
• None of The Consulted Tribes objected to the proposed re-interment, and
• Texas State University, Center for Archaeological Studies and Department of Anthropology, may proceed with the proposed re-interment of the culturally unidentifiable human remains.
Re-interment is contingent on the publication of a Notice of Inventory Completion in the
Officials of the Texas State University, Center for Archaeological Studies and Department of Anthropology, have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice are Native American based on association with prehistoric artifacts and ancestry estimation.
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of six individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), a relationship of shared group identity cannot be reasonably traced between the Native American human remains and any present-day Indian Tribe.
• Pursuant to 43 CFR 10.11(c)(1), a “tribal land” or “aboriginal land” provenience cannot be ascertained.
• Pursuant to 43 CFR 10.10(g)(2)(ii) and 43 CFR 10.16, the human remains may be reinterred according to the law of the State of Texas and the City of San Marcos, Texas.
Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Todd M. Ahlman, Center for Archaeological Studies, Texas State University, 601 University Drive, San Marcos, TX 78666, telephone (512) 245–2724, email
The Texas State University, Center for Archaeological Studies and Department of Anthropology, is responsible for notifying The Consulted Tribes that this notice has been published.
National Park Service, Interior.
Notice.
The U.S. Department of Defense, Department of the Air Force, Air Education and Training Command, Barry M. Goldwater Range East, 56th Range Management Office, Luke Air Force Base, has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian tribes, and has determined that there is a cultural
Lineal descendants or representatives of any Indian tribe not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to the 56th Range Management Office, Luke Air Force Base by July 31, 2017.
Mr. Charles Buchanan, Director, 56th Range Management Office, 7101 Jerstad Lane, Building 500, Luke Air Force Base, AZ 85309, phone (623) 856–5820, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of the 56th Range Management Office, Luke Air Force Base, and in physical custody of the Arizona State Museum, Tucson, AZ. The human remains and associated funerary objects were removed from site AZ Y:8:001 (ASM), Maricopa County, AZ.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the Department of the Air Force, 56th Range Management Office, Luke Air Force Base, which has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by Arizona State Museum and the 56th Range Management Office, Luke Air Force Base, professional staff in consultation with representatives of the Ak Chin Indian Community (previously listed as the Ak Chin Indian Community of the Maricopa (Ak Chin) Indian Reservation, Arizona); Gila River Indian Community of the Gila River Indian Reservation, Arizona; Quechan Tribe of the Fort Yuma Indian Reservation, California & Arizona; Salt River Pima-Maricopa Indian Community of the Salt River Reservation, Arizona; Tohono O'odham Nation of Arizona; and Yavapai-Apache Nation of the Camp Verde Indian Reservation, Arizona. The following Indian tribes were invited to consult but did not participate in consultations: The Cocopah Tribe of Arizona; Colorado River Indian Tribes of the Colorado River Indian Reservation, Arizona and California; Fort McDowell Yavapai Nation, Arizona; Fort Mohave Indian Tribe of Arizona, California & Nevada; Hopi Tribe of Arizona; San Carlos Apache Tribe of the San Carlos Reservation, Arizona; Yavapai-Prescott Indian Tribe (previously listed as the Yavapai-Prescott Tribe of the Yavapai Reservation, Arizona); and Zuni Tribe of the Zuni Reservation, New Mexico. All tribes listed are referred to as the “Invited and Consulted Tribes.”
On September 21, 1978, human remains representing, at minimum, one individual were removed from site AZ Y:8:001 (ASM) on the Barry M. Goldwater Range East, Maricopa County, AZ (formerly the Luke AFB Bombing and Gunnery Range). The human remains, Cremation 1, were removed from Component 2, during an authorized archeological excavation under the direction of Dr. Bruce Huckell, Arizona State Museum, AZ. The collection was transferred to the Arizona State Museum on September 28, 1978, where it is currently curated. A professional report on the collection was published in 1979:
The estimated age of the individual at death is older than 40 years based on dentition and ectocranial suture of the sagittal suture. The sex of the cremation was determined to be male based on evidence from the skull and in nominate. The stature of the individual is indeterminate due to the fragmentary nature of the long bones. No known individuals were identified. The 21 associated funerary objects include 1 reconstructed Tanque Verde Red-on-Brown ceramic pitcher with missing handle (1979–145–1); 1 lot of sherds of a burned Colorado Red bowl (1979–145–10); 1 bone awl (1979–145–6); 3 rim sherds of a burned Tonto Polychrome bowl (1979–145–7:x); 14 body sherds of the same burned Tonto Polychrome bowl (1979–145–8:x), and 1 piece of worked animal bone (None–1979–145–C1–01).
Based on morphological characteristics, geographic location, archeological context, and the presence of culturally and temporally identifiable ceramics, and consistency in cremation pit size and orientation, the human remains have been determined to be Native American dating to the Classic period (A.D. 1150–1450) Tucson Basin Hohokam. The cremation pit and orientation of the remains (the long-axis of the body was aligned east-west, with the head at the east) are consistent with Classic Period Hohokam sites in the Gila Bend area and Tucson Basin. The cremation pit is identical in size and shape with primary cremations from site AZ AA:12:46 (ASM), the Rabid Ruin, a Tucson Basin Hohokam site.
A relationship of shared group identity can reasonably be traced between members of the Hohokam culture and the four southern O'odham tribes of Arizona. The O'odham comprise four Federally recognized Indian tribes (Ak Chin Indian Community of the Maricopa (Ak Chin) Indian Reservation, Arizona); Gila River Indian Community of the Gila River Indian Reservation, Arizona; Salt River Pima-Maricopa Indian Community of the Salt River Reservation, Arizona; and Tohono O'odham Nation of Arizona. Historically the Pimeria Alta is the traditional homeland of the O'odham; including the river people (Akimel), the desert people (Tohono) and the sand people (Hia C-ed O'odham). O'odham oral history teaches that the O'odham were created in this land and have always lived here. Places mentioned in the Creation Story and other stories and songs have been identified on the landscape throughout the Sonoran Desert.
A relationship of shared group identity may also reasonably be traced between members of the Hohokam culture of the Phoenix Basin and clans of the Hopi Tribe of Arizona. Hopi history is based, in large part, on clan migration narratives. The Hopi consider all of Arizona to be within traditional Hopi lands,
A relationship of shared group identity can also reasonably be traced between members of the Hohokam
A relationship of shared group identity may also be reasonably be traced between members of the Patayan culture and the Quechan tribe of the Fort Yuma Indian Reservation, California & Arizona. The Colorado Red bowl is associated with the archeological culture identified as Patayan, which the Quechan believe were their ancestors.
Officials of the 56th Range Management Office, Luke Air Force Base have determined that:
• Pursuant to 25 U.S.C. 301(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• Pursuant to 25 U.S.C. 301(3)(A), the 21 objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 301(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and associated funerary objects and the Ak Chin Indian Community (previously listed as the Ak Chin Indian Community of the Maricopa (Ak Chin) Indian Reservation, Arizona; Gila River Indian Community of the Gila River Indian Reservation, Arizona; Hopi Tribe of Arizona; Quechan Tribe of the Fort Yuma Indian Reservation, California & Arizona; Salt River Pima-Maricopa Indian Community of the Salt River Reservation, Arizona; Tohono O'odham Nation of Arizona; and Zuni Tribe of the Zuni Reservation, New Mexico.
Lineal descendants or representatives of any Indian tribe not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to Mr. Charles Buchanan, Director, 56th Range Management Office, Barry M. Goldwater Range East, 7101 Jerstad Lane, Luke Air Force Base, AZ 85309, phone (623) 856–8520, email
The 56th Range Management Office, Luke Air Force Base, is responsible for notifying the Invited and Consulted Tribes that this notice has been published.
National Park Service, Interior.
Notice.
The U.S. Department of Agriculture, Forest Service, Deschutes National Forest has completed an inventory of human remains, in consultation with the appropriate Indian tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the human remains and any present-day Indian tribes or Native Hawaiian organizations. Representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the Deschutes National Forest. If no additional requestors come forward, transfer of control of the human remains to the Indian tribes or Native Hawaiian organizations stated in this notice may proceed.
Representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the Deschutes National Forest at the address in this notice by July 31, 2017.
John Allen, Deschutes National Forest, 63095 Deschutes Market Road, Bend, OR 97701, telephone (541) 383–5512, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of the Deschutes National Forest, Bend, OR. The human remains were removed from Federal lands in central Oregon.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3) and 43 CFR 10.11(d). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Deschutes National Forest professional staff, with assistance by the University of Oregon, Department of Anthropology, in consultation with representatives of the Burns Paiute Tribe (previously listed as the Burns Paiute Tribe of the Burns Paiute Indian Colony of Oregon), Confederated Tribes of the Warm Springs Reservation of Oregon, and Klamath Tribes.
In 1989, human remains representing, at minimum, three individuals were removed from individual homes of persons arrested for violations of the Archeological Resource Protection Act. The three individuals were apprehended while looting an archeological site on the Deschutes National Forest. Pre-contact human remains were discovered during a search of the individuals' residences. The Deschutes National Forest is unable to determine the exact provenience of the human remains, other than their origination from Federal lands in central Oregon. The human remains remained in possession of Federal law enforcement until 1997, when they were returned to the Deschutes National Forest. In 2009, the Deschutes National
Officials of the Deschutes National Forest have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice are Native American based on the analysis performed by the University of Oregon Department of Anthropology.
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of three individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), a relationship of shared group identity cannot be reasonably traced between the Native American human remains and any present-day Indian tribe.
• According to final judgments of the Indian Claims Commission or the Court of Federal Claims, the land from which the Native American human remains were removed is the aboriginal land of the Burns Paiute Tribe (previously listed as the Burns Paiute Tribe of the Burns Paiute Indian Colony of Oregon), Confederated Tribes of the Warm Springs Reservation of Oregon, and Klamath Tribes.
• Treaties, Acts of Congress, or Executive Orders, indicate that the land from which the Native American human remains were removed is the aboriginal land of the Burns Paiute Tribe (previously listed as the Burns Paiute Tribe of the Burns Paiute Indian Colony of Oregon), Confederated Tribes of the Warm Springs Reservation of Oregon, and Klamath Tribes.
• Pursuant to 43 CFR 10.11(c)(1), the disposition of the human remains may be to the Burns Paiute Tribe (previously listed as the Burns Paiute Tribe of the Burns Paiute Indian Colony of Oregon), Confederated Tribes of the Warm Springs Reservation of Oregon, and Klamath Tribes.
Representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to John Allen, Deschutes National Forest, 63095 Deschutes Market Road, Bend, OR 97701, telephone (541) 383–5512, email
The Deschutes National Forest is responsible for notifying the Burns Paiute Tribe (previously listed as the Burns Paiute Tribe of the Burns Paiute Indian Colony of Oregon), Confederated Tribes of the Warm Springs Reservation of Oregon, and Klamath Tribes that this notice has been published.
National Park Service, Interior.
Notice.
The Arkansas Archeological Survey, in consultation with the appropriate Indian tribes or Native Hawaiian organizations, has determined that the cultural items listed in this notice meet the definition of unassociated funerary objects. Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request to the Arkansas Archeological Survey. If no additional claimants come forward, transfer of control of the cultural items to the lineal descendants, Indian tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request with information in support of the claim to the Arkansas Archeological Survey at the address in this notice by July 31, 2017.
Dr. George Sabo, Director, Arkansas Archeological Survey, 2475 North Hatch Avenue, Fayetteville, AR 72704, telephone (479) 575–3556.
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3005, of the intent to repatriate cultural items under the control of the Arkansas Archeological Survey that meet the definition of unassociated funerary objects under 25 U.S.C. 3001.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American cultural items. The National Park Service is not responsible for the determinations in this notice.
In 1972, three cultural items were removed from the Cryer Field site (3LA35) in Lafayette County, AR. The 3 unassociated funerary objects are one Handy Engraved bottle, one Washington Stamped jar, and one Pease Brushed-Incised jar (Cat. 72–406–68–1, 2, 3).
The pottery types are well-known examples of Caddo tradition wares. All are contemporaneous, ranging from A.D. 1300 to 1500, and are attributed to the Haley Phase of the Middle Caddo period. These pottery types are found throughout Southwest Arkansas, and into adjoining corners of Texas, Louisiana, and Oklahoma. All three cultural items were made before European contact and during the Caddo tradition.
The Caddo archeological tradition developed between A.D. 900 and 1000 in the four corners region of Arkansas, Texas, Louisiana, and Oklahoma. Distinctive characteristics include a dispersed residential settlement of families with a lifestyle grounded in farming and collecting wild plants and animals. The core of community life was a religious and political center with ceremonial and burial mounds, public areas for community events and rituals, and a small residential population
The Caddo continued to practice traditional settlement arrangements and material crafts well into the contact period. This is confirmed in part by past discoveries of distinctive Caddo ceramics and other artifacts found with European trade items in locations where French and Spanish observers documented their settlements. There is thus a strong material link between historic Caddo Tribal communities and pre-contact archeological remains. The collection enumerated here is entirely typical of pre-contact Caddo Tradition material culture.
Officials of the Arkansas Archeological Survey have determined that:
• Pursuant to 25 U.S.C. 3001(3)(B), the 3 cultural items described above are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony and are believed, by a preponderance of the evidence, to have been removed from a specific burial site of a Native American individual.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the unassociated funerary objects and the Caddo Nation of Oklahoma.
Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request with information in support of the claim to Dr. George Sabo, Director, Arkansas Archeological Survey, 2475 North Hatch Avenue, Fayetteville, AR 72704, telephone (479) 575–3556 by July 31, 2017. After that date, if no additional claimants have come forward, transfer of control of the unassociated funerary objects to the Caddo Nation of Oklahoma may proceed.
The Arkansas Archeological Survey is responsible for notifying the Caddo Nation of Oklahoma that this notice has been published.
National Park Service, Interior.
Notice.
The University of Massachusetts Amherst, Department of Anthropology, has completed an inventory of human remains, in consultation with the appropriate Indian tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and present-day Indian tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the Department of Anthropology at the University of Massachusetts, Amherst. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the address in this notice by July 31, 2017.
Dr. Sonya Atalay, Chair, Repatriation Committee, Department of Anthropology, 217 Machmer Hall, University of Massachusetts, 240 Hicks Way, Amherst, MA 01003, telephone (413) 545–2702, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of the University of Massachusetts Amherst, Department of Anthropology. The human remains were removed from an unknown location in East Springfield, NY.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the University of Massachusetts Amherst, Department of Anthropology, professional staff in consultation with representatives of the Haudenosaunee Standing Committee on Burial Rights and Regulations, and the following federally-recognized tribes: Cayuga Nation; Oneida Nation; Oneida Nation of New York; Onondaga Nation; Saint Regis Mohawk Tribe (previously listed as the St. Regis Band of Mohawk Indians of New York); Seneca Nation of Indians (previously listed as the Seneca Nation of New York); Seneca-Cayuga Nation (previously listed as the Seneca-Cayuga Tribe of Oklahoma); Tonawanda Band of Seneca (previously listed as the Tonawanda Band of Seneca Indians of New York); and Tuscarora Nation (hereinafter known as the Haudenosaunee Confederacy).
In the 1950s, human remains representing, at minimum, one individual were removed from the farm of Harriet R. and Raymond Rogers in East Springfield, Otsego County, NY. After keeping the human remains several years, a farmer transferred possession to an artist who visited the farm. That artist later learned about NAGPRA and transferred the human remains to the University of Massachusetts, Department of Anthropology. The date of this transfer was not recorded. No known individual was identified. No associated funerary objects are present.
Also in the possession of the University of Massachusetts, Department of Anthropology are human remains representing, at minimum, one individual from an unknown provenience, represented by the vault portion of the cranium (top, sides and back of the head). The following identification is written on the back of the cranium in black ink: “Prehistoric Iriquois [sic] UU 21524/2.” No known individual was identified. No associated funerary objects are present.
No further contextual information accompanies either set of human remains. Both have remained in the possession of the University of Massachusetts since legal control was established.
Officials of the University of Massachusetts Amherst, Department of Anthropology have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of two individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between these Native American human remains and the Haudenosaunee Confederacy.
Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a formal written request with information in support of the claim to Dr. Sonya Atalay, Chair, Repatriation Committee, Department of Anthropology, 217 Machmer Hall, University of Massachusetts, 240 Hicks Way, Amherst, MA 01003, telephone (413) 545–2702, email
The University of Massachusetts Amherst, Department of Anthropology, is responsible for notifying the Haudenosaunee Standing Committee on Burial Rights and Regulations and the member nations of the Haudenosaunee Confederacy that this notice has been published.
National Park Service, Interior.
Notice.
The Museum of Natural History and Planetarium, Roger Williams Park, has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Museum of Natural History and Planetarium, Roger Williams Park. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to the Museum of Natural History and Planetarium, Roger Williams Park, at the address in this notice by July 31, 2017.
Michael W. Kieron, Museum of Natural History and Planetarium, Roger Williams Park, 1000 Elmwood Avenue, Providence, RI 02907, telephone (401) 680–7248, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of the Museum of Natural History and Planetarium, Roger Williams Park. The human remains and associated funerary objects were removed from the Miller Cave site (23PU2) in Pulaski County, MO.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Museum of Natural History and Planetarium, Roger Williams Park, professional staff in consultation with representatives of the Apache Tribe of Oklahoma; Comanche Nation, Oklahoma; Eastern Band of Cherokee Indians; Kiowa Indian Tribe of Oklahoma; and The Osage Nation (previously listed as the Osage Tribe).
In 1927, human remains representing, at minimum, one individual were removed from the Miller Cave site (23PU2) in Pulaski County, MO, by Mr. and Mrs. Edward H. Nadeau. The human remains, consisting of one adult metacarpal, and the associated funerary objects were donated to the Museum of Natural History and Planetarium, Roger Williams Park, by Mr. and Mrs. Nadeau on January 23, 1933. No known individuals were identified. The 16 associated funerary objects include 1 polished tip of a white-tailed deer antler, 1 partial white-tailed deer antler, 9 partial white-tailed deer bones, 1 piece of a spiny softshell turtle carapace, and 4 potsherds. Most of the objects were labeled as being from Miller Cave, Pulaski County, MO.
The human remains and associated funerary objects were part of a collection of 50 lots of American Indian objects and geological specimens collected in the 1920s by the Nadeaus. No records related to this donation have been located.
The human remains and associated funerary objects were accessioned (catalog number E2730, accession number 8943) and stored with objects collected in 1927 from North Carolina and Young County, Texas. The objects from North Carolina and Texas were labeled according to their provenience. The entire group was entered into the catalog as “Bones and Potsherds, Pulaski Co., Missouri; Young Co., Texas; North Carolina.” Many of the American Indian objects donated at this time were
Due to this generalized catalog entry, the human remains were originally reported by the Museum of Natural History and Planetarium in an inventory as culturally unidentifiable (CUI). A 1983 study identified the human remains as American Indian based on the associated funerary objects. Following an examination by representatives of The Osage Nation (previously listed as the Osage Tribe) in January 2016, The Osage Nation and the Museum of Natural History and Planetarium, Roger Williams Park concurred that the human remains and associated funerary objects are from a burial site located on Osage ancestral lands.
Officials of the Museum of Natural History and Planetarium, Roger Williams Park, have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of 1 individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the 16 objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and associated funerary objects and The Osage Nation (previously listed as the Osage Tribe).
Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to Michael W. Kieron, Museum of Natural History and Planetarium, Roger Williams Park, 1000 Elmwood Avenue, Providence, RI 02907, telephone (401) 680–7248, email
The Museum of Natural History and Planetarium, Roger Williams Park, is responsible for notifying the Apache Tribe of Oklahoma; Comanche Nation, Oklahoma; Eastern Band of Cherokee Indians; Kiowa Indian Tribe of Oklahoma; and The Osage Nation (previously listed as the Osage Tribe) that this notice has been published.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 11) issued by the presiding administrative law judge (“ALJ”) on May 31, 2017, terminating the last remaining respondent based on a withdrawal of the complaint. The Commission requests written submissions, under the schedule set forth below, on remedy, public interest, and bonding concerning a previously defaulted respondent.
Robert Needham, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708–5468. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205–2000. General information concerning the Commission may also be obtained by accessing its Internet server (
The Commission instituted this investigation on January 13, 2017, based on a complaint filed by Kent Displays, Inc. (“Kent Displays”) of Kent, Ohio. 82 FR 4418. The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“section 337”), in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain liquid crystal eWriters and components thereof that infringe U.S. Patent Nos. 7,351,506 and 8,947,604.
On April 11, 2017, the ALJ issued an ID finding iQbe in default for failing to respond to the complaint, the notice of investigation, and multiple discovery requests, and for failing to respond to an order to show cause why it should not be found in default. Order No. 9,
On May 24, 2017, Kent Displays moved to terminate the investigation with respect to Howshare based on a withdrawal of the complaint. On May 26, 2017, Howshare responded that it did not oppose its termination from the investigation.
On May 31, 2017, the ALJ issued the subject ID, granting the motion and terminating the investigation with respect to Howshare. Order No. 11. No petitions for review of the ID were filed.
The Commission has determined not to review the subject ID.
On June 1, 2017, Kent Displays filed a declaration seeking relief against the defaulted respondent iQbe pursuant to section 337(g)(1) and Commission Rule 210.16(c), 19 CFR 210.16(c). The declaration contains Kent Displays' views on remedy, the public interest, and bonding. A proposed limited exclusion order and a proposed cease and desist order are attached to the declaration.
Section 337(g)(1) and Commission Rule 210.16(c) authorize the Commission to order relief against a respondent found in default, unless, after considering the public interest, it finds that such relief should not issue.
In connection with the final disposition of this investigation, the
If the Commission contemplates some form of remedy, it must consider the effects of that remedy upon the public interest. The factors that the Commission will consider include the effect that the exclusion order and/or cease and desists orders would have on (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.
If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve or disapprove the Commission's action.
Written submissions must be filed no later than the close of business on July 10, 2017. Reply submissions must be filed no later than the close of business July 17, 2017. No further submissions on these issues will be permitted unless otherwise ordered by the Commission.
Persons filing written submissions must file the original document electronically on or before the deadline stated above and submit eight true paper copies to the Office of the Secretary pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the investigation number (“Inv. No. 337–TA–1035”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
On the basis of the record
The Commission, pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)), instituted this review on April 1, 2016 (81 FR 18882) and determined on July 5, 2016 that it would conduct a full review (81 FR 45306, July 13, 2016). Notice of the scheduling of the Commission's review and of a public hearing to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the
The Commission made this determination pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)). It completed and filed its determination in this review on June 26, 2017. The views of the Commission are contained in USITC Publication 4701 (June 2017), entitled
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the presiding administrative law judge (“ALJ”) has issued a Final Initial Determination and Recommended Determination on Remedy and Bonding in the above-captioned investigation. The Commission is soliciting comments on public interest issues raised by the recommended relief should the Commission find a violation. The ALJ recommended only a limited exclusion order with a certification provision directed against certain infringing radio frequency identification (“RFID”) products and components thereof imported by Respondents Kapsch TrafficCom IVHS, Inc. of McLean, Virginia; Kapsch TrafficCom Holding Corp. of McLean, Virginia; Kapsch TrafficCom Canada, Inc. of Mississauga, Ontario, Canada; Star Systems International, Ltd. of Kwai Chung, Hong Kong; and STAR RFID Co., Ltd. of Bangkok, Thailand. This notice is soliciting public interest comments from the public only.
Cathy Chen, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205–2392. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205–2000. General information concerning the Commission may also be obtained by accessing its Internet server at
Section 337 of the Tariff Act of 1930 provides that if the Commission finds a violation it shall exclude the articles concerned from the United States:
unless, after considering the effect of such exclusion upon the public health and welfare, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, and United States consumers, it finds that such articles should not be excluded from entry.
19 U.S.C. 1337(d)(1). A similar provision applies to cease and desist orders. 19 U.S.C. 1337(f)(1).
The Commission is interested in further development of the record on the public interest in its investigations. Accordingly, members of the public are invited to file submissions of no more than five (5) pages, inclusive of attachments, concerning the public interest in light of the administrative law judge's Recommended Determination on Remedy and Bonding issued in this investigation on June 22, 2017. Comments should address whether issuance of an exclusion order and/or cease and desist orders in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the recommended orders are used in the United States;
(ii) Identify any public health, safety, or welfare concerns in the United States relating to the recommended orders;
(iii) Indicate the extent to which like or directly competitive articles are produced in the United States or are otherwise available in the United States, with respect to the articles potentially subject to the recommended orders;
(iv) Indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the recommended orders within a commercially reasonable time; and
(v) Explain how the recommended orders would impact consumers in the United States.
Written submissions must be filed no later than by close of business on July 28, 2017.
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to Commission Rule 210.4(f), 19 CFR part 210.4(f). Submissions should refer to the investigation number (“Inv. No. 979”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in part 210 of the Commission's Rules of Practice and Procedure, 19 CFR part 210.
By order of the Commission.
Employment and Training Administration, Labor.
Notice.
This Notice announces allocations for Program Year (PY) 2017 for the WIOA Title I Section 167 National Farmworker Jobs Program (NFJP) program as required under Section 182(d) of the Workforce Innovation and Opportunity Act of 2014.
The NFJP allocations are distributed to the state service areas by a formula that estimates, by State, the relative demand for NFJP services. The formula factors used to allocate funds for the NFJP were published in the
The PY 2017 NFJP allocations become effective for the program year beginning on July 1, 2017.
Questions on the allocations can be submitted to the Employment and Training Administration, Office of Financial Administration, 200 Constitution Ave. NW., Room N–4702, Washington, DC 20210, Attention: Ms. Anita Harvey, (202) 693–3958 (phone), (202) 693–2859 (fax), or email:
Laura Ibañez, Unit Chief (202) 693–3645 or Steven Rietzke, Division Chief (202) 693–3912. Individuals with hearing or speech impairments may access the telephone numbers above via TTY by calling the toll-free Federal Information Relay Service at 1–877–889–5627 (TTY–TDD).
The Department of Labor (DOL or Department) is announcing final PY 2017 allocations for the NFJP. This notice provides information on the amount of funds available during PY 2017 to State service areas awarded grants through the PY 2016 Funding Opportunity Announcement (FOA) for the National Farmworker Jobs Program (NFJP) Employment and Training and Housing Assistance Grants. The allocations are based on the funds appropriated in the Consolidated Appropriations Act, 2017, Public Law 115–31, May 5, 2017 (from this point forward, referred to as “the Act”). In appropriating these funds, Congress provided $75,885,000 for Employment and Training Grants; $5,517,000 for Housing Assistance Grants; and $494,000 for Technical Assistance and Training. The Act, Division H, Title I, sec. 106(b), allows the Secretary to set aside up to 0.5 percent of each discretionary appropriation for activities related to program integrity. For 2017, the Department set aside the full 0.5 percent of most discretionary appropriations, including migrant and seasonal farmworker program formula grants and housing. This reduced the amount available for NFJP Employment and Training grants to $75,505,575 and Housing Assistance grants to $5,489,415. The amount appropriated for discretionary purposes (technical assistance and training) was not adjusted. Included below is the table listing the PY 2017 allocations for the NFJP Employment and Training Grants, as well as the sub-allocation table for California. California is the only State service area with more than one grant; the current sub-allocation formula for California was developed in collaboration with the existing grantees. Individual grants are awarded for Housing Assistance as a result of the grants competition and are further distributed according to language in the appropriations law requiring that of the total amount available, not less than 70 percent shall be allocated to permanent housing activities, leaving not more than 30 percent to temporary housing activities.
The calculation of the PY 2017 formula allocation distribution incorporates the state-by-state relative shares of eligible farmworkers developed for the PY 2005 formula allocations using the updated datasets described above, with various adjustments applied since that time. The PY 2005 calculation adjusted those state-by-state relative shares by “hold-harmless” and “stop-loss”/”stop-gain” limits due to the introduction of the updated data. The following year, the PY 2006 formula allocations were proportionately based on the PY 2005 formula allocations and further adjusted by an additional $3.8 million appropriated by Congress for States whose PY 2005 allocation had been reduced as a result of the updated data used for the PY 2005 formula allocation distribution. Detailed descriptions of the formula methodology for PY 2005 and PY 2006 formula allocations were provided in the applicable
There will be a single plan of service for operating the PY 2017 NFJP in the State service areas of Delaware and Maryland and the State service areas of Rhode Island and Connecticut. The sub-allocations for multiple sub-state service areas in California were discussed earlier in this Notice.
In February and April 2017, the Employment and Training Administration (ETA) hosted a national online dialogue to gather ideas from NFJP grantees, research analysts, economists, and other professionals on revising the existing formula and its databases to ensure incorporation of the latest available data, as required under WIOA Section 182(a). The ideas suggested by the multiple stakeholders who participated in the national online dialogue helped inform the proposed formula for PY 2018. ETA will publish the PY 2018 proposed allocation formula for comment in the fall of 2017.
Notice.
On June 30, 2017, the Department of Labor (DOL) will submit the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, “Concrete and Masonry Construction Standard,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before July 31, 2017.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL–OSHA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202–395–5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202–693–4129, TTY 202–693–8064, (these are not toll-free numbers) or by email at
This ICR seeks to extend PRA authority for the Concrete and Masonry Construction Standard information collection. An Occupational Safety and Health Act (OSH Act) covered construction firm engaged in the erection of concrete formwork must post warning signs/barriers, in accordance with regulations 29 CFR 1926.701(c)(2), to reduce exposure of non-essential employees to the hazards of post-tensioning operations. Paragraphs 29 CFR 1926.702(a)(2), (j)(1), and (j)(2) are general lockout/tagout measures to protect workers from injury associated with equipment and machinery. Paragraph 29 CFR 1926.703(a)(2) requires an employer to make available drawings or plans for jack layout, formwork, working decks and scaffolds. Paragraph 1926.705(b) requires an employer to mark the rated capacity of jacks and lifting units. OSH Act section 6(b)(7) authorizes this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on June 30, 2017. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
44 U.S.C. 3507(a)(1)(D).
Notice.
The Department of Labor (DOL) is submitting the Wage and Hour Division (WHD) sponsored information collection request (ICR) titled, “Disclosures to Workers Under the Migrant and Seasonal Agricultural Worker Protection Act,” to the Office of Management and Budget (OMB) for review and approval for continued use,
The OMB will consider all written comments that agency receives on or before July 31, 2017.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the
Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL–WHD, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202–395–5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202–693–4129, TTY 202–693–8064, (these are not toll-free numbers) or by email at
This ICR seeks to extend PRA authority for the Disclosures to Workers Under the Migrant and Seasonal Agricultural Worker Protection Act (MSPA) information collection. Agricultural employers, associations, and farm labor contractors use this information collection to make MSPA required disclosures of employment terms and conditions, wage statements, and housing terms and conditions to migrant and seasonal agricultural workers. MSPA section 201 authorizes this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on June 30, 2017. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
44 U.S.C. 3507(a)(1)(D).
National Credit Union Administration (NCUA).
Request for comment.
In a voluntary effort to invite input from stakeholders, the NCUA Board (Board) is seeking comments on proposed changes to the Overhead Transfer Rate (OTR) methodology. The primary goal of the proposed changes are to reduce the complexity of the OTR methodology. The proposed changes would also reduce the resources needed to administer the OTR. This document provides a summary of and response to comments received on the current OTR methodology, and explains and solicits comments on the proposed changes to the OTR methodology.
Comments must be received on or before August 29, 2017 to ensure consideration.
You may submit comments by any one of the following methods (Please send comments by one method only):
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Russell Moore or Julie Decker, Loss/Risk Analysis Officers, Office of Examination and Insurance, National Credit Union Administration, 1775 Duke Street, Alexandria, Virginia 22314 or telephone: (703) 518–6383 or (703) 518–6384.
NCUA requested comments on the current OTR methodologies and processes through a notice in the
• Whether the OTR should continue to be determined using a formula-driven approach, or instead be set largely at the discretion of the Board;
• the definition NCUA uses for insurance-related activities;
• adjustments or changes to the current calculation; and
• alternate methodologies to arrive at an accurate and fair allocation of costs.
Within the 90-day comment period, NCUA received 40 comment letters on the OTR methodology. The commenters included federally insured state-chartered credit unions, national credit union trade organizations, state leagues, and state supervisory authorities. There were no comment letters received from federal credit unions. While there were only 40 comment letters, the comments addressed a broad range of complex issues. In addition to reviewing comments for input on the existing approach, NCUA staff explored options for the Board to consider for improving the OTR methodology. Many of the comment letters discussed the methodologies for both the OTR and the Operating Fee as well as other budget-related issues. This request for comments focuses specifically on the OTR methodology. Comments related to the Operating Fee methodology and other budget-related issues were referred to the appropriate office.
Based on the comments and NCUA's internal assessment, the Board is considering changes to the OTR methodology.
NCUA administers the Federal Credit Union Act (the Act), which is comprised of three Titles: Title I—General Provisions, Title II—Share Insurance, and Title III—Central Liquidity Facility. The agency's mission is to “provide, through regulation and supervision, a safe and sound credit union system, which promotes confidence in the national system of cooperative credit.”
NCUA is responsible for ensuring federally insured credit unions operate safely and soundly and comply with all applicable laws and regulations within NCUA's jurisdiction.
To achieve its statutory mission, the agency incurs various expenses, including those involved in examining and supervising federally insured credit unions. The Board adopts an Operating Budget each year to fund the vast majority of the costs of operating the agency.
In 1972, the Government Accountability Office recommended NCUA adopt a method for properly allocating Operating Budget costs—that is the portion to be funded by requisitions from the Share Insurance Fund and the portion to be covered by Operating Fees paid by federal credit unions.
NCUA has employed various allocation methods over the years, with the current methodology adopted in 2003. For a chronological summary of the history of the OTR, refer to
The Board detailed the legal parameters within which it must fund the NCUA Operating Budget in the January 2016 notice and request for comment.
NCUA charters, regulates and insures shares in federal credit unions and insures shares and deposits in federally insured state-chartered credit unions. To cover expenses related to its statutory mission, the Board adopts an Operating Budget in the fall of each year. The Act authorizes two primary sources to fund the Operating Budget: (1) Requisitions from the Share Insurance Fund “for such administrative and other expenses incurred in carrying out the purposes of
To allocate agency expenses between these two primary funding sources, NCUA uses the OTR. The OTR represents the formula NCUA uses to allocate insurance-related expenses to the Share Insurance Fund under Title II. Almost all other operating expenses are collected through annual Operating Fees paid by federal credit unions.
In response to its initial OTR notice, NCUA received a variety of comments related to the legal authority to requisition funds from the Share Insurance Fund to cover a portion of the Operating Budget. Several commenters stated the agency does not have authority or discretion to establish and determine the OTR. Some commenters asserted that NCUA lacks the legal authority to use the Share Insurance Fund to cover costs of operating the agency. Other commenters claimed NCUA has only very narrow authority to allocate costs, has too broadly interpreted its authority, and may assign to the Share Insurance Fund only those costs directly associated with share insurance payments for failed or troubled credit unions. Some commenters insisted NCUA is required to fund the vast majority of the cost of operating the agency through Operating Fees charged to federal credit unions, claiming Congress intended that Operating Fees were to subsidize costs in managing risk to the Share Insurance Fund. Having considered these comments, NCUA maintains that a plain reading of the Act, as described in section II.a. above and in the January 2016 notice, supports the agency's legal authority and broad discretion in allocating operating costs.
Various commenters disagreed with the agency's legal analysis and argued that some combination of 12 U.S.C. 1781(b)(1), 1782(a)(5), and 1790 also limit NCUA's requisition of funds from the Share Insurance Fund for the Operating Budget. Several commenters went further and argued that Title II's legislative history indicates the savings from NCUA's reliance on Title I and State Supervisory Authority examinations and reports should accrue to the benefit of the Share Insurance Fund. The Act's plain language does not require an analysis of the legislative history.
Multiple commenters stated that the plain language of the Act requires the Board to structure examinations and Call Reports originally required under Title I so they may be used for Title II share insurance purposes.
While the Board did not cite 12 U.S.C. 1790 as an additional limitation in its earlier notice, the Board agrees with commenters stating that this provision should inform NCUA's interpretation of Title II so that it consciously avoids discrimination against federally insured
As background, all federally insured credit unions are subject to the same requirements for funding the Share Insurance Fund. Specifically, § 1782(c)(1)(A)(i) requires that “[e]ach insured credit union shall pay to and maintain with the [Share Insurance Fund] a deposit in an amount equaling 1 per centum of the credit union's insured shares.” Section 1782(c)(2)(A) requires that “[e]ach insured credit union shall, at such times as the Board prescribes (but not more than twice in any calendar year), pay to the Fund a premium charge for insurance in an amount stated as a percentage of insured shares (which shall be the same for all insured credit unions).” Thus, in funding the Share Insurance Fund, federal credit unions and federally insured state-chartered credit unions are not treated any differently. Similarly, the requisitions from the Share Insurance Fund used to fund the insurance-related expenses of NCUA's Operating Budget under § 1783(a) do not distinguish between federal credit unions and federally insured state-chartered credit unions.
As for the OTR methodology and whether it complies with § 1790, the OTR methodology only considers the type of activity (
The Act clearly permits expenses related to insurance to be funded by the Share Insurance Fund regardless of charter. Specifically, 12 U.S.C. 1783(a) expressly allows expenses “incurred in carrying out the purposes of [Title II]” to be allocated to the Share Insurance Fund. The costs NCUA incurs in safeguarding the Share Insurance Fund relate to the risks in federal credit unions and federally insured state-chartered credit unions. The Act provides the Board with a number of specific authorities that relate to costs NCUA incurs in carrying out its obligations under Title II. For instance, Title II of the Act authorizes the Board “to appoint examiners who shall have the power, on its behalf, to examine any insured credit union . . . whenever in the judgment of the Board an examination is necessary to determine the condition of any such credit union for insurance purposes.”
• “Appoint such officers and employees as are not otherwise provided for in this chapter;”
• “employ experts and consultants or organizations thereof;”
• “prescribe the manner in which its general business may be conducted and the privileges granted to it by law may be exercised and enjoyed;”
• “exercise all powers specifically granted by the provisions of this subchapter and such incidental powers as shall be necessary to carry out the power so granted;”
• “make examinations of and require information and reports from insured credit unions, as provided in this subchapter.”
The Board concludes that these authorities taken together provide NCUA as insurer with broad discretion to impose regulations on and examine all insured credit unions. In addition, the cost of the agency activities associated with exercising these and other accompanying authorities can properly be considered costs of carrying out Title II of the Act.
Finally, a number of commenters argued that the OTR methodology and/or calculations either should or must go through full APA notice and comment rulemaking. The APA does not require notice and comment for the OTR methodology. The legal analysis of NCUA's Office of General Counsel on the applicability of the notice and comment provisions of the APA to the OTR methodology is summarized in the January 2016 OTR notice
The majority of commenters expressed support for NCUA's continued use of a formula to determine the OTR. The Board agrees NCUA should continue to use a formula to determine the OTR. Use of a well-designed and comprehensive formula represents a good faith effort to consider all of the agency's costs relative to how NCUA is carrying out its various responsibilities. A formula also helps ensure costs assigned to the OTR relate to agency activities to carry out Title II responsibilities. NCUA's goal in using a formula-driven OTR methodology is to provide a comprehensive, fair, and equitable allocation of costs within a framework that can be administered at a relatively low cost. Though it is formula driven, the Board can adjust the methodology at any time to ensure it continues to reflect the most equitable and suitable approach to allocating costs.
However, five commenters favored setting the OTR at a fixed 50 percent of
Ten commenters objected to the Board's delegation of the OTR calculation to NCUA staff. They argued that by doing so the Board abdicated its oversight and discretion over the OTR and that it will result in reduced transparency. During the November 29, 2015, Board meeting, the Board approved the delegation of authority to administer the Board approved OTR methodology to the Director of the Office of Examination and Insurance (E&I).
Delegating the ministerial application of the Board approved OTR methodology does not mean the Board has abdicated its oversight and discretion for the OTR. With limited exceptions not at play here, the Act permits the Board to “delegate to any officer or employee of the Administration such of its functions as it deems appropriate.”
The delegation has not resulted in a reduction in transparency. As was done prior to the delegation, each year staff submits a report to the Board on the results of the calculation and conducts a briefing at a public Board meeting. The materials supporting the OTR calculation and the result are provided as part of the public Board briefing and posted on the agency's Web site. The Board intends for this public reporting to continue. Further, the Board is committed to soliciting public input at least every three years on the OTR methodology, and any time a change to the methodology is considered.
Nine commenters stated that the current OTR methodology is not sufficiently transparent. NCUA has made various efforts over the years to be transparent with respect to the OTR, and recently published extensive information about the OTR. The setting of the OTR has been briefed and acted on each year at a public Board meeting. The associated Board Action Memorandums, which are public records, fully detailed the calculation and included supporting materials. The current methodology was extensively reviewed at a public Board meeting when adopted in 2003. All related materials have been made a matter of public record and posted on NCUA's Web site. Numerous analyses, independent evaluations, and other documents are available in public records and on NCUA's Web site. To improve transparency further, the agency organized and posted a variety of new and historical materials on its Web site in 2015.
NCUA's definition of insurance-related activities received the most comments. Of the 36 commenters on this topic, most disagree with the definition NCUA uses for insurance-related activities. Many commenters objected to equating “safety and soundness” with “insurance-related,” with some arguing that the charterer/prudential regulator cares about safety and soundness and it is therefore not the sole domain of the insurer. Commenters asserted the definition assumes that NCUA has no safety and soundness oversight in its role as regulator and charterer of federal credit unions. By doing so, commenters claim NCUA is shifting expenses that should fall under the operating fee paid by federal credit unions to the Share Insurance Fund.
NCUA recognizes the historical role of a charterer/prudential regulator involves enforcing laws and implementing public policy. Before the advent of federal deposit insurance, federal financial institution regulators were concerned with protecting the stability of the financial system by “regulating” it. Thus, financial institution examinations focused on ensuring (1) statutes and regulations were followed to protect consumers, and (2) institutions were viable to protect consumer deposits, preserve access to financial services, and safeguard the stability of the economy. Though not responsible for the financial liability that comes with the role of insurer, prudential regulators are concerned with potential threats to the viability of their financial institutions to protect consumers and their jurisdiction's economy. This focus on viability benefits the insurer, whose primary role is to protect depositors and the taxpayer and contribute to the stability of the financial system.
NCUA has a unique dual role in that it serves as both the regulator of federal credit unions and the insurer of all federally insured credit unions.
Given its multiple roles, NCUA appropriately allocates costs associated with activities connected to each role. Various provisions of the Act, as noted earlier, govern or inform this allocation. Thus, NCUA currently categorizes those activities designed to manage risk to the Share Insurance Fund as “insurance-related.” This includes activities designed to enforce regulations NCUA adopts to carry out the purpose of Title II (Share Insurance) as well as related examination and supervision activities.
Thus, NCUA currently allocates costs associated with regulating and examining the safety and soundness of insured institutions as insurance-related. Worthy of note, Congress uses “safety and soundness” and related terminology in the Act.
However, NCUA acknowledges that safety and soundness is not the sole domain of the insurer; prudential regulators have various responsibilities with respect to the “safety and soundness” of institutions they oversee. In some respects this is recognized in the current OTR formula through the “Imputed SSA Value.” To better reflect that the prudential regulator and insurer both have responsibilities for safety and soundness, the Board is considering adjusting the OTR methodology so safety and soundness is not accounted for as the primary domain of the insurer. For more information on the proposed change to the OTR methodology, see section IV.
One commenter stated that routine examinations of all insured credit unions should be paid through Operating Fees. Another commenter asserted that the OTR should only be used for examinations of federally insured state-chartered credit unions and examinations of troubled federal credit unions. These recommendations assume that as insurer, NCUA takes only a reactive approach to managing risk to the Share Insurance Fund.
The Board notes that NCUA's role as insurer is best fulfilled by a proactive approach to preventing losses, not just addressing troubled or failed institutions. Since the implementation of federal share insurance in 1970, the Board has instituted a more proactive examination and supervision program geared toward safety and soundness to better manage risk to the Share Insurance Fund. Additionally, as credit unions have become larger and more complex, the risks to the Share Insurance Fund have changed, with NCUA making corresponding adaptions to its operations. In 2002, the Board strengthened its commitment to fulfilling NCUA's role as insurer by implementing the Risk-Focused Examination Program. As recently as 2016, the Board made the examination program even more risk-based by adopting an extended examination cycle for healthy, well-run credit unions. These programs base examination scope and timing largely on the risks an institution poses to the Share Insurance Fund. Further, the objective of the risk-focused examination is to enable NCUA to identify and address risks before they become a major problem. All of these changes have resulted in an increase in the agency's insurance-related activities.
The Act and NCUA Regulations have also evolved, resulting in more emphasis on safeguarding the Share Insurance Fund. For example:
1. The Credit Union Membership Access Act was enacted into law in 1998.
2. During the aftermath of the financial crisis, the Board strengthened critical safety and soundness rules, such as interest rate risk and liquidity management standards.
3. NCUA also has been providing regulatory relief. New authorities and less prescriptive, more principles-based rules have helped to reduce compliance burdens and provide credit unions with more authority to serve members and manage risk. They result in examiners devoting more time to ensuring safety and soundness through the examination process rather than relying on regulatory limits.
Under this proactive approach, the Board's primary motivation for many of the agency's current regulations and the majority of the examination program is to manage risk to the Share Insurance Fund.
The Board acknowledges there is not always a clear separation between the role of a prudential regulator concerned with enforcing laws and implementing public policy and that of an insurer. For example, NCUA relies, to the extent feasible, on the examination work performed by state regulators to manage risk to the Share Insurance Fund posed by federally insured state-chartered credit unions. This results in some cost savings in the NCUA Operating Budget. Since 2004, the value of the insurance-related work conducted by state regulators and relied on by NCUA has been reflected in the OTR methodology as the “Imputed SSA Value.” To ensure equitable treatment, the Imputed SSA Value is calculated on the same cost basis as if NCUA had to conduct the work itself.
The Board recognizes that another plausible approach to accounting for the related missions of charterer/prudential regulator and insurer is to employ an alternating or partnership framework within the OTR methodology. This would simplify the OTR methodology and avoid having to delineate safety and soundness as the primary domain of the insurer. The concept of an alternating or partnership framework being applied to the OTR methodology is described in detail in section IV of this document.
Some commenters asserted that because NCUA equates safety and soundness with insurance-related activities, the OTR methodology is not fair and equitable as state regulators also examine federally insured state-chartered credit unions for safety and soundness. As a result, some commenters contended federally insured state-chartered credit unions are charged twice for safety and soundness examinations; once by their state regulator via an operating fee and then by NCUA via the OTR. Further, some commenters claimed that federally insured state-chartered credit unions are disadvantaged when the OTR rises due to increased NCUA examination time allocated to insurance, because the NCUA operating fee paid by federal credit unions declines.
NCUA appreciates the work state regulators do in contributing to the safety and soundness of the credit union system. The agency will continue to partner and coordinate closely with state regulators in this regard. It is important to note that ultimately NCUA is accountable for carrying out the purpose of Title II of the Act and managing risk to the Share Insurance Fund. The extent state regulators examine for safety and soundness is the choice of state governments. This choice, along with the adequacy of the examination, affects the extent to which it is feasible for NCUA to rely on these examination reports to meet its Title II responsibilities. State governments also choose the extent to which they rely on the work of NCUA in its role as insurer to reduce overall state costs and burden.
State-chartered credit unions are not charged twice as a result of state regulators also examining for safety and soundness. The extent to which state regulators examine for safety and soundness in a manner that can be relied on by NCUA reduces the overall agency costs to which the OTR is applied, benefiting all insured credit unions. Conversely, NCUA's involvement in developing reporting and examination systems for all insured credit unions, publishing guidance, training and equipping most state examiners, and participating in the examination of federally insured state-chartered credit unions reduces overall state regulator costs.
Some commenters suggested that if the OTR continued to define all safety and soundness activities as insurance-related, NCUA should use each state regulator's actual costs instead of an imputed value. Others argued NCUA should pay the state governments for their actual costs instead of merely reducing the OTR.
NCUA notes that it is neither feasible nor appropriate to use the actual state regulator costs in determining the OTR. To ensure the methodology is fair and equitable across all federally insured institutions, the Imputed SSA Value is intentionally designed to reflect the replacement cost to NCUA if the agency had to do the insurance-related work it relies on the state regulators to conduct. The cost structure for state regulators can vary widely and include non-germane and potentially inordinate costs. Also, it is not feasible to obtain reliable and comprehensive information
As part of the process of evaluating the suggestion to use actual state regulator costs, NCUA attempted to obtain and review the costs of state regulators and their methodologies for annual and/or examination fees for state-chartered credit unions. This included determining how costs are allocated to the credit union specific activities for state regulators housed within state offices with broader responsibilities.
Based on Call Report data, NCUA did compare the total Operating Fees as a percent of average assets paid by federal credit unions to those reported by federally insured state-chartered credit unions. Though this comparison has some limitations, the trends in Graph 1 below show that Operating Fees recorded by federal credit unions and federally insured state-chartered credit unions are comparable in aggregate.
Further, federal credit unions continue to bear the majority of NCUA's operating costs. For NCUA's 2017 Operating Budget, federal credit unions cover 67 percent of the total Operating Budget through the operating fee and their proportional share of the OTR.
NCUA has mapped all examination-related rules and regulations to one of two categories: Insurance regulatory related, or non-insurance and consumer regulatory related. A third party has reviewed the regulatory mapping.
Since NCUA equates safety and soundness with the term insurance-related in the current OTR methodology, commenters argued that the mapping of NCUA's rules and regulations is faulty. Some commenters asserted that classifying NCUA rules as insurance-related is flawed because NCUA as charterer/prudential regulator is charged with ensuring compliance with all the provisions contained within the rules and regulations.
As noted in the Legal Analysis section above, the Board has the authority to promulgate rules and regulations to carry out the provisions of Title II (Share Insurance) of the Act, as well as examine credit unions for share insurance purposes.
As noted above, the Board recognizes that another plausible approach to accounting for the related missions of charterer/prudential regulator and insurer is to employ an alternating or partnership framework within the OTR methodology. This would simplify the OTR methodology in part by avoiding having to map regulations to a specific role as it relates to federal credit unions. The concept of an alternating or partnership framework being applied to
NCUA received 23 comments suggesting various other changes to the current OTR process. The areas of the calculation receiving comments were the examiner time survey, the allocation factors for various NCUA central offices, and the use of insured shares in the calculation.
• Examiner time survey:
It is not necessary to have 100 percent coverage of all examination and supervision contacts to form a statistically valid basis for the survey. A complete census of all federal credit union examinations and supervision contacts would result in additional agency costs—all staff would have to be trained annually and all examinations and supervision contact hours would need to be increased for the time necessary to complete the survey.
• Allocation factors for various NCUA central offices: Some commenters stated the allocation of costs for NCUA's non-field offices are not based on standard or consistent criteria. Overall, NCUA agrees that improvements can be made in allocation methods involving the non-field cost centers, and is addressing this in the proposed changes to the OTR methodology. Some noted that the Office of National Examinations and Supervision (ONES) costs cannot be 100 percent safety and soundness as it examines natural person credit unions with assets over $10 billion and, therefore, has regulatory responsibility. Other commenters noted ONES is also responsible for reviewing Bank Secrecy Act compliance for the corporate credit unions it supervises, suggesting some non-insurance time is spent supervising them. NCUA agrees that ONES time is not 100 percent insurance related and this issue was addressed in the 2017 OTR calculation. Other commenters questioned why the Office of Small Credit Union Initiatives and the Office of Consumer Financial Protection and Access vary in their methodology for classifying time spent on field of membership expansion. NCUA agrees that there are differences in the time allocations and has developed a consistent standard for use in the proposed changes to the OTR methodology discussed in section IV.
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The proposed simplification of the OTR formula is intended to facilitate greater understanding of the methodology, and will decrease the agency resources necessary to administer the OTR. The new approach is within NCUA's authority and, though simplified, would provide a sufficient level of precision with respect to the allocation of agency costs. The simplified formula applies the following underlying principles to the allocation of agency operating costs:
1. Time spent examining and supervising federal credit unions is allocated as 50 percent insurance related. The 50 percent allocation mathematically emulates an examination and supervision program design where NCUA would alternate examinations, and/or conduct joint examinations, between its insurance function and its prudential regulator function if they were separate units within NCUA. It reflects an equal sharing of supervisory responsibilities between NCUA's dual roles as charterer/prudential regulator and insurer given both roles have a vested interest in the safety and soundness of federal credit unions.
2. All time and costs NCUA spends supervising or evaluating the risks posed by federally insured state-chartered credit unions or other entities NCUA does not charter or regulate (for example, third-party vendors and CUSOs) is allocated as 100 percent insurance related. NCUA does not charter state-chartered credit unions nor
3. Time and costs related to NCUA's role as charterer and enforcer of consumer protection and other non-insurance based laws governing the operation of credit unions (like field of membership requirements) are allocated as 0 percent insurance related.
4. Time and costs related to NCUA's role in administering federal share insurance and the Share Insurance Fund are allocated as 100 percent insurance related. NCUA conducts liquidations of credit unions, insured share payouts, and other resolution activities in its role as insurer. Also, activities related to share insurance, such as answering consumer inquiries about insurance coverage, are a function of NCUA's role as insurer.
These four principles are applied to the activities and costs of the agency to arrive at the portion of the agency's Operating Budget to be charged to the Share Insurance Fund as discussed in detail below.
Annually, NCUA develops a workload budget based on NCUA's examination and supervision program to carry out the agency's core mission. The workload budget reflects the amount of time necessary to examine and supervise federally insured credit unions, along with other related activities, and therefore the level of field staff needed to implement the exam program. Applying principles 1, 2, and 3 (those relevant to the workload budget) to the applicable elements of the workload budget results in a composite rate that reflects the portion of the agency's overall mission program activities that are insurance related. For illustrative purposes, Table 1 shows the application of the allocation principles to the 2017 workload budget.
The Operating Budget represents the costs of the activities associated with achieving the strategic goals and objectives set forth in the NCUA Strategic Plan. The Operating Budget is based on agency priorities and initiatives that drive resulting resource needs and allocations. Information related to NCUA's budget process, including detailed information on the Board-approved 2017 Operating Budget, is available on the agency's Web site.
The agency achieves its primary mission through the examination and supervision program. For the proposed formula, as applied to the 2017 Operating Budget, the percentage of insurance-related workload hours (61 percent) derived from Step 1 represents the main allocation factor used in Step 2 for the costs of the field offices (the Regions and ONES). A few agency offices have roles that are significantly distinct enough to warrant their own allocation factors, as discussed below. A weighted average allocation factor (60 percent) representing the aggregate budgets for the Regions, Ones, and the specific agency offices listed in Step 2 is applied to the central offices that design or oversee the examination and supervision program, or support the agency's overall operations. These costs in total make up NCUA's Operating Budget. Table 2 reflects the application
The financial budget for the agency's five regional offices and ONES is allocated based on the weighted average of non-insurance and insurance-related activities calculated in Step 1. The Regions and ONES execute NCUA's examination programs; thus, the budgeted costs related to these offices should receive the same allocation basis as the programs themselves. The allocation factor is based on principles 1, 2, and 3 as documented in Table 1. The budget for the regional offices and ONES is allocated at 61.0 percent for insurance-related activities.
NCUA conducts credit union liquidations and performs management and recovery of assets through the Asset Management and Assistance Center. The Asset Management Assistance Center assists NCUA regional offices with the review of large, complex loan portfolios and actual or potential bond claims. It also participates extensively in the operational phases of conservatorships and records reconstruction. The purpose of the Asset Management Assistance Center is to manage and reduce costs to the Share Insurance Fund and credit union members of credit union failures. Thus, OTR allocation is based on principle 4 at 100 percent insurance related.
This division is responsible for NCUA's consumer financial literacy efforts, consumer inquiries and complaints, consumer protection compliance and rulemaking, fair lending examinations, interagency coordination and outreach, chartering and field-of-membership matters, low-income designations, charter conversions, and bylaw amendments. The majority of the work performed by the Office of Consumer Financial Protection and Access is related to NCUA's role as prudential regulator and
The composite rate of this office's insurance-related activities calculates as 13 percent as reflected in Table 3. Thus, an allocation factor of 13 percent is applied to the office's financial budget in the OTR calculation.
The office's administrative staff provides support for the whole office. Ten percent of this unit's work was devoted to supporting insurance-related functions, like responding to consumer inquiries on share insurance coverage. Thus, principle 4 is applied to those activities as 100 percent insurance related while the remaining 90 percent of their time was spent supporting charting, bylaw, field of membership, and related activities, which fall under principle 3 as 0 percent insurance related.
The Division of Consumer Access staff spent 25 percent of their time addressing insurance-related functions, like insurability standards for mergers and insurance applicants where principle 4 applies. The remainder of this unit's time was spent processing various chartering and field of membership expansion applications and bylaw matters where principle 3 applies.
The Division of Consumer Affairs staff spent 5 percent of its time addressing share insurance questions received from consumers which falls under principle 4. The division spent the remaining 95 percent of its time on consumer related activities like administering the Financial Literacy Program, which falls under principle 3.
The Division of Consumer Compliance Policy and Outreach focuses on issues related to consumer regulations including implementing the Equal Credit Opportunity Act, the Home Mortgage Disclosure Act, the Truth in Lending Act, and the Real Estate Settlement Procedures Act. All of these activities fall under principle 3; therefore, 100 percent of the division's staff time is allocated as 0 percent insurance related.
The proposed methodology allocates the cost of the Office of Small Credit Union Initiatives based on principles 1 and 2. The office tracks the time the Economic Development Specialists spent consulting and training both federal credit unions and federally insured state-charted credit unions. The proportion of time spent on federal credit unions is allocated based on principle 1 while federally insured state-chartered credit union work is allocated based on principle 2. Other office personnel process grants and loans for both federal credit unions and federally insured state-chartered credit unions. Grant and loan activities are allocated the same way as the consulting and training time using principles 1 and 2. The resulting allocation factor for the Office of Small Credit Union Initiatives is 60 percent as shown in Tables 4 and 5.
Table 4 illustrates the allocation for the Office of Small Credit Union Initiative's consulting hours between federal and state-chartered credit unions applied to the budgeted hours for 2017. Principle 1 is applied for federal charters and principle 2 is applied for state charters. The result is a composite rate of 59.3 percent insurance-related hours for the Economic Development Specialists.
Table 5 illustrates the allocation of the grant and loan activities performed by the Office of Small Credit Union Initiatives by charter type. Principle 1 is applied for federal charters and principle 2 is applied for state charters. This results in a composite rate of 63.7 percent insurance-related activities for grants and loans.
Table 6 shows the resulting overall composite rate of 59.8 percent insurance-related activities for the Office of Small Credit Union Initiatives. This factor is applied to the financial budget for this office in the OTR calculation.
NCUA's remaining offices design or oversee the agency's mission and its related offices, or provide necessary support to mission offices or the entire agency. As such, the proportion of insurance-related activities for these offices corresponds to that of the mission offices. It would be administratively burdensome to attempt to account for any variation in activity levels from the mission functions, and would not result in a material difference in outcomes. Therefore, these office costs are allocated based on the weighted average of insurance-related activities calculated in the subtotal of agency costs for the offices above that have a distinct allocation factor. The budgeted costs for the following offices are allocated at 60.0 percent insurance-related activities for purposes of calculating the OTR:
• NCUA Board,
• Executive Director,
• General Counsel,
• Chief Financial Officer,
• Chief Information Officer,
• Chief Economist,
• Human Resources,
• Examination and Insurance,
• Inspector General,
• Minority and Women Inclusion,
• Public and Congressional Affairs, and
• Continuity and Security Management.
The OTR represents the percentage of the NCUA Operating Budget that is funded by a transfer from the Share Insurance Fund.
Based on data used to determine the OTR for 2017, the proposed changes to the OTR methodology would result in an OTR of 60.0 percent. The current methodology resulted in an OTR of 67.7 percent for 2017. Table 8 summarizes the results for the 2017 OTR calculation using the current and proposed methodologies.
For
The
In addition to the proposed changes to the OTR methodology, the Board proposes to formally adopt the following OTR related processes:
• To solicit through the
• Maintain the staff delegation to administer the OTR methodology but require public board briefings every year, no later than each December, on the results of the calculation and to post all related materials to NCUA's Web site.
• As part of future rulemaking, indicate for any proposed regulation involving the activities and authorities of credit unions whether the regulation is based on Title I, Title II, and/or Title III of the Act and seek comment on this determination. While the proposed new OTR methodology would no longer rely on mapping of regulations, this will increase clarity regarding the purpose of and authority for any new or updated regulations and preserve future flexibility with respect to any desired changes to the OTR methodology.
The Board seeks comments on all the proposed revisions to the OTR methodology and formal adoption of the procedures discussed above. In particular, the Board is interested in comments on alternative approaches to arriving at an allocation factor for the cost of examining and supervising federal credit unions (principle 1). For example, within the context of the overall simplification of the OTR methodology, should federal credit union examination and supervision activity be allocated primarily to the operating fee, or should it continue to reflect that much of NCUA's examination and supervision focus is on managing risk to the Share Insurance Fund.
Commenters are also encouraged to discuss any other relevant issues they believe NCUA should consider with respect to the OTR methodology and, to the extent feasible, provide documentation to support any recommendations.
U.S. Office of Personnel Management.
60-Day notice and request for comments.
The National Background Investigation Bureau (NBIB), U.S. Office of Personnel Management (OPM) is notifying the general public and other Federal agencies that OPM is seeking Office of Management and Budget (OMB) approval of a revised information collection, Questionnaire for Non-Sensitive Positions, (SF 85).
Comments are encouraged and will be accepted until August 29, 2017.
Interested persons are invited to submit written comments on the proposed information collection to NBIB, U.S. Office of Personnel Management, 1900 E Street NW., Washington, DC 20415, Attention: Donna McLeod or by electronic mail at
A copy of this information collection, with applicable supporting documentation, may be obtained by contacting the NBIB, U.S. Office of Personnel Management, 1900 E Street NW., Washington, DC 20415, Attention: Donna McLeod or by electronic mail at
OPM is soliciting comments for this collection as required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3507(a)(1). The Office of Management and Budget is particularly interested in comments that:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Questionnaire for Non-Sensitive Positions, SF 85, including accompanying releases, housed in a system named e-QIP (Electronic Questionnaires for Investigative Processing), is an information collection completed by applicants for, or incumbents of, Federal Government civilian positions, and other individuals performing work on behalf of the Federal Government and requiring logical and physical access to Federal systems and facilities,
• The Federal Government in conducting background investigations of persons under consideration for non-sensitive, low-risk positions as defined in Executive Order 13764 and 5 CFR part 731;
• agencies in determining whether a person performing work for or on behalf of the Federal Government should be deemed eligible for physical and logical access to federally controlled facilities or information systems.
The SF 85 is completed by applicants for, or incumbents of, Federal Government civilian positions, or other individuals requiring logical or physical access to perform work on behalf of the Federal Government. For applicants, the SF 85 is to be used only after a conditional offer of employment has been made, unless OPM has provided an exception. The Electronic Questionnaires for Investigations Processing (e-QIP) is a web-based system application that houses the SF 85. A variable in assessing burden hours is the nature of the electronic application. The electronic application includes branching questions and instructions which provide for a tailored collection from the respondent based on varying factors in the respondent's personal history. The burden on the respondent is reduced when the respondent's personal history is not relevant to particular question, since the question branches, or expands for additional details, only for those persons who have pertinent information to provide regarding that line of questioning. Accordingly, the burden on the respondent will vary depending on whether the information collection relates to the respondent's personal history.
OPM proposes new changes to the SF 85. The instructional portion of the form will be modified. OPM will provide additional information regarding the investigative process. OPM will remove instructions that were needed only for persons completing a paper form, as the form is now collected by OPM only through electronic means. The Privacy Act Routine Uses provided on the form were updated to conform to the most recent publication of the OPM/Central 9 Personnel Investigations Records system of records notice. Section 6, your “Identifying Information” will be expanded to request additional identifiers. OPM will request, in Section 7, “Your Contact Information” that the respondent provide three contact numbers to facilitate contact between investigative personnel and the respondent; however respondents will be advised that only one number is required. Section 9, “Citizenship” will be expanded to collect additional information to assist in verifying derived citizenship of respondents born outside of the U.S. Section 10, “Dual/Multiple Citizenship” will include questions regarding the time period(s) of dual/multiple citizenship and an explanation of how such citizenship was acquired. Section 11, “Where You Have Lived” will include branching questions that replace detailed instructions for all respondents and instead tailor the collection to elicit information based on the respondent's relevant personal history. Section 12, “Where You Went to School” instructions will be changed regarding the requirement to list degree or diploma information. Section 13a, “Employment Activities-Employment & Unemployment Record” branching questions will be added to reduce detailed instructions for all respondents and tailor instructions as applicable to the respondent. Additionally, branching questions for foreign addresses and contacts will be added to assist with conducting the background investigation. Section 13b, “Employment Activities-Former Federal Service” will be added to capture former federal civilian service, excluding military service not previously provided. Section 13c, “Employment Record” branching questions will be added to prompt the applicant to enter the required information following each positive response.
In an effort to streamline information collection from the respondents, changes are proposed to add five areas of questioning found on the Declaration of Federal Employment form (OF 306) to the SF 85. The recommendation is to have questions pertaining to Selective Service record, military discharge, police records and court(s) martial, debarment from federal employment, and financial history included on the SF 85. This change would provide information needed in support of the background investigation and limit multiple reporting requirements for respondents for the purpose of the background investigation.
Section 15, “Military History” branching questions will be added to collect information pertaining to the types of military discharge received and information regarding military disciplinary actions. Branching questions will be added to elicit information regarding foreign military service, if applicable, in addition to U.S. military service, and to collect details of such service. Section 17, “Police Record” will include questions regarding offenses, charges, and arrests, and branching questions will be added to inquire about the disposition of criminal proceedings. Section 21, “Financial Record” will be added with branching questions to elicit specific detailed information pertaining to
Section 16, “People Who Know You Well” branching questions will be added to clarify and collect additional information pertaining to the references. Section 18, “Illegal Use of Drugs and Drug Activity” will include instruction to clarify that drug use or activity illegal under Federal laws must be reported, even if that use or activity is legal under state or local law(s). Branching questions will be added regarding drug treatment details, which is pertinent information needed to support final adjudication. Section 19, “Investigations and Clearance Record” will be added with branching questions to elicit information necessary to obtain relevant details regarding prior records, including debarment from government employment. Section 22, “Association Record” will be added with branching questions which collect detailed information pertinent to a respondent's involvement in terrorist organizations, association with persons involved in activities to further terrorism and/or to overthrow the U.S. Government by force or violence.
The general “Authorization for Release of Information” will include clarifying language noting that information gathered during the investigation may include publicly available electronic information, including electronic social media information that has been published or broadcast for public consumption, is available on request to the public, is accessible on-line to the public, is available to the public by subscription or purchase, or is otherwise lawfully accessible to the public. A change is also proposed to the expiration timeframe of the General Release to five years. This change is consistent with the investigative coverage period for low risk, non-sensitive positions. In the event that review of financial information is needed for a particular investigation, the “Fair Credit Reporting Disclosure and Authorization” will be added to the collection.
U.S. Office of Personnel Management.
Notice of meeting.
The Hispanic Council on Federal Employment (Council) meeting will be held on Tuesday, August 1, 2017 at the following time and location shown below:
The Council is an advisory committee composed of representatives from Hispanic organizations and senior government officials. Along with its other responsibilities, the Council shall advise the Director of the Office of Personnel Management on matters involving the recruitment, hiring, and advancement of Hispanics in the Federal workforce. The Council is co-chaired by the Director of the Office of Personnel Management and the Chair of the National Hispanic Leadership Agenda (NHLA).
The meeting is open to the public. Please contact the Office of Personnel Management at the address shown below if you wish to present material to the Council at any of the meetings. The manner and time prescribed for presentations may be limited, depending upon the number of parties that express interest in presenting information.
Zina Sutch, Director, for the Office of Diversity and Inclusion, Office of Personnel Management, 1900 E Street NW., Suite 5H35, Washington, DC 20415. Phone (202) 606–2433 FAX (202) 606–6012 or email at
U.S. Office of Personnel Management.
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202–268–3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on June 21, 2017, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service
Elizabeth A. Reed, 202–268–3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on June 21, 2017, it filed with the Postal Regulatory Commission a
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange is filing a proposal to amend Exchange Rules 307, Position Limits, and 309, Exercise Limits, to extend the pilot program that eliminates the position and exercise limits for physically-settled options on the SPDR® S&P 500® ETF Trust (“SPY Pilot Program”).
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
Exchange Rules 307, Position Limits, and 309, Exercise Limits, establish position and exercise limits for aggregate positions in option contracts traded on the Exchange. Interpretations and Policies .01 to Rule 307 lists specific position limits for options on specific underlying securities, and Interpretations and Policies .01 to Rule 309 lists specific exercise limits for options on specific underlying securities. Among the listed specific underlying securities is the SPDR® S&P 500® ETF Trust (“SPY”). Currently, each of these Rules provides that there is no position limit and no exercise limit on options overlying SPY. The position and exercise limits for options overlying SPY in each of these Rules are the subject of a pilot program, which is scheduled to expire on July 12, 2017.
The Exchange proposes to amend Exchange Rule 307, Interpretations and Policies .01, and Exchange Rule 309, Interpretations and Policies .01, to extend the duration of the SPY Pilot Program through July 12, 2018. There are no substantive changes being proposed to the SPY Pilot Program. The Exchange affirms its consideration of several factors that support the proposal to establish and extend the SPY Pilot Program, which include: (1) The liquidity of the option and the underlying security; (2) the market capitalization of the underlying security and the securities that make up the S&P 500 Index; (3) options reporting requirements; and (4) financial requirements imposed by MIAX Options and the Commission.
The Exchange notes that it is not aware of any problems created by the current SPY Pilot Program and does not foresee any problems with the proposed extension. The Exchange has formally submitted a Report for the SPY Pilot Program as part of this filing.
The Exchange proposes to extend the SPY Pilot Program in order for the Exchange and the Commission to have additional time to evaluate the Pilot and its effect on the market and to determine whether to seek permanent approval. Prior to the expiration of the SPY Pilot Program and based upon the findings of the SPY Pilot Program Report, the Exchange will be able to either extend the SPY Pilot Program, adopt the SPY Pilot Program on a permanent basis, or terminate the SPY Pilot Program. If the SPY Pilot Program is not extended or adopted on a permanent basis by the expiration of the extended SPY Pilot Program, the position limits for options overlying SPY would revert to limits in effect prior to the commencement of the SPY Pilot Program.
MIAX believes that its proposed rule change is consistent with Section 6(b) of the Act
Specifically, the Exchange believes that extending the SPY Pilot Program promotes just and equitable principles of trade by permitting market participants, including market makers, institutional investors and retail investors, to establish greater positions when pursuing their investment goals and needs. The Exchange believes that the elimination of position limits for SPY options would not increase market volatility or facilitate the ability to manipulate the market.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. The proposed rule change is not designed to address any aspect of competition, whether between the Exchange and its competitors, or among market participants. Instead, the proposed rule change is designed to allow the SPY Pilot Program to continue as the Exchange believes other competing options exchanges will also extend the SPY Pilot Program for another year.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b–4(f)(6) thereunder.
A proposed rule change filed pursuant to Rule 19b–4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(7) of the Securities Exchange Act of 1934 (the “Act”)
OneChicago is proposing to amend OneChicago Rule 902 (Contract Specifications) to decrease the minimum price increment for outright Single Stock Futures (“SSFs”)
The minimum price fluctuation is set forth in OneChicago Rule 902, which provides general contract specifications for all OneChicago SSFs. Because the minimum price increment for blocks, EFPs, and spread transactions was already set at $0.0001, upon amending OneChicago Rule 902(e), all SSF trade types, including outright trades, will quote and trade with minimum fluctuations of $0.0001 (
Further, as currently drafted, OneChicago Rule 902(e) provides that the Exchange may amend the minimum price fluctuation for SSFs without amending the text of the rule itself. Specifically, the clause “or as otherwise stated by the Exchange” effectively permits the Exchange to set a minimum price fluctuation by notice or other means. OneChicago is now proposing to amend OneChicago Rule 902(e) to delete this clause, thereby providing certainty to market participants that the minimum price fluctuation is stated solely in OneChicago Rule 902, and will not be amended other than through the rule change process.
The text of the proposed rule change is attached as
In its filing with the Commission, OneChicago included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared a summary of the most significant aspects of such statements.
OneChicago is proposing to amend OneChicago Rule 902 (Contract Specifications) to decrease the minimum fluctuation for outright SSF quotes and trades from $0.01 to $0.0001 per share effective July 10, 2017.
This change will harmonize the pricing of all OneChicago trade types to four decimal places, and permit the same level of precision in central limit order book (“CLOB”) outright trades as is currently available for block trades. This change may also remove a potential barrier to entry to OneChicago's competitive marketplace, and could encourage market participants to transition away from the block marketplace and to the CLOB.
OneChicago acknowledges that sub-penny pricing is currently prohibited in NMS securities.
Unlike securities—which are assets—SSFs are contingent liabilities that represent the forward value of the underlying security. The primary
Since a trade in an SSF is not the purchase of an asset, but instead allows the individual to carry a position to a future time, the most accurate way to price the interest rate of the trade is in basis points. In order to trade in basis points, market participants need the ability to price trades to the fourth numerical decimal point.
OneChicago believes that two decimal pricing is not sufficient to translate a dollar value to an interest rate with precision. For example, an SSF bid-ask spread of $4.01 by $4.02 on a $4.00 underlying stock with sixty-four days left until expiration would represent a 1.40% (140 bps) difference between the best bid and best ask. Specifically, the bid at $4.01 translates to a 1.41% (141 bps) interest rate, whereas the offer at $4.02 translates to a 2.81% (281 bps) interest rate.
Although SSF trade prices are represented in dollar values, they also encompass interest rate and time until expiration. By using the trade price and time until expiration, market participants can determine the corresponding interest rate of the trade. Likewise, if a market participant is seeking a particular interest rate, that market participant can calculate the trade price by taking into account the desired interest rate and days until expiry. This is distinguished from trading in the underlying securities where the trade price directly represents the value of the asset itself. Accordingly, when market participants trade an SSF, they are calculating the futures trade price by considering not only the stock price, but also the days left to expiry and the prevailing interest rate.
OneChicago has considered whether permitting market participants to quote and trade SSFs in up to four decimals will impose any burdens on or otherwise negatively impact the SSF marketplace.
Additionally, unlike the equity markets in which hundreds of trades occur every second, OneChicago's markets are strictly governed to limit order frequency. The overwhelming majority of volume executed on the exchange occurs through the use of manual front-end systems, whereby the individual trader fills out each order ticket with the relevant order parameters. Further, even market participants trading programmatically (and who are not market-makers) are limited to a maximum of ten orders per second across all products, which minimizes the potential that any one market participant would repeatedly enter and modify orders in one particular product.
Accordingly, OneChicago believes that it is unlikely that limit orders will be frequently stepped ahead of due to the low messaging quantity threshold permitted by the Exchange. OneChicago notes on this topic that if a limit order loses execution priority to another limit order priced exactly $0.0001 above (in the case of a buy order) or $0.0001 below (in the case of a sell order) the resting order, this loss of priority typically would not have occurred for a nominal amount.
Furthermore, OneChicago does not anticipate any capacity burden generated as a result of permitting four
OneChicago believes that the primary beneficiaries of this rule change will be retail investors. OneChicago's SSFs offer retail investors an alternative to financing their equity securities positions via margin loan from their brokers, and offer these investors the ability to acquire synthetic exposure to equity securities at competitive financing rates. OneChicago believes the lack of four decimal pricing for outright trades has hampered the ability of the Exchange's market makers to make competitive markets which would allow retail investors to transact at competitive financing rates. With four decimal pricing in the CLOB for outright trades, OneChicago anticipates that new market makers will enter the marketplace and make more competitive markets, increasing trading activity on the CLOB.
Further, as stated above, this rule change will encourage market participants to transact in OneChicago's CLOB, rather than in the block marketplace, thereby increasing competition in trading and quoting these products. Currently, block trades, which are privately negotiated transactions available only to eligible contract participants, as that term is defined in section 1a(18) of the CEA,
As stated above, OneChicago does not anticipate that the transition of outright SSF trading to four decimals will harm or disadvantage any market participant. Nonetheless, in order to address any concerns related to stepping ahead, the Exchange plans to monitor its trading activity to determine whether permitting outright SSFs to trade in up to four decimal places has caused any harm to investors or deterioration in market quality. OneChicago plans to monitor this in two ways. First, the Exchange plans to monitor its trading directly for any incidence of stepping ahead. To do so, the Exchange will implement surveillance procedures that identify instances in which a market participant uses the third or fourth decimal place to step ahead of limit orders on the CLOB. OneChicago will review such activity and determine whether there is a pattern or practice of conduct not in line with just and equitable principles of trade. Second, OneChicago will, on a periodic basis, assess its market quality by looking to various factors such as spreads, market depth, and number and diversity of market participants. Using this two-pronged approached, the Exchange can determine whether permitting quoting and trading of SSFs in up to four decimals has promoted market quality, while ensuring market integrity. If OneChicago makes the determination that four decimal pricing has harmed either market quality or integrity, the Exchange will amend OneChicago Rule 902 to return to two decimal pricing. In order to provide its market participants with sufficient notice regarding this this [sic] change, OneChicago plans to distribute a Notice to Members before implementing the change to permit its market participants to make any necessary technology or operational changes, which OneChicago anticipates will be minimal.
OneChicago believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that the proposed rule change is equitable and not unfairly discriminatory because it would apply equally to all market participants. The ability to trade outright transactions in up to four decimal places will not be limited to any class of market participant, and all market participants are eligible to trade on OneChicago's CLOB. The requirements to trade on the CLOB are no more restrictive than the requirements to trade block, EFP, or spread transactions. Permitting outright transactions to trade in up to four decimal allows all OneChicago participants to trade in the same way, thereby promoting just and equitable principles of trade.
OneChicago has considered whether permitting SSFs to quote and trade in up to four decimal places could permit manipulation or other violative activity in either the underlying equity or SSF, and has determined that no such concern exists. Four decimal pricing for SSFs would not present any new methods for market participants to engage in behavior that may be violative of Exchange Rules or any applicable law.
Further, as currently drafted, OneChicago Rule 902(e) provides that the Exchange may amend the minimum price fluctuation for SSFs without amending the text of the rule itself. Specifically, the clause “or as otherwise stated by the Exchange” effectively permits the Exchange to set a minimum price fluctuation by notice or other means. OneChicago is now proposing to amend OneChicago Rule 902(e) to delete
OneChicago does not believe that the rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act, in that the rule change simply allows an additional type of transaction to be priced in up to four decimal places. This change will allow all market participants to more precisely price the interest rate component of their outright transactions. By pricing futures trades more precisely, market participants will be able to submit more competitive bids and offers on the Exchange. Further, as described above, OneChicago believes this rule change will increase competition in that it will allow all market participants to transact at four decimal places, and not just sophisticated parties who qualify as eligible contract participants.
No written comments were solicited or received with respect to the proposed rule change.
The proposed rule change has become effective on June 16, 2017 and will be implemented on July 10, 2017.
At any time within 60 days of the date of effectiveness of the proposed rule change, the Commission, after consultation with the CFTC, may summarily abrogate the proposed rule change and require that the proposed rule change be refiled in accordance with the provisions of Section 19(b)(1) of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
FINRA is proposing to amend FINRA Rule 6730 (Transaction Reporting) to provide a temporary exception to permit member alternative trading systems (“ATSs”) and member subscribers to report aggregate trade information to TRACE for certain transactions in U.S. Treasury Securities.
The text of the proposed rule change is available on FINRA's Web site at
In its filing with the Commission, FINRA included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. FINRA has prepared summaries, set forth in sections A, B,
FINRA is proposing to amend Rule 6730 to add new Supplementary Material .06 (Temporary Exception for Aggregate Transaction Reporting of U.S. Treasury Securities Executed in ATS Trading Sessions) to provide members additional time to report individual transactions in U.S. Treasury Securities, as required by Rule 6730 (Transaction Reporting), that occur on member ATSs as part of a trading session, as described below.
FINRA Rule 6730 sets forth a member's trade reporting obligations with regard to transactions in TRACE-Eligible Securities, which, beginning July 10, 2017,
FINRA understands that ATSs that permit subscribers to trade U.S. Treasury Securities on their platforms may permit subscribers to initiate a “trading session,” which is a discrete or timed order-matching event during which one or more additional subscribers can interact with the original order on the opposite side of the market or add to the initial order on the same side of the market.
For example, suppose Subscriber A initiates a trading session to sell $25 million of a particular U.S. Treasury Security at a specific price. In a typical crossing scenario involving an ATS, the ATS would match the incoming sell order with a buy order from Subscriber B thus executing some or all of the original order. In this scenario, under TRACE rules, Subscriber A is required to report a sell to the ATS for the amount crossed, and Subscriber B would report a purchase from the ATS for that same amount.
FINRA understands that trading sessions involving U.S. Treasury Securities can, and often do, work in very different ways. Using the above example, Subscriber A may initiate a trading session to sell $25 million in a particular U.S. Treasury Security at a specific price. Subscriber B, however, may only wish to purchase $10 million. In this case, although there will be a sell from Subscriber A to the ATS and a subsequent sell from the ATS to Subscriber B (and offsetting trades for the purchase from the ATS by Subscriber B and the purchase from Subscriber A by the ATS), there may be further activity during the trading session. To continue the example, after Subscriber B agrees to purchase $10 million, Subscriber C agrees to purchase $15 million at the same price (meaning that, at this point, Subscriber A has sold all $25 million of the initial order). Subscriber D then joins the trading session and offers to sell $10 million of the same U.S. Treasury Security at the same price. Subscriber E purchases $5 million, and Subscriber B decides to purchase an additional $5 million. If, after the period of time defined by the ATS, no further interest is indicated, the trading session closes.
Using the above example, at the end of the trading session, the individual trades are as follows:
FINRA understand that, under current practices, after the close of the trading session an ATS will provide each subscriber with a single trade message indicating the subscriber's aggregate activity during the trading session (including, for example, an aggregate size and average price), and that the execution time provided to a subscriber can vary depending upon the convention used by the particular ATS. FINRA also understands that, although information on the individual transactions within the trading session is generally available on a real-time basis to the subscribers during the trading session to track the status of the order, this information is not included on the final trade message, which FINRA understands currently is the message that would be used systematically by the member ATS and its subscribers for transaction reporting purposes.
Under Rule 6730, each individual trade that occurs during a trading session is a separate transaction and, as such, must be reported individually. For example, using the example above, at 11:34:03.155 (“Trade No. 1”), there is a trade agreed to between Subscribers A and B and all of the terms of the trade that are sufficient to calculate the dollar price of the trade are known at that time, including the security, the price, and the parties to the trade (
• Subscriber A reports a sell to the ATS for $10 million in the security with a Time of Execution of 11:34:03.155.
• Subscriber B reports a purchase from the ATS for $10 million in the security with a Time of Execution of 11:34:03.155.
• The ATS submits two reports, a buy from Subscriber A and a sell to Subscriber B for $10 million in the security, both with a Time of Execution of 11:34:03.155.
The proposed rule change will, until July 10, 2018, permit members the flexibility to report trades that occurred in a U.S. Treasury Security executed within discrete ATS trading sessions (sometimes referred to as “work-up sessions”) on an aggregate, rather than individual, basis. The proposed rule change is intended to provide members with additional time to complete systems changes necessary to report each individual transaction in the trading session as required by Rule 6730, as discussed below.
FINRA understands that certain ATSs that are active in the market for U.S. Treasury Securities currently are set up to deliver aggregate trading session transaction information to each subscriber that participated in the trading session through a single trade message generated at the conclusion of a trading session. The ATSs use this final trade message for purposes of back office processes (which would include generating trade reports) and believe their subscribers use the final trade messages similarly. As a result, FINRA understands that significant systems changes would be required by the ATSs to create and generate the individual trade information within a trading session in a form that could be integrated into the ATSs', as well as their subscribers', back office processes to enable the reporting of individual, rather than aggregate, trading session transaction information to TRACE, and that these changes cannot be made by July 10, 2017. As a result, FINRA is proposing to provide a temporary exception by adopting Supplementary Material .06 to permit members to report to TRACE aggregate, rather than individual, transaction information reflecting the aggregate size and average price of such transactions, and to permit trade reports to use a Time of Execution communicated by the ATS to each Party to a Transaction.
FINRA believes it is appropriate to provide the proposed relief in recognition of the fact that impacted members are unable to implement necessary changes by the July 10, 2017 effective date for TRACE reporting of transactions in U.S. Treasury Securities. FINRA believes the proposal strikes an appropriate balance in that FINRA will continue to receive transaction information for purchases and sales that occur as part of an ATS trading session, albeit aggregated. A member ATS availing itself of this exception must provide individual transaction information for each trade in a U.S. Treasury Security occurring in a trading session to FINRA upon request. In addition, FINRA notes that transparency will not be impacted by the proposed temporary relief because transaction information in U.S. Treasury Securities currently is not subject to dissemination.
FINRA has filed the proposed rule change for immediate effectiveness. The operative date of the proposed rule change will be July 10, 2017 and it will sunset on July 10, 2018, which FINRA believes will provide members with the additional time necessary to complete necessary systems changes and result in a more orderly implementation of the TRACE reporting requirements for Treasury securities.
FINRA believes that the proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Act,
FINRA does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The proposed rule change should benefit members whose trades are executed on member ATSs as part of a trading session, as it provides members with additional time to build or upgrade systems to enable reporting of individual transactions in the trading section. While the proposed rule change will temporarily lessen the requirements on ATSs and their subscribers as compared to other market participants, FINRA believes the proposed rule change is appropriate to allow sufficient time to make the technological changes necessary to comply with the rule and such accommodation will be limited in duration. Moreover, FINRA retains the right to require a member ATS availing itself of this exception to provide individual transaction information for each trade in a U.S. Treasury Security occurring in a trading session upon request.
The proposed temporary relief is not expected to undermine the potential benefits of Rule 6730, as the transaction information reflecting the aggregate size and average price of such transactions should still assist the regulators to conduct monitoring and surveillance of the U.S. Treasury Securities markets, in order to detect potential disruptive trading practices and risks to market stability.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
FINRA has asked the Commission to waive the 30-day operative delay so that the proposal will become operative immediately upon filing. FINRA represents that it only recently was made aware of the significant technological changes to member systems that will be necessary to comply with FINRA's requirements to report transactions in U.S. Treasury Securities to TRACE. FINRA also represented that it was informed by members that these systems changes cannot be completed by July 10, 2017, the date on which the new reporting requirements come into force. The proposed rule change appears to be a reasonable accommodation for members who are affected by unforeseen difficulties associated with systems reprogramming because it is of reasonably short duration and FINRA will still be able to request full transaction information from an ATS that benefits from the accommodation. Therefore, to facilitate orderly application of the TRACE reporting rules on July 10, 2017, the Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest and designates the proposal operative upon filing.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to extend the operation of a pilot program that eliminates position and exercise limits for physically-settled SPY options (“SPY Pilot Program”). The text of the proposed rule change is provided below.
(additions are
No changes.
.01–.06 No change.
.07 The position limits under Rule 4.11 applicable to options on shares or other securities that represent interests in registered investment companies (or series thereof) organized as open-end management investment companies, unit investment trusts or similar entities that satisfy the criteria set forth in Interpretation and Policy .06 under Rule 5.3 shall be the same as the position limits applicable to equity options under Rule 4.11 and Interpretations and Policies thereunder; except that the position limits under Rule 4.11 applicable to option contracts on the securities listed in the below chart are as follows:
Position limits for SPY options are subject to a pilot program through [July 12, 2017]
.08 No change.
The text of the proposed rule change is also available on the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Interpretation and Policy .07 to Rule 4.11 (Position Limits) to extend the
In proposing to extend the SPY Pilot Program, the Exchange reaffirms its consideration of several factors that supported its original proposal to establish the SPY Pilot Program, which include: (1) The liquidity of the option and the underlying security; (2) the market capitalization of the underlying security and the securities that make up the S&P 500 Index; (3) options reporting requirements; and (4) financial requirements imposed by CBOE and the Commission. When the SPY Pilot Program was most recently renewed in July 2016, CBOE submitted a report providing an analysis of the SPY Pilot Program during the period June 2015 through April 2016 (the “Pilot Report”). In the July 2016 extension, the Exchange stated that if it were to submit a proposal to either extend the SPY Pilot Program, adopt the SPY Pilot Program on a permanent basis, or terminate the SPY Pilot Program, it would submit another Pilot Report covering the period since the previous extension.
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change is not designed to address any aspect of competition, whether between the Exchange and its competitors, or among market participants. Instead, the proposed rule change is designed to allow the SPY Pilot Program to continue as the Exchange expects other SROs will propose similar extensions.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b–4(f)(6) thereunder.
A proposed rule change filed pursuant to Rule 19b–4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange is filing a proposal to amend the MIAX Options Fee Schedule (the “Fee Schedule”).
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend the list of MIAX Select Symbols
The Exchange has decided not to include Altaba in the list of MIAX Select Symbols. Thus, the Exchange is amending its Fee Schedule to delete the symbol YHOO from the list of MIAX Select Symbols contained in the Program to correspond with this change. This amendment is intended to
The Exchange believes that its proposal to amend its fee schedule is consistent with Section 6(b) of the Act
In particular, the proposal to delete the symbol YHOO from the list of MIAX Select Symbols contained in the Program is consistent with Section 6(b)(4) of the Act because the proposed change will allow for continued benefit to investors by providing them an updated list of MIAX Select Symbols contained in the Program on the Fee Schedule.
The Exchange believes that the proposal to amend an option class that qualifies for the credit for transactions in MIAX Select Symbols is fair, equitable and not unreasonably discriminatory. The Exchange believes that the Program itself is reasonably designed because it incentivizes providers of Priority Customer
The Exchange also believes that its proposal is consistent with Section 6(b)(5) of the Act because it will apply equally to all Priority Customer orders in MIAX Select Symbols in the Program. All similarly situated Priority Customer orders in MIAX Select Symbols are subject to the same rebate schedule, and access to the Exchange is offered on terms that are not unfairly discriminatory.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change is a not a competitive filing but rather is designed to update the list of MIAX Select Symbols contained in the Program in order to avoid potential confusion on the part of market participants.
Written comments were neither solicited nor received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to apply the Non-Priority Customer license surcharge set forth in Section IV.B of the Schedule of Fees to orders that are routed to away markets.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to apply the Non-Priority Customer (
Today, the Exchange charges Non-Priority Customers route-out fees for orders in Non-Select Symbols
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
Likewise, in
Further, “[n]o one disputes that competition for order flow is `fierce.' . . . As the SEC explained, `[i]n the U.S.
The Exchange believes that its proposal to apply the License Surcharge to Non-Priority Customer orders in licensed products that are routed to away markets in connection with the Plan is reasonable and equitable because it offsets both the costs associated with executing orders on away markets as well as the licensing costs associated with listing and trading these products. In particular, the Exchange's route-out fees are presently not calculated to cover the licensing costs for BKX and NDX. The Exchange notes that a license agreement is required to trade these products regardless of whether the order is executed on the Exchange or routed to another exchange in connection with the Plan. As such, the Exchange believes that extending the License Surcharge to those orders that are routed to away markets (in addition to those orders executed on the Exchange) is a reasonable and equitable means of recovering the costs of the license. Furthermore, the Exchange must pay the actual transaction fees charged by the exchange the order is routed to, which includes the license surcharge that such exchange assesses for those products. The Exchange's route-out fees are currently not calculated to cover these license surcharges assessed by other exchanges and therefore seeks to recover these costs under this proposal. For example, an NDX order that is routed to the Chicago Board Options Exchange (“CBOE”) in connection with the Plan would be assessed a $0.25 license surcharge by CBOE on top of the actual transaction fees that CBOE would charge for the NDX order.
The Exchange also believes that its proposal is reasonable and equitable because Non-Priority Customers would be able to avoid paying the License Surcharge by sending the Exchange orders in these licensed products to be routed to another market and only pay the Exchange's route-out fee. The Exchange would, however, still be required to pay all of the actual transaction fees (including the license surcharge) charged by the exchange the order is routed to. For example, a Non-Priority Customer order in NDX that is routed to CBOE today would only be assessed the $0.95 per contract route-out fee while the Exchange would pay the $0.25 per contract license surcharge on top of the actual transaction fees CBOE would charge for the NDX order. The Exchange therefore believes that it is reasonable and equitable to assess the License Surcharge to orders in those licensed products which are routed to other exchanges in order to avoid this scenario.
Finally, the Exchange believes that the proposed fee change is equitable and not unfairly discriminatory because the Exchange will apply the same fee to all similarly situated members. In particular, the License Surcharge would be applied to all Non-Priority Customer orders in those licensed products which are routed to away markets in connection with the Plan. The Exchange believes it is equitable and not unfairly discriminatory to assess this surcharge on all participants other than Priority Customers because the Exchange seeks to encourage Priority Customer order flow and the liquidity such order flow brings to the marketplace, which in turn benefits all market participants.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges. Because competitors are free to modify their own fees in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited.
In this instance, the proposed application of the License Surcharge to orders that are routed to one or more exchanges in connection with the Plan does not impose a burden on competition because the Exchange's execution services are completely voluntary and subject to extensive competition from other exchanges. If the changes proposed herein are unattractive to market participants, it is likely that the Exchange will lose market share as a result. Accordingly, the Exchange does not believe that its proposal will impair the ability of members to maintain their competitive standing in the financial markets.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the NYSE Listed Company Manual (the “Manual”) to require listed companies to provide notice to the Exchange at least 10 minutes before making any public announcement with respect to a dividend or stock distribution in all cases, including outside of the hours in which the Exchange's immediate release policy is in operation. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Manual to require listed companies to provide notice to the Exchange at least 10 minutes before making any public announcement with respect to a dividend or stock distribution in all cases, including outside of the hours in which the Exchange's immediate release policy is in operation.
The Exchange's immediate release policy, set forth in Sections 202.05 and 202.06 of the Manual, already requires companies releasing material news between 7.00 a.m. ET and the NYSE close (generally 4.00 p.m. ET) to call the Exchange's Market Watch team at least 10 minutes before issuing their announcement to discuss the content of the announcement and also email a copy of the proposed announcement to Market Watch at least 10 minutes before its release. Listed companies announcing dividends during these hours are required to comply with the immediate release policy in connection with such announcement.
Section 204.12 of the Manual requires listed companies to give prompt notice to the Exchange as to any dividend action or action relating to a stock distribution in respect of a listed stock (including the omission or postponement of a dividend action at the customary time as well as the declaration of a dividend). This notice must be given at least ten days in advance of the record date and is in addition to the requirement to publicly disclose the information pursuant to the immediate release policy. The dividend notice must be given to the Exchange in accordance with Section 204.00.
In addition, Section 204.21 of the Manual requires listed companies to give prompt notice to the Exchange of the fixing of a date for the taking of a record of shareholders, or for the closing of transfer books (in respect of a listed security), for any purpose. The notice must state the purpose or purposes for which the record date has been fixed. This notice must be provided to the
The Exchange proposes to amend each of Sections 204.12 and 204.21 to specify that notice of any dividend or stock distribution required by Section 204.12 must be provided to the Exchange at least 10 minutes before any public announcement, including when such announcement is being made outside of Exchange trading hours. The principal effect of this amendment would be to require listed companies to provide 10 minutes advance notice to the Exchange with respect to a dividend announcement made at any time, rather than just during the hours of operation of the immediate release policy as is currently the case.
The Exchange also proposes to amend Section 202.06(B) to emphasize the Exchange's consistent interpretation of that rule as requiring listed companies to comply with the immediate release policy with respect to all announcements relating to a dividend or stock distribution.
The Exchange believes there are significant benefits to requiring listed companies to provide all announcements of dividends and stock distributions to the Exchange prior to their public dissemination. In particular, if the Exchange is provided dividend information prior to its public availability, Exchange staff will be able to address any issues that may arise in relation to any announcement of a dividend or stock distribution. The proposed advance notice requirement would enable Exchange staff to ensure that a listed company's proposed dividend schedule complied with applicable Exchange requirements, including the requirement to provide 10 days advanced notice of the record date, and that the company's disclosure of the application of the Exchange's “ex'-dividend trading policy was accurate. The Exchange intends to have staff available at all times to review dividend notifications immediately upon receipt, regardless of what time or day of the week they are provided. The staff will contact a listed company immediately if there is a problem with its notification. Addressing problems with dividend notifications before they are issued publicly will avoid any confusion in the marketplace resulting from the dissemination of inaccurate information.
The Exchange believes that the proposed rule change is consistent with Section 6(b)
The Exchange believes that the proposed rule change is consistent with Section 6(b)
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to apply the Non-Priority Customer license surcharge set forth in Section I of the Schedule of Fees to orders that are routed to away markets.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to apply the Non-Priority Customer (
Today, the Exchange charges Non-Priority Customers route-out fees for orders in Non-Penny Symbols
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
Likewise, in
Further, “[n]o one disputes that competition for order flow is `fierce.' . . . As the SEC explained, `[i]n the U.S. national market system, buyers and sellers of securities, and the broker-dealers that act as their order-routing agents, have a wide range of choices of where to route orders for execution'; [and] `no exchange can afford to take its market share percentages for granted' because `no exchange possesses a monopoly, regulatory or otherwise, in the execution of order flow from broker dealers'. . . .”
The Exchange believes that its proposal to apply the NDX Surcharge to Non-Priority Customer orders in NDX that are routed to away markets in connection with the Plan is reasonable and equitable because it offsets both the costs associated with executing orders on away markets as well as the licensing costs associated with listing and trading NDX. The Exchange's route-out fees are presently not calculated to cover the licensing costs for NDX. The Exchange notes that a license agreement is required to trade NDX regardless of whether the NDX order is executed on the Exchange or routed to another exchange in connection with the Plan. As such, the Exchange believes that extending the NDX Surcharge to NDX orders routed to away markets (in addition to those orders executed on the Exchange) is a reasonable and equitable means of recovering the costs of the license. Furthermore, the Exchange must pay the actual transaction fees charged by the exchange the NDX order is routed to, which includes the license surcharge that such exchange assesses for NDX orders. The Exchange's route-out fees are currently not calculated to cover these license surcharges assessed by other exchanges and therefore seeks to recover these costs under this proposal. For example, an NDX order that is routed to the Chicago Board Options Exchange (“CBOE”) in connection with the Plan would be assessed a $0.25 license surcharge by CBOE on top of the actual transaction fees CBOE would charge for the NDX order.
The Exchange also believes that its proposal is reasonable and equitable because Non-Priority Customers would be able to avoid paying the NDX Surcharge by sending the Exchange NDX orders to be routed to another market and only pay the Exchange's route-out fee. The Exchange would, however, still be required to pay all of the actual transaction fees (including the license surcharge) charged by the exchange the order is routed to. For example, a Non-Priority Customer order in NDX that is routed to CBOE today would only be assessed the $0.95 per contract route-out fee while the Exchange would pay the $0.25 per contract license surcharge on top of the actual transaction fees CBOE would charge for the NDX order. The Exchange therefore believes that it is reasonable and equitable to assess the NDX Surcharge to NDX orders that are routed to other exchanges in order to avoid this scenario.
Finally, the Exchange believes that the proposed fee change is equitable and not unfairly discriminatory because the Exchange will apply the same fee to all similarly situated members. In particular, the NDX Surcharge would be applied to all Non-Priority Customer orders routed to away markets in connection with the Plan. The Exchange believes it is equitable and not unfairly discriminatory to assess this surcharge on all participants other than Priority Customers because the Exchange seeks to encourage Priority Customer order flow and the liquidity such order flow brings to the marketplace, which in turn benefits all market participants.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges. Because competitors are free to modify their own fees in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited.
In this instance, the proposed application of the NDX Surcharge to NDX orders that are routed to one or more exchanges in connection with the Plan does not impose a burden on competition because the Exchange's execution services are completely voluntary and subject to extensive competition from other exchanges. If the changes proposed herein are unattractive to market participants, it is likely that the Exchange will lose market share as a result. Accordingly, the Exchange does not believe that its proposal will impair the ability of members to maintain their competitive standing in the financial markets.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Selective Service System.
Notice of Amendment to Systems of Records.
Selective Service System has amended an existing system of records subject to the Privacy Act of 1974. This action is necessary to meet the requirements of the Privacy Act to publish in the
The changes became effective in 2012. The system has been operational for five years.
Chief Information Officer, Office of Information Technology, Operations Directorate, Selective Service System, 1515 Wilson Boulevard, Arlington, Virginia 22209–2425.
This notice serves to update, amend, and consolidate the System of Records Notice for SSS–5 Reserve Force and National Guard Personnel Records; SSS–6 Uncompensated Personnel Records; and SSS–8 Pay Records published in the
5 U.S.C. 552a
Integrated Mobilization Information Management System (IMIS) and Reserve and National Guard Personnel Records.
None.
National Headquarters, Selective Service System, 1515 Wilson Boulevard, Arlington, VA 22209–2425.
The Selective Service System is an independent agency of the United States government that maintains information on those potentially subject to military conscription. The statutory mission of the Selective Service is to be prepared to provide trained and untrained personnel to the DoD in the event of a national emergency and to be prepared to implement an alternative service program for registrants classified as conscientious objectors. These records are maintained at the National Headquarters Office in Arlington, VA.
The Selective Service System's Integrated Mobilization Information Management System (IMIS) is an application created by the Agency to manage reserve force officers and resources assigned to the Agency, various budget allocations and expenditures, local area boards, state directors, and Agency material resources. The Agency developed IMIS to manage resources needed to facilitate mission readiness; resources consist of assigned personnel, material, and budget management.
The records contain information relating to selection, placement and utilization of military personnel assigned to SSS such as name, rank, Social Security account number, date of birth, physical profile, residence and business addresses, and telephone numbers.
Chapter 49, Military Selective Service Act (50 U.S.C. 3801
The purpose of these series of records is to provide information on Officers and Warrant Officers of the Reserves and National Guard currently assigned to the SSS. This system is used to verify payment information for reserve force officers assigned to the agency. Records includes full name of the individual, date of birth, selective service number (if available), mailing address, payment information, financial reports and reimbursements. Documents are scanned into this system for computer-based storage and shared with the National Business Center in Denver, Colorado. This system has some PII information unique solely to the system.
Data is kept secure in accordance with the National Institutes of Standards and Technologies'
Records are indexed by name and Service Number.
a. Use of the records or any information contained therein is limited to Selective Service System employees or Reserve Forces Members whose official duties require access.
b. Records maintained by authorized personnel only, who have been trained in the rules and regulations concerning disclosures of information.
c. Periodic security checks and other emergency planning.
Chief Information Officer, Office of Information Technology, Operations Directorate, Selective Service System, 1515 Wilson Boulevard, Arlington, VA 22209–2425.
Temporary. Cutoff at the end of the calendar year. Destroy immediately after employee is no longer assigned to Selective Service System.
SSS Reserve Forces Members or former members who wish to gain access to their records should make their request in writing addressed to: Selective Service System, 1515 Wilson Boulevard, Arlington, VA 22209–2425, Attn: Military Personnel.
It is necessary to include the Member's full name, rank, branch of service, address, and Social Security Account Number.
See Record Access Procedures, above.
Information in this system is obtained directly from the individual to whom it applies or is derived from information supplied or is provided by the individual Branch of the Armed Forces.
None.
Selective Service System.
Notice of Amendment to Systems of Records.
Selective Service System has amended an existing system of records subject to the Privacy Act of 1974. This action is necessary to meet the requirements of the Privacy Act to publish in the
The changes became effective in 2012. The system has been operational for five years.
Chief Information Officer, Office of Information Technology, Operations Directorate, Selective Service System, 1515 Wilson Boulevard, Arlington, Virginia 22209–2425.
This notice serves to update, amend, and consolidate the Systems of Records Notice for SSS–2 General Files Registrant Processing; SSS–3 Reconciliation Service Records; SSS–4 Registrant Information Bank Records; SSS–7 Suspected Violator Inventory System; and SSS–9 Registrant Reservation Records published in the
5 U.S.C. 552a.
None.
Data Management Center, Operations Directorate, Great Lakes, Illinois 60088.
Registrants of the Selective Service System after 1979 (men born after December 31, 1959). Young men register upon reaching their 18th birthday. By current law, women are not required to register.
a. Registration Form.
b. Computer database, computer tape and microfilm copies containing information provided by the registrant on Registration Form.
Chapter 49, Military Selective Service Act (50 U.S.C. 3801
The
Department of Justice—For review and processing of suspected violations of the Military Selective Service Act (MSSA), for perjury, and for defense of a civil action arising from administrative processing under such Act.
Department of State and U.S. Citizenship and Immigration Services—For collection and evaluation of data to determine a person's eligibility for United States citizenship.
Department of Defense and U.S. Coast Guard—To exchange data concerning registration, classification, induction, and examination of registrants and for identification of prospects for recruiting.
Department of Labor—To assist veterans in need of data concerning reemployment rights, and for determination of eligibility for benefits under the Workforce Investment Act.
Department of Education—To determine eligibility for student financial assistance.
U.S. Census Bureau—For the purposes of planning or carrying out a census or survey or related activity pursuant to the provisions of Title 13.
Office of Personnel Management and U.S. Postal Service—To determine eligibility for employment.
Department of Health and Human Services—To determine a person's proper Social Security Account Number and for locating parents pursuant to the Child Support Enforcement Act.
State and Local Governments—To provide data that may constitute evidence and facilitate the enforcement of state and local law.
Alternative Service Employers—During conscription, to exchange information with employers regarding a registrant who is a conscientious objector for the purpose of placement and supervision of performance of alternative service in lieu of induction into the military service.
General Public—Registrant's name, Selective Service Registration Number, Date of Birth and Classification, (Military Selective Service Act, 50 U.S.C. 3806(h)).
Records are maintained on microfilm and in the computer system. Microfilm records are indexed by Document Locator Number, and the computer system lists these numbers for document retrieval from the microfilm records.
The system is indexed by Selective Service Number, but records can be located by searching for specific data.
Measures that have been taken to prevent unauthorized disclosures of records are:
a. Records are maintained by authorized personnel only, who have been trained in the rules and regulations concerning disclosures of information; offices are locked when authorized personnel are not on duty, and are protected by an electronic security access system at all times.
b. Periodic security checks and other emergency planning.
c. Microfilm records transferred to a Federal Records Center for storage are boxed and taped; records in transit for temporary custody of another office are sealed.
d. Selective Service System employees access the application via customized user interface—access is controlled by user id and password credentials.
e. Records eligible for destruction are destroyed by maceration, shredding, burning or purging from the RCV database.
Individual Processing Records:
1. Registration Form—Destroyed by maceration when its information has been transferred onto microfilm, added to the computer system, and an image has been transferred to the National Archives. Original microfilm is stored at a Federal Records Center. A microfilm non-record copy is retained at the Data Management Center, in locked steel cabinets. The copies are retained until no longer needed for reference purposes. Also, registration files are stored on hard drives/network storage.
2. The record copy of microfilm and computer database will be retained until the registrant reaches 85 years of age.
Chief Information Officer, Office of Information Technology, Operations Directorate, Selective Service System, 1515 Wilson Boulevard, Arlington, VA 22209–2425.
The agency office address to which inquiries should be addressed and the location at which an individual may present a request as to whether the RCV System (after 1979) contains records pertaining to himself is: Chief Information Officer, Selective Service System, 1515 Wilson Boulevard, Arlington, VA 22209–2425.
It is necessary to furnish the following information in order to identify the individual whose records are requested:
a. Full name of the individual.
b. Selective Service Number or Social Security Account Number, date of birth and address at the time of registration if Selective Service Number is not known.
c. Mailing address to which the reply should be mailed.
See Record Access Procedures, above.
Information contained in the Registrant Registration Records System is obtained from the individual.
None.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of TENNESSEE (FEMA–4320–DR), dated 06/23/2017.
Effective 06/23/2017.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416, (202) 205–6734.
Notice is hereby given that as a result of the President's major disaster declaration on 06/23/2017, Private Non-Profit organizations that provide essential services of governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 15187B and for economic injury is 15188B.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of IDAHO (FEMA–4313–DR), dated 05/18/2017.
Effective 06/22/2017.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416, (202) 205–6734.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of IDAHO, dated 05/18/2017, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
Acting under the authority of and in accordance with section 1(b) of Executive Order 13224 of September 23, 2001, as amended by Executive Order 13268 of July 2, 2002, and Executive Order 13284 of January 23, 2003, I hereby determine that the person known as Mohammad Yusuf Shah, also known as Mohd Yusuf Shah, also known as Mohammad Yousuf Shah, also known as Mohd Yousuf Shah, also known as Mohd Yosuf Shah, also known as Mohammed Yusaf Shah, also known as Syed Mohammed Yusuf Shah, also known as Syed Salahuddin, also known as Syed Salahudin, also known as Sayeed Salahudeen, also known as Peer Sahib, also known as Salauddin committed, or poses a significant risk of committing, acts of terrorism that threaten the security of U.S. nationals or the national security, foreign policy, or economy of the United States.
Consistent with the determination in section 10 of Executive Order 13224 that prior notice to persons determined to be subject to the Order who might have a constitutional presence in the United States would render ineffectual the blocking and other measures authorized in the Order because of the ability to transfer funds instantaneously, I determine that no prior notice needs to be provided to any person subject to this determination who might have a constitutional presence in the United States, because to do so would render ineffectual the measures authorized in the Order.
This notice shall be published in the
Notice of request for public comment and submission to OMB of proposed collection of information.
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Submit comments directly to the Office of Management and Budget (OMB) up to July 31, 2017.
Direct comments to the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB). You may submit comments by the following methods:
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Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Derek A. Rivers, Bureau of Consular Affairs, Overseas Citizens Services (CA/OCS/PMO), U.S. Department of State, 2201 C. St. NW., Washington, DC 20522, who may be reached at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
Federal Aviation Administration, DOT.
Notice.
The Federal Aviation Administration (FAA) announces that it is reviewing a proposed noise compatibility program that was submitted for Hawthorne Municipal Airport under the Aviation Safety and Noise Abatement Act, (hereinafter referred to as “the Act”) and 14 Code of Federal Regulations (CFR) part 150 by the City of Hawthorne, Los Angeles County, California. This program was submitted subsequent to a determination by FAA that associated noise exposure maps submitted under 14 CFR part 150 for Hawthorne Municipal Airport were in compliance with applicable requirements, effective April 11, 2014, 79 FR 24488–24489. The proposed noise compatibility program will be approved or disapproved on or before December 20, 2017.
The effective date of the start of FAA's review of the noise compatibility program is June 23, 2017. The public comment period ends August 22, 2017.
Victor Globa, Federal Aviation Administration, Los Angeles Airports District Office, 15000 Aviation Boulevard, Room 3000, Lawndale, California 90261, Telephone: 310/725–3637. Comments on the proposed noise compatibility program should also be submitted to the above office.
This notice announces that the FAA is reviewing a proposed noise compatibility program for Hawthorne Municipal Airport which will be approved or disapproved on or before December 20, 2017. This notice also announces the availability of this program for public review and comment.
An airport operator who has submitted noise exposure maps that are found by FAA to be in compliance with the requirements of 14 CFR part 150, promulgated pursuant to the Act, may submit a noise compatibility program for FAA approval which sets forth the measures the operator has taken or proposes to reduce existing non-compatible uses and prevent the introduction of additional non-compatible uses.
The FAA has formally received the noise compatibility program for Hawthorne Municipal Airport, effective on December 20, 2016. The airport operator has requested that the FAA review this material and that the noise mitigation measures, to be implemented jointly by the airport and surrounding communities, be approved as a noise compatibility program under section 47504 of the Act. Preliminary review of the submitted material indicates that it conforms to 14 CFR part 150 requirements for the submittal of noise compatibility programs, but that further review will be necessary prior to approval or disapproval of the program. The formal review period, limited by law to a maximum of 180 days, will be completed on or before December 20, 2017.
The FAA's detailed evaluation will be conducted under the provisions of 14 CFR part 150, section 150.33. The primary considerations in the evaluation process are whether the proposed measures may reduce the level of aviation safety or create an undue burden on interstate or foreign commerce, and whether they are reasonably consistent with obtaining the goal of reducing existing non-compatible land uses and preventing the introduction of additional non-compatible land uses.
Interested persons are invited to comment on the proposed program with specific reference to these factors. All comments relating to these factors, other than those properly addressed to local land use authorities, will be considered by the FAA to the extent practicable. Copies of the noise exposure maps and the proposed noise compatibility program are available for examination at the following locations:
Federal Aviation Administration (FAA), DOT.
Notice of petition for exemption received.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of the FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number involved and must be received on or before July 20, 2017.
Send comments identified by docket number FAA–2017–0535 using any of the following methods:
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Deana Stedman, ANM–113, Federal Aviation Administration, 1601 Lind Avenue SW., Renton, WA 98057–3356, email
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before July 20, 2017.
Send comments identified by docket number {FAA–2017–0379} using any of the following methods:
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Alphonso Pendergrass (202) 267–4713, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice of request to release airport property.
The FAA proposes to rule and invites public comment on the release of land at the Dallas/Fort Worth International Airport under the provisions of Section 125 of the Wendell H. Ford Aviation Investment Reform Act for the 21st Century (AIR 21).
Comments must be received on or before July 31, 2017.
Comments on this application may be mailed or delivered to the FAA at the following address: Mr. Ben Guttery, Manager, Federal Aviation Administration, Southwest Region, Airports Division, Texas Airports District Office, ASW–650, 10101 Hillwood Parkway, Fort Worth, Texas 76177.
In addition, one copy of any comments submitted to the FAA must
Mr. Steven Cooks, Program Manager, Federal Aviation Administration, Texas Airports District Office, ASW–650, 10101 Hillwood Parkway, Fort Worth, TX 76177, Telephone: (817) 222–5608, email:
The request to release property may be reviewed in person at this same location.
The FAA invites public comment on the request to release property at the Dallas/Fort Worth International Airport under the provisions of the AIR 21.
The following is a brief overview of the request:
The Dallas/Fort Worth International Airport requests the release of 41.096 acres of non-aeronautical airport property for permanent easement to the Fort Worth Transportation Authority. The permanent easement to be released will be used for public mass transit improvements and revenues shall be used to further develop, operate and maintain DFW Airport.
Any person may inspect the request in person at the FAA office listed above under
In addition, any person may, upon request, inspect the application, notice and other documents relevant to the application in person at the: Dallas/Fort Worth International Airport, Telephone Number (972) 973–4646.
Federal Aviation Administration (FAA), DOT.
Notice of petition for exemption received.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of the FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number involved and must be received on or before July 20, 2017.
Send comments identified by docket number FAA–2017–0259 using any of the following methods:
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Lynette Mitterer, ANM–113, Federal Aviation Administration, 1601 Lind Avenue SW., Renton, WA 98057–3356, email
This notice is published pursuant to 14 CFR 11.85.
Federal Railroad Administration (FRA), U.S. Department of Transportation
Notice and request for comments.
Under the Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, FRA seeks approval of proposed information collection activities listed below. Before submitting these information collection requests (ICRs) to the Office of Management and Budget (OMB) for approval, FRA is soliciting public comment on specific aspects of the activities identified in this notice.
Comments must be received no later than August 29, 2017.
Submit written comments on the information collection activities by mail to either: Mr. Robert Brogan, Information Collection Clearance Officer, Office of Railroad Safety, Regulatory Analysis Division, RRS–21, Federal Railroad Administration, 1200 New Jersey Avenue SE., Mail Stop 25, Washington, DC 20590; or Ms. Kim Toone, Information Collection Clearance Officer, Office of Information Technology, RAD–20, Federal Railroad Administration, 1200 New Jersey Avenue SE., Mail Stop 35, Washington, DC 20590. Commenters requesting FRA to acknowledge receipt of their respective comments must include a self-addressed stamped postcard stating, “Comments on OMB Control Number 2130–XXXX,” (the relevant OMB
Mr. Robert Brogan, Information Collection Clearance Officer, Office of Railroad Safety, Regulatory Analysis Division, RRS–21, Federal Railroad Administration, 1200 New Jersey Avenue SE., Mail Stop 25, Washington, DC 20590 (telephone: (202) 493–6292) or Ms. Kim Toone, Information Collection Clearance Officer, Office of Information Technology, RAD–20, Federal Railroad Administration, 1200 New Jersey Avenue SE., Mail Stop 35, Washington, DC 20590 (telephone: (202) 493–6132). (These telephone numbers are not toll free.)
The PRA, 44 U.S.C. 3501–3520, and its implementing regulations, 5 CFR part 1320, require Federal agencies to provide 60-days' notice to the public to allow comment on information collection activities before seeking OMB approval of the activities.
FRA believes soliciting public comment will promote its efforts to reduce the administrative and paperwork burdens associated with the collection of information Federal regulations mandate. In summary, FRA reasons comments received will advance three objectives: (1) Reduce reporting burdens; (2) ensure it organizes information collection requirements in a “user-friendly” format to improve the use of such information; and (3) accurately assess the resources expended to retrieve and produce information requested.
Below is a brief summary of currently approved information collection activities FRA will submit for OMB clearance as the PRA requires:
Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi), FRA informs all interested parties that it may not conduct or sponsor, and a respondent is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
44 U.S.C. 3501–3520.
Maritime Administration.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before July 31, 2017.
Comments should refer to docket number MARAD–2017–0107. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23–453, Washington, DC 20590. Telephone 202–366–9309, Email
As described by the applicant the intended service of the vessel SEA RAVEN is:
The complete application is given in DOT docket MARAD–20170107 at
In accordance with 5 U.S.C. 553(c), DOT/MARAD solicits comments from the public to better inform its rulemaking process. DOT/MARAD posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121.
By Order of the Maritime Administrator.
Maritime Administration.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before July 31, 2017.
Comments should refer to docket number MARAD–2017–0114. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23–453, Washington, DC 20590. Telephone 202–366–9309, Email
As described by the applicant the intended service of the vessel FRIDAY is:
The complete application is given in DOT docket MARAD–2017–0114 at
In accordance with 5 U.S.C. 553(c), DOT/MARAD solicits comments from the public to better inform its rulemaking process. DOT/MARAD posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121
By Order of the Maritime Administrator.
Maritime Administration.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before July 31, 2017.
Comments should refer to docket number MARAD–2017–0108. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23–453, Washington, DC 20590. Telephone 202–366–9309, Email
As described by the applicant the intended service of the vessel TRAVELER is:
The complete application is given in DOT docket MARAD–2017–0108 at
In accordance with 5 U.S.C. 553(c), DOT/MARAD solicits comments from the public to better inform its rulemaking process. DOT/MARAD posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121.
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before July 31, 2017.
Comments should refer to docket number MARAD–2017–0109. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23–453, Washington, DC 20590. Telephone 202–366–9309, Email
As described by the applicant the intended service of the vessel GATO GORDO is:
The complete application is given in DOT docket MARAD–2017–0109 at
In accordance with 5 U.S.C. 553(c), DOT/MARAD solicits comments from the public to better inform its rulemaking process. DOT/MARAD posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121.
By Order of the Maritime Administrator.
Maritime Administration
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before July 31, 2017.
Comments should refer to docket number MARAD–2017–0111. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23–453, Washington, DC 20590. Telephone 202–366–9309, Email
As described by the applicant the intended service of the vessel MARBELA is:
The complete application is given in DOT docket MARAD–2017–0111 at
In accordance with 5 U.S.C. 553(c), DOT/MARAD solicits comments from the public to better inform its rulemaking process. DOT/MARAD posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121.
By Order of the Maritime Administrator.
Maritime Administration
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before July 31, 2017.
Comments should refer to docket number MARAD–2017–0106. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23–453, Washington, DC 20590. Telephone 202–366–9309, Email
As described by the applicant the intended service of the vessel PRINCESS DONNA is:
The complete application is given in DOT docket MARAD–2017–0106 at
In accordance with 5 U.S.C. 553(c), DOT/MARAD solicits comments from the public to better inform its rulemaking process. DOT/MARAD posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121.
By Order of the Maritime Administrator.
Maritime Administration.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief
Submit comments on or before July 31, 2017.
Comments should refer to docket number MARAD–2017–0112. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23–453, Washington, DC 20590. Telephone 202–366–9309, Email
As described by the applicant the intended service of the vessel MARIE KNIGHT is:
The complete application is given in DOT docket MARAD–2017–0112 at
In accordance with 5 U.S.C. 553(c), DOT/MARAD solicits comments from the public to better inform its rulemaking process. DOT/MARAD posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121.
By Order of the Maritime Administrator.
Maritime Administration
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before July 31, 2017.
Comments should refer to docket number MARAD–2017–0115. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23–453, Washington, DC 20590. Telephone 202–366–9309, Email
As described by the applicant the intended service of the vessel HYP NAUTIC is:
The complete application is given in DOT docket MARAD–2017–0115 at
In accordance with 5 U.S.C. 553(c), DOT/MARAD solicits comments from the public to better inform its rulemaking process. DOT/MARAD posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121.
A.
B.
C.
D.
E.
A.
The CDFI Fund reserves the right, in its sole discretion, to provide a CMF Award in an amount other than that which the Applicant requests; however, the award amount will not exceed the Applicant's award request as stated in its Application. An Applicant may receive only one award through the FY 2017 CMF Program Funding Round.
B.
C.
If providing Homeownership assistance, a CMF Award may be used in conjunction with awards/allocations from other CDFI Fund programs only if the Project can be divided into such phases, and the CMF Award is used in a different phase from the other CDFI Fund program awards/allocations. To clarify, a CMF Award cannot be used for a Homeownership property that is permanently financed (or supported) by both the Recipient's CMF Award and an award/allocation from another CDFI Fund program (
2. Costs financed/supported by the Recipient's other awards/allocations from CDFI Fund programs, including awards from prior CMF rounds, may not be counted or reported as Leveraged Costs for the CMF Award, as further set forth in the Assistance Agreement. While the Recipient's other CMF Awards may be used to finance/support the same property, each award must separately meet the program requirements as outlined in the applicable Assistance Agreement and the CMF interim rule (12 CFR part 1807). The term Recipient includes the CMF Award Recipient and any Affiliates.
In all cases, the CMF Award remains subject to the following restriction imposed by the CDFI Bond Guarantee Program: Award funds received under any CDFI Fund program cannot be used by any participant of the CDFI Bond Guarantee Program, including Qualified Issuers, Eligible CDFIs, and Secondary Borrowers, to pay principal, interest, fees, administrative costs, or issuance costs (including Bond Issuance Fees) related to the CDFI Bond Guarantee Program, or to fund the Risk Share Pool for a Bond Issue (all capitalized terms used in this sentence, other than “CMF Award”, shall have the meanings ascribed to them in the CDFI Bond Guarantee Program regulations and applicable guidance).
D.
E.
Any Applicant that does not meet the criteria in Table 2 is ineligible to apply for a CMF Award under this NOFA. Further, Section III.B describes additional considerations applicable to prior award Recipients and/or Allocatees under any CDFI Fund program.
1. Debarment/Do not pay verification: The CDFI Fund will conduct a debarment check and will not consider an Application if the Applicant is delinquent on any Federal debt or otherwise ineligible to receive a Federal award. The Do Not Pay Business Center was developed to support Federal agencies in their efforts to reduce the number of improper payments made through programs funded by the Federal government and provides delinquency information to the CDFI Fund to assist with the debarment check.
2. Entities that Submit Applications Together with Affiliates: As part of the Application review process, the CDFI Fund considers whether Applicants are Affiliates, as such term is defined in 12 CFR1807.104. If an Applicant and its Affiliates wish to submit Applications, they must do so collectively, in one Application; an Applicant and its Affiliates may not submit separate Applications. If Affiliates submit multiple or separate Applications, the CDFI Fund will reject all such Applications received.
Furthermore, an Applicant that receives an award in this CMF round may not become an Affiliate of another Applicant that receives an award in this CMF round at any time after the submission of a CMF Application under this NOFA. This requirement will also be a term and condition of the Assistance Agreement (see additional Application guidance materials on the CDFI Fund's Web site at
3. An Applicant will not be eligible to receive a CMF Award if the Applicant fails to demonstrate in the Application that its CMF Award would result in Eligible Project Costs (Leveraged Costs plus those costs funded by the CMF Award) that equal at least 10 times the amount of the CMF Award. Note that no costs attributable to Direct Administrative Expenses may be considered Eligible Project Costs.
The CDFI Fund has a sequential, two-step process that requires the submission of Application documents in separate systems and on separate deadlines. The SF–424 form must be submitted through
Applicants are strongly encouraged to submit the SF–424 as early as possible through
The CDFI Fund strongly encourages Applicants to start the
E.
1. Submission Deadlines: Table 5 lists the deadlines for submission of the documents related to the FY 2017 CMF Program Funding Round:
2. Confirmation of Application Submission in
(a)
(b) Award Management Information System (AMIS) Submission Information: AMIS is a web-based portal where Applicants will directly enter their Application information and add required attachments listed in Table 4. AMIS will verify that the Applicant provided the minimum information required to submit an Application. Applicants are responsible for the quality and accuracy of the information and attachments included in the Application submitted in AMIS. The CDFI Fund strongly encourages the Applicant to allow sufficient time to confirm the Application content, review the material submitted, and remedy any issues prior to the Application deadline. Applicants can only submit one Application in AMIS. Upon submission, the Application will be locked and cannot be resubmitted, edited, or modified in any way. The CDFI Fund will not unlock or allow multiple Application submissions.
3. Multiple Application Submissions: If an Applicant submits multiple SF–424 Applications in
4. Late Submission: The CDFI Fund will not accept an Application submitted after the applicable
5. Intergovernmental Review: Not Applicable.
6. Funding Restrictions: CMF Awards are limited by the following:
(a) A Recipient shall use CMF Award funds only for the eligible activities set forth in 12 CFR 1807.301 and as described in Section II.C and Section II.E of this NOFA and its Assistance Agreement.
(b) A Recipient may not disburse CMF Award funds to an Affiliate, Subsidiary, or any other entity without the CDFI Fund's prior written approval.
(c) CMF Award Payment shall only be made to the Recipient.
(d) The CDFI Fund, in its sole discretion, may pay CMF Awards in amounts, or under terms and conditions, which are different from those requested by an Applicant.
7. Other Submission Requirements: Each Applicant must register as an organization in AMIS in order to submit the required Application materials through this portal. The Authorized Representative and/or application point(s) of contact must be included as “Contacts” in the Applicant's AMIS account. The Authorized Representative must also be a “user” in AMIS and must electronically sign the Application prior to submission through AMIS. An Applicant that fails to properly register and update its AMIS account may miss important communications from the CDFI Fund or fail to submit an Application successfully. After submitting its Application, the Applicant will not be permitted to revise or modify its Application in any way or attempt to negotiate the terms of an award.
A.
B.
The CDFI Fund will evaluate each complete and eligible Application using the multi-phase review process described in this Section.
1. Quantitative Assessment: Each complete and eligible Application will receive a numeric score based on the responses to quantitative questions in the Application. Applications may receive a score of up to 100 points based on the following factors outlined in Table 6.
Within the Business and Leveraging Strategy Section of the Quantitative Assessment, an Applicant will generally score more favorably to the extent it: Is leveraging a high multiplier of private capital, particularly third party capital; has a proven track record; and is leveraging some portion of capital at the Applicant-level.
Within the Community Impact Section, an Applicant will generally score more favorably to the extent that it: Commits to producing a higher percentage of rental housing units targeted to Very Low-Income Families (if proposing to use CMF for rental housing); commits to producing a higher percentage of homeownership units targeted to Low-Income Families (if proposing to use CMF for homeownership); commits to only financing Economic Development Activities in Low-Income Areas (if proposing to use CMF for economic development); and commits to producing a higher percentage of units in Areas of Economic Distress. Areas of Economic Distress are census tracts: (a) Where at least 20 percent of households that are Very Low-Income (50% of AMI or below) spend more than half of their income on housing; or (b) where the unemployment rate is at least 1.5 times the national average; or (c) that are Low-Income Housing Tax Credit Qualified Census Tracts; or (d) where greater than 20 percent of households have incomes below the poverty rate and the rental vacancy rate is at least 10 percent; or (e) where greater than 20 percent of the households have incomes below the poverty rate and the homeownership vacancy rate is at least 10 percent; or (f) Are Underserved Rural Areas as defined in the CMF Interim Rule (as amended February 8, 2016; 12 CFR part 1807). Within the Financial Health section, Applicants will generally score more favorably to the extent that their 3-year financial data indicates: Strong capitalization, operating performance, and liquidity; positive net income; and that the Applicant has not had any negative results (
Once the quantitative score is determined, Applicants will be grouped into two categories: (1) Those with a maximum Non-Metropolitan Area investment of 50 percent or greater and (2) all other Applicants. Applicants in each category will be ranked in descending order based on their quantitative review score. The top 75 percent of Applications in each category will be forwarded to the next level of review: External Application Review. The CDFI Fund reserves the right to forward additional Applications to the External Application Review phase in order to ensure that a diversity of geographies are served by the Applicants reviewed in the External Application Review phase. The CDFI Fund also reserves the right not to implement the Quantitative Assessment if it receives fewer than 140 CMF Applications.
2. External Application Review: Applications that advance from the Quantitative Assessment will be separately scored by more than one external non-Federal reviewer who are selected based on criteria that include: A professional background in affordable housing and community and economic development finance with extensive background in affordable housing. These reviewers must complete the CDFI Fund's conflict of interest process and be approved by the CDFI Fund. Reviewers will be assigned a set number of Applications to review. The reviewer will provide a score for each of the Applications assessed in accordance with the scoring criteria outlined in Section V.B.2 of this NOFA and the Application materials.
The external reviewer's evaluation will result in the Application being awarded up to 100 total points by each reviewer. These points will be distributed across three sections: Business and Leveraging Strategy (40 possible points), Community Impact (35 possible points), and Organizational Capacity (25 possible points). An Applicant's final External Application review score will be a composite based on the external reviewers' evaluation and Quantitative Assessment factors. The majority of the score will be based on the external reviewers' evaluation.
(a) Business and Leveraging Strategy (40 points): In the Business and Leveraging Strategy section, the Applicant will address: (i) The needs of communities and persons in its proposed Service Area(s) and the extent to which the proposed strategy addresses these needs; (ii) the affordable housing and financing gaps addressed by its business strategy; (iii) the projected CMF activities and track record; (iv) plans to incorporate a CMF Award into project finance; (v) its strategy for leveraging private capital with a CMF Award, particularly third-party capital; and (vi) its strategy for leveraging its CMF Award at the Enterprise-level and/or through re-investments (if applicable).
An Applicant will generally score more favorably in the criteria evaluated by the external reviewer to the extent that it: (i) Clearly aligns its proposed CMF Award activities with the affordable housing and financing gaps it identifies; (ii) demonstrates that its projected activities are achievable based on the Applicant's strategy and track record; (iii) describes a clear process for locating projects and proposes activities that have a clear need for CMF financing; (iv) has a clear strategy for and track record of leveraging private capital; and (v) has a clear strategy for and demonstrates a track record of leveraging funds at the enterprise-level and/or through re-investments (if applicable).
(b) Community Impact (35 points): In the Community Impact Section, the Applicant will address: (i) Projected outcomes and impacts of Affordable Housing Activities and Economic Development Activities; (ii) its strategy and track record of producing housing
(c) Organizational Capacity (25 points): In the Organizational Capacity section, the Applicant will discuss: (i) Its management team and key staff; (ii) the roles and responsibilities of those staff in managing a CMF Award; (iii) its past experience managing other Federal Awards; and (iv) its financial health and lending portfolio (if applicable).
An Applicant will generally score more favorably in the criteria evaluated by the external reviewer to the extent that it demonstrates: (i) Strong qualifications of its key personnel with respect to their skills and experience identifying investments, underwriting similar projects, managing a portfolio of similar activities and ensuring compliance with program requirements; (ii) success in administering prior CMF Awards and/or other Federal program awards; (iii) strong financial health; and (iv) solid portfolio performance (if applicable).
(d) Scoring anomaly: If, in the case of a particular Application, the reviewers' total external Application review scores vary significantly, the CDFI Fund may, in its sole discretion, obtain the evaluation and numeric scoring of an additional reviewer to determine whether the anomalous score should be replaced with the score of the additional reviewer.
3. Internal Application Review: At the conclusion of the External Application Review phase, Applications will be ranked based on their external review score. Up to 50 of the highest scoring Applications in the External Application Review phase will be forwarded to Internal Application Review in descending order of rank score to receive further consideration for an Award. These forwarded applications will constitute the highly qualified pool. During the Internal Application Review, CDFI Fund staff will prioritize the Applications in the highly qualified pool for award based on the following criteria: (i) Final external Application review score, (ii) alignment with CMF statutory and policy priorities, and (iii) the overall quality of the Applicant's strategy.
In assessing the Application's alignment with CMF statutory and policy priorities, CDFI Fund staff will consider the following factors, including, but not limited to: The Applicant's proposed outcomes and benefits in areas of economic distress; income targeting of the portfolio of affordable units to be produced; and the amount of third-party private capital that the Applicant will attract to its Service Area.
In assessing the quality of the Applicant's strategy, the CDFI Fund staff will consider the following factors, including, but not limited to: (i) The quality of the Applicant's strategy with respect to how the strategy and financing activities address community needs; (ii) whether these outcomes are likely to be achieved if the Applicant's strategy is implemented and the extent to which these outcomes are quantifiable and evidence-based; (iii) whether the Applicant's projections are supported by its track record; (iv) whether the proposed financing activities will help to fill the financing gaps in their market; (v) whether the CMF funds will contribute to the Applicant offering more favorable rates and terms than are currently available in that market; (vi) the likely success of the strategy to leverage private capital; (vii) whether the strategy is adaptable to changing market conditions; (viii) whether the proposed deployment/redeployment schedule is realistic and achievable; and (ix) whether the Applicant has the appropriate financial, organizational, and programmatic capacity to implement the strategy.
The Internal Review will also include an analysis of the Applicant's likely capacity to: Meet award management standards; file appropriate reports and address findings from audits; and the Applicant's ability to effectively implement Federal requirements. Applicants may be re-prioritized for an award or award amounts may be reduced as a result of this analysis. In the case of an Applicant that has received awards from other Federal programs, the CDFI Fund reserves the right to contact officials from the appropriate Federal agency or agencies to determine whether the Recipient is in compliance with current or prior assistance agreements, and to take such information into consideration before making a CMF Award. In the case of an Applicant that has previously received funding through any CDFI Fund program, the CDFI Fund will consider and may, in its discretion, deduct up to 5 points from the External Application Review score for those Applicants (or their Affiliates) that, within 24 months prior to the Application deadline, are late in meeting reporting requirements for existing awards.
4. Selection: Once Applications have been internally evaluated and preliminary award determinations have been made, the Applications will be forwarded to a selecting official for a final award determination. After preliminary award determinations are made, the selecting official will review the list of potential Recipients to determine whether the Recipient pool meets the following statutory objectives:
(a) The potential Recipients' proposed Service Areas collectively represent broad geographic coverage throughout the United States; and
(b) The potential Recipients' proposed activities equitably represent both Metropolitan Areas and Non-Metropolitan Areas, as defined in the CMF Interim Rule, and as further set forth in the Application.
To the extent practicable, the CDFI Fund reserves the right to modify CMF Award amounts and/or the CMF Recipient pool if deemed necessary to achieve either of these desired outcomes. In order to evaluate the geographic coverage of the potential CMF Recipient pool, Applicants will be asked to designate one of the following three Service Area types in their Applications: Local, Statewide, or Multi-State. These Service Area types are further defined in the Application; the largest Service Area an Applicant can propose is a 10 state Multi-State Service Area. To achieve greater investment in Non-Metropolitan Areas and/or broader geographic coverage, the CDFI Fund may consider an Application ranked outside of the highly qualified pool to receive an award. However, the CDFI Fund will not award an Application that scores in the bottom 50 percent of the External Review score rankings.
In cases where the selecting official's award determination varies significantly from the initial CMF Award amount recommended by the CDFI Fund staff
(c) Insured Depository Institution Applicants: In the case of Applicants that are Insured Depository Institutions or Insured Credit Unions, the CDFI Fund will consider safety and soundness information from the Appropriate Federal Banking Agency or Appropriate State Agency, as applicable. If the Applicant is a CDFI Depository Institution Holding Company, the CDFI Fund will consider information provided by the Appropriate Federal Banking Agency and Appropriate State Agency about both the CDFI Depository Institution Holding Company and the CDFI Insured Depository Institution that will expend and carry out the award. If the Appropriate Federal Banking Agency or Appropriate State Agency identifies safety and soundness concerns, the CDFI Fund will assess whether the concerns cause or will cause the Applicant to be incapable of undertaking the activities for which funding has been requested.
5. Right of Rejection: The CDFI Fund reserves the right to reject an Application if information (including administrative errors) comes to the attention of the CDFI Fund that adversely affects an Applicant's eligibility for an award, adversely affects the CDFI Fund's evaluation or scoring of an Application, or indicates fraud or mismanagement on the Applicant's part. If the CDFI Fund determines that any portion of the Application is incorrect in any material respect, the CDFI Fund reserves the right, in its sole discretion, to reject the Application. The CDFI Fund reserves the right to change its eligibility and evaluation criteria and procedures, if the CDFI Fund deems it appropriate. If said changes materially affect the CDFI Fund's award decisions, the CDFI Fund will provide information regarding the changes through the CDFI Fund's Web site. There is no right to appeal the CDFI Fund's award decisions. The CDFI Fund's award decisions are final.
6. Anticipated Award Announcement: The CDFI Fund anticipates making CMF Award announcements in late 2017 or early 2018.
A.
B.
If the Recipient's certification status as a CDFI changes, the CDFI Fund reserves the right, in its sole discretion, to re-calculate the CMF Award, or modify the Assistance Agreement based on the Recipient's non-CDFI status.
By executing an Assistance Agreement, the Recipient agrees that, if the CDFI Fund becomes aware of any information (including an administrative error) prior to the Effective Date of the Assistance Agreement that either adversely affects the Recipient's eligibility for an CMF Award, or adversely affects the CDFI Fund's evaluation of the award Recipient's Application, or indicates fraud or mismanagement on the part of the Recipient, the CDFI Fund may, in its discretion and without advance notice to the Recipient, terminate the Assistance Agreement or take other actions as it deems appropriate.
The CDFI Fund reserves the right, in its sole discretion, to rescind an award if the Recipient fails to return the Assistance Agreement, signed by an Authorized Representative of the award Recipient, and/or provide the CDFI Fund with any other requested documentation, within the CDFI Fund's deadlines.
In addition, the CDFI Fund reserves the right, in its sole discretion, to terminate and rescind the Assistance Agreement and the award made under this NOFA for any criteria described in Table 7:
C.
1. The Assistance Agreement will set forth certain required terms and conditions of the CMF Award, which will include, but not be limited to:
(a) The amount of the award;
(b) The approved uses of the award;
(c) The approved Service Area in which the award may be used;
(d) Performance goals and measures; and
(e) Reporting requirements for all Recipients.
2. The Assistance Agreement shall provide that, prior to any determination by the CDFI Fund that a Recipient has failed to comply substantially with the Act, the CMF Interim Rule, or the environmental quality regulations, the CDFI Fund shall provide the Recipient with reasonable notice and opportunity for hearing. For failure by the Recipient to comply substantially with the Assistance Agreement, the CDFI Fund may:
(a) Require changes in the performance goals set forth in the Assistance Agreement;
(b) Reduce or terminate the CMF Award; or
(c) Require repayment of any CMF Award that has been distributed to the Recipient.
3. The Assistance Agreement shall also provide that, if the CDFI Fund determines noncompliance with the terms and conditions of the Assistance Agreement on the part of the Recipient, the CDFI Fund may:
(a) Bar the Recipient from reapplying for any assistance from the CDFI Fund; or
(b) Take such other actions as the CDFI Fund deems appropriate or as set forth in the Assistance Agreement.
4. In addition to entering into an Assistance Agreement, each Applicant selected to receive a CMF Award must furnish to the CDFI Fund a certificate of good standing from the jurisdiction in which it was formed. The CDFI Fund may, in its sole discretion, also require the Applicant to furnish an opinion from its legal counsel, the content of which may be further specified in the Assistance Agreement, and which, among other matters, opines that:
(a) The Recipient is duly formed and in good standing in the jurisdiction in which it was formed and the jurisdiction(s) in which it transacts business;
(b) The Recipient has the authority to enter into the Assistance Agreement and
(c) The Recipient has no pending or threatened litigation that would materially affect its ability to enter into and carry out the activities specified in the Assistance Agreement;
(d) The Recipient is not in default of its articles of incorporation or formation, bylaws or operating agreements, other organizational or establishing documents, or any agreements with the Federal government; and
(e) The CMF affordability restrictions that are to be imposed by deed restrictions, covenants running with the land, or other CDFI Fund approved mechanisms are recordable and enforceable under the laws of the State and locality where the Recipient will undertake its CMF activities.
D.
E.
The CDFI Fund may collect information from each Recipient including, but not limited to, an Annual Report with the components listed in Table 8:
Each Recipient is responsible for the timely and complete submission of the annual reporting documents. The CDFI Fund will use such information to monitor each Recipient's compliance with the requirements set forth in the Assistance Agreement and to assess the impact of the CMF. The CDFI Fund reserves the right, in its sole discretion, to modify these reporting requirements if it determines it to be appropriate and necessary; however, such reporting requirements will be modified only after notice to Recipients.
F.
The cost principles used by Recipients must be consistent with Federal cost principles; must support the accumulation of costs as required by the principles; and must provide for adequate documentation to support costs charged to the CMF Award. In addition, the CDFI Fund will require Recipients to: Maintain effective internal controls; comply with applicable statutes and regulations, the Assistance Agreement, and related guidance; evaluate and monitor compliance; take action when not in compliance; and safeguard personally identifiable information.
A.
B.
The preferred method of contact is to submit a Service Request (SR) within AMIS. For a CMF Application question, select “General Inquiry” for the record type and select “CMF-Application” for the type. For a CDFI Certification or Compliance question, select “General Inquiry” for the record type and select the appropriate type. For Information Technology, select “General Inquiry” for the record type and select “CMF–AMIS technical problem” for the type. Failure to select the appropriate type of SR could result in delays in responding to your question.
C.
Pub. L. 110–289. 12 U.S.C. 4701, 12 CFR part 1805, 12 CFR part 1807, 12 CFR part 1815, 12 U.S.C. 4502.
Office of Foreign Assets Control, Department of the Treasury.
Notice.
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of persons whose property and interests in property are blocked pursuant to the following authorities: Executive Order (E.O.) 13660, E.O. 13661, and E.O. 13685, or who are subject to the prohibitions of one or more directives under E.O. 13662.
OFAC's actions described in this notice were effective on June 20, 2017.
The Department of the Treasury's Office of Foreign Assets Control: Assistant Director for Licensing, tel.: 202–622–2480, Assistant Director for Regulatory Affairs, tel.: 202–622–4855, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202–622–2490; or the Department of the Treasury's Office of the Chief Counsel (Foreign Assets Control), Office of the General Counsel, tel.: 202–622–2410.
The list of Specially Designated Nationals and Blocked Persons (SDN List) and additional information concerning OFAC sanctions programs are available on OFAC's Web site at
On June 20, 2017, OFAC blocked the property and interests in property of the following persons pursuant to E.O. 13660, “Blocking Property of Certain Persons Contributing to the Situation in Ukraine”:
On June 20, 2017, OFAC determined that AK Transneft OAO owns, directly or indirectly, a 50 percent or greater interest in the entities listed below. As a result of such ownership, these entities are subject to the prohibitions of Directive 2 (as amended) of September 12, 2014, issued pursuant to E.O. 13662, “Blocking Property of Additional Persons Contributing to the Situation in Ukraine” and 31 CFR 589.406 and 589.802, and following the Secretary of the Treasury's determination of July 16, 2014 pursuant to section l(a)(i) of E.O. 13662 with respect to the energy sector of the Russian Federation economy.
On June 20, 2017, OFAC blocked the property and interests in property of the following persons pursuant to E.O. 13685, “Blocking Property of Certain Persons and Prohibiting Certain Transactions With Respect to the Crimea Region of Ukraine”:
Departmental Offices, U.S. Department of the Treasury.
Notice.
The Department of the Treasury will submit the following information collection request(s) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on the collection(s) listed below.
Comments should be received on or before July 31, 2017 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submissions may be obtained from Jennifer Leonard by emailing
Abstract: A taxpayer that wants to revoke its election to be treated as a domestic corporation for all purposes of the Internal Revenue Code (Code) must file a revocation statement with the Internal Revenue Service (IRS). This revenue procedure provides guidance for implementing the elections (and revocation of such elections) established under the “FSC Repeal and Extraterritorial Income Exclusion Act of 2000.”
Abstract: Form 13560 is completed by Health Plan Administrators (HPAs) and accompanies a return of funds in order to ensure proper handling. This form serves as supporting documentation for any funds returned by an HPA and clarifies where the payment should be applied and why it is being sent.
44 U.S.C. 3501
Departmental Offices, U.S. Department of the Treasury.
Notice.
The Department of the Treasury will submit the following information collection request(s) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on the collection(s) listed below.
Comments should be received on or before July 31, 2017 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submissions may be obtained from Jennifer Leonard by emailing
44 U.S.C. 3501
Departmental Offices, U.S. Department of the Treasury.
Notice.
The Department of the Treasury will submit the following information collection request(s) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on the collection(s) listed below.
Comments should be received on or before July 31, 2017 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submissions may be obtained from Jennifer Leonard by emailing
44 U.S.C. 3501
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act, 5 U.S.C., App. 2, that the Research Advisory Committee on Gulf War Veterans' Illnesses will meet on August 1–2, 2017, at 999 California Street, San Francisco, CA, from 9:00 a.m. until 5:00 p.m. (Pacific) on August 1 and from 8:45 a.m. to 12:45 p.m. (Pacific) on August 2. All sessions will be open to the public, and for interested parties who cannot attend in person, there is a toll-free telephone number (800) 767–1750; access code 56978#.
The purpose of the Committee is to provide advice and make recommendations to the Secretary of Veterans Affairs on proposed research studies, research plans, and research strategies relating to the health consequences of military service in the Southwest Asia theater of operations during the Gulf War in 1990–1991.
The Committee will review VA program activities related to Gulf War Veterans' illnesses, and updates on relevant scientific research published since the last Committee meeting. Presentations will include updates on the VA Gulf War research program, along with presentations describing new areas of research in sleep, aging, and neuroscience that can be applied to the health problems of Gulf War Veterans. Also, there will be a discussion of Committee business and activities.
The meeting will include time reserved for public comments in the afternoon. A sign-up sheet for 5-minute comments will be available at the meeting. Individuals who wish to address the Committee may submit a 1–2 page summary of their comments for inclusion in the official meeting record. Members of the public may also submit written statements for the Committee's review to Dr. Victor Kalasinsky via email at
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
Veterans Benefits Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before August 29, 2017.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Cynthia Harvey-Pryor at (202) 461–5870.
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
Public Law 104–13; 44 U.S.C. 3501–3521.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of
Comments must be submitted on or before July 31, 2017.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Department Clearance Officer—OI&T (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461–5870 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Written comments and recommendations on the proposed collection of information should be received on or before July 31, 2017.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461–5870 or email
a. VA Form 26–1820 is completed by lenders closing VA-guaranteed and insured loans under the automatic or prior approval procedures.
b. VA Form 26–8497 is used by lenders to verify a loan applicant's income and employment information when making guaranteed and insured loans. VA does not require the exclusive use of this form for verification purposes, any alternative verification document would be acceptable provided that all information requested on VA Form 26–8497 is provided.
c. Lenders making guaranteed and insured loans complete VA Form 26–8497a to verify the applicant's deposits in banks and other savings institutions.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Board of Veterans' Appeals, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Board of Veterans' Appeals, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before July 31, 2017.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461–5870 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
National Cemetery Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the National Cemetery Administration (NCA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before July 31, 2017.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461–5870 or email
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before July 31, 2017.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461–5870 or email
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By direction of the Secretary.
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed rule.
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Quality Payment Program for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of two tracks: Advanced Alternative Payment Models (APMs); or the Merit-based Incentive Payment System (MIPS). We began implementing the Quality Payment Program through rulemaking for calendar year (CY) 2017. This rule provides proposed updates for the second and future years of the Quality Payment Program.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on August 21, 2017.
In commenting, please refer to file code CMS–5522–P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed):
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Please allow sufficient time for mailed comments to be received before the close of the comment period.
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a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445–G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786–7195 in advance to schedule your arrival with one of our staff members. Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. For information on viewing public comments, see the beginning of the
Molly MacHarris, (410) 786–4461, for inquiries related to MIPS.
Benjamin Chin, (410) 786–0679, for inquiries related to APMs.
Because of the many terms to which we refer by acronym in this rule, we are listing the acronyms used and their corresponding meanings in alphabetical order below:
This proposed rule would make payment and policy changes to the Quality Payment Program. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114–10, enacted April 16, 2015) amended title XVIII of the Social Security Act (the Act) to repeal the Medicare sustainable growth rate (SGR), to reauthorize the Children's Health Insurance Program, and to strengthen Medicare access by improving physician and other clinician payments and making other improvements.
The MACRA advances a forward-looking, coordinated framework for clinicians to successfully take part in the Quality Payment Program that rewards value and outcomes in one of two ways:
• Advanced Alternative Payment Models (Advanced APMs).
• Merit-based Incentive Payment System (MIPS).
These policies are collectively referred to as the Quality Payment Program. Recognizing that the Quality Payment Program represents a major milestone in the way that we bring quality measurement and improvement together with payment, we have taken efforts to review existing policies to identify how to move the program forward in the least burdensome manner possible. Our goal is to support patients and clinicians in making their own decisions about health care using data driven insights, increasingly aligned and meaningful quality measures, and technology that allows clinicians to focus on providing high quality healthcare for their patients. We believe our existing APMs alongside the proposals in this proposed rule provide opportunities that support state flexibility, local leadership, regulatory relief and innovative approaches to improve quality accessibility and affordability. By driving changes in how care is delivered, we believe the Quality Payment Program supports eligible clinicians in improving the health of their patients and increasing care efficiency. To implement this vision, the Quality Payment Program emphasizes high-value care and patient outcomes while minimizing burden on eligible clinicians; the Program is also designed to be flexible, transparent, and structured to improve over time with input from clinicians, patients, and other stakeholders. We have sought and continue to seek feedback from the health care community through various public avenues such as rulemaking, listening sessions and stakeholder engagement. Last year, when we engaged in rulemaking to establish policies for effective implementation of the Quality Payment Program, we did so with the explicit understanding that technology, infrastructure, physician support systems, and clinical practices will change over the next few years. For more information, see the Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models final rule with comment period (81 FR 77008, November 4, 2016), hereinafter referred to as the “CY 2017 Quality Payment Program final rule.” In addition, we are aware of the diversity among clinician practices in their experience with quality-based payments. As a result of these factors, we expect the Quality Payment Program to evolve over multiple years in order to achieve our national goals. To date, we have laid the groundwork for expansion toward an innovative, outcome-focused, patient-centered, resource-effective health system that leverages health information technology to support clinicians and patients and builds collaboration across care settings. This proposed rule is the next part of a staged approach to develop policies that are reflective of system capabilities and grounded in our core strategies to drive progress and reform efforts. We commit to continue evolving these policies.
CMS strives to put patients first, ensuring that they can make decisions about their own healthcare along with their clinicians. We want to ensure innovative approaches to improve quality, accessibility and affordability while paying particular attention to improving clinicians and beneficiaries experience when interacting with CMS programs. The Quality Payment Program aims to (1) support care improvement by focusing on better outcomes for patients, decreased clinician burden, and preservation of independent clinical practice; (2) promote adoption of APMs that align incentives for high-quality, low-cost care across healthcare stakeholders; and (3) advance existing delivery system reform efforts, including ensuring a smooth transition to a healthcare system that promotes high-value, efficient care through unification of CMS legacy programs.
We previously finalized the transition year Quality Payment Program policies in the CY 2017 Quality Payment Program final rule. In that final rule, we implemented policies to improve physician and other clinician payments by changing the way Medicare incorporates quality measurement into payments and by developing new policies to address and incentivize participation in APMs. The final rule established the Quality Payment Program and its two interrelated pathways: Advanced APMs, and the MIPS. The final rule established incentives for participation in Advanced APMs, supporting the goals of transitioning from fee-for-service (FFS) payments to payments for quality and value, including approaches that focus on better care, smarter spending, and healthier people. The final rule included definitions and processes to identify Qualifying APM Participants (QPs) in Advanced APMs and outlined the criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations to the Secretary on proposals for physician-focused payment models (PFPMs).
The final rule also established policies to implement MIPS, a program for certain eligible clinicians that makes Medicare payment adjustments based on performance on quality, cost and other measures and activities, and that consolidates components of three precursor programs—the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for eligible professionals (EPs). As prescribed by MACRA, MIPS focuses on the following: quality—including a set of evidence-based, specialty-specific standards; cost; practice-based improvement activities; and use of certified electronic health record (EHR) technology (CEHRT) to support interoperability and advanced quality objectives in a single, cohesive program that avoids redundancies.
In this proposed rule, we are building and improving Quality Payment Program policies that will be familiar to stakeholders and are designed to integrate easily across clinical practices during the second and future years of implementation. We strive to continue our focus on priorities that can drive improvements toward better patient outcomes without creating undue
As discussed in the CY 2017 Quality Payment Program final rule (81 FR 77010), after extensive outreach with clinicians, patients and other stakeholders, we created six strategic objectives to drive continued progress and improvement. These objectives guided our final policies and will guide our future rulemaking in order to design, implement, and evolve a Quality Payment Program that aims to improve health outcomes, promote efficiency, minimize burden of participation, and provide fairness and transparency in operations. These strategic objectives are as follows: (1) To improve beneficiary outcomes and engage patients through patient-centered Advanced APM and MIPS policies; (2) to enhance clinician experience through flexible and transparent program design and interactions with easy-to-use program tools; (3) to increase the availability and adoption of Advanced APMs; (4) to promote program understanding and maximize participation through customized communication, education, outreach and support that meet the needs of the diversity of physician practices and patients, especially the unique needs of small practices; (5) to improve data and information sharing to provide accurate, timely, and actionable feedback to clinicians and other stakeholders; and (6) to promote IT systems capabilities that meet the needs of users and are seamless, efficient and valuable on the front and back-end. We also believe it is important to ensure the Quality Payment Program maintains operational excellence as the program develops. Therefore we are adding a seventh objective, specifically to ensure operational excellence in program implementation and ongoing development. More information on these objectives and the Quality Payment Program can be found at
With these objectives, we recognize that the Quality Payment Program provides new opportunities to improve care delivery by supporting and rewarding clinicians as they find new ways to engage patients, families, and caregivers and to improve care coordination and population health management. In addition, we recognize that by developing a program that is flexible instead of one-size-fits-all, clinicians will be able to choose to participate in a way that is best for them, their practice, and their patients. For eligible clinicians interested in APMs, we believe that by setting ambitious yet achievable goals, eligible clinicians will move with greater certainty toward these new approaches of delivering care. APMs are a vital part of bending the Medicare cost curve by encouraging the delivery of high-quality, low-cost care. To these ends, and to allow this program to work for all stakeholders, we further recognize that we must provide ongoing education, support, and technical assistance so that clinicians can understand program requirements, use available tools to enhance their practices, and improve quality and progress toward participation in APMs if that is the best choice for their practice. Finally, we understand that we must achieve excellence in program management, focusing on customer needs, promoting problem-solving, teamwork, and leadership to provide continuous improvements in the Quality Payment Program.
Clinicians have told us that they do not separate their patient care into domains, and that the Quality Payment Program needs to reflect typical clinical workflows in order to achieve its goal of better patient care. Advanced APMs, the focus of one pathway of the Quality Payment Program, contribute to better care and smarter spending by allowing physicians and other clinicians to deliver coordinated, customized, high-value care to their patients in a streamlined and cost-effective manner. Within MIPS, the second pathway of the Quality Payment Program, we believe that integration into typical clinical workflows can best be accomplished by making connections across the four statutory pillars of the MIPS incentive structure—quality, clinical practice improvement activities (referred to as “improvement activities”), meaningful use of CEHRT (referred to as “advancing care information”), and resource use (referred to as “cost”)—and by emphasizing that the Quality Payment Program is at its core about improving the quality of patient care.
Although there are two separate pathways within the Quality Payment Program, the Advanced APM and MIPS tracks both contribute toward the goal of seamless integration of the Quality Payment Program into clinical practice workflows. Advanced APMs promote this seamless integration by way of payment methodology and design that incentivize care coordination, and the MIPS builds the capacity of eligible clinicians across the four pillars of MIPS to prepare them for participation in MIPS APMs and Advanced APMs in later years of the Quality Payment Program. Indeed, the bedrock of the Quality Payment Program is high-value, patient-centered care, informed by useful feedback, in a continuous cycle of improvement. The principal way that MIPS measures quality of care is through a set of clinical quality measures (CQMs) from which MIPS eligible clinicians can select. The CQMs are evidence-based, and the vast majority are created or supported by clinicians. Over time, the portfolio of quality measures will grow and develop, driving towards outcomes that are of the greatest importance to patients and clinicians and away from process, or “check the box” type measures.
Through MIPS, we have the opportunity to measure quality, not only through evidence-based quality measures, but also by accounting for activities that clinicians themselves identify: namely, practice-driven quality improvement. MIPS also requires us to assess whether CEHRT is used meaningfully. Based on significant feedback, this area was simplified to support the exchange of patient information, engagement of patients in their own care through technology, and the way technology specifically supports the quality goals selected by the practice. The cost performance category was simplified and weighted at zero percent of the final score for the transition year of CY 2017 to allow clinicians an opportunity to ease into the Quality Payment Program. We further note the cost performance category requires no separate submissions for participation which minimizes burden on clinicians. The assessment of cost is a vital part of ensuring that clinicians are providing Medicare beneficiaries with high-value care. Given the primary focus on value, we indicated in the CY 2017 Quality
We believe the second year of the Quality Payment Program should build upon the foundation that has been established which provides a trajectory for clinicians to value-based care. This trajectory provides to clinicians the ability to participate in the program through two pathways: MIPS and Advanced APMs. As we indicated in the CY 2017 Quality Payment Program final rule (81 FR 77011), we believed that a second transition period would be necessary to build upon the iterative learning and development period as we build towards a steady state. We continue to believe this to be true and have therefore crafted our policies to extend flexibilities into Quality Payment Program Year 2.
The support of small, independent practices remains an important thematic objective for the implementation of the Quality Payment Program and is expected to be carried throughout future rulemaking. For MIPS performance periods occurring in 2017, many small practices are excluded from new requirements due to the low-volume threshold, which was set at less than or equal to $30,000 in Medicare Part B allowed charges or less than or equal to 100 Medicare Part B patients. We have heard feedback, however, from many small practices that challenges still exist in their ability to participate in the program. We are proposing additional flexibilities including: Implementing the virtual groups provisions; increasing the low-volume threshold to less than or equal to $90,000 in Medicare Part B allowed charges or less than or equal to 200 Medicare Part B patients; adding a significant hardship exception from the advancing care information performance category for MIPS eligible clinicians in small practices; and providing bonus points that are added to the final scores of MIPS eligible clinicians who are in small practices. We believe that these additional flexibilities and reduction in barriers will further enhance the ability of small practices to participate successfully in the Quality Payment Program.
In keeping with the objectives to provide education about the Quality Payment Program and maximize participation, and as mandated by the statute, during a period of 5 years, $100 million in funding was provided for technical assistance to be available to provide guidance and assistance to MIPS eligible clinicians in small practices through contracts with regional health collaboratives, and others. Guidance and assistance on the MIPS performance categories or the transition to APM participation will be available to MIPS eligible clinicians in practices of 15 or fewer clinicians with priority given to practices located in rural areas or medically underserved areas (MUAs), and practices with low MIPS final scores. More information on the technical assistance support available to small practices can be found at
As discussed in section V.C. of this proposed rule, we have also performed an updated regulatory impact analysis, accounting for flexibilities, many of which are continuing into the Quality Payment Program Year 2, that have been created to ease the burden for small and solo practices. We estimate that at least 80 percent of clinicians in small practices with 1–15 clinicians will receive a positive or neutral MIPS payment adjustment. We refer readers to section V.C. of this proposed rule for details on how this estimate was developed.
APMs represent an important step forward in our efforts to move our healthcare system from volume-based to value-based care. APMs that meet the criteria to be Advanced APMs provide the pathway through which eligible clinicians, who would otherwise fall under the MIPS, can become Qualifying APM Participants (QPs), thereby earning incentive payments for their Advanced APM participation. In the CY 2017 Quality Payment Program final rule (81 FR 77516), we estimated that 70,000 to 120,000 eligible clinicians would be QPs for payment year 2019 based on Advanced APM participation in performance year 2017. With new Advanced APMs expected to be available for participation in 2018, including the Medicare ACO Track 1 Plus (1+) Model, and the reopening of the application process to new participants for some current Advanced APMs, such as the Next Generation ACO Model and Comprehensive Primary Care Plus Model, we anticipate higher numbers of QPs in subsequent years of the program. We currently estimate that approximately 180,000 to 245,000 eligible clinicians may become QPs for payment year 2020 based on Advanced APM participation in performance year 2018.
In the CY 2017 Quality Payment Program final rule (81 FR 77408), to be considered an Advanced APM, we finalized that an APM must meet all three of the following criteria, as required under section 1833(z)(3)(D) of the Act: (1) The APM must require participants to use CEHRT; (2) The APM must provide for payment for covered professional services based on quality measures comparable to those in the quality performance category under MIPS and; (3) The APM must either require that participating APM Entities bear risk for monetary losses of a more than nominal amount under the APM, or be a Medical Home Model expanded under section 1115A(c) of the Act.
We are proposing to maintain the generally applicable revenue-based nominal amount standard at 8 percent of the estimated average total Parts A and B revenue of eligible clinicians in participating APM Entities for QP Performance Periods 2019 and 2020.
QPs are eligible clinicians in an Advanced APM who have met a threshold for a certain percentage of their patients or payments through an Advanced APM. QPs are excluded from MIPS for the year, and receive a 5 percent APM Incentive Payment for each year they are QPs beginning in 2019 through 2024. The statute sets thresholds for the level of participation in Advanced APMs required for an eligible clinician to become a QP for a year. For Advanced APMs that start or end during the Medicare QP Performance Period and operate
The All-Payer Combination Option, which uses a calculation based on both the Medicare Option and the eligible clinician's participation in Other Payer Advanced APMs to conduct QP determinations, is applicable beginning in performance year 2019. To become a QP through the All-Payer Combination Option, an eligible clinician must participate in an Advanced APM with CMS, as well as an Other Payer Advanced APM. We identify Other Payer Advanced APMs based on information submitted to us by eligible clinicians, APM Entities, and in some cases by payers, including states and Medicare Advantage Organizations. In addition, the eligible clinician or the APM Entity must submit information to CMS so that we can determine whether other payer arrangements are Other Payer Advanced APMs and whether the eligible clinician meets the requisite QP threshold of participation. To be an Other Payer Advanced APM, as set forth in section 1833(z)(2)(B)(ii) and (C)(ii) of the Act and implemented in the CY 2017 Quality Payment Program final rule, a payment arrangement with a payer (for example, payment arrangements authorized under Title XIX, Medicare Health Plan payment arrangements, and payment arrangements in CMS Multi-Payer Models) must meet all three of the following criteria: (1) CEHRT is used; (2) the payment arrangement must require the use of quality measures comparable to those in the quality performance category under MIPS and; (3) the payment arrangement must either require the APM Entities to bear more than nominal financial risk if actual aggregate expenditures exceed expected aggregate expenditures, or be a Medicaid Medical Home Model that meets criteria comparable to Medical Home Models expanded under section 1115A(c) of the Act.
We are proposing modifications pertaining to the third criterion that the payment arrangement must either require the APM Entities to bear more than nominal financial risk if actual aggregate expenditures exceed expected aggregate expenditures; or be a Medicaid Medical Home Model that meets criteria comparable to Medical Home Models expanded under section 1115A(c) of the Act. Specifically, we are proposing to add a revenue-based nominal amount standard in addition to the benchmark-based nominal amount standard that would be applicable only to payment arrangements in which risk is expressly defined in terms of revenue.
We are proposing modifications to our methodologies to determine whether eligible clinicians will meet the QP thresholds using the All-Payer Combination Option. Specifically, we are proposing to conduct all QP determinations under the All-Payer Combination Option at the individual eligible clinician level and are seeking comment on any possible exceptions to this proposed policy that would be warranted, such as a determination based on APM Entity group performance under the All-Payer Combination Option for eligible clinicians participating in CMS Multi-Payer Models. We are also proposing to establish an All-Payer QP Performance Period to assess participation in Other Payer Advanced APMs under the All-Payer Combination Option, and to rename the QP Performance Period we established in rulemaking last year as the Medicare QP Performance Period.
We are proposing to modify the information submission requirements for the All-Payer Combination Option. Specifically, we are proposing modifications to the information we require to make APM Entity or eligible clinician initiated determinations of Other Payer Advanced APMs after the All-Payer QP Performance Period, as well as the information we require to perform QP determinations under the All-Payer Combination Option. We are also proposing policies on the handling of information submitted for purposes of assessment under the All-Payer Combination Option.
We are proposing a Payer Initiated Other Payer Advanced APM Determination Process, which would allow certain other payers, including payment arrangements authorized under Title XIX, Medicare Health Plans, and payers with payment arrangements in CMS Multi-Payer Models, to request that we determine whether their other payer arrangements are Other Payer Advanced APMs starting prior to the 2019 All-Payer QP Performance Period and each year thereafter.
The PTAC is an 11-member federal advisory committee that is an important avenue for the creation of innovative payment models. The PTAC is charged with reviewing stakeholders' proposed PFPMs, and making comments and recommendations to the Secretary regarding whether they meet the PFPM criteria established by the Secretary through rulemaking in the CY 2017 Quality Payment Program final rule. PTAC comments and recommendations will be reviewed by the CMS Innovation Center and the Secretary, and we will post a detailed response to them on the CMS Web site. We are seeking comments on broadening the definition of PFPM to include payment arrangements that involve Medicaid or the Children's Health Insurance Program (CHIP) as a payer even if Medicare is not included as a payer. This broadened definition might be more inclusive of potential PFPMs that could focus on areas not generally applicable to the Medicare population, and could engage more stakeholders in designing PFPMs. In addition, as we gain experience with public submission of PFPM proposals to the PTAC, we are seeking comments on the Secretary's criteria and stakeholders' needs in developing PFPM proposals aimed at meeting the criteria.
For Quality Payment Program Year 2 which is the second year of the MIPS and includes the performance periods in 2018 and the 2020 MIPS payment year, we are proposing the following policies:
We previously finalized that the quality performance category would comprise 60 percent of the final score for the transition year and 50 percent of the final score for the 2020 MIPS payment year (81 FR 77100). For the 2020 MIPS payment year, now we are proposing to maintain a 60 percent weight for the quality performance category contingent upon our proposal to reweight the cost performance category to zero for the 2020 MIPS payment year as discussed in section II.C.6.b.(2) in this proposed rule. Quality measures are selected annually through a call for quality measures, and a final list of quality measures will be published in the
For the 2018 MIPS performance period, we previously finalized that the data completeness threshold would increase to 60 percent for data submitted on quality measures using QCDRs, qualified registries, via EHR, or Medicare Part B claims. We noted that these thresholds for data submitted on quality measures using QCDRs, qualified registries, via EHR, or Medicare Part B claims would increase for performance periods occurring in 2019 and future years. However, as discussed in section II.C.6.b. of this proposed rule, we are proposing for the 2018 MIPS performance period to maintain the transition year data completeness threshold of 50 percent for data submitted on quality measures using QCDRs, qualified registries, EHR, or Medicare Part B claims to provide an additional year for individual MIPS eligible clinicians and groups to gain experience with the MIPS before increasing the data completeness threshold. However, we are proposing to increase the data completeness threshold for the 2021 MIPS payment year to 60 percent for data submitted on quality measures using QCDRs, qualified registries, EHR, or Medicare Part B claims. We anticipate that for performance periods going forward, as MIPS eligible clinicians gain experience with the MIPS, we would further increase these thresholds over time.
Improvement activities are those that support broad aims within healthcare delivery, including care coordination, beneficiary engagement, population management, and health equity. In response to comments from experts and stakeholders across the healthcare system, improvement activities were given relative weights of high and medium. For the 2020 MIPS payment year, we previously finalized that the improvement activities performance category would comprise 15 percent of the final score (81 FR 77179). For performance periods occurring in 2018, we are not proposing any changes in improvement activities scoring as discussed in the CY 2017 Quality Payment Program final rule (81 FR 77312).
As discussed in the appendices of this proposed rule, we are proposing new improvement activities (Table F) and improvement activities with changes (Table G) for the 2018 MIPS performance period and future years for inclusion in the Improvement Activities Inventory. Activities proposed in this section would apply for the 2018 MIPS performance period and future performance periods unless further modified via notice and comment rulemaking. We refer readers to Table H of the CY 2017 Quality Payment Program final rule for a list of all the previously finalized improvement activities (81 FR 77817 through 77831).
As discussed in section II.C.6.e.3.(c) of this proposed rule, we are proposing to expand our definition of how we will recognize an individual MIPS eligible clinician or group as being a certified patient-centered medical home or comparable specialty practice. We finalized at § 414.1380(b)(3)(iv) in the CY 2017 Quality Payment Program final rule that a certified patient-centered medical home includes practice sites with current certification from a national program, regional or state program, private payer or other body that administers patient-centered medical home accreditation. We are proposing in section II.C.6.e.(3)(b) of this proposed rule that eligible clinicians in practices that have been randomized to the control group in the CPC+ model would also receive full credit as a Medical Home Model. In addition, for group reporters, for the 2018 MIPS performance period and future performance periods, we are proposing to require that at least 50 percent of the practice sites within a TIN must be recognized as a certified or recognized patient-centered medical home or comparable specialty practice to receive full credit in the improvement activities performance category.
As discussed in section II.C.6.f.(2)(d) of this proposed rule, in recognition of improvement activities as supporting the central mission of a unified Quality Payment Program, we propose to continue to designate activities in the Improvement Activities Inventory that will also qualify for the advancing care information bonus score. This is consistent with our desire to recognize that CEHRT is often deployed to improve care in ways that our programs should recognize.
For the Quality Payment Program Year 2, the advancing care information performance category comprises 25 percent of the final score. However, if a MIPS eligible clinician is participating in a MIPS APM the advancing care information performance category may comprise 30 percent or 75 percent of the final score depending on the availability of APM quality data for reporting. Objectives and measures in the advancing care information performance category focus on the secure exchange of health information and the use CEHRT to support patient engagement and improved healthcare quality. While we continue to recommend that physicians and clinicians migrate to the implementation and use of EHR technology certified to the 2015 Edition so they may take advantage of improved functionalities, including care coordination and technical advancements such as application programming interfaces, or APIs, we recognize that some practices may have challenges in adopting new certified health IT. Therefore we are proposing that MIPS eligible clinicians may continue to use EHR technology certified to the 2014 Edition for the performance period in CY 2018. We are proposing minor modifications to the advancing care information objectives and measures and the 2017 advancing care information transition objectives and measures. We are also proposing to add an exclusion for the e-Prescribing and Health Information Exchange Objectives. We are proposing to modify our scoring policy for the Public Health and Clinical Data Registry Reporting Objectives and Measures for the performance score and the bonus score.
We are also proposing to implement several provisions of the 21st Century Cures Act (Pub. L. 114–255, enacted on December 13, 2016) pertaining to hospital-based MIPS eligible clinicians, ambulatory surgical center-based MIPS eligible clinicians, MIPS eligible clinicians using decertified EHR technology, and significant hardship exceptions under the MIPS. We are also proposing to add a significant hardship exception for MIPS eligible clinicians in small practices.
In this proposed rule, we are proposing to weight the cost performance category at zero percent of the final score for the 2020 MIPS payment year in order to improve clinician understanding of the measures
For the 2018 MIPS performance period, we are proposing to adopt for the cost performance category the total per capita costs for all attributed beneficiaries measure and the Medicare Spending per Beneficiary (MSPB) measure that were adopted for the 2017 MIPS performance period. For the 2018 MIPS performance period, we are not proposing to use the 10 episode-based measures that were adopted for the 2017 MIPS performance period. Although data on the episode-based measures has been made available to clinicians in the past, we are in the process of developing new episode-based measures with significant clinician input and believe it would be more prudent to introduce these new measures over time. We will continue to offer performance feedback on episode-based measures prior to potential inclusion of these measures in MIPS to increase clinician familiarity with the concept as well as specific episode-based measures.
Specifically, we intend to provide feedback on these new episode-based cost measures in the fall of this year for informational purposes only. We intend to provide performance feedback on the MSPB and total per capita cost measures by July 1, 2018, consistent with section 1848(q)(12) of the Act. In addition, we intend to offer feedback on another set of newly developed episode-based cost measures in 2018 as well. Therefore, clinicians would have received feedback on cost measures at several points prior to the cost performance category counting as part of the final score.
As discussed in section II.6.a. of this proposed rule, we are proposing additional flexibility for submitting data. Individual MIPS eligible clinicians or groups would be able to submit measures and activities, as available and applicable, via as many mechanisms as necessary to meet the requirements of the quality, improvement activities, or advancing care information performance categories. We expect that this option will provide clinicians the ability to select the measures most meaningful to them, regardless of the submission mechanism.
There are generally three ways to participate in MIPS: (1) As an individual; (2) as a group; and (3) as a virtual group. In this proposed rule, we are proposing to establish requirements for MIPS participation at the virtual group level. We propose to define a virtual group as a combination of two or more TINs composed of a solo practitioner (a MIPS eligible clinician (as defined at § 414.1305) who bills under a TIN with no other NPIs billing under such TIN) or a group (as defined at § 414.1305) with 10 or fewer eligible clinicians under the TIN that elects to form a virtual group with at least one other such solo practitioner or group for a performance period for a year.
To provide support and reduce burden, we intend to make technical assistance (TA) available, to the extent feasible and appropriate, to support clinicians who choose to come together as a virtual group for the first 2 years of virtual group implementation applicable to the 2018 and 2019 performance years. Clinicians can access the TA infrastructure that they may be already utilizing. For Quality Payment Program Year 3, we intend to provide an electronic election process if technically feasible. Clinicians who do not elect to contact their designated TA representative would still have the option of contacting the Quality Payment Program Service Center. We believe that our proposal will create an election process that is simple and straightforward.
In the CY 2017 Quality Payment Program final rule (81 FR 77246), we finalized that MIPS eligible clinicians who participate in MIPS APMs will be scored using the APM scoring standard instead of the generally applicable MIPS scoring standard. For the 2018 performance period, we are proposing modifications to the quality performance category reporting requirements and scoring for MIPS eligible clinicians in most MIPS APMs, and other modifications to the APM scoring standard. For purposes of the APM scoring standard, we are proposing to add a fourth snapshot date that would be used only to identify APM Entity groups participating in those MIPS APMs that require full TIN participation. Along with the other APM Entity groups, these APM Entity groups would be used for the purposes of reporting and scoring under the APM scoring standard described the CY 2017 Quality Payment Program final rule (81 FR 77246).
For the transition year of MIPS, we considered an option for facility-based MIPS eligible clinicians to elect to use their institution's performance rates as a proxy for the MIPS eligible clinician's performance in the quality and cost performance categories. However, we did not propose an option for the transition year of MIPS because there were several operational considerations that needed to be addressed before this option could be implemented. After consideration of comments received on the CY 2017 Quality Payment Program proposed rule (81 FR 28192) and other comments received, we have decided to implement facility-based measures for the 2018 MIPS performance period and future performance periods to add more flexibility for clinicians to be assessed in the context of the facilities at which they work. As discussed in section II.C.7.b. of this proposed rule, we are proposing facility-based measures policies related to applicable measures, applicability to facility-based measurement, group participation, and facility attribution.
For clinicians whose primary professional responsibilities are in a healthcare facility we present a method to assess performance in the quality and cost performance categories of MIPS based on the performance of that facility in another value-based purchasing program. While we propose to limit that opportunity to clinicians who practice primarily in the hospital, we seek to expand the program to other value-based payment programs as appropriate in the future. We discuss that new method of scoring in section II.C.7.b.(4) of this proposed rule.
In the CY 2017 Quality Payment Program final rule, we finalized a unified scoring system to determine a final score across the 4 performance categories (81 FR 77273 through 77276). For the 2018 MIPS performance period, we propose to build on the scoring methodology we finalized for the transition year, focusing on encouraging MIPS eligible clinicians to meet data completeness requirements.
For quality performance category scoring, we are proposing to extend some of the transition year policies to the 2018 MIPS performance period and are also proposing several modifications to existing policy. For the 2018 MIPS performance period, we are proposing to maintain the 3 point floor for measures that can be reliably scored against a benchmark. We are also proposing, to maintain the policy to assign 3 points to measures that are submitted but do not have a benchmark or do not meet the case minimum, which does not apply to the CMS Web Interface measures and administrative claims based measures. For the 2018 MIPS performance period, we are also proposing to lower the number of points available for measures that do not meet the data completeness
Beginning with the 2018 MIPS performance period, we are proposing to add performance standards for scoring improvement for the quality and cost performance categories. We are also proposing a systematic approach to address topped out quality measures.
For the 2018 MIPS performance period, we are proposing that 3 performance category scores (quality, improvement activities, and advancing care information) would be given weight in the final score, or be reweighted if a performance category score is not available. We are also proposing to add final score bonuses for small practices and for MIPS eligible clinicians that care for complex patients.
We are also proposing that the final score will be compared against a MIPS performance threshold of 15 points, which can be achieved via multiple pathways and continues the gradual transition into MIPS.
We are proposing to provide Quality Payment Program performance feedback to eligible clinicians and groups. Initially, we would provide performance feedback on an annual basis. In future years, we aim to provide performance feedback on a more frequent basis, which is in line with clinician requests for timely, actionable feedback that they can use to improve care.
In the CY 2017 Quality Payment Program final rule (81 FR 77353), we finalized a targeted review process under MIPS wherein a MIPS eligible clinician or group may request that we review the calculation of the MIPS payment adjustment factor and, as applicable, the calculation of the additional MIPS payment adjustment factor applicable to such MIPS eligible clinician or group for a year. We are not proposing any changes to this process for the second year of the MIPS.
We believe that third party intermediaries that collect or submit data on behalf of individual eligible clinicians and groups participating in MIPS and allowing for flexible reporting options, will provide individual MIPS eligible clinicians and groups with options to accommodate different practices and make measurement meaningful. In the CY 2017 Quality Payment Program final rule (81 FR 77362), we finalized that qualified registries, QCDRs, health IT vendors, and CMS-approved survey vendors will have the ability to act as intermediaries on behalf of individual MIPS eligible clinicians and groups for submission of data to CMS across the quality, improvement activities, and advancing care information performance categories. As discussed in section II.C.10.a.(3) of this proposed rule, we propose to eliminate the self-nomination submission method of email and require that QCDRs and qualified registries submit their self-nomination applications via a web-based tool for future program years beginning with performance periods occurring in 2018. We are proposing, beginning with the 2019 performance period, a simplified process in which existing QCDRs or qualified registries in good standing may continue their participation in MIPS by attesting that their approved data validation plan, cost, approved QCDR measures (applicable to QCDRs only), MIPS quality measures, activities, services, and performance categories offered in the previous year's performance period of MIPS have no changes. QCDRs and qualified registries in good standing, may also make substantive or minimal changes to their approved self-nomination application from the previous year of MIPS that would be submitted during the self-nomination period for CMS review and approval. By attesting that certain aspects of their application will remain the same, as approved from the previous year, existing QCDRs in good standing and qualified registries will be spending less time completing the self-nomination application, as was previously required. This process will be conducted on an annual basis.
In addition, we are proposing that the term “QCDR measures” replace the term “non-MIPS measures,” without proposing any changes to the definition, criteria, or requirements that were finalized in the CY 2017 Quality Payment Program final rule (81 FR 77375). We are not proposing any changes to the health IT vendors that obtain data from CEHRT requirements.
Lastly, we are proposing for future program years, beginning with performance periods occurring in 2018 that we remove the April 30th survey vendor application deadline. We are proposing for the Quality Payment Program Year 2 and future years that the vendor application deadline be January 31st of the applicable performance year or a later date specified by CMS. We will notify vendors of the application deadline, to become a CMS-approved survey vendor through additional communications and postings.
As discussed in section II.C.11. of this proposed rule, we are proposing public reporting of certain eligible clinician and group Quality Payment Program information, including MIPS and APM data in an easily understandable format as required under the MACRA.
In section II.C.1.f. of this proposed rule, we are proposing to modify the definition of a non-patient facing MIPS eligible clinician to apply to virtual groups. We are also proposing to specify that groups considered to be non-patient facing (more than 75 percent of the NPIs billing under the group's TIN meet the definition of a non-patient facing individual MIPS eligible clinician) during the non-patient facing determination period would automatically have their advancing care information performance category reweighted to zero. Additionally, in section II.C.3.c. of this proposed rule, we are proposing to modify the low-volume threshold policy established in the CY 2017 Quality Payment Program final rule. As discussed in section II.C.3.c of this proposed rule, we believe that increasing the low-volume threshold to less than or equal to $90,000 in Medicare Part B charges or 200 or fewer Part-B enrolled Medicare beneficiaries would further decrease burden on MIPS eligible clinicians that practice in rural areas or are part of a small practice or are solo practitioners.
As discussed in section V.C. of this proposed rule, for the 2020 payment year based on Advanced APM participation in 2018 performance period, we estimate that approximately 180,000 to 245,000 clinicians will become QPs, and therefore be exempt from MIPS and qualify for lump sum incentive payments based on 5 percent of their Part B allowable charges for covered professional services. We estimate that the total lump sum incentive payments will be between approximately $590 and $800 million for the 2020 Quality Payment Program payment year. This expected growth in QPs between the first and second year of the program is due in part to reopening of CPC+ and Next Generation ACO for 2018, and the ACO Track 1+ which is projected to have a large number of participants, with a large majority reaching QP status.
Under the policies in this proposed rule, we estimate that approximately 572,000 eligible clinicians would be required to participate in MIPS in the 2018 MIPS performance period, although this number may vary depending on the number of eligible clinicians excluded from MIPS based on their status as QPs or Partial QPs. After restricting the population to eligible clinician types who are not newly enrolled, the proposed increase in the low-volume threshold is expected to exclude 585,560 clinicians who do not exceed the low-volume threshold. In the 2020 MIPS payment year, MIPS payment adjustments will be applied based on MIPS eligible clinicians' performance on specified measures and activities within three integrated performance categories; the fourth category of cost, as previously outlined, would be weighted to zero in the 2020 MIPS payment year. Assuming that 90 percent of eligible clinicians of all practice sizes participate in MIPS, we estimate that MIPS payment adjustments will be approximately equally distributed between negative MIPS payment adjustments ($173 million) and positive MIPS payment adjustments ($173 million) to MIPS eligible clinicians, as required by the statute to ensure budget neutrality. Positive MIPS payment adjustments will also include up to an additional $500 million for exceptional performance to MIPS eligible clinicians whose final score meets or exceeds the additional performance threshold of 70 points. These MIPS payment adjustments are expected to drive quality improvement in the provision of MIPS eligible clinicians' care to Medicare beneficiaries and to all patients in the health care system. However, the distribution will change based on the final population of MIPS eligible clinicians for CY 2020 and the distribution of scores under the program. We believe that starting with these modest initial MIPS payment adjustments is in the long-term best interest of maximizing participation and starting the Quality Payment Program off on the right foot, even if it limits the magnitude of MIPS positive adjustments during the 2018 MIPS performance period. The increased availability of Advanced APM opportunities, including through Medical Home models, also provides earlier avenues to earn APM incentive payments for those eligible clinicians who choose to participate.
The Quality Payment Program may result in quality improvements and improvements to the patients' experience of care as MIPS eligible clinicians respond to the incentives for high-quality care provided by MIPS and implement care quality improvements in their clinical practices.
We also quantify several costs associated with this rule. We estimate that this proposed rule will result in approximately $857 million in collection of information-related burden. We estimate that the incremental collection of information-related burden associated with this proposed rule is approximately $12.4 million relative to the estimated burden of continuing the policies the CY 2017 Quality Payment Program final rule, which is $869 million. We also estimate regulatory review costs of $4.8 million for this proposed rule, comparable to the regulatory review costs of the CY 2017 Quality Payment Program proposed rule. We estimate that federal expenditures will include $173 million in revenue neutral payment adjustments and $500 million for exceptional performance payments. Additional federal expenditures include approximately $590-$800 million in APM incentive payments to QPs.
In developing this proposed rule, we sought feedback from stakeholders and the public throughout the process, including in the CY 2017 Quality Payment Program final rule with comment period, listening sessions, webinars, and other listening venues. We received a high degree of interest from a broad spectrum of stakeholders. We thank our many commenters and acknowledge their valued input throughout the rulemaking process. We discuss the substance of relevant comments in the appropriate sections of this proposed rule, though we were not able to address all comments or all issues that all commenters brought forth due to the volume of comments and feedback. In general, commenters continue to support establishment of the Quality Payment Program and maintain optimism as we move from pure FFS Medicare payment towards an enhanced focus on the quality and value of care. Public support for our proposed approach and policies in the proposed rule focused on the potential for improving the quality of care delivered to beneficiaries and increasing value to the public—while rewarding eligible clinicians for their efforts.
We thank stakeholders again for their considered responses throughout our process, in various venues, including comments on the Request for Information Regarding Implementation of the Merit-based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models (herein referred to as the MIPS and APMs RFI) (80 FR 59102 through 59113) and the CY 2017 Quality Payment Program final rule (81 FR 77008 through 77831). We intend to continue open communication with stakeholders, including consultation with tribes and tribal officials, on an ongoing basis as we develop the Quality Payment Program in future years.
The Quality Payment Program, authorized by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is a new approach for reforming care across the health care delivery system for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of two pathways: Advanced Alternative Payment Models (APMs); or the Merit-based Incentive Payment System (MIPS). We began implementing the Quality Payment Program through rulemaking for calendar year (CY) 2017. This rule provides proposed updates for the second and future years of the Quality Payment Program.
At § 414.1305, subpart O, we propose to define the following terms:
We propose to revise the definitions of the following terms:
We propose to remove the following terms:
These terms and definitions are discussed in detail in relevant sections of this proposed rule.
In the CY 2017 Quality Payment Program final rule (81 FR77040 through 77041), we defined at § 414.1305 a MIPS eligible clinician, as identified by a unique billing TIN and NPI combination used to assess performance, as any of the following (excluding those identified at § 414.1310(b)): A physician (as defined in section 1861(r) of the Act), a physician assistant, nurse practitioner, and clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act), a certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act), and a group that includes such clinicians. We established at § 414.1310(b) and (c) that the following are excluded from this definition per the statutory exclusions defined in section 1848(q)(1)(C)(ii) and (v) of the Act: (1) QPs; (2) Partial QPs who choose not to report on applicable measures and activities that are required to be reported under MIPS for any given performance period in a year; (3) low-volume threshold eligible clinicians; and (4) new Medicare-enrolled eligible clinicians. In accordance with sections 1848(q)(1)(A) and (q)(1)(C)(vi) of the Act, we established at § 414.1310(b)(2) that eligible clinicians (as defined at § 414.1305) who are not MIPS eligible clinicians have the option to voluntarily report measures and activities for MIPS. Additionally, we established at § 414.1310(d) that in no case will a MIPS payment adjustment apply to the items and services furnished during a year by eligible clinicians who are not MIPS eligible clinicians, as described in § 414.1310(b) and (c), including those who voluntarily report on applicable measures and activities specified under MIPS.
In the CY 2017 Quality Payment Program final rule (81 FR 77340), we noted that the MIPS payment adjustment applies only to the amount otherwise paid under Part B with respect to items and services furnished by a MIPS eligible clinician during a year, in which we will apply the MIPS payment adjustment at the TIN/NPI level. We have received requests for additional clarifications on which specific Part B services are subject to the MIPS payment adjustment, as well as which Part B services are included for eligibility determinations. We note that when Part B items or services are rendered by suppliers that are also MIPS eligible clinicians, there may be circumstances in which it is not operationally feasible for us to attribute those items or services to a MIPS eligible clinician at an NPI level in order to include them for purposes of applying the MIPS payment adjustment or making eligibility determinations.
To further clarify, there are circumstances that involve Part B prescription drugs and durable medical equipment where the supplier may also be a MIPS eligible clinician. In circumstances in which a MIPS eligible clinician furnishes a Part B covered item or service such as prescribing Part B drugs that are dispensed, administered, and billed by a supplier that is a MIPS eligible clinician, or ordering durable medical equipment that is administered and billed by a supplier that is a MIPS eligible clinician, it is not operationally feasible for us at this time to associate those billed allowable charges with a MIPS eligible clinician at an NPI level in order to include them for purposes of applying the MIPS payment adjustment or making eligibility determinations. For Part B items and services furnished by a MIPS eligible clinician such as purchasing and administering Part B drugs that are billed by the MIPS eligible clinician, such items and services may be subject to MIPS adjustment based on the MIPS eligible clinician's performance during the applicable performance period or included for eligibility determinations. For those billed Medicare Part B allowable charges relating to the purchasing and administration of Part B drugs that we are able to associate with a MIPS eligible clinician at an NPI level, such items and services furnished by the MIPS eligible clinician would be included for purposes of applying the MIPS payment adjustment or making eligibility determinations.
As discussed in the CY 2017 Quality Payment Program final rule (81 FR 77088 through 77831), we indicated that we will assess performance either for individual MIPS eligible clinicians or for groups. We defined a group at § 414.1305 as a single Taxpayer Identification Number (TIN) with two or more eligible clinicians (including at least one MIPS eligible clinician), as identified by their individual NPI, who have reassigned their Medicare billing rights to the TIN. We recognize that MIPS eligible clinicians participating in MIPS may be part of a TIN that has one portion of its NPIs participating in MIPS according to the generally applicable scoring criteria while the remaining portion of its NPIs is participating in a MIPS APM or an Advanced APM according to the MIPS APM scoring standard. In the CY 2017 Quality Payment Program final rule (81 FR 77058), we noted that except for groups containing APM participants, we are not permitting groups to “split” TINs if they choose to participate in MIPS as a group. Thus, we would like to clarify that we consider a group to be either an entire single TIN or portion of a TIN that: (1) Is participating in MIPS according to the generally applicable scoring criteria while the remaining portion of the TIN is participating in a MIPS APM or an Advanced APM according to the MIPS APM scoring standard; and (2) chooses to participate in MIPS at the group level. Also, we defined an APM Entity group at § 414.1305 as a group of eligible clinicians participating in an APM Entity, as identified by a combination of the APM identifier, APM Entity identifier, TIN, and NPI for each participating eligible clinician.
In the CY 2017 Quality Payment Program final rule (81 FR 77188), we defined the term small practices at § 414.1305 as practices consisting of 15 or fewer clinicians and solo practitioners. In section II.C.4.d. of this proposed rule, we discuss how small practice status would apply to virtual groups. Also, in the final rule, we noted that we would not make an eligibility determination regarding the size of small practices, but indicated that small practices would attest to the size of their group practice (81 FR 77057). However, we have since realized that our system needs to account for small practice size in advance of a performance period for operational purposes relating to assessing and scoring the improvement activities performance category, determining hardship exceptions for small practices as proposed in this proposed rule, calculating the small practice bonus for the final score as proposed in this proposed rule, and identifying small practices eligible for technical assistance. As a result, we believe it is critical to modify the way in which small practice size would be determined. To make eligibility determinations regarding the size of small practices for performance periods occurring in 2018 and future years, we propose that CMS would determine the size of small practices as described in this section of the proposed rule. As noted in the CY 2017 Quality Payment
To make eligibility determinations regarding the size of small practices for performance periods occurring in 2018 and future years, we propose that CMS would determine the size of small practices by utilizing claims data. For purposes of this section, we are coining the term “small practice size determination period” to mean a 12-month assessment period, which consists of an analysis of claims data that spans from the last 4 months of a calendar year 2 years prior to the performance period followed by the first 8 months of the next calendar year and includes a 30-day claims run out. This would allow us to inform small practices of their status near the beginning of the performance period as it pertains to eligibility relating to technical assistance, applicable improvement activities criteria, the proposed hardship exception for small practices under the advancing care information performance category, and the proposed small practice bonus for the final score.
Thus, for purposes of performance periods occurring in 2018 and the 2020 MIPS payment year, we would identify small practices based on 12 months of data starting from September 1, 2016 to August 31, 2017. We would not change an eligibility determination regarding the size of a small practice once the determination is made for a given performance period and MIPS payment year. We recognize that there may be circumstances in which the small practice size determinations made by CMS do not reflect the real-time size of such practices. We considered two options that could address such potential discrepancies. One option would include an expansion of the proposed small practice size determination period to 24 months with two 12-month segments of data analysis (before and during the performance period), in which CMS would conduct a second analysis of claims data during the performance period. Such an expanded determination period may better capture the real-time size of small practices, but determinations made during the performance period prevent our system from being able to account for the assessment and scoring of the improvement activities performance category and identification of small practices eligible for technical assistance prior to the performance period. Specifically, our system needs to capture small practice determinations in advance of the performance period in order for the system to reflect the applicable requirements for the improvement activities performance category and when a small practice bonus would be applied. A second option would include an attestation component, in which a small practice that was not identified as a small practice during the proposed small practice size determination period would be able to attest to the size of their group practice prior to the performance period. However, this second option would require us to develop several operational improvements, such as a manual process or system that would provide an attestation mechanism for small practices, and a verification process to ensure that only small practices are identified as eligible for technical assistance. Since individual MIPS eligible clinicians and groups are not required to register to participate in MIPS (except for groups utilizing the CMS Web Interface for the Quality Payment Program or administering the CAHPS for MIPS survey), requiring small practices to attest to the size of their group practice prior to the performance period could increase burden on individual MIPS eligible clinicians and groups that are not already utilizing the CMS Web Interface for the Quality Payment Program or administering the CAHPS for MIPS survey. We solicit public comment on the proposal regarding how CMS would determine small practice size.
In the CY 2017 Quality Payment Program final rule (81 FR 77188), we finalized at § 414.1380 that for individual MIPS eligible clinicians and groups that are located in rural areas or geographic HPSAs, to achieve full credit under the improvement activities performance category, one high-weighted or two medium-weighted improvement activities are required. In addition, we defined rural areas at § 414.1305 as clinicians in ZIP codes designated as rural, using the most recent Health Resources and Services Administration (HRSA) Area Health Resource File data set available; and Health Professional Shortage Areas (HPSAs) at § 414.1305 as areas designated under section 332(a)(1)(A) of the Public Health Service Act. For technical accuracy purposes, we are proposing to modify the definition of a rural areas at § 414.1305 as ZIP codes designated as rural, using the most recent Health Resources and Services Administration (HRSA) Area Health Resource File data set available. We recognize that there are cases in which an individual MIPS eligible clinician (including a solo practitioner) or a group may have multiple practice sites associated with its TIN and as a result, it is critical for us to outline the application of rural area and HPSA practice designations to such practices. For performance periods occurring in 2017, we consider an individual MIPS eligible clinician or a group with at least one practice site under its TIN in a ZIP code designated as a rural area or HPSA to be a rural area or HPSA practice. For performance periods occurring in 2018 and future years, we believe that a higher threshold than one practice within a TIN is necessary to designate an individual MIPS eligible clinician, a group, or a virtual group as a rural or HPSA practice. We recognize that the establishment of a higher threshold starting in 2018 would more appropriately identify groups and virtual groups with multiple practices under a group's TIN or TINs that are part of a virtual group as rural or HPSA practices and ensure that groups and virtual groups are assessed and scored according to requirements that are applicable and appropriate. We note that in the CY 2017 Quality Payment Program final rule (81 FR 77048 through 77049), we defined a non-patient facing MIPS eligible clinician at § 414.1305 as including a group provided that more than 75 percent of the NPIs billing under the group's TIN meet the definition of a non-patient facing individual MIPS eligible clinician during the non-patient facing determination period. We refer readers to section II.C.1.e. of this proposed rule for our proposal to modify the definition of a non-patient facing MIPS eligible clinician. We believe that using a similar threshold for applying the rural and HPSA designation to an individual MIPS eligible clinician, a group, or virtual group with multiple practices under its TIN or TINs within a virtual group will add consistency for such practices across the MIPS as it pertains to groups and virtual groups obtaining such statuses. Also, we believe that establishing a 75 percent threshold renders an adequate representation of a group or virtual group where a significant portion of a group or a virtual group is identified as having such status. Therefore, for performance periods occurring in 2018 and future
Section 1848(q)(2)(C)(iv) of the Act requires the Secretary, in specifying measures and activities for a performance category, to give consideration to the circumstances of professional types (or subcategories of those types determined by practice characteristics) who typically furnish services that do not involve face-to-face interaction with a patient. To the extent feasible and appropriate, the Secretary may take those circumstances into account and apply alternative measures or activities that fulfill the goals of the applicable performance category to such non-patient facing MIPS eligible clinicians. In carrying out these provisions, we are required to consult with non-patient facing MIPS eligible clinicians.
In addition, section 1848(q)(5)(F) of the Act allows the Secretary to re-weight MIPS performance categories if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician. We assume many non-patient facing MIPS eligible clinicians will not have sufficient measures and activities applicable and available to report under the performance categories under MIPS. We refer readers to section II.C.6.f.(7) of this proposed rule for the discussion regarding how we address performance category weighting for MIPS eligible clinicians for whom no measures or activities are applicable and available in a given category.
In the CY 2017 Quality Payment Program final rule (81 FR 77048 through 77049), we defined a non-patient facing MIPS eligible clinician for MIPS at § 414.1305 as an individual MIPS eligible clinician that bills 100 or fewer patient-facing encounters (including Medicare telehealth services defined in section 1834(m) of the Act) during the non-patient facing determination period, and a group provided that more than 75 percent of the NPIs billing under the group's TIN meet the definition of a non-patient facing individual MIPS eligible clinician during the non-patient facing determination period. In order to account for the formation of virtual groups starting in the 2018 performance year and how non-patient facing determinations would apply to virtual groups, we need to modify the definition of a non-patient facing MIPS eligible clinician. Therefore, for performance periods occurring in 2018 and future years, we propose to modify the definition of a non-patient facing MIPS eligible clinician at § 414.1305 to mean an individual MIPS eligible clinician that bills 100 or fewer patient-facing encounters (including Medicare telehealth services defined in section 1834(m) of the Act) during the non-patient facing determination period, and a group or virtual group provided that more than 75 percent of the NPIs billing under the group's TIN or within a virtual group, as applicable, meet the definition of a non-patient facing individual MIPS eligible clinician during the non-patient facing determination period.
We considered a patient-facing encounter to be an instance in which the individual MIPS eligible clinician or group billed for items and services furnished such as general office visits, outpatient visits, and procedure codes under the PFS. We published the list of patient-facing encounter codes for performance periods occurring in 2017 at
The list of patient-facing encounter codes include two general categories of codes: Evaluation and Management (E&M) codes; and Surgical and Procedural codes. E&M codes capture clinician-patient encounters that occur in a variety of care settings, including office or other outpatient settings, hospital inpatient settings, emergency departments, and nursing facilities, in which clinicians utilize information provided by patients regarding history, present illness, and symptoms to determine the type of assessments to conduct. Assessments are conducted on the affected body area(s) or organ system(s) for clinicians to make medical decisions that establish a diagnosis or select a management option(s).
Surgical and Procedural codes capture clinician-patient encounters that involve procedures, surgeries, and other medical services conducted by clinicians to treat medical conditions. In the case of many of these services, evaluation and management work is included in the payment for the single code instead of separately reported. Patient-facing encounter codes from both of these categories describe direct services furnished by eligible clinicians with impact on patient safety, quality of care, and health outcomes.
For purposes of the non-patient facing policies under MIPS, the utilization of E&M codes and Surgical and Procedural codes allows for accurate identification of patient-facing encounters, and thus accurate eligibility determinations regarding non-patient facing status. As a result, MIPS eligible clinicians considered non-patient facing are able to prepare to meet requirements applicable to non-patient facing MIPS eligible clinicians. We propose to continue applying these policies for purposes of the 2020 MIPS payment year and future years.
As described in the CY 2017 Quality Payment Program final rule, we established the non-patient facing determination period for purposes of identifying non-patient facing MIPS eligible clinicians in advance of the performance period and during the performance period using historical and performance period claims data. This eligibility determination process allows us to begin identifying non-patient facing MIPS eligible clinicians prior to or shortly after the start of the performance period. The non-patient facing determination period is a 24-month assessment period, which includes a two-segment analysis of claims data regarding patient-facing encounters during an initial 12-month period prior to the performance period followed by another 12-month period during the performance period. The initial 12-month segment of the non-patient facing determination period spans from the last 4 months of a calendar year 2 years prior to the performance period followed by the first 8 months of the next calendar year and includes a 60-day claims run out, which allows us to inform individual MIPS eligible clinicians and groups of their non-patient facing status during the month (December) prior to the start of the performance period. The second 12-month segment of the non-patient facing determination period spans from the last 4 months of a calendar year 1 year prior to the performance period followed by the first 8 months of the performance period in the next calendar year and includes a 60-day claims run out, which will allow us to inform additional individual MIPS eligible clinicians and groups of their non-patient status during the performance period.
However, based on our analysis of data from the initial segment of the non-patient facing determination period for performance periods occurring in 2017 (that is, data spanning from September 1, 2015 to August 31, 2016), we found that it may not be necessary to include a 60-day claims run out since we could achieve a similar outcome for such eligibility determinations by utilizing a 30-day claims run out. In our comparison of data analysis results utilizing a 60-day claims run out versus a 30-day claims run out, there was a 1 percent decrease in data completeness (see Table 1 for data completeness regarding comparative analysis of a 60-day and 30-day claims run out). The small decrease in data completeness would not negatively impact individual MIPS eligible clinicians or groups regarding non-patient facing determinations. We believe that a 30-day claims run out would allow us to complete the analysis and provide such determinations in a more timely manner.
For performance periods occurring in 2018 and future years, we propose a modification to the non-patient facing determination period, in which the initial 12-month segment of the non-patient facing determination period would span from the last 4 months of a calendar year 2 years prior to the performance period followed by the first 8 months of the next calendar year and include a 30-day claims run out; and the second 12-month segment of the non-patient facing determination period would span from the last 4 months of a calendar year 1 year prior to the performance period followed by the first 8 months of the performance period in the next calendar year and include a 30-day claims run out. This proposal would only change the duration of the claims run out, not the 12-month timeframes used for the first and second segments of data analysis.
For purposes of the 2020 MIPS payment year, we would initially identify individual MIPS eligible clinicians and groups who are considered non-patient facing MIPS eligible clinicians based on 12 months of data starting from September 1, 2016, to August 31, 2017. To account for the identification of additional individual MIPS eligible clinicians and groups that may qualify as non-patient facing during performance periods occurring in 2018, we would conduct another eligibility determination analysis based on 12 months of data starting from September 1, 2017, to August 31, 2018.
Similarly, for future years, we would conduct an initial eligibility determination analysis based on 12 months of data (consisting of the last 4 months of the calendar year 2 years prior to the performance period and the first 8 months of the calendar year prior to the performance period) to determine the non-patient facing status of individual MIPS eligible clinicians and groups, and conduct another eligibility determination analysis based on 12 months of data (consisting of the last 4 months of the calendar year prior to the performance period and the first 8 months of the performance period) to determine the non-patient facing status of additional individual MIPS eligible clinicians and groups. We would not change the non-patient facing status of any individual MIPS eligible clinician or group identified as non-patient facing during the first eligibility determination analysis based on the second eligibility determination analysis. Thus, an individual MIPS eligible clinician or group that is identified as non-patient facing during the first eligibility determination analysis would continue to be considered non-patient facing for the duration of the performance period and MIPS payment year regardless of the results of the second eligibility determination analysis. We would conduct the second eligibility determination analysis to account for the identification of additional, previously unidentified individual MIPS eligible clinicians and groups that are considered non-patient facing.
Additionally, in the CY 2017 Quality Payment Program final rule (81 FR 77241), we established a policy regarding the re-weighting of the advancing care information performance category for non-patient facing MIPS eligible clinicians. Specifically, MIPS eligible clinicians who are considered to be non-patient facing will have their advancing care information performance category automatically reweighted to zero (81 FR 77241). For groups that are considered to be non-patient facing (that is, more than 75 percent of the NPIs billing under the group's TIN meet the definition of a non-patient facing individual MIPS eligible clinician) during the non-patient facing determination period, we are proposing in section II.C.7.b.(3) of this proposed rule to automatically reweight their advancing care information performance category to zero.
We propose to continue applying these policies for purposes of the 2020 MIPS payment year and future years. We solicit public comment on these proposals.
In the CY 2017 Quality Payment Program final rule (81 FR 77049), we noted that MIPS eligible clinicians who practice in CAHs that bill under Method I (Method I CAHs), the MIPS payment adjustment would apply to payments made for items and services billed by MIPS eligible clinicians, but it would not apply to the facility payment to the CAH itself. For MIPS eligible clinicians who practice in Method II CAHs and have not assigned their billing rights to the CAH, the MIPS payment adjustment would apply in the same manner as for MIPS eligible clinicians who bill for items and services in Method I CAHs. As established in the CY 2017 Quality Payment Program final rule (81 FR 77051), the MIPS payment adjustment will apply to Method II CAH payments under section 1834(g)(2)(B) of the Act when MIPS eligible clinicians who practice in Method II CAHs have assigned their billing rights to the CAH.
We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77049 through 77051) for our discussion of MIPS eligible clinicians who practice in Method II CAHs.
As established in the CY 2017 Quality Payment Program final rule (81 FR 77051 through 77053), services rendered by an eligible clinician under the RHC or FQHC methodology, will not be subject to the MIPS payments adjustments. As noted, these eligible clinicians have the option to voluntarily report on applicable measures and activities for MIPS, in which the data received will not be used to assess their
We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77051 through 77053) for our discussion of MIPS eligible clinicians who practice in RHCs or FQHCs.
Section 1848(q)(6)(E) of the Act provides that the MIPS payment adjustment is applied to the amount otherwise paid under Part B with respect to the items and services furnished by a MIPS eligible clinician during a year. Some eligible clinicians may not receive MIPS payment adjustments due to their billing methodologies. If a MIPS eligible clinician furnishes items and services in an ASC, HHA, Hospice, and/or HOPD and the facility bills for those items and services (including prescription drugs) under the facility's all-inclusive payment methodology or prospective payment system methodology, the MIPS adjustment would not apply to the facility payment itself. However, if a MIPS eligible clinician furnishes other items and services in an ASC, HHA, Hospice, and/or HOPD and bills for those items and services separately, such as under the PFS, the MIPS adjustment would apply to payments made for such items and services. Such items and services would also be considered for purposes of applying the low-volume threshold. Therefore, we propose that services rendered by an eligible clinician that are payable under the ASC, HHA, Hospice, or HOPD methodology would not be subject to the MIPS payments adjustments. However, these eligible clinicians have the option to voluntarily report on applicable measures and activities for MIPS, in which the data received would not be used to assess their performance for the purpose of the MIPS payment adjustment. We note that eligible clinicians who bill under both the PFS and one of these other billing methodologies (ASC, HHA, Hospice, and/or HOPD) may be required to participate in MIPS if they exceed the low-volume threshold and are otherwise eligible clinicians; in such case, data reported would be used to determine their MIPS payment adjustment. We solicit public comments on this proposal.
As described in the CY 2017 Quality Payment Program final rule (81 FR 77057), we established that the use of multiple identifiers that allow MIPS eligible clinicians to be measured as an individual or collectively through a group's performance and that the same identifier be used for all four performance categories. While we have multiple identifiers for participation and performance, we established the use of a single identifier, TIN/NPI, for applying the MIPS payment adjustment, regardless of how the MIPS eligible clinician is assessed.
As established in the CY 2017 Quality Payment Program final rule (81 FR 77058), we define a MIPS eligible clinician at § 414.1305 to mean the use of a combination of unique billing TIN and NPI combination as the identifier to assess performance of an individual MIPS eligible clinician. Each unique TIN/NPI combination is considered a different MIPS eligible clinician, and MIPS performance is assessed separately for each TIN under which an individual bills.
As established in the CY 2017 Quality Payment Program final rule (81 FR 77059), we codified the definition of a group at § 414.1305 to mean a group that consists of a single TIN with two or more eligible clinicians (including at least one MIPS eligible clinician), as identified by their individual NPI, who have reassigned their billing rights to the TIN.
As described in the CY 2017 Quality Payment Program final rule (81 FR 77060), we established that each eligible clinician who is a participant of an APM Entity is identified by a unique APM participant identifier. The unique APM participant identifier is a combination of four identifiers: (1) APM Identifier (established by CMS; for example, XXXXXX); (2) APM Entity identifier (established under the APM by CMS; for example, AA00001111); (3) TIN(s) (9 numeric characters; for example, XXXXXXXXX); (4) EP NPI (10 numeric characters; for example, 1111111111). We codified the definition of an APM Entity group at § 414.1305 to mean a group of eligible clinicians participating in an APM Entity, as identified by a combination of the APM identifier, APM Entity identifier, TIN, and NPI for each participating eligible clinician.
As established in the CY 2017 Quality Payment Program final rule (81 FR 77061 through 77062), we defined a new Medicare-enrolled eligible clinician at § 414.1305 as a professional who first becomes a Medicare-enrolled eligible clinician within the PECOS during the performance period for a year and had not previously submitted claims under Medicare such as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier. Additionally, we established at § 414.1310(c) that these eligible clinicians will not be treated as a MIPS eligible clinician until the subsequent year and the performance period for such subsequent year. We established at § 414.1310(d) that in no case would a MIPS payment adjustment apply to the items and services furnished during a year by new Medicare-enrolled eligible clinicians for the applicable performance period.
We used the term “new Medicare-enrolled eligible clinician determination period” to refer to the 12 months of a calendar year applicable to the performance period. During the new Medicare-enrolled eligible clinician determination period, we conduct eligibility determinations on a quarterly basis to the extent that is technically feasible to identify new Medicare-enrolled eligible clinicians that would be excluded from the requirement to participate in MIPS for the applicable performance period.
In the CY 2017 Quality Payment Program final rule (81 FR 77062), we established at § 414.1305 that a QP (as defined at § 414.1305) is not a MIPS eligible clinician, and is therefore excluded from MIPS. Also, we established that a Partial QP (as defined, at § 414.1305) who does not report on applicable measures and activities that are required to be reported under MIPS for any given performance period in a year is not a MIPS eligible clinician.
Section 1848(q)(1)(C)(ii)(III) of the Act provides that the definition of a MIPS eligible clinician does not include MIPS eligible clinicians who are below the low-volume threshold selected by the Secretary under section 1848(q)(1)(C)(iv) of the Act for a given year. Section 1848(q)(1)(C)(iv) of the Act requires the Secretary to select a low-volume
In the CY 2017 Quality Payment Program final rule (81 FR 77069 through 77070), we defined individual MIPS eligible clinicians or groups who do not exceed the low-volume threshold at § 414.1305 as an individual MIPS eligible clinician or group who, during the low-volume threshold determination period, has Medicare Part B allowed charges less than or equal to $30,000 or provides care for 100 or fewer Part B-enrolled Medicare beneficiaries. We established at § 414.1310(b) that for a year, MIPS eligible clinicians who do not exceed the low-volume threshold (as defined at § 414.1305) are excluded from MIPS for the performance period for a given calendar year.
In the CY 2017 Quality Payment Program final rule (81 FR 77069 through 77070), we defined the low-volume threshold determination period to mean a 24-month assessment period, which includes a two-segment analysis of claims data during an initial 12-month period prior to the performance period followed by another 12-month period during the performance period. The initial 12-month segment of the low-volume threshold determination period spans from the last 4 months of a calendar year 2 years prior to the performance period followed by the first 8 months of the next calendar year and includes a 60-day claims run out, which allows us to inform eligible clinicians and groups of their low-volume status during the month (December) prior to the start of the performance period. The second 12-month segment of the low-volume threshold determination period spans from the last 4 months of a calendar year 1 year prior to the performance period followed by the first 8 months of the performance period in the next calendar year and includes a 60-day claims run out, which allows us to inform additional eligible clinicians and groups of their low-volume status during the performance period.
We recognize that individual MIPS eligible clinicians and groups that are small practices or practicing in designated rural areas face unique dynamics and challenges such as fiscal limitations and workforce shortages, but serve as a critical access point for care and provide a safety net for vulnerable populations. Claims data shows that approximately 15 percent of individual MIPS eligible clinicians (TIN/NPIs) are considered to be practicing in rural areas after applying all exclusions. Also, we have heard from stakeholders that MIPS eligible clinicians practicing in small practices and designated rural areas tend to have a patient population with a higher proportion of older adults, as well as higher rates of poor health outcomes, co-morbidities, chronic conditions, and other social risk factors, which can result in the costs of providing care and services being significantly higher compared to non-rural areas. We also have heard from many solo practitioners and small practices who still face challenges and additional resource burden in participating in the MIPS.
In the CY 2017 Quality Payment Program final rule, we did not establish an adjustment for social risk factors in assessing and scoring performance. In response to the CY 2017 Quality Payment Program final rule, we received public comments indicating that individual MIPS eligible clinicians and groups practicing in designated rural areas would be negatively impacted and at a disadvantage if assessment and scoring methodology did not adjust for social risk factors. Additionally, commenters expressed concern that such individual MIPS eligible clinicians and groups may be disproportionately more susceptible to lower performance scores across all performance categories and negative MIPS payments adjustments, and as a result, such outcomes may further strain already limited fiscal resources and workforce shortages, and negatively impact access to care (reduction and/or elimination of available services).
After the consideration of stakeholder feedback provided during informal listening sessions since the publication of the CY 2017 Quality Payment Program final rule, we are proposing to modify the low-volume threshold policy established in the CY 2017 Quality Payment Program final rule. We believe that increasing the dollar amount and beneficiary count of the low-volume threshold would further reduce the number of eligible clinicians that are required to participate in the MIPS, which would reduce the burden on individual MIPS eligible clinicians and groups practicing in small practices and designated rural areas. Based on our analysis of claims data, we found that increasing the low-volume threshold to to exclude individual eligible clinicians or groups that have Medicare Part B allowed charges less than or equal to $90,000 or that provide care for 200 or fewer Part B-enrolled Medicare beneficiaries will exclude approximately 134,000 additional clinicians from MIPS from the approximately 700,000 clinicians that would have been eligible based on the low-volume threshold that was finalized in the CY 2017 Quality Payment Program final rule. Almost half of the additionally excluded clinicians are in small practices and approximately 17 percent are clinicians from practices in designated rural areas. Applying this criterion decreases the percent of the MIPS eligible clinicians that come from small practices. For example, prior to any exclusions, clinicians in small practices represent 35 percent of all clinicians billing Part B services. After applying the eligibility criteria for the CY 2017 Quality Payment Program final rule, MIPS eligible clinicians in small practices represent approximately 27 percent of the clinicians eligible for MIPS; however, with the increased low-volume threshold, approximately 22 percent of the clinicians eligible for MIPS are from small practices. In our analysis, the proposed changes to the low-volume threshold showed little impact on MIPS eligible clinicians from practices in designated rural areas. MIPS eligible clinicians from practices in designated rural areas account for 15 to 16 percent of the total MIPS eligible population. We note that, due to data limitations, we assessed rural status based on the status of individual TIN/NPI and did not model any group definition for practices in designated rural areas.
We believe that increasing the number of such individual eligible clinicians and groups excluded from MIPS participation would reduce burden and mitigate, to the extent feasible, the issue surrounding confounding variables impacting performance under the MIPS. Therefore, beginning with the 2018 MIPS performance period, we are proposing to increase the low-volume threshold. Specifically, at § 414.1305, we are proposing to define an individual MIPS eligible clinician or group who does not exceed the low-volume threshold as an individual MIPS eligible clinician or group who, during the low-volume threshold determination period, has Medicare Part B allowed charges less than or equal to $90,000 or provides care for 200 or fewer Part B-enrolled Medicare beneficiaries. This
We recognize that increasing the dollar amount and beneficiary count of the low-volume threshold would increase the number of individual MIPS eligible clinicians and groups excluded from MIPS. We assessed various levels of increases and found that $90,000 as the dollar amount and 200 as the beneficiary count balances the need to account for individual MIPS eligible clinicians and groups who face additional participation burden while not excluding a significant portion of the clinician population.
MIPS eligible clinicians who do not exceed the low-volume threshold (as defined at § 414.1305) are excluded from MIPS for the performance period with respect to a year. The low-volume threshold also applies to MIPS eligible clinicians who practice in APMs under the APM scoring standard at the APM Entity level, in which APM Entities do not exceed the low-volume threshold. In such cases, the MIPS eligible clinicians participating in the MIPS APM Entity would be excluded from the MIPS requirements for the applicable performance period and not subject to a MIPS payment adjustment for the applicable year. Such an exclusion would not affect an APM Entity's QP determination if the APM Entity is an Advanced APM.
In the CY 2017 Quality Payment Program final rule, we established the low-volume threshold determination period to refer to the timeframe used to assess claims data for making eligibility determinations for the low-volume threshold exclusion (81 FR 77069 through 77070). We defined the low-volume threshold determination period to mean a 24-month assessment period, which includes a two-segment analysis of claims data during an initial 12-month period prior to the performance period followed by another 12-month period during the performance period. Based on our analysis of data from the initial segment of the low-volume threshold determination period for performance periods occurring in 2017 (that is, data spanning from September 1, 2015 to August 31, 2016), we found that it may not be necessary to include a 60-day claims run out since we could achieve a similar outcome for such eligibility determinations by utilizing a 30-day claims run out.
In our comparison of data analysis results utilizing a 60-day claims run out versus a 30-day claims run out, there was a 1 percent decrease in data completeness. The small decrease in data completeness would not substantially impact individual MIPS eligible clinicians or groups regarding low-volume threshold determinations. We believe that a 30-day claims run out would allow us to complete the analysis and provide such determinations in a more timely manner. For performance periods occurring in 2018 and future years, we propose a modification to the low-volume threshold determination period, in which the initial 12-month segment of the low-volume threshold determination period would span from the last 4 months of a calendar year 2 years prior to the performance period followed by the first 8 months of the next calendar year and include a 30-day claims run out; and the second 12-month segment of the low-volume threshold determination period would span from the last 4 months of a calendar year 1 year prior to the performance period followed by the first 8 months of the performance period in the next calendar year and include a 30-day claims run out. This proposal would only change the duration of the claims run out, not the 12-month timeframes used for the first and second segments of data analysis.
For purposes of the 2020 MIPS payment year, we would initially identify individual eligible clinicians and groups that do not exceed the low-volume threshold based on 12 months of data starting from September 1, 2016 to August 31, 2017. To account for the identification of additional individual eligible clinicians and groups that do not exceed the low-volume threshold during performance periods occurring in 2018, we would conduct another eligibility determination analysis based on 12 months of data starting from September 1, 2017 to August 31, 2018. We would not change the low-volume status of any individual eligible clinician or group identified as not exceeding the low-volume threshold during the first eligibility determination analysis based on the second eligibility determination analysis. Thus, an individual eligible clinician or group that is identified as not exceeding the low-volume threshold during the first eligibility determination analysis would continue to be excluded from MIPS for the duration of the performance period regardless of the results of the second eligibility determination analysis. We established our policy to include two eligibility determination analyses in order to prevent any potential confusion for an individual eligible clinician or group to know whether or not participate in MIPS; also, such policy makes it clear from the onset as to which individual eligible clinicians and groups would be required to participate in MIPS. We would conduct the second eligibility determination analysis to account for the identification of additional, previously unidentified individual eligible clinicians and groups who do not exceed the low-volume threshold. We note that low-volume threshold determinations are made at the individual and group level, and not at the virtual group level.
We note that section 1848(q)(1)(C)(iv) of the Act requires the Secretary to select a low-volume threshold to apply for the purposes of this exclusion which may include one or more of the following: (1) The minimum number, as determined by the Secretary, of Part B-enrolled individuals who are treated by the MIPS eligible clinician for a particular performance period; (2) the minimum number, as determined by the Secretary, of items and services furnished to Part B-enrolled individuals by the MIPS eligible clinician for a particular performance period; and (3) the minimum amount, as determined by the Secretary, of allowed charges billed by the MIPS eligible clinician for a particular performance period. We have established a low-volume threshold that accounts for the minimum number of Part-B enrolled individuals who are treated by a MIPS eligible clinician and that accounts for the minimum amount of allowed charges billed by a MIPS eligible clinician. We have not made proposals specific to a minimum number of items and service furnished to Part-B enrolled individuals by a MIPS eligible clinician.
In order to expand the ways in which claims data could be analyzed for purposes of determining a more comprehensive assessment of the low-volume threshold, we have assessed the option of establishing a low-volume threshold for items and services furnished to Part-B enrolled individuals by a MIPS eligible clinician. We have considered defining items and services by using the number of patient encounters or procedures associated with a clinician. Defining items and services by patient encounters would assess each patient per visit or encounter with the MIPS eligible clinician. We believe that defining items and services by using the number of patient encounters or procedures is a simple and straightforward approach for stakeholders to understand. However,
For the individual MIPS eligible clinicians and groups that would be excluded from MIPS participation as a result of an increased low-volume threshold, we believe that in future years it would be beneficial to provide, to the extent feasible, such individual MIPS eligible clinicians and groups with the option to opt-in to MIPS participation if they might otherwise be excluded under the low-volume threshold such as where they only meet one of the threshold determinations (including a third determination based on Part B items and services, if established). For example, if a clinician meets the low-volume threshold of $90,000 in allowed charges, but does not meet the threshold of 200 patients or, if established, the threshold pertaining to Part B items and services, we believe the clinician should, to the extent feasible, have the opportunity to choose whether or not to participate in the MIPS and be subject to MIPS payment adjustments. We recognize that this choice would present additional complexity to clinicians in understanding all of their available options and may impose additional burden on clinicians by requiring them to notify CMS of their decision. Because of these concerns and our desire to establish options in a way that is a low-burden and user-focused experience for all MIPS eligible clinicians, we would not be able to offer this additional flexibility until performance periods occurring in 2019. Therefore, as a means of expanding options for clinicians and offering them the ability to participate in MIPS if they otherwise would not be included, for the purposes of the 2021 MIPS payment year, we propose to provide clinicians the ability to opt-in to the MIPS if they meet or exceed one, but not all, of the low-volume threshold determinations, including as defined by dollar amount, beneficiary count or, if established, items and services. We request public comment on this proposal.
We note that there may be additional considerations we should address for scenarios in which an individual eligible clinician or a group does not exceed the low-volume threshold and opts-in to participate in MIPS. We therefore seek comment on any additional considerations we should address when establishing this opt-in policy. Such as, should we establish parameters for individual clinicians or groups who elect to opt-in to participate in MIPS such as required length of participation? Additionally, we note that there is the potential with this opt-in policy for there to be an impact on our ability to create quality benchmarks that meet our sample size requirements. For example, if particularly small practices or solo practitioners with low Part B beneficiary volumes opt-in, such clinician's may lack sufficient sample size to be scored on many quality measures, especially measures that do not apply to all of a MIPS eligible clinician's patients. We therefore seek comment on how to address any potential impact on our ability to create quality benchmarks that meet our sample size requirements.
We solicit public comments on these proposals.
As described in the CY 2017 Quality Payment Program final rule, we established the following requirements for groups (81 FR 77072):
• Individual eligible clinicians and individual MIPS eligible clinicians will have their performance assessed as a group as part of a single TIN associated with two or more eligible clinicians (including at least one MIPS eligible clinician), as identified by a NPI, who have reassigned their Medicare billing rights to the TIN (at § 414.1310(e)(1)).
• A group must meet the definition of a group at all times during the performance period for the MIPS payment year in order to have its performance assessed as a group (at § 414.1310(e)(2)).
• Individual eligible clinicians and individual MIPS eligible clinicians within a group must aggregate their performance data across the TIN to have their performance assessed as a group (at § 414.1310(e)(3)).
• A group that elects to have its performance assessed as a group will be assessed as a group across all four MIPS performance categories (at § 414.1310(e)(4)).
As noted in the CY 2017 Quality Payment Program final rule, we would not make an eligibility determination regarding group size, but indicated that groups would attest to their group size for purpose of using the CMS Web Interface or a group identifying as a small practice (81 FR 77057). In section II.C.1.d. of this proposed rule, we are proposing to modify the way in which size would be determined for small practices by establishing a process under which CMS would utilize claims data to make small practice size determinations. Also, in section II.C.4.e. of this proposed rule, we are proposing to establish a policy under which CMS would utilize claims data to determine group size for groups of 10 or fewer eligible clinicians seeking to form or join a virtual group.
As noted in the CY 2017 Quality Payment Program final rule, a group size would be determined before exclusions are applied (81 FR 77057). We note that group size determinations are based on the number of NPIs associated with a TIN, which would include clinicians (NPIs) who may be excluded from MIPS participation and do not meet the definition of a MIPS eligible clinician.
As described in the CY 2017 Quality Payment Program final rule (81 FR 77072 through 77073), we established, the following policies:
• A group must adhere to an election process established and required by CMS (§ 414.1310(e)(5)), which includes:
++ Groups will not be required to register to have their performance assessed as a group except for groups submitting data on performance measures via participation in the CMS Web Interface or groups electing to report the CAHPS for MIPS survey for the quality performance category. For all other data submission mechanisms, groups must work with appropriate third party intermediaries as necessary to ensure the data submitted clearly indicates that the data represent a group submission rather than an individual submission.
++ In order for groups to elect participation via the CMS Web Interface or administration of the CAHPS for MIPS survey, such groups must register by June 30 of the applicable performance period (that is, June 30, 2018, for performance periods occurring in 2018). We note that groups participating in APMs that require APM Entities to report using the CMS Web Interface are not required to register for the CMS Web Interface or administer the CAHPS for MIPS survey separate from the APM.
When groups submit data utilizing third party intermediaries, such as a qualified registry, QCDR, or EHR, we are able to obtain group information from the third party intermediary and discern whether the data submitted represents group submission or individual submission once the data are submitted.
In the CY 2017 Quality Payment Program final rule (81 FR 77072 through 77073), we discussed the implementation of a voluntary registration process if technically feasible. Since the publication of the CY 2017 Quality Payment Program final rule, we have determined that it is not technically feasible to develop and build a voluntary registration process. Until further notice, we are not implementing a voluntary registration process.
Also, in the CY 2017 Quality Payment Program final rule (81 FR 77075), we expressed our commitment to pursue the active engagement of stakeholders throughout the process of establishing and implementing virtual groups. We received public comments in response to the CY 2017 Quality Payment Program final rule and additional stakeholder feedback by hosting several virtual group listening sessions and convening user groups. Many stakeholders requested that CMS provide an option that would permit a portion of a group to participate in MIPS outside the group by reporting as a separate subgroup or forming a virtual group. Stakeholders indicated that the option would measure performance more effectively, enable groups to identify areas for improvement at a granular level that would further improve quality of care and health outcomes, and increase coordination of care.
We recognize that groups, including multi-specialty groups, have requested over the years that we make an option available to them that would allow a portion of a group to report as a separate subgroup on measures and activities that are more applicable to the subgroup and be assessed and scored accordingly based on the performance of the subgroup. In future rulemaking, we intend to explore the feasibility of establishing group-related policies that would permit participation in MIPS at a subgroup level and create such functionality through a new identifier. We solicit public comment on the ways in which participation in MIPS at the subgroup level could be established.
There are generally three ways to participate in MIPS: (1) Individual-level reporting; (2) group-level reporting; and (3) virtual group-level reporting. We refer readers to sections II.C.1., II.C.3., and II.C.5. of this proposed rule for a discussion of the previously established requirements for individual- and group-level participation and our proposed policies for performance periods occurring in 2018 and future years. In this rule, we are proposing to establish requirements for MIPS participation at the virtual group level.
Section 1848(q)(5)(I) of the Act provides for the use of voluntary virtual groups for certain assessment purposes, including the election of practices to be a virtual group and the requirements for the election process. Section 1848(q)(5)(I)(i) of the Act provides that MIPS eligible clinicians electing to be a virtual group must: (1) Have their performance assessed for the quality and cost performance categories in a manner that applies the combined performance of all the MIPS eligible clinicians in the virtual group to each MIPS eligible clinician in the virtual group for the applicable performance period; and (2) be scored for the quality and cost performance categories based on such assessment. Section 1848(q)(5)(I)(ii) of the Act requires, in accordance with section 1848(q)(5)(I)(iii) of the Act, the establishment and implementation of a process that allows an individual MIPS eligible clinician or a group consisting of not more than 10 MIPS eligible clinicians to elect, for a given performance period, to be a virtual group with at least one other such individual MIPS eligible clinician or group. The virtual group may be based on appropriate classifications of providers, such as by geographic areas or by provider specialties defined by nationally recognized specialty boards of certification or equivalent certification boards.
Section 1848(q)(5)(I)(iii) of the Act provides that the virtual group election process must include the following requirements: (1) An individual MIPS eligible clinician or group electing to be in a virtual group must make their election prior to the start of the applicable performance period and cannot change their election during the performance period; (2) an individual MIPS eligible clinician or group may elect to be in no more than one virtual group for a performance period, and, in the case of a group, the election applies to all MIPS eligible clinicians in the group; (3) a virtual group is a combination of TINs; (4) the requirements must provide for formal written agreements among individual MIPS eligible clinicians and groups electing to be a virtual group; and (5) such other requirements as the Secretary determines appropriate.
As noted above, section 1848(q)(5)(I)(ii) of the Act requires, in accordance with section 1848(q)(5)(I)(iii) of the Act, the establishment and implementation of a process that allows an individual MIPS eligible clinician or group consisting of not more than 10 MIPS eligible clinicians to elect, for a given performance period, to be a virtual group with at least one other such individual MIPS eligible clinician or group. Given that section 1848(q)(5)(I)(iii)(V) of the Act provides that a virtual group is a combination of TINs, we interpret the references to an “individual” MIPS eligible clinician in section 1848(q)(5)(I)(ii) of the Act to mean a solo practitioner, which, for purposes of section 1848(q)(5)(I) of the Act, we propose to define as a MIPS eligible clinician (as defined at § 414.1305) who bills under a TIN with no other NPIs billing under such TIN.
Also, we recognize that a group (TIN) may include not only NPIs who meet the definition of a MIPS eligible clinician, but also NPIs who do not meet the definition of a MIPS eligible clinician at § 414.1305 and who are excluded from MIPS under § 414.1310(b) or (c) based on one of four exclusions (new Medicare-enrolled eligible clinician; QP; Partial QP who chooses not to report on measures and activities under MIPS; and eligible clinicians that do not exceed the low-volume threshold). Thus, we interpret the references to a group “consisting of not more than 10” MIPS eligible clinicians in section 1848(q)(5)(I)(ii) of the Act to mean that a group with 10 or fewer eligible clinicians (as defined at § 414.1305) would be eligible to form or join a virtual group. For purposes of the MIPS payment adjustment, the adjustment would apply only to NPIs in the virtual group who meet the definition of a MIPS eligible clinician at § 414.1305 and who are not excluded from MIPS under § 414.1310(b) or (c). We note that such groups, as defined at § 414.1305, would need to include at least one MIPS eligible clinician in order to be eligible to join or form a virtual group. We refer readers to section II.C.4.g. of this proposed rule for discussion regarding the assessment and scoring of groups participating in MIPS as a virtual group.
We propose to define a virtual group at § 414.1305 as a combination of two or more TINs composed of a solo practitioner (a MIPS eligible clinician (as defined at § 414.1305) who bills under a TIN with no other NPIs billing under such TIN), or a group (as defined at § 414.1305) with 10 or fewer eligible clinicians under the TIN that elects to form a virtual group with at least one
Lastly, we note that qualifications as a virtual group for purposes of MIPS do not change the application of the physician self-referral law to a financial relationship between a physician and an entity furnishing designated health services, nor does it change the need for such a financial relationship to comply with the physician self-referral law.
We note that while entire TINs participate in a virtual group, including each NPI under a TIN, and are assessed and scored collectively as a virtual group, only NPIs that meet the definition of a MIPS eligible clinician would be subject to a MIPS payment adjustment. However, we note that, as discussed in section II.C.4.h. of this proposed rule, any MIPS eligible clinician who is part of a TIN participating in a virtual group and participating in a MIPS APM or Advanced APM under the MIPS APM scoring standard would not receive a MIPS payment adjustment based on the virtual group's final score, but would receive a payment adjustment based on the MIPS APM scoring standard.
Additionally, we recognize that there are circumstances in which a TIN may have one portion of its NPIs participating under the generally applicable MIPS scoring criteria while the remaining portion of NPIs under the TIN is participating in a MIPS APM or an Advanced APM under the MIPS APM scoring standard. In the CY 2017 Quality Payment Program final rule (81 FR 77058), we noted that except for groups containing APM participants, we are not permitting groups to “split” TINs if they choose to participate in MIPS as a group (81 FR 77058). Thus, we consider a group to mean an entire single TIN that elects to participate in MIPS at the group or virtual group level, including groups that have a portion of its NPIs participating in a MIPS APM or an Advanced APM. We note that such groups would participate in MIPS similar to other groups.
To clarify, for all groups, including groups containing participants in a MIPS APM or an Advanced APM, the group's performance assessment consists of the entire TIN regardless of whether the group participates in MIPS as part of a virtual group. Generally, for groups other than groups containing participants in a MIPS APM or an Advanced APM, each MIPS eligible clinician under the TIN (TIN/NPI) receives a MIPS adjustment based on the entire group's performance assessment (entire TIN). For groups containing participants in a MIPS APM or an Advanced APM, only the portion of the TIN that is being scored for MIPS according to the generally applicable scoring criteria (TIN/NPI) receives a MIPS adjustment based on the entire group's performance assessment (entire TIN). The remaining portion of the TIN that is being scored according to the APM scoring standard (TIN/NPI) receives a MIPS adjustment based on that standard, or may be exempt from MIPS if they achieve QP or Partial QP status.
We propose to apply a similar policy to groups, including groups containing participants in a MIPS APM or an Advanced APM, that are participating in MIPS as part of a virtual group. Specifically, for groups other than groups containing participants in a MIPS APM or an Advanced APM, each MIPS eligible clinician (TIN/NPI) would receive a MIPS adjustment based on the virtual group's combined performance assessment (combination of TINs). For groups containing participants in a MIPS APM or an Advanced APM, only the portion of the TIN that is being scored for MIPS according to the generally applicable scoring criteria (TIN/NPI) would receive a MIPS adjustment based on the virtual group's combined performance assessment (combination of TINs). As discussed in section II.C.4.h. of this proposed rule, we are proposing to use waiver authority to ensure that any participants in the group who are participating in a MIPS APM receive their payment adjustment based on their score under the APM scoring standard (TIN/NPI). Such participants may be exempt from MIPS if they achieve QP or Partial QP status.
We refer readers to section II.C.4.e. of this proposed rule for a discussion of the proposed virtual group election process and section II.C.4.g. of this proposed rule for discussion of our proposals regarding the assessment and scoring of virtual groups.
We recognize that virtual groups would each have unique characteristics and varying patient populations. As noted in section II.C.4.a. of this proposed rule, the statute provides the Secretary with discretion to establish appropriate classifications regarding the composition of virtual groups such as by geographic area or specialty. However, we believe it is important for virtual groups to have the flexibility to determine their own composition at this time, and, as a result, we are not proposing to establish any such classifications regarding virtual group composition. We further note that the statute does not limit the number of TINs that may form a virtual group, and we are not proposing to establish such a limit at this time. We did consider however proposing to establish such a limit, such as 50 or 100 participants. In particular, we are concerned that virtual groups of too substantial a size (for example, 10 percent of all MIPS eligible clinicians in a given specialty or sub-specialty) may make it difficult to compare performance between and among clinicians. We believe that limiting the number of virtual group participants could eventually assist virtual groups as they aggregate their performance data across the virtual group. However, we believe that as we initially implement virtual groups, it is important for virtual groups to have the flexibility to determine their own size, and thus, a better approach is to not place such a limit on virtual group size. We will, however, monitor the ways in which solo practitioners and groups with 10 or fewer eligible clinicians form virtual groups and may propose to establish appropriate classifications regarding virtual group composition or a limit on the number of TINs that may form a virtual group in future rulemaking as necessary. We solicit public comment on these proposals, as well as our approach of not establishing appropriate classifications (such as classification by geographic area or specialty) regarding virtual group composition or a limit on the number of TINs that may form a virtual group at this time.
In the CY 2017 Quality Payment Program final rule (81 FR 77073 through 77077), we expressed our commitment to pursue the active engagement of stakeholders throughout the process of establishing and implementing virtual groups. We received public comments in response to the CY 2017 Quality Payment Program final rule and additional stakeholder feedback by hosting several virtual group listening sessions and convening user groups. Many stakeholders requested that CMS provide an option that would permit a portion of a group to participate in MIPS outside the group by reporting separately or forming a virtual group. We refer readers to section II.C.b.3. of this proposed rule for discussion regarding a potential option for addressing such issue.
To ensure that we have accurately captured all of the MIPS eligible clinicians participating in a virtual group, we propose that each MIPS eligible clinician who is part of a virtual group would be identified by a unique virtual group participant identifier. The unique virtual group participant
In the CY 2017 Quality Payment Program final rule (81 FR 77070 through 77072), we finalized various requirements for groups under MIPS at § 414.1310(e), under which groups electing to report at the group level are assessed and scored across the TIN for all four performance categories. We propose to apply our previously finalized and proposed group policies to virtual groups, unless otherwise specified. We recognize that there are instances in which we may need to clarify or modify the application of certain previously finalized or proposed group-related policies to virtual groups, such as the definition of a non-patient facing MIPS eligible clinician; small practice, rural area and HPSA designations; and groups that have a portion of its NPIs participating in a MIPS APM or an Advanced APM (see section II.C.4.b. of this proposed rule). More generally, such policies may include those that require a calculation of the number of NPIs across a TIN (given that a virtual group is a combination of TINs), the application of any virtual group participant's status or designation to the entire virtual group, and the applicability and availability of certain measures and activities to any virtual group participant and to the entire virtual group.
With regard to the applicability of the non-patient facing policies to virtual groups, in the CY 2017 Quality Payment Program final rule (81 FR 77048 through 77049), we defined the term non-patient facing MIPS eligible clinician at § 414.1305 as an individual MIPS eligible clinician that bills 100 or fewer patient facing encounters (including Medicare telehealth services defined in section 1834(m) of the Act) during the non-patient facing determination period, and a group provided that more than 75 percent of the NPIs billing under the group's TIN meet the definition of a non-patient facing individual MIPS eligible clinician during the non-patient facing determination period. We are proposing to modify the definition of a non-patient facing MIPS eligible clinician to include clinicians in a virtual group provided that more than 75 percent of the NPIs billing under the virtual group's TINs meet the definition of a non-patient facing individual MIPS eligible clinician during the non-patient facing determination period. We refer readers to section II.C.4.f. of this rule for the proposed modification. We note that other policies previously established and proposed in this proposed rule for non-patient facing groups would apply to virtual groups. For example, as discussed in section II.C.1.e. of this proposed rule, virtual groups determined to be non-patient facing would have their advancing care information performance category automatically reweighted to zero.
In regard to the application of small practice status to virtual groups, we are proposing that a virtual group would be identified as having a small practice status if the virtual group does not have 16 or more members of a virtual group (NPIs). We refer readers to section II.C.4.d. of this proposed rule for discussion regarding how small practice status would apply to virtual groups for scoring under MIPS. In the CY 2017 Quality Payment Program final rule (81 FR 77188), we defined the term small practices at § 414.1305 as practices consisting of 15 or fewer clinicians and solo practitioners. In section II.C.1.c. of this proposed rule, we are proposing for performance periods occurring in 2018 and future years to identify small practices by utilizing claims data. For performance periods occurring in 2018, we would identify small practices based on 12 months of data starting from September 1, 2016 to August 31, 2017.
In section II.C.1.e. of this rule, we propose to determine rural area and HPSA practice designations for groups participating in MIPS at the group level. We note that in section II.C.7.b we describe our scoring proposals for practices that are in a rural area or HPSA practice. For performance periods occurring in 2018 and future years, we are proposing that a group with 75 percent or more of the TIN's practice sites designated as rural areas or HPSA practices would be designated as a rural area or HPSA at the group level. We are proposing that a virtual group with 75 percent or more of the virtual group's TINs designated as rural areas or HPSA practices would be designated as a rural area or HPSA practice at the virtual group level. We note that other policies previously established and proposed in this proposed rule for rural area and HPSA groups would apply to virtual groups.
We recognize that the measures and activities available to groups would also be available to virtual groups. Virtual groups would be required to meet the reporting requirements for each measure and activity, and the virtual group would be responsible for ensuring that their measures and activities are aggregated across the virtual group (for example, across their TINs). We note that other previously established group-related policies and proposed policies in this proposed rule pertaining to the four performance categories would apply to virtual groups.
Therefore, we propose to apply MIPS group policies to virtual groups except as otherwise specified. We solicit public comment on this proposal. We are also interested on receiving feedback on how such group-related policies previously established and proposed in this proposed rule either would or would not apply to virtual groups. In addition, we request public comment on any other policies that may need to be clarified or modified with respect to virtual groups, such as those that require a calculation of the number of NPIs across a TIN (given that a virtual group is a combination of TINs), the application of any virtual group participant's status or designation to the entire virtual group, the application of the group reporting requirements for the individual performance categories to virtual groups, and the applicability and availability of certain measures and activities to any virtual group participant and to the entire virtual group.
As noted above, section 1848(q)(5)(I)(iii)(I) and (II) of the Act provides that the virtual group election process must include certain requirements, including that: (1) An individual MIPS eligible clinician or group electing to be in a virtual group must make their election prior to the start of the applicable performance period and cannot change their election during the performance period; and (2) an individual MIPS eligible clinician or group may elect to be in no more than one virtual group for a performance period, and, in the case of a group, the election applies to all MIPS eligible clinicians in the group. We propose to codify at § 414.1315(a) that a solo practitioner or a group of 10 or fewer eligible clinicians must make their election prior to the start of the applicable performance period and cannot change their election during the performance period. Virtual group participants may elect to be in no more than one virtual group for a performance period and, in the case of a group, the election applies to all MIPS eligible
We propose to codify at § 414.1315(b) that, beginning with performance periods occurring in 2018, a solo practitioner, or group of 10 or fewer eligible clinicians electing to be in a virtual group must make their election by December 1 of the calendar year preceding the applicable performance period. For example, a solo practitioner or group would need to make their election by December 1, 2017 to participate in MIPS as a virtual group during the 2018 performance period. Prior to the election deadline, a virtual group representative would have the opportunity to make an election, on behalf of the members of a virtual group, regarding the formation of a virtual group for an applicable performance period. We intend to publish the beginning date of the virtual group election period applicable to the 2018 performance period and future years in subregulatory guidance.
In order to provide support and reduce burden, we intend to make technical assistance (TA) available, to the extent feasible and appropriate, to support clinicians who choose to come together as a virtual group. Clinicians can access TA infrastructure and resources that they may already be utilizing). For Quality Payment Program year 3, we intend to provide an electronic election process if technically feasible. We propose that clinicians who do not elect to contact their designated TA representative would still have the option of contacting the Quality Payment Program Service Center.
We propose to codify at § 414.1315(c) a two-stage virtual group election process, stage 1 of which is optional, for the applicable 2018 and 2019 performance periods. Stage 1 pertains to virtual group eligibility determinations. In stage 1, solo practitioners and groups with 10 or fewer eligible clinicians interested in forming or joining a virtual group would have the option to contact their designated TA representative or the Quality Payment Program Service Center in order to obtain information pertaining to virtual groups and/or determine whether or not they are eligible, as it relates to the practice size requirement of a solo practitioner or a group of 10 or fewer eligible clinicians, to participate in MIPS as a virtual group (§ 414.1315(a)(1)(i)). We note that activity involved in stage 1 is not required, but a resource available to solo practitioners and groups with 10 or fewer eligible clinicians; otherwise, solo practitioners or groups with 10 or fewer eligible clinicians that do not engage in any activity during stage 1, they would begin the election process at stage 2. For solo practitioners and groups who engage in stage 1 and were determined eligible for virtual group participation, they would proceed to stage 2. Engaging in stage 1 would provide solo practitioners and groups with the option to confirm whether or not they are eligible to join or form a virtual group before going to the lengths of executing formal written agreements, submitting a formal election registration, allocating resources for virtual group implementation, and other related activities; whereas, engaging directly in stage 2 as an initial step, solo practitioners and groups may have conducted all such efforts to only have their election registration be rejected with no recourse or remaining time to amend and resubmit.
During stage 1 of the virtual group election process, we would determine whether or not a TIN is eligible to form or join a virtual group. In order for a solo practitioner to be eligible to form or join a virtual group, the solo practitioner would need to be considered a MIPS eligible clinician (defined at § 414.1305) who bills under a TIN with no other NPIs billing under such TIN, and not excluded from MIPS under § 414.1310(b) and (c). In order for a group to be eligible to form or join a virtual group, a group would need to have a TIN size that does not exceed 10 eligible clinicians and not excluded from MIPS based on the low-volume threshold exclusion at the group level. For purposes of determining TIN size for virtual group participation eligibility, we coin the term “virtual group eligibility determination period” and define it to mean an analysis of claims data during an assessment period of up to five months that would begin on July 1 and end as late as November 30 of a calendar year prior to the performance year and includes a 30-day claims run out.
To capture a real-time representation of TIN size, we propose to analyze up to five months of claims data on a rolling basis, in which virtual group eligibility determinations for each TIN would be updated and made available monthly. We note that an eligibility determination regarding TIN size is based on a relative point in time within the five-month virtual group eligibility determination period, and not an eligibility determination made at the end of such five-month determination period. If at any time a TIN is determined to be eligible to participate in MIPS as part of a virtual group, the TIN would retain that status for the duration of the election period and the applicable performance period. TINs could determine their status by contacting their designated TA representative or the Quality Payment Program Service Center; otherwise, the TIN's status would be determined at the time that the TIN's virtual group election is submitted. For example, if a group contacted their designated TA representative or the Quality Payment Program Service Center on October 20, 2017, the claims data analysis would include the months of July through September of 2017, and if determined not to exceed 10 eligible clinicians, such TIN's size status would be identified at such time and would be retained for the duration of the election period and the 2018 performance period. If another group contacted their designated TA representative or the Quality Payment Program Service Center on November 20, 2017, the claims data analysis would include the months of July through October of 2017, and if determined not to exceed 10 eligible clinicians, such TIN's size status would be identified at such time and would be retained for the duration of the election period and the 2018 performance period.
We believe such a virtual group determination period process provides a relative representation of real-time group size for purposes of virtual group eligibility and allows groups to know their real-time size status immediately and plan accordingly for virtual group implementation. It is anticipated that starting in September of each calendar year prior to the applicable performance year beginning in 2018, groups would be able to contact their designated TA representative or the Quality Payment Program Service Center and inquire about virtual group participation eligibility. We note that TIN size determinations are based on the number of NPIs associated with a TIN, which would include clinicians (NPIs) excluded from MIPS participation and who do not meet the definition of a MIPS eligible clinician.
For groups that do not choose to participate in stage 1 of the election process (that is, the group does not request an eligibility determination), we will make an eligibility determination during stage 2 of the election process. If a group began the election process at stage 2 and if its TIN size is determined not to exceed 10 eligible clinicians and not excluded based on the low-volume threshold exclusion at the group level, the group is determined eligible to participate in MIPS as part of a virtual group, and such virtual group eligibility determination status would be retained
Stage 2 pertains to virtual group formation. For stage two, we propose the following:
• TINs comprising a virtual group must establish a written formal agreement between each member of a virtual group prior to an election (§ 414.1315(c)(2)(i)).
• On behalf of a virtual group, the official designated virtual group representative must submit an election by December 1 of the calendar year prior to the start of the applicable performance period. (§ 414.1315(c)(2)(ii)). We anticipate this election will occur via email to the Quality Payment Program Service Center using the following email address:
• The submission of a virtual group election must include, at a minimum, information pertaining to each TIN and NPI associated with the virtual group and contact information for the virtual group representative (§ 414.1315(c)(2)(iii). A virtual group representative would submit the following type of information: each TIN associated with the virtual group; each NPI associated with a TIN that is part of the virtual group; name of the virtual group representative; affiliation of the virtual group representative to the virtual group; contact information for the virtual group representative; and confirm through acknowledgment that a written formal agreement has been established between each member of the virtual group prior to election and each member of the virtual group is aware of participating in MIPS as a virtual group for an applicable performance period. Each member of the virtual group must retain a copy of the virtual group's written agreement. We note that the virtual group agreement is subject to the MIPS data validation and auditing requirements as described in section II.C.9.c. of this rule.
• Once an election is made, the virtual group representative must contact their designated CMS contact to update any election information that changed during an applicable performance period one time prior to the start of an applicable submission period (§ 414.1315(c)(2)(iv)). We anticipate that virtual groups will use the Quality Payment Program Service Center as their designated CMS contact; however, we will define this further in subregulatory guidance.
For stage 2 of the election process, we would review all submitted election information; confirm whether or not each TIN within a virtual group is eligible to participate in MIPS as part of a virtual group; identify the NPIs within each TIN participating in a virtual group that are excluded from MIPS in order to ensure that such NPIs would not receive a MIPS payment adjustment or, when applicable and when information is available, would receive a payment adjustment based on a MIPS APM scoring standard; calculate the low-volume threshold at the individual and group levels in order to determine whether or not a solo practitioner or group is eligible to participate in MIPS as part of a virtual group; and notify virtual groups as to whether or not they are considered official virtual groups for the applicable performance period. For virtual groups that are determined to have met the virtual group formation criteria and identified as an official virtual group participating in MIPS for an applicable performance period, we would contact the official designated virtual group representative via email notifying the virtual group of its official virtual group status and issuing a virtual group identifier for performance (as described in section II.C.4.c. of this proposed rule) that would accompany the virtual group's submission of performance data during the submission period.
In regard to virtual group determinations pertaining to the low-volume threshold, we recognize that such determinations are made at the individual and group level, but not at the virtual group level. The low-volume threshold determinations are applicable to the way in which individual eligible clinicians and groups participate in MIPS as individual MIPS eligible clinicians (solo practitioners) or groups. For example, if an individual MIPS eligible clinician is part of a practice that is participating in MIPS at the individual level (reporting at the individual level), then the low-volume threshold determination is made at the individual level. Whereas, if an individual MIPS eligible clinician is part of a practice that is participating in MIPS at the group level (reporting at the group level), then the low-volume threshold determination at the group level would be applicable to such MIPS eligible clinician regardless of the low-volume threshold determination made at the individual level because such individual MIPS eligible clinician is part of a group reporting at the group level and the low-volume threshold determinations for groups applies to the group as a whole. Similarly, if a solo practitioner or a group with 10 or fewer eligible clinicians seeks to participate in MIPS at the virtual group level (reporting at the virtual group level), then the low-volume threshold determination at the individual or group level would be applicable to such solo practitioner or group with 10 or fewer eligible clinicians. Thus, solo practitioners (individual MIPS eligible clinicians) or groups with 10 or fewer eligible clinicians that are determined not to exceed the low-volume threshold at the individual or group level would not be eligible to participate in MIPS as an individual, group, or virtual group.
As we engaged in various discussions with stakeholders during the rulemaking process through listening sessions and user groups, stakeholders indicated that many solo practitioners and small groups have limited resources and technical capacities, which may make it difficult for the entities to form virtual groups without sufficient time and technical assistance. Depending on the resources and technical capacities of the entities, stakeholders conveyed that it may take entities 3 to 18 months to prepare to participate in MIPS as a virtual group. The majority of stakeholders indicated that virtual groups would need at least 6 to 12 months prior to the start of the 2018 performance period to form virtual groups, prepare health IT systems, and train staff to be ready for the implementation of virtual group related activities by January 1, 2018.
We recognize that for the first year of virtual group formation and implementation prior to the start of the 2018 performance period, the timeframe for virtual groups to make an election by registering would be relatively short, particularly from the date we issue the publication of a final rule toward the end of the 2017 calendar year. To provide solo practitioners and groups with 10 or fewer eligible clinicians with additional time to assemble and coordinate resources, and form a virtual group prior to the start of the 2018 performance period, we are providing virtual groups with an opportunity to make an election prior to the publication of our final rule. We intend for the virtual group election process to be available as early as mid-September of 2017; we will publicize the specific opening date via subregulatory guidance. Virtual groups would have from mid-September to December 1, 2017 to make an election for the 2018 performance year. In regard to our proposed policies pertaining to virtual group implementation (for example, definition of a virtual group and election process requirements), we intend to closely align with the statutory requirements in order to establish clear expectations for solo practitioners and
As previously noted, groups participating in a virtual group would have the size of their TIN determined for eligibility purposes. The virtual group size would be determined one time for each performance period. We recognize that the size of a group may fluctuate during a performance period with eligible clinicians and/or MIPS eligible clinicians joining or leaving a group. For groups within a virtual group that are determined to have a group size of 10 eligible clinicians or less based on the one time determination per applicable performance year, any new eligible clinicians or MIPS eligible clinicians that join the group during the performance period would participate in MIPS as part of the virtual group. In such cases, we recognize that a group may exceed 10 eligible clinicians associated with its TIN during an applicable performance period, but at the time of election, such group would have been determined eligible to form or join a virtual group given that the TIN did not have more than 10 eligible clinicians associated with its TIN. As previously noted, the virtual group representative would need to contact the Quality Payment Program Service Center to update the virtual group's information that was provided during the election period if any information changed during an applicable performance period one time prior to the start of an applicable submission period (for example, include new NPIs who joined a TIN that is part of a virtual group). Virtual groups must re-register before each performance period.
The statute provides that a solo practitioner (TIN/NPI) and a group with 10 or fewer eligible clinicians may elect to be in no more than one virtual group for a performance period. We note that such a solo practitioner or a group that is part of a virtual group may not elect to be in more than one virtual group for a performance period. Also, the statute determines that a virtual group election by the group for an applicable performance period applies to all MIPS eligible clinicians in the group. In the case of a TIN within a virtual group being acquired or merged with another TIN, or no longer operating as a TIN (for example, a group practice closes) during a performance period, such solo practitioner or group's performance data would continue to be attributed to the virtual group. The remaining members of a virtual group would continue to be part of the virtual group even if only one solo practitioner or group remains. We consider a TIN that is acquired or merged with another TIN, or no longer operating as a TIN (
As outlined in section 1848(q)(5)(I)(iii) of the Act and previously noted, a virtual group is a combination of TINs, which would include at least two separate TINs associated with a solo practitioner (TIN/NPI), or a group with 10 or fewer eligible clinicians and another such solo practitioner, or group. However, given that a virtual group must be a combination of TINs, we recognize that the composition of a virtual group could include, for example, one solo practitioner (NPI) who is practicing under multiple TINs, in which the solo practitioner would be able to form a virtual group with his or her own self based on each TIN assigned to the solo practitioner. For the number of TINs able to form a virtual group, we note that there is not a limit to the number of TINs able to comprise a virtual group.
The statute provides for formal written agreements among the MIPS eligible clinicians electing to form a virtual group. We propose that each virtual group member would be required to execute formal written agreements with each other virtual group member to ensure that requirements and expectations of participation in MIPS are clearly articulated, understood, and agreed upon. We note that a virtual group may not include a solo practitioner or group as part of the virtual group unless an authorized person of the TIN has executed a formal written agreement. During the election process and submission of a virtual group election, a designated virtual group representative would be required to confirm through acknowledgement that an agreement is in place between each member of the virtual group. An agreement would be executed for at least one performance period. If a NPI joins or leaves a TIN, or a change is made to a TIN that impacts the agreement itself, such as a legal business name change, during the applicable performance year, a virtual group would be required to update the agreement to reflect such changes and submit changes to CMS via the Quality Payment Program Service Center.
We propose, at § 414.1315(c)(3), that a formal written agreement between each member of a virtual group must include the following elements:
• Expressly state the only parties to the agreement are the TINs and NPIs of the virtual group (at § 414.1315(c)(3)(i)). For example, the agreement may not be between a virtual group and another entity, such as an independent practice association (IPA) or management company that in turn has an agreement with one or more TINs within the virtual group. Similarly, virtual groups should not use existing contracts between TINs that include third parties.
• Be executed on behalf of the TINs and the NPIs by individuals who are authorized to bind the TINs and the NPIs, respectively at § 414.1315(c)(3)(ii)).
• Expressly require each member of the virtual group (including each NPI under each TIN) to agree to participate in MIPS as a virtual group and comply with the requirements of the MIPS and all other applicable laws and regulations (including, but not limited to, federal criminal law, False Claims Act, anti-kickback statute, civil monetary penalties law, Health Insurance Portability and Accountability Act, and physician self-referral law) at § 414.1315(c)(3)(iii)).
• Require each TIN within a virtual group to notify all NPIs associated with the TIN of their participation in the MIPS as a virtual group at § 414.1315(c)(3)(iv)).
• Set forth the NPI's rights and obligations in, and representation by, the virtual group, including without limitation, the reporting requirements and how participation in MIPS as a virtual group affects the ability of the NPI to participate in the MIPS outside of the virtual group at § 414.1315(c)(3)(v)).
• Describe how the opportunity to receive payment adjustments will encourage each member of the virtual group (including each NPI under each TIN) to adhere to quality assurance and improvement at § 414.1315(c)(3)(vi)).
• Require each member of the virtual group to update its Medicare enrollment information, including the addition and deletion of NPIs billing through a TIN that is part of a virtual group, on a timely basis in accordance with Medicare program requirements and to notify the virtual group of any such changes within 30 days after the change at § 414.1315(c)(3)(vii)).
• Be for a term of at least one performance period as specified in the formal written agreement at § 414.1315(c)(3)(viii)).
• Require completion of a close-out process upon termination or expiration of the agreement that requires the TIN (group part of the virtual group) or NPI (solo practitioner part of the virtual group) to furnish all data necessary in order for the virtual group to aggregate its data across the virtual group at § 414.1315(c)(3)(ix)).
As part of the virtual group election ICR, we filed a 60-day notice on June 14, 2017 (82 FR 27257), which includes an agreement template that could be used by virtual groups and will be made available via subregulatory guidance. The agreement template is not required, but serves as a model agreement that could be utilized by virtual groups. The agreement template includes all necessary elements required for such an agreement.
We solicit public comment on these proposals.
Through the formal written agreements, we want to ensure that all members of a virtual group are aware of their participation in a virtual group. As noted above, formal written agreements must include a provision that requires each TIN within a virtual group to notify all NPIs associated with the TIN regarding their participation in the MIPS as a virtual group in order to ensure that each member of a virtual group is aware of their participation in the MIPS as a virtual group. We want to implement an approach that considers a balance between the need to ensure that all members of a virtual group are aware of their participation in a virtual group and the minimization of administration burden. We solicit public comment on approaches for virtual groups to ensure that all members of a virtual group are aware of their participation in the virtual group.
As we noted in this proposed rule, we believe virtual groups should generally be treated under the MIPS as groups. Therefore, for MIPS eligible clinicians participating at the virtual group level, we propose the following requirements:
• Individual eligible clinicians and individual MIPS eligible clinicians who are part of a TIN participating in MIPS at the virtual group level would have their performance assessed as a virtual group at § 414.1315(d)(1).
• Individual eligible clinicians and individual MIPS eligible clinicians who are part of a TIN participating in MIPS at the virtual group level would need to meet the definition of a virtual group at all times during the performance period for the MIPS payment year (at § 414. 1315(d)(2)).
• Individual eligible clinicians and individual MIPS eligible clinicians who are part of a TIN participating in MIPS at the virtual group level must aggregate their performance data across multiple TINs in order for their performance to be assessed as a virtual group (at § 414.1315(d)(3)).
• MIPS eligible clinicians that elect to participate in MIPS at the virtual group level would have their performance assessed at the virtual group level across all four MIPS performance categories (at § 414.1315(d)(4)).
• Virtual groups would need to adhere to an election process established and required by CMS (at § 414.1315(d)(5)).
We solicit public comment on these proposals.
As noted above, section 1848(q)(5)(I)(i) of the Act provides that eligible clinicians electing to be a virtual group will: (1) Have their performance assessed for the quality and cost performance categories in a manner that applies the combined performance of all eligible clinicians in the virtual group to each MIPS eligible clinician (except for those participating in a MIPS APM or an Advanced APM under the MIPS APM scoring standard) in the virtual group for a performance period of a year; and (2) be scored based on the assessment of the combined performance described above regarding the quality and cost performance categories for a performance period. We believe it is critical for virtual groups to be assessed and scored at the virtual group level for all performance categories; it eliminates the burden of virtual group members having to report as a virtual group and separately outside of a virtual group. Additionally, we believe that the assessment and scoring at the virtual group level provides for a comprehensive measurement of performance, shared responsibility, and an opportunity to effectively and efficiently coordinate resources to also achieve performance under the improvement activities and the advancing care information performance categories. We propose at § 414.1315 that virtual groups would be assessed and scored across all four MIPS performance categories at the virtual group level for a performance period of a year.
In the CY 2017 Quality Payment Program final rule (81 FR 77319 through 77329), we established the MIPS final score methodology, which will apply to virtual groups. We refer readers to sections II.C.7.b. and II.C.8. of this proposed rule for scoring policies that would apply to virtual groups.
As previously noted, we propose to allow solo practitioners and groups with 10 or fewer eligible clinicians that have elected to be part of a virtual group to have their performance measured and aggregated at the virtual group level across all four performance categories; however, we would apply payment adjustments at the individual TIN/NPI level. Each TIN/NPI would receive a final score based on the virtual group performance, but the payment adjustment would still be applied at the TIN/NPI level. We would assign the virtual group score to all TIN/NPIs billing under a TIN in the virtual group during the performance period.
During the performance year, we recognize that NPIs in a TIN that has joined a virtual group may also be participants in an APM. The TIN, as part of the virtual group, must submit performance data for all eligible clinicians associated with the TIN, including those participating in APMs, to ensure that all eligible clinicians associated with the TIN are being measured under MIPS.
For participants in MIPS APMs, we propose to use our authority under section 1115A(d)(1) for MIPS APM authorized under section 1115A of the Act, and under section 1899(f) for the Shared Savings Program, to waive the requirement under section 1848 (q)(2)(5)(I)(i)(II) of the Act that requires performance category scores from virtual group reporting must be used to generate the composite score upon which the MIPS payment adjustment is based for all TIN/NPIs in the virtual group. Instead, we would use the score assigned to the MIPS eligible clinician based on the applicable APM Entity score to determine MIPS payment adjustments for all MIPS eligible clinicians that are part of an APM Entity participating in a MIPS APM, in accordance with § 414.1370, instead of determining MIPS payment adjustments for these MIPS eligible clinicians using the composite score of their virtual group.
APMs seek to deliver better care at lower cost and to test new ways of paying for care and measuring and assessing performance. In the CY 2017 Quality Payment Program final rule, we established policies to the address concerns we have expressed in regard to the application of certain MIPS policies to MIPS eligible clinicians in MIPS APMs (81 FR 77246 through 77269). In section II.C.6.g. of this proposed rule, we reiterate those concerns and propose additional policies for the APM scoring standard. We believe it is important to
We note that MIPS eligible clinicians who are participants in both a virtual group and a MIPS APM would be assessed under MIPS as part of the virtual group and under the APM scoring standard as part of an APM Entity group, but would receive their payment adjustment based only on the APM Entity score. In the case of an eligible clinician participating in both a virtual group and an Advanced APM who has achieved QP status, the clinician would be assessed under MIPS as part of the virtual group, but would still be excluded from the MIPS payment adjustment as a result of his or her QP status. We refer readers to section II.C.6.g.(2) of this proposed rule for further discussion regarding the waiver and the CY 2017 Quality Payment Program final rule (81 FR 77013) for discussion regarding the timeframe used for determining QP status.
In the CY 2017 Quality Payment Program final rule (81 FR 77085), we finalized at § 414.1320(b)(1) that for purposes of the MIPS payment year 2020, the performance period for the quality and cost performance categories is CY 2018 (January 1, 2018 through December 31, 2018). For the improvement activities and advancing care information performance categories, we finalized at § 414.1320(b)(2) that for purposes of the MIPS payment year 2020, the performance period for the improvement activities and advancing care information performance categories is a minimum of a continuous 90-day period within CY 2018, up to and including the full CY 2018 (January 1, 2018, through December 31, 2018). We are not proposing any changes to these policies.
We also finalized at § 414.1325(f)(2) to use claims with dates of service during the performance period that must be processed no later than 60 days following the close of the performance period for purposes of assessing performance and computing the MIPS payment adjustment. Lastly, we finalized that individual MIPS eligible clinicians or groups who report less than 12 months of data (due to family leave, etc.) would be required to report all performance data available from the applicable performance period (for example, CY 2018 or a minimum of a continuous 90-day period within CY 2018).
We are proposing at § 414.1320(c) and (c)(1) that for purposes of the MIPS payment year 2021 and future years, for the quality and cost performance categories, the performance period under MIPS would be the full calendar year (January 1 through December 31) that occurs 2 years prior to the applicable payment year. For example, for the MIPS payment year 2021, the performance period would be CY 2019 (January 1, 2019 through December 31, 2019), and for the MIPS payment year 2022 the performance period would be CY 2020 (January 1, 2020 through December 31, 2020).
We are proposing at § 414.1320(d) and (d)(1) that for purposes of the MIPS payment year 2021, the performance period for the improvement activities and advancing care information performance categories would be a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable payment year, up to and including the full CY 2019 (January 1, 2019 through December 31, 2019).
We request comments on our proposals for the performance period for MIPS payment year 2021 and future years.
We finalized in the CY 2017 Quality Payment Program final rule (81 FR 77094) at § 414.1325(a) that individual MIPS eligible clinicians and groups must submit measures and activities, as applicable, for the quality, improvement activities, and advancing care information performance categories. For the cost performance category, we finalized that each individual MIPS eligible clinician's and group's cost performance would be calculated using administrative claims data. As a result, individual MIPS eligible clinicians and groups are not required to submit any additional information for the cost performance category. For individual eligible clinicians and groups that are not MIPS eligible clinicians, such as physical therapists, but elect to report to MIPS, we will calculate administrative claims-based cost measures and quality measures, if data are available. We finalized in the CY 2017 Quality Payment Program final rule (81 FR 77094 through 77095) multiple data submission mechanisms for MIPS, which provide individual MIPS eligible clinicians and groups with the flexibility to submit their MIPS measures and activities in a manner that best accommodates the characteristics of their practice, as indicated in Tables 2 and 3. Table 2 summarizes the data submission mechanisms for individual MIPS eligible clinicians that we finalized at § 414.1325(b) and (e). Table 3 summarizes the data submission mechanisms for groups that are not reporting through an APM that we finalized at § 414.1325(c) and (e).
We
We are proposing to revise § 414.1325(d) for purposes of the 2020 MIPS payment year and future years, beginning with performance periods occurring in 2018, to allow individual MIPS eligible clinicians and groups to submit data on measures and activities, as applicable, via multiple data submission mechanisms for a single performance category (specifically, the quality, improvement activities, or advancing care information performance category). Under this proposal, individual MIPS eligible clinicians and groups that have fewer than the required number of measures and activities applicable and available under one submission mechanism could be required to submit data on additional measures and activities via one or more additional submission mechanisms, as necessary, provided that such measures and activities are applicable and available to them to receive the maximum number of points under a performance category. We considered an approach that would require MIPS eligible clinicians to first submit data on as many required measures and activities as possible via one submission mechanism before submitting data via an additional submission mechanism, but we believe that such an approach would limit flexibility.
If an individual MIPS eligible clinician or group submits the same measure through two different mechanisms, each submission would be calculated and scored separately. We do not have the ability to aggregate data on the same measure across submission mechanisms. We would only count the submission that gives the clinician the higher score, thereby avoiding the double count. We refer readers to section II.C.7. of this proposed rule, which further outlines how we propose to score measures and activities regardless of submission mechanism.
We believe that this flexible approach would help individual MIPS eligible clinicians and groups with reporting, as it provides more options for the submission of data for the applicable
As discussed in section II.C.4. of this proposed rule, we are proposing to generally apply our previously finalized and proposed group policies to virtual groups. With respect to data submission mechanisms, we are proposing that virtual groups would be able to use a different submission mechanism for each performance category, and would be able to utilize multiple submission mechanisms for the quality performance category, beginning with performance periods occurring in 2018. However, virtual groups would be required to utilize the same submission mechanism for the improvement activities and the advancing care information performance categories.
For those MIPS eligible clinicians participating in a MIPS APM, who are on an APM Participant List on at least one of the three snapshot dates as finalized in the CY 2017 Quality Payment Program Final Rule (81 FR 77444 through 77445), or for MIPS eligible clinicians participating in a full TIN MIPS APM, who are on an APM Participant List on at least one of the four snapshot dates as discussed in section II.C.6.g.(2) of this proposed rule, the APM scoring standard applies. We refer readers to § 414.1370 and the CY 2017 Quality Payment Program final rule (81 FR 77246), which describes how MIPS eligible clinicians participating in APM entities submit data to MIPS in the form and manner required, including separate approaches to the quality and cost performance categories applicable to MIPS APMs. We are not proposing any changes to how APM entities in MIPS APMs and their participating MIPS eligible clinicians submit data to MIPS.
In the CY 2017 Quality Payment Program final rule (81 FR 77097), we finalized submission deadlines by which all associated data for all performance categories must be submitted for the submission mechanisms described in this rule.
As specified at § 414.1325(f)(1), the data submission deadline for the qualified registry, QCDR, EHR, and attestation submission mechanisms is March 31 following the close of the performance period. The submission period will begin prior to January 2 following the close of the performance period, if technically feasible. For example, for performance periods occurring in 2018, the data submission period will occur prior to January 2, 2019, if technically feasible, through March 31, 2019. If it is not technically feasible to allow the submission period to begin prior to January 2 following the close of the performance period, the submission period will occur from January 2 through March 31 following the close of the performance period. In any case, the final deadline will remain March 31, 2019.
At § 414.1325(f)(2), we specified that for the Medicare Part B claims submission mechanism, data must be submitted on claims with dates of service during the performance period that must be processed no later than 60 days following the close of the performance period. Lastly, for the CMS Web Interface submission mechanism, at § 414.1325(f)(3), we specified that the data must be submitted during an 8-week period following the close of the performance period that will begin no earlier than January 2, and end no later than March 31. For example, the CMS Web Interface submission period could span an 8-week timeframe beginning January 16 and ending March 13. The specific deadline during this timeframe will be published on the CMS Web site. We are not proposing any changes to the submission deadlines in this proposed rule.
Sections 1848(q)(1)(A)(i) and (ii) of the Act require the Secretary to develop a methodology for assessing the total performance of each MIPS eligible clinician according to performance standards and, using that methodology, to provide for a final score for each MIPS eligible clinician. Section 1848(q)(2)(A)(i) of the Act requires us to use the quality performance category in determining each MIPS eligible clinician's final score, and section 1848(q)(2)(B)(i) of the Act describes the measures and activities that must be specified under the quality performance category.
The statute does not specify the number of quality measures on which a MIPS eligible clinician must report, nor does it specify the amount or type of information that a MIPS eligible clinician must report on each quality measure. However, section 1848(q)(2)(C)(i) of the Act requires the Secretary, as feasible, to emphasize the application of outcomes-based measures.
Sections 1848(q)(1)(E) of the Act requires the Secretary to encourage the use of QCDRs, and section 1848(q)(5)(B)(ii)(I) of the Act requires the Secretary to encourage the use of CEHRT and QCDRs for reporting measures under the quality performance category under the final score methodology, but the statute does not limit the Secretary's discretion to establish other reporting mechanisms.
Section 1848(q)(2)(C)(iv) of the Act generally requires the Secretary to give consideration to the circumstances of non-patient facing MIPS eligible clinicians and allows the Secretary, to the extent feasible and appropriate, to apply alternative measures or activities to such clinicians.
As discussed in the CY 2017 Quality Payment Program final rule (81 FR 77098 through 77099), we finalized MIPS quality criteria that focus on measures that are important to beneficiaries and maintain some of the
• To encourage meaningful measurement, we finalized allowing individual MIPS eligible clinicians and groups the flexibility to determine the most meaningful measures and data submission mechanisms for their practice.
• To simplify the reporting criteria, we aligned the submission criteria for several of the data submission mechanisms.
• To reduce administrative burden and focus on measures that matter, we lowered the required number of the measures for several of the data submission mechanisms, yet still required that certain types of measures, particularly outcome measures, be reported.
• To create alignment with other payers and reduce burden on MIPS eligible clinicians, we incorporated measures that align with other national payers.
• To create a more comprehensive picture of a practice's performance, we also finalized the use of all-payer data where possible.
As beneficiary health is always our top priority, we finalized criteria to continue encouraging the reporting of certain measures such as outcome, appropriate use, patient safety, efficiency, care coordination, or patient experience measures. However, as discussed in the CY 2017 Quality Payment Program final rule (81 FR 77098), we removed the requirement for measures to span across multiple domains of the NQS. We continue to believe the NQS domains are extremely important, and we encourage MIPS eligible clinicians to continue to strive to provide care that focuses on: Effective clinical care, communication and care coordination, efficiency and cost reduction, person and caregiver-centered experience and outcomes, community and population health, and patient safety. While we do not require that MIPS eligible clinicians select measures across multiple domains, we encourage them to do so. In addition, we believe the MIPS program overall, with the focus on the quality, cost, improvement activities, and advancing care information performance categories, will naturally cover many elements in the NQS.
For MIPS payment year 2019, the quality performance category will account for 60 percent of the final score, subject to the Secretary's authority to assign different scoring weights under section 1848(q)(5)(F) of the Act. Section 1848(q)(2)(E)(i)(I)(aa) of the Act states that the quality performance category will account for 30 percent of the final score for MIPS. However, section 1848(q)(2)(E)(i)(I)(bb) of the Act stipulates that for the first and second years for which MIPS applies to payments, the percentage of the final score applicable for the quality performance category will be increased so that the total percentage points of the increase equals the total number of percentage points by which the percentage applied for the cost performance category is less than 30 percent. Section 1848(q)(2)(E)(i)(II)(bb) of the Act requires that, for the transition year for which MIPS applies to payments, not more than 10 percent of the final score shall be based on the cost performance category. Furthermore, section 1848(q)(2)(E)(i)(II)(bb) of the Act states that, for the second year for which MIPS applies to payments, not more than 15 percent of the final score shall be based on the cost performance category.
In the CY 2017 Quality Payment Program final rule (81 FR 77100), we finalized at § 414.1330(b) that, for MIPS payment years 2019 and 2020, 60 percent and 50 percent, respectively, of the MIPS final score will be based on the quality performance category. For the third and future years, 30 percent of the MIPS final score will be based on the quality performance category.
As discussed in section II.C.6.d. of this proposed rule, we are proposing to weight the cost performance category at zero percent for the second MIPS payment year (2020). In accordance with section 1848(q)(5)(E)(i)(I)(bb) of the Act, for the first 2 years, the percentage of the MIPS final score that would otherwise be based on the quality performance category (that is, 30 percent) must be increased by the same number of percentage points by which the percentage based on the cost performance category is less than 30 percent. Therefore, if our proposal to reweight the cost performance category for MIPS payment year 2020 is finalized, we would need to inversely reweight the quality performance category for the same year. Accordingly, we are proposing to modify § 414.1330(b)(2) to reweight the percentage of the MIPS final score based on the quality performance category for MIPS payment year 2020 as may be necessary to account for any reweighting of the cost performance category, if finalized. For example, if our proposal to reweight the cost performance category to zero percent for MIPS payment year 2020 is finalized, then we would modify § 414.1330(b)(2) to provide that performance in the quality performance category will comprise 60 percent of a MIPS eligible clinician's final score for MIPS payment year 2020. We refer readers to section II.C.6.d. for more information on the cost performance category.
As also discussed in section II.C.6.d. of this proposed rule, we note that by reweighting the cost performance category to zero percent in performance period 2018, there will be a sharp increase in the cost performance category to a 30 percent weight in performance period 2019. In order to assist MIPS eligible clinicians and groups in obtaining additional comfort with measurement based on the cost performance category, we considered maintaining our previously-finalized cost performance category weight of 10 percent for the 2018 performance period. However, in our discussions with some MIPS eligible clinicians and clinician societies, eligible clinicians expressed their desire to down-weight the cost performance category to zero percent for an additional year with full knowledge that the cost performance category weight is set at 30 percent under the statute for the 2021 MIPS payment year. The clinicians we spoke with preferred our proposed approach and noted that they are actively preparing for full cost performance category implementation and would be prepared for the 30 percent statutory weight for the cost performance category for the 2021 MIPS payment year.
We intend to provide an initial opportunity for clinicians to review their performance based on the new episode-based measures at some point in the fall of 2017, as the measures are developed and as the information is available. We note that this feedback will be specific to the new episode-based measures that are developed under the process described above and may be presented in a different format than MIPS eligible clinicians' performance feedback as described in section II.C.9.a. of this proposed rule. However, our intention is to align the feedback as much as possible to ensure clinicians receive opportunities to review their performance on potential new episode-based measures for the cost performance category prior to the proposed 2019 MIPS performance period. We are unable to offer a list of new episode-based measures on which we will provide feedback because that will be determined in our ongoing development work described above. We are concerned that continuing to
Section 1848(q)(5)(B)(i) of the Act requires the Secretary to treat any MIPS eligible clinician who fails to report on a required measure or activity as achieving the lowest potential score applicable to the measure or activity. Specifically, under our finalized scoring policies, an individual MIPS eligible clinician or group that reports on all required measures and activities could potentially obtain the highest score possible within the performance category, assuming they perform well on the measures and activities they report. An individual MIPS eligible clinician or group who does not submit data on a required measure or activity would receive a zero score for the unreported items in the performance category (in accordance with section 1848(q)(5)(B)(i) of the Act). The individual MIPS eligible clinician or group could still obtain a relatively good score by performing very well on the remaining items, but a zero score would prevent the individual MIPS eligible clinician or group from obtaining the highest possible score within the performance category.
In the CY 2017 Quality Payment Program final rule (81 FR 77114), we finalized at § 414.1335(a)(1) that individual MIPS eligible clinicians submitting data via claims and individual MIPS eligible clinicians and groups submitting data via all mechanisms (excluding the CMS Web Interface and the CAHPS for MIPS survey) are required to meet the following submission criteria. For the applicable period during the performance period, the individual MIPS eligible clinician or group will report at least six measures, including at least one outcome measure. If an applicable outcome measure is not available, the individual MIPS eligible clinician or group will be required to report one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures) in lieu of an outcome measure. If fewer than six measures apply to the individual MIPS eligible clinician or group, then the individual MIPS eligible clinician or group would be required to report on each measure that is applicable. We defined “applicable” to mean measures relevant to a particular MIPS eligible clinician's services or care rendered. As discussed in section II.C.7.a.(2)(e)., we will only make determinations as to whether a sufficient number of measures are applicable for claims-based and registry submission mechanisms; we will not make this determination for EHR and QCDR submission mechanisms, for example.
Alternatively, the individual MIPS eligible clinician or group will report one specialty measure set, or the measure set defined at the subspecialty level, if applicable. If the measure set contains fewer than six measures, MIPS eligible clinicians will be required to report all available measures within the set. If the measure set contains six or more measures, MIPS eligible clinicians will be required to report at least six measures within the set. Regardless of the number of measures that are contained in the measure set, MIPS eligible clinicians reporting on a measure set will be required to report at least one outcome measure or, if no outcome measures are available in the measure set, the MIPS eligible clinician will report another high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures) within the measure set in lieu of an outcome measure. MIPS eligible clinicians may choose to report measures in addition to those contained in the specialty measure set and will not be penalized for doing so, provided that such MIPS eligible clinicians follow all requirements discussed here.
In accordance with § 414.1335(a)(1)(ii), individual MIPS eligible clinicians and groups will select their measures from either the set of all MIPS measures listed or referenced in Table A of the Appendix in this proposed rule or one of the specialty measure sets listed in Table B of the Appendix in this proposed rule. We note that some specialty measure sets include measures grouped by subspecialty; in these cases, the measure set is defined at the subspecialty level. Previously finalized quality measures may be found in the CY 2017 Quality Payment Program final rule (81 FR 77558 through 77816).
We also finalized the definition of a high priority measure at § 414.1305 to mean an outcome, appropriate use, patient safety, efficiency, patient experience, or care coordination quality measure. Except as discussed in section II.C.6.b.(3)(a) of this proposed rule with regard to the CMS Web Interface and the CAHPS for MIPS survey, we are not proposing any changes to the submission criteria or definitions established for measures in this proposed rule.
In the CY 2017 Quality Payment Program final rule (81 FR 77114), we solicited comments regarding adding a requirement to our finalized policy that patient-facing MIPS eligible clinicians would be required to report at least one cross-cutting measure in addition to the high priority measure requirement for further consideration for the Quality Payment Program Year 2 and future years. For clarification, we consider a cross-cutting measure to be any measure that is broadly applicable across multiple clinical settings and individual MIPS eligible clinicians or groups within a variety of specialties. We specifically requested feedback on how we could construct a cross-cutting measure requirement that would be most meaningful to MIPS eligible clinicians from different specialties and that would have the greatest impact on improving the health of populations. We received conflicting feedback on adding a future requirement for MIPS eligible clinicians to report at least one cross-cutting measure in the Quality Payment Program Year 2 and future years.
Many commenters agreed that cross-cutting measures are applicable across multiple clinical settings and that MIPS eligible clinicians within a variety of specialties should report at least one cross-cutting measure. Some stated that cross-cutting measures promote shared accountability and improve the health of populations. Others recommended we continue to work with stakeholders and specialists, including solo and small practices, to develop cross-cutting measures for all settings, whether they be patient-facing or non-patient facing practices that are patient-centric (that is, following the patient and not the site of care) and recommended the term “patient-centered measures” rather than “cross-cutting measures.” In addition, some commenters stated we should consider measures that are multidisciplinary, foster cross-collaboration within virtual groups, improve patient outcomes, target high-cost areas, target areas with gaps in care, and include individual patient preferences in shared decision-making. A few commenters provided specific measures that they recommended utilizing as cross-cutting measures, such as: Screening for Hepatitis C; Controlling High Blood Pressure; Tobacco Use Cessation Counseling and Treatment; Advance Care Planning; or Medication Reconciliation. One commenter recommended we utilize shared accountability measures around surgical goals of care, shared decision making relying on some form of risk estimation such as a risk calculator, medication reconciliation, and a shared plan of care across clinicians. Another commenter suggested that instead of having a cross-cutting measure requirement, we could use health IT as a cross-cutting requirement. Specifically, the commenter noted we could require that at least one measure using end-to-end electronic reporting, or that at least one measure be tied to an improvement activity the clinician is performing. Other commenters suggested that we provide bonus points to practices that elect to submit data on cross-cutting measures and hold harmless from any future cross-cutting measure requirements MIPS eligible clinicians who have less than 15 instances in the measure denominator during the performance period, allow MIPS eligible clinicians to use high-priority measures in the place of a cross-cutting measure if necessary, and apply the guiding principles listed in NQF's “Attribution: Principles and Approaches” final report which may be found at
Other commenters appreciated our decision not to finalize the requirement to report a cross-cutting measure in the transition year and requested that we not require cross-cutting measures in the future, as they believed it is administratively burdensome for clinicians and QCDRs and removes focus and resources from quality measures that are more relevant to MIPS eligible clinicians' scope of practice and important to their patients' treatment and outcomes. They stated that PQRS demonstrated the challenge of identifying cross-cutting measures that are truly meaningful across different specialties and that truly have an impact on improving the health of populations. Some stated we should focus on high-priority measures over cross-cutting measures. A few commenters did not agree that cross-cutting measures were relevant and stated they should not be a requirement in MIPS until all MIPS eligible clinicians can successfully meet the current requirements. Others did not agree that QCDRs should be required to submit cross-cutting measures because they believed that Congress did not intend for QCDRs to submit clinical process measures, that implementation may be complicated by practices that upgrade their health IT, and vendors have indicated it would take 12 to 18 months to implement system changes to support capture of cross-cutting measures. They also questioned the value of investing additional time and resources in this effort, especially if these cross-cutting measures are ultimately found to be topped out or removed. Others believed we should delay implementation until the Quality Payment Program Year 3 in order to allow MIPS eligible clinicians to focus on implementing new CEHRT requirements and modifying their processes to address lessons learned from reporting in the first 2 years.
Except as discussed in section II.C.6.b.(3)(a)(iii). of this proposed rule with regard to the CAHPS for MIPS survey, we are not proposing any changes to the submission criteria for quality measures in this proposed rule. We thank the commenters for their feedback and will take the comments into consideration in future rulemaking. We welcome additional feedback on meaningful ways to incorporate cross-cutting measurement into MIPS and the Quality Payment Program generally.
In the CY 2017 Quality Payment Program final rule (81 FR 77116), we finalized at § 414.1335(a)(2) the following criteria for the submission of data on quality measures by registered groups of 25 or more eligible clinicians who want to report via the CMS Web Interface. For the applicable 12-month performance period, the group would be required to report on all measures included in the CMS Web Interface completely, accurately, and timely by populating data fields for the first 248 consecutively ranked and assigned Medicare beneficiaries in the order in which they appear in the group's sample for each module or measure. If the sample of eligible assigned beneficiaries is less than 248, then the group would report on 100 percent of assigned beneficiaries. A group would be required to report on at least one measure for which there is Medicare patient data. Groups reporting via the CMS Web Interface are required to report on all of the measures in the set. Any measures not reported would be considered zero performance for that measure in our scoring algorithm. In addition, we are proposing to clarify that these criteria apply to groups of 25 or more eligible clinicians. Specifically, we propose to revise § 414.1335(a)(2)(i) to provide criteria applicable to groups of 25 or more eligible clinicians, report on all measures included in the CMS Web Interface. The group must report on the first 248 consecutively ranked beneficiaries in the sample for each measure or module.
In the CY 2017 Quality Payment Program final rule (81 FR 77116), we finalized to continue to align the 2019 CMS Web Interface beneficiary assignment methodology with the attribution methodology for two of the measures that were formerly in the VM: The population quality measure discussed in the CY 2017 Quality Payment Program proposed rule (81 FR 28188) and total per capita cost for all attributed beneficiaries discussed in the CY 2017 Quality Payment Program proposed rule (81 FR 28196). When establishing MIPS, we also finalized a modified attribution process to update the definition of primary care services and to adapt the attribution to different identifiers used in MIPS. These changes are discussed in the CY 2017 Quality Payment Program proposed rule (81 FR 28196). We note that groups reporting via the CMS Web Interface may also report the CAHPS for MIPS survey and receive bonus points for submitting that
In the CY 2017 Quality Payment Program final rule (81 FR 77100), we finalized at § 414.1335(a)(3) the following criteria for the submission of data on the CAHPS for MIPS survey by registered groups via CMS-approved survey vendor: For the applicable 12-month performance period, a group that wishes to voluntarily elect to participate in the CAHPS for MIPS survey measure must use a survey vendor that is approved by CMS for a particular performance period to transmit survey measures data to CMS. The CAHPS for MIPS survey counts for one measure towards the MIPS quality performance category and, as a patient experience measure, also fulfills the requirement to report at least one high priority measure in the absence of an applicable outcome measure. In addition, groups that elect this data submission mechanism must select an additional group data submission mechanism (that is, qualified registries, QCDRs, EHR, etc.) in order to meet the data submission criteria for the MIPS quality performance category. The CAHPS for MIPS survey will count as one patient experience measure, and the group will be required to submit at least five other measures through one other data submission mechanism. A group may report any five measures within MIPS plus the CAHPS for MIPS survey to achieve the six measures threshold. We are not proposing any changes to the performance criteria for quality measures for groups electing to report the CAHPS for MIPS survey in this proposed rule.
In the CY 2017 Quality Payment Program final rule (see 81 FR 77120), we finalized retaining the CAHPS for MIPS survey administration period that was utilized for PQRS of November to February. However, this survey administration period has become operationally problematic for the administration of MIPS. In order to compute scoring, we must have the CAHPS for MIPS survey data earlier than the current survey administration period deadline allows. Therefore, we are proposing for the Quality Payment Program Year 2 and future years that the survey administration period would, at a minimum, span over 8 weeks and would end no later than February 28th following the applicable performance period. In addition, we propose to further specify the start and end timeframes of the survey administration period through our normal communication channels.
In addition, as discussed in the CY 2017 Quality Payment Program final rule (81 FR 77116), we anticipated exploring the possibility of updating the CAHPS for MIPS survey under MIPS, specifically not finalizing all of the proposed Summary Survey Measures (SSMs). The CAHPS for MIPS survey currently consists of the core CAHPS Clinician & Group (CG–CAHPS) Survey developed by the Agency for Healthcare Research and Quality (AHRQ), plus additional survey questions to meet CMS's program needs. We are proposing for the Quality Payment Program Year 2 and future years to remove two SSMs, specifically, “Helping You to Take Medication as Directed” and “Between Visit Communication” from the CAHPS for MIPS survey. We are proposing to remove the SSM entitled “Helping You to Take Medication as Directed” due to low reliability. In 2014 and 2015, the majority of groups had very low reliability on this SSM. Furthermore, based on analyses conducted of SSMs in an attempt to improve their reliability, removing questions from this SSM did not result in any improvements in reliability. The SSM, “Helping You to Take Medication as Directed,” has also never been a scored measure with the Medicare Shared Savings Program CAHPS for Accountable Care Organizations (ACOs) Survey. We refer readers to the CY 2014 Physician Fee Schedule final rule for a discussion on the CAHPS for ACO survey scoring (79 FR 67909 through 67910) and measure tables (79 FR 67916 through 67917). The SSM entitled “Between Visit Communication” currently contains only one question. This question could also be considered related to other SSMs entitled: “Care Coordination” or “Courteous and Helpful Office Staff,” but does not directly overlap with any of the questions under that SSM. However, we are proposing to remove this SSM in order to maintain consistency with the Medicare Shared Savings Program which, utilizes the CAHPS for Accountable Care Organizations (ACOs) Survey. The SSM entitled “Between Visit Communication” has never been a scored measure with the Medicare Shared Savings Program CAHPS for ACOs Survey.
In addition to public comments we receive, we will also take into consideration analysis we will be conducting before finalizing this proposal. Specifically, we will review the findings of the CAHPS for ACO survey pilot, which was administered from November 2016 through February 2017. The CAHPS for ACO survey pilot utilized a survey instrument which did not contain the two SSMs we are proposing for removal from the CAHPS for MIPS survey. For more information on the other SSMs within the CAHPS for MIPS survey, please see the explanation of the CAHPS for PQRS survey in the CY 2016 PFS final rule with comment period (80 FR 71142 through 71143).
We are seeking comment on expanding the patient experience data available for the CAHPS for MIPS survey. Currently, the CAHPS for MIPS survey is available for groups to report under the MIPS. The patient experience survey data that is available on Physician Compare is highly valued by patients and their caregivers as they evaluate their health care options. However, in user testing with patients and caregivers in regard to the Physician Compare Web site, the users regularly ask for more information from patients like them in their own words. Patients regularly request that we include narrative reviews of individual clinicians and groups on the Web site. AHRQ is fielding a beta version of the CAHPS Patient Narrative Elicitation Protocol (
We are requiring, where possible, all-payer data for all reporting mechanisms, yet certain reporting mechanisms are limited to Medicare Part B data. Specifically, the CAHPS for MIPS survey currently relies on sampling protocols based on Medicare Part B billing; therefore, only Medicare Part B beneficiaries are sampled through that methodology. In the CY 2017 Quality Payment Program proposed rule (81 FR 28189), we requested comments on ways to modify the methodology to assign and sample patients for these mechanisms using data from other payers. We received mixed feedback on the use of all-payer data overall. The full discussion of the comments and the responses can be found in the CY 2017 Quality Payment Program final rule (81 FR 77123 through 77125). We are requesting additional comments on ways to modify the methodology to assign and sample patients using data from other payers for reporting mechanisms that are currently limited to Medicare Part B data. In particular, we are seeking comment on the ability of groups to provide information on the patients to whom they provide care during a calendar year, whether it would be possible to identify a list of patients seen by individual clinicians in the group, and what type of patient contact information groups would be able to provide. Further, we would like to seek comment on the challenges groups may anticipate in trying to provide this type of information, especially for vulnerable beneficiary populations, such as those lacking stable housing. We are also seeking comment on EHR vendors' ability to provide information on the patients who receive care from their client groups.
In the CY 2017 Quality Payment Program final rule (81 FR 77125), we finalized data completeness criteria for the transition year and MIPS payment year 2020. We finalized at § 414.1340 the data completeness criteria below for performance periods occurring in 2017.
• Individual MIPS eligible clinicians or groups submitting data on quality measures using QCDRs, qualified registries, or via EHR must report on at least 50 percent of the individual MIPS eligible clinician or group's patients that meet the measure's denominator criteria, regardless of payer for the performance period. In other words, for these submission mechanisms, we expect to receive quality data for both Medicare and non-Medicare patients. For the transition year, MIPS eligible clinicians whose measures fall below the data completeness threshold of 50 percent would receive 3 points for submitting the measure.
• Individual MIPS eligible clinicians submitting data on quality measures data using Medicare Part B claims, would report on at least 50 percent of the Medicare Part B patients seen during the performance period to which the measure applies. For the transition year, MIPS eligible clinicians whose measures fall below the data completeness threshold of 50 percent would receive 3 points for submitting the measure.
• Groups submitting quality measures data using the CMS Web Interface or a CMS-approved survey vendor to report the CAHPS for MIPS survey must meet the data submission requirements on the sample of the Medicare Part B patients CMS provides.
In addition, we finalized an increased data completeness threshold of 60 percent for MIPS for performance periods occurring in 2018 for data submitted on quality measures using QCDRs, qualified registries, via EHR, or Medicare Part B claims. We noted that these thresholds for data submitted on quality measures using QCDRs, qualified registries, via EHR, or Medicare Part B claims would increase for performance periods occurring in 2019 and onward.
We are proposing to modify the previously established data completeness criteria for MIPS payment year 2020. Specifically, we would like to provide an additional year for individual MIPS eligible clinicians and groups to gain experience with MIPS before increasing the data completeness thresholds for data submitted on quality measures using QCDRs, qualified registries, via EHR, or Medicare Part B claims. We are concerned about the unintended consequences of accelerating the data completeness threshold so quickly, which may jeopardize MIPS eligible clinicians' ability to participate and perform well under the MIPS, particularly those clinicians who are least experienced with MIPS quality measure data submission. We want to ensure that an appropriate yet achievable level of data completeness is applied to all MIPS eligible clinicians. We continue to believe it is important to incorporate higher data completeness thresholds in future years to ensure a more accurate assessment of a MIPS eligible clinician's performance on quality measures and to avoid any selection bias. Therefore, we propose, below, a 60 percent data completeness threshold for MIPS payment year 2021. We strongly encourage all MIPS eligible clinicians to perform the quality actions associated with the quality measures on their patients. The data submitted for each measure is expected to be representative of the individual MIPS eligible clinician's or group's overall performance for that measure. The data completeness threshold of less than 100 percent is intended to reduce burden and accommodate operational issues that may arise during data collection during the initial years of the program. We are providing this notice to MIPS eligible clinicians so that they can take the necessary steps to prepare for higher data completeness thresholds in future years.
Therefore, we propose to revise the data completeness criteria for the quality performance category at § 414.1340(a)(2) to provide that MIPS eligible clinicians and groups submitting quality measures data using the QCDR, qualified registry, or EHR submission mechanism must submit data on at least 50 percent of the individual MIPS eligible clinician's or group's patients that meet the measure's denominator criteria, regardless of payer, for MIPS payment year 2020. We also propose to revise the data completeness criteria for the quality performance category at § 414.1340(b)(2) to provide that MIPS eligible clinicians and groups submitting quality measures data using Medicare Part B claims, must submit data on at least 50 percent of the applicable Medicare Part B patients seen during the performance period to which the measure applies for MIPS payment year 2020. We further propose at § 414.1340(a)(3), that MIPS eligible clinicians and groups submitting quality measures data using the QCDR, qualified registry, or EHR submission mechanism must submit data on at least 60 percent of the individual MIPS eligible clinician or group's patients that meet the measure's denominator criteria, regardless of payer for MIPS payment year 2021. We also propose at § 414.1340(b)(3), that MIPS eligible clinicians and groups submitting quality measures data using Medicare Part B claims, must submit data on at least 60 percent of the applicable Medicare Part
In the CY 2017 Quality Payment Program final rule (81 FR 77125 through 77126), we finalized our approach of including all-payer data for the QCDR, qualified registry, and EHR submission mechanisms because we believed this approach provides a more complete picture of each MIPS eligible clinician's scope of practice and provides more access to data about specialties and subspecialties not currently captured in PQRS. In addition, those clinicians who utilize a QCDR, qualified registry, or EHR submission must contain a minimum of one quality measure for at least one Medicare patient. We are not proposing any changes to these policies in this proposed rule. As noted in the CY 2017 Quality Payment Program final rule, those MIPS eligible clinicians who fall below the data completeness thresholds will receive 3 points for the specific measures that fall below the data completeness threshold in the transition year of MIPS only. For the Quality Payment Program Year 2, we are proposing that MIPS eligible clinicians would receive 1 point for measures that fall below the data completeness threshold, with an exception for small practices of 15 or fewer who would still receive 3 points for measures that fail data completeness. We refer readers to section II.C.6.b.(3)(b) of this proposed rule for our proposed policies on instances when MIPS eligible clinicians' measures fall below the data completeness threshold.
Table 5 reflects our proposed quality data submission criteria for MIPS payment year 2020 via Medicare Part B claims, QCDR, qualified registry, EHR, CMS Web Interface, and the CAHPS for MIPS survey. It is important to note that while we finalized at § 414.1325(d) in the CY 2017 Quality Payment Program final rule that individual MIPS eligible clinicians and groups may only use one submission mechanism per performance category, in section II.C.6.a.(1) of this rule, we are proposing to revise § 414.1325(d) for purposes of the 2020 MIPS payment year and future years to allow individual MIPS eligible clinicians and groups to submit measures and activities, as applicable, via as many submission mechanisms as necessary to meet the requirements of the quality, improvement activities, or advancing care information performance categories. We refer readers to section II.C.6.a.(1) of this proposed rule for further discussion of this proposal.
As discussed in section II.C.4.d. of this proposed rule, we are proposing to generally apply our previously finalized and proposed group policies to virtual groups.
In the CY 2017 Quality Payment Program final rule (81 FR 77127), we finalized at § 414.1335 that non-patient facing MIPS eligible clinicians would be required to meet the applicable submission criteria that apply for all MIPS eligible clinicians for the quality performance category. We are not proposing any changes to this policy in this proposed rule.
Section 1848(q)(2)(C)(ii) of the Act provides that the Secretary may use measures used for payment systems other than for physicians, such as measures used for inpatient hospitals, for purposes of the quality and cost performance categories. However, the Secretary may not use measures for hospital outpatient departments, except in the case of items and services furnished by emergency physicians, radiologists, and anesthesiologists. We refer readers to section II.C.7.a.(4) of this proposed rule for a full discussion of our proposals regarding the application of facility-based measures.
In the CY 2017 Quality Payment Program final rule (81 FR 77136), we did not finalize all of our proposals on global and population-based measures as part of the quality score. Specifically, we did not finalize our proposal to use the acute and chronic composite measures of the AHRQ Prevention Quality Indicators (PQIs). We agreed with commenters that additional enhancements, including the addition of risk adjustment, needed to be made to these measures prior to inclusion in MIPS. We did, however, calculate these measures at the TIN level, through the QRURs released in September 2016, and this data can be used by MIPS eligible clinicians for informational purposes.
We did finalize the all-cause hospital readmissions (ACR) measure from the VM Program as part of the quality measure domain for the MIPS total performance score. We finalized this measure with the following modifications. We did not apply the ACR measure to solo practices or small groups (groups of 15 or less). We did apply the ACR measure to groups of 16 or more who meet the case volume of 200 cases. A group was scored on the ACR measure even if it did not submit any quality measures, if it submitted in other performance categories. Otherwise, the group was not scored on the readmission measure if it did not submit data in any of the performance categories. In our transition year policies, the readmission measure alone would not produce a neutral to positive MIPS payment adjustment since in order to achieve a neutral to positive MIPS payment adjustment, an individual MIPS eligible clinician or group must submit information on one of the three performance categories as discussed in the CY 2017 Quality Payment Program final rule (81 FR 77329). In addition, the ACR measure in the MIPS transition year CY 2017 was based on the performance period (January 1, 2017 through December 31, 2017). However, for MIPS eligible clinicians who did not meet the minimum case requirements, the ACR measure was not applicable. We are not proposing any changes for the global and population-based measures in this proposed rule. As discussed in section II.C.4.d. of this rule, we are proposing to generally apply our previously finalized and proposed group policies to virtual groups.
Under section 1848(q)(2)(D)(i) of the Act, the Secretary, through notice and comment rulemaking, must establish an annual list of MIPS quality measures from which MIPS eligible clinicians may choose for purposes of assessment for a performance period. The annual list of MIPS quality measures must be published in the
Under section 1848(q)(2)(D)(ii) of the Act, the Secretary must solicit a “Call for Quality Measures” each year. Specifically, the Secretary must request that eligible clinician organizations and other relevant stakeholders identify and submit quality measures to be considered for selection in the annual list of MIPS quality measures, as well as updates to the measures. Under section 1848(q)(2)(D)(ii) of the Act, eligible clinician organizations are professional organizations as defined by nationally recognized specialty boards of certification or equivalent certification boards. However, we do not believe there needs to be any special restrictions on the type or make-up of the organizations that submit measures for consideration through the call for measures. Any such restriction would limit the type of quality measures and the scope and utility of the quality measures that may be considered for inclusion under the MIPS.
As we described previously in the CY 2017 Quality Payment Program final rule (81 FR 77137), we will accept quality measures submissions at any time, but only measures submitted during the timeframe provided by us through the pre-rulemaking process of each year will be considered for inclusion in the annual list of MIPS quality measures for the performance period beginning 2 years after the measure is submitted. This process is consistent with the pre-rulemaking process and the annual call for measures, which are further described at (
Submission of potential quality measures, regardless of whether they were previously published in a proposed rule or endorsed by an entity with a contract under section 1890(a) of the Act, which is currently the National Quality Forum, is encouraged. The annual Call for Measures process allows eligible clinician organizations and other relevant stakeholder organizations to identify and submit quality measures for consideration. Presumably, stakeholders would not submit measures for consideration unless they believe that the measure is applicable to clinicians and can be reliably and validly measured at the individual clinician level. The NQF-convened Measure Application Partnership (MAP) provides an additional opportunity for stakeholders to provide input on whether or not they believe the measures are applicable to clinicians as well as feasible, scientifically acceptable, and reliable and valid at the clinician level. Furthermore, we must go through notice and comment rulemaking to establish the annual list of quality measures, which gives stakeholders an additional opportunity to review the measures and provide input on whether or not they believe the measures are applicable to clinicians, as well as feasible, scientifically acceptable, and reliable and valid at the clinician level. Additionally, we are required by statute to submit new measures to an applicable specialty-appropriate, peer-reviewed journal.
As previously noted, we encourage the submission of potential quality measures regardless of whether such measures were previously published in a proposed rule or endorsed by an entity with a contract under section 1890(a) of the Act. However, we propose to request that stakeholders apply the following considerations when submitting quality measures for possible inclusion in MIPS:
• Measures that are not duplicative of an existing or proposed measure.
• Measures that are beyond the measure concept phase of development and have started testing, at a minimum, with strong encouragement and preference for measures that complete or are near completion of reliability and validity testing.
• Measures that include a data submission method beyond claims-based data submission.
• Measures that are outcome-based rather than clinical process measures.
• Measures that address patient safety and adverse events.
• Measures that identify appropriate use of diagnosis and therapeutics.
• Measures that address the domain for care coordination.
• Measures that address the domain for patient and caregiver experience.
• Measures that address efficiency, cost, and resource use.
• Measures that address significant variation in performance.
We will apply these considerations when considering quality measures for possible inclusion in MIPS.
In addition, we note that we are likely to reject measures that do not provide substantial evidence of variation in performance; for example, if a measure developer submits data showing a small variation in performance among a group already composed of high performers, such evidence would not be substantial enough to assure us that sufficient variation in performance exists. We also note that we are likely to reject measures that are not outcome-based measures, unless (1) there is substantial documented and peer reviewed evidence that the clinical process measured varies directly with the outcome of interest and (2) it is not possible to measure the outcome of interest in a reasonable timeframe.
We also note that retired measures that were in one of CMS's previous quality programs, such as the Physician Quality Reporting System (PQRS) program, will likely be rejected if proposed for inclusion. This includes measures that were retired due to being topped out, as defined below. For example, measures may be retired due to attaining topped out status because of high performance, or measures that are retired due to a change in the evidence supporting their use.
In the CY 2017 Quality Payment Program final rule (81 FR 77153), we established that we will categorize measures into the six NQS domains (patient safety, person- and caregiver-centered experience and outcomes, communication and care coordination, effective clinical care, community/population health, and efficiency and cost reduction). We intend to submit future MIPS quality measures to the NQF-convened Measure Application Partnership's (MAP), as appropriate, and we intend to consider the MAP's recommendations as part of the comprehensive assessment of each measure considered for inclusion under MIPS.
In the CY 2017 Quality Payment Program final rule (81 FR 77155), we established that we use the Call for Quality Measures process as a forum to gather the information necessary to draft the journal articles for submission from measure developers, measure owners and measure stewards since we do not always develop measures for the quality programs. The submission of this information does not preclude us from conducting our own research using Medicare claims data, Medicare survey results, and other data sources that we possess. We submit new measures for publication in applicable specialty-appropriate, peer-reviewed journals before including such measures in the final annual list of quality measures.
In the CY 2017 Quality Payment Program final rule (81 FR 77158), we established at § 414.1330(a)(2) that for purposes of assessing performance of MIPS eligible clinicians on the quality performance category, we use quality measures developed by QCDRs. In the circumstances where a QCDR wants to
Previously finalized MIPS quality measures can be found in the CY 2017 Quality Payment Program final rule (81 FR 77558 through 77675). Updates may include the proposal to add new MIPS quality measures, including measures selected 2 years ago during the Call for Measures process. The new MIPS quality measures proposed for inclusion in MIPS for the 2018 performance period and future years are found in Table A. The proposed new and modified MIPS specialty sets for the 2018 performance period and future years are listed in Table B, and include existing measures that are proposed with modifications, new measures, and measures finalized in the CY 2017 Quality Payment Program final rule. We note that the modifications made to the specialty sets may include the removal of certain quality measures that were previously finalized. The specialty measure sets should be used as a guide for eligible clinicians to choose measures applicable to their specialty. To clarify, some of the MIPS specialty sets have further defined subspecialty sets, each of which is effectively a separate specialty set. In instances where an individual MIPS eligible clinician or group reports on a specialty or subspecialty set, if the set has less than six measures, that is all the clinician is required to report. MIPS eligible clinicians are not required to report on the specialty measure sets, but they are suggested measures for specific specialties. Throughout measure utilization, measure maintenance should be a continuous process done by the measure owners, to include environmental scans of scientific literature about the measure. New information gathered during this ongoing review may trigger an ad hoc review. The specialty measure sets in Table B of the Appendix, include existing measures that are proposed with modifications, new measures, and measures that were previously finalized in the CY 2017 Quality Payment Program final rule. Please note that these specialty specific measure sets are not all inclusive of every specialty or subspecialty. On January 25, 2017, we announced that we would be accepting recommendations for potential new specialty measure sets for year 2 of MIPS under the Quality Payment Program. These recommendations were based on the MIPS quality measures finalized in the CY 2017 Quality Payment Program final rule, and include recommendations to add or remove the current MIPS quality measures from the specialty measure sets. The current specialty measure sets can be found on the Quality Payment Program Web site at
As a result, we propose to add new quality measures to MIPS (Table A), revise the specialty measure sets in MIPS (Table B), remove specific MIPS quality measures only from specialty sets (Table C.1), and propose to remove specific MIPS quality measures from the MIPS program for the 2018 performance period (Table C.2). The aforementioned measure tables can be found in the Appendix of this proposed rule. In addition, we are proposing to also remove cross cutting measures from most of the specialty sets. Specialty groups and societies reported that cross cutting measures may or may not be relevant to their practices, contingent on the eligible clinicians or groups. CMS chose to retain the cross cutting measures in Family Practice, Internal Medicine and Pediatrics specialty sets because they are frequently used in these practices. The proposed 2017 cross cutting measures, (81 FR 28447 through 28449), were compiled and placed in a separate table for eligible clinicians to elect to use or not, for reporting. To clarify, the cross-cutting measures are intended to provide clinicians with a list of measures that are broadly applicable to all clinicians regardless of the clinician's specialty. Even though it is not required to report on cross-cutting measures, it is provided as a reference to clinicians who are looking for additional measures to report outside their specialty. We continue to consider cross-cutting measures to be an important part of our quality measure programs, and seek comment on ways to incorporate cross-cutting measures into MIPS in the future. The proposed Table of Cross-Cutting Measures can be found in Table D of the Appendix.
For MIPS quality measures that are undergoing substantive changes, we propose to identify measures including, but not limited to measures that have had measure specification, measure title, and domain changes. MIPS quality measures with proposed substantive changes can be found at Table E of the Appendix.
The measures that would be used for the APM scoring standard and our authority for waiving certain measure requirements are described in section II.C.6.g.(3)(b)(ii) and the measures that would be used to calculate a quality score for the APM scoring standard are proposed in Tables 14, 15, and 16.
We also seek comment for this rule, on whether there are any MIPS quality measures that commenters believe should be classified in a different NQS domain than what is being proposed, or that should be classified as a different measure type (for example, process vs. outcome) than what is being proposed in this rule.
As defined in the CY 2017 Quality Payment Program final rule at (81 FR 77136), a measure may be considered topped out if measure performance is so high and unvarying that meaningful distinctions and improvement in performance can no longer be made. Topped out measures could have a disproportionate impact on the scores for certain MIPS eligible clinicians, and provide little room for improvement for the majority of MIPS eligible clinicians. We refer readers to section II.C.7.a.(2)(c) of this proposed rule for additional information regarding the scoring of topped out measures.
We noted in the CY 2017 Quality Payment Program final rule that we anticipate removing topped out measures over time and sought comment on what point in time we should remove topped out measures from MIPS (81 FR 77286). We received the following comments.
Many commenters recommended that we retain topped out quality measures for 2 or more years because commenters believed they serve to motivate continued high-quality care; more clinicians may participate in MIPS compared to prior programs such as PQRS, and thus there may be more performance variation in MIPS showing that the measure is not actually topped out; declines in performance will not be captured if a measure is eliminated; it will help provide stability and encourage reporting in the early years of the MIPS program; removing topped out measures could further limit the number of measures available to specialists; and providing eligible clinicians and the public with information about high performance is as important as informing them about deficits.
A few commenters recommended that we publish information about topped out and potentially topped out measures prior to the performance period to allow clinicians time to adjust their reporting
Finally, a few commenters recommended that we consider specialty, case mix, and rural location before determining that a measure is topped out, specifically whether there is still room for improvement among certain specialist groups and to ensure that rural provider improvement is recognized. One commenter recommended that we determine topped out measures based on reporting in the Quality Payment Program rather than PQRS or value modifier reporting because the commenter believed using historical performance disadvantages small groups. A few commenters requested that the process for identifying and determining the removal of topped out measures be transparent, evidence-based, patient-centered, and include feedback from all appropriate stakeholders, including the medical community and measures owner. A few commenters specifically recommended that determining whether to remove a topped out measure be part of a rulemaking process while another commenter suggested that we seek out stakeholder input from the Measure Applications Partnership (MAP) on whether a measure should be removed, awarded lower points, or remain with benchmarks as a flat percentage.
We propose a 3-year timeline for identifying and proposing to remove topped out measures. After a measure has been identified as topped out for three consecutive years, we may propose to remove the measure through comment and rulemaking for the 4th year. Therefore, in the 4th year, if finalized through rulemaking, the measure would be removed and would no longer be available for reporting during the performance period. This proposal provides a path toward removing topped out measures over time, and will apply to the MIPS quality measures. QCDR measures that consistently are identified as topped out according to the same timeline as proposed below, would not be approved for use in year 4 during the QCDR self-nomination review process, and would not go through the comment and rulemaking process described below.
We propose to phase in this policy starting with a select set of six highly topped out measures identified in section II.C.7.a.(2)(c) of this proposed rule. In section II.C.7.a.(2)(c) of this proposed rule, we are also proposing to phase in special scoring for measures identified as topped out in the published benchmarks for two consecutive performance periods, starting with the select set of highly topped out measures for the 2018 MIPS performance period. An example illustrating the proposed timeline for the removal and special scoring of topped out measures, as it would be applied to the select set of highly topped out measures identified in section II.C.7.a.(2)(c), is as follows:
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For all other measures, the timeline would apply starting with the benchmarks for the 2018 MIPS performance period. Thus, the first year any other topped out measure could be proposed for removal would be in rulemaking for the 2021 MIPS performance period, based on the benchmarks being topped out in the 2018, 2019, and 2020 MIPS performance periods. If the measure benchmark is not topped out during one of the three MIPS performance periods, then the lifecycle would stop and start again at year 1 the next time the measure benchmark is topped out.
We seek comment on the above proposed timeline, specifically regarding the number of years before a topped out measure is identified and considered for removal, and under what circumstances we should remove topped out measures once they reach that point. For example, should we automatically remove topped out measures after they are identified for the proposed number of years or should we review measures identified for removal and consider certain criteria before removing the measure? If so what criteria should be considered? We would like to note that if for some reason a measure benchmark is topped out for only one submission mechanism benchmark, then we would remove that measure from the submission mechanism, but not remove the measure from other submission mechanisms available for submitting that measure.
We also seek comment on whether topped out Summary Survey Measures (SSMs), if topped out, should be considered for removal from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Clinician or Group Survey measure due to high, unvarying performance within the SSM, or whether there is another alternative policy that could be applied for topped out SSMs within the CAHPS for MIPS Clinician or Group Survey measure.
In the CY 2017 Quality Payment Program final rule, we state that we do not believe it would be appropriate to remove topped out measures from the CMS Web Interface for the Quality Payment Program because the CMS Web Interface measures are used in MIPS and in APMs, such as the Shared Savings Program. Removing topped out measures from the CMS Web Interface would not be appropriate because we have aligned policies where possible, with the Shared Savings Program, such as using the Shared Savings Program benchmarks for the CMS Web Interface measures (81 FR 77285). In the CY 2017 Quality Payment Program final rule, we also finalized that MIPS eligible clinicians reporting via the CMS Web Interface must report all measures included in the CMS Web Interface (81 FR 77116). Thus, if a CMS Web Interface measure is topped out, the CMS Web Interface reporter cannot select other measures. We refer readers to section II.C.7.a.(2) of this proposed rule for information on scoring policies with regards to topped out measures from the CMS Web Interface for the Quality Payment Program. We are not proposing to include CMS Web Interface measures
In the CY 2017 Quality Payment Program final rule, we sought comment on whether we should remove non-outcomes measures for which performance cannot reliably be scored against a benchmark (for example, measures that do not have 20 reporters with 20 cases that meet the data completeness standard) for 3 years in a row (81 FR 77288).
A few commenters recommended that measures that cannot be scored against a benchmark should be removed from the MIPS score. One commenter recommended that non-outcome measures that are unscorable should be given a weight of zero or re-weighted in the performance category. One commenter supported removing non-outcomes measures for which performance cannot reliably be scored against a benchmark for 3 years in a row. One commenter believed it would also be appropriate to remove outcomes measures under a separate more protracted timeline because the commenter believed the reporting of outcome measures is more difficult and expected to increase at a slower pace, while maintaining outcome measures would encourage the testing and availability of such measures.
Based on the need for CMS to further assess this issue, we are not proposing to remove non-outcome measures in this proposed rule. However, we seek comment on what the best timeline for removing both non-outcome and outcome measures that cannot be reliably scored against a benchmark for 3 years. We intend to revisit this issue and make proposals in future rulemaking.
Under the MIPS, individual MIPS eligible clinicians are generally required to submit at least one outcome measure, or, if no outcome measure is available, one high priority measure. As such, our determinations as to whether a measure is an outcome measure is of importance to stakeholders. We utilize the following as a basis to determine if a measure is considered an outcome measure:
• Measure Steward and National Quality Forum (NQF) designation—For most measures, we will utilize the designation as determined by the measure steward and the measure's NQF designation to determine if it is an outcome measure or not. If this is not clear, we will consider the following step.
• Utilization of the CMS Blueprint definitions for outcome measures:
We also note that patient-reported outcome measures are considered outcome measures, as they measure the health of the patient directly resulting from the health care provided. Efficiency measures are not considered outcome measures, as they are measuring the cost of care associated with a specific level of care, but we do note that efficiency is considered a high priority measure.
After a MIPS quality measure is established in the program, it is generally only reviewed again if there are significant changes to a measure for the next program year that might warrant a change to the designation of outcome or not. In most cases, these updates are significant enough that they are usually presented as a new measure from the measure owner. New measures to the program will follow the criteria outlined above. QCDR measures however, are reviewed on a yearly basis (during the fall) regardless if there is a significant change or not. We refer readers to section II.C.10.a. for additional information on the QCDR self-nomination and measures review and approval process.
We seek comment on the criteria and process outlined above on how we designate outcome measures. Specifically are there additional criteria we should take into consideration when we determine if a measure meets the criteria of an outcome measure? Should we use different criteria for MIPS measures versus QCDR measures?
Measuring cost is an integral part of measuring value as part of MIPS. In implementing the cost performance category for the transition year (2017 MIPS performance period/2019 MIPS payment year), we started with measures that had been used in previous programs but noted our intent to move towards episode-based measurement as soon as possible, consistent with the statute and the feedback from the clinician community. Specifically, we adopted 2 measures that had been used in the VM: The total per capita costs for all attributed beneficiaries measure (referred to as the total per capita cost measure) and the MSPB measure (81 FR 77166 through 77168). We also adopted 10 episode-based measures that had previously been included in the Supplemental Quality and Resource Use Reports (sQRURs) (81 FR 77171 through 77174).
At § 414.1325(e), we finalized that all measures used under the cost performance category would be derived from Medicare administrative claims data and, thus, participation would not require additional data submission. We finalized a reliability threshold of 0.4 for measures in the cost performance category (81 FR 77170). We also finalized a case minimum of 35 for the MSPB measure (81 FR 77171) and 20 for the total per capita cost measure (81 FR 77170) and each of the 10 episode-based measures (81 FR 77175) in the cost performance category to ensure the reliability threshold is met.
For the transition year, we finalized a policy to weight the cost performance category at zero percent in the final score in order to give clinicians more opportunity to understand the attribution and the scoring methodology and gain more familiarity with the measures through performance feedback (81 FR 77165 through 77166) so that clinicians may be able to act to improve their performance. In the CY 2017 Quality Payment Program final rule, we finalized a cost performance category weight of 10 percent for the 2020 MIPS payment year (81 FR 77165). For the 2021 MIPS payment year and beyond, the cost performance category will have a weight of 30 percent of the final score as required by section 1848(q)(5)(E)(i)(II)(aa) of the Act.
For descriptions of the statutory basis and our existing policies for the cost performance category, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77162 through 77177).
As finalized at § 414.1370(g)(2), the cost performance category is weighted at zero percent for MIPS eligible clinicians scored under the MIPS APM scoring standard because many MIPS APM models incorporate cost measurement in other ways. For more on the APM scoring standard, see II.C.6.E. of this proposed rule.
We are proposing at § 414.1350(b)(2) to change the weight of the cost performance category from 10 percent to zero percent for the 2020 MIPS payment year. We continue to have concerns
Although we believe reducing this weight is appropriate given the level of understanding of the measures and the scoring standards, we note that section 1848(q)(5)(E)(i)(II)(aa) of the Act requires the cost performance category be assigned a weight of 30 percent of the MIPS final score beginning in the 2021 MIPS payment year. We recognize that assigning a zero percent weight to the cost performance category for the 2020 MIPS payment year may not provide a smooth enough transition for integrating cost measures into MIPS and may not provide enough encouragement to clinicians to review their performance on cost measures. This policy could reduce understanding of the measures when we reach the 2021 MIPS payment year and the cost performance category will be used to determine 30 percent of the final score for MIPS eligible clinicians, when in the two previous years it was weighted at zero. Therefore, we also seek comment on keeping the weight of the cost performance category at 10 percent for the 2020 MIPS payment year.
In our discussions with clinicians and clinician societies, clinicians expressed their desire to down-weight the cost performance category to zero percent for an additional year with full knowledge that the cost performance category weight is set at 30 percent under the statute for the 2021 MIPS payment year. The clinicians we spoke with preferred a low weighting and noted that they are actively preparing for cost performance category implementation and would be prepared for the 30 percent statutory weight for the cost performance category for the 2021 MIPS payment year. We intend to continue to provide education to clinicians to help them prepare for the upcoming 30 percent weight.
We invite public comments on this proposal of a zero percent weighting for the cost performance category and the alternative option of 10 percent weighting for the cost performance category for the 2020 MIPS payment year.
Under § 414.1350(a), we specify cost measures for a performance period to assess the performance of MIPS eligible clinicians on the cost performance category. For the 2017 MIPS performance period, we will utilize 12 cost measures that are derived from Medicare administrative claims data. Two of these measures, the MSPB measure and total per capita cost measure, have been used in the VM (81 FR 77166 through 77168), and the remaining 10 are episode-based measures that were included in the sQRURs in 2014 and 2015 (81 FR 77171 through 77174).
Section 1848(r) of the Act specifies a series of steps and activities for the Secretary to undertake to involve the physician, practitioner, and other stakeholder communities in enhancing the infrastructure for cost measurement, including for purposes of MIPS. Section 1848(r)(2) of the Act requires the development of care episode and patient condition groups, and classification codes for such groups, and provides for care episode and patient condition groups to account for a target of an estimated one-half of expenditures under Parts A and B (with this target increasing over time as appropriate). Section 1848(r) of the Act requires us to consider several factors when establishing these groups. For care episode groups, we must consider the patient's clinical problems at the time items and services are furnished during an episode of care, such as clinical conditions or diagnoses, whether inpatient hospitalization occurs, the principal procedures or services furnished, and other factors determined appropriate by the Secretary. For patient condition groups, we must consider the patient's clinical history at the time of a medical visit, such as the patient's combination of chronic conditions, current health status, and recent significant history (such as hospitalization and major surgery during a previous period), and other factors determined appropriate.
Section 1848(r)(2) of the Act requires us to post on the CMS Web site a draft list of care episode and patient condition groups and codes for solicitation of input from stakeholders, and subsequently, post on the CMS Web site an operational list of such groups and codes. In December 2016, we published the Episode-Based Cost Measure Development for the Quality Program (
We will be posting the operational list of care episode and patient condition groups in December 2017, as required by section 1848(r)(2)(G) of the Act. Section 1848(r)(2)(H) of the Act also requires that not later than November 1 of each year (beginning with 2018), the Secretary shall, through rulemaking, revise the operational list as the Secretary determines may be appropriate.
For the 2018 MIPS performance period and future performance periods, we are proposing to include in the cost performance category the total per capita cost measure and the MSPB measure as finalized for the 2017 MIPS performance period. We refer readers to the description of these measures in the CY 2017 Quality Payment Program final rule (81 FR 77164 through 77171). We are proposing to include the total per capita cost measure because it is a global measure of all Medicare Part A and Part B costs during the performance period. MIPS eligible clinicians are familiar with the total per capita cost measure because the measure has been used in the VM since the 2015 payment adjustment period and performance feedback has been provided through the annual QRUR since 2013 (for a subset of groups that had 20 or more eligible professionals, based on 2014 performance) and to all groups in the annual QRUR since 2014 (based on 2013 performance) and mid-year QRUR since 2015. We are proposing to use the MSPB measure because many MIPS eligible
We are not proposing any changes to the methodologies for payment standardization, risk adjustment, and specialty adjustment for these measures and refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77164 through 77171) for more information about these methodologies.
We will continue to evaluate cost measures that are included in MIPS on a regular basis and anticipate that measures could be added or removed, subject to rulemaking under applicable law, as measure development continues. We will also maintain the measures that are used in the cost performance category by updating specifications, risk adjustment, and attribution as appropriate. We anticipate including a list of cost measures for a given performance period in annual rulemaking.
We invite public comments on these proposals.
Episode-based measures differ from the total per capita cost measure and MSPB measure because their specifications only include services that are related to the episode of care for a clinical condition or procedure (as defined by procedure and diagnosis codes), as opposed to including all services that are provided to a patient over a given period of time. For the 2018 MIPS performance period, we are not proposing to include in the cost performance category the 10 episode-based measures that we adopted for the 2017 MIPS performance period in the CY 2017 Quality Payment Program final rule (81 FR 77171 through 77174). We instead will work to develop new episode-based measures, with significant clinician input, for future performance periods.
We received extensive comments on our proposal to include 41 of these episode-based measures for the 2017 MIPS performance period, which we responded to in the CY 2017 Quality Payment Program final rule (81 FR 77171 through 77174). We also received additional comments after publication of that final rule with comment period about the decision to include 10 episode-based measures for the 2017 MIPS performance period. Although comments were generally in favor of the inclusion of episode-based measures in the future, there was also overwhelming stakeholder interest in more clinician involvement in the development of these episode-based measures as required by section 1848(r)(2) of the Act. Although there was an opportunity for clinician involvement in the development of some of the episode-based measures included for the 2017 MIPS performance period, it was not as extensive as the process we are currently using to develop episode-based measures. We believe that the new episode-based measures, which we intend to propose in future rulemaking to include in the cost performance category for the 2019 MIPS performance period, will be substantially improved by more extensive stakeholder feedback and involvement in the process.
Thus far, stakeholder feedback has been sought in several ways. First, stakeholder feedback has been sought through various public postings. In October 2015 and April 2016, pursuant to section 1848(r)(2)(B) and (C) of the Act, we gathered input from stakeholders on the episode groups previously developed under section 1848(n)(9)(A) of the Act that has been used to inform the process of constructing the new episode-based cost measures. This feedback emphasized several key aspects of cost measure development such as attribution, risk adjustment, and alignment with quality measurement and patient outcomes. Stakeholders have also emphasized that feedback related to cost measures should be actionable and timely. In addition, a draft list of care episode and patient condition groups, along with trigger codes, was posted for comment in December 2016 (
This draft list of care episode and patient condition groups and trigger codes was informed by engagement with clinicians from over 50 clinician specialty societies through a Clinical Committee formed to participate in cost measure development. The Clinical Committee work has provided input from a diverse array of clinicians on identifying conditions and procedures for episode groups. Moving forward, the Clinical Committee will recommend which services or claims would be counted in episode costs. This will ensure that cost measures in development are directly informed by a substantial number of clinicians and members of specialty societies.
In addition, a technical expert panel has met 3 times to provide oversight and guidance for our development of episode-based cost measures. The technical expert panel has offered recommendations for defining an episode group, assigning costs to the group, and attributing episode groups to clinicians. This expert feedback has been built into the current cost measure development process.
As this process continues, we are continuing to seek input from clinicians. Earlier this year, we opened an opportunity to submit the names of clinicians to participate in this process. This process remains open to additional individuals. We believe that episode-based measures will benefit from this comprehensive approach to development. In addition, because it is possible that the new episode-based measures under development could address similar conditions as those in the episode-based measures finalized for the 2017 MIPS performance period, we believe that it would be better to focus attention on the new episode-based measures, so that clinicians would not receive feedback or scores from two measures for the same patient condition or procedure. Recognizing that under section 1848(q)(5)(E)(i)(II)(aa) of the Act, we must assign a weight of 30 percent to the cost performance category for the 2021 MIPS payment year, we will endeavor to have as many episode-based measures available as possible for the proposed 2019 MIPS performance period.
We plan to include episode-based measures in the cost performance category in future years as they are developed and would propose new measures in future rulemaking.
Although we are not proposing to include any episode-based measures in calculating the cost performance category score for the 2020 MIPS payment year, we do plan to continue to provide confidential performance feedback to clinicians on their performance on episode-based measures developed under the processes required by section 1848(r)(2) of the Act as appropriate in order to increase familiarity with the concept of episode-based measurement as well as the specific episodes that could be included
As previously finalized in the CY 2017 Quality Payment Program final rule (81 FR 77173), the episode-based measures that we are not proposing for the 2018 MIPS performance period will be used for determining the cost performance category score for the 2019 MIPS payment year, although the cost performance category score will be weighted at zero percent in that year.
We invite public comments on this proposal.
In the CY 2017 Quality Payment Program final rule, we changed the list of primary care services that had been used to determine attribution for the total per capita cost measure by adding transitional care management (CPT codes 99495 and 99496) codes and a chronic care management code (CPT code 99490) (81 FR 77169). In the CY 2017 Physician Fee Schedule final rule, we changed the payment status for two existing CPT codes (CPT codes 99487 and 99489) that could be used to describe care management from B (bundled) to A (active) meaning that the services would be paid under the Physician Fee Schedule (81 FR 80349). The services described by these codes are substantially similar to those described by the chronic care management code that we added to the list of primary care services beginning with the 2017 performance period. We therefore propose to add CPT codes 99487 and 99489, both describing complex chronic care management, to the list of primary care services used to attribute patients under the total per capita cost measure.
We are not proposing any changes to the attribution methods for the MSPB measure and refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77168 through 77169) for more information.
We invite public comment on our proposals.
In the CY 2017 Quality Payment Program final rule (81 FR 77169 through 77170), we finalized a reliability threshold of 0.4 for measures in the cost performance category. Reliability is an important evaluation for cost measures to ensure that differences in performance are not the result of random variation. Statistically, reliability depends on performance variation for a measure across clinicians (“signal”), the random variation in performance for a measure within a clinician's attributed beneficiaries (“noise”), and the number of beneficiaries attributed to the clinician. High reliability for a measure suggests that comparisons of relative performance among clinicians are likely to be stable over different performance periods and that the performance of one clinician on the measure can be confidently distinguished from another. As an example of the statistical concept of reliability, a test in which the same individual received very different scores depending on how the included questions are framed would not be reliable. Potential reliability values range from 0.00 to 1.00, where 1.00 (highest possible reliability) signifies that all variation in the measure's rates is the result of variation in differences in performance across clinicians, whereas 0.0 (lowest possible reliability) signifies that all variation could be a result of measurement error. The 0.4 reliability threshold that we adopted for the cost performance category measures in MIPS means that the majority of MIPS eligible clinicians and groups who meet the case minimum required for scoring under a measure have measure reliability scores that exceed 0.4. We generally consider reliability levels between 0.4 and 0.7 to indicate “moderate” reliability and levels above 0.7 to indicate “high” reliability.
We addressed comments we received on the CY 2017 Quality Payment Program proposed rule (81 FR 77169 through 77171), that expressed concern that our 0.4 reliability threshold was too low. Many commenters recommended that cost measures be included only when they could meet the standard of “high” reliability (0.7 or above). Many commenters on the CY 2017 Quality Payment Program final rule made similar comments. Commenters emphasized the importance of reliability; however, we have also seen commenters incorrectly refer to measures as being 40 percent reliable. Reliability is not a percentage but is instead a coefficient so a measure with 0.4 reliability does not reflect that it is only correct for 40 percent of those measured. We encourage a review of our analysis of reliability for the total per capita cost measure (80 FR 71282) and MSPB (81 FR 77169 through 77171).
Reliability is an important evaluation tool for an individual measure, but it is only one element of evaluation. Reliability generally increases as we increase the case size but a high reliability may also reflect low variation. A measure in which all clinicians perform at nearly the same rate would be reliable but not valuable in a program
We are not proposing any changes for how we attribute cost measures to individual and group reporters. We refer readers to the CY 2017 Quality Payment Program final rule for more information (81 FR 77175 through 77176).
Both measures proposed for inclusion in the cost performance category for the 2018 MIPS performance period are risk adjusted at the measure level. Although the risk adjustment of the 2 measures is not identical, in both cases it is used to recognize the higher risk associated with demographic factors (such as age) or certain clinical conditions. We recognize that the risks accounted for with this adjustment are not the only potential attributes that could lead to a higher cost patient. Stakeholders have pointed to many other factors such as income level, race, and geography that they believe contribute to increased costs. These issues and our plans for attempting to address them are discussed in length in section II.C.7.b.(1)(a) of this rule.
In section II.C.7.a.(1)(c) of this proposed rule, we discuss our proposal to assess performance on any measures impacted by ICD–10 updates based only on the first 9 months of the 12-month performance period. Because the total per capita cost and MSPB measures include costs from all Medicare Part A and B services, regardless of the specific ICD–10 codes that are used on claims, and do not assign patients based on ICD–10, we do not anticipate that any measures for the cost performance category would be affected by this ICD–10 issue during the 2018 MIPS performance period. However, as we continue our plans to expand cost measures to incorporate episode-based measures, ICD–10 changes could become important. Episode-based measures may be opened (triggered) by and may assign services based on ICD–10 codes. Therefore, a change to ICD–10 coding could have a significant effect on an episode-based measure. Changes to ICD–10 codes will be incorporated into the measure specifications on a regular basis through the measure maintenance process.
We are not proposing changes to the policy we finalized in the CY 2017 Quality Payment Program final rule (81 FR 77176) that we will attribute cost measures to non-patient facing MIPS eligible clinicians who have sufficient case volume, in accordance with the attribution methodology.
Section 1848(q)(2)(C)(iv) of the Act requires the Secretary to consider the circumstances of professional types who typically furnish services without patient facing interaction (non-patient facing) when determining the application of measures and activities. In addition, this section allows the Secretary to apply alternative measures or activities to non-patient facing MIPS eligible clinicians that fulfill the goals of a performance category. Section 1848(q)(5)(F) of the Act allows the Secretary to re-weight MIPS performance categories if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician involved.
We believe that non-patient facing clinicians are an integral part of the care team and that their services do contributed to the overall costs but at this time we believe it better to focus on the development of a comprehensive system of episode-based measures which focus on the role of patient-facing clinicians. Accordingly, for the 2018 MIPS performance period, we are not proposing alternative cost measures for non-patient facing MIPS eligible clinicians or groups. This means that non-patient facing MIPS eligible clinicians or groups are unlikely to be attributed any cost measures that are generally attributed to clinicians who have patient-facing encounters with patients. Therefore, we anticipate that, similar to MIPS eligible clinicians or groups that do not meet the required case minimums for any cost measures, many non-patient facing MIPS eligible clinicians may not have sufficient cost measures applicable and available to them and would not be scored on the cost performance category under MIPS. We continue to consider opportunities to develop alternative cost measures for non-patient facing clinicians and solicit comment on this topic to inform our future rulemaking.
In section II.C.7.a.(4) of this proposed rule, we discuss our proposal to implement section 1848(q)(2)(C)(ii) of the Act by assessing clinicians who meet certain requirements and elect participation based on the performance of their associated hospital in the Hospital VBP Program. We refer readers to that section for full details on our proposals related to facility-based measurement, including the measures and how the measures are scored, for the cost performance category.
Section 1848(q)(2)(C)(v)(III) of the Act defines an improvement activity as an activity that relevant eligible clinician organizations and other relevant stakeholders identify as improving clinical practice or care delivery, and that the Secretary determines, when effectively executed, is likely to result in improved outcomes. Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to specify improvement activities under subcategories for the performance period, which must include at least the subcategories specified in section 1848(q)(2)(B)(iii)(I) through (VI) of the Act, and in doing so to give consideration to the circumstances of small practices, and practices located in rural areas and geographic health professional shortage areas (HPSAs).
Section 1848(q)(2)(C)(iv) of the Act generally requires the Secretary to give consideration to the circumstances of
Section 1848(q)(2)(C)(v) of the Act required the Secretary to use a request for information (RFI) to solicit recommendations from stakeholders to identify improvement activities and specify criteria for such improvement activities, and provides that the Secretary may contract with entities to assist in identifying activities, specifying criteria for the activities, and determining whether individual MIPS eligible clinicians or groups meet the criteria set. For a detailed discussion of the feedback received from the MIPS and APMs RFI, see the CY 2017 Quality Payment Program 2017 final rule (81 FR 77177).
We defined improvement activities at § 414.1305 as an activity that relevant MIPS eligible clinicians, organizations and other relevant stakeholders identify as improving clinical practice or care delivery and that the Secretary determines, when effectively executed, is likely to result in improved outcomes.
In the CY 2017 Quality Payment Program final rule (81 FR 77199), we solicited comments on activities that would advance the usage of health IT to support improvement activities. We received several comments in support of the concept to include emerging certified health IT capabilities as part of the activities in the Improvement Activities Inventory and several commenters supported our assessment that using CEHRT can aid in improving clinical practices and help healthcare organizations achieve success on numerous improvement activities, as well as the continued integration of improvement activities and advancing clinical information. However, several commenters expressed concern about health IT-associated burdens and costs and recommended that we also continue to offer diverse activities that do not rely on emerging capabilities of certified health IT, as they are not universally available or may only be offered as high cost add-on capabilities. Some commenters also requested that we be less prescriptive in our requirements for the use of health IT.
In response to the comments, we will continue to focus on incentivizing the use of health IT, telehealth, and connection of patients to community-based services. The use of health IT is an important aspect of care delivery processes described in many of the proposed new improvement activities in Table F in the Appendix of this proposed rule, and in Table H: Finalized Improvement Activities Inventory that we finalized in the CY 2017 Quality Payment Program final rule (81 FR 77817 through 77831). In that same final rule, we also finalized a policy to allow MIPS eligible clinicians to achieve a bonus in the advancing care information performance category when they use functions included in CEHRT to complete eligible activities from the Improvement Activities Inventory. Please refer to section II.C.6.f.(2)(d) of this proposed rule for details on how improvement activities using CEHRT relate to the objectives and measures of the advancing care information and improvement activities performance categories. We are not proposing any changes to these policies for incentivizing the use of health IT in this proposed rule; however, we will continue to consider including emerging certified health IT capabilities as part of activities within the Improvement Activities Inventory in future years.
In addition, as noted previously, we believe a key goal of the Quality Payment Program is to establish a program that allows for close alignment of the four performance categories. Although we are not proposing any specific new policies, we seek comment on how we might provide flexibility for MIPS eligible clinicians to effectively demonstrate improvement through health IT usage while also measuring such improvement. We welcome public comment on these considerations.
In the CY 2017 Quality Payment Program final rule (81 FR 77179 through 77180), we finalized at § 414.1355 that the improvement activities performance category would account for 15 percent of the final score. We also finalized at § 414.1380(b)(3)(iv) criteria for recognition as a certified-patient centered medical home or comparable specialty practice. We are proposing to clarify the term “certified” patient-centered medical home finalized at § 414.1380(b)(3)(iv). It has come to our attention that the common terminology utilized in the general medical community for “certified” patient-centered medical home is “recognized” patient-centered medical home. Therefore, in order to provide clarity we are proposing that the term “recognized” be accepted as equivalent to the term “certified” when referring to the requirements for a patient-centered medical home to receive full credit for the improvement activities performance category for MIPS. Specifically, we propose to revise § 414.1380(b)(3)(iv) to provide that a MIPS eligible clinician or group in a practice that is certified or recognized as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, receives full credit for performance on the improvement activities performance category. For purposes of § 414.1380 (b)(3)(iv), “full credit” means that the MIPS eligible clinician or group has met the highest potential category score of 40 points. A practice is certified or recognized as a patient-centered medical home if it meets any of the criteria specified under § 414.1380(b)(3)(iv).
In the CY 2017 Quality Payment Program final rule (81 FR 77198), we requested commenters' specific suggestions for additional activities or activities that may merit additional points beyond the “high” level. Several commenters urged us to increase the overall number of high-weighted activities in this performance category. Some commenters recommended additional criteria for designating high-weighted activities, such as an improvement activity's impact on population health, medication adherence, and shared decision-making tools, and encouraged us to be more transparent in our weighting decisions. Several commenters recommended that we weight registry-related activities as high, and suggested that we award individual MIPS eligible clinicians and groups in APMs full credit in this performance category. The commenters also offered many recommendations for changing current medium-weighted activities to high and offered many specific suggestions for new high-weighted improvement activities.
In response to the comments, we are proposing new, high-weighted activities in Table F in the Appendix of this proposed rule. As explained in the CY 2017 Quality Payment Program final rule (81 FR 77194), we believe that high weighting should be used for activities that directly address areas with the greatest impact on beneficiary care, safety, health, and well-being. We are not proposing changes to this approach in this proposed rule; however, we will take these suggested additional criteria into consideration for designating high-weighted activities in future rulemaking. For MIPS eligible clinicians participating in MIPS APMs, we finalized a policy to reduce reporting burden through the APM scoring standard for this category to recognize improvement activities work performed through participation in MIPS APMs. This policy is codified at § 414.1370(g)(3), and we refer readers to the CY 2017 Quality Payment Program
In the CY 2017 Quality Payment Program final rule (81 FR 77180), we discussed that for the transition year of MIPS we would allow for submission of data for the improvement activities performance category using the qualified registry, EHR, QCDR, CMS Web Interface, and attestation data submission mechanisms through attestation. Specifically, we finalized a policy that regardless of the data submission method, with the exception of MIPS eligible clinicians in MIPS APMs, all individual MIPS eligible clinicians or groups must select activities from the Improvement Activities Inventory. In addition, we finalized at § 414.1360 that for the transition year of MIPS, all individual MIPS eligible clinicians or groups, or third party intermediaries such as health IT vendors, QCDRs and qualified registries that submit on behalf of an individual MIPS eligible clinician or group, must designate a “yes” response for activities on the Improvement Activities Inventory. In the case where an individual MIPS eligible clinician or group is using a health IT vendor, QCDR, or qualified registry for their data submission, the individual MIPS eligible clinician or group will certify all improvement activities were performed and the health IT vendor, QCDR, or qualified registry would submit on their behalf. We would like to maintain stability in the Quality Payment Program and continue this policy into future years. Therefore, we are proposing at § 414.1360 that for purposes of the transition year of MIPS and future years all individual MIPS eligible clinicians or groups, or third party intermediaries such as health IT vendors, QCDRs and qualified registries that submit on behalf of an individual MIPS eligible clinician or group, must designate a “yes” response for activities on the Improvement Activities Inventory. In the case where an individual MIPS eligible clinician or group is using a health IT vendor, QCDR, or qualified registry for their data submission, the MIPS eligible clinician or group will certify all improvement activities were performed and the health IT vendor, QCDR, or qualified registry would submit on their behalf. In addition, as discussed in section II.C.4.d. of this proposed rule, we are proposing to generally apply our previously finalized and proposed group policies to virtual groups.
We would like to note that while we finalized at § 414.1325(d) in the CY 2017 Quality Payment Program final rule that individual MIPS eligible clinicians and groups may only use one submission mechanism per performance category, in section II.C.6.a.(1) of this proposed rule, we are proposing to revise § 414.1325(d) for purposes of the 2020 MIPS payment year and future years to allow individual MIPS eligible clinicians and groups to submit measures and activities, as applicable, via as many submission mechanisms as necessary to meet the requirements of the quality, improvement activities, or advancing care information performance categories. We refer readers to section II.C.6.a.(1) of this proposed rule for further discussion of this proposal.
We also included a designation column in the Improvement Activities Inventory at Table H in the Appendix of the CY 2017 Quality Payment Program final rule (81 FR 77817) that indicated which activities qualified for the advancing care information bonus finalized at § 414.1380. In future updates to the Improvement Activities Inventory we intend to continue to indicate which activities qualify for the advancing care information performance category bonus.
In the CY 2017 Quality Payment Program final rule (81 FR 77181), we clarified that if one MIPS eligible clinician (NPI) in a group completed an improvement activity, the entire group (TIN) would receive credit for that activity. In addition, we specified that all MIPS eligible clinicians reporting as a group would receive the same score for the improvement activities performance category if at least one clinician within the group is performing the activity for a continuous 90 days in the performance period. As discussed in section II.C.4.d. of this proposed rule, we are proposing to generally apply our previously finalized and proposed group policies to virtual groups. We are not proposing any changes to this policy in this proposed rule. However, we are requesting comment on whether we should establish a minimum threshold (for example, 50 percent) of the clinicians (NPIs) that must complete an improvement activity in order for the entire group (TIN) to receive credit in the improvement activities performance category in future years. In addition, we are requesting comments on recommended minimum threshold percentages and whether we should establish different thresholds based on the size of the group. For example, in considering different thresholds we could attribute recognition as a certified or recognized patient-centered medical home or comparable specialty practice at the individual TIN/NPI level, and attribute this designation to the group under which they bill if they are participating in MIPS as a group or as part of a virtual group. A group or virtual group consisting of 100 NPIs could have a reporting threshold of 50 percent while a group consisting of 10 NPIs could have a lower reporting threshold of 10 percent. We are concerned that while establishing any specific threshold for the percentage of NPIs in a TIN that must participate in an improvement activity for credit will incentivize some groups to move closer to the threshold, it may have the unintended consequence of incentivizing groups who are exceeding the threshold to gravitate back toward the threshold. Therefore, we are requesting comments on how to set this threshold while maintaining the goal of promoting greater participation in an improvement activity.
Additionally, we noted in the CY 2017 Quality Payment Program final rule (81 FR 77197) that we intended, in future years, to score the improvement activities performance category based on performance and improvement, rather than simple attestation. We seek comment on how we could measure performance and improvement; we are especially interested in ways to measure performance without imposing additional burden on eligible clinicians, such as by using data captured in eligible clinicians' daily work.
In the CY 2017 Quality Payment Program final rule (81 FR 77185), we finalized at § 414.1380 to set the improvement activities submission criteria under MIPS, to achieve the highest potential score, at two high-weighted improvement activities or four medium-weighted improvement activities, or some combination of high and medium-weighted improvement activities. While the minimum reporting period for one improvement activity is 90 days, the maximum frequency with which an improvement activity may be reported would be once during the 12-month performance period. In addition, as discussed in section II.C.4.d. of this proposed rule, we are proposing to generally apply our previously finalized and proposed group policies to virtual groups.
We established exceptions to the above for: small practices; practices located in rural areas; practices located in geographic HPSAs; non-patient facing
Under the APM scoring standard, all clinicians identified on the Participation List of an APM receive at least one-half of the highest score applicable to the MIPS APM. To develop the improvement activities score assigned to each MIPS APM, we compare the requirements of the specific MIPS APM with the list of activities in the Improvement Activities Inventory and score those activities in the same manner that they are otherwise scored for MIPS eligible clinicians. If by our assessment the MIPS APM does not receive the maximum improvement activities performance category score then the APM entity can submit additional improvement activities. All other individual MIPS eligible clinicians or groups that we identify as participating in APMs that are not MIPS APMs will need to select additional improvement activities to achieve the improvement activities highest score. We refer readers to section II.C.6.g. of this proposed rule for further discussion of the APM scoring standard.
We also provided full credit for the improvement activities performance category, as required by law, for an individual MIPS eligible clinician or group that has received certification or accreditation as a patient-centered medical home or comparable specialty practice from a national program or from a regional or state program, private payer or other body that administers patient-centered medical home accreditation and certifies 500 or more practices for patient-centered medical home accreditation or comparable specialty practice certification, or for an individual MIPS eligible clinician or group that is a participant in a medical home model.
We also noted in the CY 2017 Quality Payment Program final rule that practices may receive this designation at a practice level and that TINs may be comprised of both undesignated practices and designated practices (81 FR 77178). We finalized at § 414.1380(b)(3)(viii) that to receive full credit as a certified patient-centered medical home or comparable specialty practice, a TIN that is reporting must include at least one practice that is a certified patient-centered medical home or comparable specialty practice. We also indicated that we would continue to have more stringent requirements in future years, and would lay the groundwork for expansion towards continuous improvement over time (81 FR 77189). We received many comments on the CY 2017 Quality Payment Program final rule regarding our transition year policy that only one practice site within a TIN needs to be certified as a patient-centered medical home for the entire TIN to receive full credit in the improvement activities performance category. While several commenters supported our transition year policy, others disagreed and suggested to move to a more stringent requirement in future years while still offering some flexibility. Accordingly, we propose to revise § 414.1380(b)(3)(x) to provide that for the 2020 MIPS payment year and future years, to receive full credit as a certified or recognized patient-centered medical home or comparable specialty practice, at least 50 percent of the practice sites within the TIN must be recognized as a patient-centered medical home or comparable specialty practice. This is an increase to the requirement that only one practice site within a TIN needs to be certified as a patient-centered medical home, but does not require every site be certified, which could be overly restrictive given that some sites within a TIN may be in the process of being certified as patient-centered medical homes. In addition, we believe a 50 percent threshold is achievable which is supported by a study of physician-owned primary care groups in a recent Annals of Family Medicine article (Casalino, et al., 2016)
We have determined that the Comprehensive Primary Care Plus (CPC+) APM design satisfies the requirements to be designated as a medical home model, as defined in § 414.1305, and is therefore a certified or recognized patient-centered medical home for purposes of the improvement activities performance category. The CPC+ model meets the criteria to be an Advanced APM. CPC+ eligibility criteria for practices include, but are not limited to, the use of CEHRT and care delivery activities such as: Assigning patients to clinician panels; providing 24/7 clinician access; and supporting quality improvement activities. Control groups in CPC+ are required to meet the same eligibility criteria as those selected to be active participants in the model. For Round 2 of CPC+, CMS is randomly assigning accepted practices into the intervention group or a control group. Practices accepted into CPC+ and randomized into the control group have satisfied the requirements for participation in CPC+, a medical home model, and we believe that the MIPS eligible clinicians in the control group should therefore receive full credit for the improvement activities performance category. In addition, the practices randomized to the CPC+ control group must sign a Participation Agreement with us; the agreement will require practices in a control group to maintain a Practitioner Roster of all MIPS eligible clinicians in the practice.
Accordingly, we are proposing that MIPS eligible clinicians in practices that have been randomized to the control group in the CPC+ APM would receive full credit as a medical home model, and therefore a certified patient-centered medical home, for the improvement activities performance category. MIPS eligible clinicians who attest that they are in practices that have been randomized to the control group in the CPC+ APM would receive full credit for the improvement activities performance category for each performance period in which they are on the Practitioner Roster, the official list of eligible clinicians participating in a practice in the CPC+ control group. The inclusion of MIPS eligible clinicians in practices that have been randomized into the CPC+ control group recognizes that they have met the
We request comments on these proposals.
In the CY 2017 Quality Payment Program final rule (81 FR 77186), we specified at § 414.1360 that MIPS eligible clinicians or groups must perform improvement activities for at least 90 consecutive days during the performance period for improvement activities performance category credit. Activities, where applicable, may be continuing (that is, could have started prior to the performance period and are continuing) or be adopted in the performance period as long as an activity is being performed for at least 90 days during the performance period. In addition, as discussed in section II.C.4.d. of this proposed rule, we are proposing to generally apply our previously finalized and proposed group policies to virtual groups. We are not proposing any changes to the required period of time for performing an activity for the improvement activities performance category in this proposed rule.
In the CY 2017 Quality Payment Program final rule (81 FR 77187), we specified at § 414.1380(b)(3)(vii) that for non-patient facing individual MIPS eligible clinicians or groups, to achieve the highest score one high-weighted or two medium-weighted improvement activities are required. For these individual MIPS eligible clinicians and groups, in order to achieve one-half of the highest score, one medium-weighted improvement activity is required. We are not proposing any changes to the application of improvement activities to non-patient facing individual MIPS eligible clinicians and groups for the improvement activities performance category in this proposed rule.
In the CY 2017 Quality Payment Program final rule (81 FR 77188), we finalized at § 414.1380(b)(3)(vii) that one high-weighted or two medium-weighted improvement activities are required for individual MIPS eligible clinicians and groups that are small practices or located in rural areas, or geographic HPSAs, to achieve full credit. In addition, we specified at § 414.1305 that a rural area means ZIP codes designated as rural, using the most recent HRSA Area Health Resource File data set available. Lastly, we finalized the following definitions at § 414.1305: (1) Small practices is defined to mean practices consisting of 15 or fewer clinicians and solo practitioners; and (2) Health Professional Shortage Areas (HPSA) refers to areas as designated under section 332(a)(1)(A) of the Public Health Service Act. We are not proposing any changes to the special consideration for small, rural, or health professional shortage areas practices for the improvement activities performance category in this proposed rule.
In the CY 2017 Quality Payment Program final rule (81 FR 77190), we finalized at § 414.1365 that the improvement activities performance category will include the subcategories of activities provided at section 1848(q)(2)(B)(iii) of the Act. In addition, we finalized at § 414.1365 the following additional subcategories: Achieving Health Equity; Integrated Behavioral and Mental Health; and Emergency Preparedness and Response. We are not proposing any changes to the improvement activities subcategories for the improvement activities performance category in this proposed rule.
In Table H in the Appendix of the CY 2017 Quality Payment Program final rule (81 FR 77817), we finalized the Improvement Activities Inventory for MIPS. In addition, through subregulatory guidance we provided an informal process for submitting new improvement activities for potential inclusion in the comprehensive Improvement Activities Inventory for the Quality Payment Program Year 2. During this transition period we received input from various MIPS eligible clinicians and organizations suggesting possible new activities via a nomination form that was posted on the CMS Web site at
For the Quality Payment Program Year 3 and future years, we are proposing to formalize an Annual Call for Activities process for adding possible new activities to the Improvement Activities Inventory. We believe this is a way to engage eligible clinician organizations and other relevant stakeholders, including beneficiaries, in the identification and submission of improvement activities for consideration. We propose that individual MIPS eligible clinicians or groups and other relevant stakeholders may recommend activities for potential inclusion in the Improvement Activities Inventory via a similar nomination form utilized in the transition year of MIPS found on the Quality Payment Program Web site at
We request comments on this proposed annual Call for Activities process.
We propose for the Quality Payment Program Year 2 and future years that stakeholders would apply one or more of the following criteria when submitting improvement activities in response to the Annual Call for Activities:
• Relevance to an existing improvement activities subcategory (or a proposed new subcategory);
• Importance of an activity toward achieving improved beneficiary health outcome;
• Importance of an activity that could lead to improvement in practice to reduce health care disparities;
• Aligned with patient-centered medical homes;
• Activities that may be considered for an advancing care information bonus;
• Representative of activities that multiple individual MIPS eligible clinicians or groups could perform (for example, primary care, specialty care);
• Feasible to implement, recognizing importance in minimizing burden, especially for small practices, practices in rural areas, or in areas designated as geographic HPSAs by HRSA;
• Evidence supports that an activity has a high probability of contributing to improved beneficiary health outcomes; or
• CMS is able to validate the activity.
We note that in future rulemaking, activities that overlap with other performance categories may be included if such activities support the key goals of the program.
We request comments on this proposal.
It is our intention that the nomination and acceptance process will, to the best extent possible, parallel the Annual Call for Measures process already conducted for MIPS quality measures. Aligned with this approach, we propose to accept submissions for prospective improvement activities at any time during the performance period for the Annual Call for Activities and create an Improvement Activities under Review (IAUR) list. This list will be considered by us and may include federal partners in collaboration with stakeholders. The IAUR list will be analyzed with consideration of the proposed criteria for inclusion of improvement activities in the Improvement Activities Inventory. In addition, we propose that for the Annual Call for Activities, only activities submitted by March 1 would be considered for inclusion in the Improvement Activities Inventory for the performance periods occurring in the following calendar year. This proposal is slightly different than the Call for Measures timeline. The Annual Call for Measures requires a 2-year implementation timeline because the measures being considered for inclusion in MIPS undergo the pre-rulemaking process with review by the Measures Application Partnership (MAP). We are not proposing that improvement activities undergo MAP review. Therefore, our intention is to close the Annual Call for Activities submissions by March 1 before the applicable performance period, which will enable us to propose the new improvement activities for adoption in the same year's rulemaking cycle for implementation in the following year. For example, an improvement activity submitted prior to March 1, 2018, would be considered for performance periods occurring in 2019. In addition, we propose that we will add new improvement activities to the inventory through notice-and-comment rulemaking. In future years we anticipate developing a process and establishing criteria for identifying activities for removal from the Improvement Activities Inventory through the Annual Call for Activities process. We are requesting comments on what criteria should be used to identify improvement activities for removal from the Improvement Activities Inventory.
In the CY 2017 Quality Payment Program final rule (81 FR 77197), we finalized the following criteria for adding a new subcategory to the improvement activities performance category:
• The new subcategory represents an area that could highlight improved beneficiary health outcomes, patient engagement and safety based on evidence.
• The new subcategory has a designated number of activities that meet the criteria for an improvement activity and cannot be classified under the existing subcategories.
• Newly identified subcategories would contribute to improvement in patient care practices or improvement in performance on quality measures and cost performance categories.
We are not proposing any changes to the approach for adding new subcategories for the improvement activities performance category in this proposed rule. However, we are proposing that in future years of the Quality Payment Program we will add new improvement activities subcategories through notice-and-comment rulemaking. In addition, we are seeking comments on new improvement activities subcategories.
A number of stakeholders have suggested that a separate subcategory for improvement activities specifically related to health IT would make it easier for MIPS eligible clinicians and vendors to understand and earn points toward their final score through the use of health IT. Such a health IT subcategory could include only improvement activities that are specifically related to the advancing care information performance category measures and allow MIPS eligible clinicians to earn credit in the improvement activities performance category, while receiving a bonus in the advancing care information performance category as well. We are seeking suggestions on how a health IT subcategory within the improvement activities performance category could be structured to afford MIPS eligible clinicians with flexible opportunities to gain experience in using CEHRT and other health IT to improve their practice. Should the current policies where improvement activities earn bonus points within the advancing care information performance category be enhanced? Are there additional policies that should be explored in future rulemaking? We welcome public comment on this potential health IT subcategory.
In the CY 2017 Quality Payment Program final rule (81 FR 77195), we finalized specifics regarding the CMS Study on Improvement Activities and Measurement including the study purpose, study participation credit and requirements, and the study procedure. We are modifying the name of the study in this proposed rule to the “CMS study on burdens associated with reporting quality measures” to more accurately reflect the purpose of the study. The study assesses clinician burden and data submission errors associated with the collection and submission of clinician quality measures for MIPS, enrolling groups of different sizes and individuals in both rural and non-rural settings and also different specialties. We also noted that study participants would receive full credit in the improvement activities performance category after successfully electing, participating, and submitting data to the study coordinators at CMS for the full calendar year (81 FR 77196). We requested comment on the study, and received generally supportive feedback for the study.
We are not proposing any changes to the study purpose. We are proposing changes to the study participation credit and requirements sample size, how the study sample is categorized into groups, and the frequency of quality data submission, focus groups, and surveys. In addition to performing descriptive statistics to compare the trends in errors and burden between study years 2017 and 2018, we would like to perform a more rigorous statistical analysis with the 2018 data, which will require a larger sample size. We propose this increase in the sample size for 2018 to
Specifically, we are interested in whether there are any significant differences in quality measurement data submission errors and/or clinician burdens between rural clinicians submitting either individually or as a group, and urban clinicians submitting as an individual or as a group. A statistical power analysis was performed and a total sample size of 118 will be adequate for the main objective of the study. However, allowance will be made to account for attrition and other additional (or secondary) analysis.
This analysis would be compared at different sizes of practices (<3 eligible clinicians, between 3–8 eligible clinicians, etc.). This assessment is important since it facilitates tracing the root causes of measurement burdens and data submission errors that may be associated with any sub-group of clinician practice. This comparison may further break the sample down into more than four categories and a much larger sample size is a requisite for significant results with adequate probability of certainty.
The sample size for performance periods occurring in 2017 consisted of 42 MIPS groups as stated by MIPS criteria from the following seven categories:
• 10 urban individual or groups of <3 eligible clinicians.
• 10 rural individual or groups of <3 eligible clinicians.
• 10 groups of 3–8 eligible clinicians.
• 5 groups of 8–20 eligible clinicians.
• 3 groups of 20–100 eligible clinicians.
• 2 groups of 100 or greater eligible clinicians.
• 2 specialty groups.
We are proposing to increase the sample size for the performance periods occurring in 2018 to a minimum of:
• 20 urban individual or groups of <3 eligible clinicians—(broken down into 10 individuals & 10 groups).
• 20 rural individual or groups of <3 eligible clinicians—(broken down into 10 individuals & 10 groups).
• 10 groups of 3–8 eligible clinicians.
• 10 groups of 8–20 eligible clinicians.
• 10 groups of 20–100 eligible clinicians.
• 10 groups of 100 or greater eligible clinicians.
• 6 groups of >20 eligible clinicians reporting as individuals—(broken down into 3 urban & 3 rural).
• 6 specialty groups—(broken down into 3 reporting individually & 3 reporting as a group).
• Up to 10 non-MIPS eligible clinicians reporting as a group or individual (any number of individuals and any group size).
In addition, we are proposing changes to the study procedures. In the transition year of MIPS, study participants were required to attend a monthly focus group to share lessons learned in submitting quality data along with providing survey feedback to monitor effectiveness. However, an individual MIPS eligible clinician or group who chooses to report all 6 measures within a period of 90 days may not need to be a part of all of the focus groups and survey sessions after their first focus group and survey following the measurement data submission. This is because they may have nothing new to contribute in terms of discussion of errors or clinician burdens. This also applies to MIPS eligible clinicians that submit only three MIPS measures within the performance period, if they submitted all three measures within the 90-day period or at one submission. All study participants would participate in surveys and focus group meetings at least once after each measures data submission. For those who elect to report data for a 90-day period, we would make further engagement optional. Therefore, we are proposing that for Quality Payment Program Year 2 and future years that study participants would be required to attend as frequently as four monthly surveys and focus group sessions throughout the year, but certain study participants would be able to attend less frequently.
Further, the CY 2017 study requires study measurement data to be collected at baseline and at every 3 months (quarterly basis) afterwards for the duration of the calendar year. It also calls for a minimum requirement of three MIPS quality measures four times within the year. We believe this is inconsistent with clinicians reporting a full year's data as we believe some study participants may choose to submit data for all measures at one time, or alternatively, may choose to submit data up to six times during the 1-year period. We are proposing for the Quality Payment Program Year 2 and future years to offer study participants flexibility in their submissions so that they could submit once, as can occur in the MIPS program, and participate in study surveys and focus groups while still earning improvement activities credit.
It must be noted that although the aforementioned activities constitute an information collection request as defined in the implementing regulations of the Paperwork Reduction Act of 1995 (5 CFR 1320), the associated burden is exempt from application of the Paperwork Reduction Act. Specifically, section 1848(s)(7) of the Act, as added by section 102 of the MACRA (Pub. L. 114–10) states that Chapter 35 of title 44, United States Code, shall not apply to the collection of information for the development of quality measures. Our goals for new measures are to develop new high quality, low cost measures that are meaningful, easily understandable and operable, and also, reliably and validly measure what they purport. This study shall inform us (and our contractors) on the root causes of clinicians' performance measure data collection and data submission burdens and challenges that hinders accurate and timely quality measurement activities. In addition, this study will inform us on the characteristic attributes that our new measures must possess to be able to accurately capture and measure the priorities and gaps MACRA aims for, as described in the Quality Measures Development Plan.
We request comments on our study on burdens associated with reporting quality measures proposals regarding sample size for the performance periods occurring in 2018, study procedures for the performance periods occurring in 2018 and future years, and data submissions for the performance periods occurring in 2018 and future years.
Section 1848(q)(2)(A) of the Act includes the meaningful use of CEHRT as a performance category under the MIPS. We refer to this performance
Section 1848(q)(5)(E)(i)(IV) of the Act states that 25 percent of the MIPS final score shall be based on performance for the advancing care information performance category. We established at § 414.1380(b)(4) that the score for the advancing care information performance category would be comprised of a base score, performance score, and potential bonus points for reporting on certain measures and activities. For further explanation of our scoring policies for the advancing care information performance category, we refer readers to 81 FR 77216–77227.
For the CY 2018 performance period, we are not proposing any changes to the base score methodology as established in the CY 2017 Quality Payment Program final rule (81 FR 77217–77223). We established the policy that MIPS eligible clinicians must report a numerator of at least one for the numerator/denominator measures, or a “yes” response for the yes/no measure in order to earn the 50 percentage points in the base score. In addition, if the base score requirements are not met, a MIPS eligible clinician would receive a score of zero for the ACI performance category.
In the CY 2017 Quality Payment Program final rule (81 FR 77223 through 77226), we finalized that MIPS eligible clinicians can earn 10 percentage points in the performance score for meeting the Immunization Registry Reporting Measure. We believe we should modify this policy because we have learned that there are areas of the country where immunization registries are not available, and we did not intend to disadvantage MIPS eligible clinicians practicing in those areas. Thus, we are proposing to modify the scoring of the Public Health and Clinical Data Registry Reporting objective beginning with the performance period in CY 2018. We propose if a MIPS eligible clinician fulfills the Immunization Registry Reporting Measure, the MIPS eligible clinician would earn 10 percentage points in the performance score. If a MIPS eligible clinician cannot fulfill the Immunization Registry Reporting Measure, we are proposing that the MIPS eligible clinician could earn 5 percentage points in the performance score for each public health agency or clinical data registry to which the clinician reports for the following measures, up to a maximum of 10 percentage points: Syndromic Surveillance Reporting; Electronic Case Reporting; Public Health Registry Reporting; and Clinical Data Registry Reporting. A MIPS eligible clinician who chooses to report to more than one public health agency or clinical data registry may receive credit in the performance score for the submission to more than one agency or registry; however, the MIPS eligible clinician would not earn more than a total of 10 percentage points for such reporting.
We further propose similar flexibility for MIPS eligible clinicians who choose to report the measures specified for the Public Health Reporting Objective of the 2018 Advancing Care Information Transition Objective and Measure set. (In section II.C.6.f.(6)(b) of this proposed rule, we are proposing to allow MIPS eligible clinicians to report using the 2018 Advancing Care Information Transition Objectives and Measures in 2018.) We propose if a MIPS eligible clinician fulfills the Immunization Registry Reporting Measure, the MIPS eligible clinician would earn 10 percentage points in the performance score. If a MIPS eligible clinician cannot fulfill the Immunization Registry Reporting Measure, we are proposing that the MIPS eligible clinician could earn 5 percentage points in the performance score for each public health agency or specialized registry to which the clinician reports for the following measures, up to a maximum of 10 percentage points: Syndromic Surveillance Reporting; Specialized Registry Reporting. A MIPS eligible clinician who chooses to report to more than one specialized registry or public health agency to submit syndromic surveillance data may earn 5 percentage points in the performance score for reporting to each one, up to a maximum of 10 percentage points.
By proposing to expand the options for fulfilling the Public Health and Clinical Data Registry Reporting and the Public Health Reporting objectives, we believe that we are adding flexibility so that additional MIPS eligible clinicians can successfully fulfill this objective and earn 10 percentage points in the performance score. We are not proposing to change the maximum performance score that a MIPS eligible clinician can earn; it remains at 90 percent.
We are inviting public comment on these proposals.
In the CY 2017 Quality Payment Program final rule (81 FR 77220 through 77226), for the Public Health and Clinical Data Registry Reporting objective and the Public Health Reporting objective, we finalized that MIPS eligible clinicians who report to one or more public health agencies or clinical data registries beyond the Immunization Registry Reporting Measure will earn a bonus score of 5 percentage points in the advancing care information performance category. (In section II.C.6.f.(6)(b) of this proposed rule, we are proposing to allow MIPS eligible clinicians to report using the 2018 Advancing Care Information Transition Objectives and Measures in 2018.) Based on our proposals above to allow MIPS eligible clinicians who cannot fulfill the Immunization Registry Reporting Measure to earn additional points in the performance score, we believe we should modify this policy so that MIPS eligible clinicians cannot earn points in both the performance score and bonus score for reporting to the same public health agency or clinical data registry. We are proposing to modify our policy beginning with the performance period in CY 2018. We are proposing that a MIPS eligible clinician may only earn the bonus score of 5 percentage points for reporting to at least one additional public health agency or clinical data registry that is different from the agency/agencies or registry/or registries to which the MIPS eligible clinician reports to earn a performance score. For example, if a MIPS eligible clinician reports to a public health agency and a clinical data registry for the performance score, they could earn the bonus score of 5 percentage points by reporting to a different agency or registry that the clinician did not identify for purposes of the performance score. A MIPS eligible clinician would not receive credit under both the performance score and bonus score for reporting to the same agency or registry.
We are proposing that for the Advancing Care Information Objectives and Measures, a bonus of 5 percentage points would be awarded if the MIPS eligible clinician reports “yes” for any one of the following measures associated with the Public Health and Clinical Data Registry Reporting
We are inviting public comment on this proposal.
In the CY 2017 Quality Payment Program final rule (81 FR 77202), we discussed our approach to the measurement of the use of health IT to allow MIPS eligible clinicians and groups the flexibility to implement health IT in a way that supports their clinical needs. In addition, we discussed the need to move toward measurement of health IT use with respect to its contribution to effective care coordination and improving outcomes for patients. We stated that this approach would allow us to more directly link health IT adoption and use to patient outcomes, moving MIPS beyond the measurement of EHR adoption and process measurement and into a more patient-focused health IT program. Toward that end, we adopted a policy to award a bonus score to MIPS eligible clinicians who use CEHRT to complete certain activities in the improvement activities performance category based on our belief that the use of CEHRT in carrying out these activities could further the outcomes of clinical practice improvement.
We adopted a final policy to award a 10 percent bonus for the advancing care information performance category if a MIPS eligible clinician attests to completing at least one of the improvement activities we have specified using CEHRT (81 FR 77209). We refer readers to Table 8 in the CY 2017 Quality Payment Program final rule (81 FR 77202–77209) for a list of the improvement activities eligible for the advancing care information performance category bonus. In this proposed rule, we are proposing to expand this policy beginning with the CY 2018 performance period by identifying additional improvement activities in Table 6 that would be eligible for the advancing care information performance category bonus score if they are completed using CEHRT functionality. The activities eligible for the bonus score would include those listed in Table 6, as well as those listed in Table 8 in last year's final rule. We refer readers to the Improvement Activities section of this proposed rule (section II.C.6.e. of this proposed rule) for a discussion of the proposed new improvement activities and proposed changes to the improvement activities for 2018.
Ten percentage points is the maximum bonus a MIPS eligible clinician would receive if they attest to using CEHRT for one or more of the activities we have identified as eligible for the bonus. This bonus is intended to support progression toward holistic health IT use and measurement; attesting to even one improvement activity demonstrates that the MIPS eligible clinician is working toward this holistic approach to the use of their CEHRT. The weight of the improvement activity for the improvement activities performance category has no effect on the bonus awarded in the advancing care information performance category.
We invite comment on this proposal.
In the CY 2017 Quality Payment Program final rule (81 FR 77210 through 77211), we established a performance period for the advancing care information performance category to align with the overall MIPS performance period of one full year to ensure all four performance categories are measured and scored based on the same period of time. We believe this will lower reporting burden, focus clinician quality improvement efforts and align administrative actions so that MIPS eligible clinicians can use common systems and reporting pathways. We stated for the first and second performance periods of MIPS (CYs 2017 and 2018), we will accept a minimum of 90 consecutive days of data and encourage MIPS eligible clinicians to report data for the full year performance period. We are maintaining this policy as finalized for the performance period in CY 2018, and will accept a minimum of 90 consecutive days of data in CY 2018. We are proposing the same policy for the advancing care information performance category for the performance period in CY 2019, Quality Payment Program Year 3, and would accept a minimum of 90 consecutive days of data in CY 2019. We refer readers to section II.C.5. in this proposed rule for additional information on the MIPS performance period.
In the CY 2017 Quality Payment Program final rule (81 FR 77211 through 77213), we outlined the requirements for MIPS eligible clinicians using CEHRT during the CY 2017 performance period for the advancing care information performance category as it relates to the objectives and measures they select to report, and also outlined requirements for the CY 2018 performance period. We additionally adopted a definition of CEHRT at § 414.1305 for MIPS eligible clinicians that is based on the definition that applies in the EHR Incentive Programs under § 495.4.
For the CY 2017 performance period, we adopted a policy by which MIPS eligible clinicians may use EHR
We received significant comments and feedback from stakeholders requesting that we extend the use of 2014 Edition CEHRT beyond CY 2017 into CY 2018 and even CY 2019. Many commenters noted the lack of products certified to the 2015 Edition. Others stated that switching from the 2014 Edition to the 2015 Edition requires a large amount of time and planning and if it is rushed there is a potential risk to patient health. Some commenters noted the significant burden of combining outputs from multiple CEHRTs. A few mentioned that the cost to switch to the 2015 Edition is prohibitive for smaller practices.
Our experience with the transition from EHR technology certified to the 2011 Edition to EHR technology certified to the 2014 Edition did make us aware of the many issues associated with the adoption of EHR technology certified to a new Edition. These include the time that will be necessary to effectively deploy EHR technology certified to the 2015 Edition standards and certification criteria and to make the necessary patient safety, staff training, and workflow investments to be prepared to report for the advancing care information performance category for 2018. We understand and appreciate these concerns, and are working in collaboration with our federal partners at the Office of the National Coordinator for Health Information Technology (ONC) to monitor progress on the 2015 Edition upgrade.
As noted in the FY 2018 Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System proposed rule (referred to as the FY 2018 IPPS/LTCH PPS proposed rule) (82 FR 20136), ONC is working with health IT developers to analyze and monitor the status of developer readiness for 2015 Edition technology. As part of these analyses, ONC also reviewed health IT being certified to 2015 Edition by health IT developers who have products that were certified for the 2014 Edition and were used by EHR Incentive Program participants to attest. This analysis compared the pace of 2014 Edition certification with the pace of 2015 Edition certification to date. As of the beginning of the second quarter of CY 2017, ONC confirmed that at least 53 percent of eligible clinicians and 80 percent of eligible hospitals have 2015 Edition certified EHR technology available based on previous EHR Incentive Programs attestation data. Based on these data, and as compared to the transition from 2011 Edition to 2014 Edition, it appears that the transition from the 2014 Edition to the 2015 Edition is on schedule for the CY 2018 performance period.
However, the analysis also considered market trends such as consolidation and the number of large and small developers covering various groups of participants and the potential impact on readiness. The eligible hospital market is fairly concentrated, with nearly 98 percent of eligible hospital EHR Incentive Program participants using health IT from the top ten developers (ranked by market share) with a significant majority of that coverage by the top five developers. For hospitals, some developers representing a smaller market share also have certified health IT already available and are not expected to have a release schedule much different from their larger competitors. Considering market factors and using previous EHR Incentive Programs attestation data, ONC estimates that at least 85 percent of eligible hospitals would have EHR technology certified to the 2015 Edition available for use by the end of CY 2017 for program participation in 2018. In the FY 2018 IPPS/LTCH PPS proposed rule (82 FR 20136), we proposed to shorten the EHR reporting period to a minimum of any continuous 90-day period within CY 2018 for eligible hospitals and CAHs, as well as EPs who attest for a state's Medicaid EHR Incentive Program, to allow additional time for successful implementation of EHR technology certified to the 2015 Edition in CY 2018.
For MIPS eligible clinicians, the concern of potential impact on participation readiness when reviewing these market factors may be more significant. As noted in the FY 2018 IPPS/LTCH PPS proposed rule (82 FR 20136), historical data indicates eligible professionals were more likely to use a wider range of certified health IT, including those which individually make up a smaller segment of the overall market. Therefore, when market factors are taken into account, there exists a larger proportion of readiness that is unknown due to the wider range of certified health IT which may be used by MIPS eligible clinicians. This necessitated a more conservative approach for MIPS eligible clinician readiness. That estimate is that 74 percent of MIPS eligible clinicians will be ready to participate in MIPS using 2015 Edition certified EHR technologies by January 1, 2018.
However, subsequent to the preliminary analysis, ONC has continued to monitor readiness and to receive feedback from stakeholders on factors influencing variations in the development and implementation timelines for developers supporting different segments of the market, as well as the relationship between the developer readiness timeline and participant readiness. This continuing analysis supports a potential need for a longer implementation timeline for MIPS eligible clinicians. Stakeholder feedback suggests that while the estimate for known readiness remains the same, readiness among the remaining MIPS eligible clinicians may not be on the same timeline. About one quarter of eligible professional EHR Incentive Program participants in prior years used certified health IT from small developers that each has an historical market share of 1 percent or less. Therefore, MIPS eligible clinicians will need a significant number of smaller developers to reach the same readiness on the same timeline as larger companies in order to support program participants seeking to upgrade to the 2015 Edition. However, small developers generally offer a limited number or type of products, and may have more limited resources to dedicate to upgrade development, testing and certification, and implementation, which may affect availability and timing. In addition, the same factors may impact the capacity of some developers to support participants during the process and therefore the timeline for participant readiness would also potentially be longer. This is supported by historical analysis as a smaller percentage of eligible professionals used 2014 Edition certified EHR technology for participation in the EHR Incentive Programs during the 2014 calendar year than eligible hospitals and CAHs for the same year. For this reason, we believe additional flexibility for MIPS eligible clinicians is essential to support successful participation in the advancing care information performance category.
We continue to believe that there are many benefits for switching to EHR technology certified to the 2015 Edition. As noted in the FY 2018 IPPS/LTCH PPS proposed rule (82 FR 20136), the 2015 Edition health IT certification criteria enables health information exchange through new and enhanced certification criteria standards, and through implementation specifications
However, in light of the conservative readiness estimates for MIPS eligible clinicians, and in line with our commitment to supporting small practices, solo practitioners and specialties which may be more likely to use certified health IT offered by small developers, we are proposing that MIPS eligible clinicians may use EHR technology certified to either the 2014 or 2015 Edition certification criteria, or a combination of the two for the CY 2018 performance period. We propose to amend § 414.1305 to reflect this change. We further note, that to encourage new participants to adopt certified health IT and to incentivize participants to upgrade their technology to 2015 Edition products which better support interoperability across the care continuum, we are proposing to offer a bonus of 10 percentage points under the advancing care information performance category for MIPS eligible clinicians who report the Advancing Care Information Objectives and Measures for the performance period in CY 2018 using only 2015 Edition CEHRT. We are proposing to amend § 414.1380(b)(4)C)(3) to reflect this change. We are proposing this one-time bonus for CY 2018 to support and recognize MIPS eligible clinicians and groups that invest in implementing certified EHR technology in their practice. Specifically, we intend this bonus to support new participants that may be adopting health IT for the first time in CY 2018 and do not have 2014 Edition technology available to use or that may have no prior experience with meaningful use objectives and measures. We believe this bonus will help recognize their investment to adopt health IT and support their participation in the advancing care information performance category in MIPS. In addition, we believe this bonus will help to incentivize participants to continue the process of upgrading from 2014 Edition to 2015 Edition, especially small practices where the investment in updated workflows and implementation may present unique challenges. We intend this bonus to support and recognize their efforts to engage with the advancing care information measures using technology certified to the 2015 Edition, which include more robust measures using updated standards and functions which support interoperability. We seek comment on this proposed bonus. Specifically, we seek comment on if the percentage of the bonus is appropriate, or whether it should be limited to new participants in MIPS and small practices.
This bonus is not available to MIPS eligible clinicians who use a combination of the 2014 and 2015 Editions. We note that with the addition of the 2015 Edition CEHRT bonus of 10 percentage points, MIPS eligible clinicians would be able to earn a bonus score of up to 25 percentage points in CY 2018 under the advancing care information performance category, an increase from the 15 percentage point bonus score available in CY 2017.
To facilitate readers in identifying the requirements of CEHRT for the Advancing Care Information Objectives and Measures, we are including Table 8 in section II.C.6.f.(6)(a) which lists the 2015 Edition and 2014 Edition certification criteria required to meet the objectives and measures.
We invite comments on these proposals.
Section 1848(q)(5)(E)(i)(IV) of the Act states that 25 percent of the MIPS final score shall be based on performance for the advancing care information performance category. Further, section 1848(q)(5)(E)(ii) of the Act, provides that in any year in which the Secretary estimates that the proportion of eligible professionals (as defined in section 1848(o)(5) of the Act) who are meaningful EHR users (as determined under section 1848(o)(2) of the Act) is 75 percent or greater, the Secretary may reduce the applicable percentage weight of the advancing care information performance category in the MIPS final score, but not below 15 percent, and increase the weightings of the other performance categories such that the total percentage points of the increase equals the total percentage points of the reduction. We note that section 1848(o)(5) of the Act defines an eligible professional as a physician, as defined in section 1861(r) of the Act.
In CY 2017 Quality Payment Program final rule (81 FR 77226–77227), we established a final policy, for purposes of applying section 1848(q)(5)(E)(ii) of the Act, to estimate the proportion of physicians as defined in section 1861(r) of the Act who are meaningful EHR users as those physician MIPS eligible clinicians who earn an advancing care information performance category score of at least 75 percent for a performance period. We established that we will base this estimation on data from the relevant performance period, if we have sufficient data available from that period. For example, if feasible, we would consider whether to reduce the applicable percentage weight of the advancing care information performance category in the MIPS final score for the 2019 MIPS payment year based on an estimation using the data from the 2017 performance period. We stated that we will not include in the estimation physicians for whom the advancing care information performance category is weighted at zero percent under section 1848(q)(5)(F) of the Act, which we relied on in the CY 2017 Quality Payment Program final rule (81 FR 77226 through 77227) to establish policies under which we would weigh the advancing care information performance category at zero percent of the final score. In addition, we are proposing not to include in the estimation physicians for whom the advancing care information performance category would be weighted at zero percent under our proposal in section II.C.6.f.(7) of this proposed rule to implement certain provisions of the 21st Century Cures Act (that is, physicians who are determined hospital-based or ambulatory surgical center-based, or who are granted an exception based on
We are considering modifications to the policy we established in last year's rulemaking to base our estimation of physicians who are meaningful EHR users for a MIPS payment year (for example, 2019) on data from the relevant performance period (for example, 2017). We are concerned that if in future rulemaking we decide to propose to change the weight of the advancing care information performance category based on our estimation, such a change may cause confusion to MIPS eligible clinicians who are adjusting to the MIPS program and believe this performance category will make up 25 percent of the final score for the 2019 MIPS payment year. The earliest we would be able to make our estimation based on 2017 data and propose in future rulemaking to change the weight of the advancing care information performance category for the 2019 MIPS payment year would be in mid-2018, as the deadline for data submission is March 31, 2018. We are requesting public comments on whether this timeframe is sufficient, or whether a more extended timeframe would be preferable. We are proposing to modify our existing policy such that we would base our estimation of physicians who are meaningful EHR users for a MIPS payment year on data from the performance period that occurs four years before the MIPS payment year. For example, we would use data from the 2017 performance period to estimate the proportion of physicians who are meaningful EHR users for purposes of reweighting the advancing care information performance category for the 2021 MIPS payment year.
We invite comments on this proposal.
We are proposing to maintain for the CY 2018 performance period the Advancing Care Information Objectives and Measures as finalized in the CY 2017 Quality Payment Program final rule (81 FR 77227 through 77229) with the modifications proposed below. As we noted (81 FR 77227), these objectives and measures were adapted from the Stage 3 objectives and measures finalized in the 2015 EHR Incentive Programs final rule (80 FR 62829 through 62871), however, we did not maintain the previously established thresholds for MIPS. For a more detailed discussion of the Stage 3 objectives and measures, including explanatory material and defined terms, we refer readers to the 2015 EHR Incentive Programs final rule (80 FR 62829 through 62871).
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We inadvertently used the term “health care clinician” and are proposing to replace it with the more appropriate term “health care provider”. We are proposing this change would apply beginning with the performance period in 2017.
We inadvertently used the term “health care clinician” and are proposing to replace it with the more appropriate term “health care provider”. We are proposing this change would apply beginning with the 2017 performance period.
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We note that the functionality to be bi-directional is part of EHR technology certified to the 2015 Edition (80 FR 62554). It means that in addition to sending the immunization record to the immunization registry, the CEHRT must be able to receive and display a consolidated immunization history and forecast.
We note that we have split the Specialized Registry Reporting Measure that we adopted under the 2017 Advancing Care Information Transition Objectives and Measures into two separate measures, Public Health Registry and Clinical Data Registry Reporting to better define the registries available for reporting. We want to continue to encourage those MIPS eligible clinicians who have already started down the path of reporting to a specialized registry to continue to engage in public health and clinical data registry reporting. Therefore, we propose to allow MIPS eligible clinicians and groups to continue to count active engagement in electronic
As noted previously, to facilitate readers in identifying the requirements of CEHRT for the Advancing Care Information Objectives and Measures, we are including the following Table 8, which includes the 2015 Edition and 2014 Edition certification criteria required to meet the objectives and measures.
We are inviting public comment on these proposals.
In the CY 2017 Quality Payment Program final rule (81 FR 77229 through 77237), we finalized the 2017 Advancing Care Information Transition Objectives and Measures for MIPS eligible clinicians using EHR technology certified to the 2014 Edition. We noted (81 FR 77229 that these objectives and measures have been adapted from the Modified Stage 2 objectives and measures finalized in the 2015 EHR Incentive Programs final rule (80 FR 62793 through 62825); however, we did not maintain the previously established thresholds for MIPS. For a more detailed discussion of the Modified Stage 2 Objectives and Measures, including explanatory material and defined terms, we refer readers to the 2015 EHR Incentive Programs final rule (80 FR 62793 through 62825). We are proposing to make several modifications identified and described below to the 2017 Advancing Care Information Transition Objectives and Measures for the advancing care information performance category of MIPS for the 2017 and 2018 performance periods. These modifications would not require changes to EHR technology that has been certified to the 2014 Edition.
We finalized the 2017 Advancing Care Information Transition Objectives and Measures only for the 2017 performance period because these objectives and measures are for MIPS eligible clinicians using EHR technology certified to the 2014 Edition. Because we are proposing in section II.C.6.f.(4) to continue to allow the use of EHR technology certified to the 2014 Edition in the 2018 performance period, we are also proposing to allow MIPS eligible clinicians to report the Advancing Care Information Transition Objectives and Measures in 2018.
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Proposed Change to the Objective: The MIPS eligible clinician uses clinically relevant information from CEHRT to identify patient-specific educational resources and provide those resources to the patient. We inadvertently finalized the description of the Patient Electronic Access objective for the Patient-Specific Education Objective, so that the Patient-Specific Education Objective had the wrong description. We are proposing to correct this error by adopting the description of the Patient-Specific Education Objective adopted under modified Stage 2 in the 2015 EHR Incentive Programs final rule (80 FR 62809 and 80 FR 62815). We are proposing this change would apply beginning with the performance period in 2017.
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We inadvertently used the term “health care clinician” and are proposing to replace it with the more appropriate term “health care provider”. We are proposing this change would
This change reflects the change proposed to the Health Information Exchange objective replacing “health care clinician” with “health care provider”. We are proposing this change would apply beginning with the performance period in 2017.
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We are proposing to modify the numerator by removing medication list, medication allergy list, and current problem list. These three criteria were adopted for Stage 3 (80 FR 62862) but not for Modified Stage 2 (80 FR 62811). We are proposing this change would apply beginning with the performance period in 2017.
We invite public comments on these proposals.
We are proposing to add exclusions to the measures associated with the Health Information Exchange and Electronic Prescribing objectives required for the base score. We propose these exclusions would apply beginning with the CY 2017 performance period. In the CY 2017 Quality Payment Program final rule (81 FR 77237 through 77238), we did not finalize any exclusions for the measures specified for the advancing care information performance category as we believe that the MIPS exclusion criteria and that the advancing care information performance category scoring methodology together accomplish the same end as the previously established exclusions for the majority of the advancing care information performance category measures. We further noted that it was not necessary to finalize the proposed exclusion for the Immunization Registry Reporting Measure because MIPS eligible clinicians have the flexibility to choose whether to report the measure because it is part of the performance score of the advancing care information performance category. However, we understand that many MIPS eligible clinicians may not achieve a base score because they cannot fulfill the measures associated with the Health Information Exchange objective in the base score because they seldom refer or transition patients, and we believe that the implementation burden of the objective is too high to require of those with only a small number of referrals or transitions. Similarly, we understand that many MIPS eligible clinicians do not often write prescriptions in their practice or lack prescribing authority, and thus could not meet the E-prescribing Measure and would also fail to earn a base score. As this was not our intention, we are proposing to establish exclusions for these measures, as described below.
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We note that we proposed above to replace “health care clinician” with “health care provider”.
We note that we proposed above to replace “health care clinician” with “health care provider”.
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We note that we are proposing above to replace “health care clinician” with “health care provider”.
We note that we are proposing above to replace “health care clinician” with “health care provider”.
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We note that we are proposing above to replace “health care clinician” with “health care provider”.
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We are inviting public comment on these proposals.
As we noted in the CY 2017 Quality Payment Program final rule (81 FR 77238), section 101(b)(1)(A) of the MACRA amended section 1848(a)(7)(A) of the Act to sunset the meaningful use payment adjustment at the end of CY 2018. Section 1848(a)(7) of the Act includes certain statutory exceptions to the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act. Specifically, section 1848(a)(7)(D) of the Act exempts hospital-based EPs from the application of the payment adjustment under section 1848(a)(7)(A) of the Act. In addition, section 1848(a)(7)(B) of the Act provides that the Secretary may, on a case-by-case basis, exempt an EP from the application of the payment adjustment under section 1848(a)(7)(A) of the Act if the Secretary determines, subject to annual renewal, that compliance with the requirement for being a meaningful EHR user would result in a significant hardship, such as in the case of an EP who practices in a rural area without sufficient internet access. The last sentence of section 1848(a)(7)(B) of the Act also provides that in no case may an exemption be granted under subparagraph (B) for more than 5 years. The MACRA did not maintain these statutory exceptions for the advancing care information performance category of the MIPS. Thus, we had previously stated that the provisions under sections 1848(a)(7)(B) and (D) of the Act are limited to the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act and do not apply in the context of the MIPS.
Following the publication of the CY 2017 Quality Payment Program final rule, the 21st Century Cures Act (Pub. L. 114–255) was enacted on December 13, 2016. Section 4002(b)(1)(B) of the 21st Century Cures Act amended section 1848(o)(2)(D) of the Act to state that the provisions of sections 1848(a)(7)(B) and (D) of the Act shall apply to assessments of MIPS eligible clinicians under section 1848(q) of the Act with respect to the performance category described in subsection (q)(2)(A)(iv) (the advancing care information performance category) in an appropriate manner which may be similar to the manner in which such provisions apply with respect to the meaningful use payment adjustment made under section 1848(a)(7)(A) of the Act. As a result of this legislative change, we believe that the general exceptions described under sections 1848(a)(7)(B) and (D) of the Act are applicable under the MIPS program. We include below proposals to implement these provisions as applied to assessments of MIPS eligible clinicians under section 1848(q) of the Act with respect to the advancing care information performance category.
In the CY 2017 Quality Payment Program final rule (81 FR 77240 through 77243), we recognized that there may not be sufficient measures applicable and available under the advancing care information performance category to MIPS eligible clinicians facing a significant hardship, such as those who lack sufficient internet connectivity, face extreme and uncontrollable circumstances, lack control over the availability of CEHRT, or do not have face-to-face interactions with patients. We relied on section 1848(q)(5)(F) of the Act to establish a final policy to assign a zero percent weighting to the advancing care information performance category in the final score if there are not sufficient measures and activities applicable and available to MIPS eligible clinicians within the categories of significant hardship noted above (81 FR 77243). Additionally, under the final policy (81 FR 77243), we did not impose a limitation on the total number of MIPS payment years for which the advancing care information performance category could be weighted at zero percent, in contrast with the 5-year limitation on significant hardship exceptions under the Medicare EHR Incentive Program as required by section 1848(a)(7)(B) of the Act.
We are not proposing substantive changes to this policy; however, as a result of the changes in the law made by the 21st Century Cures Act discussed above, we will not rely on section 1848(q)(5)(F) of the Act and instead are proposing to use the authority in the last sentence of section 1848(o)(2)(D) of the Act for significant hardship exceptions under the advancing care information performance category under MIPS. Section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, states in part that the provisions of section 1848(a)(7)(B) of the Act shall apply to assessments of MIPS eligible clinicians with respect to the advancing care information performance category in an appropriate manner which may be similar to the manner in which such provisions apply with respect to the payment adjustment made under section 1848(a)(7)(A) of the Act. We would assign a zero percent weighting to the advancing care information performance category in the MIPS final score for a MIPS payment year for MIPS eligible clinicians who successfully demonstrate a significant hardship through the application process. We would use the same categories of significant hardship and application process as established in the CY 2017 Quality Payment Program final rule (81 FR 77240–77243). We would automatically reweight the advancing care information performance category to zero percent for a MIPS eligible clinician who lacks face-to-face patient interaction and is classified as a non-patient facing MIPS eligible clinician without requiring an application. If a MIPS eligible clinician submits an application for a significant hardship exception or is classified as a non-patient facing MIPS eligible clinician, but also reports on the measures specified for the advancing care information performance category, they would be scored on the advancing care information performance category like all other MIPS eligible clinicians, and the category would be given the weighting prescribed by section 1848(q)(5)(E) of the Act regardless of the MIPS eligible clinician's score.
We believe this policy would be an appropriate application of the provisions of section 1848(a)(7)(B) of the Act to MIPS eligible clinicians and is similar to the manner in which those provisions apply with respect to the payment adjustment made under section 1848(a)(7)(A) of the Act. Under the Medicare EHR Incentive Program an approved hardship exception exempted an EP from the payment adjustment. We believe that weighting the advancing care information performance category to zero percent is similar in effect to an exemption from the requirements of that performance category.
As required under section 1848(a)(7)(B) of the Act, eligible professionals were not granted significant hardship exceptions for the payment adjustments under the Medicare EHR Incentive Program for more than 5 years. We propose not to apply the 5-year limitation under section 1848(a)(7)(B) of the Act to significant hardship exceptions for the advancing care information performance category under MIPS. We believe this proposal is an appropriate application of the provisions of section 1848(a)(7)(B)
We solicit comments on the proposed use of the authority provided in the 21st Century Cures Act in section 1848(o)(2)(D) of the Act as it relates to application of significant hardship exceptions under MIPS and the proposal not to apply a 5-year limit to such exceptions.
Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to give consideration to the circumstances of small practices (consisting of 15 or fewer professionals) and practices located in rural areas and geographic HPSAs in establishing improvement activities under MIPS. In the CY 2017 Quality Payment Program final rule (81 FR 77187 through 77188), we finalized that for MIPS eligible clinicians and groups that are in small practices or located in rural areas, or geographic health professional shortage areas (HPSAs), to achieve full credit under the improvement activities category, one high-weighted or two medium-weighted improvement activities are required.
While there is no corresponding statutory provision for the advancing care information performance category, we believe that special consideration should also be available for MIPS eligible clinicians located in small practices. Through comments received on the CY 2017 Quality Payment Program proposed rule (81 FR 28161–28586), we heard many concerns about the impact of MIPS on eligible clinicians in small practices. Some commenters stated that there was not a meaningful exclusion for small practices that cannot afford the upfront investments (including investments in EHR technology) (81 FR 77066). Many noted there are still many small practices that have not adopted EHRs due to the administrative and financial burden. Some expressed concern that small group and solo practices would be driven out of business because of the potential negative payment adjustments under MIPS (81 FR 77055). A few commenters were concerned about the impact of MACRA on small practices and asked CMS to remain sensitive to this concern and offer special opportunities for MIPS eligible clinicians in areas threatened by access problems (81 FR 77055).
Based on these concerns, we are proposing a significant hardship exception for the advancing care information performance category for MIPS eligible clinicians who are in small practices, under the authority in section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act (see discussion of the statutory authority for significant hardship exceptions in section II.C.6.f.(7)(ii). We are proposing that this hardship exception would be available to MIPS eligible clinicians in small practices as defined under § 414.1305 (15 or fewer clinicians and solo practitioners). We are proposing in section II.C.1.e. of this proposed rule, that CMS would make eligibility determinations regarding the size of small practices for performance periods occurring in 2018 and future years. We are proposing to reweight the advancing care information performance category to zero percent of the MIPS final score for MIPS eligible clinicians who qualify for this hardship exception. We are proposing this exception would be available beginning with the 2018 performance period and 2020 MIPS payment year. We are proposing a MIPS eligible clinician seeking to qualify for this exception would submit an application in the form and manner specified by us by December 31st of the performance period or a later date specified by us. We are also proposing MIPS eligible clinicians seeking this exception must demonstrate in the application that there are overwhelming barriers that prevent the MIPS eligible clinician from complying with the requirements for the advancing care information performance category. In accordance with section 1848(a)(7)(B) of the Act, the exception would be subject to annual renewal. Under our proposal in section II.C.6.f.(7)(a), the 5-year limitation under section 1848(a)(7)(B) of the Act would not apply to this significant hardship exception for MIPS eligible clinicians in small practices.
We believe that applying the significant hardship exception in this way would be appropriate given the challenges small practices face as described by the commenters. In addition, we believe this application would be similar to the manner in which the exception applies with respect to the payment adjustment made under section 1848(a)(7)(A) of the Act because weighting the advancing care information performance category to zero percent is similar in effect to an exemption from the requirements of that performance category.
While we would be making this significant hardship exception available to small practices in particular, we are considering whether other categories or types of clinicians might similarly require an exception. We solicit comment on what those categories or types are, why such an exception is required, and any data available to support the necessity of the exception. We note that supporting data would be particularly helpful to our consideration of whether any additional exceptions would be appropriate.
We are seeking comments on these proposals.
In the CY 2017 Quality Payment Program final rule (81 FR 77238 through 77240), we defined a hospital-based MIPS eligible clinician under § 414.1305 as a MIPS eligible clinician who furnishes 75 percent or more of his or her covered professional services in sites of service identified by the Place of Service (POS) codes used in the HIPAA standard transaction as an inpatient hospital (POS 21), on-campus outpatient hospital (POS 22), or emergency room (POS 23) setting, based on claims for a period prior to the performance period as specified by CMS. We intend to use claims with dates of service between September 1 of the calendar year 2 years preceding the performance period through August 31 of the calendar year preceding the performance period, but in the event it is not operationally feasible to use claims from this time period, we will use a 12-month period as close as practicable to this time period. We discussed our assumption that MIPS eligible clinicians who are determined hospital-based do not have
We are not proposing substantive changes to this policy; however, as a result of the changes in the law made by the 21st Century Cures Act discussed above, we will not rely on section 1848(q)(5)(F) of the Act and instead are proposing to use the authority in the last sentence of section 1848(o)(2)(D) of the Act for exceptions for hospital-based MIPS eligible clinicians under the advancing care information performance category. Section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, states in part that the provisions of section 1848(a)(7)(D) of the Act shall apply to assessments of MIPS eligible clinicians with respect to the advancing care information performance category in an appropriate manner which may be similar to the manner in which such provisions apply with respect to the payment adjustment made under section 1848(a)(7)(A) of the Act. We would assign a zero percent weighting to the advancing care information performance category in the MIPS final score for a MIPS payment year for hospital-based MIPS eligible clinicians as previously defined. A hospital-based MIPS eligible clinician would have the option to report the advancing care information measures for the performance period for the MIPS payment year for which they are determined hospital-based. However, if a MIPS eligible clinician who is determined hospital-based chooses to report on the advancing care information measures, they would be scored on the advancing care information performance category like all other MIPS eligible clinicians, and the category would be given the weighting prescribed by section 1848(q)(5)(E) of the Act regardless of their score.
We believe this policy would be an appropriate application of the provisions of section 1848(a)(7)(D) of the Act to MIPS eligible clinicians and is similar to the manner in which those provisions apply with respect to the payment adjustment made under section 1848(a)(7)(A) of the Act. Under the Medicare EHR Incentive Program an approved hardship exception exempted an EP from the payment adjustment. We believe that weighting the advancing care information performance category to zero percent is similar in effect to an exemption from the requirements of that performance category.
We propose to amend § 414.1380(c)(1) and (2) of the regulation text to reflect this proposal.
We request comments on the proposed use of the authority provided in the 21st Century Cures Act in section 1848(o)(2)(D) of the Act as it relates to hospital-based MIPS eligible clinicians.
Section 16003 of the 21st Century Cures Act amended section 1848(a)(7)(D) of the Act to provide that no payment adjustment may be made under section 1848(a)(7)(A) of the Act for 2017 and 2018 in the case of an eligible professional who furnishes substantially all of his or her covered professional services in an ambulatory surgical center (ASC). Section 1848(a)(7)(D)(iii) of the Act provides that determinations of whether an eligible professional is ASC-based may be made based on the site of service as defined by the Secretary or an attestation, but shall be made without regard to any employment or billing arrangement between the eligible professional and any other supplier or provider of services. Section 1848(a)(7)(D)(iv) of the Act provides that the ASC-based exception shall no longer apply as of the first year that begins more than 3 years after the date on which the Secretary determines, through notice and comment rulemaking, that CEHRT applicable to the ASC setting is available.
Under section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, the ASC-based provisions of section 1848(a)(7)(D) of the Act shall apply to assessments of MIPS eligible clinicians under section 1848(q) of the Act with respect to the advancing care information performance category in an appropriate manner which may be similar to the manner in which such provisions apply with respect to the payment adjustment made under section 1848(a)(7)(A) of the Act. We believe our proposals set forth below for ASC-based MIPS eligible clinicians are an appropriate application of the provisions of section 1848(a)(7)(D) of the Act to MIPS eligible clinicians. Under the Medicare EHR Incentive Program an approved hardship exception exempted an EP from the payment adjustment. We believe that weighting the advancing care information performance category to zero percent is similar in effect to an exemption from the requirements of that performance category.
To align with our hospital-based MIPS eligible clinician policy, we are proposing to define at § 414.1305 an ASC-based MIPS eligible clinician as a MIPS eligible clinician who furnishes 75 percent or more of his or her covered professional services in sites of service identified by the Place of Service (POS) code 24 used in the HIPAA standard transaction based on claims for a period prior to the performance period as specified by us. We request comments on this proposal and solicit comments as to whether other POS codes should be used to identify a MIPS eligible clinician's ASC-based status or if an alternative methodology should be used. We note that the ASC-based determination will be made independent of the hospital-based determination.
To determine a MIPS eligible clinician's ASC-based status, we are proposing to use claims with dates of service between September 1 of the calendar year 2 years preceding the performance period through August 31 of the calendar year preceding the performance period, but in the event it is not operationally feasible to use claims from this time period, we would use a 12-month period as close as practicable to this time period. For example, for the 2018 performance period (2020 MIPS payment year), we would use the data available at the end of October 2017 for Medicare claims with dates of service between September 1, 2016 through August 31, 2017, to determine whether a MIPS eligible clinician is considered ASC-based under our proposed definition. We are proposing this timeline to allow us to notify MIPS eligible clinicians of their ASC-based status prior to the start of the performance period and to align with the hospital-based MIPS eligible clinician determination period. For the 2019 MIPS payment year, we would not be able to notify MIPS eligible clinicians of their ASC-based status until after the final rule is published, which we anticipate would be later in 2017. We expect that we would provide this notification through
For MIPS eligible clinicians who we determine are ASC-based, we propose to assign a zero percent weighting to the advancing care information performance category in the MIPS final score for the MIPS payment year. However, if a MIPS eligible clinician who is determined ASC-based chooses to report on the advancing care information measures for the performance period for the MIPS payment year for which they are determined ASC-based, we propose they would be scored on the advancing care information performance category like
We are proposing these ASC-based policies would apply beginning with the 2017 performance period/2019 MIPS payment year.
We propose to amend § 414.1380(c)(1) and (2) of the regulation text to reflect these proposals.
We request comments on these proposals.
Section 4002(b)(1)(A) of the 21st Century Cures Act amended section 1848(a)(7)(B) of the Act to provide that the Secretary shall exempt an eligible professional from the application of the payment adjustment under section 1848(a)(7)(A) of the Act with respect to a year, subject to annual renewal, if the Secretary determines that compliance with the requirement for being a meaningful EHR user is not possible because the CEHRT used by such professional has been decertified under ONC's Health IT Certification Program. Section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, states in part that the provisions of section 1848(a)(7)(B) of the Act shall apply to assessments of MIPS eligible clinicians with respect to the advancing care information performance category in an appropriate manner which may be similar to the manner in which such provisions apply with respect to the payment adjustment made under section 1848(a)(7)(A) of the Act.
We are proposing that a MIPS eligible clinician may demonstrate through an application process that reporting on the measures specified for the advancing care information performance category is not possible because the CEHRT used by the MIPS eligible clinician has been decertified under ONC's Health IT Certification Program. We are proposing that if the MIPS eligible clinician's demonstration is successful and an exception is granted, we would assign a zero percent weighting to the advancing care information performance category in the MIPS final score for the MIPS payment year. In accordance with section 1848(a)(7)(B) of the Act, the exception would be subject to annual renewal, and in no case may a MIPS eligible clinician be granted an exception for more than 5 years. We are proposing this exception would be available beginning with the CY 2018 performance period and the 2020 MIPS payment year.
We are proposing that a MIPS eligible clinician may qualify for this exception if their CEHRT was decertified either during the performance period for the MIPS payment year or during the calendar year preceding the performance period for the MIPS payment year. We believe that this timeframe is appropriate because the loss of certification may prevent a MIPS eligible clinician from reporting for the advancing care information performance category because it will require that the MIPS eligible clinician switch to an alternate CEHRT, a process that we believe may take up to 2 years. For example, for the 2020 MIPS payment year, if the MIPS eligible clinician's EHR technology was decertified during the CY 2018 performance period or during CY 2017, the MIPS eligible clinician may qualify for this exception. In addition, we are proposing that the MIPS eligible clinician must demonstrate in their application and through supporting documentation if available that the MIPS eligible clinician made a good faith effort to adopt and implement another CEHRT in advance of the performance period. We are proposing a MIPS eligible clinician seeking to qualify for this exception would submit an application in the form and manner specified by us by December 31st of the performance period, or a later date specified by us.
We believe that applying the exception in this way is an appropriate application of the provisions of section 1848(a)(7)(B) of the Act to MIPS eligible clinicians given that weighting the advancing care information performance category to zero percent is similar in effect to an exemption from the requirements of that performance category. Under the Medicare EHR Incentive Program an approved hardship exception exempted an EP from the payment adjustment. We believe that weighting the advancing care information performance category to zero percent is similar in effect to an exemption from the requirements of that performance category.
The ONC Health IT Certification Program: Enhanced Oversight and Accountability final rule (“EOA final rule”) (81 FR 72404), effective December 19, 2016, created a regulatory framework for the ONC's direct review of health information technology (health IT) certified under the ONC Health IT Certification Program, including, when necessary, requiring the correction of non-conformities found in health IT certified under the Program and/or terminating certifications issued to certified health IT. Prior to the EOA final rule, ONC-Authorized Certification Bodies (ONC–ACBs) had the only authority to terminate or revoke certification of health IT under the program, which they used on previous occasions. On September 23, 2015, we posted an FAQ discussing the requirements for using a decertified CEHRT.
Once all administrative processes, if any, are complete, then notice of a “termination of certification” is listed on the of the Certified Health IT Product List (CPHL) Web page.
We further note that in comparison to termination actions taken by ONC and ONC–ACBs, a health IT developer may voluntarily withdraw a certification that is in good standing under the ONC Health IT Certification Program. A voluntary withdrawal may be the result of the health IT developer going out of business, the developer no longer supporting the product, or for other reasons that are not in response to ONC–ACB surveillance, ONC direct review, or a finding of non-conformity by ONC or an ONC–ACB.
We propose to amend § 414.1380(c)(1) and (2) of the regulation text to reflect these proposals. We are seeking comments on these proposals.
In the CY 2017 Quality Payment Program final rule (81 FR 77238 through 77240, we defined a hospital-based MIPS eligible clinician as a MIPS eligible clinician who furnishes 75 percent or more of his or her covered professional services in sites of services identified by the Place of Service (POS) codes used in the HIPAA standard transaction as an inpatient hospital (POS 21), on campus outpatient hospital
We are proposing to modify our policy to include covered professional services furnished by MIPS eligible clinicians in an off-campus-outpatient hospital (POS 19) in the definition of hospital-based MIPS eligible clinician. POS 19 was developed in 2015 in order to capture the numerous physicians that are paid for a portion of their services in an “off campus-outpatient hospital” versus an on campus-outpatient hospital, (POS 22). We also believe that these MIPS eligible clinicians would not typically have control of the development and maintenance of their EHR systems, just like those who bill using POS 22. We propose to add POS 19 to our existing definition of a hospital-based MIPS eligible clinician beginning with the performance period in 2018.
We invite comment on this proposal.
In the CY 2017 Quality Payment Program final rule (81 FR 77243–77244), we discussed our belief that certain types of MIPS eligible clinicians (NPs, PAs, CNSs, and CRNAs) may lack experience with the adoption and use of CEHRT. Because many of these non-physician clinicians are not eligible to participate in the Medicare or Medicaid EHR Incentive Program, we stated that we have little evidence as to whether there are sufficient measures applicable and available to these types of MIPS eligible clinicians under the advancing care information performance category. We established a policy under section 1848(q)(5)(F) of the Act to assign a weight of zero to the advancing care information performance category in the MIPS final score if there are not sufficient measures applicable and available to NPs, PAs, CRNAs, and CNSs. We will assign a weight of zero only in the event that an NP, PA, CRNA, or CNS does not submit any data for any of the measures specified for the advancing care information performance category. We encouraged all NPs, PAs, CRNAs, and CNSs to report on these measures to the extent they are applicable and available, however, we understand that some NPs, PAs, CRNAs, and CNSs may choose to accept a weight of zero for this performance category if they are unable to fully report the advancing care information measures. These MIPS eligible clinicians may choose to submit advancing care information measures should they determine that these measures are applicable and available to them; however, we noted that if they choose to report, they will be scored on the advancing care information performance category like all other MIPS eligible clinicians and the performance category will be given the weighting prescribed by section 1848(q)(5)(E) of the Act regardless of their advancing care information performance category score.
We stated that this approach is appropriate for the first MIPS performance period based on the payment consequences associated with reporting, the fact that many of these types of MIPS eligible clinicians may lack experience with EHR use, and our current uncertainty as to whether we have adopted sufficient measures that are applicable and available to these types of MIPS eligible clinicians. We noted that we would use the first MIPS performance period to further evaluate the participation of these MIPS eligible clinicians in the advancing care information performance category and would consider for subsequent years whether the measures specified for this category are applicable and available to these MIPS eligible clinicians. At this time we have no additional information because the first MIPS performance period is currently underway, and thus we propose the same policy for NPs, PAs, CRNAs, and CNSs for the 2018 performance period as well. We still intend to evaluate the participation of these MIPS eligible clinicians in the advancing care information performance category for 2017 and expect to adopt measures applicable and available to them in subsequent years.
We are seeking comment on how the advancing care information performance category could be applied to NPs, PAs, CRNAs, and CNSs in future years of MIPS, and the types of measures that would be applicable and available to these types of MIPS eligible clinicians. In addition, through the Call for Measures Process we are seeking new measures that may be more broadly applicable to these additional types of MIPS eligible clinicians in future program years. For more information on the Call for Measures, see
We are inviting public comment on these proposals.
In any of the situations described in the sections above, we would assign a zero percent weighting to the advancing care information performance category in the MIPS final score for the MIPS payment year if the MIPS eligible clinician meets certain specified requirements for this weighting. We noted that these MIPS eligible clinicians may choose to submit advancing care information measures; however, if they choose to report, they will be scored on the advancing care information performance category like all other MIPS eligible clinicians and the performance category will be given the weighting prescribed by section 1848(q)(5)(E) of the Act regardless of their advancing care information performance category score. This policy includes MIPS eligible clinicians choosing to report as part of a group practice or part of a virtual group.
Group practices as defined at § 414.1310(e)(1) are required to aggregate their performance data across the TIN in order for their performance to be assessed as a group (81 FR 77058). Additionally, groups that elect to have their performance assessed as a group will be assessed as a group across all four MIPS performance categories. By reporting as part of a group practice, MIPS eligible clinicians are subscribing to the data reporting and scoring requirements of the group practice. We note that the data submission criteria for groups reporting advancing care information performance category described in the CY 2017 Quality Payment Program final rule (81 FR 77215) state that group data should be aggregated for all MIPS eligible clinicians within the group practice. This includes those MIPS eligible clinicians who may qualify for a zero percent weighting of the advancing care information performance category due to the circumstances as described above, such as a significant hardship or other type of exception, hospital-based or ASC-based status, or certain types of non-physician practitioners (NPs, PAs, CNSs, and CRNAs). If these MIPS eligible clinicians report as part of a group practice or virtual group, they will be scored on the advancing care information performance category like all other MIPS eligible clinicians and the performance category will be given the weighting prescribed by section 1848(q)(5)(E) of the Act regardless of the group practice's advancing care information performance category score.
In the CY 2017 Quality Payment Program final rule (81 FR77240–77243), we established the timeline for the submission of applications to reweight the advancing care information performance category in the MIPS final score to align with the data submission timeline for MIPS. We established that all applications for reweighting the advancing care information performance category be submitted by the MIPS eligible clinician or designated group representative in the form and manner specified by us. All applications may be submitted on a rolling basis, but must be received by us no later than the close of the submission period for the relevant performance period, or a later date specified by us. An application would need to be submitted annually to be considered for reweighting each year.
The Quality Payment Program Exception Application will be used to apply for the following exceptions: Insufficient Internet Connectivity; Extreme and Uncontrollable Circumstances; Lack of Control over the Availability of CEHRT; Decertification of CEHRT; and Small Practice.
We are proposing to change the submission deadline for the application as we believe that aligning the data submission deadline with the reweighting application deadline could disadvantages MIPS eligible clinicians. We are proposing to change the submission deadline for the CY 2017 performance period to December 31, 2017, or a later date specified by us. We believe this change would help MIPS eligible clinicians by allowing them to learn whether their application is approved prior to the data submission deadline for the CY 2017 performance period, March 31, 2018. We plan to have the application available in mid-2017. We encourage MIPS eligible clinicians to apply early as we expect to process the applications on a rolling basis. We note that if a MIPS eligible clinician submits data for the advancing care information category after an application has been submitted, the data would be scored, the application would be considered voided and the advancing care information performance category would not be reweighted.
We further propose that the submission deadline for the 2018 performance period will be December 31, 2018, or a later date as specified by us. We believe this would help MIPS eligible clinicians by allowing them to learn whether their application is approved prior to the data submission deadline for the CY 2018 performance period, March 31, 2019.
We request comments on these proposals.
Under section 1848(q)(1)(C)(ii)(1) of the Act, Qualifying APM Participants (QPs) are not MIPS eligible clinicians and are thus excluded from MIPS reporting requirements and payment adjustments. Similarly, under section 1848(q)(1)(c)(ii)(II) of the Act, Partial Qualifying APM Participants (Partial QPs) are also not MIPS eligible clinicians unless they opt to report and be scored under MIPS. All other eligible clinicians, including those participating in MIPS APMs, are MIPS eligible clinicians and subject to MIPS reporting requirements and payment adjustments unless they are excluded on another basis such as being newly enrolled in Medicare or not exceeding the low volume threshold.
In the CY 2017 Quality Payment Program final rule (81 FR 77246–77269, 77543), we finalized the APM scoring standard, which is designed to reduce reporting burden for participants in certain APMs by minimizing the need for them to make duplicative data submissions for both MIPS and their respective APMs. We also sought to ensure that eligible clinicians in APM Entities that participate in certain types of APMs that assess their participants on quality and cost are assessed as consistently as possible across MIPS and their respective APMs. Given that many APMs already assess their participants on cost and quality of care and require engagement in certain improvement activities, we believe that without the APM scoring standard, misalignments could be quite common between the evaluation of performance under the terms of the APM and evaluation of performance on measures and activities under MIPS.
In the CY 2017 Quality Payment Program final rule (81 FR 77249), we identified the types of APMs for which the APM scoring standard would apply as MIPS APMs. We finalized that to be a MIPS APM, an APM must satisfy the following criteria: (1) APM Entities participate in the APM under an agreement with CMS or by law or regulation; (2) the APM requires that APM Entities include at least one MIPS eligible clinician on a Participation List; and (3) the APM bases payment incentives on performance (either at the APM Entity or eligible clinician level) on cost/utilization and quality measures. We specified that we will post the list of MIPS APMs prior to the first day of the MIPS performance year for each year (81 FR 77250). We finalized in the regulation at § 414.1370(b) that for a new APM to be a MIPS APM, its first performance year must start on or before the first day of the MIPS performance year. A list of MIPS APMs is available at
We established in the regulation at § 414.1370(c) that the MIPS performance year under § 414.1320 of the regulations applies for the APM scoring standard.
We finalized that under section § 414.1370(f) of our regulations on the APM scoring standard, MIPS eligible clinicians will be scored at the APM Entity group level and each eligible clinician will receive the APM Entity group's final score. The MIPS payment adjustment is applied at the TIN/NPI level for each of the MIPS eligible clinicians in the APM Entity. The MIPS final score is comprised of the four MIPS performance category scores, as described in our regulation at § 414.1370(g): quality, cost, improvement activities, and advancing care information. Both the Medicare Shared Savings Program and Next Generation ACO Model are MIPS APMs for the CY 2017 performance year. For these two MIPS APMs, in accordance with our regulation at § 414.1370(h), the MIPS performance category scores are weighted as follows: Quality at 50 percent; cost at zero percent; improvement activities at 20 percent; and advancing care information at 30 percent of the final score. For all other MIPS APMs for the CY 2017 performance year, quality and cost are each weighted at zero percent, improvement activities at 25 percent, and advancing care information at 75 percent of the final score.
As explained in the following sections, we propose to: Add an APM participant assessment date for full TIN APMs; add the CAHPS for ACOs survey to the Shared Savings Program and Next Generation ACO quality measures included for scoring under the MIPS APM quality performance category; define Other MIPS APMs; and add scoring for quality improvement to the MIPS APM quality performance category for MIPS APMs beginning in 2018. We also propose a Quality Payment Program 2018 performance year quality scoring methodology for Other MIPS APMs, and describe the scoring methodology for quality improvement for Other MIPS APMs as applicable.
In reviewing these proposals, we remind readers that the APM scoring
In the CY 2017 Quality Payment Program final rule, we specified in the regulation at § 414.1370(e) that the APM Entity group for purposes of scoring under the APM scoring standard is determined in the manner prescribed at § 414.1425(b)(1), which provides that eligible clinicians who are on a Participation List on at least one of three dates (March 31, June 30, and August 31) would be considered part of the APM Entity group. Under these regulations, MIPS eligible clinicians who are not on a Participation List on one of these three assessment dates are not scored under the APM scoring standard. Instead, they would need to submit data to MIPS through one of the MIPS data submission mechanisms and their performance would be assessed either as individual MIPS eligible clinicians or as a group according to the generally applicable MIPS reporting and scoring criteria.
We will continue to use the three assessment dates of March 31, June 30, and August 31 to identify MIPS eligible clinicians who are on an APM Entity's Participation List and determine the APM Entity group that is used for purposes of the APM scoring standard. Beginning in the 2018 performance year, we propose to add a fourth assessment date of December 31 to identify those MIPS eligible clinicians who participate in a full TIN APM. We propose to define full TIN APM at § 414.1305 to mean an APM where participation is determined at the TIN level, and all eligible clinicians who have assigned their billing rights to a participating TIN are therefore participating in the APM. An example of a full TIN APM is the Shared Savings Program which requires all individuals and entities that have reassigned their right to receive Medicare payment to the TIN of an ACO participant to participate in the ACO and comply with the requirements of the Shared Savings Program.
If an eligible clinician elects to reassign their billing rights to a TIN participating in a full TIN APM, the eligible clinician is necessarily participating in the full TIN APM. We propose to add this fourth date of December 31 only for eligible clinicians in a full TIN APM, and only for purposes of applying the APM scoring standard. We are not proposing to use this additional assessment date of December 31 for purposes of QP determinations. Therefore, we propose to amend § 414.1370(e) to identify the four assessment dates that would be used to identify the APM Entity group for purposes of the APM scoring standard, and to specify that the December 31 date would be used only to identify eligible clinicians on the APM Entity's Participation List for a MIPS APM that is a full TIN APM in order to add them to the APM Entity group that is scored under the APM scoring standard.
We propose to use this fourth assessment date of December 31 to extend the APM scoring standard to only those MIPS eligible clinicians participating in MIPS APMs that are full TIN APMs, ensuring that an eligible clinician who joins the full TIN APM late in the performance year would be scored under the APM scoring standard. We considered proposing to use the fourth assessment date more broadly for all MIPS APMs. However, we believe that this approach would have allowed MIPS eligible clinicians to inappropriately leverage the fourth assessment date to avoid reporting and scoring under the generally applicable MIPS scoring standard when they were part of the MIPS APM for only a very limited portion of the performance year. That is, for MIPS APMs that allow split TIN participation, it would be possible for eligible clinicians to briefly join a MIPS APM principally in order to benefit from the APM scoring standard, despite having limited opportunity to contribute to the APM Entity's performance in the MIPS APM. In contrast, we believe MIPS eligible clinicians would be less likely to join a full TIN APM principally to avail themselves of the APM scoring standard, since doing so would require either that the entire TIN join the MIPS APM or the administratively burdensome act of the eligible clinician reassigning their billing rights to the TIN of an entity participating in the full TIN APM.
We will continue to use only the three dates of March 31, June 30, and August 31 to determine, based on Participation Lists, the MIPS eligible clinicians who participate in MIPS APMs that are not full TIN APMs. We seek comment on the proposed addition of the fourth date of December 31 to assess Participation Lists to identify MIPS eligible clinicians who participate in MIPS APMs that are full TIN APMs for purposes of the APM scoring standard.
In the CY 2017 Quality Payment Program final rule, we established a scoring standard for MIPS eligible clinicians participating in MIPS APMs to reduce participant reporting burden by reducing the need for eligible clinicians participating in these types of APMs to make duplicative data submissions for both MIPS and their respective APMs (81 FR 77246 through 77271). In accordance with section 1848(q)(1)(D)(i) of the Act, we proposed to assess the performance of a group of MIPS eligible clinicians in an APM Entity that participates in one or more MIPS APMs based on their collective performance as an APM Entity group, as defined at § 414.1305.
In addition to reducing reporting burden, we sought to ensure that eligible clinicians in MIPS APMs are not assessed in multiple ways on the same performance activities. Depending on the terms of the particular MIPS APM, we believe that misalignments could be common between the evaluation of performance on quality and cost under MIPS versus under the terms of the APM. We believe requiring eligible clinicians in MIPS APMs to submit data, be scored on measures, and be subject
In the CY 2017 Quality Payment Program final rule, for MIPS eligible clinicians participating in MIPS APMs, we used our authority to waive requirements under the Medicare statute to reduce the scoring weight for the cost performance category to zero (81 FR 77258, 77262, and 77266). We did this for MIPS APMs authorized under section 1115A of the Act using our authority under section 1115A(d)(1) of the Act to waive the requirement under section 1848(q)(5)(E)(i)(II) of the Act that specifies the scoring weight for the cost performance category. Having reduced the cost performance category weight to zero, we further used our authority under section 1115A(d)(1) of the Act to waive the requirements under sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of the Act to specify and use, respectively, cost measures in calculating the MIPS final score for MIPS eligible clinicians participating in Other MIPS APMs (81 FR 77261 through 77262 and 77265 through 77266). Similarly, for MIPS eligible clinicians participating in the Medicare Shared Savings Program, we used our authority under section 1899(f) of the Act to waive the same requirements of section 1848 of the Act for the MIPS cost performance category (81 FR 77257 through 77258). We finalized this policy because: (1) APM Entity groups are already subject to cost and utilization performance assessment under the MIPS APMs; (2) MIPS APMs usually measure cost in terms of total cost of care, which is a broader accountability standard that inherently encompasses the purpose of the claims-based measures that have relatively narrow clinical scopes, and MIPS APMs that do not measure cost in terms of total cost of care may depart entirely from MIPS measures; and (3) the beneficiary attribution methodologies differ for measuring cost under APMs and MIPS, leading to an unpredictable degree of overlap (for eligible clinicians and for CMS) between the sets of beneficiaries for which eligible clinicians would be responsible that would vary based on the unique APM Entity characteristics such as which and how many eligible clinicians comprise an APM Entity group. We believe that with an APM Entity's finite resources for engaging in efforts to improve quality and lower costs for a specified beneficiary population, measurement of the population identified through the APM must take priority in order to ensure that the goals and the model evaluation associated with the APM are as clear and free of confounding factors as possible. The potential for different, conflicting results across APMs and MIPS assessments may create uncertainty for MIPS eligible clinicians who are attempting to strategically transform their respective practices and succeed under the terms of the APM. We are not proposing changes to these policies.
We welcome comment on our proposal to continue to waive the weighting of the cost performance category for the 2020 payment year forward.
In setting performance standards with respect to measures and activities in each MIPS performance category, section 1848(q)(3)(B) of the Act requires us to consider, historical performance standards, improvement, and the opportunity for continued improvement. Section 1848(q)(5)(D)(i)(I) requires us to introduce the measurement of improvement into performance scores in the cost performance category for MIPS eligible clinicians for the 2020 MIPS Payment Year if data sufficient to measure improvement are available. Section 1848(q)(5)(D)(i)(II) permits us to take into account improvement in the case of performance scores in other performance categories. Given that we have in effect waivers of the scoring weight for the cost performance category, and of the requirement to specify and use cost measures in calculating the MIPS final score for MIPS eligible clinicians participating in MIPS APMs, and for the same reasons that we initially waived those requirements, we propose to use our authority under section 1115A(d)(1) of the Act for MIPS APMs authorized under section 1115A of the Act and under section 1899(f) of the Act for MIPS APMs under the Medicare Shared Savings Program, to waive the requirement under section 1848(q)(5)(D)(i)(I) of the Act to take improvement into account for performance scores in the cost performance category beginning with the 2018 MIPS performance year.
We seek comment on this proposal.
We finalized in the CY 2017 Quality Payment Program final rule that under the APM scoring standard, participants in the Shared Savings Program and Next Generation ACO Model would be assessed for the purposes of generating a MIPS APM quality performance category score based exclusively on quality measures submitted using the CMS Web Interface (81 FR 77256 and 77261). In the CY 2017 Quality Payment Program final rule, we recognized that ACOs in both the Shared Savings Program and Next Generation ACO Model use the CMS Web Interface to submit data on quality measures, and that the measures they would report were also MIPS measures for 2017. For the Shared Savings Program and the Next Generation ACO Model, we finalized a policy to use quality measures and data submitted by the participant ACOs to the CMS Web Interface (as required under the rules for these initiatives) and MIPS benchmarks for these measures to score quality for MIPS eligible clinicians in these MIPS APMs at the APM Entity level (81 FR 77256, 77261). For these MIPS APMs, which we refer to as Web Interface reporters going forward, we established that quality performance data that are not submitted to the CMS Web Interface, for example the CAHPS for ACOs survey and claims-based measures, will not be included in the MIPS APM quality performance category score for 2017.
For the Shared Savings Program and Next Generation ACO Model, we propose to score the CAHPS for ACOs survey, in addition to the CMS Web Interface measures that are used to calculate the MIPS APM quality performance category score for the Shared Savings Program and Next Generation ACO Model, beginning in the 2018 performance year. The CAHPS for ACOs survey is already required in the Shared Savings Program and Next Generation ACO Model, and including the CAHPS for ACOs survey would better align the measures on which participants in these MIPS APMs are assessed under the APM scoring standard with the measures used to
We did not initially propose to include the CAHPS for ACOs survey as part of the MIPS APM quality performance category scoring for the Shared Savings Program and Next Generation ACO Model because we believed that the CAHPS for ACOs survey would not be collected and scored in time to produce a MIPS quality performance category score. However, operational efficiencies have recently been introduced that have made it possible to score the CAHPS for ACOs survey on the same timeline as the CAHPS for MIPS survey. Under our proposal, the CAHPS for ACOs survey would be added to the total number of quality performance category measures available for scoring in these MIPS APMs.
While the CAHPS for ACOs survey is new to MIPS APM scoring, the CG–CAHPS survey upon which it is based is also the basis for the CAHPS for MIPS survey, which was included on the MIPS final list for the 2017 performance year. For a further discussion of the CAHPS for ACOs survey, and the way it will be scored, we refer readers to II.C.6.b.(3)(a)(ii) of this proposed rule, which describes the identical CAHPS for MIPS survey and its scoring method that will be used for MIPS in the 2018 performance year. We note that although each question in the CAHPS for ACOs survey can also be found in the CAHPS for MIPS survey, the CAHPS for ACOs survey will have one fewer survey question the SSM entitled “Between Visit Communication”, which has never been a scored measure with the Medicare Shared Savings Program CAHPS for ACOs Survey and which we believe to be inappropriate for use by ACOs.
We refer readers to section II.C.7.a.(1)(h)(ii) of this proposed rule for our summary of finalized policies and proposed changes related to calculating the MIPS quality performance category percent score for MIPS eligible clinicians, including APM Entity groups reporting through the CMS Web Interface. Those policies and proposed changes in section II.C.7.a.(1)(h)(ii) of this proposed rule would apply in the same manner under the APM scoring standard except as otherwise noted in this section of the proposed rule. However, we propose not to subject MIPS APM Web Interface reporters to a 3 point floor because we do not believe it is necessary to apply this transition year policy to eligible clinicians participating in previously established MIPS APMs.
In the CY 2017 Quality Payment Program final rule, we finalized that for CMS Web Interface reporters, we will apply bonus points based on the finalized set of measures reportable through the CMS Web Interface. (81 FR 77291 through 77294). We will assign two bonus points for reporting two or more outcome or patient experience measures and one bonus point for reporting any other high priority measure, beyond the first high priority measure. We note that in addition to the measures required by the APM to be submitted through the CMS Web Interface, APM Entities in the Shared Savings Program and Next Generation ACO Models must also report the CAHPS for ACOs survey and we propose that beginning for the 2020 payment year forward they may receive bonus points under the APM scoring standard for submitting that measure. Participants in MIPS APMs, like all MIPS eligible clinicians, are also subject to the 10 percent cap on bonus points for reporting high priority measures. APM Entities reporting through the CMS Web Interface will only receive bonus points if they submit a high priority measure with a performance rate that is greater than zero, provided that the measure meets the case minimum requirements.
Beginning in the CY 2018 performance year, section 1848(q)(5)(D)(i)(I) of the Act requires us to score improvement for the MIPS quality performance category for MIPS eligible clinicians, including those participating in MIPS APMs, if data sufficient to measure quality improvement are available. We propose to calculate the quality improvement score using the methodology described in section II.C.7.a.(1)(i) for scoring quality improvement for eligible clinicians submitting quality measures via the CMS Web Interface. We believe aligning the scoring methodology used for all CMS Web Interface submissions will minimize confusion among MIPS eligible clinicians receiving a MIPS score, including those participating in MIPS APMs.
We propose to calculate the total quality percent score for MIPS eligible clinicians using the CMS Web Interface according to the methodology described
We seek comment on our proposed quality performance category scoring methodology for CMS Web Interface reporters.
We propose to define the term Other MIPS APM at § 414.1305 as a MIPS APM that does not require reporting through the CMS Web Interface. We propose to add this definition as we believe it will be useful in discussing our policies for the APM scoring standard. In the 2018 MIPS performance period, Other MIPS APMs will include the Comprehensive ESRD Care Model, the Comprehensive Primary Care Plus Model (CPC+), and the Oncology Care Model.
In the CY 2017 Quality Payment Program final rule, we explained that current MIPS APMs have requirements regarding the number of quality measures, measure specifications, as well as the measure reporting method(s) and frequency of reporting, and have an established mechanism for submission of these measures to us within the structure of the specific MIPS APM. We explained that operational considerations and constraints interfered with our ability to use the quality measure data from some MIPS APMs for the purpose of satisfying MIPS data submission requirements for the quality performance category for the first performance year. We concluded that there was insufficient time to adequately implement changes to the current MIPS APM quality measure data collection timelines and infrastructure in the first performance year to conduct a smooth hand-off to the MIPS system that would enable use of APM quality measure data to satisfy the MIPS quality performance category requirements in the first MIPS performance year (81 FR 77264). Out of concern that subjecting MIPS eligible clinicians who participate in MIPS APMs to multiple, potentially duplicative or inconsistent performance assessments could undermine the validity of testing or performance evaluation under the MIPS APMs; and that there was insufficient time to make adjustments in operationally complex systems and processes related to the alignment, submission and collection of APM quality measures for purposes of MIPS, we used our authority under section 1115A(d)(1) to waive certain requirements of section 1848(q).
We finalized that for the first MIPS performance year only, for MIPS eligible clinicians participating in APM Entities in Other MIPS APMs, the weight for the quality performance category is zero (81 FR 77268). To avoid risking adverse operational or program evaluation consequences for MIPS APMs while we worked toward incorporating MIPS APM quality measures into scoring for future performance years, we used the authority provided by section 1115A(d)(1) of the Act to waive the quality performance category weight required under section 1848(q)(5)(E)(i)(I) of the Act, and we indicated that with the reduction of the quality performance category weight to zero, it was unnecessary to establish for MIPS APMs a final list of quality measures as required under section 1848(q)(2)(D) of the Act or to specify and use quality measures in determining the MIPS final score for these MIPS eligible clinicians. As such, we further waived the requirements under sections 1848(q)(2)(D), 1848(q)(2)(B)(i) and 1848(q)(2)(A)(i) of the Act to establish a final list of quality measures (using certain criteria and processes); and to specify and use, respectively, quality measures in calculating the MIPS final score for the first MIPS performance year.
In the CY 2017 Quality Payment Program final rule, we anticipated that beginning with the second MIPS performance year, the APM quality measure data submitted to us during the MIPS performance year would be used to derive a MIPS quality performance score for APM Entities in all MIPS APMs.
We also anticipated that it may be necessary to propose policies and waivers of requirements of the statute, such as section 1848(q)(2)(D) of the Act, to enable the use of non-MIPS quality measures in the quality performance category score. We anticipated that by the second performance year we would have had sufficient time to resolve operational constraints related to use of separate quality measure systems and to adjust quality measure data submission timelines. Accordingly, we stated our intention to, in future rulemaking, use our section 1115A(d)(1) waiver authority to establish that the quality measures and data that are used to evaluate performance for APM Entities in MIPS APMs would be used to calculate a MIPS quality performance score under the APM scoring standard.
We have since designed the means to overcome the operational constraints that prevented us from scoring quality under the APM scoring standard in the first performance year, and we propose to adopt quality measures for use under the APM scoring standard, and begin collecting MIPS APM quality measure performance data in order to generate a MIPS quality performance category score for APM Entities participating in MIPS APMs beginning with the 2018 performance year.
In the CY 2017 Quality Payment Program final rule, we explained the concerns that led us to express our intent to use the quality measures and data that apply in the MIPS APM for purposes of the APM scoring standard, including concerns about the application of multiple, potentially duplicative or inconsistent performance assessments that could negatively impact our ability to evaluate MIPS APMs (81 FR 77246). Additionally, the quality and cost/utilization measures that are used to calculate performance-based payments in MIPS APMs may vary from one MIPS APM to another. Factors such as the type and quantity of measures required, the MIPS APM's particular measure specifications, how frequently the measures must be reported, and the mechanisms used to collect or submit the measures all add to the diversity in the quality and cost/utilization measures used to evaluate performance among MIPS APMs. Given these concerns and the differences between and among the quality measures used to evaluate performance within MIPS APMs as opposed to those used more generally under MIPS, we propose to use our authority under section 1115A(d)(1) of the Act to waive requirements under section 1848(q)(2)(D) of the Act, which requires the Secretary to use certain criteria and processes to establish an annual MIPS final list of quality measures from which all MIPS eligible clinicians may choose measures for purposes of assessment, and instead to establish a MIPS APM quality measure list for purposes of the APM scoring standard. The MIPS APM quality measure list would be adopted as the final list of MIPS quality measures under the APM scoring standard, and would reflect the quality measures that are used to evaluate performance on quality within each MIPS APM.
The MIPS APM quality measure list we propose in Table 13, would define distinct measure sets for participants in each MIPS APM for purposes of the APM scoring standard, based on the measures that are used by the APM, and for which data will be collected by the close of the MIPS submission period. The measure sets on the MIPS APM measure list would represent all possible measures which may contribute to an APM Entity's MIPS score for the MIPS quality performance
Because the quality measure sets for each Other MIPS APM are unique, we propose to calculate the MIPS quality performance category score using APM-specific quality measures. For purposes of the APM scoring standard, we will score only measures that: (1) Are tied to payment as described under the terms of the APM, (2) are available for scoring near the close of the MIPS submission period, (3) have a minimum of 20 cases available for reporting, and (4) have an available benchmark. We discuss each of these requirements for Other MIPS APM quality measures below.
For purposes of the APM scoring standard, we will consider a measure to be tied to payment if an APM Entity group will receive a payment adjustment or other incentive payment under the terms of the APM, based on the APM Entity's performance on the measure.
Some MIPS APM quality measure results are not available until late in the calendar year subsequent to the MIPS performance year, which would prevent us from including them in the MIPS APM quality performance category score due to the larger programmatic timelines for providing MIPS eligible clinician performance feedback by July and issuing budget-neutral MIPS payment adjustments. Consequently, we propose to only use the MIPS APM quality measure data that are submitted by the close of the MIPS submission period and are available for scoring in time for inclusion to calculate a MIPS quality performance category score. Measures are to be submitted according to requirements under the terms of the APM; the measure data will then be aggregated and prepared for submission to MIPS for the purpose of creating a MIPS quality performance category score.
We believe using the Other MIPS APMs' quality measure data that have been submitted no later than the close of the MIPS submission period and have been processed and made available to MIPS for scoring in time to calculate a MIPS quality performance category score is consistent with our intent to decrease duplicative reporting for MIPS eligible clinicians who would otherwise need to report quality measures to both MIPS and their APM. Going forward, these are the measures to which we are referring when we limit scoring to measures that are available near the close of the MIPS submission period.
We also believe that a 20 case minimum, in alignment with the one finalized generally under MIPS in the CY 2017 Quality Payment Program final rule (81 FR 77288), is necessary to ensure the reliability of the measure data submitted, as explained the CY 2017 Quality Payment Program final rule.
As under the general policy for MIPS, when an APM Entity reports a quality measure that includes less than 20 cases, that measure would receive a null score for that measure's achievement points, and the measure would be removed from both the numerator and the denominator of the MIPS quality performance category percentage. We propose to apply this policy under the APM scoring standard.
An APM Entity's score on each quality measure would be calculated in part by comparing the APM Entity's performance on the measure with a benchmark performance score. Therefore, we would need all scored measures to have a benchmark available by the time that the MIPS quality performance category score is calculated, in order to make that comparison.
We propose that, for the APM scoring standard, the benchmark score used for a quality measure would be the benchmark used in the MIPS APM for calculation of the performance based payments, where such a benchmark is available. If the APM does not produce a benchmark score for a reportable measure that is included on the APM measures list, we would use the benchmark score for the measure that is used for the MIPS quality performance category generally (outside of the APM scoring standard) for that performance year, provided the measure specifications for the measure are the same under both the MIPS final list and the APM measures list. If neither the APM nor MIPS has a benchmark available for a reported measure, the APM Entity that reported that measure would receive a null score for that measure's achievement points, and the measure would be removed from both the numerator and the denominator of the quality performance category percentage.
Eligible clinicians who participate in Other MIPS APMs are subject to specific quality measure reporting requirements within these APMs. To best align with APM design and objectives, we propose that the minimum number of required measures to be reported for the APM scoring standard would be the minimum number of quality measures that are required by the MIPS APM and are collected and available in time to be included in the calculation for the APM Entity score under the APM scoring standard. For example, if an Other MIPS APM requires participating APM Entities to report nine of 14 quality measures by a specific date and the APM Entity misses the MIPS submission deadline, then for the purposes of calculating an APM Entity quality performance category score, the APM Entity would receive a zero for those measures. An APM Entity that does not submit any APM quality measures by the MIPS submission deadline would receive a zero for its MIPS APM quality performance category percent score for the performance year.
We propose that if an APM Entity submits some, but not all of the measures required by the MIPS APM by the close of the MIPS submission period, the APM Entity would receive points for the measures that were submitted, but would receive a score of zero for each remaining measure between the number of measures reported and the number of measures required by the APM that were available for scoring.
For example, if an APM Entity in the above hypothetical MIPS APM submits quality performance data on three of the APM's measures, instead of the required nine, the APM Entity would receive quality points in the APM scoring standard quality performance category percent score for the three measures it submitted, but would receive zero points for each of the six remaining measures that were required under the terms of the MIPS APM. On the other hand, if an APM Entity reports on more than the minimum number of measures required to be reported under the MIPS APM and the measures meet the other
If a measure is reported but fails to meet the 20 case minimum or does not have a benchmark available, there would be a null score for that measure, and it would be removed from both the numerator and the denominator, so as not to negatively affect the APM Entity's quality performance category score.
We propose to assign bonus points for reporting high priority measures or measures with end-to-end CEHRT reporting as described for general MIPS scoring in the CY 2017 Quality Payment Program final rule (81 FR 77297 through 77299).
An APM Entity's MIPS quality measure score will be calculated by comparing the APM Entity's performance on a given measure with a benchmark performance score. We propose that the benchmark score used for a quality measure would be the benchmark used by the MIPS APM for calculation of the performance based payments within the APM, if possible, in order to best align the measure performance outcomes between the APM and MIPS programs. If the MIPS APM does not produce a benchmark score for a reportable measure that will be available at the close of the MIPS submission period, the benchmark score for the measure that is used for the MIPS quality performance category generally for that performance year would be used, provided the measure specifications are the same for both. If neither the APM nor MIPS has a benchmark available for a reported measure, the APM Entity that reported that measure will receive a null score for that measure's achievement points, and the measure will be removed from both the numerator and the denominator of the quality performance category percentage.
We are proposing that for measures that are pay for reporting or which do not measure performance on a continuum of performance, we will consider these measures to be lacking a benchmark and they will be treated as such. For example, if a model only requires that an APM Entity must surpass a threshold and does not measure APM Entities on performance beyond surpassing a threshold, we would not consider such a measure to measure performance on a continuum.
We propose to score quality measure performance under the APM scoring standard using a percentile distribution, separated by decile categories, as described in the finalized MIPS quality scoring methodology (81 FR 77282 through 77284). For each benchmark, we will calculate the decile breaks for measure performance and assign points based on the benchmark decile range into which the APM Entity's measure performance falls.
We propose to use a graduated points-assignment approach, where a measure is assigned a continuum of points out to one decimal place, based on its place in the decile. For example, a raw score of 55 percent would fall within the sixth decile of 41.0 percent to 61.9 percent and would receive between 6.0 and 6.9 points.
We seek comment on this proposed method.
For the APM scoring standard quality performance category, we propose that each APM Entity that reports on quality measures would receive between 1 and 10 achievement points for each measure reported that can be reliably scored against a benchmark, up to the number of measures that are required to be reported by the APM. Because measures that lack benchmarks or 20 reported cases are removed from the numerator and denominator of the quality performance category percentage, it is unnecessary to include a point-floor for scoring of Other MIPS APMs. Similarly, because the quality measures reported by the MIPS APM for MIPS eligible clinicians under the APM scoring standard are required to be submitted to the APM under the terms of participation in the APM, and the MIPS eligible clinicians do not select their APM measures, there will be no cap on topped out measures for MIPS APM participants being scored under the APM scoring standard, which differs from the policy for other MIPS eligible clinicians proposed at section II.C.7.a.(2)(c) of this proposed rule.
Beginning in the 2018 MIPS performance year, we propose that APM Entities in MIPS APMs, like other MIPS eligible clinicians, would be eligible to receive bonus points for the MIPS quality performance category for reporting on high priority measures or measures submitted via CEHRT (for example, end-to-end submission) according to the criteria described in section II.C.7.a.(1) of this proposed rule. For each Other MIPS APM, we propose to identify whether any of their available measures meets the criteria to receive a bonus, and add the bonus points to the quality achievement points. Further, we propose that the total number of awarded bonus points may not exceed 10 percent of the APM Entity's total available achievement points for the MIPS quality performance category score.
To generate the APM Entity's quality performance category percentage, achievement points would be added to any applicable bonus points, and then divided by the total number of available achievement points, with a cap of 100
Under the APM scoring standard for Other MIPS APMs, the number of available achievement points would be the number of measures required under the terms of the APM and available for scoring multiplied by ten. If, however, an APM Entity reports on a required measure that fails the 20 case minimum requirement, or which has no available benchmark for that performance year, the measure would receive a null score and all points from that measure would be removed from both the numerator and the denominator.
For example, if an APM Entity reports on four out of four measures required to be reported by the MIPS APM, and receives an achievement score of five on each and no bonus points, the APM Entity's quality performance category percentage would be [(5 points × 4 measures) + 0 bonus points]/(4 measures × 10 max available points), or 50 percent. If, however, one of those measures failed the 20 case minimum requirement or had no benchmark available, that measure would have a null value and would be removed from both the numerator and denominator to create a quality performance category percentage of [(5 points × 3 measures) + 0 bonus points]/(3measures × 10 max available points), or 50 percent.
If an APM Entity fails to meet the 20 case minimum on all available APM measures, that APM Entity would have its quality performance category score reweighted to zero, as described below.
We request comment on the above proposals for calculating the quality category percent score.
Beginning in the 2018 performance year, we propose to score improvement as well as achievement in the quality performance category.
For the APM scoring standard, we propose that the quality improvement percentage points would be awarded based on the following formula:
For a more detailed discussion of improvement scoring for the quality performance category under the APM scoring standard, we refer readers to the discussion on calculating improvement at the quality performance category level for MIPS at section II.C.7.a.(1)(i) of this proposed rule.
We propose that the APM Entity's total quality performance category score would be equal to [(achievement points + bonus points)/total available achievement points] + quality improvement score. The APM Entity's total quality performance category score may not exceed 100 percent. We request comment on the above proposed quality scoring methodology.
We seek comment on the proposed quality performance category scoring methodology for APM Entities participating in Other MIPS APMs.
As finalized in the CY 2017 Quality Payment Program final rule, for all MIPS APMs we will assign the same improvement activities score to each APM Entity based on the activities involved in participation in a MIPS APM. APM Entities will receive a minimum of one half of the total possible points. This policy is in accordance with section 1848(q)(5)(C)(ii) of the Act. In the event that the assigned score does not represent the maximum improvement activities score, the APM Entity group will have the opportunity to report additional improvement activities to add points to the APM Entity level score.
In the CY 2017 Quality Payment Program final rule, we finalized our policy to attribute one score to each MIPS eligible clinician in an APM Entity group by looking for both individual and group TIN level data submitted for a MIPS eligible clinician, and using the highest available score (81 FR 77268). We will then use these scores to create an APM Entity's score based on the average of the highest scores available for all MIPS eligible clinicians in the APM Entity group. If an individual or TIN did not report on the advancing care information performance category, they will contribute a zero to the APM Entity's aggregate score. Each MIPS eligible clinician in an APM Entity group will receive one score, weighted equally with the scores of every other MIPS eligible clinician in the APM Entity group, and we will use these to calculate a single APM Entity-level advancing care information performance category score.
We refer readers to section II.C.6.f.(6) of this proposed rule for our summary of proposed changes related to scoring the advancing care information performance category.
As described in the CY 2017 Quality Payment Program final rule (81 FR 77238–77245), under the generally applicable MIPS scoring standard, we will assign a weight of zero percent to the advancing care information performance category in the final score for MIPS eligible clinicians who meet specific criteria: hospital-based MIPS eligible clinicians, MIPS eligible clinicians who are facing a significant hardship, and certain types of non-physician practitioners (NPs, PAs, CRNAs, CNSs) who are MIPS eligible clinicians. In section II.C.7.a.(6) of this proposed rule, we are also proposing to include in this weighting policy ASC-based MIPS eligible clinicians and MIPS eligible clinicians who are using decertified EHR technology.
Under the APM scoring standard, we propose that if a MIPS eligible clinician who qualifies for a zero percent weighting of the advancing care information performance category in the final score is part of a TIN that includes one or more MIPS eligible clinicians who do not qualify for a zero percent weighting, we would not apply the zero percent weighting to the qualifying MIPS eligible clinician, and the TIN would still be required to report on behalf of the group, although the TIN would not need to report data for the qualifying MIPS eligible clinician. All MIPS eligible clinicians in the TIN would count towards the TIN's weight when calculating an aggregated APM Entity score for the advancing care information performance category.
If, however, the MIPS eligible clinician is a solo practitioner and qualifies for a zero percent weighting, or if all MIPS eligible clinicians in a TIN qualify for the zero percent weighting, the TIN would not be required to report on the advancing care information performance category, and if the TIN chooses not to report that TIN would be assigned a weight of 0 when calculating the APM Entity's advancing care information performance category score.
If advancing care information data are reported by one or more TINs in an APM Entity, an advancing care information performance category score will be calculated for, and will be applicable to, all MIPS eligible clinicians in the APM Entity group. If all MIPS eligible clinicians in all TINs in an APM Entity group qualify for a zero percent weighting of have the advancing care information performance category, or in the case of a solo practitioner who comprises an entire
As discussed in section II.C.6.g.(3)(a) of this proposed rule, we propose to continue to use our authority to waive sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of the Act to specify and use, respectively, cost measures; and to maintain the cost performance category weight of zero under the APM scoring standard for the 2018 performance period and subsequent MIPS performance periods. Because the cost performance category would be reweighted to zero that weight would need to be redistributed to other performance categories. We propose to use our authority under section 1115A(d)(1) to waive requirements under sections 1848(q)(5)(E)(i)(I)(bb), 1848(q)(5)(E)(i)(III) and 1848(q)(5)(E)(i)(IV) of the Act that prescribe the weights, respectively, for the quality, improvement activities, and ACI performance categories. We propose to weight the quality performance category score to 50 percent, the improvement activities performance category to 20 percent, and the advancing care information performance category to 30 percent of the final score for all APM Entities in Other MIPS APMs. We propose these weights to align the Other MIPS APM performance category weights with those assigned to the Web Interface reporters, which we adopted as explained in the CY 2017 Quality Payment Program final rule at 81 FR 77262 through 77263. We believe it is appropriate to align the performance category weights for APM Entities in MIPS APMs that require reporting through the Web Interface with those in Other MIPS APMs. By aligning the performance category weights among all MIPS APMs, we would create greater scoring parity among the MIPS eligible clinicians in MIPS APMs who are being scored under the APM scoring standard. These proposals are summarized in Table 12.
It is possible that there could be instances where an Other MIPS APM has no measures available to score for the quality performance category for a MIPS performance period; for example, it is possible that none of the Other MIPS APM's measures would be available for calculating a quality performance category score by or shortly after the close of the MIPS submission period because the measures were removed due to changes in clinical practice guidelines. In addition, as explained in section II.C.6.g.(3)(d)(i) of this proposed rule, the MIPS eligible clinicians in an APM Entity may qualify for a zero percent weighting for the advancing care information performance category. In such instances, under the APM scoring standard, we propose to reweight the affected performance category to zero, in accordance with section 1848(q)(5)(F) of the Act.
If the quality performance category is reweighted to zero, we propose to reweight the improvement activities and advancing care information performance categories to 25 and 75 percent, respectively. If the advancing care information performance category is reweighted to zero, the quality performance category weight would be
We seek comment on the proposed reweighting for APM Entities participating in MIPS APMs.
Section 1848(q)(1)(G) of the Act requires us to consider risk factors in our scoring methodology. Specifically, that section provides that the Secretary, on an ongoing basis, shall, as the Secretary determines appropriate and based on individuals' health status and other risk factors, assess appropriate adjustments to quality measures, cost measures, and other measures used under MIPS and assess and implement appropriate adjustments to payment adjustments, final scores, scores for performance categories, or scores for measures or activities under the MIPS.
We refer readers to II.C.7.b.(1) of this proposed rule for a description of the risk factor adjustment and its application to APM Entities.
We believe an adjustment for eligible clinicians in small practices (referred to herein as the small practice bonus) is appropriate to recognize barriers faced by small practices, such as unique challenges related to financial and other resources, environmental factors, and access to health information technology, and to incentivize eligible clinicians in small practices to participate in the Quality Payment Program and to overcome any performance discrepancy due to practice size.
We refer readers to section II.C.7.b.(2) of this proposed rule for a discussion of the small practice adjustment and its application to APM Entities.
In the CY 2017 Quality Payment Program final rule, we finalized the methodology for calculating a final score of 0–100 based on the four performance categories (81 FR 77320). We refer readers to section II.C.7.c. of this proposed rule for a discussion of the changes we are proposing for the final score methodology.
In the CY 2017 Quality Payment Program final rule (81 FR 77270), we finalized that all MIPS eligible clinicians scored under the APM scoring standard will receive performance feedback as specified under section 1848(q)(12) of the Act on the quality and cost performance categories to the extent applicable, based on data collected in the September 2016 QRUR, unless they did not have data included in the September 2016 QRUR. Those eligible clinicians without data included in the September 2016 QRUR will not receive any performance feedback until performance data is available for feedback.
Beginning with the 2018 performance year, we propose that MIPS eligible clinicians whose MIPS payment adjustment is based on their score under the APM scoring standard will receive performance feedback as specified
We believe that with an APM Entity's finite resources for engaging in efforts to improve quality and lower costs for a specified beneficiary population, the incentives of the APM must take priority over those offered by MIPS in order to ensure that the goals and evaluation associated with the APM are as clear and free of confounding factors as possible. The potential for different, conflicting messages in performance feedback provided by the APMs and that provided by MIPS may create uncertainty for MIPS eligible clinicians who are attempting to strategically transform their respective practices and succeed under the terms of the APM. Accordingly, under section 1115A(d)(1) and section 1899(f), for all performance years we propose to waive—for MIPS eligible clinicians participating in MIPS APMs—the requirement under section 1848(q)(12)(A)(i)(I) of the Act to provide performance feedback for the cost performance category.
We request comment on these proposals to waive requirements for performance feedback on the cost performance category indefinitely, and for the other performance categories in years for which the weight for those categories has been reweighted to zero.
In summary, we have proposed the following in this section:
• We propose to amend the regulation at § 414.1370(e) to identify the four assessment dates that would be used to identify the APM Entity group for purposes of the APM scoring standard, and to specify that the December 31 date will be used only to identify eligible clinicians on the APM Entity's Participation List for a MIPS APM that is a full TIN APM in order to add them to the APM Entity group that is scored under the APM scoring standard. We propose to use this fourth assessment date of December 31 to extend the APM scoring standard to only those MIPS eligible clinicians participating in MIPS APMs that are full TIN APMs, ensuring that an eligible clinician who joins the full TIN APM late in the performance year would be scored under the APM scoring standard.
• We propose to continue to weight the cost performance category under the APM scoring standard for Web Interface reporters at zero percent for the 2020 payment year forward.
• Aligned with our proposal to weight the cost performance category at zero percent, we propose not to take improvement into account for performance scores in the cost performance category for Web Interface reporters beginning with the 2020 MIPS Payment Year.
• We propose to score the CAHPS for ACOs survey, in addition to the CMS Web Interface measures that are used to calculate the MIPS APM quality performance category score for Web Interface reporters including the Shared Savings Program and Next Generation ACO Model), beginning in the 2018 performance year.
• We propose that, beginning for the 2018 performance year, eligible clinicians in MIPS APMs that are Web Interface reporters may receive bonus points under the APM scoring standard for submitting the CAHPS for ACOs survey.
• We propose to calculate the quality improvement score for MIPS eligible clinicians submitting quality measures via the CMS Web Interface using the methodology described in section II.C.7.a.(1)(i).
• We propose to calculate the total quality percent score for MIPS eligible clinicians using the CMS Web Interface according to the methodology described in section II.C.7.a.(1)(h)(2) of this proposed rule.
• We propose to establish a separate MIPS final list of quality measures for each Other MIPS APM that would be the quality measure list used for purposes of the APM scoring standard.
• We propose to calculate the MIPS quality performance category score for Other MIPS APMs using MIPS APM-specific quality measures. For purposes of the APM scoring standard, we would score only measures that: (1) Are tied to payment as described under the terms of the APM, (2) are available for scoring near the close of the MIPS submission period, (3) have a minimum of 20 cases available for reporting, and (4) have an available benchmark.
• We propose to only use the MIPS APM quality measure data that are submitted by the close of the MIPS submission period and are available for scoring in time for inclusion to calculate a MIPS quality performance category score.
• We propose that, for the APM scoring standard, the benchmark score used for a quality measure would be the benchmark used in the MIPS APM for calculation of the performance based payments, where such a benchmark is available. If the APM does not produce a benchmark score for a reportable measure that is included on the APM measures list, we would use the benchmark score for the measure that is used for the MIPS quality performance category generally (outside of the APM scoring standard) for that performance year, provided the measure specifications for the measure are the same under both the MIPS final list and the APM measures list.
• We propose that the minimum number of quality measures required to be reported for the APM scoring standard would be the minimum number of quality measures that are required within the MIPS APM and are collected and available in time to be included in the calculation for the APM Entity score under the APM scoring standard. We propose that if an APM Entity submits some, but not all of the measures required by the MIPS APM by the close of the MIPS submission period, the APM Entity would receive points for the measures that were submitted, but would receive a score of zero for each remaining measure between the number of measures reported and the number of measures required by the APM that were available for scoring.
• We propose that the benchmark score used for a quality measure would be the benchmark used by the MIPS APM for calculation of the performance based payments within the APM, if possible, in order to best align the measure performance outcomes between the two programs. We are proposing that for measures that are pay for reporting or which do not measure performance on a continuum of performance, we will consider these measures to be lacking a benchmark and they will be treated as such.
• We propose to score quality measure performance under the APM scoring standard using a percentile distribution, separated by decile categories, as described in the finalized MIPS quality scoring methodology. We propose to use a graduated points-assignment approach, where a measure is assigned a continuum of points out to one decimal place, based on its place in the decile.
• We propose that each APM Entity that reports on quality measures would receive between 1 and 10 achievement points for each measure reported that can be reliably scored against a benchmark, up to the number of
• We propose that APM Entities in MIPS APMs, like other MIPS eligible clinicians, would be eligible to receive bonus points for the MIPS quality performance category for reporting on high priority measures or measures submitted via CEHRT. For each Other MIPS APM, we propose to identify whether any of their available measures meets the criteria to receive a bonus, and add the bonus points to the quality achievement points.
• Beginning in the 2018 performance year, we propose to score improvement as well as achievement in the quality performance category. For the APM scoring standard, we propose that the improvement percentage points would be awarded based on the following formula:
• We propose that the APM Entity's total quality performance category score would be equal to [(achievement points + bonus points)/total available achievement points] + quality improvement score.
• Under the APM scoring standard, we propose that if a MIPS eligible clinician who qualifies for a zero percent weighting of the advancing care information performance category in the final score is part of a TIN that includes one or more MIPS eligible clinicians who do not qualify for a zero percent weighting, we would not apply the zero percent weighting to the qualifying MIPS eligible clinician, and the TIN would still be required to report on behalf of the group, although the TIN would not need to report data for the qualifying MIPS eligible clinician.
• We propose to maintain the cost performance category weight of zero for Other MIPS APMs under the APM scoring standard for the 2020 MIPS payment year and subsequent MIPS payment years. Because the cost performance category would be reweighted to zero that weight would need to be redistributed to other performance categories. We propose to align the Other MIPS APM performance category weights with those proposed for Web Interface reporters and weight the quality performance category to 50 percent, the improvement activities performance category to 20 percent, and the advancing care information performance category to 30 percent of the APM Entity final score.
• It is possible that none of the Other MIPS APM's measures would be available for calculating a quality performance category score by or shortly after the close of the MIPS submission period, for example, due to changes in clinical practice guidelines. In addition, the MIPS eligible clinicians in an APM Entity may qualify for a zero percent weighting for the advancing care information performance category. In such instances, under the APM scoring standard, we propose to reweight the affected performance category to zero.
• Beginning with the 2018 performance year, we propose that MIPS eligible clinicians whose MIPS payment adjustment is based on their score under the APM scoring standard will receive performance feedback as specified under section 1848(q)(12) of the Act for the quality, advancing care information, and improvement activities performance categories to the extent data are available for the MIPS performance year. Further, we propose that in cases where the MIPS APM performance category has been weighted to zero for that performance year, we would not provide performance feedback on that MIPS performance category.
The following tables represent the measures being introduced for notice and comment, and would serve as the measure set used by participants in the identified MIPS APMs in order to create a MIPS score under the APM scoring standard, as described in section II.C.6.g.(3)(b)(ii)(A) of this proposed rule. Once this list is finalized, no measures may be added to this list.
For the 2020 MIPS payment year, we intend to build on the scoring methodology we finalized for the transition year, which allows for accountability and alignment across the performance categories and minimizes burden on MIPS eligible clinicians, while continuing to prepare MIPS eligible clinicians for the performance threshold required for the 2021 MIPS payment year. Our rationale for our scoring methodology continues to be grounded in the understanding that the MIPS scoring system has many components and numerous moving parts.
As we continue to move forward in implementing the MIPS program, we strive to balance the statutory requirements and programmatic goals
We intend to continue the transition of MIPS by proposing the following policies:
• Continuation of many transition year scoring policies in the quality performance category, with an adjustment to the number of achievement points available for measures that fail to meet the data completeness criteria, to encourage MIPS eligible clinician to meet data completeness while providing an exception for small practices;
• An improvement scoring methodology that rewards MIPS eligible clinicians who improve their performance in the quality and cost performance categories;
• A new scoring option for the quality and cost performance categories that allows facility-based MIPS eligible clinicians to be scored based on their facility's performance;
• Special considerations for MIPS eligible clinicians in small practices or those who care for complex patients; and
• Policies that allow multiple pathways for MIPS eligible clinicians to receive a neutral to positive MIPS payment adjustment.
We believe these sets of proposed policies will help clinicians smoothly transition from the transition year to the 2021 MIPS payment year, for which the performance threshold (which represents the final score that would earn a neutral MIPS adjustment) will be either the mean or median (as selected by the Secretary) of the MIPS final scores for all MIPS eligible clinicians from a previous period specified by the Secretary.
Unless otherwise noted, for purposes of this section II.C.7. on scoring, the term “MIPS eligible clinician” will refer to MIPS eligible clinicians that submit data and are scored at either the individual- or group-level, including virtual groups, but will not refer to MIPS eligible clinicians who elect facility-based scoring. The scoring rules for facility-based measurement are discussed in section II.C.7.a.(4). of this proposed rule. We also note that the APM scoring standard applies to APM Entities in MIPS APMs, and those policies take precedence where applicable; however, where those policies do not apply, scoring for MIPS eligible clinicians as described in this section II.C.7. on scoring will apply. We refer readers to section II.C.6.g. of this proposed rule for additional information about the APM scoring standard.
The detailed policies and proposals for scoring the four performance categories are described in detail in section II.C.7.a. of this proposed rule. However, as the four performance categories collectively create a single MIPS final score, there are several policies that apply across categories, which we discuss in section II.C.7.a.(1) of this proposed rule.
In accordance with section 1848(q)(3) of the Act, in the CY 2017 Quality Payment Program final rule, we finalized performance standards for the four performance categories. We refer readers to the CY 2017 Quality Payment Program final rule for a description of the performance standards against which measures and activities in the four performance categories are scored (81 FR 77271 through 77272).
As discussed in section II.C.7.a.(1)(b)(i) of this proposed rule, we are proposing to add an improvement scoring standard to the quality and cost performance categories starting for the 2020 MIPS payment year.
In accordance with section 1848(q)(5)(D)(i) of the Act, beginning with the 2020 MIPS payment year, if data sufficient to measure improvement are available, the final score methodology shall take into account improvement of the MIPS eligible clinician in calculating the performance score for the quality and cost performance categories and may take into account improvement for the improvement activities and advancing care information performance categories. In addition, section 1848(q)(3)(B) of the Act provides that the Secretary, in establishing performance standards for measures and activities for the MIPS performance categories, shall consider: Historical performance standards; improvement; and the opportunity for continued improvement. Section 1848(q)(5)(D)(ii) of the Act also provides that achievement may be weighted higher than improvement.
In the CY 2017 Quality Payment Program final rule, we summarized public comments received on the proposed rule regarding potential ways to incorporate improvement into the scoring methodology moving forward, including approaches based on methodologies used in the Hospital VBP Program, the Shared Savings Program, and Medicare Advantage 5-star Ratings Program (81 FR 77306 through 77308). We did not finalize a policy at that time on this topic and indicated we would take comments into account in developing a proposal for future rulemaking.
When considering the applicability of these programs to MIPS, we looked at the approach that was used to measure improvement for each of the programs and how improvement was incorporated into the overall scoring system. An approach that focuses on measure-level comparison enables a more granular assessment of improvement because performance on a specific measure can be considered and compared from year to year. All options that we considered last year use a standard set of measures that do not provide for choice of measures to assess performance; therefore, they are better structured to compare changes in performance based on the same measure from year to year. The aforementioned programs do not use a category-level approach; however, we believe that a category-level approach would provide a broader perspective, particularly in the absence of a standard set of measures, because it would allow for a more flexible approach that enables MIPS eligible clinicians to select measures and data submission mechanisms that can change from year to year and be more appropriate to their practice in a given year.
We believe that both approaches are viable options for measuring improvement. Accordingly, we believe that an appropriate approach for measuring improvement for the quality performance category and the cost performance category should consider the unique characteristics of each performance category rather than necessarily applying a uniform approach across both performance categories. For the quality performance category, clinicians are offered a variety of different measures which can be submitted by different mechanisms, rather than a standard set of measures or a single data submission mechanism.
When considering the applicability of these programs to MIPS, we also considered how scoring improvement is incorporated into the overall scoring system, including when only achievement or improvement is incorporated into a final score or when improvement and achievement are both incorporated into a final score.
We considered whether we could adapt the Hospital VBP Program's general approach for assessing improvement to MIPS and note that many commenters, in response to the CY 2017 Quality Payment Program proposed rule, recommended this methodology for MIPS because it is familiar to the health care community. However, we decided that the Hospital VBP Program's improvement scoring methodology, which compares changes in performance based on the same measure from year to year, is not fully translatable to MIPS for the quality performance category and the cost performance category. The scoring methodology used to assess achievement in the Hospital VBP Program, as required by section 1886(o)(5)(B)(ii) of the Act, does not reward points for achievement in the same method as MIPS, because hospitals that fall below the achievement threshold (the median performance during the benchmark period) are not awarded achievement points. We refer readers to the Hospital Inpatient VBP Program Final Rule (76 FR 26516 through 26525) for additional discussion of the Hospital VBP Program's scoring methodology. In addition, the Hospital VBP Program requires the use of either the achievement score or the improvement points, but not both, for the Program's performance scoring calculation. Adopting the Hospital VBP Program method for MIPS would require significant changes to the scoring methodology used for the quality and cost performance categories. For the quality performance category, there are a wide variety of measures available in MIPS, and clinicians have flexibility in selecting measures and submission mechanisms, with the potential for clinicians to select different measures from year to year, which would affect our ability to capture performance changes at the measure level.
We continue to believe that flexibility for clinicians to select meaningful measures is appropriate for MIPS, especially for the quality performance category. The Hospital VBP Program methodology, which relies on consistent measures from year to year in order to track improvement, would limit our ability to measure improvement in MIPS.
We also considered adopting the Shared Savings Program's approach for assessing improvement, where participants can receive bonus points for improving on quality measures over time. The Shared Savings Program methodology could be adopted without an underlying change to the scoring of achievement in the quality and cost performance categories with an approach that considers both achievement and improvement in its overall scoring calculation and would align MIPS and the Shared Savings Program. However, we believe that the Shared Savings Program's improvement methodology would not be appropriate for the MIPS quality performance category because we are again concerned about the wide variety of quality measures available in MIPS and the flexibility clinicians have in selecting measures and submission mechanisms that could affect our ability to capture performance changes at the measure level. We seek to balance a system that allows for meaningful measurement to clinicians and accommodates the various practice types by allowing for a choice of measures and submission mechanisms that may differ from year to year for the quality performance category. However, as we discuss in section II.C.7.a.(3)(a) of this proposed rule, we do believe the Shared Savings Program measure level methodology could be translated for cost measures in the cost performance category.
Finally, we also considered adopting the Medicare Advantage Program's 5-Star Rating approach for assessing improvement, where Medicare Advantage contracts are rated on quality and performance measures. Under this approach, we would identify an overall “improvement measure score” by comparing the underlying numeric data for measures from the prior year with the data from measures for the performance period. To obtain an “improvement measure score” MIPS eligible clinicians would need to have data for both years in at least half of the required measures for the quality performance category (81 FR 77307). We are again concerned that the wide variety of measures available in MIPS and the flexibility clinicians have in selecting different measures and submission mechanisms from year to year could affect our ability to capture performance changes at the measure level, particularly for the quality performance category. Accordingly, we do not believe this is an appropriate approach for the quality performance category. Although this approach could be considered for the cost performance category, we believe that the Shared Savings Program is more analogous to MIPS and that the improvement methodology used in that program is one with which more stakeholders in MIPS would be familiar.
After taking all of this into consideration, we are proposing two different approaches for scoring improvement from year to year. As described in section II.C.7.a.(2)(i)(i) of this proposed rule, we are proposing to measure improvement at the performance category level for the quality performance category score. Because clinicians can elect the submission mechanisms and quality measures that are most meaningful to their practice, and these choices can change from year to year, we want a flexible methodology that allows for improvement scoring even when the quality measures change. This is particularly important as we encourage MIPS eligible clinicians to move away from topped out measures and toward more outcome measures. We do not want the flexibility that is offered to MIPS eligible clinicians in the quality performance category to limit clinicians' ability to move towards outcome measures, or limit our ability to measure improvement. Our proposal for taking improvement into account as part of the quality performance category score is addressed in detail in sections II.C.7.a.(2)(i) through II.C.7.a.(2)(j) of this proposed rule.
We believe that there is reason to adopt a different methodology for scoring improvement for the cost performance category from that used for the quality performance category. In contrast to the quality performance category, for the cost performance category, MIPS eligible clinicians do not have a choice in measures or submission mechanisms; rather, all MIPS eligible clinicians are assessed on all measures based on the availability and applicability of the measure to their practice, and all measures are derived from administrative claims data. Therefore, for the cost performance category, we propose in section II.C.7.a.(3)(a)(i) of this proposed rule to measure improvement at the measure
We are not proposing to score improvement in the improvement activities performance category or the advancing care information performance category at this time, though we may address improvement scoring for these performance categories in future rulemaking.
We propose to amend § 414.1380(a)(1)(i) to add that improvement scoring is available for performance in the quality performance category and for the cost performance category at § 414.1380(a)(1)(ii) beginning with the 2020 MIPS payment year.
We invite public comment on our proposals to score improvement for the quality and cost performance categories starting with the 2020 MIPS payment year.
Section 1848(q)(5)(D)(i) of the Act requires us to measure improvement for the quality and cost performance categories of MIPS if data sufficient to measure improvement are available, which we interpret to mean that we would measure improvement when we can identify data from a current performance period that can be compared to data from a prior performance period or data that compares performance from year to year. In section II.C.7.a.(2)(i)(ii) of this proposed rule, we propose for the quality performance category that we would measure improvement when data are available because there is a performance category score for the prior performance period. In section II.C.7.a.(3)(a)(i) of this proposed rule, we propose for the cost performance category that we would measure improvement when data are available which is when there is sufficient case volume to provide measurable data on measures in subsequent years with the same identifier. We refer readers to the noted sections for details on these proposals.
The quality and cost performance categories rely on measures that use detailed measure specifications that include ICD–10–CM/PCS (“ICD–10”) code sets. We annually issue new ICD–10 coding updates, which are effective from October 1, through September 30 (
To provide scoring flexibility for MIPS eligible clinicians and groups for measures impacted by ICD–10 coding changes in the final quarter of the Quality Payment Program performance period—which may render the measures no longer comparable to the historical benchmark—we propose at § 414.1380(b)(1)(xviii) and § 414.1320(c)(2) to provide that we will assess performance on measures considered significantly impacted by ICD–10 updates based only on the first 9 months of the 12-month performance period (for example, January 1, 2018 through September 30, 2018, for the 2018 MIPS performance period). We believe it would be appropriate to assess performance for significantly impacted measures based on the first 9 months of the performance period, rather than the full 12 months, because the indicated performance for the last quarter could be affected by the coding changes rather than actual differences in performance. Performance on measures that are not significantly impacted by changes to ICD–10 codes would continue to be assessed on the full 12-month performance period (January 1 through December 31).
Any measure that relies on an ICD–10 code which is added, modified, or removed, such as in the measure numerator, denominator, exclusions, or exceptions, could have an impact on the indicated performance on the measure, although the impact may not always be significant. We propose an annual review process to analyze the measures that have a code impact and assess the subset of measures significantly impacted by ICD–10 coding changes during the performance period. Depending on the data available, we anticipate that our determination as to whether a measure is significantly impacted by ICD–10 coding changes would include these factors: A more than 10 percent change in codes in the measure numerator, denominator, exclusions, and exceptions; guideline changes or new products or procedures reflected in ICD–10 code changes; and feedback on a measure received from measure developers and stewards. We considered an approach where we would consider any change in ICD–10 coding to impact performance on a measure and thus only rely on the first 9 months of the 12-month performance period for such measures. However, we believe such an approach would be too broad and truncate measurement for too many measures where performance may not be significantly affected. We believe that our proposed approach ensures the measures on which individual MIPS eligible clinicians and groups will have their performance assessed are accurate for the performance period and are consistent with the benchmark set for the performance period.
We propose to publish on the CMS Web site which measures are significantly impacted by ICD–10 coding changes and would require the 9-month assessment. We propose to publish this information by October 1st of the performance period if technically feasible, but by no later than the beginning of the data submission period, which is January 1, 2019 for the 2018 performance period.
We request comment on the proposal to address ICD–10 measures specification changes during the performance period by relying on the first 9 months of the 12-month performance period. We also request comment on potential alternate approaches to address measures that are significantly impacted due to ICD–10 changes during the performance period, including the factors we might use to determine whether a measure is significantly impacted.
Many comments submitted in response to the CY 2017 Quality Payment Program final rule requested additional clarification on our finalized scoring methodology for the 2019 MIPS payment year. To provide further clarity to MIPS eligible clinicians about the transition year scoring policies, before describing our proposed scoring policies for the 2020 MIPS payment year, we provide a summary of the scoring policies finalized in the CY 2017 Quality Payment Program final rule along with examples of how they apply under several scenarios.
In the CY 2017 Quality Payment Program final rule (81 FR 77286 through
This resulting quality performance category score is a fraction from zero to 1, which can be formatted as a percent; therefore, for this section, we will present the quality performance category score as a percent and refer to it as “quality performance category percent score.” We also propose to amend § 414.1380(b)(1)(xv) (which we propose to redesignate as § 414.1380(b)(1)(xvii) in this proposed rule) to use this term in place of “quality performance category score”. Thus, the formula for the quality performance category percent score that we will use in this section is as follows:
In the CY 2017 Quality Payment Program final rule, we finalized that for the quality performance category, an individual MIPS eligible clinician or group that submits data on quality measures via EHR, QCDR, qualified registry, claims, or a CMS-approved survey vendor for the CAHPS for MIPS survey will be assigned measure achievement points for 6 measures (1 outcome or, if an outcome measure is not available, other high priority measure and the next 5 highest scoring measures) as available and applicable, and will receive applicable measure bonus points for all measures submitted that meet the bonus criteria (81 FR 77282 through 77301).
In addition, for groups of 16 or more clinicians who meet the case minimum of 200, we will also automatically score the administrative claims-based all-cause hospital readmission measure as a seventh measure (81 FR 77287). For individual MIPS eligible clinicians and groups for whom the readmission measure does not apply, the denominator is generally 60 (10 available measure achievement points multiplied by 6 available measures). For groups for whom the readmission measure applies, the denominator is generally 70 points.
If we determined that a MIPS eligible clinician has fewer than 6 measures available and applicable, we will score only the number of measures that are available and adjust the denominator accordingly to the total available measure achievement points (81 FR 77291). We refer readers to section II.C.7.a.(2)(e) of this proposed rule, for a description of the validation process to determine measure availability.
For the 2019 MIPS payment year, a MIPS eligible clinician that submits quality measure data via claims, EHR, or third party data submission options (that is, QCDR, qualified registry, EHR, or CMS-approved survey vendor for the CAHPS for MIPS survey), can earn between 3 and 10 measure achievement points for quality measures submitted for the performance period of greater than or equal to 90 continuous days during CY 2017. A MIPS eligible clinician can earn measure bonus points (subject to a cap) if they submit additional high priority measures with a performance rate that is greater than zero, and that meet the case minimum and data completeness requirements, or submit a measure using an end-to-end electronic pathway. An individual MIPS eligible clinician that has 6 or more quality measures available and applicable will have 60 total available measure achievement points. For example, as shown in Table 17, if an individual MIPS eligible clinician submits 7 measures, including one required outcome measure and 2 additional high priority measures, the MIPS eligible clinician will be assigned points based on achievement for the required outcome measure and the next 5 measures with the highest number of measure achievement points. In this example, the second high priority measure has the lowest number of measure achievement points and therefore is not included in the total measure achievement points calculated (81 FR 77300), but the MIPS eligible clinician will still receive a bonus point for submitting a high priority measure (81 FR 77291 through 77294). We note that in the CY 2017 Quality Payment Program proposed rule, we proposed that bonus points would be available for high priority measures that are not scored (not included in the top 6 measures for the quality performance category score) as long as the measure has the required case minimum, data completeness, and has a performance rate greater than zero, because we believed these qualities would allow us to include the measure in future benchmark development (81 FR 28255). Although we received public comments on this policy, responded to those comments, and reiterated this proposal in the CY 2017 Quality Payment Program final rule (81 FR 77292), we would like to clarify that our policy to assign measure bonus points for high priority measures, even if the measure's achievement points are not included in the total measure achievement points for calculating the quality performance category percent score, as long as the measure has the required case minimum, data completeness, and has a performance rate greater than zero, applies beginning with the transition year. We propose to amend § 414.1380(b)(1)(xiii)(A) (which we propose to redesignate as § 414.1380(b)(1)(xiv)(A)) to state that measure bonus points may be included in the calculation of the quality performance category percent score regardless of whether the measure is included in the calculation of the total measure achievement points. We also propose a technical correction to the second sentence of that paragraph to state that to qualify for measure bonus points, each measure must be reported with sufficient case volume to meet the required case minimum, meet the required data completeness criteria, and
A group of 16 or more clinicians will also be automatically scored on the hospital readmission measure if they meet the case minimum. Table 18 illustrates an example of a group that submitted the 6 required quality measures, including an additional high priority measure, and received 3 measure achievement points for each submitted measure and the all-cause readmission measure.
In the CY 2017 Quality Payment Program final rule, we also finalized scoring policies specific to groups of 25 or more that submit their quality performance measures using the CMS Web Interface (81 FR 77278 through 77306).
Although we are not proposing to change the basic scoring system that we finalized in the CY 2017 Quality Payment Program final rule for the 2020 MIPS payment year, we are proposing several modifications to scoring the quality performance category, including adjusting scoring for measures that do not meet the data completeness criteria, adding a method for scoring measures submitted via multiple mechanisms, adding a method for scoring selected topped out measures, and adding a method for scoring improvement. We also note that in section II.C.7.a.(4) of this proposed rule, we are also proposing an additional option for facility-based scoring for the quality performance category.
We are not proposing to change the policies on benchmarking finalized in the CY 2017 Quality Payment Program final rule and codified at paragraphs (b)(1)(i) through (iii) of § 414.1380; however, we are proposing a technical correction to paragraphs (i) and (ii) to clarify that measure benchmark data are separated into decile categories based on percentile distribution, and that, other than using performance period data, performance period benchmarks are created in the same manner as historical benchmarks using decile categories based on a percentile distribution and that each benchmark must have a minimum of 20 individual clinicians or groups who reported on the measure meeting the data completeness requirement and case minimum case size criteria and performance greater than zero. We refer
We note that in section II.C.2.c. of this proposed rule, we are proposing to increase the low-volume threshold which, because we include MIPS eligible clinicians and comparable APMs that meet our benchmark criteria in our measure benchmarks, could have an impact on our MIPS benchmarks, specifically by reducing the number of individual eligible clinicians and groups that meet the definition of a MIPS eligible clinician and contribute to our benchmarks. Therefore, we seek feedback on whether we should broaden the criteria for creating our MIPS benchmarks to include PQRS and any data from MIPS, including voluntary reporters, that meet our benchmark performance, case minimum and data completeness criteria when creating our benchmarks.
In the CY 2017 Quality Payment Program final rule, we did not stratify benchmarks by practice characteristics, such as practice size, because we did not believe there was a compelling rationale for such an approach, and we believed that stratifying could have unintended negative consequences for the stability of the benchmarks, equity across practices, and quality of care for beneficiaries (81 FR 77282). However, we sought comment on any rationales for or against stratifying by practice size we may not have considered. We note that we do create separate benchmarks for each of the following submission mechanisms: EHR submission options; QCDR and qualified registry submission options; claims submission options; CMS Web Interface submission options; CMS-approved survey vendor for CAHPS for MIPS submission options; and administrative claims submission options (for measures derived from claims data, such as the all-cause hospital readmission measure) (81 FR 77282).
Several commenters who responded to our solicitation of comment in the final rule supported stratifying measure benchmarks by practice size because the commenters believed it would help small practices, which have limited resources compared to larger practices, and because quality measures may have characteristics that are less favorable to small groups. One commenter recommended that we stratify by practice size during the 5 years in which technical assistance is available. One commenter recommended that we develop criteria for determining when a benchmark should be stratified by group size, and another commenter recommended if we do not stratify benchmarks by practice size, we adjust MIPS payment adjustments for practice size. Several commenters recommended that we stratify benchmarks beyond practice size and include adjustments for disease severity and socioeconomic status of patients, specialty or sub-specialty, geographic region, and/or site of service. One commenter specifically suggested that we use peer comparison groups when establishing measure benchmarks.
After consideration of the comments we received, we are not proposing to change our policies related to stratifying benchmarks by practice size for the 2020 MIPS payment year. For many measures, the benchmarks may not need stratification as they are only meaningful to certain specialties and only expected to be submitted by those certain specialists. We would like to further clarify that in the majority of instances our current benchmarking approach only compares like clinicians to like clinicians. We continue to believe that stratifying by practice size could have unintended negative consequences for the stability of the benchmarks, equity across practices, and quality of care for beneficiaries. However, we seek comment on methods by which we could stratify benchmarks, while maintaining reliability and stability of the benchmarks, to use in developing future rulemaking for future performance and payment years. Specifically, we seek comment on methods for stratifying benchmarks by specialty or by place of service. We also request comment on specific criteria to consider for stratifying measures, such as how we should stratify submissions by multi-specialty practices or by practices that operate in multiple places of service.
In the CY 2017 Quality Payment Program final rule, we finalized at § 414.1380(b)(1) that a MIPS quality measure must have a measure benchmark to be scored based on performance. MIPS quality measures that do not have a benchmark (for example, because fewer than 20 MIPS eligible clinicians or groups submitted data that met our criteria to create a reliable benchmark) will not be scored based on performance (81 FR 77286). We are not proposing any changes to this policy, but we are proposing a technical correction to the regulatory text at § 414.1380(b)(1) to delete the term “MIPS” before “quality measure” in third sentence of that paragraph and to delete the term MIPS before “quality measures” in the fourth sentence of that paragraph because this policy applies to all quality measures, including the measures finalized for the MIPS program and the quality measures submitted through a QCDR that have been approved for MIPS.
We are also not proposing to change the policies to score quality measure performance using a percentile distribution, separated by decile categories and assign partial points based on the percentile distribution finalized in the CY 2017 Quality Payment Program final rule and codified at paragraphs (b)(1)(ix), (x), and (xi) of § 414.1380; however, we propose a technical correction to paragraph (ix) to clarify that measures are scored against measure benchmarks. We refer readers to the discussion at 81 FR 77286 for more details on those policies.
For illustration, Table 19 provides an example of assigning points for performance based on benchmarks using a percentile distribution, separated by decile categories. The example is of the benchmarks for Measure 130 Documentation of Current Medications in the Medical Record, which is based on our 2015 benchmark file for the 2017 MIPS performance period.
In Table 19, the cells with “—” represent where there is a cluster at the top of benchmark distribution. For example, for the claims benchmark, over 50 percent of the MIPS eligible clinicians submitting that measure had a performance rate of 100 percent based on 2015 PQRS data. Because of the cluster, clinicians who are at the 6, 7, 8, and 9th decile all would have performance rates of 100 percent and would all receive a score of 10 points, indicated by dashes for those deciles. Based on this clustered distribution, those clinicians with performance of 99.99 percent fall into decile 5 and receive points in the range from 5.0 to 5.9 points. For this measure, the benchmark for each submission mechanism is topped out.
We note that for quality measures for which baseline period data is available, we will publish the numerical baseline period benchmarks with deciles prior to the start of the performance period (or as soon as possible thereafter) (81 FR 77282). For quality measures for which there is no comparable data from the baseline period, we will publish the numerical performance period benchmarks after the end of the performance period (81 FR 77282). We will also publish further explanation of how we calculate partial points at
For the 2017 MIPS performance period, we also finalized at § 414.1380(b)(1) a global 3-point floor for each scored quality measure, as well as for the hospital readmission measure (if applicable), such that MIPS eligible clinicians would receive between 3 and 10 measure achievement points for each submitted measure that can be reliably scored against a benchmark, which requires meeting the case minimum and data completeness requirements (81 FR 77286 through 77287). Likewise, for measures without a benchmark based on the baseline period, we stated that we would continue to assign between 3 and 10 measure achievement points for performance years after the first transition year because it would help to ensure that the MIPS eligible clinicians are protected from a poor performance score that they would not be able to anticipate (81 FR 77282; 81 FR 77287). For measures with benchmarks based on the baseline period, we stated the 3-point floor was for the transition year and that we would revisit the 3-point floor in future years (81 FR 77286 through 77287).
For the 2018 MIPS performance period, we propose to again apply a 3-point floor for each measure that can be reliably scored against a benchmark based on the baseline period, and to amend § 414.1380(b)(1) accordingly. We refer readers to section II.C.7.a.(2)(h)(ii) of this rule, for our proposal to score measures in the CMS Web Interface for the Quality Payment Program for which performance is below the 30th percentile. We will revisit the 3-point floor for such measures again in future rulemaking.
We invite public comment on this proposal to again apply this 3-point floor for quality measures that can be reliably scored against a baseline benchmark in the 2018 MIPS performance period.
In the CY 2017 Quality Payment Program final rule, we finalized a policy for the CAHPS for MIPS measure, such that each Summary Survey Measure (SSM) will have an individual benchmark, that we will score each SSM individually and compare it against the benchmark to establish the number of points, and the CAHPS score will be the average number of points across SSMs (81 FR 77284).
As described in section II.C.6.b.(3)(a)(iii) of this proposed rule, we are proposing to remove two SSMs from the CAHPS for MIPS survey, which would result in the collection of 10 SSMs in the CAHPS for MIPS survey. Eight of those 10 SSMs have had high reliability for scoring in prior years, or reliability is expected to improve for the revised version of the measure, and they also represent elements of patient experience for which we can measure the effect one practice has compared to other practices participating in MIPS. The “Health Status and Functional Status” SSM, however, assesses underlying characteristics of a group's patient population characteristics and is less of a reflection of patient experience of care with the group. Moreover, to the extent that health and functional status reflects experience with the practice, case-mix adjustment is not sufficient to separate how much of the score is due to patient experience versus due to aspects of the underlying health of patients. The “Access to Specialists” SSM has low reliability; historically it has had small sample sizes, and therefore, the majority of groups do not achieve adequate reliability, which means there is limited ability to distinguish between practices' performance.
For these reasons, we propose not to score the “Health Status and Functional Status” SSM and the “Access to Specialists” SSM beginning with the 2018 MIPS performance period. Despite not being suitable for scoring, both SSMs provide important information about patient care. Qualitative work suggests that “Access to Specialists” is a critical issue for Medicare FFS beneficiaries. The survey is also a useful tool for assessing beneficiaries' self-reported health status and functional status, even if this measure is not used for scoring practices' care experiences. Therefore, we believe that continued collection of the data for these two SSMs is appropriate even though we do not propose to score them.
Other than these two SSMs, we propose to score the remaining 8 SSMs because they have had high reliability for scoring in prior years, or reliability is expected to improve for the revised version of the measure, and they also
We invite comment on our proposal not to score the “Health Status and Functional Status” and “Access to Specialists” SSMs beginning with the 2018 MIPS performance period.
We note that in section II.C.6.g.(3)(b)(i)(A) of this proposed rule, we are proposing to add the CAHPS for ACOs survey as an available measure for calculating the MIPS APM score for the Shared Savings Program and Next Generation ACO Model. We refer readers participating in ACOs to section II.C.6.g.(3)(b) of this proposed rule for the CAHPS for ACOs scoring methodology.
Section 1848(q)(3)(B) of the Act requires that, in establishing performance standards with respect to measures and activities, we consider, among other things, the opportunity for continued improvement. We finalized in the CY 2017 Quality Payment Program final rule that we would identify topped out process measures as those with a median performance rate of 95 percent or higher (81 FR 77286). For non-process measures we finalized a topped out definition similar to the definition used in the Hospital VBP Program: Truncated Coefficient of Variation is less than 0.10 and the 75th and 90th percentiles are within 2 standard errors (81 FR 77286). When a measure is topped out, a large majority of clinicians submitting the measure performs at or very near the top of the distribution; therefore, there is little or no room for the majority of MIPS eligible clinicians who submit the measure to improve. We understand that every measure we have identified as topped out may offer room for improvement for some MIPS eligible clinicians; however, we believe asking clinicians to submit measures that we have identified as topped out and measures for which they already excel is an unnecessary burden that does not add value or improve beneficiary outcomes.
Based on 2015 historic benchmark data,
In the CY 2017 Quality Payment Program final rule, we finalized that for the 2019 MIPS payment year, we would score topped out quality measures in the same manner as other measures (81 FR 77286). We finalized that we would not modify the benchmark methodology for topped out measures for the first year that the measure has been identified as topped out, but that we would modify the benchmark methodology for topped out measures beginning with the 2020 MIPS payment year, provided that it is the second year the measure has been identified as topped out. As described in detail later in this section, we are proposing a phased in approach to apply special scoring to topped out measures, beginning with the 2018 MIPS performance period (2020 MIPS payment year), rather than modifying the benchmark methodology for topped out measures as indicated in the CY 2017 Quality Payment Program final rule.
In the CY 2017 Quality Payment Program final rule, we sought comment on how topped out measures should be scored provided that it is the second year the measure has been identified as topped out (81 FR 77286). We suggested three possible options: (1) Score the measures using a mid-cluster approach; (2) remove topped out measures; or (3) apply a flat percentage in building the benchmarks for topped out measures. Flat percentages assign points based directly on the percentage of performance rather than by a percentile distribution by decile. Flat-rate would provide high scores to virtually all clinicians submitting the measure because performance rates tend to be high. Cluster-based benchmarks for topped out measures are based on a percentile distribution, but because many submitters are clustered at the top of performance, there can be large drops in points assigned for relatively small differences in performance. The current top of the cluster approach can result in many clinicians receiving 10 points. A mid-cluster approach would limit the maximum number of points a topped out measure can achieve based on how clustered the score are, and could still result in large drops, although less than with the top of the cluster approach, in points assigned for relatively small differences in performance. We also noted in the CY 2017 Quality Payment Program final rule that we anticipate removing topped out measures over time and sought comment on what point in time we should remove topped out measures from MIPS (81 FR 77286). The comments and our proposed policy for removing topped out measures are described in section II.C.6.c.(2) of this proposed rule.
In response to our request for comment in the CY 2017 Quality Payment Program final rule, a few
As described in section II.C.6.c.(2) of this proposed rule, we are proposing a lifecycle for topped out measures by which, after a measure benchmark is identified as topped out in the published benchmark for 2 years, in the third consecutive year it is identified as topped out it will be considered for removal through notice-and-comment rulemaking or the QCDR approval process and may be removed from the benchmark list in the fourth year, subject to the phased in approach described in section II.C.6.c.(2) of this proposed rule.
As part of the lifecycle for topped out measures, we also propose in this section II.C.7.a.(2)(c) of this proposed rule, a method to phase in special scoring for topped out measure benchmarks starting with the 2018 MIPS performance period, provided that is the second consecutive year the measure benchmark is identified as topped out in the benchmarks published for the performance period. This special scoring would not apply to measures in the CMS Web Interface, as explained later in this section. The phased-in approach described in this section represents our first step in methodically implementing special scoring for topped out measures.
We are not proposing to remove topped out measures for the 2018 MIPS performance period because we recognize that there are currently a large number of topped out measures and removing them may impact the ability of some MIPS eligible clinicians to submit 6 measures and may impact some specialties more than others. We note, however, that as described in section II.C.6.c.(2) of this proposed rule, we are proposing a timeline for removing topped out measures in future years. We believe this provides MIPS eligible clinicians the ability to anticipate and plan for the removal of specific topped out measures, while providing measure developers time to develop new measures.
We note that because we create a separate benchmark for each submission mechanism available for a measure, a benchmark for one submission mechanism for the measure may be identified as topped out while another submission mechanism's benchmark may not be topped out. The topped out designation and special scoring apply only to the specific benchmark that is topped out, not necessarily every benchmark for a measure. For example, the benchmark for the claims submission mechanism may be topped out for a measure, but the benchmark for the EHR submission mechanisms for that same measure may not be topped out. In this case, the topped out scoring would only apply to measures submitted via the claims submission mechanism, which has the topped out benchmark. We also describe in section II.C.6.c.(2) of this proposed rule that, similarly, only the submission mechanism that is topped out for the measure would be removed.
We propose to cap the score of topped out measures at 6 measure achievement points. We are proposing a 6-point cap for multiple reasons. First, we believe applying a cap to the current method of scoring a measure against a benchmark is a simple approach that can easily be predicted by clinicians. Second, the cap will create incentives for clinicians to submit other measures for which they can improve and earn future improvement points. Third, considering our proposed topped out measure lifecycle, we believe this cap would only be used for a few years and the simplicity of a cap on the current benchmarks would outweigh the cluster-based options or applying a cap on benchmarks based on flat-percentage, which are more complicated. The rationale for a 6-point cap is that 6 points is the median score for any measure as it represents the start of the 6th decile for performance and represents the spot between the bottom 5 deciles and start of the top 5 deciles.
We believe this proposed capped scoring methodology will incentivize MIPS eligible clinicians to begin submitting non-topped out measures without performing below the median score. This methodology also would not impact scoring for those MIPS eligible clinicians that do not perform near the top of the measure and therefore have significant room to improve on the measure. We may also consider lowering the cap below 6 points in future years, especially if we remove the 3-point floor for performance in future years.
We note that although we are proposing a new methodology for assigning measure achievement points for topped out measures, we are not changing the policy for awarding measure bonus points for topped out measures. Topped out measures will still be eligible for measure bonus points if they meet the required criteria. We refer readers to sections II.C.7.a.(2)(f) and II.C.7.a.(2)(g) of this proposed rule for more information about measure bonus points.
We request comments on our proposal to score topped out measures differently by applying a 6-point cap, provided it is the second consecutive year the measure is identified as topped out. Specifically, we seek feedback on whether 6 points is the appropriate cap or whether we should consider another value. We also seek comment on other possible options for scoring topped out measures that would meet our policy goals to encourage clinicians to begin to submit measures that are not topped out while also providing stability for MIPS eligible clinicians.
While we believe it is important to score topped out measures differently because they could have a disproportionate impact on the scores for certain MIPS eligible clinicians and topped out measures provide little room for improvement for the majority of MIPS eligible clinicians who submit them, we also recognize that numerous measure benchmarks are currently identified as topped out and special scoring for topped out measures could impact some specialties more than others. Therefore, we considered ways to phase in special scoring for topped out measures in a way that will begin to apply special scoring, but would not overwhelm any one specialty and would also provide additional time to evaluate the impact of topped out measures before implementing it for all topped out measures, while also beginning to encourage submission of measures that are not topped out.
We believe the best way to accomplish this is by applying special topped out scoring to a select number of measures for the 2018 performance period and to then apply the special topped out scoring to all topped out measures for the 2019 performance period, provided it is the second consecutive year the measure is topped out. We believe this approach allows us time to further evaluate the impact of topped out measures and allows for a methodical way to phase in topped out scoring.
We identified measures we believe should be scored with the special topped out scoring for the 2018 performance period by using the following set criteria, which are only intended as a way to phase in our topped-out measure policy for selected measures and are not intended to be criteria for use in future policies:
• Measure is topped out and there is no difference in performance between decile 3 through decile 10. We applied this limitation because, based on historical data, there is no room for improvement for over 80 percent of MIPS eligible clinicians that reported on these measures.
• Process measures only because we want to continue to encourage reporting on high priority outcome measures, and the small subset of structure measures was confined to only three specialties.
• MIPS measures only (which does not include measures that can only be reported through a QCDR) given that QCDR measures go through a separate process for approval and because we want to encourage use of QCDRs required by section 1848(q)(1)(E) of the Act.
• Measure is topped out for all mechanisms by which the measure can be submitted. Because we create a separate benchmark for each submission mechanism available for a measure, a benchmark for one submission mechanism for the measure may be identified as topped out while another submission mechanism's benchmark may not be topped out. For example, the benchmark for the claims submission mechanism may be topped out for a measure, but the benchmark for the EHR submission mechanisms for that same measure may not be topped out. We decided to limit our criteria to only measures that were topped out for all measures for simplicity and to avoid confusion about what scoring is applied to a measure.
• Measure is in a specialty set with at least 10 measures, because 2 measures in the pathology specialty set, which only has 8 measures total would have been included.
Applying these criteria results in the 6 measures as listed in Table 21.
We propose to apply the special topped out scoring method that we finalize for the 2018 performance period to only the 6 measures in Table 21 for the 2018 performance period, provided they are again identified as topped out in the benchmarks for the 2018 performance period. If these measures are not identified as topped out in the benchmarks published for the 2018 performance period, they will not be scored differently because they would not be topped out for a second consecutive year.
We seek comment on our proposal to apply special topped out scoring only to the 6 measures identified in Table 21 for the 2018 performance period.
Starting with the 2019 performance period, we propose to apply the special topped out scoring method to all topped out measures, provided it is the second (or more) consecutive year the measure is identified as topped out. We seek comment on our proposal to apply special topped out scoring to all topped out measures, provided it is the second (or more) consecutive year the measure is identified as topped out.
We illustrate the lifecycle for scoring and removing topped out measures based on our proposals as follows:
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An example of applying the proposed scoring cap compared to scoring applied for the 2017 MIPS performance period is provided in Table 22.
Together the proposed policies for phasing in capped scoring and removing topped out measures are intended to provide an incentive for MIPS eligible clinicians to begin to submit measures that are not topped out while also providing stability by allowing MIPS eligible clinicians who have few alternative measures to continue to receive standard scoring for most topped out measures for an additional year, and not perform below the median score for those 6 measures that receive special scoring. It also provides MIPS eligible clinicians the ability to anticipate and plan for the removal of specific topped out measures, while providing measure developers time to develop new measures.
We propose to add a new paragraph at § 414.1380(b)(1)(xiii) to codify our proposal for the lifecycle for removing topped out measures.
We also propose to add at § 414.1380(b)(1)(xiii)(A) that for the 2018 MIPS performance period, the 6 measures identified in Table 21 will receive a maximum of 6 measure achievement points, provided that the measure benchmarks are identified as topped out again in the benchmarks published for the 2018 MIPS performance period. We also propose to add at § 414.1380(b)(1)(xiii)(B) that beginning with the 2019 MIPS performance period, measure benchmarks, except for measures in the CMS Web Interface, that are identified as topped out for two 2 or more consecutive years will receive a maximum of 6 measure achievement points in the second consecutive year it is identified as topped out, and beyond. We specifically seek comment on whether the proposed policy to cap the score of topped out measures beginning with the 2019 performance period should apply to SSMs in the CAHPS for MIPS survey measure or whether there is another alternative policy that could be applied for the CAHPS for MIPS survey measure due to high, unvarying performance within the SSM. We note that we would like to encourage groups to report the CAHPS for MIPS survey as it incorporates beneficiary feedback.
We stated in the CY 2017 Quality Payment Program final rule that we do not believe it would be appropriate to remove topped out measures from the CMS Web Interface for the Quality Payment Program because the CMS Web Interface measures are used in MIPS and in APMs such as the Shared Savings Program and because we have aligned policies, where possible, with the Shared Savings Program, such as using the Shared Savings Program benchmarks for the CMS Web Interface measures (81 FR 77285). In the CY 2017 Quality Payment Program final rule, we also finalized that MIPS eligible clinicians submitting via the CMS Web Interface must submit all measures included in the CMS Web Interface (81 FR 77116). Thus, if a CMS Web Interface measure is topped out, the CMS Web Interface submitter cannot select other measures. Because of the lack of ability to select measures, we are not proposing to apply a special scoring adjustment to topped out measures for CMS Web Interface for the Quality Payment Program.
Additionally, because the Shared Savings Program incorporates a methodology for measures with high performance into the benchmark, we do not believe capping benchmarks from the CMS Web Interface for the Quality Payment Program is appropriate. We finalized in the CY 2017 Quality Payment Program final rule at § 414.1380(b)(1)(ii)(A) to use benchmarks from the corresponding reporting year of the Shared Savings Program. The Shared Savings Program adjusts some benchmarks to a flat percentage when the 60th percentile is equal to or greater than 80.00 percent for individual measures (78 FR 74759 through 74763), and, for other measures, benchmarks are set using flat percentages when the 90th percentile for a measure are equal to or greater than 95.00 percent (79 FR 67925). Thus, we are not proposing to apply the topped out measure cap to measures in the CMS Web Interface for the Quality Payment Program.
We seek comment on this proposal not to apply the topped out measure cap to measures in the CMS Web Interface for the Quality Payment Program.
To help ensure reliable measurement, in the CY 2017 Quality Payment Program final rule (81 FR 77288), we finalized a 20-case minimum for all quality measures except the all-cause hospital readmission measure. For the all-cause hospital readmission measure, we finalized in the CY 2017 Quality Payment Program final rule a 200-case minimum and finalized to apply the all-cause hospital readmission measure only to groups of 16 or more clinicians that meet the 200-case minimum requirement (81 FR 77288).
We are not proposing any changes to these policies.
For the 2019 MIPS payment year, we finalized in the CY 2017 Quality Payment Program final rule that if the measure is submitted but is unable to be scored because it does not meet the required case minimum, does not have a benchmark, or does not meet the data completeness requirement, the measure would receive a score of 3 points (81 FR 77288 through 77289). We identified two classes of measures for the transition year. Class
We propose to maintain the policy to assign 3 points for measures that are submitted but do not meet the required case minimum or does not have a benchmark for the 2020 MIPS payment year and amend § 414.1380(b)(1)(vii) accordingly.
We also propose a change to the policy for scoring measures that do not meet the data completeness requirement for the 2020 MIPS payment year.
To encourage complete reporting, we are proposing that in the 2020 MIPS payment year, measures that do not meet data completeness standards will receive 1 point instead of the 3 points that were awarded in the 2019 MIPS payment year. We propose lowering the point floor to 1 for measures that do not meet data completeness standards for several reasons. First, we want to encourage complete reporting because data completeness is needed to reliably measure quality. Second, unlike case minimum and availability of a benchmark, data completeness is within the direct control of the MIPS eligible clinician. In the future, we intend that measures that do not meet the completeness criteria will receive zero points; however, we believe that during the second year of transitioning to MIPS, clinicians should continue to receive at least 1 measure achievement point for any submitted measure, even if the measure does not meet the data completeness standards.
We are concerned, however, that data completeness may be harder to achieve for small practices. For example, small practices tend to have small case volume and missing one or two cases could cause the MIPS eligible clinician to miss the data completeness standard as each case may represent multiple percentage points for data completeness. For example, for a small practice with only 20 cases for a measure, each case is worth 5 percentage points, and if they miss reporting just 11 or more cases, they would fail to meet the data completeness threshold, whereas for a practice with 200 cases, each case is worth 0.5 percentage points towards data completeness and the practice would have to miss more than 100 cases to fail to meet the data completeness criteria. Applying 1 point for missing data completeness based on missing a relatively small number of cases could disadvantage these clinicians, who may have additional burdens for reporting in MIPS, although we also recognize that failing to report on 10 or more patients is undesirable. In addition, we know that many small practices may have less experience with submitting quality performance category data and may not yet have systems in place to ensure they can meet the data completeness criteria. Thus, we are also proposing an exception to the proposed policy for measures submitted by small practices, as defined in § 414.1305. We propose that these clinicians would continue to receive 3 points for measures that do not meet data completeness.
Therefore, we propose to revise Class 2 measures to include only measures that cannot be scored based on performance because they do not have a benchmark or do not have at least 20 cases. We also propose to create Class 3 measures, which are measures that do not meet the data completeness requirement. We propose that the revised Class 2 measure would continue to receive 3 points. The proposed Class 3 measures would receive 1 point, except if the measure is submitted by a small practice in which case the Class 3 measure would receive 3 points. However, consistent with the policy finalized in the CY 2017 Quality Payment Program final rule, these policies for Class 2 and Class 3 measures would not apply to measures submitted with the CMS Web Interface or administrative claims-based measures. A summary of the proposals is provided in Table 23.
We propose to amend § 414.1380(b)(1)(vii) to assign 3 points for measures that do not meet the case minimum or do not have a benchmark in the 2020 MIPS payment year, and to assign 1 point for measures that do not meet data completeness requirements, unless the measure is submitted by a small practice, in which case it would receive 3 points.
We invite comment on our proposal to assign 1 point to measures that do not meet data completeness criteria, with an exception for measures submitted by small practices.
We are not proposing to change the methodology we use to score measures submitted via the CMS Web Interface that do not meet the case minimum, do not have a benchmark, or do not meet the data completeness requirement finalized in the CY 2017 Quality Payment Program final rule and codified at paragraph (b)(1)(viii) of § 414.1380. However, we note that as described in section II.C.7.a.(2)(h)(ii) of this proposed rule, we are proposing to add that CMS Web Interface measures with a benchmark that are redesignated from pay for performance to pay for reporting by the Shared Savings Program will not be scored. We refer readers to the discussion at 81 FR 77288 for more details on our previously finalized policy.
We are also not proposing any changes to the policy to not include administrative claims measures in the quality performance category percent score if the case minimum is not met or if the measure does not have a benchmark finalized in the CY 2017 Quality Payment Program final rule and codified at paragraph (b)(1)(viii) of § 414.1380. We refer readers to the discussion at 81 FR 77288 for more details on that policy.
To clarify the exclusion of measures submitted via the CMS Web Interface and based on administrative claims from the policy changes proposed to be codified at paragraph (b)(1)(vii) previously, we are amending paragraph (b)(1)(vii) to make it subject to paragraph (b)(1)(viii), which codifies the exclusion.
In the CY 2017 Quality Payment Program final rule, we finalized that MIPS eligible clinicians who fail to submit a measure that is required to satisfy the quality performance category submission criteria would receive zero points for that measure (81 FR 77291). For each required measure that is not submitted, a MIPS eligible clinician would receive zero points out of 10. For example, if a MIPS eligible clinician had 6 measures available and applicable but submitted only 4 measures, the MIPS eligible clinician would be assigned zero out of 10 measure achievement points for the 2 missing measures, which would be calculated into their performance category percent score.
We are not proposing any changes to the policy to assign zero points for failing to submit a measure that is required in this proposed rule.
In the CY 2017 Quality Payment Program final rule, we also finalized implementation of a validation process for claims and registry submissions to validate whether MIPS eligible clinicians have 6 applicable and available measures, whether an outcome measure is available or whether another high priority measure is available if an outcome measure is not available (81 FR 77290 through 77291).
We are not proposing any changes to apply a process to validate whether MIPS eligible clinicians that submit measures via claims and registry submissions have measures available and applicable. As stated in the CY 2017 Quality Payment Program final rule (81 FR 77290), we did not intend to establish a validation process for QCDRs because we expect that MIPS eligible clinicians that enroll in QCDRs will have sufficient meaningful measures to meet the quality performance category criteria (81 FR 77290 through 77291). We do not propose any changes to this policy.
We also stated that if a MIPS eligible clinician did not have 6 measures relevant within their EHR to meet the full specialty set requirements or meet the requirement to submit 6 measures, the MIPS eligible clinician should select a different submission mechanism to meet the quality performance category requirements and should work with their EHR vendors to incorporate applicable measures as feasible (81 FR 77290 through 77291). Under our proposals in section II.C.6.a.(1) of this proposed rule to allow measures to be submitted and scored via multiple mechanisms within a performance category, we anticipate that MIPS
Therefore, given our proposal to score multiple mechanisms, if a MIPS eligible clinician submits any quality measures via EHR or QCDR, we would not conduct a validation process because we expect these MIPS eligible clinicians to have sufficient measures available to meet the quality performance category requirements.
Given our proposal in section II.C.7.a.(2)(h) of this proposed rule to score measures submitted via multiple mechanisms, we propose to validate the availability and applicability of measures only if a MIPS eligible clinician submits via claims submission options only, registry submission options only, or a combination of claims and registry submission options. In these cases, we propose that we will apply the validation process to determine if other measures are available and applicable broadly across claims and registry submission options. We will not check if there are measures available via EHR or QCDR submission options for these reporters. We note that groups cannot report via claims and therefore groups and virtual groups will only have validation applied across registries. We would validate the availability and applicability of a measure through a clinically related measure analysis based on patient type, procedure, or clinical action associated with the measure specifications. For us to recognize fewer than 6 measures, an individual MIPS eligible clinician must submit exclusively using claims or qualified registries or a combination of the two, and a group or virtual group must submit exclusively using qualified registries. Given our proposal in section II.C.7.a.(2)(h) of this proposed rule to score measures submitted via multiple mechanisms, validation will be conducted first by applying the clinically related measure analysis for the individual measure and then, to the extent technically feasible, validation will be applied to check for available measures available via both claims and registries.
We recognize that in extremely rare instances there may be a MIPS eligible clinician who may not have available and applicable quality measures. For example, a subspecialist who focuses on a very targeted clinical area may not have any measures available. However, in many cases, the clinician may be part of a broader group or would have the ability to select some of the cross-cutting measures that are available. Given the wide array of submission options, including QCDRs which have the flexibility to develop additional measures, we believe this scenario should be extremely rare. If we are not able to score the quality performance category, we may reweight their score according to the reweighting policies described in section II.C.7.b.(3)(b) and II.C.7.b.(3)(d) of this proposed rule. We note that we anticipate this will be a rare circumstance given our proposals to allow measures to be submitted and scored via multiple mechanisms within a performance category and to allow facility-based measurement for the quality performance category.
In the CY 2017 Quality Payment Program final rule, we finalized that we would award 2 bonus points for each outcome or patient experience measure and 1 bonus point for each additional high priority measure that is reported in addition to the 1 high priority measure that is already required to be reported under the quality performance category submission criteria, provided the measure has a performance rate greater than zero, and the measure meets the case minimum and data completeness requirements (81 FR 77293). High priority measures were defined as outcome, appropriate use, patient safety, efficiency, patient experience and care coordination measures, as identified in Tables A and E in the Appendix of the CY 2017 Quality Payment Program final rule (81 FR 77558 and 77686). We also finalized that we will apply measure bonus points for the CMS Web Interface for the Quality Payment Program based on the finalized set of measures reportable through that submission mechanism (81 FR 77293). We note that in addition to the 14 required measures, CMS Web Interface reporters may also report the CAHPS for MIPS survey and receive measure bonus points for submitting that measure.
We are not proposing any changes to these policies for awarding measure bonus points for reporting high priority measures in this proposed rule.
In the CY 2017 Quality Payment Program final rule, we finalized a cap on high priority measure bonus points at 10 percent of the denominator (total possible measure achievement points the MIPS eligible clinician could receive in the quality performance category) of the quality performance category for the first 2 years of MIPS (81 FR 77294). Groups that submit via the CMS Web Interface for the Quality Payment Program are also subject to the 10 percent cap on high priority measure bonus points. We are not proposing any changes to the cap on measure bonus points for reporting high priority measures, which is codified at § 414.1380(b)(1)(xiv)(D)
Section 1848(q)(5)(B)(ii) of the Act outlines specific scoring rules to encourage the use of CEHRT under the quality performance category. For more of the statutory background and description of the proposed and finalized policies, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77294 through 77299).
In the CY 2017 Quality Payment Program final rule at § 414.1380(b)(1)(xiv), we codified that 1 bonus point is available for each quality measure submitted with end-to-end electronic reporting, under certain criteria described below (81 FR 77297). We also finalized a policy capping the number of bonus points available for electronic end-to-end reporting at 10 percent of the denominator of the quality performance category percent score, for the first 2 years of the program (81 FR 77297). For example, when the denominator is 60, the number of measure bonus points will be capped at 6 points. We also finalized that the CEHRT bonus would be available to all submission mechanisms except claims submissions. Specifically, MIPS eligible clinicians who report via qualified registries, QCDRs, EHR submission mechanisms, or the CMS Web Interface for the Quality Payment Program, in a manner that meets the end-to-end reporting requirements, may receive 1 bonus point for each reported measure with a cap as described (81 FR 77297).
We are not proposing changes to these policies related to bonus points for using CEHRT for end-to-end reporting in this proposed rule. However, we are seeking comment on the use of health IT in quality measurement and how HHS can encourage the use of certified EHR technology in quality measurement as established in the statute. What other incentives within this category for reporting in an end-to-end manner could be leveraged to incentivize more clinicians to report electronically? What format should these incentives take? For
In section II.C.7.a.(2)(i) of this proposed rule, we are proposing a new methodology to reward improvement based on achievement, from 1 year to another, which requires modifying the calculation of the quality performance category percent score. In this section II.C.7.a.(2)(h) of the proposed rule, we are summarizing the policies for calculating the total measure achievement points and total measure bonus points, prior to scoring improvement and the final quality performance category percent score. We note that we will refer to policies finalized in the CY 2017 Quality Payment Program final rule that apply to the quality performance category score, which is referred to as the quality performance category percent score in this proposed rule, in this section. We are also proposing some refinements to address the ability for MIPS eligible clinicians to submit quality data via multiple submission mechanisms.
In the CY 2017 Quality Payment Program final rule (81 FR 77300), we finalized that if a MIPS eligible clinician elects to report more than the minimum number of measures to meet the MIPS quality performance category criteria, then we will only include the scores for the measures with the highest number of assigned points, once the first outcome measure is scored, or if an outcome measure is not available, once another high priority measure is scored. We are not proposing any changes to the policy to score the measures with the highest number of assigned points in this proposed rule; however, we are proposing refinements to account for measures being submitted across multiple submission mechanisms.
In the CY 2017 Quality Payment Program final rule, we sought comment on whether to score measures submitted across multiple submission mechanisms (81 FR 77275). As described in section II.C.6.a.(1) of this proposed rule, we are proposing that MIPS eligible clinicians be able to submit measures within a performance category via multiple submission mechanisms. In the CY 2017 Quality Payment Program final rule, we also sought comment on what approach we should use to combine the scores for quality measures from multiple submission mechanisms into a single aggregate score for the quality performance category (81 FR 77275). Examples of possible scoring options were a weighted average score on quality measures submitted through two or more different mechanisms or taking the highest scores for any submitted measure regardless of how the measure is submitted. A few comments received in response to the CY 2017 Quality Payment Program final rule did not support developing different weights for different submission methods. One commenter recommended that we take the highest score for any submitted measure, regardless of submission mechanisms, or alternatively, calculate independent scores that would each contribute equally to the final score.
After consideration of the comments we received, we are proposing, beginning with the 2018 MIPS performance period, a method to score quality measures if a MIPS eligible clinician submits measures via more than one of the following submission mechanisms: Claims, qualified registry, EHR or QCDR submission options. We believe that allowing MIPS eligible clinicians to be scored across these data submission mechanisms in the quality performance category will provide additional options for MIPS eligible clinicians to report the measures required to meet the quality performance category criteria, and encourage MIPS eligible clinicians to begin using electronic submission mechanisms, even if they may not have 6 measures to report via a single electronic submission mechanism alone. We note that we also continue to score the CMS-approved survey vendor for CAHPS for MIPS submission options in conjunction with other submission mechanisms (81 FR 77275) as noted in Table 24.
We propose to score measures across multiple mechanisms using the following rules:
• As with the rest of MIPS, we will only score measures within a single identifier. For example, as codified in § 414.1310(e), eligible clinicians and MIPS eligible clinicians within a group aggregate their performance data across the TIN in order for their performance to be assessed as a group. Therefore, measures can only be scored across multiple mechanisms if reported by the same individual MIPS eligible clinician, group, virtual group or APM Entity, as described in Table 24.
• We do not propose to aggregate measure results across different submitters to create a single score for an individual measure (for example, we are not going to aggregate scores from different TINs within a virtual group TIN to create a single virtual group score for the measures; rather, virtual groups must perform that aggregation across TINs prior to data submission to CMS). Virtual groups are treated like other groups and must report all of their measures at the virtual group level, for the measures to be scored. Data completeness and all the other criteria will be evaluated at the virtual group level. Then the same rules apply for selecting which measures are used for scoring. In other words, if a virtual group representative submits some measures via a qualified registry and other measures via EHR, but an individual TIN within the virtual group also submits measures, we will only use the scores from the measures that were submitted at the virtual group level, because the TIN submission does not use the virtual group identifier. This is consistent with our other scoring principles, where, for virtual groups, all quality measures are scored at the virtual group level.
• Separately, as also described in Table 24, because CMS Web Interface and facility-based measurement each have a comprehensive set of measures that meet the proposed MIPS submission requirements, we do not propose to combine CMS Web Interface measures or facility-based measurement with other group submission mechanisms (other than CAHPS for MIPS, which can be submitted in conjunction with the CMS Web Interface). We refer readers to section II.C.7.a.(2)(h)(ii) of this proposed rule for discussion of calculating the total measure achievement and measure bonus points for CMS Web Interface reporters and to section II.C.7.a.(4) of this proposed rule for a description of our proposed policies on facility-based measurement. We list these submission mechanisms in Table 24, to illustrate that CMS Web Interface submissions and facility-based measurement cannot be combined with other submission options, except that the CAHPS for MIPS survey can be combined with CMS Web Interface, as described in section II.C.7.a.(2)(h)(ii) of this proposed rule.
• If a MIPS eligible clinician submits the same measure via 2 different submission mechanisms, we will score each mechanism by which the measure is submitted for achievement and take the highest measure achievement points of the 2 mechanisms.
• Measure bonus points for high priority measures would be added for all measures submitted via all the different submission mechanisms available, even if more than 6 measures are submitted, but high priority measure bonus points are only available once for each unique measure (as noted by the measure number) that meets the criteria for earning the bonus point. For example, if a MIPS eligible clinician submits 8 measures—6 process and 2 outcome—and both outcome measures meet the criteria for a high priority bonus (meeting the required data completeness, case minimum, and has a performance rate greater than zero), the outcome measure with the highest measure achievement points would be scored as the required outcome measure and then the measures with the next 5 highest measure achievement points will contribute to the final quality score. This could include the second outcome measure but does not have to. Even if the measure achievement points for the second outcome measure are not part of the quality performance category percent score, measure bonus points would still be available for submitting a second outcome measure and meeting the requirement for the high priority measure bonus points. The rationale for providing measure bonus points for measures that do not contribute measure achievement points to the quality performance category percent score is that it would help create better benchmarks for outcome and other high priority measures by encouraging clinicians to report them even if they may not have high performance on the measure. We also want to encourage MIPS eligible clinicians to submit to us all of their available MIPS data, not only the data that they or their intermediary deem to be their best data. We believe it will be in the best interest of all MIPS eligible clinicians that we determine which measures will result in the clinician receiving the highest MIPS score. If the same measure is submitted through multiple submission mechanisms, we would apply the bonus points only once to the measure. We propose to amend § 414.1380(b)(1)(xiv) (as redesignated from § 414.1380(b)(1)(xiii)) to add paragraph (b)(1)(xiv)(E) that if the same high priority measure is submitted via two or more submission mechanisms, as determined using the measure ID, the measure will receive high priority measure bonus points only once for the measure. The total measure bonus points for high-priority measures would still be capped at 10 percent of the total possible measure achievement points.
• Measure bonus points that are available for the use of end-to-end electronic reporting would be calculated for all submitted measures across all submission mechanisms, including measures that cannot be reliably scored against a benchmark. If the same measure is submitted through multiple submission mechanisms, then we would apply the bonus points only once to the measure. For example, if the same measure is submitted using end-to-end reporting via both a QCDR and EHR reporting mechanism, the measure would only get a measure bonus point one time. We propose to amend § 414.1380(b)(1)(xv) (as redesignated) to add that if the same measure is submitted via two or more submission mechanisms, as determined using the measure ID, the measure will receive measure bonus points only once for the measure. The total measure bonus points for end-to-end electronic reporting would still be capped at 10 percent of the total available measure achievement points.
Although we provide a policy to account for scoring in those circumstances when the same measure is submitted via multiple mechanisms, we anticipate that this will be a rare circumstance and do not encourage clinicians to submit the same measure via multiple mechanisms. Table 25 illustrates how we would assign total measure achievement points and total measure bonus points across multiple submission mechanisms under our proposal. In this example, a MIPS eligible clinician elects to submit quality data via 3 submission mechanisms: 3 Measures via registry, 4 measures via claims, and 5 measures via EHR. The 3 registry measures are also submitted via claims (as noted by the same measure letter in this example). The EHR measures do not overlap with either the registry or claims measures. In this example, we assign measure achievement and bonus points for each measure. If the same measure (as determined by measure ID) is submitted, then we use the highest achievement points for that measure. For the bonus points, we assess which of the outcome measures meets the outcome measure requirement and then we identify any other unique measures that qualify for the high priority bonus. We also identify the unique measures that qualify for end-to-end electronic reporting bonus.
We propose to amend § 414.1380(b)(1)(xii) to add paragraph (A) to state that if a MIPS eligible clinician submits measures via claims, qualified registry, EHR, or QCDR submission options, and submits more than the required number of measures, they are scored on the required measures with the highest assigned measure achievement points. MIPS eligible clinicians that report a measure via more than 1 submission mechanism can be scored on only 1 submission mechanism, which will be the submission mechanism with the highest measure achievement points. Groups that submit via these submission mechanisms may also submit and be scored on CMS-approved survey vendor for CAHPS for MIPS submission mechanisms.
We invite comments on our proposal to calculate the total measure achievement points by using the measures with the 6 highest measure achievement points across multiple submission mechanisms. We invite comments on our proposal that if the same measure is submitted via 2 or more mechanisms, we will only take the one with the highest measure achievement points. We invite comments on our proposal to assign high priority measure bonus points to all measures, with performance greater than zero, that meet case minimums, and that meet data completeness requirements, regardless of submission mechanism and to assign measure
We are not proposing any changes to our policy that if a MIPS eligible clinician does not have any scored measures, then a quality performance category percent score will not be calculated as finalized in the CY 2017 Quality Payment Program final rule at 81 FR 77300. We refer readers to the discussion at 81 FR 77299 through 77300 for more details on that policy. As stated in section II.C.7.a.(2)(e) of this proposed rule, we anticipate that it will be only in rare case that a MIPS eligible clinician does not have any scored measures and a quality performance category percent score cannot be calculated.
In the CY 2017 Quality Payment Program final rule, we finalized that CMS Web Interface reporters are required to report 14 measures, 13 individual measures, and a 2-component measure for diabetes (81 FR 77302 through 77305). We note that for the transition year, 3 measures did not have a benchmark in the Shared Savings Program. Therefore, for the transition year, CMS Web Interface reporters are scored on 11 of the total 14 required measures, provided that they report all 14 required measures.
In the CY 2017 Quality Payment Program final rule, we finalized a global floor of 3 points for all CMS Web Interface measures submitted in the transition year, even with measures at zero percent performance rate, provided that these measures have met the data completeness criteria, have a benchmark and meet the case minimum requirements (82 FR 77305). Therefore, measures with performance below the 30th percentile will be assigned a value of 3 points during the transition year to be consistent with the floor established for other measures and because the Shared Savings Program does not publish benchmarks below the 30th percentile (82 FR 77305). We stated that we will reassess scoring for measures below the 30th percentile in future years.
We propose to continue to assign 3 points for measures with performance below the 30th percentile, provided the measure meets data completeness, has a benchmark, and meets the case minimum requirements for the 2018 MIPS performance year; we make this proposal in order to continue to align with the 3-point floor for other measures and because the Shared Savings Program does not publish benchmarks with values below the 30th percentile. We will reassess this policy again next year through rulemaking.
We are not proposing any changes to our previously finalized policy to exclude from scoring CMS Web Interface measures that are submitted but that do not meet the case minimum requirement or that lack a benchmark, or to our policy that measures that are not submitted and measures submitted below the data completeness requirements will receive a zero score (82 FR 77305). However, to further increase alignment with the Shared Savings Program, we propose to also exclude CMS Web Interface measures from scoring if the measure is redesignated from pay for performance to pay for reporting for all Shared Savings Program ACOs, although we will recognize the measure was submitted. While the Shared Savings Program designates measures that are pay for performance in advance of the reporting year, the Shared Savings Program may redesignate a measure as pay for reporting under certain circumstances (see 42 CFR 425.502(a)(5)). Therefore, we propose to amend § 414.1380(b)(1)(viii) to add that CMS Web Interface measures that have a measure benchmark but are redesignated as pay for reporting for all Shared Savings Program ACOs by the Shared Savings Program will not be scored, as long as the data completeness requirement is met.
We invite comment on our proposal to not score CMS Web Interface measures redesignated as pay for reporting by the Shared Savings Program.
We also note that, while we did not state explicitly in the CY 2017 Quality Payment Program final rule, groups that choose to report quality measures via the CMS Web Interface may, in addition to the 14 required measures, also submit the CAHPS for MIPS survey in the quality performance category (81 FR 77094 through 77095; 81 FR 77292). If they do so, they can receive bonus points for submitting this high priority measure and will be scored on it as an additional measure. Therefore, we propose to amend § 414.1380(b)(1)(xii) to add paragraph (B) to state that groups that submit measures via the CMS Web Interface may also submit and be scored on CMS-approved survey vendor for CAHPS for MIPS submission options.
In addition, groups of 16 or more eligible clinicians that meet the case minimum for administrative claims measures will automatically be scored on the all-cause hospital readmission measure and have that measure score included in their quality category performance percent score.
We are not proposing any changes to calculating the total measure achievement points and measure bonus points for CMS Web Interface measures in this proposed rule, although we are proposing to add improvement to the quality performance category percent score for such submissions (as well as other submission mechanisms) in section II.C.7.a.(2)(j) of this proposed rule.
In the CY 2017 Quality Payment Program final rule, we noted that we consider achievement to mean how a MIPS eligible clinician performs relative to performance standards, and improvement to mean how a MIPS eligible clinician performs compared to the MIPS eligible clinician's own previous performance on measures and activities in the performance category (81 FR 77274). We also solicited public comments in the CY 2017 Quality Payment Program proposed rule on potential ways to incorporate improvement in the scoring methodology. In section II.C.7.a.(1)(b)(i) of this proposed rule, we explain why we believe that the options set forth in the CY 2017 Quality Payment Program proposed rule, including the Hospital VBP Program, the Shared Savings Program, and Medicare Advantage 5-star Ratings Program, were not fully translatable to MIPS. Beginning with the 2018 MIPS performance period, we propose here to score improvement as well as achievement in the quality performance category level when data is sufficient. We believe that scoring improvement at the performance category level, rather than measuring improvement at the measure level, for the quality performance category would allow improvement to be available to the broadest number of MIPS eligible clinicians because we are connecting performance to previous MIPS quality performance as a whole rather than changes in performance for individual measures. Just as we believe it is important for a MIPS eligible clinician to have the flexibility to choose measures that are meaningful to their practice, we want them to be able to adopt new measures without concern
We propose at § 414.1380(b)(1)(xvi)(E) to define an improvement percent score to mean the score that represents improvement for the purposes of calculating the quality performance category percent score. We also propose at § 414.1380(b)(1)(xvi)(C) that an improvement percent score would be assessed at the quality performance category level and included in the calculation of the quality performance category percent score. When we evaluated different improvement scoring options, we saw two general methods for incorporating improvement. One method measures both achievement and improvement and takes the higher of the two scores for each measure that is compared. The Hospital VBP Program incorporates such a methodology. The second method is to calculate an achievement score and then add an improvement score if improvement is measured. The Shared Savings Program utilizes a similar methodology for measuring improvement. For the quality performance category, we are proposing to calculate improvement at the category level and believe adding improvement to an existing achievement percent score would be the most straight-forward and simple way to incorporate improvement. For the purpose of improvement scoring methodology, the term “quality performance category achievement percent score” means the total measure achievement points divided by the total possible available measure achievement points, without consideration of bonus points or improvement adjustments and is discussed in section II.C.7.a.(2)(i)(iv) of this proposed rule.
Consistent with bonuses available in the quality performance category, we propose at § 414.1380(b)(1)(xvi)(B) that the improvement percent score may not total more than 10 percentage points.
We invite public comments on these proposals.
Section 1848(q)(5)(D)(i) of the Act stipulates that beginning with the second year to which the MIPS applies, if data sufficient to measure improvement is available then we shall measure improvement for the quality performance category. Measuring improvement requires a direct comparison of data from one Quality Payment Program year to another. Starting with the 2020 MIPS payment year, we propose that a MIPS eligible clinician's data would be sufficient to score improvement in the quality performance category if the MIPS eligible clinician had a comparable quality performance category achievement percent score for the MIPS performance period immediately prior to the current MIPS performance period; we explain our proposal to identify how we will identify “comparable” quality performance category achievement percent scores below. We believe that this approach would allow improvement to be broadly available to MIPS eligible clinicians and encourage continued participation in the MIPS program. Moreover, this approach would encourage MIPS eligible clinicians to focus on efforts to improve the quality of care delivered. We note that, by measuring improvement based only on the overall quality performance category achievement percent score, some MIPS eligible clinicians and groups may generate an improvement score simply by switching to measures on which they perform more highly, rather than actually improving at the same measures. We will monitor how frequently improvement is due to actual improvement versus potentially perceived improvement by switching measures and will address through future rulemaking, as needed. We also solicit comment on whether we should require some level of year to year consistency when scoring improvement.
We propose that “comparability” of quality performance category achievement percent scores would be established by looking first at the submitter of the data. As discussed in more detail in section II.C.7.a.(2)(i)(i) of this proposed rule, we are comparing results at the category, rather than the performance measure level because we believe that the performance category score from 1 year is comparable to the performance category score from the prior year, even if the measures in the performance category have changed from year to year.
We propose to compare results from an identifier when we receive submissions with that same identifier (either TIN/NPI for individual, or TIN for group, APM entity, or virtual group identifier) for two consecutive performance periods. However, if we do not have the same identifier for two consecutive performance periods, we propose a methodology to create a comparable performance category score that can be used for improvement measurement. Just as we do not want to remove the opportunity to earn an improvement score from those who elect new measures between performance periods for the quality performance category, we also do not want to restrict improvement for those MIPS eligible clinicians who elect to participate in MIPS using a different identifier.
There are times when submissions from a particular individual clinician or group of clinicians use different identifiers between 2 years. For example, a group of 20 MIPS eligible clinicians could choose to submit as a group (using their TIN identifier) for the current performance period. If the group also submitted as a group for the previous year's performance period, we would simply compare the group scores associated with the previous performance period to the current performance period (following the methodology explained in section II.C.7.a.(2)(i)(iv) of this proposed rule). However, if the group members had previously elected to submit to MIPS as individual clinicians, we would not have a group score at the TIN level from the previous performance period to which to compare the current performance period.
In circumstances where we do not have the same identifier for two consecutive performance periods, we propose to identify a comparable score for individual submissions or calculate a comparable score for group, virtual group, and APM entity submissions. For individual submissions, if we do not have a quality performance category achievement percent score for the same individual identifier in the immediately prior period, then we propose to apply the hierarchy logic that is described in section II.C.8.a.(2) of this proposed rule to identify the quality performance category achievement score associated with the final score that would be applied to the TIN/NPI for payment purposes. For example, if there is no historical score for the TIN/NPI, but there is a TIN score (because in the previous period the TIN submitted as a group), then we would use the quality performance category achievement
When we do not have a comparable TIN group, virtual group, or APM Entity score, we propose to calculate a score based on the individual TIN/NPIs in the practice for the current performance period. For example, in a group of 20 clinicians that previously participated in MIPS as individuals, but now want to participate as a group, we would not have a comparable TIN score to use for scoring improvement. We believe however it is still important to provide to the MIPS eligible clinicians the improvement points they have earned. Similarly, in cases where a group of clinicians previously participated in MIPS as individuals, but now participates as a new TIN, or a new virtual group, or a new APM Entity submitting data in the performance period, we would not have a comparable TIN, virtual group, or APM Entity score to use for scoring improvement. Therefore, we propose to calculate a score by taking the average of the individual quality performance category achievement scores for the MIPS eligible clinicians that were in the group for the current performance period. If we have more than one quality performance category achievement percent score for the same individual identifier in the immediately prior period, then we propose to apply the hierarchy logic that is described in section II.C.8.a.(2) of this proposed rule to identify the quality performance category score associated with the final score that would be applied to the TIN/NPI for payment purposes. We would exclude any TIN/NPI's that did not have a final score because they were not eligible for MIPS. We would include quality performance category achievement percent scores of zero in the average.
There are instances where we would not be able to measure improvement due to lack of sufficient data. For example, if the MIPS eligible clinicians did not participate in MIPS in the previous performance period because they were not eligible for MIPS, we could not calculate improvement because we would not have a previous quality performance category achievement percent score.
Table 26 summarizes the different cases when a group or individual would be eligible for improvement scoring under this proposal.
We propose at § 414.1380(b)(1)(xvi)(A) to state that improvement scoring is available when the data sufficiency standard is met, which means when data are available and a MIPS eligible clinician or group has a quality performance category achievement percent score for the previous performance period. We also propose at § 414.1380(b)(1)(xvi)(A)(1) that data must be comparable to meet the requirement of data sufficiency,
We also seek comment on an alternative to this proposal: Whether we should restrict improvement to those who submit quality performance data using the same identifier for two consecutive MIPS performance periods. We believe this option would be simpler to apply, communicate and understand than our proposal is, but this alternative could have the unintended consequence of not allowing improvement scoring for certain MIPS eligible clinicians, groups, virtual groups and APM entities.
To receive a quality performance category improvement percent score greater than zero, we are also proposing that MIPS eligible clinicians must fully participate, which we propose in § 414.1380(b)(1)(xvi)(F) to mean compliance with § 414.1330 and § 414.1340, in the current performance year. Compliance with those referenced regulations entails the submission of all required measures, including meeting data completeness, for the quality performance category for the current performance period. For example, for MIPS eligible clinicians submitting via QCDR, full participation would generally mean submitting 6 measures including 1 outcome measure if an outcome measure is available or 1 high priority measure if an outcome measure is not available, and meeting the 50 percent data completeness criteria for each of the 6 measures.
We believe that improvement is most meaningful and valid when we have a full set of quality measures. A comparison of data resulting from full participation of a MIPS eligible clinician from 1 year to another enables a more accurate assessment of improvement because the performance being compared is based on the applicable and available measures for the performance periods and not from changes in participation. While we are not requiring full participation for both performance periods, requiring full participation for the current performance period means that any future improvement scores for a clinician or group would be derived solely from changes in performance and not because the clinician or group submitted more measures. We propose at § 414.1380(b)(1)(xvi)(C)(5) that the quality improvement percent score is zero if the clinician did not fully participate in the quality performance category for the current performance period.
Because we want to award improvement for net increases in performance and not just improved participation in MIPS, we want to measure improvement above a floor for the 2018 MIPS performance period, to account for our transition year policies. We considered that MIPS eligible clinicians who chose the “test” option of the “pick your pace” approach for the transition year may not have submitted all the required measures and, as a result, may have a relatively low quality performance category achievement score for the 2017 MIPS performance period. Due to the transition year policy to award at least 3 measure achievement points for any submitted measure via claims, EHR, QCDR, qualified registry, and CMS-approved survey vendor for CAHPS for MIPS, and the 3-point floor for the all-cause readmission measure (if the measure applies), a MIPS eligible clinician that submitted some data via these mechanisms on the required number of measures would automatically have a quality performance category achievement score of at least 30 percent because they would receive at least 3 of 10 possible measure achievement points for each required measure. For example, if a solo practitioner submitted 6 measures and received 3 points for each measure, then the solo practitioner would have 18 measure achievement points out of a possible 60 total possible measure achievement points (3 measure achievement points × 6 measures). The quality performance category achievement percent score is 18/60 which equals 30 percent. For groups with 16 or more clinicians that submitted 6 measures and receive 3 measure achievement points for each submitted measure as well as the all-cause hospital readmission measure, then the group would have 21 measure achievement points out of 70 total possible measure achievement points or a quality performance category achievement percent score of 21/70 which equals 30 percent (3 measure achievement points × 7 measures). For the CMS Web Interface submission option, MIPS eligible clinicians that fully participate by submitting and meeting data completeness for all measures, would also be able to achieve a quality performance category achievement percent score of at least 30 percent, as each scored measure would receive 3 measure achievement points out of 10 possible measure achievement points.
Therefore, we propose at § 414.1380(b)(1)(xvi)(C)(4) that if a MIPS eligible clinician has a previous year quality performance category score less than or equal to 30 percent, we would compare 2018 performance to an assumed 2017 quality performance category achievement percent score of 30 percent. In effect, for the MIPS 2018 performance period, improvement would be measured only if the clinician's 2018 quality performance category achievement percent score for the quality performance category exceeds 30 percent. We believe this approach appropriately recognizes the participation of MIPS eligible clinicians who participated in the transition year and accounts for MIPS eligible clinicians who participated minimally and may otherwise be awarded for an increase in participation rather than an increase in achievement performance.
We invite public comment on these proposals.
To calculate improvement with a focus on quality performance, we are proposing to focus on improvement based on achievement performance and would not consider measure bonus
Table 27 illustrates how the quality performance category achievement percent score is calculated. For simplicity, we assume the MIPS eligible clinician received 6 measure achievement points for each of the submitted 6 required measures in the current performance period, which equals 36 total measure achievement points. This is compared to the previous performance period when the MIPS eligible clinician received only 5 measure achievement points per measure, for 30 total measure achievement points. The quality performance category achievement percent score is represented in line 2. For improvement, performance in the current 2018 MIPS performance period (60 percent) is compared to the performance category achievement percent score in the 2017 MIPS performance period (50 percent).
The current MIPS performance period quality performance category achievement percent score is compared to the previous performance period quality performance category achievement percent score. If the current score is higher, the MIPS eligible clinician may qualify for an improvement percent score to be added into the quality performance category percent score for the current performance year.
We propose to amend the regulatory text at § 414.1380(b)(1)(xvi) to state that improvement scoring is available to MIPS eligible clinicians and groups that demonstrate improvement in performance in the current MIPS performance period compared to the performance in the previous MIPS performance period, based on achievement. Bonus points or improvement percent score adjustments made to the category score in the prior or current performance period are not taken into account when determining whether an improvement has occurred or the size of any improvement percent score.
We invite public comment on our proposal to award improvement based on changes in the quality performance category achievement percent score.
We believe the improvement scoring methodology that we are proposing for the quality performance category recognizes the rate of increase in quality performance category scores of MIPS eligible clinicians from one performance period to another performance period so that a higher rate of improvement results in a higher improvement percent score. We believe this is particularly true for those clinicians with lower performance who will be incentivized to begin improving with the opportunity to increase their improvement significantly and achieve a higher improvement percent score.
We propose to award an “improvement percent score” based on the following formula:
Using the example from Table 27, the quality performance category achievement percent score for the current performance period is 60 percent, and the previous performance period achievement percent score is 50 percent. The increase in achievement is 10 percentage points (60 percent—50 percent). Therefore, the improvement percent score is 10 percent (increase in achievement)/50 percent (previous performance period achievement percent score) * 10 percent = 2 percentage points. Another way to explain the logic is a 20 percent rate of improvement for achievement (for example increasing the achievement percent score 10 percentage points which is 20 percent higher than the original 50 percent achievement percent score) is worth a 2 percentage point increase to the quality performance category achievement percent score.
We believe that this improvement scoring methodology provides an easily explained and applied approach that is consistent for all MIPS eligible clinicians. Additionally, it provides additional incentives for MIPS eligible clinicians who are lower performers to improve performance. We believe that providing larger incentives for MIPS eligible clinicians with lower quality performance category scores to improve will not only increase the quality performance category scores but also will have the greatest impact on improving quality for beneficiaries.
We also propose that the improvement percent score cannot be negative (that is, lower than zero percentage points). The improvement percent score would be zero for those who do not have sufficient data or who are not eligible under our proposal for improvement points. For example, as noted in section II.C.7.a.(2)(i)(ii) of this proposed rule, a MIPS eligible clinician would not be eligible for improvement if the clinician was not eligible for MIPS
Table 28 illustrates examples of the proposed improvement percent scoring methodology, which is based on rate of increase in quality performance category achievement percent scores.
We also considered an alternative to measuring the rate of improvement. The alternative would use band levels to determine the improvement points for MIPS eligible clinicians who qualify for improvement points. Under the band level methodology, a MIPS eligible clinician's improvement points would be determined by an improvement in the quality performance category achievement percent score from 1 year to the next year to determine improvement in the same manner as set forth in the rate of improvement methodology. However, for the band level methodology, an improvement percent score would then be assigned by taking into account a portion (50, 75 or 100 percent) of the improvement in achievement, based on the clinician's performance category achievement percent score for the prior year. Bands would be set for category achievement percent scores, with increases from lower category achievement scores earning a larger portion (percentage) of the improvement points. Under this alternative, simple improvement percentage points for improvement are awarded to MIPS eligible clinicians whose category scores improved across years according to the band level, up to a maximum of 10 percent of the total score.
In Table 29, we illustrate the band levels we considered as part of this alternative proposal. The chart depicts the band level and the improvement points allotted for the increases in improvement scores that fall within the transition year score range.
Table 30 illustrates examples of the improvement scoring methodology based on band levels. Generally, this methodology would generate a higher improvement percent score for clinicians; however, we believe the policy we proposed would provide a score that better represents true improvement at the performance category level, rather than comparing simple increases in performance category scores.
In addition, we considered another alternative that would adopt the improvement scoring methodology of the Shared Savings Program
We considered the Shared Savings Program methodology because it would promote alignment with ACOs. We ultimately decided not to adopt this scoring methodology because we believe having a single performance category level approach for all quality performance category scores encourages a uniformity in our approach to improvement scoring and simplifies the scoring rules for MIPS eligible clinicians. It also allows us greater flexibility to compare performance scores across the diverse submission mechanisms, which makes improvement scoring more broadly available to eligible clinicians and groups that elect different ways of participating in MIPS.
We propose to add regulatory text at § 414.1380(b)(1)(xvi)(C)(
We invite public comments on our proposal to calculate improvement scoring using a methodology that awards improvement points based on the rate of improvement and, alternatively, on rewarding improvement at the band level or using the Shared Saving Program approach for CMS Web Interface submissions.
In the CY 2017 Quality Payment Program final rule, we finalized at § 414.1380(b)(1)(xv) that the quality performance category score is the sum of all points assigned for the measures required for the quality performance category criteria plus bonus points, divided by the sum of total possible points (81 FR 77300). Using the terminology proposed in section II.C.7.a.(2) of this proposed rule, this formula can be represented as:
We propose to incorporate the improvement percent score, which is proposed in section II.C.7.a.(2)(i)(i) of this proposed rule, into the quality performance category percent score. We propose to amend § 414.1380(b)(1)(xv) (redesignated as § 414.1380(b)(1)(xvii)) to add the improvement percent score (as calculated pursuant to proposed paragraph (b)(1)(xvi)(A) through (F)) to the quality performance score. We also propose to amend § 414.1380(b)(1)(xv) (redesignated as § 414.1380(b)(1)(xvii)) to amend the text that states the quality performance category percent score cannot exceed the total possible points for the quality performance category to clarify that the total possible points for
This same formula and logic will be applied for both CMS Web Interface and Non-CMS Web Interface reporters.
Table 31 illustrates an example of calculating the quality performance category percent score including improvement for a non-CMS Web Interface reporter. In this example, an individual MIPS eligible clinician received measure achievement points for their 6 required measures, and received 6 measure bonus points. Because this is an individual clinician and the administrative claims based measure is not applicable, the total available measure achievement points for this clinician is 60. The improvement percent score would be calculated based on the proposal in section II.C.7.a.(2)(i) of this proposed rule; Table 31 does not illustrate the underlying calculations for the improvement percent score. To calculate the quality performance category percent score, the total measures achievement points would be summed with the total measure bonus points and then divided by the total available measure achievement points. The improvement percent score would be added to that calculation. The resulting quality performance category percent score cannot exceed 100 percentage points.
We note that the quality performance category percent score is then multiplied by the performance category weight for calculating the final score.
We invite public comment on this overall methodology and formula for calculating the quality performance category percent score.
We score the cost performance category using a methodology that is generally consistent with the methodology used for the quality performance category. In the CY 2017 Quality Payment Program final rule (81 FR 77309), we codified at § 414.1380(b)(2) that a MIPS eligible clinician receives 1 to 10 achievement points for each cost measure attributed to the MIPS eligible clinician based on the MIPS eligible clinician's performance compared to the measure benchmark. We establish a single benchmark for each cost measure and base those benchmarks on the performance period (81 FR 77309). Because we base the benchmarks on the performance period, we will not be able to publish the actual numerical benchmarks in advance of the performance period (81 FR 77309). We develop a benchmark for a cost measure only if at least 20 groups (for those MIPS eligible clinicians participating in MIPS as a group practice) or TIN/NPI combinations (for those MIPS eligible clinicians participating in MIPS as an individual) can be attributed the case minimum for the measure (81 FR 77309). If a benchmark is not developed, the cost measure is not scored or included in the performance category (81 FR 77309). For each set of benchmarks, we calculate the decile breaks based on cost measure performance during the performance period and assign 1 to 10 achievement points for each measure based on which benchmark decile range the MIPS eligible clinician's performance on the measure is between (81 FR 77309 through 77310). We also codified at § 414.1380(b)(2)(iii) that a MIPS eligible clinician's cost performance category score is the equally-weighted average of all scored cost measures (81 FR 77311).
In the CY 2017 Quality Payment Program final rule (81 FR 77311), we adopted a final policy to not calculate a cost performance category score if a MIPS eligible clinician or group is not attributed any cost measures because the MIPS eligible clinician or group has not met the case minimum requirements for any of the cost measures or a benchmark has not been created for any of the cost measures that would otherwise be attributed to the clinician or group. We inadvertently failed to include this policy in the regulation text and are proposing to codify it under § 414.1380(b)(2)(v).
For more of the statutory background and descriptions of our current policies for the cost performance category, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77308 through 77311).
In section II.C.7.a.(3)(a) of this proposed rule, we propose to add improvement scoring to the cost performance category scoring methodology starting with the 2020 MIPS payment year. We do not propose any changes to the methodology for scoring achievement in the cost performance category for the 2020 MIPS payment year other than the method used for facility-based measurement described in II.C.7.a.(4) of this proposed rule. We are proposing a change in terminology to refer to the “cost performance category percent score in order to be consistent with the terminology used in the quality performance category. In section II.C.7.a.(2) of this proposed rule, we propose to calculate a “quality performance category percent score” which is reflective of performance in the quality performance category based on dividing the sum of total measure achievement points and bonus points by the total available measure achievement points. We propose to revise § 414.1380(b)(2)(iii) to provide that a
In section II.C.7.a.(1)(b) of this proposed rule, we propose to make available to MIPS eligible clinicians and groups a method of measuring improvement in the quality and cost performance categories. In section II.C.7.a.(2)(i) of this proposed rule, for the quality performance category, we propose to assess improvement on the basis of the score at the performance category level. For the cost performance category, similar to the quality performance category, we propose at § 414.1380(b)(2)(iv) that improvement scoring is available to MIPS eligible clinicians and groups that demonstrate improvement in performance in the current MIPS performance period compared to their performance in the immediately preceding MIPS performance period (for example, demonstrating improvement in the 2018 MIPS performance period over the 2017 MIPS performance period).
In section II.C.7.a.(2)(i) of this proposed rule, we note the various challenges associated with attempting to measure improvement in the quality performance category at the measure level, given the many opportunities available to clinicians to select which measures to report. The cost performance category is not subject to this same issue of measure selection. Cost measures are calculated based on Medicare administrative claims data maintained by CMS, without any additional data input from or reporting by clinicians, and MIPS eligible clinicians are not given the opportunity to select which cost measures apply to them. We believe that there are advantages to measuring cost improvement at the measure level. Principally, MIPS eligible clinicians could see their performance on each cost measure and better understand how practice improvement changes can drive changes for each specific cost measure. Additionally, as discussed in section II.C.7.a.(1)(b)(i) of this proposed rule, other Medicare value-based purchasing programs generally assess performance improvement at the measure level. Therefore, we propose at section § 414.1380(b)(2)(iv)(A) to measure cost improvement at the measure level for the cost performance category.
As described in section II.C.7.a.(1)(b)(ii) of this proposed rule, we believe that we would have data sufficient to measure improvement when we can measure performance in the current performance period compared to the prior performance period. Due to the differences in our proposals for measuring improvement for the quality and cost performance categories, such as measuring improvement at the measure level versus the performance category level, we are proposing a different data sufficiency standard for the cost performance category than for the quality performance category, which is proposed in section II.C.7.a.(2)(i)(ii) of this proposed rule. First, for data sufficient to measure improvement to be available for the cost performance category, the same cost measure(s) would need to be specified for the cost performance category for 2 consecutive performance periods. For the 2020 MIPS payment year, only 2 cost measures, the MSPB measure and the total per capita cost measure, would be eligible for improvement scoring. For a measure to be scored in either performance period, a MIPS eligible clinician would need to have a sufficient number of attributed cases to meet or exceed the case minimum for the measure.
In addition, a clinician would have to report for MIPS using the same identifier (TIN/NPI combination for individuals, TIN for groups, or virtual group identifiers for virtual groups) and be scored on the same measure(s) for 2 consecutive performance periods. We wish to encourage action on the part of clinicians in reviewing and understanding their contribution to patient costs. For example, a clinician who is shown to have lower performance on the MSPB measure could focus on the efficient use of post-acute care and be able to see that improvement reflected in the cost improvement score in future years. This review could highlight opportunities for better stewardship of healthcare costs such as better recognition of unnecessary costs related to common ordering practices. For these reasons, we believe that improvement should be evaluated only when there is a consistent identifier.
Therefore, for the cost performance category, we are proposing at § 414.1380(b)(2)(iv)(B) that we would calculate a cost improvement score only when data sufficient to measure improvement is available. We are proposing that sufficient data would be available when a MIPS eligible clinician participates in MIPS using the same identifier in 2 consecutive performance periods and is scored on the same cost measure(s) for 2 consecutive performance periods (for example, in the 2017 MIPS performance period and the 2018 MIPS performance period). If the cost improvement score cannot be calculated because sufficient data is not available, we are proposing to assign a cost improvement score of zero percentage points. While the total available cost improvement score would be limited at first because only 2 cost measures would be included in both the first and second performance periods of the program (total per capita cost and MSPB), more opportunities for improvement scoring would be available in the future as additional cost measures, including episode-based measures, are added in future rulemaking. MIPS eligible clinicians would be able to review their performance feedback and make improvements compared to the score in their previous feedback.
We invite public comments on these proposals.
In section II.C.7.a.(1)(b)(i) of this proposed rule, we discuss a number of different programs and how they measure improvement at the category or measure level as part of their scoring systems. For example, the Hospital Value-Based Purchasing (VBP) Program awards either measure improvement or measure achievement, but not both. In the proposed method for the quality performance category, we compare the overall rate of achievement on all the underlying measures in the quality performance category and measure a rate of overall improvement to calculate an improvement percent score. We then add the improvement percent score after taking into account measure achievement points and measure bonus points as described in proposed § 414.1380(b)(1)(xvii). In reviewing the methodologies that are specified in section II.C.7.a.(1)(b)(i) of this proposed rule that include consideration of improvement at the measure level, we noted that the methodology used in the Shared Savings Program would best reward achievement and improvement
We propose to determine whether there was a significant improvement or decline in performance between the 2 performance periods by applying a common standard statistical test, a t-test, as is used in the Shared Savings Program (79 FR 67930 through 67931). The t-test's statistical significance and the t-test's effect size are the 2 primary outputs of the t-test. Statistical significance indicates whether the difference between sample averages is likely to represent an actual difference between populations and the effect size indicates whether that difference is large enough to be practically meaningful. Statistical significance testing in this case assesses how unlikely it is that differences as large as those observed would be due to chance when the performance is actually the same. The test recognizes and appropriately adjusts measures at both high and low levels of performance for statistically significant levels of change. However, as an alternative, we welcome public comments on whether we should consider instead adopting an improvement scoring methodology that measures improvement in the cost performance category the same way we propose to do in the quality performance category; that is, using the rate of improvement and without requiring statistical significance. We refer readers to section II.C.7.a.(2)(i) of this proposed rule for our proposal related to measuring improvement in the quality performance category.
Section 1848(q)(5)(D)(ii) of the Act specifies that the Secretary may assign a higher scoring weight under subparagraph (F) with respect to the achievement of a MIPS eligible clinician than with respect to any improvement of such clinician with respect to a measure, activity, or category described in paragraph (2). We believe that there are many opportunities for clinicians to actively work on improving their performance on cost measures, through more active care management or reductions in certain services. However, we recognize that most clinicians are still learning about their opportunities in cost measurement. We aim to continue to educate clinicians about opportunities in cost measurement and continue to develop opportunities for robust feedback and measures that better recognize the role of clinicians. Since MIPS is still in its beginning years and we understand that clinicians are working hard to understand how we measure costs for purposes of the cost performance category, as well as how we score their performance in all other aspects of the program, we believe improvement scoring in the cost performance category should be limited to avoid creating additional confusion. Based on these considerations, we propose in section II.C.6.d.(2) of this proposed rule to weight the cost performance category at zero percent for the 2020 MIPS payment year/2018 MIPS performance period. With the entire cost performance category proposed to be weighted at zero percent, we believe that the focus of clinicians should be on achievement as opposed to improvement, and therefore we propose at § 414.1380(b)(2)(iv)(E) that although improvement would be measured according to the method described above, the maximum cost improvement score for the 2020 MIPS payment year would be zero percentage points. Section 1848(q)(5)(D)(ii) of the Act provides discretion for the Secretary to assign a higher scoring weight under subparagraph (F), which refers to section 1848(q)(5)(F) of the Act, with respect to achievement than with respect to improvement. Section 1848(q)(5)(F) of the Act provides if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician, the Secretary shall assign different scoring weights (including a weight of zero) for measures, activities, and/or performance categories. When read together, we interpret sections 1848(q)(5)(D)(ii) and 1848(q)(5)(F) of the Act to provide discretion to the Secretary to assign a scoring weight of zero for improvement on the measures specified for the cost performance category. Under the improvement scoring methodology we have proposed, we believe a maximum cost improvement score of zero would be effectively the same as a scoring weight of zero. As a result of our proposal, the cost improvement score would not contribute to the cost performance category percent score calculated for the 2020 MIPS payment year. In other words, we would calculate a cost improvement score, but the cost improvement score would not contribute any points to the cost performance category percent score for the 2020 MIPS payment year.
In section II.C.6.d.(2) of this proposed rule, we consider an alternative to make no changes to the previously finalized weight of 10 percent for the cost performance category for the 2020 MIPS payment year. If we finalize this alternative, we believe that improvement should be given weight towards the cost performance category percent score, but it should still be limited. Therefore, we propose that if we maintain a weight of 10 percent for the cost performance category for the 2020 MIPS payment year, the maximum cost improvement score available in the cost performance category would be 1 percentage point out of 100 percentage points available for the cost performance category percent score. If a clinician were measured on only one measure consistently from one performance period to the next and met the requirements for improvement, the clinician would receive one improvement percentage point in the cost performance category percent score. If a clinician were measured on 2 measures consistently, improved significantly on one, and did not show significant improvement on the other (as measured by the t-test method described above), the clinician would receive 0.5 improvement percentage points.
We invite comments on these proposals as well as alternative ways to measure changes in statistical significance for the cost measure.
In section II.C.7.a.(1)(b) of this proposed rule, we evaluated different improvement scoring options used in other CMS programs. In those programs, we saw 2 general methods for
As noted in section II.7.b.(3) of this proposed rule, we have proposed a change in terminology to express the cost performance category percent score as a percentage. We propose to revise § 414.1380(b)(2)(iii) to provide that a MIPS eligible clinician's cost performance category percent score is the sum of the following, not to exceed 100 percent: The total number of achievement points earned by the MIPS eligible clinician divided by the total number of available achievement points (which can be expressed as a percentage); and the cost improvement score. With these two proposed changes, the formula would be (Cost Achievement Points/Available Cost Achievement Points) + (Cost Improvement Score) = (Cost Performance Category Percent Score).
We invite public comments on these proposals.
In Table 32, we provide an example of cost performance category percent scores along with the determination of improvement or decline. For illustrative purposes, we are using the alternative proposal of a maximum cost improvement score of 1. This example is for group reporting where the group is measured on both the total per capita cost measure and the MSPB measure for 2 consecutive performance periods.
In this example, there are 20 total possible measure achievement points and 14.6 measure achievement points earned by the group, and the group improved on one measure but not the other, with both measures being scored in each performance period. The cost improvement score would be determined as follows: ((1 measure with significant improvement−zero measures with significant decline)/2 measures) * 1 percentage point = 0.5 percentage points. Under the proposed revised formula, the cost performance category percent score would be (14.6/20) + 0.5% = 73.5%.
As discussed in section II.C.7.b.(2) of this proposed rule, in determining the MIPS final score, the cost performance category percent score is multiplied by the cost performance category weight. For the 2020 MIPS payment year, if we finalize the cost performance category weight of zero percent, then the cost performance category percent score will not contribute to the final score.
Section 1848(q)(2)(C)(ii) of the Act provides that the Secretary may use measures used for payment systems other than for physicians, such as measures for inpatient hospitals, for purposes of the quality and cost performance categories. However, the Secretary may not use measures for hospital outpatient departments, except in the case of items and services furnished by emergency physicians, radiologists, and anesthesiologists. In the MIPS and APMs RFI (80 FR 59108), we sought comment on how we could best use this authority. We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77127) for a summary of these comments.
As noted in the CY 2017 Quality Payment Program proposed rule (81 FR 28192), we considered an option for facility-based MIPS eligible clinicians to elect to use their institution's performance rates as a proxy for the MIPS eligible clinician's quality score. However, we did not propose an option for the transition year of MIPS because there were several operational considerations that we believed needed to be addressed before this option could be implemented. We requested comments on the following issues: (1) Whether we should attribute a facility's performance to a MIPS eligible clinician for purposes of the quality and cost performance categories and under what conditions such attribution would be appropriate and representative of the MIPS eligible clinician's performance; (2) possible criteria for attributing a facility's performance to a MIPS eligible clinician for purposes of the quality and cost performance categories; (3) the specific measures and settings for which we can use the facility's quality and cost data as a proxy for the MIPS eligible clinician's quality and cost performance categories; and (4) if attribution should be automatic or if an individual MIPS eligible clinician or group should elect for it to be done and choose the facilities through a registration process.
As noted in the CY 2017 Quality Payment Program final rule (81 FR 77127 through 77130), the majority of the comments we received supported attributing a facility's performance to a MIPS eligible clinician for purposes of the quality and cost performance categories. Some commenters opposed using a facility's quality and cost performance as a proxy for MIPS eligible clinicians. Many of these commenters expressed the view that facility scores do not represent the individual MIPS eligible clinician's performance. In addition, we received suggestions on how we should attribute a facility's performance to a MIPS eligible clinician, as well as comments suggesting that attribution should be voluntary and that the facility's measures should be relevant to the MIPS eligible clinician. A full discussion of the comments we received
In addition, we have received ongoing feedback from various stakeholder associations and individuals regarding facility-based measurement for MIPS eligible clinicians, which included: Support for MIPS eligible clinicians being able to choose to be assessed in this manner; several groups' preference that value-based purchasing and quality reporting program measure data be used for facility-based scoring; support for a “hybrid” approach where MIPS eligible clinicians could select both clinician-based measures and facility-based measures for purposes of MIPS scoring; and a suggested 2-year pilot program before expanding facility-based scoring more broadly with an emphasis on no negative impact on those who are measured in this fashion. We took this feedback, as well as the comments discussed in the CY 2017 Quality Payment Program final rule, into consideration when developing proposals for the application of facility-based measures.
We believe that facility-based measurement is intended to reduce reporting burden on facility-based MIPS eligible clinicians by leveraging existing quality data sources and value-based purchasing experiences and aligning incentives between facilities and the MIPS eligible clinicians who provide services there. In addition, we believe that facility-based MIPS eligible clinicians contribute substantively to their respective facilities' performance on facility-based measures of quality and cost, and that their performance may be better reflected by their facilities' performance on such measures.
Medicare operates both pay-for-reporting programs and pay-for-performance programs. Pay-for-reporting programs incentivize the act of reporting data on quality and/or other measures and activities, typically by applying a downward payment adjustment to facilities or clinicians, as applicable, that fail to submit data as required by the Secretary. This type of program does not adjust payments based on performance. In contrast, pay-for-performance programs, such as VBP programs, score facilities or clinicians, as applicable, on their performance on specified quality and/or other measures and activities and adjust payments based on that performance. Pay-for-performance programs, such as VBP programs, are more analogous to MIPS given its focus on performance and not just reporting. For this reason, we believe that facility-based measurement under MIPS should be based on pay-for-performance programs rather than pay-for-reporting programs.
Many Medicare payment systems include a pay-for-performance program, such as the Hospital VBP Program, the Skilled Nursing Facility VBP Program (SNF VBP), the End Stage Renal Disease Quality Incentive Program (ESRD QIP), and the Home Health Value-Based Purchasing Program (HHVBP). We believe that clinicians play a role in contributing to quality performance in all of these programs. However, we believe that a larger and more diverse group of clinicians contributes to quality in the inpatient hospital setting than in other settings in which we might begin to implement this measurement option. In addition, the inpatient hospital setting has a mature value-based purchasing program, first established to adjust payment for hospitals in FY 2013 (76 FR 26489). Therefore, we believe it is appropriate to implement this scoring option in a limited fashion in the first year of incorporating additional facility-based measures under MIPS by focusing on inpatient hospital measures that are used for certain pay-for-performance programs as facility-based measures.
The inpatient hospital setting includes three distinct pay-for-performance programs: The Hospital VBP Program, the Hospital Readmissions Reduction Program (HRRP), and the Hospital-Acquired Condition Reduction Program (HACRP). We believe that the Hospital VBP Program is most analogous to the MIPS program at this time because the Hospital VBP Program compares facilities on a series of different measures that intend to capture the breadth of care provided in a facility. In contrast, the HACRP and HRRP each focus on a single type of outcome for patients treated in a hospital (safety and readmissions, respectively), though we note that these outcomes are critically important to health care improvement. The payment adjustments associated with those 2 programs are intended to provide negative adjustments for poor performance but do not similarly reward high performance. In contrast, the Hospital VBP Program compares performance among hospitals and rewards high performers and provides negative adjustments to poor performers.
We also considered program timing when determining what Hospital VBP Program year to use for facility-based measurement for the 2020 MIPS payment year. Quality measurement for the FY 2019 Hospital VBP Program's performance period will be concluded by December 31, 2017 (we refer readers to the finalized FY 2019 performance periods in the FY 2017 Inpatient Prospective Payment System/Long-Term Care Hospital Prospective Payment System Final Rule, 81 FR 57002), and the Hospital VBP Program scoring reports (referred to as the Percentage Payment Summary Reports) will be provided to participating hospitals not later than 60 days prior to the beginning of FY 2019, pursuant to the Hospital VBP Program's statutory requirement at section 1886(o)(8) of the Act. We further note that hospitals must meet case and measure minimums during the performance period to receive a Total Performance Score under that Program. We discuss eligibility for facility-based measurement in section II.C.7.b.(4)(c) of this proposed rule, and we note that the determination of the applicable hospital will be made on the basis of a period that overlaps with the applicable Hospital VBP Program performance period. Although Hospital VBP Program measures have different measurement periods, the FY 2019 measures all overlap from January to June in 2017, which also overlaps with our first 12-month period to determine MIPS eligibility.
We believe that MIPS eligible clinicians electing the facility-based measurement option under MIPS should be able to consider as much information as possible when making that decision, including how their attributed hospital performed in the Hospital VBP Program because an individual clinician is a part of the clinical team in the hospital, rather than the sole clinician responsible for care as tracked by quality measures. Therefore, we concluded that we should be as transparent as possible with MIPS eligible clinicians about their potential facility-based scores before they begin data submission for the MIPS performance period since this policy option is intended to minimize reporting burdens on clinicians that are already participating in quality improvement efforts through other CMS programs. We expect that MIPS eligible clinicians that would consider facility-based scoring would generally be aware of their hospital's performance on its quality measures, but believe that providing this information directly to clinicians ensures that such clinicians are fully aware of the implications of their scoring elections under MIPS. However, we note that this policy could conceivably place non-facility-based MIPS eligible clinicians at a competitive
The performance periods proposed in section II.C.5. of this proposed rule for the 2020 MIPS payment year occur in 2018, with data submission for most mechanisms starting in January 2019. To provide potential facility-based scores to clinicians by the time the data submission period for the 2018 MIPS performance period begins assuming that timeframe is operationally feasible), we believe that the FY 2019 program year of the Hospital VBP Program, as well as the corresponding performance periods, is the most appropriate program year to use for purposes of facility-based measurement under the quality and cost performance categories for the 2020 MIPS payment year. However, we note also that Hospital VBP performance periods can run for periods as long as 36 months, and for some FY 2019 Hospital VBP Program measures, the performance period begins in 2014. We request comment on whether this lengthy performance period duration should override our desire to include all Hospital VBP Program measures as discussed further below. We propose at § 414.1380(e)(6)(iii) that the performance period for facility-based measurement is the performance period for the measures for the measures adopted under the value-based purchasing program of the facility of the year specified.
We considered whether we should include the entire set of Hospital VBP Program measures for purposes of facility-based measurement under MIPS or attempt to differentiate those which may be more influenced by clinicians' contribution to quality performance than others. However, we believe that clinicians have a broad and important role as part of the healthcare team at a hospital and that attempting to differentiate certain measures undermines the team-based approach of facility-based measurement. We propose at § 414.1380(e)(6)(i) that the quality and cost measures are those adopted under the value-based purchasing program of the facility program for the year specified.
Therefore, we propose for the 2020 MIPS payment year to include all the measures adopted for the FY 2019 Hospital VBP Program on the MIPS list of quality measures and cost measures. Under this proposal, we consider the FY 2019 Hospital VBP Program measures to meet the definition of additional system-based measures provided in section 1848(q)(2)(C)(ii) of the Act, and we propose at § 414.1380(e)(1)(i) that facility-based measures available for the 2018 MIPS performance period are the measures adopted for the FY 2019 Hospital VBP Program year authorized by section 1886(o) of the Act and codified in our regulations at §§ 412.160 through 412.167. Measures in the FY 2019 Hospital VBP Program have different performance periods as noted in Table 33.
We request comments on these proposals. We also request comments on what other programs, if any, we should consider including for purposes of facility-based measurement under MIPS in future program years.
The percentage of professional time a clinician spends working in a hospital varies considerably. Some clinicians may provide services in the hospital regularly, but also treat patients extensively in an outpatient office or another environment. Other clinicians may practice exclusively within a hospital. Recognizing the various levels of presence of different clinicians within a hospital environment, we seek to limit the potential applicability of facility-based measurement to those MIPS eligible clinicians with a significant presence in the hospital.
In the CY 2017 Quality Payment Program final rule (81 FR 77238 through 77240), we adopted a definition of “hospital-based MIPS eligible clinician” under § 414.1305 for purposes of the advancing care information performance category. Section 414.1305 defines a hospital-based MIPS eligible clinician as a MIPS eligible clinician who furnishes 75 percent or more of his or her covered professional services in sites of service identified by the POS codes used in the HIPAA standard transaction as an inpatient hospital, on-campus outpatient hospital, or emergency room setting, based on claims for a period prior to the performance period as specified by CMS. We considered whether we should simply use this definition to determine eligibility for facility-based measurement under MIPS. However, we are concerned that this definition could include many clinicians that have limited or no presence in the inpatient hospital setting. We have noted that hospital-based clinicians may not have control over important aspects of the certified EHR technology that is available in the hospital setting (81 FR 77238). In that regard, there is little difference between outpatient and inpatient hospital settings. But we are proposing to determine a MIPS eligible clinician's quality performance category score and cost performance category score based on a hospital's Hospital VBP performance, which is based on inpatient services. Section 1848(q)(2)(C)(ii) of the Act limits our ability to incorporate measures used for hospital outpatient departments. Our proposal at section II.C.6.f.(7)(a)(i) of this proposed rule to expand the definition of a hospital-based MIPS eligible clinician for the advancing care information performance category to include clinicians who practice primarily in off-campus outpatient hospitals could include clinicians that practice many miles away from the hospital in practices which are owned by the hospital, but do not substantially contribute to the hospital's Hospital VBP Program performance. As we discuss further in this section, the measures used in the Hospital VBP Program are focused on care provided in the inpatient setting. We do not believe it is appropriate for a MIPS eligible clinician to use a hospital's Hospital VBP Program performance for MIPS scoring if they did not provide services in that setting.
Therefore, we believe establishing a different definition for purposes of facility-based measurement is necessary to implement this option. We also note that, since we are seeking comments above on other programs to consider including for purposes of facility-based measurement in future years, we believe establishing a separate definition that could be expanded as needed for this purpose is appropriate. We propose at § 414.1380(e)(2) that a MIPS eligible clinician is eligible for facility-based
We note that this more limited definition would mean that a clinician who is determined to be facility-based likely would also be determined to be hospital-based for purposes of the advancing care information performance category, because this proposed definition of facility-based is narrower than the hospital-based definition established for that purpose. Clinicians would be determined to be facility-based through an evaluation of covered professional services between September 1 of the calendar year 2 years preceding the performance period through August 31 of the calendar year preceding the performance period with a 30-day claims run out. For example, for the 2020 MIPS payment year, where we have adopted a performance period of CY 2018 for the quality and cost performance categories, we would use the data available at the end of October 2017 to determine whether a MIPS eligible clinician is considered facility-based by our definition. At that time, those data would include Medicare claims with dates of service between September 1, 2016 and August 31, 2017. In the event that it is not operationally feasible to use claims from this exact time period, we would use a 12-month period as close as practicable to September 1 of the calendar year 2 years preceding the performance period and August 31 of the calendar year preceding the performance period. This determination would allow clinicians to be made aware of their eligibility for facility-based measurement near the beginning of the MIPS performance period. We believe that this definition allows us to identify MIPS eligible clinicians who are significant contributors to facilities' care for Medicare beneficiaries and other patients for purposes of facility-based measurement.
We also recognize that in addition to the variation in the percentage of time a clinician is present in the hospital, there is also great variability in the types of services that clinicians perform. Some may be responsible for overall management of patients throughout their stay, others may perform a procedure, and others may serve a role in supporting diagnostics. We considered whether certain clinicians should be identified as eligible for this facility-based measurement option based on characteristics in addition to their percentage of covered professional services furnished in the inpatient hospital or emergency room setting, such as by requiring a certain specialty such as hospital medicine or by limiting eligibility to those who served in patient-facing roles. However, we believe that all MIPS eligible clinicians with a significant presence in the facility play a role in the overall performance of a facility, and therefore, are not proposing at this time to further limit this option based on characteristics other than the percentage of covered professional services furnished in an inpatient hospital or emergency room setting. Additionally, we believe that allowing facility-based MIPS eligible clinicians the most flexibility possible, while still being able to accurately measure the value of care those clinicians provide, as we continue implementation of the Quality Payment Program is paramount in ensuring that clinicians understand the program and its effects on the care they provide.
We request comments on this proposal.
We are also proposing at § 414.1380(e)(2) that a MIPS eligible clinician is eligible for facility-based measurement under MIPS if they are determined facility-based as part of a group. We are proposing at § 414.1380(e)(2)(ii) that a facility-based group is a group in which 75 percent or more of the MIPS eligible clinician NPIs billing under the group's TIN are eligible for facility-based measurement as individuals as defined in § 414.1380(e)(2)(i). We also considered an alternative proposal in which a facility-based group would be a group where the TIN overall furnishes 75 percent or more of its covered professional services (as defined in section 1848(k)(3)(A) of the Act) in sites of service identified by the POS codes used in the HIPAA standard transaction as an inpatient hospital, as identified by POS code 21, or the emergency room, as identified by POS code 23, based on claims for a period prior to the performance period as specified by CMS. Groups would be determined to be facility-based through an evaluation of covered professional services between September 1 of the calendar year 2 years preceding the performance period through August 31 of the calendar year preceding the performance period with a 30 day claims run out period (or if not operationally feasible to use claims from this exact time period, a 12-month period as close as practicable to September 1 of the calendar year 2 years preceding the performance period and August 31 of the calendar year preceding the performance period).
We request comments on our proposal and alternative proposal.
Many MIPS eligible clinicians provide services at more than one hospital, so we must develop a method to identify which hospital's scores should be associated with that MIPS eligible clinician under this facility-based measurement option. We considered
Therefore, we propose at § 414.1380(e)(5) that MIPS eligible clinicians who elect facility-based measurement would receive scores derived from the value-based purchasing score (using the methodology described in section II.B.7.b.4 of this proposed rule) for the facility at which they provided services for the most Medicare beneficiaries during the period of September 1 of the calendar year 2 years preceding the performance period through August 31 of the calendar year preceding the performance period with a 30 day claims run out. This mirrors our period of determining if a clinician is eligible for facility-based measurement and also overlaps with parts of the performance period for the applicable Hospital VBP program measures. For the first year, the value-based purchasing score for the facility is the FY 2019 Hospital VBP Program's Total Performance Score. In cases in which there was an equal number of Medicare beneficiaries treated at more than one facility, we propose to use the value-based purchasing score from the facility with the highest score.
Stakeholders have expressed a strong preference that facility-based measurement be a voluntary process, and we agree with this preference considering our general goal in making MIPS as flexible as possible. Therefore, we propose at § 414.1380(e)(3) that individual MIPS eligible clinicians or groups who wish to have their quality and cost performance category scores determined based on a facility's performance must elect to do so. We propose that those clinicians or groups who are eligible for and wish to elect facility-based measurement would be required to submit their election during the data submission period as determined at § 414.1325(f) through the attestation submission mechanism established for the improvement activities and advancing care information performance categories. If technically feasible, we would let the MIPS eligible clinician know that they were eligible for facility-based measurement prior to the submission period, so that MIPS eligible clinicians would be informed if this option is available to them.
We also considered an alternative approach of not requiring an election process but instead automatically applying facility-based measurement to MIPS eligible clinicians and groups who are eligible for facility-based measurement, if technically feasible. Under this approach, we would calculate a MIPS eligible clinician's facility-based measurement score based on the hospital's (as identified using the process described in section II.C.6.b. of this proposed rule) performance using the methodology described in section II.C.7.a.2.b. of this proposed rule, and automatically use that facility-based measurement score for the quality and cost performance category scores if the facility-based measurement score is higher than the quality and cost performance category scores as determined based on data submitted by the MIPS eligible clinician through any available reporting mechanism. This facility-based measurement score would be calculated even if an individual MIPS eligible clinician or group did not submit any data for the quality performance category. This option would reduce burden for MIPS eligible clinicians by not requiring them to elect facility-based measurement, but is contrary to stakeholders' request for a voluntary policy. Additionally, under this option, our considerations about Hospital VBP Program timing would be less applicable. That is, we explained our rationale for specifying the FY 2019 Hospital VBP Program above, in part to ensure that MIPS eligible clinicians are informed about their potential facility-based scores prior to the conclusion of the MIPS performance period. However, under an automatic process, we could consider automatically using other Hospital VBP Program years' scores. For example, we could apply FY 2020 Hospital VBP Program scores instead of FY 2019. We intend in general to align Hospital VBP and MIPS performance periods when feasible, and the timing considerations we described above led us to conclude that FY 2019 was the most appropriate Hospital VBP Program year for the first year of the facility-based measurement option under MIPS, and selecting other years would result in further divergence between the MIPS performance period and the Hospital VBP Program's performance periods. We are also concerned that a method that does not require active selection may result in MIPS eligible clinicians being scored on measures at a facility and being unaware that such scoring is taking place. We are also concerned that such a method could provide an advantage to those facility-based clinicians who do not submit quality measures in comparison to those who work in other environments. We also note that this option may not be technically feasible for us to implement for the 2018 MIPS performance period.
We invite comments on this proposal and alternate proposal.
For the FY 2019 program year, the Hospital VBP Program has adopted 13 quality and efficiency measures. The Hospital VBP Program currently includes 4 domains: Person and community engagement, clinical care, safety, and efficiency and cost reduction. These domains align with many MIPS high priority measures (outcome, appropriate use, patient safety, efficiency, patient experience, and care coordination measures) in the quality performance category and the efficiency and cost reduction domain closely aligns with our cost performance category. We believe this set of measures covering 4 domains and composed primarily of measures that would be considered high priority under the MIPS quality performance category capture a broad picture of hospital-based care. For example, the HCAHPS survey under the Hospital VBP Program is a patient experience measure, which would make it a high-priority measure under MIPS. Additionally, the Hospital VBP Program has adopted several measures of clinical outcomes in the form of 30-day mortality measures, and clinical outcomes are a high-priority topic for MIPS. The Hospital VBP Program includes several measures in a Safety domain, which meets our definition of patient safety measures as high-priority. Therefore, we propose that facility-based individual MIPS eligible clinicians or groups that are attributed to a hospital would be scored on all the measures on which the hospital is scored for the Hospital VBP Program via the Hospital VBP Program's Total
The Hospital VBP Program's FY 2019 measures, and their associated performance periods, have been reproduced in Table 33 (see 81 FR 56985 and 57002).
We note that the Patient Safety Composite Measure (PSI–90) was proposed for removal beginning with the FY 2019 measure set in the FY 2018 IPPS/LTCH proposed rule (82 FR 19970) due to issues with calculating the measure score. If the proposal to remove that measure from the hospital measure set is finalized, we would remove the measure from the list of those adopted for facility-based measurement in the MIPS program.
We propose at § 414.1380(e)(4) that there are no data submission requirements for the facility-based measures used to assess performance in the quality and cost performance categories, other than electing the option through attestation as proposed in section II.C.7.a.(4)(e). We also refer readers to section II.C.7. of this proposed rule for further details on how we will incorporate scoring for facility-based measurements into MIPS.
As we discuss above in subsection (b), we believe that the Hospital VBP Program represents the most appropriate value-based purchasing program with which to begin implementation of the facility-based measurement option under MIPS.
Section 1886(o) of the Act, as added by section 3001(a)(1) of the Affordable Care Act, requires the Secretary to establish a hospital value-based purchasing program (the Hospital VBP Program) under which value-based incentive payments are made in a fiscal year to hospitals that meet performance standards established for a performance period for such fiscal year. These value-based incentive payments are funded through a reduction to participating hospitals' base-operating DRG payment amounts, with the amount of the reduction specified by statute. For the FY 2019 program year, that reduction will be equal to 2 percent. Participating hospitals then receive value-based incentive payments depending on their performance on measures adopted
As noted previously, the FY 2019 Hospital VBP Program will score participating hospitals on 13 measures covering 4 domains of care, although as discussed in the FY 2018 IPPS/LTCH proposed rule (82 FR 19970), we have proposed to remove the PSI 90 Patient Safety Composite measure from the FY 2019 measure set. For each of the measures, performance standards are established for the applicable fiscal year that include levels of achievement and improvement. For the FY 2019 program year, the achievement threshold and benchmark are calculated using baseline period data with respect to that fiscal year, with the achievement threshold for each of these measures being the median of hospital performance on the measure during the baseline period and the benchmark for each of these measures being the arithmetic mean of the top decile of hospital performance during the baseline period. The achievement threshold and benchmark for the MSPB measure are calculated using the same methodology, except that we use performance period data instead of baseline period data in our calculations. We then calculate hospital performance on each measure during the performance period for which they have sufficient data and calculate a measure score based on that performance as compared with the performance standards that apply to the measure. For achievement scoring, those hospitals that perform below (or above in the case of measures for which a lower rate is better) the level of the achievement threshold are not awarded any achievement points. Those that perform between the level of the achievement threshold and the benchmark are awarded points based on the relative performance of the hospital, according to formulas specified by the Hospital VBP Program (see the Hospital Inpatient VBP Program final rule, 76 FR 26518 through 26519). Those hospitals whose performance meets or exceeds the benchmark are awarded 10 achievement points for the measure. Hospitals are also provided the opportunity to receive improvement points based on their improvement between the baseline period for the measure and the performance period. A hospital is awarded between 0 and 10 points for achievement and 0 and 9 points for improvement, and is awarded the higher of the 2 scores for each individual measure. There are no floors established for scoring and no bonus points are available in this scoring system.
Points awarded for measures within each domain are summed to reach the unweighted domain score. We note for the person and community engagement domain only, the domain score consists of a base score and a consistency score. The base score is based on the greater of improvement or achievement points for each of the 8 HCAHPS survey dimensions. Consistency points are awarded based on a hospital's lowest HCAHPS dimension score during the performance period relative to national hospital scores on that dimension during the baseline period. The domain scores are then weighted according to domain weights specified each Program year, then summed to reach the Total Performance Score, which is converted to a value-based incentive payment percentage that is used to adjust payments to each hospital for inpatient services furnished during the applicable program year. For the FY 2019 program year, all 4 domains will be weighted equally. We refer readers to 81 FR 57005 and 81 FR 79857 through 79858 for additional information on the Hospital VBP Program's performance standards, as well as the QualityNet Web site for certain technical updates to the performance standards.
We considered several methods to incorporate facility-based measures into scoring for the 2020 MIPS payment year, including selecting hospitals' measure scores, domain scores, and the Hospital VBP Program Total Performance Scores to form the basis for the cost and quality performance category scores for individual MIPS eligible clinicians and groups that are eligible to participate in facility-based measurement. Although each of these approaches may have merit, we have proposed the option that we believe provides the fairest comparison between performance in the 2 programs and will best allow us to expand the opportunity to other programs in the future.
Unlike MIPS, the Hospital VBP Program does not have performance categories. There are instead four domains of measures. We considered whether we should try to identify certain domains or measures that were more closely aligned with those identified in the quality performance category or the cost performance category. We also considered whether we should limit the application of facility-based measurement to the quality performance category and calculate the cost performance category score as we do for other clinicians. However, we believe that value-based purchasing programs are generally constructed to assess an overall picture of the care provided by the facility, taking into account both the costs and the quality of care provided. Given our focus on alignment between quality and cost, we also do not believe it is appropriate to measure quality on one unit (a hospital) and cost on another (such as an individual clinician or TIN). Therefore, we propose at § 414.1380(e) that facility-based scoring is available for the quality and cost performance categories and that the facility-based measurement scoring standard is the MIPS scoring methodology applicable for those who meet facility-based eligibility requirements and who elect facility-based measurement.
Measures in the MIPS quality performance category are benchmarked to historical performance on the basis of performance during the 12-month calendar year that is 2 years prior to the performance period for the MIPS payment year. If a historical benchmark cannot be established, a benchmark is calculated during the performance period. In the cost performance category, benchmarks are established during the performance period because changes in payment policies year to year can make it challenging to compare performance on cost measure year to year. Although we propose a different performance period for MIPS eligible clinicians in facility-based measurement, the baseline period used for creating MIPS benchmarks is generally consistent with this approach. We note that the Hospital VBP Program uses measures for the same fiscal year even if those measures do not have the same performance period length, but the baseline period closes well before the performance period. The MSPB is benchmarked in a manner that is similar to measures in the MIPS cost performance category. The MSPB only uses a historical baseline period for improvement scoring and bases its achievement threshold and benchmark solely on the performance period (81 FR 57002). We propose at § 414.1380(e)(6)(ii) that the benchmarks for facility-based measurement are those that are adopted under the value-based purchasing program of the facility for the year specified.
Performance measurement in the Hospital VBP Program and MIPS is quite different in part due to the design and the maturity of the programs. As noted above, the Hospital VBP Program only assigns achievement points to a hospital for its performance on a measure if the hospital's performance during the performance period meets or exceeds the median of hospital performance on that measure during the applicable baseline period, whereas MIPS assigns achievement points to all measures that meet the required data completeness and case minimums. In addition, the Hospital VBP Program has removed many process measures and topped out measures since its first program year (FY 2013), while both process and topped out measures are available in MIPS. With respect to the FY 2017 program year, for example, the median Total Performance Score for a hospital in Hospital VBP was 33.88 out of 100 possible points. If we were to simply assign the Hospital VBP Total Performance Score for a hospital to a clinician, the performance of those MIPS eligible clinicians electing facility-based measurement would likely be lower than most who participated in the MIPS program, particularly in the quality performance category.
We believe that we should recognize relative performance in the facility programs that reflects their different designs. Therefore, we propose at § 414.1380(e)(6)(iv) that the quality performance category score for facility-based measurement is reached by determining the percentile performance of the facility determined in the value-based purchasing program for the specified year as described under § 414.1380(e)(5) and awarding a score associated with that same percentile performance in the MIPS quality performance category score for those clinicians who are not scored using facility-based measurement. We also propose at § 414.1380(e)(6)(v) that the cost performance category score for facility-based measurement is established by determining the percentile performance of the facility determined in the value-based purchasing program for the specified year as described in § 414.1380(e)(5) and awarding the number of points associated with that same percentile performance in the MIPS cost performance category score for those clinicians who are not scored using facility-based measurement. For example, if the median Hospital VBP Program Total Performance Score was 35 out of 100 possible points and the median quality performance category percent score in MIPS was 75 percent and the median cost performance category score was 50 percent, then a clinician or group that is evaluated based on a hospital that received an Hospital VBP Program Total Performance Score of 35 points would receive a score of 75 percent for the quality performance category and 50 percent for the cost performance category. The percentile distribution for both the Hospital VBP Program and MIPS would be based on the distribution during the applicable performance periods for each of the programs and not on a previous benchmark year.
We believe this proposal offers a fairer comparison of the performance among participants in MIPS and the Hospital VBP Program compared to other options we considered and provides an objective means to normalize differences in measured performance between the programs. In addition, we believe this method will make it simpler to apply the concept of facility-based measurement to additional programs in the future.
We welcome public comments on this proposal.
The Hospital VBP Program includes a methodology for recognizing improvement on individual measures which is then incorporated into the total performance score for each participating hospital. A hospital's performance on a measure is compared to a national benchmark as well as its own performance from a corresponding baseline period.
In this proposed rule, we have proposed to consider improvement in the quality and cost performance categories. In section II.C.7.a.(2)(i) of this proposed rule, we propose to measure improvement in the quality performance category based on improved achievement for the performance category percent score and award improvement even if, under certain circumstances, a clinician moves from one identifier to another from 1 year to the next. For those who may be measured under facility-based measurement, improvement is already captured in the scoring method used by the Hospital VBP Program, so we do not believe it is appropriate to separately measure improvement using the proposed MIPS methodology. Although the improvement methodology is not identical, a hospital that demonstrated improvement in the individual measures would in turn receive a higher score through the Hospital VBP Program methodology, so that improvement is reflected in the underlying Hospital VBP Program measurement. In addition, improvement is already captured in the distribution of MIPS performance scores that is used to translate Hospital VBP Total Performance Score into a MIPS quality performance category score. Therefore, we are not proposing any additional improvement scoring for facility-based measurement for either the quality or cost performance category.
Because we intend to allow clinicians the flexibility to elect facility-based measurement on an annual basis, some clinicians may be measured through facility-based measurement in 1 year and through another MIPS method in the next. Because the first MIPS performance period in which a clinician could switch from facility-based measurement to another MIPS method would be in 2019, we seek comment on how to assess improvement for those that switch from facility-based scoring to another MIPS method. We request comment on whether it is appropriate to include measurement of improvement in the MIPS quality performance category for facility-based measured clinicians and groups given that the Hospital VBP Program already takes improvement into account in its scoring methodology.
In section II.C.7.a.(3)(a) of this proposed rule, we discuss our proposal to measure improvement in the cost performance category at the measure level. We propose that clinicians under facility-based measurement would not be eligible for a cost improvement score in the cost performance category. As in the quality performance category, we believe that a clinician participating in facility-based measurement in subsequent years would already have improvement recognized as part of the Hospital VBP Program methodology and should therefore not be given additional credit. In addition, because we propose to limit measurement of improvement to those MIPS eligible clinicians that participate in MIPS using the same identifier and are scored on the same cost measure(s) in 2 consecutive performance periods, those MIPS eligible clinicians who elect facility-based measurement would not be eligible for a cost improvement score in the cost performance category under our proposed methodology because they would not be scored on the same cost measure(s) for 2 consecutive performance periods.
We invite comments on these proposals.
MIPS eligible clinicians that report on quality measures are eligible for bonus points for the reporting of additional outcome and high priority measures beyond the one that is required. 2 bonus points are awarded for each additional outcome or patient experience measure, and one bonus point is awarded for each additional other high priority measure. These bonus points are intended to encourage the use of measures that are more impactful on patients and better reflect the overall goals of the MIPS program. Many of the measures in the Hospital VBP Program meet the criteria that we have adopted for high-priority measures. We support measurement that takes clinicians' focus away from clinical process measures; however, our proposed scoring method described above is based on a percentile distribution of scores within the quality and cost performance categories that already accounts for bonus points. For this reason, we are not proposing to calculate additional high priority bonus points for facility-based measurement.
We note that clinicians have an additional opportunity to receive bonus points in the quality performance category score for using end-to-end electronic submission of quality measures. The Hospital VBP Program does not capture whether or not measures are reported using end-to-end electronic reporting. In addition, our proposed facility-based scoring method described above is based on a percentile distribution of scores within the quality and cost performance categories that already accounts for bonus points. For this reason, we are not proposing to calculate additional end-to-end electronic reporting bonus points for facility-based measurement.
We welcome public comments on our approach.
Some hospitals do not receive a Total Performance Score in a given year in the Hospital VBP Program, whether due to insufficient quality measure data, failure to meet requirements under the Hospital Inpatient Quality Reporting Program, or other reasons. In these cases, we would be unable to calculate a facility-based score based on the hospital's performance, and facility-based clinicians would be required to participate in MIPS via another method. Most hospitals which do not receive a Total Performance Score in the Hospital VBP Program are routinely excluded, such as hospitals in Maryland. In such cases, facility-based clinicians would know well in advance that the hospital would not receive a Total Performance Score, and that they would need to participate in MIPS through another method. However, we are concerned that some facility-based clinicians may provide services in hospitals which they expect will receive a Total Performance Score but do not due to various rare circumstances such as natural disasters. In section II.C.7.b.(3)(c) of this proposed rule, we propose a process for requesting a reweighting assessment for the quality, cost and improvement activities performance categories due to extreme and uncontrollable circumstances, such as natural disasters. We propose that MIPS eligible clinicians who are facility-based and affected by extreme and uncontrollable circumstances, such as natural disasters, may apply for reweighting.
In addition, we note that hospitals may submit correction requests to their Total Performance Scores calculated under the Hospital VBP Program, and may also appeal the calculations of their Total Performance Scores, subject to Hospital VBP Program requirements established in prior rulemaking. We intend to use the final Hospital VBP Total Performance Score for the facility-based measurement option under MIPS. In the event that a hospital obtains a successful correction or appeal of its Total Performance Score, we would update MIPS eligible clinicians' quality and cost performance category scores accordingly, as long as the update could be made prior to the application of the MIPS payment adjustment for the relevant MIPS payment year. We welcome public comments on whether a different deadline should be considered.
Additionally, although we wish to tie the hospital and clinician performance as closely together as possible for purposes of the facility-based scoring policy, we do not wish to disadvantage those clinicians and groups that select this measurement method. In section II.C.7.a.(2) of this proposed rule, we propose to retain a policy equivalent to the 3-point floor for all measures with complete data in the quality performance category scored against a benchmark in the 2020 MIPS payment year. However, the Hospital VBP Program does not have a corresponding scoring floor. Therefore, we propose to adopt a floor on the Hospital VBP Program Total Performance Score for purposes of facility-based measurement under MIPS so that any score in the quality performance category, once translated into the percentile distribution described above, that would result in a score of below 30 percent would be reset to a score of 30 percent in the quality performance category. We believe that this adjustment is important to maintain consistency with our other policies. There is no similar floor established for measures in the cost performance category under MIPS, so we do not propose any floor for the cost performance category for facility-based measurement.
Some MIPS eligible clinicians who select facility-based measurement could have sufficient numbers of attributed patients to meet the case minimums for the cost measures established under MIPS. Although there is no additional data reporting for cost measures, we believe that, to facilitate the relationship between cost and quality measures, they should be evaluated covering the same population as opposed to comparing a hospital population and a population attributed to an individual clinician or group. In addition, we believe that including additional cost measures in the cost performance category score for MIPS eligible clinicians who elect facility-based measurement would reduce the alignment of incentives between the hospital and the clinician. Thus, we are proposing at § 414.1380(e)(6)(v)(A) that MIPS eligible clinicians who elect facility-based measurement would not be scored on other cost measures specified for the cost performance category, even if they meet the case minimum for a cost measure.
If a clinician or a group elects facility-based measurement but also submits quality data through another MIPS mechanism, we propose to use the higher of the two scores for the quality performance category and base the score of the cost performance category on the same method (that is, if the facility-based quality performance category score is higher, facility-based measurement is used for quality and cost). Since this policy may result in a higher final score, it may provide facility-based clinicians with a substantial incentive to elect facility-based measurement, whether or not the clinician believes such measures are the most accurate or useful measures of that clinician's performance. Therefore, this policy may create an unfair advantage for facility-based clinicians over non-facility-based clinicians, since non-facility-based clinicians would not have the opportunity to use the higher of two scores. Therefore, we seek comment on whether this proposal to use the higher score is the best approach to score the performance of facility-based clinicians
Section 1848(q)(5)(C) of the Act specifies scoring rules for the improvement activities performance category. For more of the statutory background and description of the proposed and finalized policies, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77311 through 77319). We have also codified certain requirements for the improvement activities performance category at § 414.1380(b)(3). Based on these criteria, we finalized at § 414.1380(b)(3) in the CY 2017 Quality Payment Program final rule the scoring methodology for this category, which assigns points based on certified patient-centered medical home participation or comparable specialty practice participation, APM participation, and the improvement activities reported by the MIPS eligible clinician (81 FR 77312). A MIPS eligible clinician's performance will be evaluated by comparing the reported improvement activities to the highest possible score (40 points). We are not proposing any changes to the scoring of the improvement activities performance category in this proposed rule.
We will assign points for each reported improvement activity within 2 categories: Medium-weighted and high-weighted activities. Each medium-weighted activity is worth 10 points toward the total category score of 40 points, and each high-weighted activity is worth 20 points toward the total category score of 40 points. These points are doubled for small practices, practices in rural areas, or practices located in geographic HPSAs, and non-patient facing MIPS eligible clinicians. We refer readers to § 414.1380(b)(3) and the CY 2017 Quality Payment Program final rule (81 FR 78312) for further detail on improvement activities scoring.
Activities will be weighted as high based on the extent to which they align with activities that support the certified patient-centered medical home, since that is consistent with the standard under section 1848(q)(5)(C)(i) of the Act for achieving the highest potential score for the improvement activities performance category, as well as with our priorities for transforming clinical practice (81 FR 77311). Additionally, activities that require performance of multiple actions, such as participation in the Transforming Clinical Practice Initiative (TCPI), participation in a MIPS eligible clinician's state Medicaid program, or an activity identified as a public health priority (such as emphasis on anticoagulation management or utilization of prescription drug monitoring programs) are justifiably weighted as high (81 FR 77311 through 77312).
We refer readers to Table 26 of the CY 2017 Quality Payment Program final rule for a summary of the previously finalized improvement activities that are weighted as high (81 FR 77312 through 77313), and we refer readers to Table H of the same final rule, for a list of all the previously finalized improvement activities, both medium- and high-weighted (81 FR 77817 through 77831). Please refer to Table F and Table G in the appendices of this proposed rule for proposed additions and changes to the Improvement Activities Inventory for the 2020 MIPS payment year and future years. Activities included in these proposed tables would apply for the 2020 MIPS payment year and future years unless further modified via notice and comment rulemaking. Consistent with our unified scoring system principles, we finalized in the CY 2017 Quality Payment Program final rule that MIPS eligible clinicians will know in advance how many potential points they could receive for each improvement activity (81 FR 77311 through 77319).
At § 414.1380(b)(3), we finalized that we will require a total of 40 points to receive the highest score for the improvement activities performance category (81 FR 77315). For more of the statutory background and description of the proposed and finalized policies, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77314 through 77315).
For small practices, practices in rural areas and geographic HPSA practices and non-patient facing MIPS eligible clinicians, the weight for any activity selected is doubled so that these practices and eligible clinicians only need to select one high- or two medium-weighted activities to achieve the highest score of 40 points (81 FR 77312).
In accordance with section 1848(q)(5)(C)(ii) of the Act, we codified at § 414.1380(b)(3)(ix) that individual MIPS eligible clinicians or groups who are participating in an APM (as defined in section 1833(z)(3)(C) of the Act) for a performance period will automatically earn at least one half of the highest potential score for the improvement activities performance category for the performance period. In addition, MIPS eligible clinicians that are participating in MIPS APMs will be assigned an improvement activity score, which may be higher than one half of the highest potential score. This assignment is based on the extent to which the requirements of the specific model meet the list of activities in the Improvement Activities Inventory. For a further description of improvement activities and the APM scoring standard for MIPS, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77246). For all other individual MIPS eligible clinicians or groups, we refer readers to the scoring requirements for individual MIPS eligible clinicians and groups in the CY 2017 Quality Payment Program final rule (81 FR 77270). An individual MIPS eligible clinician or group is not required to perform activities in each improvement activities subcategory or participate in an APM to achieve the highest potential score in accordance with section 1848(q)(5)(C)(iii) of the Act (81 FR 77178).
In the CY 2017 Quality Payment Program final rule, we also finalized that individual MIPS eligible clinicians and groups that successfully participate and submit data to fulfill the requirements for the CMS Study on Improvement Activities and Measurement will receive the highest score for the improvement activities performance category (81 FR 77315). We refer readers to section II.C.6.e.(7) of this proposed rule for further detail on this study.
Section 1848(q)(5)(C)(i) of the Act specifies that a MIPS eligible clinician who is in a practice that is certified as a patient-centered medical home or comparable specialty practice for a performance period, as determined by the Secretary, must be given the highest potential score for the improvement activities performance category for the performance period. Accordingly, at § 414.1380(b)(3)(iv), we specify that a MIPS eligible clinician who is in a practice that is certified as a patient-centered medical home, including a Medicaid Medical Home, Medical Home Model, or comparable specialty practice, will receive the highest potential score for the improvement activities performance category (81 FR 77196 through 77180).
We are not proposing any changes to the scoring of the patient-centered medical home or comparable specialty
In the CY 2017 Quality Payment Program final rule (81 FR 77318), we finalized that individual MIPS eligible clinicians and groups must earn a total of 40 points to receive the highest score for the improvement activities performance category. To determine the improvement activities performance category score, we sum the points for all of a MIPS eligible clinician's reported activities and divide by the improvement activities performance category highest potential score of 40. A perfect score will be 40 points divided by 40 possible points, which equals 100 percent. If MIPS eligible clinicians have more than 40 improvement activities points we will cap the resulting improvement activities performance category score at 100 percent.
Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to give consideration to the circumstances of small practices and practices located in rural areas and in geographic HPSAs (as designated under section 332(a)(1)(A) of the PHS Act) in defining activities. Section 1848(q)(2)(C)(iv) of the Act also requires the Secretary to give consideration to non-patient facing MIPS eligible clinicians. Further, section 1848(q)(5)(F) of the Act allows the Secretary to assign different scoring weights for measures, activities, and performance categories, if there are not sufficient measures and activities applicable and available to each type of eligible clinician.
Accordingly, we finalized that the following scoring applies to MIPS eligible clinicians who are a non-patient facing MIPS eligible clinician, a small practice (consisting of 15 or fewer professionals), a practice located in a rural area, or practice in a geographic HPSA or any combination thereof:
• Reporting of one medium-weighted activity will result in 20 points or one-half of the highest score.
• Reporting of two medium-weighted activities will result in 40 points or the highest score.
• Reporting of one high-weighted activity will result in 40 points or the highest score.
The following scoring applies to MIPS eligible clinicians who are not a non-patient facing clinician, a small practice, a practice located in a rural area, or a practice in a geographic HPSA:
• Reporting of one medium-weighted activity will result in 10 points which is one-fourth of the highest score.
• Reporting of two medium-weighted activities will result in 20 points which is one-half of the highest score.
• Reporting of three medium-weighted activities will result in 30 points which is three-fourths of the highest score.
• Reporting of four medium-weighted activities will result in 40 points which is the highest score.
• Reporting of one high-weighted activity will result in 20 points which is one-half of the highest score.
• Reporting of two high-weighted activities will result in 40 points which is the highest score.
• Reporting of a combination of medium-weighted and high-weighted activities where the total number of points achieved are calculated based on the number of activities selected and the weighting assigned to that activity (number of medium-weighted activities selected × 10 points + number of high-weighted activities selected × 20 points) (81 FR 78318).
We also finalized in the CY 2017 Quality Payment Program final rule that certain activities in the improvement activities performance category will also qualify for a bonus under the advancing care information performance category (81 FR 78318). This bonus will be calculated under the advancing care information performance category and not under the improvement activities performance category. We refer readers to section II.C.6.f.5.(d) of this proposed rule for further details. For more information about our finalized improvement activities scoring policies and for several sample scoring charts, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 78319). Finally, in that same final rule, we codified at § 414.1380(b)(3)(ix) that MIPS eligible clinicians participating in APMs that are not certified patient-centered medical homes will automatically earn a minimum score of one-half of the highest potential score for the performance category, as required by section 1848(q)(5)(C)(ii) of the Act. For any other MIPS eligible clinician who does not report at least one activity, including a MIPS eligible clinician who does not identify to us that they are participating in a certified patient-centered medical home or comparable specialty practice, we will calculate a score of zero points (81 FR 77319).
We also noted in the CY 2017 Quality Payment Program final rule (81 FR 77319), that individual MIPS eligible clinicians or groups participating in APMs would not be required to self-identify as participating in an APM, but that all MIPS eligible clinicians would be required to self-identify if they were part of a certified patient-centered medical home or comparable specialty practice, a non-patient facing MIPS eligible clinician, a small practice, a practice located in a rural area, or a practice in a geographic HPSA or any combination thereof, and that we would validate these self-identifications as appropriate. However, beginning with the 2018 MIPS performance period, we are proposing to no longer require these self-identifications for a non-patient facing MIPS eligible clinician, a small practice, a practice located in a rural area, or a practice in a geographic HPSA or any combination thereof because it is technically feasible for us to identify these MIPS eligible clinicians during attestation to the performance of improvement activities following the performance period. We define these MIPS eligible clinicians in the CY 2017 Quality Payment Program final rule (81 FR 77540), and they are discussed in this proposed rule in section II.C.1. of this proposed rule. However, MIPS eligible clinicians that are part of a certified patient-centered medical home or comparable specialty practice are still required to self-identify for the 2018 MIPS performance period, and we will validate these self-identifications as appropriate. We refer readers to section II.C.6.e.3.(c) of this proposed rule for the criteria for recognition as a certified patient-centered medical home or comparable specialty practice.
We refer readers to section II.C.6.f. of this proposed rule with comment period, where we discuss scoring the advancing care information performance category.
For a description of the statutory basis and our policies for calculating the final score for MIPS eligible clinicians, we refer readers to the discussion in the CY 2017 Quality Payment Program final rule (81 FR 77319 through 77329) and § 414.1380. In this proposed rule, we propose to add a complex patient scoring bonus and add a small practice bonus to the final score. In addition, we review the final score calculation for the
Section 1848(q)(1)(G) of the Act requires us to consider risk factors in our scoring methodology. Specifically, that section provides that the Secretary, on an ongoing basis, shall, as the Secretary determines appropriate and based on individuals' health status and other risk factors, assess appropriate adjustments to quality measures, cost measures, and other measures used under MIPS and assess and implement appropriate adjustments to payment adjustments, final scores, scores for performance categories, or scores for measures or activities under the MIPS. In doing this, the Secretary is required to take into account the relevant studies conducted under section 2(d) of the Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014 and, as appropriate, other information, including information collected before completion of such studies and recommendations. We refer readers to our discussion of risk factors for the transition year of MIPS (81 FR 77320 through 77321).
In this section, we summarize our efforts related to social risk and the relevant studies conducted under section 2(d) of the IMPACT Act of 2014. We also propose some short-term adjustments to address patient complexity.
We understand that social risk factors such as income, education, race and ethnicity, employment, disability, community resources, and social support (certain factors of which are also sometimes referred to as socioeconomic status (SES) factors or socio-demographic status (SDS) factors) play a major role in health. One of our core objectives is to improve beneficiary outcomes, including reducing health disparities, and we want to ensure that all beneficiaries, including those with social risk factors, receive high quality care. In addition, we seek to ensure that the quality of care furnished by providers and suppliers is assessed as fairly as possible under our programs while ensuring that beneficiaries have adequate access to excellent care.
We have been reviewing reports prepared by the Office of the Assistant Secretary for Planning and Evaluation (ASPE) and the National Academies of Sciences, Engineering, and Medicine on the issue of accounting for social risk factors in CMS' value-based purchasing and quality reporting programs, and considering options on how to address the issue in these programs. On December 21, 2016, ASPE submitted the first of several Reports to Congress on a study it was required to conduct under section 2(d) of the IMPACT Act of 2014. The first study analyzed the effects of certain social risk factors in Medicare beneficiaries on quality measures and measures of resource use used in one or more of nine Medicare value-based purchasing programs.
As noted in the FY 2017 IPPS/LTCH PPS final rule (81 FR 56974), the NQF has undertaken a 2-year trial period in which certain new measures and measures undergoing maintenance, and measures endorsed with the condition that they enter the trial period can be assessed to determine whether risk adjustment for selected social risk factors is appropriate for these measures. This trial entails temporarily allowing inclusion of social risk factors in the risk-adjustment approach for these measures. At the conclusion of the trial, NQF will issue recommendations on the future inclusion of social risk factors in risk adjustment for these quality measures, and we will closely review its findings.
As we continue to consider the analyses and recommendations from these and any future reports, and await the results of the NQF trial on risk adjustment for quality measures, we are continuing in this proposed rule to work with stakeholders in this process. As we have previously communicated, we are concerned about holding providers to different standards for the outcomes of their patients with social risk factors because we do not want to mask potential disparities or minimize incentives to improve the outcomes for disadvantaged populations. Keeping this concern in mind, while we sought input on this topic previously, we continue to seek public comment on whether we should account for social risk factors in the MIPS, and if so, what method or combination of methods would be most appropriate for accounting for social risk factors in the MIPS. Examples of methods include: Adjustment of MIPS eligible clinician scores (for example, stratifying the scores of MIPS eligible clinicians based on the proportion of their patients who are dual eligible); confidential reporting of stratified measure rates to MIPS eligible clinicians; public reporting of stratified measure results; risk adjustment of a particular measure as appropriate based on data and evidence; and redesigning payment incentives (for instance, rewarding improvement for clinicians caring for patients with social risk factors or incentivizing clinicians to achieve health equity). We are seeking comments on whether any of these methods should be considered, and if so, which of these methods or combination of methods would best account for social risk factors in MIPS, if any.
In addition, we are seeking public comment on which social risk factors might be most appropriate for stratifying measure scores and/or potential risk adjustment of a particular measure. Examples of social risk factors include, but are not limited to the following: Dual eligibility/low-income subsidy; race and ethnicity; and geographic area of residence. We are seeking comment on which of these factors, including current data sources where this information would be available, could be used alone or in combination, and whether other data should be collected to better capture the effects of social risk. We will take commenters' input into consideration as we continue to assess the appropriateness and feasibility of accounting for social risk factors in MIPS. We note that any such changes would be proposed through future notice and comment rulemaking.
We look forward to working with stakeholders as we consider the issue of accounting for social risk factors and reducing health disparities in CMS programs. Of note, implementing any of the above methods would be taken into consideration in the context of how this and other CMS programs operate (for example, data submission methods, availability of data, statistical considerations relating to reliability of data calculations, among others), we also welcome comment on operational considerations. CMS is committed to ensuring that its beneficiaries have access to and receive excellent care, and that the quality of care furnished by
While we work with stakeholders on these issues as we have described, we are proposing, under the authority within section 1848(q)(1)(G) of the Act, which allows us to assess and implement appropriate adjustments to payment adjustments, MIPS final scores, scores for performance categories, or scores for measures or activities under MIPS, to implement a short-term strategy for the Quality Payment Program to address the impact patient complexity may have on final scores. The overall goal when considering a bonus for complex patients is two-fold: (1) To protect access to care for complex patients and provide them with excellent care; and (2) to avoid placing MIPS eligible clinicians who care for complex patients at a potential disadvantage while we review the completed studies and research to address the underlying issues. We used the term “patient complexity” to take into account a multitude of factors that describe and have an impact on patient health outcomes; such factors include the health status and medical conditions of patients, as well as social risk factors. We believe that as the number and intensity of these factors increase for a single patient, the patient may require more services, more clinician focus, and more resources in order to achieve health outcomes that are similar to those who have fewer factors. In developing the policy for the complex patient bonus, we assessed whether there was a MIPS performance discrepancy by patient complexity using two well-established indicators in the Medicare program. Our proposal is intended to address any discrepancy, without masking performance. Because this bonus is intended to be a short-term strategy, we are proposing the bonus only for the 2018 MIPS performance period (2020 MIPS payment year) and will assess on an annual basis whether to continue the bonus and how the bonus should be structured.
When considering approaches for a complex patient bonus, we reviewed evidence to identify how indicators of patient complexity have an impact on performance under MIPS as well as availability of data to implement the bonus. Specifically, we identified two potential indicators for complexity: Medical complexity as measured through Hierarchical Condition Category (HCC) risk scores, and social risk as measured through the proportion of patients with dual eligible status. We identified these indicators because they are common indicators of patient complexity in the Medicare program and the data is readily available. As discussed below, both of these indicators have been used in Medicare programs to account for risk and both data elements are already publicly available for individual NPIs in the Medicare Physician and Other Supplier Public Use File (referred to as the Physician and Other Supplier PUF) (
We believe that average HCC risk scores are a valid proxy for medical complexity that have been used by other CMS programs. The HCC model was developed by CMS as a risk-adjustment model that uses hierarchical condition categories to assign risk scores to Medicare beneficiaries. Those scores estimate how Medicare beneficiaries' FFS spending will compare to the overall average for the entire Medicare population. According to the Physician and Other Supplier PUF methodological overview, published in January of 2017,
HCC risk scores have been used in the VM to apply an additional upward payment adjustment of +1.0x for clinicians whose attributed patient population has an average risk score that is in the top 25 percent of all beneficiary risk scores (77 FR 69325 through 69326). CMS proposes and announces changes to the HCC risk adjustment model as part of the announcement of payment policies for Medicare Advantage plans under section 1853 of the Act; the proposals and announcements are posted at
A mean HCC risk score for a MIPS eligible clinician can be calculated by averaging the HCC risk scores for the beneficiaries cared for by the clinician. In considering options for a complex patient bonus, we explored the use of average HCC risk scores while recognizing that “complexity” is one of several drivers of that metric. We believe that using the HCC risk score as a proxy for patient complexity is a helpful starting point, and will explore methods for further distinguishing complexity from other reasons a clinician could receive a high average HCC risk score.
In addition to medical complexity, patient complexity includes social risk factors, and we considered identifying patients dually eligible for Medicare and Medicaid, which we believe is a proxy for social risk factors. A ratio of beneficiaries seen by a MIPS eligible clinician who are dual eligible can be calculated using claims data based on the proportion of unique patients who are dually eligible for Medicare and full- and partial-benefit Medicaid (referred to herein as “dual eligible status”) seen by the MIPS eligible clinician during the performance year among all unique Medicare beneficiaries seen during the performance year. Dual eligible Medicare beneficiaries are qualified to receive Medicare and Medicaid benefits. In the Physician and Other Supplier PUF, beneficiaries are classified as Medicare and Medicaid entitlement if in any month in the given calendar year they were receiving full or partial Medicaid benefits.
We evaluated both indicators (average HCC risk score and proportion dual eligible status) using the 2015 Physician and Other Supplier PUF. We incorporated these factors into our scoring model that uses historical PQRS data to simulate scores for MIPS eligible clinicians including estimates for the quality, advancing care information, and improvement activities performance categories, and the small practice bonus that is proposed in section II.C.7.b.(1)(c) of this proposed rule. The scoring model is described in more detail in the regulatory impact analysis in section V.C. of this proposed rule. For HCC, we merged the average HCC risk score by NPI with each TIN/NPI in our population. We calculated a dual eligible ratio by taking a proportion of dual eligible beneficiaries and divided by total beneficiaries for each NPI. We created group level scores by taking an average of NPI scores weighted by the number of beneficiaries. We divided clinicians and groups into quartiles based on average HCC risk score and percent of duals. To assess whether there was a difference in MIPS simulated scores by these two variables, we analyzed the effect of average HCC risk score and dual eligible ratio separately for groups and individuals. When looking at individuals, we focused on individuals that reported 6 or more measures (removing individuals who reported no measures or who reported less than 6 measures). We restricted our analysis to individuals who reported 6 or more measures because we wanted to look at differences in performance for those who reported the required 6 measures, rather than differences in scores due to incomplete reporting.
We observed modest correlation between these two indicators. Using the Physician and Other Supplier PUF (after restricting to those clinicians that we estimate to be MIPS eligible in our scoring model described in section V.C of this proposed rule), the correlation coefficient for these two factors is 0.487 (some correlation is expected due to the inclusion of dual eligible status in the HCC risk model). The correlation between average HCC risk scores and proportion of patients with dual eligible status indicates that while there is overlap between these two indicators, they cannot be used interchangeably.
We also assessed the correlation of these indicators with MIPS final scores based on performance and the small practice bonus for MIPS eligible clinicians, as well as variations by practice size, submission mechanism, and specialty. Average MIPS simulated scores (prior to any complex patient bonus) varied from 82.73 (fourth HCC quartile, highest risk) to 87.14 (first HCC quartile, lowest risk) for group reporters, and from 82.36 (fourth HCC quartile, highest risk) to 86.39 (first HCC quartile, lowest risk) for individual reporters who reported 6 or more measures (see Table 34). When reviewing average HCC risk scores by practice size, we found that MIPS eligible clinicians in larger practices had slightly higher risk scores than those in small practices (average HCC risk score of 1.82 for practices with 100 or more clinicians, compared with 1.61 for practices with 1–15 clinicians) (see Table 35) and that the average HCC risk score varied by specialty, with nephrology having the highest average HCC risk score (3.05) and dermatology having the lowest (1.24). The average HCC risk score for family medicine was 1.58 (see Table 36).
We also ranked MIPS eligible clinicians by proportion of patients with dual eligibility (see Table 34). Performance for MIPS eligible clinicians ranged from 82.35 in the fourth dual quartile (highest proportion dual eligible patients) to 89.49 in the second dual quartile (second lowest proportion dual eligible patients) for group reporters. Performance for MIPS eligible clinicians reporting individually who reported 6 or more measures ranged from 83.08 in the fourth dual quartile (highest proportion dual eligible patients) to 86.80 in the first dual quartile (lowest proportion dual eligible patients).
Based on our assessment of these two indicators, we generally see high average simulated scores
We propose at § 414.1380(c)(3) to add a complex patient bonus to the final score for the 2020 MIPS payment year for MIPS eligible clinicians that submit data (as explained below) for at least one performance category. We propose at § 414.1380(c)(3)(i) to calculate an average HCC risk score, using the model adopted under section 1853 of the Act for Medicare Advantage risk adjustment purposes, for each MIPS eligible clinician or group, and to use that average HCC risk score as the complex patient bonus. We would calculate the average HCC risk score for a MIPS eligible clinician or group by averaging HCC risk scores for beneficiaries cared for by the MIPS eligible clinician or clinicians in the group during the second 12-month segment of the eligibility period, which spans from the last 4 months of a calendar year 1 year prior to the performance period followed by the first 8 months of the performance period in the next calendar year (September 1, 2017 to August 31, 2018 for the 2018 MIPS performance period) as described in section II.C.3.c. of this proposed rule. We propose the second 12-month segment of the eligibility period to align with other MIPS policies and to ensure we have sufficient time to determine the necessary calculations. The second period 12-month segment overlaps 8-months with the MIPS performance period which means that many of the patients in our complex patient bonus would have been cared for by the clinician, group, virtual group or APM Entity during the MIPS performance period.
HCC risk scores for beneficiaries would be calculated based on the calendar year immediately prior to the performance period. For the 2018 MIPS performance period, the HCC risk scores would be calculated based on beneficiary services from the 2017 calendar year. We chose this approach because CMS uses prior year diagnoses to set Medicare Advantage rates prospectively every year and has employed this approach in the VM (77 FR 69317–8). Additionally, this approach mitigates the risk of “upcoding” to get higher expected costs, which could happen if concurrent risk adjustments were incorporated. We realize using the 2017 calendar year to assess beneficiary HCC risk scores overlaps by 4-months with the 12-month data period to identify beneficiaries (which is September 1, 2017 to August 31, 2018 for the 2018 MIPS performance period); however, we annually calculate the beneficiary HCC risk score and use it for multiple purposes (like the Physician and Other Supplier PUF).
For MIPS APMs and virtual groups, we propose at § 414.1380(c)(3)(ii) to use the beneficiary weighted average HCC risk score for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation, within the APM Entity or virtual group, respectively, as the complex patient bonus. We would calculate the weighted average by taking the sum of the individual clinician's (or TIN's as appropriate) average HCC risk score multiplied by the number of unique beneficiaries cared for by the clinician and then divide by the sum of the beneficiaries cared for by each individual clinician (or TIN as appropriate) in the APM Entity or virtual group.
We propose at § 414.1380(c)(3)(iii) that the complex patient bonus cannot exceed 3 points. This value was selected because the differences in performance we observed between simulated scores between the first and fourth quartiles of average HCC risk scores was approximately 4 points for individuals and approximately 5 points for groups. We considered whether we should apply a set number of points to those in a specific quartile (for example, for the highest risk quartile only), but did not want to restrict the bonus to only certain MIPS eligible clinicians. Rather than assign points based on quartile, we believed that adding the average HCC risk score directly to the final score would achieve our goal of accounting for patient complexity without masking low performance and does provide a modest effect on the final score. The 95th percentile of HCC values for individual clinicians was 2.91 which we rounded to 3 for simplicity. We believe applying this bonus to the final score is appropriate because caring for complex and vulnerable patients can affect all aspects of a practice and not just specific performance categories. It may also create a small incentive to provide access to complex patients.
Finally, we propose that the MIPS eligible clinician, group, virtual group or APM Entity must submit data on at least one measure or activity in a performance category during the performance period to receive the complex patient bonus. Under this proposal, MIPS eligible clinicians would not need to meet submissions requirements for the quality performance category in order to receive the bonus (they could instead submit improvement activities or advancing care information measures only or submit fewer than the required number of measures for the quality performance category).
Based on our data analysis, we estimate that this bonus on average would range from 1.16 points in the first quartile based on HCC risk scores to 2.49 points in the fourth quartile for individual reporters submitting 6 or more measures, and 1.26 points in the first quartile to 2.23 points in the fourth quartile for group reporters. For example, a MIPS eligible clinician with a final score of 55.11 with an average HCC risk score of 2.01 would receive a final score of 57.12. We propose in section II.C.7.b.(2) of this proposed rule that if the result of the calculation is greater than 100 points, then the final score would be capped at 100 points.
We also seek comment on an alternative complex patient bonus methodology, similarly for the 2020 MIPS payment year only. Under the alternative, we would apply a complex patient bonus based on a ratio of patients who are dual eligible, because we believe that dual eligible status is a common indicator of social risk for
For MIPS APMs and virtual groups, we would use the average dual eligible patient ratio for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation, within the APM entity or virtual group, respectively.
Under this alternative option, we would identify dual eligible status (numerator of the ratio) using data on dual-eligibility status sourced from the state Medicare Modernization Act (MMA) files, which are files each state submits to CMS with monthly Medicaid eligibility information. We would use dual-eligibility status data from the state MMA files because it is the best available data for identifying dual eligible beneficiaries. Under this alternative option, an individual would be counted as a full-benefit or partial-benefit dual patient if the beneficiary was identified as a full-benefit or partial-benefit dual in the state MMA files at the conclusion of the second 12-month segment of the eligibility determination period.
We would define the proportion of full benefit or partial dual eligible beneficiaries as the proportion of dual eligible patients among all unique Medicare patients seen by the MIPS eligible clinician or group during the second 12-month segment of the eligibility period which spans from the last 4 months of a calendar year prior to the performance period followed by the first 8 months of the performance period in the next calendar year (September 1, 2017 to August 31, 2018 for the 2018 MIPS performance period) as described in section II.C.3.c. of this proposed rule, to identify MIPS eligible clinicians for calculation of the complex patient bonus. This date range aligns with the second low-volume threshold determination and also represents care provided during the performance period.
We would propose to multiply the dual eligible ratio by 5 points to calculate a complex patient bonus for each MIPS eligible clinician. For example, a MIPS eligible clinician who sees 400 patients with dual eligible status out of 1000 total Medicare patients seen during the second 12-month segment of the eligibility period would have a complex patient ratio of 0.4, which would be multiplied by 5 points for a complex patient bonus of 2 points toward the final score. We believe this approach is simple to explain and would be available to all clinicians who care for dual eligible beneficiaries. We also believe a complex patient bonus ranging from 1 to 5 points (with most MIPS eligible clinicians receiving a bonus between 1 and 3 points) is appropriate because, in our analysis, we estimated differences in performance between the 1st and 4th quartiles of dual eligible ratios to be approximately 3 points for individuals and approximately 6 points for groups. A bonus of less than 5 points would help to mitigate the impact of caring for patients with social risk factors while not masking poor performance. Using this approach, we estimate that the bonus would range from 0.45 (first dual quartile) to 2.42 (fourth dual quartile) for individual reporters, and from 0.63 (first dual quartile) to 2.19 (fourth dual quartile) for group reporters. Under this alternative option, we would also include the complex patient bonus in the calculation of the final score. Again, we propose in section II.C.7.b.(2) of this proposed rule that if the result of the calculation is greater than 100 points, then the final score would be capped at 100 points. We seek comments on our proposed bonus for complex patients based on average HCC risk scores, and our alternative option using a ratio of dual eligible patients in lieu of average HCC risk scores. We reiterate that the complex patient bonus is intended to be a short-term solution, which we plan to revisit on an annual basis, to incentivize clinicians to care for patients with medical complexity. We may consider alternate adjustments in future years after methods that more fully account for patient complexity in MIPS have been developed. We also seek comments on alternative methods to construct a complex patient bonus.
Eligible clinicians and groups who work in small practices are a crucial part of the health care system. The Quality Payment Program provides options designed to make it easier for these MIPS eligible clinicians and groups to report on performance and quality and participate in advanced alternative payment models for incentives. We have heard directly from clinicians in small practices that they face unique challenges related to financial and other resources, environmental factors, and access to health information technology. We heard from many commenters that the Quality Payment Program advantages large organizations because such organizations have more resources invested in the infrastructure required to track and report measures to MIPS. Based on our scoring model, which is described in the regulatory impact analysis in section V.C. of this proposed rule, practices with more than 100 clinicians may perform better in the Quality Payment Program, on average compared to smaller practices. We believe this trend is due primarily to two factors: Participation rates and submission mechanism. Based on the most recent PQRS data available, practices with 100 or more MIPS eligible clinicians have participated in the PQRS at a higher rate than small practices (99.4 percent compared to 69.7 percent, respectively). As we indicate in our regulatory impact analysis in section V.C. of this proposed rule, we believe participation rates based only on historic 2015 quality data submitted under PQRS significantly underestimate the expected participation in MIPS particularly for small practices. Therefore, we have modeled the regulatory impact analysis using minimum participation assumptions of 80 percent and 90 percent participation for each practice size category (1–15 clinicians, 16–24 clinicians, 25–99 clinicians, and 100 or more clinicians). However, even with these enhanced participation assumptions, MIPS eligible clinicians in small practices would have lower participation than MIPS eligible clinicians in larger practices as 80 or 90 percent participation is still much lower than the 99.4 percent participation for MIPS eligible clinicians in practices with 100 or more clinicians.
In addition, practices with 100 or more MIPS eligible clinicians are more likely to report as a group, rather than individually, which reduces burden to individuals within those practices due
These two factors have financial implications based on the MIPS scoring model described in section V.C. of this proposed rule. Looking at the combined impact performance, we see consistent trends for small practices in various scenarios. A combined impact of performance measurement looks at the aggregate net percent change (the combined impact of MIPS negative and positive adjustments in the final score). In analyzing the combined impact performance, we see MIPS eligible clinicians in small practices consistently have a lower combined impact performance than larger practices based on actual historical data and after we apply the 80 and 90 percent participation assumptions.
Due to these challenges, we believe an adjustment to the final score for MIPS eligible clinicians in small practices (referred to herein as the “small practice bonus”) is appropriate to recognize these barriers and to incentivize MIPS eligible clinicians in small practices to participate in the Quality Payment Program and to overcome any performance discrepancy due to practice size. To receive the small practice bonus, we propose that the MIPS eligible clinician must participate in the program by submitting data on at least one performance category in the 2018 MIPS performance period. Therefore, MIPS eligible clinicians would not need to meet submission requirements for the quality performance category in order to receive the bonus (they could instead submit improvement activities or advancing care information measures only or submit fewer than the required number of measures for the quality performance category). Additionally, we propose that group practices, virtual groups, or APM Entities that consist of a total of 15 or fewer clinicians may receive the small practice bonus.
We propose at § 414.1380(c)(4) to add a small practice bonus of five points to the final score for MIPS eligible clinicians who participate in MIPS for the 2018 MIPS performance period and are in small practices or virtual groups or APM entities with 15 or fewer clinicians (the entire virtual group or APM entity combined must include 15 or fewer clinicians to qualify for the bonus). We believe a bonus of 5 points is appropriate to acknowledge the challenges small practices face in participating in MIPS, and to help them achieve the performance threshold proposed at section II.C.8.c. of this proposed rule at 15 points for the 2020 MIPS payment year, as this bonus represents one-third of the total points needed to meet or exceed the performance threshold and receive a neutral to positive payment adjustment. With a small practice bonus of 5 points, small practices could achieve this performance threshold by reporting 2 quality measures or 1 quality measure and 1 improvement activity.
This bonus is intended to be a short-term strategy to help small practices transition to MIPS, therefore, we are proposing the bonus only for the 2018 MIPS performance period (2020 MIPS payment year) and will assess on an annual basis whether to continue the bonus and how the bonus should be structured.
We are inviting public comment on our proposal to apply a small practice bonus for the 2020 MIPS payment year.
We also considered applying a bonus for MIPS eligible clinicians that practice in either a small practice or a rural area. However, on average, we saw less than a one point difference between scores for MIPS eligible clinicians who practice in rural areas and those who do not. Therefore, we are not proposing to extend the final score bonus to those who practice in a rural area, but plan to continue to monitor the Quality Payment Program's impacts on the performance of those who practice in rural areas. We also seek comment on the application of a rural bonus in the future, including available evidence demonstrating differences in clinician performance based on rural status. If we implement a bonus for practices located in rural areas, we would use the definition for rural specified in section II.C.1. of this proposed rule for individuals and groups (including virtual groups).
With the proposed addition of the complex patient and small practice bonuses, we propose to use the formula at § 414.1380(c) to calculate the final score for all MIPS eligible clinicians, groups, virtual groups, and MIPS APMs starting with the 2020 MIPS payment year.
We propose to revise the final score calculation at § 414.1380(c) to reflect this updated formula. We also propose to revise the policy finalized in the CY 2017 Quality Payment Program final rule to assign MIPS eligible clinicians with only 1 scored performance category a final score that is equal to the performance threshold (81 FR 77326 through 77328) (we note that we inadvertently failed to codify this policy in § 414.1380(c)). We are proposing this revision to the policy to account for our proposal in section II.C.7.b.(3)(c) of this proposed rule for extreme and uncontrollable circumstances which, if finalized, could result in a scenario where a MIPS eligible clinician is not scored on any performance categories. To reflect this proposal, we propose to add to § 414.1380(c) that a MIPS eligible clinician with fewer than 2 performance category scores would receive a final score equal to the performance threshold.
With the proposed addition of the complex patient and small practice bonuses, we also propose to strike the following phrase from the final score definition at § 414.1305: “The final score is the sum of each of the products of each performance category score and each performance category's assigned weight, multiplied by 100.” We believe this portion of the definition would be incorrect and redundant of the proposed revised regulation at § 414.1380(c).
We invite public comment on the proposed final score methodology and associated revisions to regulation text.
Section 1848(q)(5)(E)(i) of the Act specifies weights for the performance categories included in the MIPS final score: In general, 30 percent for the quality performance category, 30 percent for the cost performance category, 25 percent for the advancing care information performance category, and 15 percent for the improvement activities performance category. However, that section also specifies different weightings for the quality and cost performance categories for the first and second years for which the MIPS applies to payments. Section 1848(q)(5)(E)(i)(II)(bb) of the Act specifies that for the transition year, not more than 10 percent of the final score will be based on the cost performance category, and for the 2020 MIPS payment year, not more than 15 percent will be based on the cost performance category. Under section 1848(q)(5)(E)(i)(I)(bb) of the Act, the weight of the quality performance category for each of the first 2 years will increase by the difference of 30 percent minus the weight specified for the cost performance category for the year.
In the CY 2017 Quality Payment Program final rule, we established the weights of the cost performance category as 10 percent of the final score (81 FR 77166) and the quality performance category as 50 percent of the final score (81 FR 77100) for the 2020 MIPS payment year. However, we are proposing in section II.C.6.d. of this proposed rule to change the weight of the cost performance category to zero percent and in section II.C.6.b. of this proposed rule to change the weight of the quality performance category to 60 percent for the 2020 MIPS payment year. We refer readers to sections II.C.6.b. and II.C.6.d. of this proposed rule for further information on the policies related to the weight of the quality and cost performance categories, including our rationale for our proposed weighting for each category.
As specified in section 1848(q)(5)(E)(i) of the Act, the weights for the other performance categories are 25 percent for the advancing care information performance category and 15 percent for the improvement activities performance category. Section 1848(q)(5)(E)(ii) of the Act provides that in any year in which the Secretary estimates that the proportion of eligible professionals (as defined in section 1848(o)(5) of the Act) who are meaningful EHR users (as determined in section 1848(o)(2) of the Act) is 75 percent or greater, the Secretary may reduce the applicable percentage weight of the advancing care information performance category in the final score, but not below 15 percent. For more on our policies concerning section 1848(q)(5)(E)(ii) of the Act and a review of our proposal for reweighting the advancing care information performance category in the event that the proportion of MIPS eligible clinicians who are meaningful EHR users is 75 percent or greater starting with the 2019 MIPS performance period, we refer readers to section II.C.6.f.(5) of this proposed rule.
Table 37 summarizes the weights specified for each performance category under section 1848(q)(5)(E)(i) of the Act and in accordance with our policies in the CY 2017 Quality Payment Program final rule as codified at §§ 414.1380(c)(1), 414.1330(b), 414.1350(b), 414.1355(b), and 414.1375(a), and with our proposals in section II.C.6. of this proposed rule.
Under section 1848(q)(5)(F) of the Act, if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician involved, the Secretary shall assign different scoring weights (including a weight of zero) for each performance category based on the extent to which the category is applicable and for each measure and activity based on the extent to which the measure or activity is applicable and available to the type of MIPS eligible clinician involved. For the 2020 MIPS payment year, we propose to assign a scoring weight of zero percent to a performance category and redistribute its weight to the other performance categories in the following scenarios.
For the quality performance category, we propose that having sufficient measures applicable and available means that we can calculate a quality performance category percent score for the MIPS eligible clinician because at least one quality measure is applicable and available to the MIPS eligible clinician. Based on the volume of measures available to MIPS eligible clinicians via the multiple submission mechanisms, we generally believe there will be at least one quality measure applicable and available to every MIPS eligible clinician. Given that we generally believe there will be at least one quality measure applicable and available to every MIPS eligible clinician, if we receive no quality performance category submission from a MIPS eligible clinician, the MIPS eligible clinician generally will receive a performance category score of zero (or slightly above zero if the all-cause hospital readmission measure applies because the clinician submits data for a performance category other than the quality performance category).
The proposed quality performance category scoring policies for the 2020 MIPS payment year continue many of the special scoring policies from the transition year which would enable us to determine a quality performance category percent score whenever a MIPS eligible clinician has submitted at least 1 quality measure. In addition, MIPS eligible clinicians that do not submit quality measures when they have them available and applicable would receive a quality performance category percent score of zero percent. It is only in the rare scenarios when we determine that a MIPS eligible clinician does not have any relevant quality measures available to report or the MIPS eligible clinician is approved for reweighting the quality performance category based on extreme and uncontrollable circumstances as proposed in section II.C.7.b.(3)(c) of this proposed rule, that we would reweight the quality performance category. Therefore, we continue to believe that we will not be able to calculate a score for the quality performance category only in the rare scenarios when a MIPS eligible clinician does not have any relevant quality measures available to report.
For the cost performance category, we continue to believe that having sufficient measures applicable and available means that we can reliably calculate a score for the cost measures that adequately captures and reflects the performance of a MIPS eligible clinician, and that MIPS eligible clinicians who are not attributed enough cases to be reliably measured should not be scored for the cost performance category (81 FR 77322 through 77323). We established a policy that if a MIPS eligible clinician is not attributed a sufficient number of cases for a measure (in other words, has not met the required case minimum for the measure), or if a measure does not have a benchmark, then the measure will not be scored for that clinician (81 FR 77323). If we do not score any cost measures for a MIPS eligible clinician in accordance with this policy, then the clinician would not receive a cost performance category percent score. Because we have proposed in section II.C.6.d. of this proposed rule to set the weight of the cost performance category to zero percent of the final score for the 2020 MIPS payment year, we are not proposing to redistribute the weight of the cost performance category to any other performance categories for the 2020 MIPS payment year. In the event we do not finalize this proposal, we are proposing to redistribute the weight of the cost performance category as described in section II.C.7.b.(3)(d) of this proposed rule.
For the improvement activities performance category, we believe that all MIPS eligible clinicians will have sufficient activities applicable and available; however, as discussed in section II.C.7.b.(3)(c) of this proposed rule, we believe there are limited extreme and uncontrollable circumstances, such as natural disasters, where a clinician is unable to report improvement activities. Barring these circumstances, we are not proposing any changes that would affect our ability to calculate an improvement activities performance category score.
We refer readers to section II.C.6.f. of this proposed rule for a detailed discussion of our proposals and policies under which we would not score the advancing care information performance category and would assign a weight of zero percent to that category for a MIPS eligible clinician.
We invite public comment on our interpretation of sufficient measures available and applicable in the performance categories.
In the CY 2017 Quality Payment Program final rule (81 FR 77241 through 77243), we discussed our belief that extreme and uncontrollable circumstances, such as a natural disaster in which an EHR or practice location is destroyed, can happen at any time and are outside a MIPS eligible clinician's control. We stated that if a MIPS eligible clinician's CEHRT is unavailable as a result of such circumstances, then the measures specified for the advancing care information performance category may not be available for the MIPS eligible clinician to report. We established a policy allowing a MIPS eligible clinician affected by extreme and uncontrollable circumstances to submit an application to us to be considered for reweighting of the advancing care information performance category under section 1848(q)(5)(F) of the Act. Although we are proposing in section II.C.6.f. of this proposed rule to use the authority in the last sentence of section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, as the authority for this policy, rather than section 1848(q)(5)(F) of the Act, we continue to believe that extreme and uncontrollable circumstances could affect the availability of a MIPS eligible clinician's CEHRT and the measures specified for the advancing care information performance category.
While we did not propose or finalize a similar reweighting policy for other performance categories in the transition year, we believe a similar reweighting policy may be appropriate for the quality, cost, and improvement activities performance categories beginning with the 2020 MIPS payment year. For these performance categories, we propose to define “extreme and uncontrollable circumstances” as rare (that is, highly unlikely to occur in a given year) events entirely outside the control of the clinician and of the facility in which the clinician practices that cause the MIPS eligible clinician to not be able to collect information that the clinician would submit for a performance category or to submit information that would be used to score a performance category for an extended period of time (for example, 3 months could be considered an extended period of time with regard to information a clinician would collect for the quality performance category). For example, a tornado or fire destroying the only facility in which a clinician practices likely would be considered an “extreme and uncontrollable circumstance;” however, neither the inability to renew a lease—even a long or extended lease—nor a facility being found not compliant with federal, state, or local building codes or other requirements would be considered “extreme and uncontrollable circumstances.” We propose that we would review both the circumstances and the timing independently to assess the availability and applicability of measures and activities independently for each performance category. For example, in 2018 the performance period for improvement activities is only 90 days, whereas it is 12 months for the quality performance category, so an issue lasting 3 months may have more impact on the availability of measures for the quality performance category than for the improvement activities performance category, because
We believe that extreme and uncontrollable circumstances, such as natural disasters, may affect a clinician's ability to access or submit quality measures via all submission mechanisms (effectively rendering the measures unavailable to the clinician) as well as the availability of numerous improvement activities. In addition, damage to a facility where care is provided due to a natural disaster, such as a hurricane, could result in practice management and clinical systems that are used for the collection or submission of data to be down, thus impacting a clinician's ability to submit necessary information via Qualified Registry, QCDR, CMS Web Interface, or claims. This policy would not include issues that third party intermediaries, such as EHRs, Qualified Registries, or QCDRs, might have submitting information to MIPS on behalf of a MIPS eligible clinician. Instead, this policy is geared towards events, such as natural disasters, that affect the MIPS eligible clinician's ability to submit data to the third party intermediary, which in turn, could affect the ability of the clinician (or the third party intermediary acting on their behalf) to successfully submit measures and activities to MIPS.
We also propose to use this policy for measures which we derive from claims data, such as the all-cause hospital readmission measure and the cost measures. Other programs, such as the Hospital VBP Program, allow hospitals to submit exception applications when “a hospital is able to continue to report data on measures . . . but can demonstrate that its Hospital VBP Program measure rates are negatively impacted as a result of a natural disaster or other extraordinary circumstance and, as a result, the hospital receives a lower value-based incentive payment” (78 FR 50705). For the Hospital VBP Program, we “interpret[ed] the minimum numbers of cases and measures requirement in the Act to enable us to not score . . . all applicable quality measure data from a performance period and, thus, exclude the hospital from the Hospital VBP Program for a fiscal year during which the hospital has experienced a disaster or other extraordinary circumstance” (78 FR 50705). Hospitals that request and are granted an exception are exempted from the Program entirely for the applicable year.
For the 2020 MIPS payment year, we would score quality measures and assign points even for those clinicians who do not meet the case minimums for the quality measures they submit. However, we established a policy not to score a cost measure unless a MIPS eligible clinician has met the required case minimum for the measure (81 FR 77323), and not to score administrative claims measures, such as the all-cause hospital readmission measure, if they cannot be reliably scored against a benchmark (81 FR 77288 through 77289). Even if the required case minimums have been met and we are able to reliably calculate scores for the measures that are derived from claims, we believe a MIPS eligible clinician's performance on those measures could be adversely impacted by a natural disaster or other extraordinary circumstance, similar to the issues we identified for the Hospital VBP Program. For example, the claims data used to calculate the cost measures or the all-cause hospital readmission measure could be significantly affected if a natural disaster caused wide-spread injury or health problems for the community, which could not have been prevented by high-value healthcare. In such cases, we believe that the measures are available to the clinician, but are likely not applicable, because the extreme and uncontrollable circumstance has disrupted practice and measurement processes. Therefore, we believe an approach similar to Hospital VBP Program is warranted under MIPS, and we are proposing that we would exempt a MIPS eligible clinician from all quality and cost measures calculated from administrative claims data if the clinician is granted an exception for the respective performance categories based on extreme and uncontrollable circumstances.
Beginning with the 2020 MIPS payment year, we propose that we would reweight the quality, cost, and/or improvement activities performance categories if a MIPS eligible clinician, group, or virtual group's request for a reweighting assessment based on extreme and uncontrollable circumstances is granted. We propose that MIPS eligible clinicians could request a reweighting assessment if they believe extreme and uncontrollable circumstances affect the availability and applicability of measures for the quality, cost, and improvement activities performance categories. To the extent possible, we would seek to align the requirements for submitting a reweighting assessment for extreme and uncontrollable circumstances with the requirements for requesting a significant hardship exception for the advancing care information performance category. For example, we propose to adopt the same deadline (December 31, 2018 for the 2018 MIPS performance period) for submission of a reweighting assessment (see section II.C.6.f. of this proposed rule), and we would encourage the requests to be submitted on a rolling basis. We propose the reweighting assessment must include the nature of the extreme and uncontrollable circumstance, including the type of event, date of the event, and length of time over which the event took place, performance categories impacted, and other pertinent details that impacted the ability to report on measures or activities to be considered for reweighting of the quality, cost, or improvement activities performance categories (for example, information detailing how exactly the event impacted availability and applicability of measures). If we finalize the policy to allow reweighting based on extreme and uncontrollable circumstances beginning with the 2020 MIPS payment year, we would specify the form and manner in which these reweighting applications must be submitted outside of the rulemaking process after the final rule is published.
For virtual groups, we propose to ask the virtual group to submit a reweighting assessment for extreme and uncontrollable circumstances similar to groups, and we would evaluate whether sufficient measures and activities are applicable and available to the majority of TINs in the virtual group. We are proposing that a majority of TINs in the virtual group would need to be impacted before we grant an exception. We still find it important to measure the performance of virtual group members unaffected by an extreme and uncontrollable circumstance even if some of the virtual group's TINs are affected.
We also seek comment on what additional factors we should consider for virtual groups. This reweighting assessment due to extreme and uncontrollable circumstances for the quality, cost, and improvement activities would not be available to APM Entities in the APM scoring standard for the following reasons. First, all MIPS eligible clinicians scored under the APM scoring standard will automatically receive an improvement activities category score based on the terms of their participation in a MIPS APM and need not report anything for this performance category. Second, the cost performance category has no weight under the APM scoring standard. Finally, for the quality performance category, each MIPS APM has its own rules related to quality measures and we believe any decisions related to
If we finalize these proposals for reweighting the quality, cost, and improvement activities performance categories based on extreme and uncontrollable circumstances, then it would be possible that one or more of these performance categories would not be scored and would be weighted at zero percent of the final score for a MIPS eligible clinician. We propose to assign a final score equal to the performance threshold if fewer than two performance categories are scored for a MIPS eligible clinician. This is consistent with our policy finalized in the CY 2017 Quality Payment Program final rule that because the final score is a composite score, we believe the intention of section 1848(q)(5) of the Act is for MIPS eligible clinicians to be scored based on multiple performance categories (81 FR 77326 through 77328).
We request comment on our extreme and uncontrollable circumstances proposals. We also seek comment on the types of the extreme and uncontrollable circumstances we should consider for this policy given the general parameters we describe in this section.
In the CY 2017 Quality Payment Program final rule, we codified at § 414.1380(c)(2) that we will assign different scoring weights for the performance categories if we determine there are not sufficient measures and activities applicable and available to MIPS eligible clinicians (81 FR 77327). We also finalized a policy to assign MIPS eligible clinicians with only one scored performance category a final score that is equal to the performance threshold, which means the clinician would receive a MIPS payment adjustment factor of zero percent for the year (81 FR 77326 through 77328). We are proposing in section II.C.7.b.(2) of this proposed rule to refine this policy such that a MIPS eligible clinician with fewer than 2 performance category scores would receive a final score equal to the performance threshold. This refinement is to account for our proposal in section II.C.7.b.(3)(c) of this proposed rule for extreme and uncontrollable circumstances which, if finalized, could result in a scenario where a MIPS eligible clinician is not scored on any performance categories. We refer readers to the CY 2017 Quality Payment Program final rule for a description of our policies for redistributing the weights of the performance categories (81 FR 77325 through 77329). For the 2020 MIPS payment year, we propose to redistribute the weights of the performance categories in a manner that is similar to the transition year. However, we are also proposing new scoring policies to incorporate our proposals for extreme and uncontrollable circumstances.
In section II.C.6.f. of this proposed rule, we are proposing to use the authority in the last sentence of section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, as the authority for certain policies under which we would assign a scoring weight of zero percent for the advancing care information performance category, and to amend § 414.1380(c)(2) to reflect our proposals. We are not, however, proposing substantive changes to the policy established in the CY 2017 Quality Payment Program final rule to redistribute the weight of the advancing care information performance category to the other performance categories for the transition year (81 FR 77325 through 77329).
For the 2020 MIPS payment year, if we assign a weight of zero percent for the advancing care information performance category for a MIPS eligible clinician, we propose to continue our policy from the transition year and redistribute the weight of the advancing care information performance category to the quality performance category (assuming the quality performance category does not qualify for reweighting). We believe redistributing the weight of the advancing care information performance category to the quality performance category (rather than redistributing to both the quality and improvement activities performance categories) is appropriate because MIPS eligible clinicians have more experience reporting quality measures through the PQRS program, and measurement in this performance category is more mature.
If we do not finalize our proposal at section II.C.6.d. of this proposed rule to weight the cost performance category at zero percent (which means the weight of the cost performance category is greater than zero percent), then we propose to not redistribute the weight of any other performance categories to the cost performance category. We believe this is consistent with our policy of introducing cost measurement in a deliberate fashion and recognition that clinicians are more familiar with other elements of MIPS. In the rare and unlikely scenario where a MIPS eligible clinician qualifies for reweighting of the quality performance category percent score (because there are not sufficient quality measures applicable and available to the clinician or the clinician is facing extreme and uncontrollable circumstances) and the MIPS eligible clinician is eligible to have the advancing care information performance category reweighted to zero and the MIPS eligible clinician has sufficient cost measures applicable and available to have a cost performance category percent score that is not reweighted, then we would redistribute the weight of the quality and advancing care information performance categories to the improvement activities performance category and would not redistribute the weight to the cost performance category. If we finalize the cost performance category weight at zero percent for the 2020 MIPS payment year, then we would set the final score at the performance threshold because the final score would be based on improvement activities which would not be a composite of two or more performance category scores.
For the 2020 MIPS payment year, if we do not finalize the proposal to set the cost performance category a zero percent weight, and if a MIPS eligible clinician does not receive a cost performance category percent score because there are not sufficient cost measures applicable and available to the clinician or the clinician is facing extreme and uncontrollable circumstances, we propose to redistribute the weight of the cost performance category to the quality performance category. In the rare scenarios where a MIPS eligible clinician does not receive a quality performance category percent score because there are not sufficient quality measures applicable and available to the clinician or the clinician is facing extreme and uncontrollable circumstances, we propose to redistribute the weight of the cost performance category equally to the remaining performance categories that are not reweighted.
In the rare event a MIPS eligible clinician is not scored on at least one measure in the quality performance category because there are not sufficient measures applicable and available or the clinician is facing extreme and uncontrollable circumstances, we propose for the 2020 MIPS payment year to continue our policy from the transition year and redistribute the 60 percent weight of the quality performance category so that the performance category weights are 50
We believe that all MIPS eligible clinicians will have sufficient improvement activities applicable and available. It is possible that a MIPS eligible clinician might face extreme and uncontrollable circumstances that render the improvement activities not applicable or available to the clinician; however, in that scenario, we believe it is likely that the measures specified for the other performance categories also would not be applicable or available to the clinician based on the circumstances. In the rare event that the improvement activities performance category would qualify for reweighting based on extreme and uncontrollable circumstances, and the other performance categories would not also qualify for reweighting, we propose to redistribute the improvement activities performance category weight to the quality performance category consistent with the redistribution policies for the cost and advancing care information performance categories. Should the cost performance category have available and applicable measures and the cost performance category weight is not finalized at zero percent, and the quality performance category is reweighted to zero percent, then we would redistribute the weight of the improvement activities performance category to the advancing care information performance category.
Table 38 summarizes the potential reweighting scenarios based on our proposals for the 2020 MIPS payment year should the cost performance category be weighted at zero percent.
In response to our final policy to redistribute the advancing care information performance category weight solely to the quality performance category in the CY 2017 Quality Payment Program final rule (81 FR 77327), we received some comments expressing concern that this would place undue emphasis on the quality performance category. Commenters expressed the belief that this policy would particularly affect non-patient facing MIPS eligible clinicians who have limited available measures, and would limit the ability to fairly compare different specialties that are reweighted differently. One reason for the discrepancy is that MIPS eligible clinicians that submit data to the advancing care information performance category can readily achieve a base score of 50 percent if they meet the requirements for the base score measures, whereas the quality performance category does not start at the same base. Commenters also expressed the belief that specialties with few quality measures available to them will be unfairly impacted by this reweighting policy, by putting a disproportionate weight on just a few quality measures. Commenters suggested we redistribute the weight of the advancing care information performance category to the improvement activities performance category because the improvement activities performance category allows for the most flexibility. One commenter recommended redistributing the weight of the advancing care information performance category to both the quality and improvement activities performance categories.
We continue to have concerns about increasing the weight of the improvement activities performance category, given that this performance category is based on attestation only and is not connected to a predecessor CMS program like the other MIPS performance categories. However, based on the comments we received, we considered an alternative approach for the 2020 MIPS payment year to redistribute the weight of the advancing care information performance category to the quality and improvement activities performance categories, to minimize the impact of the quality performance category on the final score. For this approach, we would redistribute 15 percent to the quality performance category (60 percent + 15 percent = 75 percent) and 10 percent to the improvement activities performance category (15 percent + 10 percent = 25 percent). We considered redistributing the weight of the advancing care information performance category equally to the quality and improvement activities performance categories. However, for simplicity, we wanted to redistribute the weights in increments of 5 points. Because MIPS eligible clinicians have more experience reporting quality measures and because these measures are more mature, under
We invite comments on our proposal for weighting the performance categories for the 2020 MIPS payment year and our alternative option for reweighting the advancing care information performance category.
For purposes of applying the MIPS payment adjustment under section 1848(q)(6)(E) of the Act, we finalized a policy in the CY 2017 Quality Payment Program final rule to use a single identifier, TIN/NPI, for all MIPS eligible clinicians, regardless of whether the TIN/NPI was measured as an individual, group or APM Entity group (81 FR 77329 through 77330). In other words, a TIN/NPI may receive a final score based on individual, group, or APM Entity group performance, but the MIPS payment adjustment would be applied at the TIN/NPI level.
We are not proposing any changes to the MIPS payment adjustment identifier.
In CY 2017 Quality Payment Program final rule (81 FR 77330 through 77332), we finalized a policy to use a TIN/NPI's historical performance from the performance period associated with the MIPS payment adjustment. We also proposed the following policies, and, although we received public comments on them and responded to those comments, we inadvertently failed to state that we were finalizing these policies, although it was our intention to do so. Thus, we clarify that the following final policies apply beginning with the transition year. For groups submitting data using the TIN identifier, we will apply the group final score to all the TIN/NPI combinations that bill under that TIN during the performance period. For individual MIPS eligible clinicians submitting data using TIN/NPI, we will use the final score associated with the TIN/NPI that is used during the performance period. For eligible clinicians in MIPS APMs, we will assign the APM Entity group's final score to all the APM Entity Participant Identifiers that are associated with the APM Entity. For eligible clinicians that participate in APMs for which the APM scoring standard does not apply, we will assign a final score using either the individual or group data submission assignments.
In the case where a MIPS eligible clinician starts working in a new practice or otherwise establishes a new TIN that did not exist during the performance period, there would be no corresponding historical performance information or final score for the new TIN/NPI. In cases where there is no final score associated with a TIN/NPI from the performance period, we will use the NPI's performance for the TIN(s) the NPI was billing under during the performance period. If the MIPS eligible clinician has only one final score associated with the NPI from the performance period, then we will use that final score. In the event that an NPI bills under multiple TINs in the performance period and bills under a new TIN in the MIPS payment year, we finalized a policy of taking the highest final score associated with that NPI in the performance period (81 FR 77332).
In some cases, a TIN/NPI could have more than one final score associated with it from the performance period, if the MIPS eligible clinician submitted duplicative data sets. In this situation, the MIPS eligible clinician has not changed practices; rather, for example, a MIPS eligible clinician has a final score for an APM Entity and a final score for a group TIN. If a MIPS eligible clinician has multiple final scores, the following hierarchy will apply. If a MIPS eligible clinician is a participant in MIPS APM, then the APM Entity final score would be used instead of any other final score. If a MIPS eligible clinician has more than one APM Entity final score, we will apply the highest APM Entity final score to the MIPS eligible clinician. If a MIPS eligible clinician reports as a group and as an individual and not as an APM Entity, we will calculate a final score for the group and individual identifier and use the highest final score for the TIN/NPI (81 FR 77332).
For a further description of our policies, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77330 through 77332).
In addition to the above policies from the CY 2017 Quality Payment Program final rule, beginning with the 2020 MIPS payment year, we are proposing to modify the policies to address the addition of virtual groups. Section 1848(q)(5)(I)(i) of the Act provides that MIPS eligible clinicians electing to be a virtual group must: (1) Have their performance assessed for the quality and cost performance categories in a manner that applies the combined performance of all the MIPS eligible clinicians in the virtual group to each MIPS eligible clinician in the virtual group for the applicable performance period; and (2) be scored for the quality
We also propose to modify our hierarchy to state that if a MIPS eligible clinician is not in an APM Entity and is in a virtual group, the MIPS eligible clinician would receive the virtual group final score over any other final score. Our policies remain unchanged for TIN/NPIs who are not in an APM Entity or virtual group.
We invite public comment on our proposals.
Table 40 illustrates the previously finalized and newly proposed policies for determining which final score to use when more than one final score is associated with a TIN/NPI.
Table 41 illustrates the previously finalized policies that apply if there is no final score associated with a TIN/NPI from the performance period, such as when a MIPS eligible clinician starts working in a new practice or otherwise establishes a new TIN.
For a description of the statutory background and further description of our policies, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77332 through 77333).
We are not proposing any changes to these policies.
Under section 1848(q)(6)(D)(i) of the Act, for each year of the MIPS, the Secretary shall compute a performance threshold with respect to which the final scores of MIPS eligible clinicians are compared for purposes of determining the MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act for a year. The performance threshold for a year must be either the mean or median (as selected by the Secretary, and which may be reassessed every 3 years) of the final scores for all MIPS eligible clinicians for a prior period specified by the Secretary. Section 1848(q)(6)(D)(iii) of the Act outlines a special rule for the initial 2 years of MIPS, which requires the Secretary, prior to the performance period for such years, to establish a performance threshold for purposes of determining the MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act and an additional performance threshold for purposes of determining the additional MIPS payment adjustment factors under section 1848(q)(6)(C) of the Act, each of which shall be based on a period prior to the performance period and take into account data available for performance on measures and activities that may be used under the performance categories and other factors determined appropriate by the Secretary. We codified the term performance threshold at § 414.1305 as the numerical threshold for a MIPS payment year against which the final scores of MIPS eligible clinicians are compared to determine the MIPS payment adjustment factors. We codified at § 414.1405(b) that a performance threshold will be specified for each MIPS payment year. We refer readers to the CY 2017 Quality Payment Program final rule for further discussion
Our goal was to encourage participation and provide an opportunity for MIPS eligible clinicians to become familiar with the MIPS Program. We determined that it would have been inappropriate to set a performance threshold that would result in downward adjustments to payments for many clinicians who may not have had time to prepare adequately to succeed under MIPS. By providing a pathway for many clinicians to succeed under MIPS, we believed that we would encourage early participation in the program, which may enable more robust and thorough engagement with the program over time. We set the performance threshold at a low number to provide MIPS eligible clinicians an opportunity to achieve a minimum level of success under the program, while gaining experience with reporting on the measures and activities and becoming familiar with other program policies and requirements. We believed if we set the threshold too high, using a new formula that is unfamiliar and confusing to clinicians, many could be discouraged from participating in the first year of the program, which may lead to lower participation rates in future years. Additionally, we believed this flexibility is particularly important to reduce the burden for MIPS eligible clinicians in small or solo practices. We believed that active participation of MIPS eligible clinicians in MIPS will improve the overall quality, cost, and care coordination of services provided to Medicare beneficiaries. In accordance with section 1848(q)(6)(D)(iii) of the Act, we took into account available data regarding performance on measures and activities, as well as other factors we determined appropriate. We refer readers to 81 FR 77333 through 77338 for details on our analysis. We also stated our intent to increase the performance threshold in the 2020 MIPS payment year, and that, beginning in the 2021 MIPS payment year, we will use the mean or median final score from a prior period as required by section 1848(q)(6)(D)(i) of the Act (81 FR 77338).
For the 2020 MIPS payment year, we again want to use the flexibility provided in section 1848(q)(6)(D)(iii) to help transition MIPS eligible clinicians to the 2021 MIPS payment year, when the performance threshold will be the mean or median of the final scores for all MIPS eligible clinicians from a prior period. We want to encourage continued participation and the collection of meaningful data by MIPS eligible clinicians. A higher performance threshold would help MIPS eligible clinicians strive to achieve more complete reporting and better performance and prepare MIPS eligible clinicians for the 2021 MIPS payment year. However, a performance threshold set too high could also create a performance barrier, particularly for MIPS eligible clinicians who did not previously participate in PQRS or the EHR Incentive Programs. We have heard from stakeholders requesting that we continue a low performance threshold and from stakeholders requesting that we ramp up the performance threshold to help MIPS eligible clinicians prepare for the 2021 MIPS payment year and to meaningfully incentivize higher performance. Given our desire to provide a meaningful ramp between the transition year's 3-point performance threshold and the 2021 MIPS payment year performance threshold using the mean or median of the final scores for all MIPS eligible clinicians for a prior period, we are proposing to set the performance threshold at 15 points for the 2020 MIPS payment year.
We propose a performance threshold of 15 points because it represents a meaningful increase in performance threshold, compared to 3 points in the transition year, while maintaining flexibility for MIPS eligible clinicians in the pathways available to achieve this performance threshold. For example, submitting the maximum number of improvement activities could qualify for a score for 15 points (40 out 40 possible points for the improvement activity which is worth 15 percent of the final score). The performance threshold could also be met by full participation in the quality performance category: By submitting all required measures with the necessary data completeness, MIPS eligible clinicians would earn at least a quality performance category percent score of 30 percent (which is 3 measure achievement points out of 10 measure points for each required measure).
If the quality performance category is weighted at 60 percent, then the quality performance category would be 30 percent × 60 percent × 100 which equals 18 points toward the final score and exceeds the performance threshold. Finally, a MIPS eligible clinician could achieve a final score of 15 points through an advancing care information performance category score of 60 percent or higher (60 percent advancing care information performance category score × 25 percent for the advancing care information performance category weight × 100 equals 15 points towards the final score). We refer readers to section II.C.8.g.(2) of this proposed rule for complete examples of how MIPS eligible clinician could exceed the performance threshold. We believe the proposed performance threshold would mitigate concerns from MIPS eligible clinicians about participating in the program for the second year. However, we remain concerned that moving from a performance threshold of 15 points for the 2020 MIPS payment year to a performance threshold of the mean or median of the final scores for all MIPS eligible clinicians for a prior period for the 2021 MIPS payment year may be a steep jump.
By the 2021 MIPS payment year, MIPS eligible clinicians would likely need to submit most of the required information and perform well on the measures and activities to receive a positive MIPS payment adjustment. Therefore, we also seek comment on setting the performance threshold either lower or higher than the proposed 15 points for the 2020 MIPS payment year. A performance threshold lower than the proposed 15 points for the 2020 MIPS payment year presents the potential for a significant increase in the final score a MIPS eligible clinician must earn to meet the performance threshold in the 2021 MIPS payment year, as well as providing for a potentially smaller total amount of negative MIPS payment adjustments upon which the total amount of the positive MIPS payment adjustments would depend due to the budget neutrality requirement under section 1848(q)(6)(F)(ii) of the Act. A performance threshold higher than the proposed 15 points would increase the final score required to receive a neutral MIPS payment adjustment, which may be particularly challenging for small practices, even with the proposed addition of the small practice bonus. A higher performance threshold would also allow for potentially higher positive MIPS payment adjustments for those who exceed the performance threshold.
We considered an alternative of setting a performance threshold of 6 points, which could be met by submitting two quality measures with required data completeness or one high-weighted improvement activity. While this lower performance threshold may provide a sharp increase to the required performance threshold in MIPS payment year 2021 (the mean or median of the final scores for all MIPS eligible clinicians for a prior period), it would continue to reward clinicians for participation in MIPS as they transition into the program.
We also considered an alternative of setting the performance threshold at 33 points, which would require full participation both in improvement activities and in the quality performance category (either for a small group or for a large group that meets data completeness standards) to meet the performance threshold. Such a threshold would make the step to the required mean or median performance threshold in MIPS payment year 2021 less steep, but could present further challenges to clinicians who have not previously participated in legacy quality reporting programs.
As required by section 1848(q)(6)(D)(iii) of the Act, for the purposes of determining the performance threshold, we considered data available for performance on measures and activities that may be used under the MIPS performance categories. Specifically, we updated our scoring model using 2019 MIPS payment year eligibility data from the initial 12-month period to identify potential MIPS eligible clinicians who are physicians (doctors of medicine, doctors of osteopathy, chiropractors, dentists, optometrists, and podiatrists), nurse practitioners, physician assistants, certified registered nurse anesthetists, and clinical nurse specialists, and who exceeded the low-volume threshold. We estimated newly enrolled Medicare clinicians who would be excluded from MIPS by using clinicians (identified by NPI) that have Part B charges in the eligibility file, but no Part B charges in 2015. To exclude QPs from our scoring model, we used a preliminary version of the file used for the predictive qualifying Alternative Payment Model participants analysis made available on
We used 2014 and 2015 PQRS and 2015 VM data to estimate scores for the quality performance category, using the published benchmarks for the 2017 MIPS performance period. We used 2015 and 2016 Medicare and Medicaid EHR Incentive files to estimate advancing care information performance category scores. We also modeled an improvement activities performance category score using assumptions based on prior PQRS and EHR Incentive Program participation. We did not model any cost measures as we proposed in section II.C.6.d.(2) of this proposed rule to weight the cost performance category at zero percent. We refer readers to the regulatory impact analysis in section V.C. of this proposed rule for a detailed description of our scoring model and data sources.
Using 2015 PQRS data, we determined which of these MIPS eligible clinicians participated in PQRS and estimated participation rates for the MIPS quality performance category based on PQRS participation, which is the performance category that accounts for the largest share (a minimum of 60 percent) of the 2020 MIPS payment year final score. We noted that 92.4 percent of the estimated MIPS eligible clinicians submitted data to PQRS, but the participation rate was lower for MIPS eligible clinicians in small practices at 69.7 percent. While we believe many of the policies in this proposed rule and the technical assistance for small practices would help increase participation, we believe it is important to keep the performance threshold low so that these small practices can learn to participate and perform well in MIPS for future years without excessive financial risk.
We invite public comments on the proposal to set the performance threshold at 15 points, and also seek comment on setting the performance threshold at the alternative of 6 points or at 33 points for the 2020 MIPS payment year.
We also seek public comments on principles and considerations for setting the performance threshold beginning with the 2021 MIPS payment year, which will be the mean or median of the final scores for all MIPS eligible clinicians from a prior period.
Section 1848(q)(6)(D)(ii) of the Act requires the Secretary to compute, for each year of the MIPS, an additional performance threshold for purposes of determining the additional MIPS payment adjustment factors for exceptional performance under paragraph (C). For each such year, the Secretary shall apply either of the following methods for computing the additional performance threshold: (1) The threshold shall be the score that is equal to the 25th percentile of the range of possible final scores above the performance threshold determined under section 1848(q)(6)(D)(i) of the Act; or (2) the threshold shall be the score that is equal to the 25th percentile of the actual final scores for MIPS eligible clinicians with final scores at or above the performance threshold for the prior period described in section 1848(q)(6)(D)(i) of the Act.
We codified at § 414.1305 the definition of additional performance threshold as the numerical threshold for a MIPS payment year against which the final scores of MIPS eligible clinicians are compared to determine the additional MIPS payment adjustment factors for exceptional performance. We also codified at § 414.1405(d) that an additional performance threshold will be specified for each of the MIPS payment years 2019 through 2024. We refer readers to the CY 2017 Quality Payment Program final rule for further discussion of the additional performance threshold (81 FR 77338 through 77339).
Based on the special rule for the initial 2 years of MIPS in section 1848(q)(6)(D)(iii) of the Act, for the transition year, we decoupled the additional performance threshold from the performance threshold and established the additional performance threshold at 70 points. We selected a 70-point numerical value for the additional performance threshold, in part, because it would require a MIPS eligible clinician to submit data for and perform well on more than one performance category (except in the event the advancing care information performance category is reweighted to zero percent and the weight is redistributed to the quality performance category making the quality performance category worth 85 percent of the final score). Under section 1848(q)(6)(C) of the Act, a MIPS eligible clinician with a final score at or above the additional performance threshold will receive an additional MIPS payment adjustment factor and may share in the $500,000,000 available for the year under section 1848(q)(6)(F)(iv) of the Act. We believed these additional incentives should only be available to those clinicians with very high performance on the MIPS measures and activities. We took into account the data available and the modeling described in section II.E.7.c.(1) of the CY 2017 Quality Payment Program final rule in selecting the additional performance threshold for the transition year (81 FR 77338 through 77339).
As we discussed in section II.C.8.c. of this proposed rule, we are relying on the special rule under section 1848(q)(6)(D)(iii) of the Act to establish the performance threshold at 15 points for 2020 MIPS payment year. We are proposing to again decouple the additional performance threshold from the performance threshold. Because we do not have actual MIPS final scores for a prior performance period, if we do not decouple the additional performance threshold from the performance threshold, then we would have to set the additional performance threshold at
We took into account the data available and the modeling described in section II.C.8.c. of this proposed rule to estimate final scores for the 2020 MIPS payment year. We believe 70 points is appropriate because it requires a MIPS eligible clinician to submit data for and perform well on more than one performance category (except in the event the advancing care information measures are not applicable and available to a MIPS eligible clinician). Generally, a MIPS eligible clinician could receive a maximum score of 60 points for the quality performance category, which is below the 70-point additional performance threshold. In addition, 70 points is at a high enough level that MIPS eligible clinicians must submit data for the quality performance category to achieve this target. For example, if a MIPS eligible clinician gets a perfect score for the improvement activities and advancing care information performance categories, but does not submit quality measures data, then the MIPS eligible clinician would only receive 40 points (0 points for quality + 15 points for improvement activities + 25 points for advancing care information), which is below the additional performance threshold. We believe the additional performance threshold at 70 points maintains the incentive for excellent performance while keeping the focus on quality performance. Finally, we believe keeping the additional performance threshold at 70 points maintains consistency with the 2019 MIPS payment year which helps to simplify the overall MIPS framework.
We invite public comment on these proposals. We also seek feedback on whether we should raise the additional performance threshold to a higher number which would in many instances require the use of an EHR for those to whom the advancing care information performance category requirements would apply. In addition, a higher additional performance threshold would incentivize better performance and would also allow MIPS eligible clinicians to receive a higher additional MIPS payment adjustment.
We also seek public comment on which method we should use to compute the additional performance threshold beginning with the 2021 MIPS payment year. Section 1848(q)(6)(D)(ii) of the Act requires the additional performance threshold to be the score that is equal to the 25th percentile of the range of possible final scores above the performance threshold for the year, or the score that is equal to the 25th percentile of the actual final scores for MIPS eligible clinicians with final scores at or above the performance threshold for the prior period described in section 1848(q)(6)(D)(i) of the Act. For example, should we use the lower of the two options, which would result in more MIPS eligible clinicians receiving an additional MIPS payment adjustment for exceptional performance? Or should we use the higher of the options, which would restrict the additional MIPS payment adjustment for exceptional performance to those with the higher final scores? Since a fixed amount is available for a year under section 1848(q)(6)(F)(iv) of the Act to fund the additional MIPS payment adjustments, the more clinicians that receive an additional MIPS payment adjustment, the lower the average clinician's additional MIPS payment adjustment will be.
We codified at § 414.1405(b)(3) that a scaling factor not to exceed 3.0 may be applied to positive MIPS payment adjustment factors to ensure budget neutrality such that the estimated increase in aggregate allowed charges resulting from the application of the positive MIPS payment adjustment factors for the MIPS payment year equals the estimated decrease in aggregate allowed charges resulting from the application of negative MIPS payment adjustment factors for the MIPS payment year. We refer readers to the CY 2017 Quality Payment Program final rule for further discussion of budget neutrality (81 FR 77339).
We are not proposing any changes to the scaling and budget neutrality requirements as they are applied to MIPS payment adjustment factors in this proposed rule.
We refer readers to the CY 2017 Quality Payment Program final rule for further discussion of the additional MIPS payment adjustment factor (81 FR 77339 through 77340). We are not proposing any changes to determine the additional MIPS payment adjustment factors.
Section 1848(q)(6)(E) of the Act provides that for items and services furnished by a MIPS eligible clinician during a year (beginning with 2019), the amount otherwise paid under Part B for such items and services and MIPS eligible clinician for such year, shall be multiplied by 1 plus the sum of the MIPS payment adjustment factor determined under section 1848(q)(6)(A) of the Act divided by 100, and as applicable, the additional MIPS payment adjustment factor determined under section 1848(q)(6)(C) of the Act divided by 100.
We codified at § 414.1405(e) the application of the MIPS payment adjustment factors. For each MIPS payment year, the MIPS payment adjustment factor, and if applicable the additional MIPS payment adjustment factor, are applied to Medicare Part B payments for items and services furnished by the MIPS eligible clinician during the year.
We are proposing to apply the MIPS payment adjustment factor, and if applicable, the additional MIPS payment adjustment factor, to the Medicare paid amount for items and services paid under Part B and furnished by the MIPS eligible clinician during the year. This proposal is consistent with the approach taken for the value-based payment modifier (77 FR 69308 through 69310) and would mean that beneficiary cost-sharing and coinsurance amounts would not be affected by the application of the MIPS payment adjustment factor and the additional MIPS payment adjustment factor. The MIPS payment adjustment applies only to the amount otherwise paid under Part B for items and services furnished by a MIPS eligible clinician during a year. Please refer to the CY 2017 Quality Payment Program final rule at 81 FR 77340 and section II.C.3.c.
Figure A provides an example of how various final scores would be converted to an adjustment factor, and potentially an additional adjustment factor, using the statutory formula and based on proposed policies. In Figure A, the performance threshold is 15 points. The applicable percentage is 5 percent for 2020. The adjustment factor is determined on a linear sliding scale from zero to 100, with zero being the lowest negative applicable percentage (negative 5 percent for the 2020 MIPS payment year), and 100 being the highest positive applicable percentage. However, there are two modifications to this linear sliding scale. First, there is an exception for a final score between zero and one-fourth of the performance threshold (zero and 3.75 points based on the proposed performance threshold for the 2020 MIPS payment year). All MIPS eligible clinicians with a final score in this range would receive the lowest negative applicable percentage (negative 5 percent for the 2020 MIPS payment year). Second, the linear sliding scale line for the positive MIPS adjustment factor is adjusted by the scaling factor (as discussed in section II.C.8.e. of this proposed rule). If the scaling factor is greater than zero and less than or equal to 1.0, then the adjustment factor for a final score of 100 would be less than or equal to 5 percent. If the scaling factor is above 1.0, but less than or equal to 3.0, then the adjustment factor for a final score of 100 would be higher than 5 percent. Only those MIPS eligible clinicians with a final score equal to 15 points (which is the performance threshold in this example) would receive a neutral MIPS payment adjustment. Because our proposed policies have set the performance threshold at 15 points, we anticipate that the scaling factor would be less than 1.0 and the payment adjustment for MIPS eligible clinicians with a final score of 100 points would be less than 5 percent.
Figure A of this proposed rule illustrates an example slope. In this example, the scaling factor for the adjustment factor is 0.22, which is much lower than 1.0. In this example, MIPS eligible clinicians with a final score equal to 100 would have an adjustment factor of 1.10 percent (5 percent × 0.22).
The additional performance threshold is 70 points. An additional adjustment factor of 0.5 percent starts at the additional performance threshold and increases on a linear sliding scale up to 10 percent times a scaling factor that is greater than zero and less than or equal to 1.0. The scaling factor will be determined so that the estimated aggregate increase in payments associated with the application of the additional adjustment factors is equal to $500,000,000. In Figure A of this proposed rule, the example scaling factor for the additional adjustment factor is 0.183. Therefore, MIPS eligible clinicians with a final score of 100 would have an additional adjustment factor of 1.83 percent (10 percent × 0.183). The total adjustment for a MIPS eligible clinician with a final score equal to 100 would be 1 + 0.0110 + 0.0183 = 1.0293, for a total positive MIPS payment adjustment of 2.93 percent.
The final MIPS payment adjustments would be determined by the distribution of final scores across MIPS eligible clinicians and the performance threshold. More MIPS eligible clinicians above the performance threshold means the scaling factors would decrease because more MIPS eligible clinicians receive a positive MIPS payment adjustment. More MIPS eligible clinicians below the performance threshold means the scaling factors would increase because more MIPS eligible clinicians would have negative MIPS payment adjustments and relatively fewer MIPS eligible clinicians receive positive MIPS payment adjustments.
Table 42 illustrates the changes in payment adjustments from the transition year to the 2020 MIPS payment year based on the proposals in this proposed rule as well as the statutorily-required increase in the applicable percent as required by section 1848(q)(6)(B) of the Act.
We have provided the following examples for the 2020 MIPS payment year to demonstrate scenarios in which MIPS eligible clinicians can achieve a final score at or above the performance threshold of 15 points.
In the example illustrated in Table 43, a MIPS eligible clinician in a small practice reporting individually meets the performance threshold by reporting one measure one time via claims and one medium-weight improvement activity. The practice does not submit data for the advancing care information performance category, but does submit a significant hardship exception application which is approved; therefore, the weight for the advancing care information performance category is reweighted to the quality performance category due to proposed reweighting policies discussed in section II.C.7.b,(3) of this proposed rule. We also assume the small practice has a cost performance category percent score of 50 percent, although the cost performance category percent score will not contribute to the final score. Finally, we assume the average HCC score for the beneficiaries seen by the MIPS eligible clinician is 1.5.
There are several special scoring rules which affect MIPS eligible clinicians in a small practice:
• 3 measure achievement points for each quality measure even if the measure does not meet data completeness standards. We refer readers to section II.C.7.a.(2)(d) of this proposed rule for discussion of this policy. Therefore, a quality measure submitted one time would receive 3 points. Because the measure is submitted via claims, it does not qualify for the end-to-end electronic reporting bonus, nor would it qualify for the high-priority bonus because it is the only measure submitted. However, because the MIPS eligible clinician does not meet full participation requirements, the MIPS eligible clinician does not qualify for improvement scoring. We refer you to section II.C.7.a.(2)(i)(iii) of this proposed rule for a discussion on full participation requirements. Therefore, the quality performance category is (3 measure achievement points + zero measure bonus points)/60 total available measure points + zero improvement percent score which is 5 percent.
• The advancing care information performance category weight is redistributed to quality so that the quality performance category percent score is worth 85 percent of the final score. We refer you to section II.C.7.b.(3)(d) of this proposed rule for a discussion of this proposed policy.
• MIPS eligible clinicians in small practices qualify for special scoring for improvement activities so a medium weighted activity is worth 20 points out of a total 40 possible points for the improvement activities performance category. We refer you to section II.C.6.e.(5) of this proposed rule for a discussion of this proposed policy.
• MIPS eligible clinicians in small practices qualify for the 5 point small practice bonus which is applied to the final score. We refer you to section II.C.7.b.(1)(c) of this proposed rule for a discussion of this proposed policy.
This MIPS eligible clinician exceeds the performance threshold of 15 points (but does not exceed the additional performance threshold). This score is summarized in Table 43.
In the example illustrated in Table 44, a MIPS eligible clinician in a medium size practice participating in MIPS as a group meets 75 percent of the quality score and 100 percent for the advancing care information and improvement activities performance categories. There are many paths for a practice to receive a 75 percent score in the quality performance category, so for simplicity we are assuming the score has been calculated. Both the performance threshold and the additional performance threshold are exceeded. Again, for simplicity, we assume the average HCC score for the group is 1.5. In this example, the group practice does not qualify for any special scoring, yet is able to exceed the additional performance threshold and achieve the additional adjustment factor.
In the example illustrated in Table 45, an individual MIPS eligible clinician that is non-patient facing and not in a small practice meets 50 percent of the quality score and 50 percent for 1 medium-weighted for improvement activity. Again, there are many paths for a practice to receive a 50 percent score in the quality performance category, so for simplicity we are assuming the score has been calculated. Because the MIPS eligible clinician is non-patient facing, they qualify for special scoring for improvement activities, they receive 20 points (out of 40 possible points) for the medium weighted activity. Also, this individual did not submit advancing care information measures and qualifies for the automatic reweighting of the advancing care information performance category to quality. The non-patient facing MIPS eligible clinician has an average HCC score of 1.5, but as the MIPS eligible clinician is not in a small practice, the MIPS eligible clinician does not qualify for the small practice bonus.
In this example, the performance threshold is exceeded while the additional performance threshold is not.
We note that these examples are not intended to be exhaustive of the types of participants nor the opportunities for reaching and exceeding the performance threshold.
As we have stated previously in the CY 2017 Quality Payment Program final rule (81 FR 77345), we will continue to engage in user research with front-line clinicians to ensure we are providing the performance feedback data in a user-friendly format, and that we are including the data most relevant to clinicians. Any suggestions from user research would be considered as we
Over the past year, we have conducted numerous user research sessions to determine what the community most needs in performance feedback. In summary we have found the users want the following:
(1) To know as soon as possible how I am performing based on my submitted data so that I have confidence that I performed the way I thought I would.
(2) To be able to quickly understand how and why my payments will be adjusted so that I can understand how my business will be impacted.
(3) To be able to quickly understand how I can improve my performance so that I can increase my payment in future program years.
(4) To know how I am performing over time so I can improve the care I am providing patients in my practice.
(5) To know how my performance compares to my peers.
Based on that research, we have already begun development of real-time feedback on data submission and scoring where technically feasible (some scoring requires all clinician data be submitted, and therefore, cannot occur until the end of the submission period). By “real-time” feedback, we mean instantaneous feedback; for example, when a clinician submits their data via our Web site or a third party submits data via our Application Program Interface (API), they will know immediately if their submission was successful.
We will continue to provide information for stakeholders who wish to participate in user research via our education and communication channels. Suggestions can also be sent via the “Contact Us” information on
Under section 1848(q)(12)(A)(i) of the Act, we are at a minimum required to provide MIPS eligible clinicians with timely (such as quarterly) confidential feedback on their performance under the quality and cost performance categories beginning July 1, 2017, and we have discretion to provide such feedback regarding the improvement activities and advancing care information performance categories.
Beginning July 1, 2018, we are proposing to provide performance feedback to MIPS eligible clinicians and groups for the quality and cost performance categories for the 2017 performance period, and if technically feasible, for the improvement activities and advancing care information performance categories. We propose to provide this performance feedback at least annually, and as, technically feasible, we would provide it more frequently, such as quarterly. If we are able to provide it more frequently, we would communicate the expected frequency to our stakeholders via our education and outreach communication channels.
Based on public comments summarized and responded to in the CY 2017 Quality Payment Program final rule (81 FR 77347), we also propose that the measures and activities specified for the CY 2017 performance period (for all four MIPS performance categories), along with the final score, would be included in the performance feedback provided on or about July 1, 2018. We request comment on these proposals.
For cost measures, since we can measure performance using any 12-month period of prior claims data, we request comment on whether it would be helpful to provide more frequent feedback on the cost performance category using rolling 12-month periods or quarterly snapshots of the most recent 12-month period; how frequent that feedback should be; and the format in which we should make it available to clinicians and groups. In addition, as described in sections II.C.6.b. and II.C.6.d. of this proposed rule, we intend to provide cost performance feedback in the fall of 2017 and the summer of 2018 on new episode-based cost measures that are currently under development by CMS. With regard to the format of feedback on cost measures, we are considering utilizing the parts of the Quality and Resource Use Reports (QRURs) that user testing has revealed beneficial while making the overall look and feel usable to clinicians. We request comment whether that format is appropriate or if other formats or revisions to that format should be used to provide performance feedback on cost measures.
We are proposing that MIPS eligible clinicians who participate in MIPS APMs would receive performance feedback in 2018 and future years of the Quality Payment Program, as technically feasible. Please refer to section II.C.6.g.(5) of this proposed rule for additional information related to this proposal.
As noted in the CY 2017 Quality Payment Program final rule (81 FR 77071), eligible clinicians who are not included in the definition of a MIPS eligible clinician during the first 2 years of MIPS (or any subsequent year) may voluntarily report on measures and activities under MIPS, but will not be subject to the payment adjustment. In the final rule (81 FR 77346), we summarized public comments requesting that eligible clinicians who are not required, but who voluntarily report on measures and activities under MIPS, should receive the same access to performance feedback as MIPS eligible clinicians, and indicated that we would take the comments into consideration in the future development of performance feedback. We propose to furnish performance feedback to eligible clinicians and groups that do not meet the definition of a MIPS eligible clinician but voluntarily report on measures and activities under MIPS. We propose that this would begin with data collected in performance period 2017, and would be available beginning July 1, 2018. Based on user and market research, we believe that making this information available would provide value in numerous ways. First, it would help clinicians who are excluded from MIPS in the 2017 performance period, but who may be considered MIPS eligible clinicians in future years, to prepare for participation in the Quality Payment Program when there are payment consequences associated with participation. Second, it would give all clinicians equal access to the CMS claims and benchmarking data available in performance feedback. And third, it would allow clinicians who may be interested in participating in an APM to make a more informed decision.
We request comments on this proposal.
Under section 1848(q)(12)(A)(ii) of the Act, the Secretary may use one or more mechanisms to make performance feedback available, which may include use of a web-based portal or other mechanisms determined appropriate by the Secretary. For the quality performance category, described in section 1848(q)(2)(A)(i) of the Act, the feedback shall, to the extent an eligible clinician chooses to participate in a data registry for purposes of MIPS (including registries under sections 1848(k) and (m) of the Act), be provided based on
As previously stated in the CY 2017 Quality Payment Program final rule (81 FR 77347 through 77349), we will use a CMS-designated system as the mechanism for making performance feedback available, which we expect will be a web-based application. We expect to use a new and improved format for the next performance feedback, anticipated to be released around July 1, 2018. It will be provided via the Quality Payment Program Web site (
We are also seeking comment on how health IT, either in the form of an EHR or as a supplemental module, could better support the feedback related to participation in the Quality Payment Program and quality improvement in general. Specifically—
• Are there specific health IT functionalities that could contribute significantly to quality improvement?
• Are there specific health IT functionalities that could be part of a certified EHR technology or made available as optional health IT modules in order to support the feedback loop related to Quality Payment Program participation or participation in other HHS reporting programs?
• In what other ways can health IT support clinicians seeking to leverage quality data reports to inform clinical improvement efforts? For example, are there existing or emerging tools or resources that could leverage an API to provide timely feedback on quality improvement activities?
• Are there opportunities to expand existing tracking and reporting for use by clinicians, for example expanding the feedback loop for patient engagement tools to support remote monitoring of patient status and access to education materials?
We welcome public comment on these questions.
We intend to continue to leverage third party intermediaries as a mechanism to provider performance feedback. In the CY 2017 Quality Payment Program final rule (81 FR 77367 through 77386) we finalized that at least 4 times per year, qualified registries and QCDRs will provide feedback on all of the MIPS performance categories that the qualified registry or QCDR reports to us (improvement activities, advancing care information, and/or quality performance category). The feedback should be given to the individual MIPS eligible clinician or group (if participating as a group) at the individual participant level or group level, as applicable, for which the qualified registry or QCDR reports. The qualified registry or QCDR is only required to provide feedback based on the MIPS eligible clinician's data that is available at the time the performance feedback is generated. In regard to third party intermediaries, we also noted we would look to propose “real time” feedback as soon as it is technically feasible.
Per the policies finalized in the CY 2017 Quality Payment Program final rule (81 FR 77367 through 77386), we continue to require qualified registries and QCDRs, as well as encourage other third party intermediaries (such as health IT vendors that submit data to us on behalf of a MIPS eligible clinician or group), to provide performance feedback to individual MIPS eligible clinicians and groups via the third party intermediary with which they are already working. We also understand that performance feedback is valuable to individual clinicians and groups, and seek feedback from third party intermediaries on when “real-time” feedback could be provided.
Additionally, we plan to continue to work with third party intermediaries as we continue to develop the mechanisms for performance feedback, to see where we may be able to develop and implement efficiencies for the Quality Payment Program. We are exploring options with an API, which could allow authenticated third party intermediaries to access the same data that we use to provide confidential feedback to the individual clinicians and groups on whose behalf the third party intermediary reports for purposes of MIPS, in accordance with applicable law, including, but not limited to, the HIPAA Privacy and Security Rules. Our goal is to enable individual clinicians and groups to more easily access their feedback via the mechanisms and relationships they already have established. We are seeking comments on this approach as we continue to develop performance feedback mechanisms. We refer readers to section II.C.10. of this proposed rule for additional information on Third Party Data Submission.
Section 1848(q)(12)(A)(v) of the Act, states that the Secretary may use the mechanisms established under section 1848(q)(12)(A)(ii) of the Act to receive information from professionals. This allows for expanded use of the feedback mechanism to not only provide feedback on performance to MIPS eligible clinicians, but to also receive information from professionals.
In the CY 2017 Quality Payment Program final rule (81 FR 77350), we discussed that we intended to explore the possibility of adding this feature to the CMS-designated system, such as a portal, in future years under MIPS. Although we are not making any specific proposals at this time, we are again seeking comment on the features that could be developed for the expanded use of the feedback mechanism. This could be a feature where eligible clinicians and groups can send their feedback (for example, if they are experiencing issues accessing their data, technical questions about their data, etc.) to us through the Quality Payment Program Service Center or the Quality Payment Program Web site. We appreciate that eligible clinicians and groups may have questions regarding the Quality Payment Program information contained in their performance feedback. To assist eligible clinicians and groups, we intend to utilize existing resources, such as a helpdesk or offer technical assistance, to help address questions with the goal of linking these resource features to the Quality Payment Program Web site and Service Center.
Section 1848(q)(12)(B)(i) of the Act states that beginning July 1, 2018, the Secretary shall make available to MIPS eligible clinicians information about the items and services for which payment is made under Title 18 that are furnished to individuals who are patients of MIPS eligible clinicians by other suppliers and providers of services. This information may be made available through mechanisms determined appropriate by the Secretary, such as the CMS-designated system that would also provide performance feedback. Section 1848(q)(12)(B)(ii) of the Act specifies that the type of information provided may include the name of such providers, the types of items and services furnished, and the dates that items and services were furnished. Historical data regarding the total, and components of, allowed charges (and
We propose, beginning with the performance feedback provided around July 1, 2018, to make available to MIPS eligible clinicians and eligible clinicians information about the items and services for which payment is made under Title 18 that are furnished to individuals who are patients of MIPS eligible clinicians and eligible clinicians by other suppliers and providers of services. We propose to include as much of the following data elements as technically feasible: The name of such suppliers and providers of services; the types of items and services furnished and received; the dollar amount of services provided and received; and the dates that items and services were furnished. We propose that the additional information would include historical data regarding the total, and components of, allowed charges (and other figures as determined appropriate). We propose that this information be provided on the aggregate level; with the exception of data on items and services, as we could consider providing this data at the patient level, if clinicians find that level of data to be useful, although we note it may contain personally identifiable information and protected health information. We propose the date range for making this information available would be based on what is most helpful to clinicians, such as the most recent data we have available, which as technically feasible would be provided from a 3 to 12-month period. We propose to make this information available via the Quality Payment Program Web site, and as technically feasible, as part of the performance feedback. Finally, because data on items and services furnished is generally kept confidential, we propose that access would be provided only after secure credentials are obtained. We request comment on these proposals.
As we have previously indicated (81 FR 77352), we intend to do as much as we can of the development of the template for performance feedback by working with the stakeholder community in a transparent manner. We believe this will encourage stakeholder commentary and make sure the result is the best possible format(s) for feedback.
To continue with our collaborative goal of working with the stakeholder community, we seek comment on the structure, format, content (for example, detailed goals, data fields, and elements) that would be useful for MIPS eligible clinicians and groups to include in performance feedback, including the data on items and services furnished, as discussed above. Additionally, we understand the term “performance feedback” may not be meaningful to clinicians or groups to clearly denote what this data might imply. Therefore, we seek comment on what to term “performance feedback.” User testing to date has provided some considerations for a name in the Quality Payment Program, such as Progress Notes, Reports, Feedback, Performance Feedback, or Performance Reports.
Any suggestions on the template to be used for performance feedback or what to call “performance feedback” can be submitted to the Quality Payment Program Web site at
In the CY 2017 Quality Payment Program final rule (81 FR 77546), we finalized at § 414.1385 that MIPS eligible clinicians or groups may request a targeted review of the calculation of the MIPS payment adjustment factor under section 1848(q)(6)(A) of the Act and, as applicable, the calculation of the additional MIPS payment adjustment factor under section 1848(q)(6)(C) of the Act applicable to such MIPS eligible clinician or group for a year. We note MIPS eligible clinicians who are scored under the APM scoring standard described in section II.C.6.g. of this proposed rule may request this targeted review. Although we are not proposing any changes to the targeted review process, we are providing information on the process that was finalized in the CY 2017 Quality Payment Program final rule (81 FR 77353 through 77358).
(1) MIPS eligible clinicians and groups have a 60-day period to submit a request for targeted review, which begins on the day we make available the MIPS payment adjustment factor, and if applicable the additional MIPS payment adjustment factor, for the MIPS payment year and ends on September 30 of the year prior to the MIPS payment year or a later date specified by us.
(2) We will respond to each request for targeted review timely submitted and determine whether a targeted review is warranted. Examples under which a MIPS eligible clinician or group may wish to request a targeted review include, but are not limited to:
• The MIPS eligible clinician or group believes that measures or activities submitted to us during the submission period and used in the calculations of the final score and determination of the adjustment factors have calculation errors or data quality issues. These submissions could be with or without the assistance of a third party intermediary; or
• The MIPS eligible clinician or group believes that there are certain errors made by us, such as performance category scores were wrongly assigned to the MIPS eligible clinician or group (for example, the MIPS eligible clinician or group should have been subject to the low-volume threshold exclusion and should not have received a performance category score).
(3) The MIPS eligible clinician or group may include additional information in support of their request for targeted review at the time the request is submitted. If we request additional information from the MIPS eligible clinician or group, it must be provided and received by us within 30 days of the request. Non-responsiveness to the request for additional information may result in the closure of the targeted review request, although the MIPS eligible clinician or group may submit another request for targeted review before the deadline.
(4) Decisions based on the targeted review are final, and there is no further review or appeal.
In the CY 2017 Quality Payment Program final rule (81 FR 77546 through 77547), we finalized at § 414.1390(a) that we will selectively audit MIPS eligible clinicians and groups on a yearly basis. If a MIPS eligible clinician or group is selected for audit, the MIPS eligible clinician or group will be required to do the following in accordance with applicable law and timelines we establish:
(1) Comply with data sharing requests, providing all data as requested by us or our designated entity. All data must be shared with us or our designated entity within 45 days of the data sharing request, or an alternate timeframe that is agreed to by us and the MIPS eligible clinician or group. Data will be submitted via email, facsimile, or an electronic method via a secure Web site maintained by us.
(2) Provide substantive, primary source documents as requested. These documents may include: Copies of claims, medical records for applicable patients, or other resources used in the data calculations for MIPS measures, objectives, and activities. Primary source documentation also may include verification of records for Medicare and non-Medicare beneficiaries where applicable. We are not proposing any changes to the requirements in section § 414.1390(a).
We indicated in the CY 2017 Quality Payment Program final rule that all
We also indicated in the CY 2017 Quality Payment Program final rule that if a MIPS eligible clinician or group is found to have submitted inaccurate data for MIPS, we would reopen and revise the determination in accordance with the rules set forth at §§ 405.980 through 405.984 (81 FR 77362). We neglected to codify this policy in regulation text of the CY 2017 Quality Payment Program final rule and further, we did not include § 405.986, which is also an applicable rule in our reopening policy. We also finalized our approach to recoup incorrect payments from the MIPS eligible clinician by the amount of any debts owed to us by the MIPS eligible clinician and likewise, we would recoup any payments from the group by the amount of any debts owed to us by the group. Thus, we are proposing to revise § 414.1390 to add a new paragraph (c) that states we may reopen and revise a MIPS payment determination in accordance with the rules set forth at §§ 405.980 through 405.986.
In the CY 2017 Quality Payment Program, we also indicated that MIPS eligible clinicians and groups should retain copies of medical records, charts, reports and any electronic data utilized for reporting under MIPS for up to 10 years after the conclusion of the performance period (81 FR 77360). We neglected to codify this policy in regulation text of the CY 2017 Quality Payment Program final rule. Thus, we are proposing to revise § 414.1390 to add a new paragraph (d) that states that all MIPS eligible clinicians or groups that submit data and information to CMS for purposes of MIPS must retain such data and information for a period of 10 years from the end the MIPS Performance Period.
Finally, we indicated in the CY 2017 Quality Payment Program final rule, that, in addition to recouping any incorrect payments, we intend to use data validation and audits as an educational opportunity for MIPS eligible clinicians and groups and we note that this process will continue to include education and support for MIPS eligible clinicians and groups selected for an audit.
In developing MIPS, our goal is to develop a program that is meaningful, understandable, and flexible for participating MIPS eligible clinicians. Flexible reporting options will provide eligible clinicians with options to accommodate different practices and make measurement meaningful. We believe that allowing eligible clinicians to participate in MIPS through the use of third party intermediaries that will collect or submit data on their behalf, will help us accomplish our goal of implementing a flexible program. We strongly encourage all third party intermediaries to work with their MIPS eligible clinicians to ensure the data submitted are representative of the individual MIPS eligible clinician's or group's overall performance for that measure or activity.
For purposes of this section, we use the term third party to refer to a qualified registry, QCDR, a health IT vendor or other third party that obtains data from a MIPS eligible clinician's Certified Electronic Health Record Technology, or a CMS approved survey vendor. In the CY 2017 Quality Payment Program final rule (81 FR 77363), we finalized at § 414.1400(a)(1) that MIPS data may be submitted by third party intermediaries on behalf of a MIPS eligible clinician or group by: (1) A qualified registry; (2) a QCDR; (3) a health IT vendor; or (4) a CMS approved survey vendor. Additionally, we finalized at § 414.1400(a)(3) that third party intermediaries must meet all the criteria designated by us as a condition of their qualification or approval to participate in MIPS as a third party intermediary. Lastly, as finalized at § 414.1400(a)(3)(ii), all submitted data must be submitted in the form and manner specified by us.
We are proposing to revise § 414.1400(a)(1) to state that MIPS data may be submitted by third party intermediaries on behalf of an individual MIPS eligible clinician, group, or virtual group. See section II.C.4. of this rule for more information related to virtual groups.
Additionally, we believe it is important that the MIPS data submitted by third party intermediaries is true, accurate, and complete. To that end, we are proposing to add a requirement at § 414.1400(a)(5) stating that all data submitted to CMS by a third party intermediary on behalf of a MIPS eligible clinician, group or virtual group must be certified by the third party intermediary to the best of its knowledge as true, accurate, and complete. We also propose that this certification occur at the time of the submission and accompany the submission. We solicit comments on this proposal.
As more clinicians participate in value based payment arrangements with multiple payers, we believe third-party intermediaries will play an important role in calculating quality measures, reporting once to all payers, and sharing actionable feedback to clinicians. A robust ecosystem of third-party intermediaries would more reliably calculate measures using data across clinical practices caring for the same patients and reduce burden by streamlining reporting to all payers and offering timely feedback to clinicians that is easier to act on in addressing gaps in care. Third-party intermediaries can also take the burden off clinical practices by integrating various types of health care data, including administrative data from payers, other utilization data, cost data, and clinical data derived from health IT systems, to provide front-line clinicians and others with a comprehensive view of the cost and quality of the care they are delivering.
We are continuing to explore how we can further encourage those third-party intermediaries that provide comprehensive data services to support eligible clinicians participating in both MIPS and APMs. For instance, should we consider implementing additional incentives for eligible clinicians to use a third-party intermediary which has demonstrated substantial participation from additional payers and/or other clinical data sources across practices caring for a cohort of Medicare beneficiaries within a given geographic area? Should these incentives also include expectations that structured, standardized data be shared with third party intermediaries? Should there be additional refinements to the approach to qualifying third party intermediaries which evaluate the degree to which these intermediaries can deliver longitudinal information on a patient to participating clinicians, for example, a
In the CY 2017 Quality Payment Program final rule (81 FR 77364), we finalized the definition and capabilities of a QCDR. We are not proposing any changes to the definition or the capabilities of a QCDR in this proposed rule, and refer readers to the CY 2017 Quality Payment Program final rule for a detailed discussion of the definition and capabilities of a QCDR.
In the CY 2017 Quality Payment Program final rule (81 FR 77365), we finalized the criteria to establish an entity seeking to qualify as a QCDR. We are not proposing any changes to the criteria in this proposed rule, and refer readers to the CY 2017 Quality Payment Program final rule for the criteria to qualify as a QCDR.
In the CY 2017 Quality Payment Program final rule (81 FR 77365 through 77366), we finalized the self-nomination period for the 2018 performance period and for future years of the program to be from September 1 of the year prior to the applicable performance period until November 1 of the same year. As an example, the self-nomination period for the 2018 performance period will begin on September 1, 2017, and will end on November 1, 2017. Entities that desire to qualify as a QCDR for the purposes of MIPS for a given performance period will need to self-nominate for that year and provide all information requested by us at the time of self-nomination. Having qualified as a QCDR in a prior year does not automatically qualify the entity to participate in MIPS as a QCDR in subsequent performance periods. Furthermore, prior performance of the QCDR (when applicable) will be taken into consideration in approval of their self-nomination. For example, a QCDR may choose not to continue participation in the program in future years, or the QCDR may be precluded from participation in a future year due to multiple data or submission errors as noted below. Finally, QCDRs may want to update or change the measures or services or performance categories they intend to provide. We believe an annual self-nomination process is the best process to ensure accurate information is conveyed to MIPS eligible clinicians and accurate data is submitted to MIPS.
However, we do understand that some QCDRs have no changes to the measure and/or activity inventory they offer to their clients and intend to participate in the MIPS for many years. Because of this, we are proposing, beginning with the 2019 performance period, a simplified process in which existing QCDRs in good standing may continue their participation in MIPS, by attesting that the QCDR's approved data validation plan, cost, measures, activities, services, and performance categories offered in the previous year's performance period of MIPS have minimal or no changes and will be used for the upcoming performance period. Specifically, existing QCDRs in good standing may attest during the self-nomination period that they have no changes to their approved self-nomination application from the previous year of MIPS. In addition, the existing QCDRs may decide to make minimal changes to their approved self-nomination application from the previous year, which would be submitted by the QCDR for CMS review and approval by the close of the self-nomination period. Minimal changes may include limited changes to their performance categories, adding or removing MIPS quality measures, and adding or updating existing services and/or cost information. Existing QCDRs in good standing, may also submit for CMS review and approval, substantive changes to measure specifications for existing QCDR measures that were approved the previous year, or submit new QCDR measures for CMS review and approval without having to complete the entire self-nomination application process, which is required to be completed by a new QCDR. By attesting that certain aspects of their approved application from the previous year have not changed, existing QCDRs in good standing would be spending less time completing the entire self-nomination form, as was previously required on a yearly basis. We are proposing such a simplified process to reduce the burden of self-nomination for those existing QCDRs who have previously participated in MIPS, and are in good standing (not on probation or disqualified, as described below) and to allow for sufficient time for us to review data submissions and to make determinations on the standing of the QCDRs. We note that substantive changes to existing QCDR measure specifications or any new QCDR measures would have to be submitted for CMS review and approval by the close of the self-nomination period. This proposed process will allow existing QCDRs in good standing to avoid completing the entire application annually, as is required in the existing process, and in alignment with the existing timeline. We request comments on this proposal. In the development of this proposal, we had reviewed the possibility of offering a multi-year approval, where QCDRs would be approved for a 2-year increment of time. We are concerned that utilizing a multi-year approval process in which QCDRs would be approved for 2 continuous years using the same fixed services they had for the first year, would not provide the QCDR with the flexibility to add or remove services and/or measures or activities based on their QCDR capabilities for the upcoming program year. Furthermore, another concern with a multi-year approval process is the concern for those QCDRs who perform poorly during the first year, and who should be placed on probation or disqualified (as described below). We request comments on this alternative.
We finalized to require other information (described below) of QCDRs at the time of self-nomination. If an entity becomes qualified as a QCDR, they will need to sign a statement confirming this information is correct prior to listing it on their Web site. Once we post the QCDR on our Web site, including the services offered by the QCDR, we will require the QCDR to support these services or measures for its clients as a condition of the entity's qualification as a QCDR for purposes of MIPS. Failure to do so will preclude the QCDR from participation in MIPS in the subsequent year.
For future years, beginning with the 2018 performance period, we are proposing that self-nomination information must be submitted via a web-based tool, and to eliminate the submission method of email. We will provide further information on the web-based tool at
In the CY 2017 Quality Payment Program final rule (81 FR 77366 through 77367), we finalized the information a QCDR must provide to us at the time of self-nomination. We are proposing to replace the term non-MIPS measures
In the CY 2017 Quality Payment Program final rule (81 FR 77367 through 77374), we finalized that a QCDR must perform specific functions to meet the criteria for data submission. While we are not proposing any changes to the criteria for data submission in this proposed rule, we would like to note the following as clarifications to existing criteria. Specifically, a QCDR—
• Must have in place mechanisms for the transparency of data elements and specifications, risk models, and measures. That is, we expect that the QCDR measures, and their data elements (that is, specifications) comprising these measures be listed on the QCDR's Web site unless the measure is a MIPS measure, in which case the specifications will be posted by us. QCDR measure specifications should be provided at a level of detail that is comparable to what is posted by us on the CMS Web site for MIPS quality measures specifications.
• Approved QCDRs may post the MIPS quality measure specifications on their Web site, if they so choose. If the MIPS quality measure specifications are posted by the QCDRs, they must replicate exactly the same as the MIPS quality measure specifications posted on the CMS Web site.
• Enter into and maintain with its participating MIPS eligible clinicians an appropriate Business Associate agreement that complies with the HIPAA Privacy and Security Rules. Ensure that the Business Associate agreement provides for the QCDR's receipt of patient-specific data from an individual MIPS eligible clinician or group, as well as the QCDR's disclosure of quality measure results and numerator and denominator data or patient specific data on Medicare and non-Medicare beneficiaries on behalf of MIPS eligible clinicians and groups.
• Must provide timely feedback at least 4 times a year, on all of the MIPS performance categories that the QCDR will report to us. We refer readers to section II.C.9.a. of this proposed rule for additional information on third party intermediaries and performance feedback.
• For purposes of distributing performance feedback to MIPS eligible clinicians, we encourage QCDRs to assist MIPS eligible clinicians in the update of their email addresses in CMS systems—including PECOS and the Identity and Access System—so that they have access to feedback as it becomes available on
As noted in the CY 2017 Quality Payment Program final rule (81 FR 77370), we will on a case-by-case basis allow QCDRs and qualified registries to request review and approval for additional MIPS measures throughout the performance period. We would like to explain that this flexibility would only apply for MIPS measures; QCDRs will not be able to request additions of any new QCDR measures throughout the performance period. QCDRs will not be able to retire any measures they are approved for during the performance period. Should a QCDR encounter an issue regarding the safety or change in evidence for a measure during the performance period, they must inform CMS of said issue and indicate whether they will or will not be reporting on the measure, and we will review measure issues on a case-by-case basis. Any measures QCDRs wish to retire would need to be retained until the next annual self-nomination process and applicable performance period.
In the CY 2017 Quality Payment Program final rule (81 FR 77374 through 77375), we specified at § 414.1400(f) that the QCDR must provide specific QCDR measures specifications criteria. We generally intend to apply a process similar to the one used for MIPS measures to QCDR measures that have been identified as topped out. We are not proposing any changes to the QCDR measure specifications criteria as finalized in the CY2017 Quality Payment Program final rule. We would like to note that for QCDR quality measures, we encourage alignment with our measures development plan, but will consider all QCDR measures submitted by the QCDR. For MIPS measures, we would also like to note that CMS expects that a QCDR reporting on MIPS measures retain and use the MIPS specifications as they exist for the performance period.
We would like to clarify that we will likely not approve retired measures that were previously in one of CMS's quality programs, such as the Physician Quality Reporting System (PQRS) program, if proposed as QCDR measures. This includes measures that were retired due to being topped out (as defined in section II.C.6.c.(2) of this proposed rule) due to high-performance or measures retired due to a change in the evidence supporting the use of the measure.
We seek comment for future rulemaking, on requiring QCDRs that develop and report on QCDR measures, must fully develop and test (that is, conduct reliability and validity testing) their QCDR measures, by the time of submission of the new measure during the self-nomination process.
Beginning with the 2018 performance period and for future program years, we propose that QCDR vendors may seek permission from another QCDR to use an existing measure that is owned by the other QCDR. If a QCDR would like report on an existing QCDR measure that is owned by another QCDR, they must have permission from the QCDR that owns the measure that they can use the measure for the performance period. Permission must be granted at the time of self-nomination, so that the QCDR that is using the measure can include the proof of permission for CMS review and approval for the measure to be used in the performance period. The QCDR measure owner (QCDR vendor) would still own and maintain the QCDR measure, but would allow other approved QCDRs to utilize their QCDR measure with proper notification. This proposal will help to harmonize clinically similar measures and limit the use of measures that only slightly differ from another. We invite comments on this proposal.
We would like to clarify from the CY 2017 Quality Payment Program final rule (81 FR 77375) that the QCDR must publicly post the measure specifications no later than 15 calendar days following our approval of these measures specifications for each QCDR measure it intends to submit for MIPS.
We refer readers to the CY 2017 Quality Payment Program final rule for the QCDR measure specifications criteria.
In the CY 2017 Quality Payment Program final rule (81 FR 77375 through 77377), we finalized the definition and types of QCDR quality measures for purposes of QCDRs submitting data for the MIPS quality performance category. We are not proposing any changes to the criteria on how to identify QCDR quality measures in this proposed rule. We would like to clarify that QCDRs are not limited to reporting on QCDR measures,
In the CY 2017 Quality Payment Program final rule (81 FR 77377), we finalized policy on the collaboration of entities to become a QCDR. We are not proposing any changes to this policy in this proposed rule, and would refer readers to the CY 2017 Quality Payment Program final rule for the criteria.
In response to the CY 2017 Quality Payment Program final rule, commenters recommended that we work with QCDRs to determine a more reasonable cycle for self-nomination, measure selection, and reporting because the current process is burdensome. Commenters also recommended that we not disqualify QCDRs that do not have the capability to allow MIPS eligible clinicians to report across all performance categories using only one submission mechanism, and noted that the ability for QCDRs to report their own measures allows MIPS eligible clinicians the ability to implement measures that are more clinically meaningful and up-to-date than those measures that may be available in the MIPS measure set. We would like to note that we are proposing above, a simplified self-nomination and measure selection process available to existing QCDRs that are in good standing, beginning in the third year of the Quality Payment Program. We would also like to explain that QCDRs are not required to report on all performance categories across the MIPS program, and would not be disqualified for not being able to report data across on performance categories only using one mechanism. We thank the commenters for their support with regards to allowing QCDRs to nominate and report on QCDR measures that may be specialty related. We thank the commenters for their feedback and will take their comments into consideration in future rule making.
In the CY 2017 Quality Payment Program final rule 81 FR 77382, we finalized definitions and criteria around health IT vendors that obtain data from MIPS eligible clinicians CEHRT. We note that, for this proposed rule, a health IT vendor that serves as a third party intermediary to collect or submit data on behalf MIPS eligible clinicians may or may not also be a “health IT developer.” Under the ONC Health IT Certification Program (Program), (80 FR 62604), a health IT developer constitutes a vendor, self-developer, or other entity that presents health IT for certification or has health IT certified under the Program. The use of “health IT developer” is consistent with the use of the term “health IT” in place of “EHR” or “EHR technology” under the Program (see 80 FR 62604; and section II.C.6.f. of this proposed rule). Throughout this proposed rule, we use the term “health IT vendor” to refer to entities that support the health IT requirements of a clinician participating in the Quality Payment Program.
We are not proposing any changes to this policy in this proposed rule, and would refer readers to the CY 2017 Quality Payment Program final rule for the criteria. However we seek comment for future rulemaking regarding the potential shift to seeking alternatives which might fully replace the QRDA III format in the Quality Payment Program in future program years.
In the CY 2017 Quality Payment Program final rule (81 FR 77382 through 77386), we finalized the definition and capability of qualified registries. We are not proposing any changes to the definition or the capabilities of qualified registries in this final rule, and refer readers to the CY 2017 Quality Payment Program final rule for the detailed definition and capabilities of a qualified registry.
In the CY 2017 Quality Payment Program final rule (81 FR 77383), we finalized the requirements for the establishment of an entity seeking to qualify as a registry. We are not proposing any changes to the criteria regarding the establishment of an entity seeking to qualify as a registry criteria in this proposed rule, and refer readers to the final rule for the criteria for establishing an entity seeking to qualify as a registry.
For the 2018 performance period, and for future years of the program, we finalized at § 414.1400(g) a self-nomination period from September 1 of the year prior to the applicable performance period, until November 1 of the same year. For example, for the 2018 performance period, the self-nomination period would begin on September 1, 2017, and end on November 1, 2017. Entities that desire to qualify as a qualified registry for purposes of MIPS for a given performance period will need to provide all requested information to us at the time of self-nomination and would need to self-nominate for that performance period. Having previously qualified as a qualified registry does not automatically qualify the entity to participate in subsequent MIPS performance periods. Furthermore, prior performance of the qualified registry (when applicable) will be taken into consideration in approval of their self-nomination. For example, a qualified registry may choose not to continue participation in the program in future years, or the qualified registry may be precluded from participation in a future year, due to multiple data or submission errors as noted below. As such, we believe an annual self-nomination process is the best process to ensure accurate information is conveyed to MIPS eligible clinicians and accurate data is submitted to MIPS.
However, we do understand that some qualified registries have no changes to the measures and/or activity inventory they offer to their clients and intend to participate in MIPS for many years. Because of this, we are proposing, beginning with the 2019 performance period, a simplified process in which existing qualified registries in good standing may continue their participation in MIPS by attesting that the qualified registry's approved data validation plan, cost, approved MIPS quality measures, services, and performance categories offered in the previous year's performance period of MIPS have minimal or no changes and will be used for the upcoming performance period. Specifically, existing qualified registries in good standing may attest during the self-nomination period that they have no changes to their approved self-nomination application from the previous year of MIPS. In addition, the existing qualified registry may decide to make minimal changes to their self-nomination application from the previous year, which would be submitted by the qualified registry for CMS review and approval by the close of the self-nomination period. Minimal changes may include limited changes to their performance categories, adding or removing MIPS quality measures, and adding or updating existing services and/or cost information. By attesting that certain aspects of their approved application from the previous year have not changed, existing qualified registries will be spending less time completing the entire self-nomination form, as was previously required on a yearly basis. We are proposing such a simplified process to reduce the burden of self-
We finalized to require further information of qualified registries at the time of self-nomination. If an entity becomes qualified as a qualified registry, they would need to sign a statement confirming this information is correct prior to us listing their qualifications on their Web site. Once we post the qualified registry on our Web site, including the services offered by the qualified registry, we would require the qualified registry to support these services/measures for its clients as a condition of the entity's qualification as a qualified registry for purposes of MIPS. Failure to do so will preclude the qualified registry from participation in MIPS in the subsequent performance year.
For the 2018 performance period and beyond, we are proposing that self-nomination information must be submitted via a web-based tool, and to eliminate the submission method of email. We will provide further information on the web-based tool at
We finalized in the CY 2017 Quality Payment Program final rule (81 FR 77384) that a qualified registry must provide specific information to us at the time of self-nomination. We are not proposing any changes to the information required at the time of self-nomination in this proposed rule, and refer readers to the final rule for specific information requirements.
In the CY 2017 Quality Payment Program final rule (81 FR 77386), we finalized the criteria for qualified registry data submission. We are not proposing any changes to the data submission criteria in this proposed rule, and refer readers to the final rule for specific criteria regarding qualified registry data submission. We would like to note two clarifications to the existing criteria:
• Enter into and maintain with its participating MIPS eligible clinicians an appropriate Business Associate agreement that complies with the HIPAA Privacy and Security Rules. Ensure that the Business Associate agreement provides for the Qualified Registry's receipt of patient-specific data from an individual MIPS eligible clinician or group, as well as the Qualified Registry's disclosure of quality measure results and numerator and denominator data or patient specific data on Medicare and non-Medicare beneficiaries on behalf of individual MIPS eligible clinicians and groups.
• We had finalized that timely feedback be provided at least four times a year, on all of the MIPS performance categories that the qualified registry will report to us. We refer readers to section II.C.9.a. of this proposed rule for additional information on third party intermediaries and performance feedback.
We had received comments in response to the CY 2017 Quality Payment Program final rule from commenters who expressed concern that the 3 percent acceptable error rate for qualified registries is too low. Commenters recommended we analyze reporting for the transition year and increase the error rate to 5 percent at the minimum because qualified registries may make a small number of errors given that 2017 is the first year of MIPS and that removing qualified registries due to a low error threshold could hurt clinicians. We thank the commenters for their feedback and will take the comments into consideration in future rulemaking.
As indicated in the CY 2017 Quality Payment Program final rule (81 FR 77370), we will on a case-by-case basis allow qualified registries to request review and approval for additional MIPS measures throughout the performance period. Any new measures that are approved by us will be added to the information related to the qualified registry on the CMS Web site, as technically feasible. We anticipate only being able to update this information on the Web site on a quarterly basis, as technically feasible.
In the CY 2017 Quality Payment Program final rule (81 FR 77386), we finalized the definition, criteria, required forms, and vendor business requirements needed to participate in MIPS as a survey vendor. We refer readers to the CY 2017 Quality Payment Program final rule for specific details on requirements. We have heard from some groups that it would be useful to have a final list of CMS-approved survey vendors to inform their decision on whether or not to participate in the CAHPS for MIPS survey. Therefore, beginning with the 2018 performance period and for future program years, we propose to remove the April 30th survey vendor application deadline because this deadline is within the timeframe of when groups can elect to participate in the CAHPS for MIPS survey. In order to provide a final list of CMS-approved survey vendors earlier in the timeframe during which groups can elect to participate in the CAHPS for MIPS survey, an earlier vendor application deadline would be necessary. This could be accomplished by having a rolling application period, where vendors would be able to submit an application by the end of the first quarter. However, in addition to
At § 414.1400(k), we finalized the process for placing third party intermediaries on probation and for disqualifying such entities for failure to meet certain standards established by us (81 FR 77386). Specifically, we proposed that if at any time we determine that a third party intermediary (that is, a QCDR, health IT vendor, qualified registry, or CMS-approved survey vendor) has not met all of the applicable criteria for qualification, we may place the third party intermediary on probation for the current performance period or the following performance period, as applicable.
In addition, we finalized that we require a corrective action plan from the third party intermediary to address any deficiencies or issues and prevent them from recurring. We finalized that the corrective action plan must be received and accepted by us within 14 days of the CMS notification to the third party intermediary of the deficiencies or probation. Failure to comply with these corrective action plan requirements would lead to disqualification from MIPS for the subsequent performance period.
We finalized for probation to mean that, for the applicable performance period, the third party intermediary must meet all applicable criteria for qualification and approval and also must submit a corrective action plan for remediation or correction of any deficiencies identified by CMS that resulted in the probation (81 FR 77548).
In addition, we finalized that if the third party intermediary has data inaccuracies including (but not limited to) TIN/NPI mismatches, formatting issues, calculation errors, data audit discrepancies affecting in excess of 3 percent (but less than 5 percent) of the total number of MIPS eligible clinicians or groups submitted by the third party intermediary, we would annotate the listing of qualified third party intermediaries on the CMS Web site, noting that the third party intermediary furnished data of poor quality and would place the entity on probation for the subsequent performance period.
Further, we finalized if the third party intermediary does not reduce their data error rate below 3 percent for the subsequent performance period, the third party intermediary would continue to be on probation and have their listing on the CMS Web site continue to note the poor quality of the data they are submitting for MIPS for one additional performance period. After 2 years on probation, the third party intermediary would be disqualified for the subsequent performance period. Data errors affecting in excess of 5 percent of the MIPS eligible clinicians or groups submitted by the third party intermediary may lead to the disqualification of the third party intermediary from participation for the following performance period. In placing the third party intermediary on probation; we would notify the third party intermediary of the identified issues, at the time of discovery of such issues.
In addition, we finalized that if the third party intermediary does not submit an acceptable corrective action plan within 14 days of notification of the deficiencies and correct the deficiencies within 30 days or before the submission deadline—whichever is sooner, we may disqualify the third party intermediary from participating in MIPS for the current performance period or the following performance period, as applicable.
We note that MIPS eligible clinicians are ultimately responsible for the data that are submitted by their third party intermediaries and expect that MIPS eligible clinicians and groups should ultimately hold their third party intermediaries accountable for accurate reporting. We will consider cases of vendors leaving the marketplace during the performance period on a case by case basis, but would note that we will not consider cases prior to the performance period. We would however, need proof that the MIPS eligible clinician had an agreement in place with the vendor at the time of their withdrawal from the marketplace. We are not proposing any changes to the process of probation and disqualification of a third party intermediary in this proposed rule.
Commenters on the final rule requested that we provide opportunities for MIPS eligible clinicians and groups that discover an issue with their third party intermediary to change reporting methods and/or third party intermediaries without restriction on the eligible clinicians. We thank the commenters for their feedback and will take the comments into consideration in future rulemaking.
In the CY 2017 Quality Payment Program final rule (81 FR 77389), we finalized at § 414.1400(j) that any third party intermediary (that is, a QCDR, health IT vendor, qualified registry, or CMS-approved survey vendor) must comply with the following procedures as a condition of their qualification and approval to participate in MIPS as a third party intermediary:
(1) The entity must make available to us the contact information of each MIPS eligible clinician or group on behalf of whom it submits data. The contact information will include, at a minimum, the MIPS eligible clinician or group's practice phone number, address, and if available, email;
(2) The entity must retain all data submitted to us for MIPS for a minimum of 10 years; and
(3) For the purposes of auditing, we may request any records or data retained for the purposes of MIPS for up to 6 years and 3 months.
We are proposing to change § 414.1400(j)(2) to clarify that the entity must retain all data submitted to us for purposes of MIPS for a minimum of 10 years from the end of the MIPS performance period.
This section contains the approach for public reporting on Physician Compare for the CY 2018 Quality Payment Program final rule, including MIPS, APMs, and other information as required by the MACRA and building on the MACRA public reporting policies previously finalized (81 FR 77390 through 77399).
Physician Compare draws its operating authority from section 10331(a)(1) of the Affordable Care Act. As required by section 10331(a)(1) of the Affordable Care Act, by January 1, 2011, we developed a Physician Compare
The first phase of Physician Compare was launched on December 30, 2010 (
Currently, Web site users can view information about approved Medicare clinicians, such as: Name; Medicare primary and secondary specialties; practice locations; group affiliations; hospital affiliations that link to the hospital's profile on Hospital Compare as available; Medicare assignment status; education; residency; and, American Board of Medical Specialties (ABMS), American Osteopathic Association (AOA), and American Board of Optometry (ABO) board certification information. For groups, users can view group names, specialties, practice locations, Medicare assignment status, and affiliated clinicians. In December 2016, we also added indicators on the results page to show those clinicians and groups that had performance scores available to view. We also included an indicator on profile pages to show those Medicare clinicians and groups that satisfactorily or successfully participated in a CMS quality program to indicate their commitment to quality.
Consistent with section 10331(a)(2) of the Affordable Care Act, Physician Compare phased in public reporting of performance scores that provide comparable information on quality and patient experience measures for reporting periods beginning January 1, 2012. To the extent that scientifically sound measures are developed and are available, Physician Compare is required to include, to the extent practicable, the following types of measures for public reporting: Measures collected under PQRS and an assessment of efficiency, patient health outcomes, and patient experience, as specified. The first set of quality measures were publicly reported on Physician Compare in February 2014. Currently, Physician Compare publicly reports 91 group-level measures collected through either the Web Interface or registry for groups participating in 2015 under the PQRS, 19 quality measures for ACOs participating in the 2015 Shared Savings Program or Pioneer ACO program, and 90 individual clinician-level measures collected either through claims or registry for individual EPs participating in 2015 under the PQRS. In addition, 31 total individual clinician-level Qualified Clinical Data Registry (QCDR) non-PQRS measures are publicly available either through Physician Compare profile pages or 2015 QCDR Web sites. A complete history of public reporting on Physician Compare is detailed in the CY 2016 PFS final rule (80 FR 71117 through 71122).
As finalized in the CY 2015 and CY 2016 PFS final rules (79 FR 67547 and 80 FR 70885, respectively), Physician Compare will continue to expand public reporting. This expansion includes publicly reporting both individual eligible professional (now referred to as eligible clinician) and group-level QCDR measures starting with 2016 data available for public reporting in late 2017, as well as the inclusion of a benchmark and 5-star rating in late 2017 based on 2016 data (80 FR 71125 and 71129), among other additions.
This expansion will continue under the MACRA. Sections 1848(q)(9)(A) and (D) of the Act facilitate the continuation of our phased approach to public reporting by requiring the Secretary to make available on the Physician Compare Web site, in an easily understandable format, individual MIPS eligible clinician and group performance information, including:
• The MIPS eligible clinician's final score;
• The MIPS eligible clinician's performance under each MIPS performance category (quality, cost, improvement activities, and advancing care information);
• Names of eligible clinicians in Advanced APMs and, to the extent feasible, the names of such Advanced APMs and the performance of such models; and,
• Aggregate information on the MIPS, posted periodically, including the range of final scores for all MIPS eligible clinicians and the range of the performance of all MIPS eligible clinicians for each performance category.
Initial plans to publicly report this performance information on Physician Compare were finalized in the CY 2017 Quality Payment Program final rule (81 FR 77390). The proposals related to each of these requirements for year 2 of the Quality Payment Program are addressed below in this section.
Section 1848(q)(9)(B) of the Act also requires that this information indicate, where appropriate, that publicized information may not be representative of the eligible clinician's entire patient population, the variety of services furnished by the eligible clinician, or the health conditions of individuals treated. The information mandated for Physician Compare under section 1848(q)(9) of the Act will generally be publicly reported consistent with sections 10331(a)(2) and 10331(b) of the Affordable Care Act, and like all measure data included on Physician Compare, will be comparable. In addition, section 10331(b) of the Affordable Care Act requires that we include, to the extent practicable, processes to ensure that data made public are statistically valid, reliable, and accurate, including risk adjustment mechanisms used by the Secretary. In addition to the public reporting standards identified in the Affordable Care Act—statistically valid and reliable data that are accurate and comparable—we have established a policy that, as determined through user testing, the data we disclose generally should resonate with and be accurately interpreted by Web site users to be included on Physician Compare profile pages. Together, we refer to these conditions as the Physician Compare public reporting standards (80 FR 71118 through 71120). Section 10331(d) of the Affordable Care Act also requires us to consider input from multi-stakeholder groups, consistent with sections 1890(b)(7) and 1890A of the Act. We continue to receive general input from stakeholders on Physician Compare through a variety of means, including rulemaking and different forms of stakeholder outreach (for example, Town Hall meetings, Open Door Forums, webinars, education and outreach, Technical Expert Panels, etc.).
In addition, section 1848(q)(9)(C) of the Act requires the Secretary to provide an opportunity for MIPS eligible clinicians to review the information that will be publicly reported prior to such information being made public. This is generally consistent with section 10331(a)(2) of the Affordable Care Act, under which we have established a 30-day preview period for all measurement performance data that allows physicians and other eligible clinicians to view
We will coordinate data review and any relevant data resubmission or correction between Physician Compare and the four performance categories of MIPS. All data available for public reporting—measure rates, scores, and attestations, etc.—are available for review and correction during the targeted review process, which will begin at least 30 days in advance of the publication of new data. Data under review is not publicly reported until the review is complete. All corrected measure rates, scores, and attestations submitted as part of this process are available for public reporting. The technical details of the process are communicated directly to affected MIPS eligible clinicians and groups and detailed outside of rulemaking with specifics made public on the Physician Compare Initiative page on
In addition, section 1848(q)(9)(D) of the Act requires that aggregate information on the MIPS be periodically posted on the Physician Compare Web site, including the range of final scores for all MIPS eligible clinicians and the range of performance for all MIPS eligible clinicians for each performance category.
Lastly, section 104(e) of the MACRA requires the Secretary to make publicly available, on an annual basis, in an easily understandable format, information for physicians and, as appropriate, other eligible clinicians related to items and services furnished to people with Medicare, and to include, at a minimum:
• Information on the number of services furnished under Part B, which may include information on the most frequent services furnished or groupings of services;
• Information on submitted charges and payments for Part B services; and,
• A unique identifier for the physician or other eligible clinician that is available to the public, such as an NPI.
The information is further required to be made searchable by at least specialty or type of physician or other eligible clinician; characteristics of the services furnished (such as, volume or groupings of services); and the location of the physician or other eligible clinician.
In accordance with section 104(e) of the MACRA, we finalized a policy in the CY 2016 PFS final rule (80 FR 71130) to add utilization data to the Physician Compare downloadable database. Utilization data is currently available at
We propose to revise the public reporting regulation at § 414.1395(a), to more completely and accurately reference the data available for public reporting on Physician Compare. We propose to modify § 414.1395(a) to remove from the heading and text references to “MIPS” and “public Web site” and instead reference “Quality Payment Program” and “Physician Compare”. Specifically, proposed § 414.1395(a) reads as follows: “Public reporting of eligible clinician and group Quality Payment Program information. For each program year, CMS posts on Physician Compare, in an easily understandable format, information regarding the performance of eligible clinicians or groups under the Quality Payment Program.” We also propose to add paragraphs (b), (c), and (d) at § 414.1395, to capture previously established policies for Physician Compare relating to the public reporting standards, first year measures, and the 30-day preview period. Specifically, at proposed § 414.1395(b), we propose that, with the exception of data that must be mandatorily reported on Physician Compare, for each program year, we rely on the established public reporting standards to guide the information available for inclusion on Physician Compare. The public reporting standards require data included on Physician Compare to be statistically valid, reliable, and accurate; be comparable across reporting mechanisms; and, meet the reliability threshold. And, to be included on the public facing profile pages, the data must also resonate with Web site users, as determined by CMS. At proposed § 414.1395(c), we propose to codify our policy regarding first year measures: “For each program year, CMS does not publicly report any first year measure, meaning any measure in its first year of use in the quality and cost performance categories. After the first year, CMS reevaluates measures to determine when and if they are suitable for public reporting.” At proposed § 414.1395(d), we propose to specify the 30-day preview period rule: “For each program year, CMS provides a 30-day preview period for any clinician or group with Quality Payment Program data before the data are publicly reported on Physician Compare.”
We believe section 10331 of the Affordable Care Act supports the overarching goals of the MACRA by providing the public with quality information that will help them make informed decisions about their health care, while encouraging clinicians to improve the quality of care they provide to their patients. In accordance with section 10331 of the Affordable Care Act, section 1848(q)(9) of the Act, and section 104(e) of the MACRA, we plan to continue to publicly report performance information on Physician Compare. As such, we propose the inclusion of the following information on Physician Compare.
Sections 1848(q)(9)(A) and (D) of the Act require that we publicly report on Physician Compare the final score for each MIPS eligible clinician, performance of each MIPS eligible clinician for each performance category, and periodically post aggregate information on the MIPS, including the range of final scores for all MIPS eligible clinicians and the range of performance of all the MIPS eligible clinicians for each performance category. We finalized such data for public reporting on Physician Compare for the transition year (81 FR 77393), and we are now proposing to add these data each year to Physician Compare for each MIPS eligible clinician or group, either on the profile pages or in the downloadable
A detailed discussion of proposals related to each performance category of MIPS data follows.
As detailed in the CY 2017 Quality Payment Program final rule (81 FR 77395), and consistent with the existing policy that makes all current PQRS measures available for public reporting, we finalized a decision to make all measures under the MIPS quality performance category available for public reporting on Physician Compare in the transition year of the Quality Payment Program, as technically feasible. This included all available measures reported via all available submission methods, and applied to both MIPS eligible clinicians and groups.
Also consistent with current policy, although all measures will be available for public reporting, not all measures will be made available on the public-facing Web site profile pages. As explained in the CY 2017 Quality Payment Program final rule (81 FR 77394), providing too much information can overwhelm Web site users and lead to poor decision making. Therefore, consistent with section 1848(q)(9)(A)(i)(II) of the Act, all measures in the quality performance category that meet the statistical public reporting standards will be included in the downloadable database, as technically feasible. We also finalized a policy that a subset of these measures will be publicly reported on the Web site's profile pages, as technically feasible, based on Web site user testing. Statistical testing and user testing will determine how and where measures are reported on Physician Compare. In addition, we adopted our existing policy of not publicly reporting first year measures, meaning new measures that have been in use for less than 1 year, regardless of submission method used, for this MIPS quality performance category. After a measure's first year in use, we will evaluate the measure to see if and when the measure is suitable for public reporting (81 FR 77395).
Currently, there is a minimum sample size requirement of 20 patients for performance data to be included on Physician Compare. We previously sought comment on moving away from this requirement and moving to a reliability threshold for public reporting. In general, commenters supported a minimum reliability threshold. As a result, we finalized instituting a minimum reliability threshold for public reporting data on Physician Compare starting with 2017 data available for public report in late 2018 and each year moving forward (81 FR 77395).
The reliability of a measure refers to the extent to which the variation in the performance rate is due to variation in quality of care as opposed to random variation due to sampling. Statistically, reliability depends on performance variation for a measure across entities, the random variation in performance for a measure within an entity's panel of attributed patients, and the number of patients attributed to the entity. High reliability for a measure suggests that comparisons of relative performance across entities, such as eligible clinicians or groups, are likely to be stable and consistent, and that the performance of one entity on the quality measure can confidently be distinguished from another. We will conduct analyses to determine the reliability of the data collected and use this to calculate the minimum reliability threshold for the data. Once an appropriate minimum reliability threshold is determined, we will only publicly report those performance rates for any given measure that meet the minimum reliability threshold. We note that reliability standards for public reporting and reliability for scoring need not align; reliability for public reporting is unique because, for example, public reporting requires ensuring additional protections to maintain confidentiality. In addition, because publicly reported measures can be compared across clinicians and across groups, it is particularly important for the most stringent reliability standards to be in place to ensure differences in performance scores reflect true differences in quality of care to promote accurate comparisons by the public. For further information on reliability as it relates to scoring of cost measures see section II.C.7.a.(3) of this proposed rule.
In the CY 2017 Quality Payment Program final rule, we established that we will include the total number of patients reported on each measure in the downloadable database to facilitate transparency and more accurate understanding and use of the data (81 FR 77395). We will begin publishing the total number of patients reported on each measure in the downloadable database with 2017 data available for public reporting in late 2018 and for each year moving forward.
Understanding that we will continue our policies to not publicly report first year quality measures, that we will only report those measures that meet the reliability threshold and meet the public reporting standards, and include the total number of patients reported on for each measure in the downloadable database, we are again proposing to make all measures under the MIPS quality performance category available for public reporting on Physician Compare, as technically feasible. This would include all available measures reported via all available submission methods for both MIPS eligible clinicians and groups, for 2018 data available for public reporting in late 2019, and for each year moving forward, these data are required by the MACRA to be available for public reporting on Physician Compare, continuing to publicly report these data ensures continued transparency and provides people with Medicare and their caregivers valuable information they can use to make informed health care decisions. We request comment on this proposal.
In addition, we seek comment on expanding the patient experience data available for public reporting on Physician Compare. Currently, the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS survey is available for groups to report under the MIPS. This patient experience survey data is highly valued by patients and their caregivers as they evaluate their health care options. However, in testing with patient and caregivers, they regularly ask for more information from patients like them in their own words. Patients regularly request we include narrative reviews of clinicians and groups on the Web site. The Agency for Healthcare Research and Quality (AHRQ) is fielding a beta version of the CAHPS Patient Narrative Elicitation Protocol (
Consistent with section 1848(q)(9)(A)(i)(II) of the Act, we finalized in the CY 2017 Quality Payment Program final rule a decision to make all measures under the MIPS cost performance category available for public reporting on Physician Compare (81 FR 77396). This included all available measures reported via all available submission methods, and applied to both MIPS eligible clinicians and groups. However, as noted in the final rule, we may not have data available for public reporting in the transition year of the Quality Payment Program for the cost performance category (2017 data available for public reporting in late 2018).
As discussed in the final rule (81 FR 77395), cost data are difficult for patients to understand and, as a result, publicly reporting these measures could lead to significant misinterpretation and misunderstanding. For this reason, we are again proposing to include on Physician Compare a sub-set of cost measures that meet the public reporting standards, either on profile pages or in the downloadable database, if technically feasible, for 2018 data available for public reporting in late 2019, and for each year moving forward. These data are required by the MACRA to be available for public reporting on Physician Compare, but we want to ensure we only share those cost measures that can help patients and caregivers make informed health care decisions on profile pages. For transparency purposes, the cost measures that meet all other public reporting standards would be included in the downloadable database. Statistical testing and Web site user testing would determine how and where measures are reported on Physician Compare to minimize passing the complexity of these measures on to patients and to ensure those measures included are accurately understood and correctly interpreted. Under this proposal, we note that the policies we previously mentioned regarding first year measures, the minimum reliability threshold, and all public reporting standards would apply. This proposal applies to all available measures reported via all available submission methods, and applies to both MIPS eligible clinicians and groups. We request comment on this proposal.
Consistent with section 1848(q)(9)(A)(i)(II) of the Act, we finalized a decision to make all activities under the MIPS improvement activities performance category available for public reporting on Physician Compare (81 FR 77396). This included all available improvement activities reported via all available submission methods, and applied to both MIPS eligible clinicians and groups.
Consistent with the policy finalized for the transition year, we are again proposing to include a subset of improvement activities data on Physician Compare that meet the public reporting standards, either on the profile pages or in the downloadable database, if technically feasible, for 2018 data available for public reporting in late 2019, and for each year moving forward. This again includes all available activities reported via all available submission methods, and applies to both MIPS eligible clinicians and groups. For those eligible clinicians or groups that successfully meet the improvement activities performance category requirements this information may be posted on Physician Compare as an indicator. This information is required by the MACRA to be available for public reporting on Physician Compare, but the improvement activities performance category is a new field of data for Physician Compare so concept and Web site user testing is still needed to ensure these data are understood by stakeholders. Therefore, we again propose that statistical testing and user testing would determine how and where improvement activities are reported on Physician Compare.
For the transition year, we proposed to exclude first year activities from public reporting. First year activities are any improvement activities in their first year of use. Starting with year 2 (2018 data available for public reporting in late 2019), we propose publicly reporting first year activities if all other reporting criteria are satisfied. This evolution in our Quality Payment Program public reporting plan provides an opportunity to make more valuable information public given that completion of or participation in activities the first year they are available is different from reporting first year quality or cost measures. Clinicians and groups can learn from the first year of quality and cost data, understand why their performance rate is what it is, and take time to improve. A waiting period for indicating completion or participation in an improvement activity is unlikely to produce the same benefit. We request comments on these proposals.
Since the beginning of the EHR Incentive Programs in 2011, participant performance data has been publicly available in the form of public use files on the CMS Web site. In the 2015 EHR Incentive Programs final rule (80 FR 62901), we addressed comments requesting that we not only continue this practice but also include a wider range of information on participation and performance. In that rule, we stated our intent to publish the performance and participation data on Stage 3 objectives and measures of meaningful use in alignment with quality programs which utilize publicly available performance data such as Physician Compare. At this time there is only an indicator on Physician Compare profile pages to show that an eligible clinician successfully participated in the current Medicare EHR Incentive Program.
As MIPS will include advancing care information as one of the four MIPS performance categories, we decided, consistent with section 1848(q)(9)(i)(II) of the Act, to include more information on an eligible clinician's or group's performance on the objectives and measures of meaningful use on Physician Compare for the transition year (81 FR 77387). An important consideration was that to meet the public reporting standards, the data added to Physician Compare must resonate with Medicare patients and their caregivers. Testing to date has shown that people with Medicare value the use of certified EHR technology and see EHR use as something that if used well can improve the quality of their care. In addition, we believe the inclusion of indicators for clinicians and groups who achieve high
Consistent with our transition year final policy, and understanding the value of this information to Web site users, we are again proposing to include an indicator on Physician Compare for any eligible clinician or group who successfully meets the advancing care information performance category, as technically feasible. Also, as technically feasible, we propose to include additional indicators, including but not limited to, objectives, activities, or measures specified in section II.C.6.f. of this proposed rule, such as, identifying if the eligible clinician or group scores high performance in patient access, care coordination and patient engagement, or health information exchange. These proposals would apply to 2018 data available for public reporting in late 2019, and for each year moving forward, as this information is required by the MACRA to be available for public reporting on Physician Compare. We also propose that any advancing care information objectives, activities, or measures would need to meet the public reporting standards applicable to data posted on Physician Compare, either on the profile pages or in the downloadable database. This would include all available objectives, activities, or measures reported via all available submission methods, and would apply to both MIPS eligible clinicians and groups. Statistical testing and Web site user testing would determine how and where objectives and measures are reported on Physician Compare. As with improvement activities, we are also proposing to allow first year advancing care information objectives, activities, and measures to be available for public reporting starting in year 2 (2018 data available for public reporting in late 2019). Again, especially if we are including an indicator over a performance rate, the benefits of waiting 1 year are not the same and thus, we believe it is more important to make more information available for public reporting as the Quality Payment Program matures. We request comment on these proposals.
Benchmarks are important to ensuring that the quality data published on Physician Compare are accurately understood. A benchmark allows Web site users to more easily evaluate the information published by providing a point of comparison between groups and between clinicians. In an effort to find the best possible methodology for Physician Compare, we embarked on a year-long information gathering and stakeholder outreach effort in advance of the CY 2016 PFS rule process. We reached out to stakeholders, including specialty societies, consumer advocacy groups, physicians and other clinicians, measure experts, and quality measure specialists, as well as other CMS Quality Programs. Based on this outreach and the recommendation of our Technical Expert Panel, we proposed and ultimately finalized (80 FR 71129) a decision to publicly report on Physician Compare an item, or measure-level, benchmark using the Achievable Benchmark of Care (ABC
We believe ABC
ABC
We finalized that the benchmark would be derived by calculating the total number of patients in the highest scoring subset receiving the intervention or the desired level of care, or achieving the desired outcome, and dividing this number by the total number of patients that were measured by the top performing doctors. This would produce a benchmark that represents the best care provided to the top 10 percent of patients by measure, by reporting mechanism.
(1) We look at the total number of patients with diabetes for all clinicians who reported this diabetes measure.
(2) We rank clinicians that reported this diabetes measure from highest performance score to lowest performance score to identify the set of top clinicians who treated at least 10 percent of the total number of patients with diabetes.
(3) We count how many of the patients with diabetes who were treated by the top clinicians also got a foot exam.
(4) This number is divided by the total number of patients with diabetes who were treated by the top clinicians, producing the ABC
To account for low denominators, ABC
The benchmarks for Physician Compare developed using the ABC
As a result of stakeholder feedback asking that we consider one consistent approach for benchmarking and parsing the data based on the benchmark across the Quality Payment Program, we did consider an alternative approach. We reviewed the benchmark and decile breaks being used to assign points and determine payment under MIPS (see II.C.7.a.(2)(b) of this proposed rule). This approach was not considered ideal for public reporting for several reasons. A primary concern was that the decile approach when used for public reporting would force a star rating distribution inconsistent with the raw distribution of scores on a given measure. If applied to star ratings, there would need to be an equal distribution of clinicians in each of the star rating categories.
Using the ABC
It is not always ideal to use the same methodology across the program as scoring for payment purposes may be designed in a somewhat different way that may incorporate factors that are not necessarily as applicable for public reporting, while the key consideration for public reporting is that the methodology used best helps patients and caregivers easily interpret the data accurately. Testing with Web site users has shown that the star rating based on the ABC
ABC
We believe that displaying the appropriate and relevant MIPS data in this user-friendly format provides more opportunities to present these data to people with Medicare in a way that is most likely to be accurately understood and interpreted. We request comment on these proposals.
In CY 2017 Quality Payment Program proposed rule (81 FR 28291), we solicited comment on the advisability and technical feasibility of including on Physician Compare data voluntarily reported by eligible clinicians and groups that are not subject to MIPS payment adjustments, such as exempt clinician types and those clinicians practicing through Rural Health Centers (RHCs), Federally Qualified Health Centers (FQHCs), etc., to be addressed through separate notice-and-comment rulemaking.
Overall, comments received were favorable. Stakeholders generally support clinicians and groups being permitted to have data available for public reporting when submitting these data voluntarily under MIPS. As a result, we are now proposing that starting with year 2 of the Quality Payment Program (2018 data available for public reporting in 2019) and for each year moving forward, to make available for public reporting all data submitted voluntarily across all MIPS performance categories, regardless of submission method, by clinician and groups not subject to the MIPS payment adjustments, as technically feasible.
If a clinician or group chooses to submit quality, cost, improvement activity, or advancing care information, these data would become available for public reporting. However, because these data would be submitted voluntarily, we propose that during the 30-day preview period these clinicians and groups would have the option to opt out of having their data publicly reported on Physician Compare. If clinicians and groups do not actively opt out at this time, their data would be available for inclusion on Physician Compare if the data meet all previously stated public reporting standards and the minimum reliability threshold. As clinicians and groups not required to report under MIPS, particularly in the first years of the Quality Payment Program, are taking additional steps to show their commitment to quality care, we want to ensure they have the opportunity to report their data and have it included on Physician Compare. We request comment on this proposal.
Section 1848(q)(9)(A)(ii) of the Act requires us to publicly report names of eligible clinicians in Advanced APMs and, to the extent feasible, the names and performance of Advanced APMs. We see this as an opportunity to continue to build on the ACO reporting we are now doing on Physician Compare. At this time, if a clinician or group submitted quality data as part of an ACO, there is an indicator on the clinician's or group's profile page indicating this. In this way, it is known which clinicians and groups took part in an ACO. Also, currently, all ACOs have a dedicated page on the Physician Compare Web site to showcase their data. For the transition year of the Quality Payment Program, we decided to use this model as a guide as we add APM data to Physician Compare. Specifically, we finalized a policy to indicate on eligible clinician and group profile pages of Physician Compare when the eligible clinician or group is participating in an APM (81 FR 77398). We also finalized a decision to link eligible clinicians and groups to their APM's data, as technically feasible, through Physician Compare. The finalized policy provides the opportunity to publicly report data for
At the outset, APMs will be very new concepts for Medicare patients and their caregivers. In these early years, indicating who participated in APMs and testing language to accurately explain that to Web site users provides useful and valuable information as we continue to evolve Physician Compare. As we come to understand how to best explain this concept to patients and their caregivers, we can continue to assess how to most fully integrate these data on the Web site. Understanding this and understanding the value of adding APM data to Physician Compare, we are again proposing to publicly report names of eligible clinicians in Advanced APMs and the names and performance of Advanced APMs and APMs that are not considered Advanced APMs related to the Quality Payment Program starting with year 2 (2018 data available for public reporting in late 2019), and for each year moving forward, as technically feasible. In addition, we again propose to continue to find ways to more clearly link clinicians and groups and the APMs they participate in on Physician Compare, as technically feasible. We request comment on these proposals.
We understand that social risk factors such as income, education, race and ethnicity, employment, disability, community resources, and social support play a major role in health. One of our core objectives is to improve the outcomes of people with Medicare, and we want to ensure that complex patients, as well as those with social risk factors receive excellent care. In addition, we seek to ensure that all clinicians are treated as fairly as possible within all CMS programs. In the CY 2017 Quality Payment Program final rule (81 FR 77395), we noted that we would review the first of several reports by the Office of the Assistant Secretary for Planning and Evaluation (ASPE).
As we continue to consider the analyses and recommendations from these and any future reports, we look forward to working with stakeholders in this process. Therefore, we seek comment only on accounting for social risk factors through public reporting on Physician Compare. Specifically, we seek comment on stratified public reporting by risk factors and ask for feedback on which social risk factors or indicators should be used and from what sources. Examples of social risk factor indicators include but are not limited to dual eligibility/low-income subsidy, race and ethnicity, social support, and geographic area of residence. We also seek comment on the process for accessing or receiving the necessary data to facilitate stratified reporting. Finally, we seek comment on whether strategies such as confidential reporting of stratified rates using social risk factor indicators should be considered in the initial years of the Quality Payment Program in lieu of publicly reporting stratified performance rates for quality and cost measures under the MIPS on Physician Compare. We seek comment only on these items for possible consideration in future rulemaking.
Finally, we propose adding additional Board Certification information to the Physician Compare Web site. Board Certification is the process of reviewing and certifying the qualifications of a physician or clinician by a board of specialists in the relevant field. We currently include ABMS, AOA, and ABO data as part of clinician profiles on Physician Compare. We appreciate that there are additional, well respected boards that are not included in the ABMS, AOA, and ABO data currently available on Physician Compare that represent clinicians and specialties represented on the Web site. Such board certification information is of interest to users as it provides additional information to use to evaluate and distinguish between clinicians on the Web site, which can help in making an informed health care decision. The more data of immediate interest that is included on Physician Compare, the more users will come to the Web site and find quality data that can help them make informed decisions. Please note we are not endorsing any particular boards.
Another board, the American Board of Wound Medicine and Surgery (ABWMS), has shown interest in being added to Physician Compare and have demonstrated that they have the data to facilitate inclusion of this information on the Web site. We believe this board fills a gap for a specialty that is not currently covered by the ABMS, so we propose to add ABWMS Board Certification information to Physician Compare.
Additionally, for all years moving forward, for any board that would like to be considered to be added to the Physician Compare Web site, we propose to establish a process for reviewing interest from these boards as it is brought to our attention on a case-by-case basis, and selecting boards as possible sources of additional board certification information for Physician Compare. We further propose that, for purposes of CMS's selection, the board would need to demonstrate that it: Fills a gap in currently available board certification information listed on Physician Compare, can make the necessary data available, and if appropriate, can make arrangements and enter into agreements to share the needed information for inclusion on Physician Compare. We propose that boards contact the Physician Compare support team at
Section 1833(z) of the Act requires that an incentive payment be made to QPs for participation in Advanced APMs. In the CY 2017 Quality Payment Program final rule (81 FR 77399 through 77491), we finalized policies relating to the following topics:
• Beginning in 2019, if an eligible clinician participated sufficiently in an Advanced APM during the QP Performance Period, that eligible clinician may become a QP for the year. Eligible clinicians who are QPs are excluded from the MIPS reporting requirements in the performance year and payment adjustment for the payment year.
• For years from 2019 through 2024, QPs receive a lump sum incentive payment equal to 5 percent of their prior year's payments for Part B covered professional services. Beginning in 2026, QPs receive a higher update under the PFS for the year than non-QPs.
• For 2019 and 2020, eligible clinicians may become QPs only through participation in Advanced APMs.
• For 2021 and later, eligible clinicians may become QPs through a combination of participation in Advanced APMs and Other Payer Advanced APMs (which we refer to as the All-Payer Combination Option).
In this proposed rule, we discuss proposals for clarifications and modifications to some of the policies that we previously finalized, and provide additional details and proposals regarding the All-Payer Combination Option.
As we continue to develop the Quality Payment Program, we have identified the need to propose additions, deletions, and changes to some of the previously finalized definitions. A list of these definitions is available in the CY 2017 Quality Payment Program final rule (81 FR 77537 through 77540).
As we discuss in section II.D.6.d.(2)(a) of this proposed rule, we propose to change the timeframe of the QP Performance Period under the All-Payer Combination Option so that it would begin on January 1 and end on June 30 of the calendar year that is 2 years prior to the payment year. We propose to add the definition of All-Payer QP Performance Period using this timeframe. We also propose to add the definition of Medicare QP Performance Period, which would begin on January 1 and end on August 31 of the calendar year that is 2 years prior to the payment year. We would replace the definition we established in the CY 2017 Quality Payment Program final rule for QP Performance Period with the definitions of All-Payer QP Performance Period and Medicare QP Performance Period. To update the regulation to incorporate this proposal, we also propose to remove “QP Performance Period” each time it occurs in our regulations and replace it with either “All-Payer QP Performance Period” or “Medicare QP Performance Period” as relevant. As we discuss in section II.D.6.d.(3)(a) of this proposed rule, we propose to make QP determinations under the All-Payer Combination Option at the eligible clincian level only. In connection with our proposals to calculate Threshold Scores for QP determinations under the All-Payer Combination Option, we do not anticipate having or receiving information about attributed beneficiaries as we do under the Medicare Option. This is because, under the All-Payer Combination Option, APM Entities or eligible clinicians would only submit aggregate payment and patient data. We would not have anything similar to a Participation List or an Affiliated Practitioner List for Other Payer Advanced APMs. Therefore, we are proposing to change the definition of attributed beneficiary so that it only applies to Advanced APMs, not to Other Payer Advanced APMs. We seek comment on these proposals.
We seek comment on these terms, including how we have defined the terms, the relationship between terms, any additional terms that we should formally define to clarify the explanation and implementation of this program, and potential conflicts with other terms we use in similar contexts. We also seek comment on the naming of the terms and whether there are ways to name or describe their relationships to one another that make the definitions more distinct and easier to understand. For instance, we would consider options for a framework of definitions that might more intuitively distinguish between APMs and Other Payer Advanced APMs and between APMs and Advanced APMs.
We propose to revise the definition of APM Entity in the regulation at § 414.1305 to clarify that a “payment arrangement with a non-Medicare payer” is an other payer arrangement as defined in § 414.1305. We propose to make technical changes to the definition of Medicaid APM in § 414.1305 to clarify that these arrangements must meet the Other Payer Advanced APM criteria set forth in § 414.1420, and not just the criteria under § 414.1420(a) as provided under the current definition.
To consolidate our regulations and avoid unnecessarily defining a term, we propose to remove the defined term for Advanced APM Entity in § 414.1305 and to replace “Advanced APM Entity” where it appears throughout the regulations with “APM Entity.” We also propose to make this substitution in the definitions of Affiliated Practitioner and Attributed Beneficiary in § 414.1305. Similarly, we propose to replace “Advanced APM Entity group” with “APM Entity group” where it appears throughout our regulations. We note that these proposed changes are technical, and would not have a substantive effect on our policies.
We propose technical changes to correct the references in the first sentence of the regulation at § 414.1415 to refer to the financial risk standard under paragraph (c)(1) or (2) and the nominal amount standard under paragraph (c)(3) or (4). Due to typographical errors, the current regulation refers to paragraphs (d)(1) through (4), and there is no paragraph (d) in this section. We also propose to correct typographical errors in § 414.1420(a)(3)(i), (ii), (d) and (d)(1). In § 414.1420(d), we propose to correct the reference to the “nominal risk standard” to instead refer to the “nominal amount standard.” We propose technical, non-substantive clarifications in §§ 414.1425(a)(1) through (3), 414.1425(b)(2), and 414.1435(d). We also propose to correct a typographical error in § 414.1460(b) to refer to participation “during a Medicare QP Performance Period” instead of “during the QP Performance Periods.”
We propose to reorganize and revise the monitoring and program integrity provisions at § 414.1460. We propose changes to paragraphs (a), (b), and (d) in this section of the proposed rule as these policies apply to both the Medicare Option and the All-Payer Combination Option. We discuss proposed changes to paragraph (c) of § 414.1460 in sections II.D.6.c.(7) and II.D.6.d.(4) of this proposed rule, and changes to paragraph (e) of § 414.1460 in sections II.D.6.c.(7)(b) and II.D.6.d.(4)(c), as the policies in these paragraphs only apply to the All-Payer Combination Option.
We finalized in the CY 2017 Quality Payment Program final rule at § 414.1460(d) that for any QPs who are terminated from an Advanced APM or found to be in violation of any federal, state, or tribal statute, regulation, or binding guidance during the QP Performance Period or Incentive Payment Base Period or terminated after these periods as a result of a violation occurring during either period we may rescind such eligible clinician's QP determinations and, if necessary, recoup
In the CY 2017 Quality Payment Program final rule, we indicated at § 414.1460(b) that CMS may reduce or deny an APM Incentive Payment to eligible clinicians who are terminated by APMs or whose APM Entities are terminated by APMs for non-compliance with all Medicare conditions of participation or the terms of the relevant Advanced APMs in which they participate during the QP Performance Period. We also finalized at § 414.1460(a) that for QPs who CMS determines are not in compliance with all Medicare conditions of participation and the terms of the relevant Advanced APMs in which they participate during the QP Performance Period, there may be a reduction or denial of the APM Incentive Payment. We propose to consolidate our policy on reducing and denying APM Incentive Payments and redesignate it to § 414.1460(d)(1). Thus, we propose to remove provisions regarding reducing and denying APM Incentive Payments from paragraphs (a) and (b) of § 414.1460, and revise paragraph (d) to discuss when CMS may reduce or deny an APM Incentive Payment to an eligible clinician. We solicit comment on these proposals.
In the CY 2017 Quality Payment Program final rule (81 FR 77408), we finalized the criteria that define an Advanced APM based on the requirements set forth in sections 1833(z)(3)(C) and (D) of the Act. An Advanced APM is an APM that:
• Requires its participants to use certified EHR technology (CEHRT) (See 81 FR 77409–44414);
• Provides for payment for covered professional services based on quality measures comparable to measures under the quality performance category under MIPS (See 81 FR 77414–77418); and
• Either requires its participating APM Entities to bear financial risk for monetary losses that are in excess of a nominal amount, or the APM is a Medical Home Model expanded under section 1115A(c) of the Act (See 81 FR 77418–77431).
APMs may offer multiple options or tracks with variations in CEHRT use requirements, quality-based payments, and the level of financial risk; or multiple tracks designed for different types of participant organizations, and we finalized in the CY 2017 Quality Payment Program final rule (81 FR 77406) that we will consider different tracks or options within an APM separately for purposes of making Advanced APM determinations.
In the CY 2017 Quality Payment Program final rule (81 FR 77418), we divided the discussion of this criterion into two main elements: (1) What it means for an APM Entity to bear financial risk for monetary losses under an APM); and (2) what levels of risk we would consider to be in excess of a nominal amount. For each of these elements, we established a generally applicable standard and a Medical Home Model standard.
As we discussed in the CY 2017 Quality Payment Program final rule, we believe that it is important to maintain the distinction between Medical Home Models and other APMs because we believe that Medical Home Models are categorically different than other types of APMs, as supported by specific provisions in the statute enabling unique treatment of Medical Home Models. Also, Medical Home Model participants tend to be smaller in size and have lower Medicare revenues relative to total Medicare spending than other APM Entities, which affects their ability to bear substantial risk, especially in relation to total cost of care. We believe that the meaning of nominal financial risk varies according to context, and that smaller practices participating in Medical Home Models, as a category, experience risk differently than much larger, multispecialty focused organizations do. Historically, Medical Home Model participants have not been required to bear financial risk, which means the assumption of any new financial risk presents a new challenge for these entities (81 FR 77420–77421). For these reasons, we finalized special standards for Medical Home Models that are exceptions to the generally applicable financial risk and nominal amount standards.
In the CY 2017 Quality Payment Program final rule, we finalized that beginning in the 2018 Medicare QP Performance Period, the Medical Home Model financial risk standard would only apply to APM Entities that participate in Medical Home Models and that have fewer than 50 eligible clinicians in the organization through which the APM Entity is owned and operated (81 FR 77430). Under this policy, in a Medical Home Model that otherwise meets the criteria to be an Advanced APM, the Medical Home Model financial risk standard would be applicable only for those APM Entities owned and operated by organizations with fewer than 50 eligible clinicians. We note this policy does not apply to Medical Home Models expanded under section 1115A of the Act.
We are proposing to exempt from this requirement any APM Entities enrolled in Round 1 of the Comprehensive Primary Care Plus Model (CPC+).
We finalized the Medical Home Model eligible clinician limit after practices applied and signed agreements with CMS to participate in CPC+ Round 1. As such, practices applying to participate in CPC+ Round 1 were not necessarily aware of the eligible clinician limit policy and will have already participated in CPC+ for one year without this requirement applying to them by the beginning of CY 2018. Thus, to permit continued and uninterrupted testing of CPC+ in existing regions, we believe it is necessary to exempt practices participating in CPC+ Round 1 from this requirement. Additionally, since in future all APM Entities would know about this requirement prior to their
We seek comment on these proposals.
We finalized in the CY 2017 Quality Payment Program final rule (81 FR 77427) that an APM would meet the generally applicable nominal amount standard if, under the terms of the APM, the total annual amount that an APM Entity potentially owes us or foregoes is equal to at least:
• For QP Performance Periods in 2017 and 2018, 8 percent of the average estimated total Medicare Parts A and B revenue of participating APM Entities (the revenue-based standard); or
• For all QP Performance Periods, 3 percent of the expected expenditures for which an APM Entity is responsible under the APM (the benchmark-based standard).
We also finalized in the CY 2017 Quality Payment Program final rule (81 FR 77428) that to be an Advanced APM, a Medical Home Model must require that the total annual amount that an Advanced APM potentially owes us or foregoes under the Medical Home Model be at least the following amounts in a given performance year:
• In 2017, 2.5 percent of the APM Entity's total Medicare Parts A and B revenue.
• In 2018, 3 percent of the APM Entity's total Medicare Parts A and B revenue.
• In 2019, 4 percent of APM Entity's total Medicare Parts A and B revenue.
• In 2020 and later, 5 percent of the APM Entity's total Medicare Parts A and B revenue.
Both the generally applicable and Medical Home Model revenue-based nominal amount standards state the standard in terms of average estimated total Medicare Parts A and B revenue of participating APM Entities. We recognize that this language may be ambiguous as to whether it is intended to include payments to all providers and suppliers in an APM Entity or only payments directly to the APM Entity itself. To eliminate this potential ambiguity, we propose to amend §§ 414.1415(c)(3)(i)(A) and (c)(4)(i)(A) through (D) to more clearly define the generally applicable revenue-based nominal amount standard and the Medical Home Model revenue-based nominal amount standard as a percentage of the average estimated total Medicare Parts A and B revenue of providers and suppliers in participating APM Entities. Under this proposed policy, when assessing whether an APM meets the generally applicable revenue-based nominal amount standard, where total risk under the model is not expressly defined in terms of revenue, we would calculate the estimated total Medicare Parts A and B revenue of providers and suppliers at risk for each APM Entity. We would then calculate an average of all the estimated total Medicare Parts A and B revenue of providers and suppliers at risk for each APM Entity, and if that average estimated total Medicare Parts A and B revenue at risk for all APM Entities was equal to or greater than 8 percent, the APM would satisfy the generally applicable revenue-based nominal amount standard.
We request comment on this proposal.
In the CY 2017 Quality Payment Program final rule we finalized the amount of the generally applicable revenue-based nominal amount standard for the first two QP Performance Periods only, and we sought comment on what the revenue-based nominal amount standard should be for the third and subsequent QP Performance Periods. Specifically, we sought comment on: (1) Setting the revenue-based standard for 2019 and later at up to 15 percent of revenue; or (2) setting the revenue-based standard at 10 percent so long as risk is at least equal to 1.5 percent of expected expenditures for which an APM Entity is responsible under an APM (81 FR 77427).
Many commenters requested that we not raise the revenue-based nominal amount standard for 2019 and beyond. Some commenters stated that maintaining the 8 percent revenue-based nominal amount standard for 2019 would allow for stability and predictability for eligible clinicians participating in certain APMs. Other commenters noted that increasing the revenue-based nominal amount standard may reduce or discourage eligible clinicians from participating in Advanced APMs and that the added complexity of requiring that a 10 percent revenue-based standard also be equivalent to at least 1.5 percent of expected expenditures would be confusing for participants and other stakeholders. A few commenters suggested that we only consider increasing the revenue-based nominal amount standard after we review how the finalized standard affects participation in Advanced APMs.
We agree that maintaining the revenue-based nominal amount standard at 8 percent of the average estimated total Medicare Parts A and B revenue of providers and suppliers in participating APM Entities would provide stability and clarity for eligible clinicians and APM Entities. We also continue to believe that 8 percent of the average estimated total Medicare Parts A and B revenue of providers and suppliers in participating APM Entities represents a reasonable standard to determine what constitutes a more than nominal amount of financial risk. We believe that the continued testing and evaluation of APMs with two-sided risk will yield critical information about the best way to structure financial incentives and financial risk, and this information may have bearing on what constitutes a more than nominal amount of risk. Therefore, we will continue to evaluate the revenue-based nominal amount standard in light of participation in Advanced APMs before considering any increase in later years.
After considering public comments submitted on the potential options for increasing the revenue-based nominal amount standard for Medicare QP Performance Periods 2019 and later, we propose to maintain the current revenue-based nominal amount standard at 8 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities for the 2019 and 2020 Medicare QP Performance Periods, and to address the standard for Medicare QP Performance Periods after 2020 through subsequent rulemaking. We seek comment on whether we should consider either a lower or higher revenue-based nominal amount standard for the 2019 and 2020 Medicare QP Performance Periods, and on the amount and structure of the revenue-based nominal amount standard for Medicare QP Performance Periods 2021 and later.
We also seek comment on whether we should consider a different, potentially lower, revenue-based nominal amount standard only for small practices and those in rural areas that are not participating in a Medical Home Model for the 2019 and 2020 Medicare QP Performance Periods. For the purposes of the Quality Payment Program, we use the definition of small practices and rural areas in § 414.1305. Specifically, we seek comment on whether such a standard should apply only to small and, or rural practices that are participants in an APM, or also small and, or rural practices that join larger APM Entities in order to participate in APMs. We also seek comment on how we should decide where a practice is located in order to determine whether it is operating in a rural area as rural area is defined in § 414.1305 of our regulations. We believe that a different, potentially lower, revenue-based nominal amount standard for the 2019 and 2020 Medicare QP Performance Periods specifically for small practices and those in rural areas that are not participating in a Medical Home Model may allow for their increased participation in Advanced APMs, which may help increase the quality and coordination of care beneficiaries receive as a result. We believe such a standard should not apply to small and, or rural practices participating in a Medical Home Model because participants in Medical Home Models with fewer than 50 eligible clinicians in their parent organization benefit from the lower Medical Home Model nominal amount standard. We also note that such a standard may have certain disadvantages, including reducing the likelihood that potential Advanced APMs will ultimately result in reductions in the growth of Medicare expenditures and increasing the complexity of the generally applicable nominal amount standard.
In the CY 2017 Quality Payment Program final rule, we finalized that if the financial risk arrangement under the Medical Home Model is not based on revenue (for example, it is based on total cost of care or a per beneficiary per month dollar amount), we will make a determination for the APM based on the risk under the Medical Home Model compared to the average estimated total Parts A and B revenue of its participating APM Entities using the most recently available data (81 FR 77428).
We received comments suggesting that few APM Entities in Medical Home Models have had experience with financial risk, and that many would be financially challenged to provide sufficient care or even remain a viable business if they were faced with the kinds of substantial disruptions in revenue that can accompany financial risk arrangements. Some commenters indicated that taking on the level of risk required under our finalized policy would still represent an increase in total risk that is too great in magnitude and premature for the many APM Entities in Medical Home Models that have little experience with financial risk.
We recognize these concerns, however, we still believe that a final Medical Home Model nominal amount standard of 5 percent is the appropriate target for the standard, and that ultimately setting the standard at 5 percent of Parts A and B revenue of providers and suppliers in participating APM Entities would strike the appropriate balance to reflect the meaning of “nominal” in the Medical Home Model context. We continue to believe that the meaning of the term “nominal” depends on the situation in which it is applied, so it is appropriate to consider the characteristics of Medical Home Models and their participating APM Entities in setting the nominal amount standard for Medical Home Models.
We have reconsidered the incremental annual increases in the nominal amount standard that we finalized to occur over several years from 2.5 percent to 5 percent. We recognize that establishing an even more gradual increase in risk for Medical Home Models with a lower risk floor for the 2018 Medicare QP Performance Period may be better suited to the circumstances of many APM Entities in Medical Home Models that have little experience with risk. We also reiterate, as we note for the generally applicable nominal amount standard, that the terms and conditions in the particular APM govern the actual risk that participants experience; the nominal amount standard merely sets a floor on the level of risk required for the APM to be considered an Advanced APM. To that end, we believe a small reduction of risk in the Medical Home Model nominal amount standard beginning in the 2018 Medicare QP Performance Period, along with a more gradual progression toward the 5 percent nominal amount standard, would allow for greater flexibility at the APM level in setting financial risk thresholds that would encourage more participation in Medical Home Models and be more sustainable for the type of APM Entities that would potentially participate in Medical Home Models.
Therefore, we are proposing that to be an Advanced APM, a Medical Home Model must require that the total annual amount that an APM Entity potentially owes us or foregoes under the Medical Home Model be at least the following:
• For Medicare QP Performance Period 2018, 2 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
• For Medicare QP Performance Period 2019, 3 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
• For Medicare QP Performance Period 2020, 4 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
• For Medicare QP Performance Periods 2021 and later, 5 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
We seek comment on this proposal.
In summary, we are making the following proposals in this section:
• We are proposing to amend our regulation at § 414.1415(c)(3)(i)(A) and (c)(4)(i)(A) through (D) to more clearly define the generally applicable revenue-based nominal amount standard and the Medical Home Model revenue-based nominal amount standard as a percentage of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
• We are proposing to amend our regulation at § 414.1415(c)(2) to any APM Entities enrolled in an Advanced APM qualifying under the Medical Home Model standard as of January 1, 2017, to exempt Round 1 of the CPC+ Model from the requirement that beginning in the 2018 Medicare QP Performance Period, the Medical Home Model financial risk standard applies only to an APM Entity that is participating in a Medical Home Model if it has fewer than 50 eligible clinicians in its parent organization.
• We are proposing to amend our regulation at § 414.1415(c)(3)(i)(A) to provide that the generally applicable revenue-based nominal amount standard remain at 8 percent of the average estimated total Medicare Parts A and B revenue of providers and suppliers in participating APM Entities for the 2019 and 2020 Medicare QP Performance Periods, and to address the standard for Medicare QP Performance Periods after 2020 through subsequent rulemaking.
• We are proposing to amend our regulation at § 414.1415(c)(4)(i)(A) through (D) to provide that, to be an Advanced APM, a Medical Home Model must require that the total annual amount that an APM Entity potentially owes us or foregoes under the Medical Home Model be at least the following amounts:
++ For Medicare QP Performance Period 2018, 2 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
++ For Medicare QP Performance Period 2019, 3 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
++ For Medicare QP Performance Period 2020, 4 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
++ For Medicare QP Performance Periods 2021 and later, 5 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
We finalized policies relating to QP and Partial QP determinations in the CY 2017 Quality Payment Program final rule (See 81 FR 77433 through 77450).
We finalized that the QP Performance Period will run from January 1 through August 31 of the calendar year that is 2 years prior to the payment year (81 FR 77446). As we discuss in section II.D.6.(d)(2)(a)of this proposed rule, we propose to refer to this time period for the Medicare Option as the Medicare QP Performance Period.
We acknowledge that there may be Advanced APMs that start after January 1 of the Medicare QP Performance Period for a year. There may also be Advanced APMs that end prior to the August 31 end of the Medicare QP Performance Period for a year. By “start” and “end,” in this context, we mean that the period of active testing of the model starts or ends such that there is no opportunity for any APM Entity to participate in the Advanced APM before it starts, or to participate in it after it ends. We consider the active testing period to mean the dates within the performance period specific to the model, which is also the time period for which we consider payment amounts or patient counts through the Advanced APM when we make QP determinations. An Advanced APM is in active testing if APM Entities are furnishing services to beneficiaries and those services will count toward the APM Entity's performance in the Advanced APM. Active testing does not include, for example, the period of time after an APM Entity has stopped furnishing services to beneficiaries under the terms of the Advanced APM but is waiting for calculation or receipt of a performance-based payment. We note that we tie this policy to the timeframe during which APM Entities, rather than eligible clinicians, participate in an Advanced APM. To the extent the participation of APM Entities and eligible clinicians is not the same, we believe it is more appropriate and consistent with other policies relating to the APM incentive, and to APMs in general, to base the active testing period for an APM on the activities of the APM Entities because they are the participants directly subject to the terms of the Advanced APM, including the specified performance period for the Advanced APM. For example, in a model like CJR, where we identify eligible clinicians for QP determinations based on the Affiliated Practitioner List, it would be possible for APM Entities to be participating in active testing of the Advanced APM without any Affiliated Practitioners for a period of time. In that case, we would consider the dates the APM Entities were able to be in active testing for CJR, as opposed to the dates when eligible clinicians began participating as Affiliated Practitioners. If a specific APM Entity joins an Advanced APM after the January 1 start and before the August 31 end of a Medicare QP Performance Period, but other APM Entities participate during the entire Medicare QP Performance Period (from January 1 through August 31), then we would consider the Advanced APM to be in active testing for the entire Medicare QP Performance Period.
For example, the performance period for an Advanced APM may start on May 1, which is after the first QP determination date (March 31) and before the second QP determination date (June 30) during the Medicare QP Performance Period. If we were to calculate Threshold Scores in such an Advanced APM using data in the denominator for all attribution-eligible beneficiaries from January through June 30, which would include data for the period before the Advanced APM is actively tested, the APM Entities, or, as applicable, individual eligible clinicians in that Advanced APM, are less likely to achieve a QP threshold on either the June 30 or the final August 31 determination date for the year. This outcome would be a direct result of our operational decisions to begin the performance period for the Advanced APM on May 1, which is outside of the control of both the participating APM Entities and eligible clinicians. As such, participants in Advanced APMs that start or end during the Medicare QP Performance Period for the year could be disadvantaged for purposes of QP determinations. This is because the numerator of the Threshold Score calculation would include payment amounts or patient counts from only the period before the QP determination date during which the Advanced APM was actively tested, while the denominator would include payment amounts or patient counts for the entire Medicare QP performance period up to the QP determination date.
We propose to modify our policies regarding the timeframe(s) for which payment amount and patient count data are included in the QP payment amount and patient count threshold calculations for Advanced APMs that start after January 1 or end before August 31 in a given Medicare QP Performance Period. In these situations, we would calculate QP Threshold Scores using only data in the numerator and denominator for the dates that APM Entities were able to participate in active testing of the Advanced APM, per the terms of the Advanced APM, so long as APM Entities were able to participate in the Advanced APM for 60 or more continuous days during the Medicare QP Performance Period. We propose to add this policy at § 414.1425(c)(6) of our regulations. The QP Threshold Score would be calculated at the APM Entity level or the Affiliated Practitioner level as set forth in § 414.1425(b); this change would not affect our established policy as to which list of eligible clinicians, the Participation List or Affiliated Practitioner List, would be used.
This proposed change would not affect how we make QP and Partial QP determinations for eligible clinicians who participate in multiple Advanced APMs as set forth by §§ 414.1425(c)(4) and 414.1425(d)(2). We propose to make those calculations using the full Medicare QP Performance Period even if the eligible clinician participates in one or more Advanced APMs that start or end during the Medicare QP Performance Period. We believe that this policy appropriately reflects the participation of the individual eligible clinician in multiple Advanced APMs and is consistent with our general framework for making QP determinations. For these QP determinations, we would include
With the exception of QP determinations for individual eligible clinicians who participate in multiple Advanced APMs, we believe it is appropriate to require that an Advanced APM must be actively tested for a minimum of 60 continuous days during the Medicare QP Performance Period in order for the payment amount or patient count data to be considered for purposes of QP determinations for the year because it is important that the QP determination be based on a measure of meaningful participation in an Advanced APM. For example, if an Advanced APM started on August 30, we do not believe a QP determination made based on only 2 days of payment amount or patient count data in the numerator and denominator would reflect a meaningful assessment of participation in an Advanced APM. We have chosen a minimum of 60 continuous days because it is the shortest amount of time between two snapshot dates: June 30 and August 31. We believe this amount of time is sufficient for purposes of measuring participation in an Advanced APM. We seek comment on whether it would be more appropriate to require that the Advanced APM be in active testing for at least 90 days, since 90 days is the shortest possible length of time we would use to make a QP determination (if the QP determination is based on January 1 through March 31).
Under this proposal, we would make QP determinations for all QP determination snapshot dates that fall after the Advanced APM meets the minimum time requirement of 60 continuous days, whether the Advanced APM starts or ends during the Medicare QP Performance Period. We would not make a QP or Partial QP determination for participants in Advanced APMs that are not actively tested for a period of at least 60 continuous days during the Medicare QP Performance Period. For example, for an Advanced APM that starts its performance period on June 1, we would not make any QP Threshold Score calculations for the June 30 snapshot date because the Advanced APM would not yet have been actively tested for 60 consecutive days. We would wait until the August 31 snapshot date because this would be the first snapshot where the Advanced APM was active for 60 or more continuous days. The QP determination would be made based on payment amounts or patient counts from the June 1 start date to August 31 in both the numerator and the denominator. For an Advanced APM that starts on or before January 1 and ends active testing on June 1, we would make QP determinations on each snapshot date, but those determinations would be made based only on payment amounts or patient counts from January 1 to June 1. Although the Advanced APM would not be actively tested between June 30 and August 31, we would still make another QP Threshold Score calculation for APM Entities or eligible clinicians who had not met the QP Threshold in case the additional time for claims run out would give us more accurate information. For an Advanced APM that started on August 30 of a year, we would not make a QP determination for that year because the APM would not be actively tested for 60 continuous days during the Medicare QP Performance Period.
We believe that this proposal allows us to properly measure performance in Advanced APMs without penalizing APM Entities or eligible clinicians for start or end dates that are wholly outside of their control. We believe this policy is needed to match the data used to assess Advanced APM participation for purposes of the APM incentive payment with the timeframe during which the Advanced APM is actively tested and to accurately reflect the participation of APM Entities and eligible clinicians. This proposed policy would not apply to Other Payer Advanced APMs because eligible clinicians have more control over the start and end dates of payment arrangements with Other Payers, such as through contract negotiations, than they do over our start and end dates, which we exclusively determine.
This proposed policy would not apply to APM Entities that had the opportunity to participate in the Advanced APM track of an APM during the entire Medicare QP Performance Period, but did not do so until partway through the Medicare QP Performance Period. For example, Oncology Care Model (OCM), has two risk tracks: One-sided and two-sided risk. Only the two-sided risk track is an Advanced APM. APM Entities participating in OCM now have the opportunity to change their risk track from one-sided to two-sided risk, to take effect on either January 1 or July 1 of the applicable calendar year. Applying this proposed policy to OCM, an APM Entity participating in OCM that requests two-sided risk to take effect beginning on July 1, 2018, would be considered a participant in and Advanced APM as of July 1, but would be subject to a QP determination based on payment and patient count data for the full Medicare QP Performance Period because that APM Entity had the opportunity to elect two-sided risk beginning on January 1, 2018. In this scenario, the APM Entity has control over its participation in an Advanced APM, and could choose to be in the Advanced APM for the full Medicare QP Performance Period.
We clarify that this proposed policy for Advanced APMs that start or end during the Medicare QP Performance Period does not apply to the CEHRT Track (Track 1) of the Comprehensive Care for Joint Replacement Model (CJR) because we have determined that Track 1 of CJR is an Advanced APM for the 2017 QP Performance Period. Therefore, we will include episodes ending on or after January 1, 2017 in QP determinations as set forth in our regulations at § 414.1425.
We propose to edit § 414.1425(c)(4) and (d)(4) to better reflect our intended policy for QP determinations and Partial QP determinations for eligible clinicians who are included in more than one APM Entity group and none of the APM Entity groups in which the eligible clinician is included meets the corresponding QP or Partial QP threshold, or who are Affiliated Practitioners. As we explained in the CY 2017 Quality Payment Program final rule (81 FR 77446–7), eligible clinicians may become QPs through any of the assessments conducted for the three snapshot dates: March 31, June 30, and August 31. If the APM Entity group meets the QP threshold under this first assessment, then all eligible clinicians in the APM Entity group will be QPs unless the APM Entity's participation in the Advanced APM is voluntarily or involuntarily terminated before the end of the Medicare QP Performance Period, or in the event of eligible clinician or APM Entity program integrity violation. We stated these same procedures apply to the QP determination made for individual eligible clinicians on an APM Entity's Affiliated Practitioner List or individual eligible clinicians in multiple Advanced APMs whose APM Entity groups did not meet the QP threshold.
We propose to amend our regulation to make clear that under § 414.1425(c)(4), if an eligible clinician is a determined to be a QP based on
In summary, we are making the following proposals in this section:
• We propose to calculate QP Threshold Scores for Advanced APMs that are actively tested continuously for a minimum of 60 days during the Medicare QP Performance Period and start or end during the Medicare QP Performance Period using only the dates that APM Entities were able to participate in the Advanced APM per the terms of the Advanced APM, not the full Medicare QP Performance Period.
• We propose to make QP determinations under § 414.1425(c)(4), for eligible clinicians participating in multiple Advanced APMs using the full Medicare QP Performance Period even if the eligible clinician participates in one or more Advanced APMs that start or end during the Medicare QP Performance Period.
• We propose to amend our regulation to make clear that under § 414.1425(c)(4), if an eligible clinician is determined to be a QP based on participation in multiple Advanced APMs, but any of the APM Entities in which the eligible clinician participates voluntarily or involuntarily terminates from the Advanced APM before the end of the Medicare QP Performance Period, the eligible clinician is not a QP.
Section 1833(z)(2)(B)(ii) of the Act requires that beginning in payment year 2021, in addition to the Medicare Option, eligible clinicians may become QPs through the Combination All-Payer and Medicare Payment Threshold Option, which we refer to as the All-Payer Combination Option. In the CY 2017 Quality Payment Program final rule (81 FR 77459), we finalized our overall approach to the All-Payer Combination Option. The Medicare Option focuses on participation in Advanced APMs, and we make determinations under this option based on Medicare Part B covered professional services attributable to services furnished through an APM Entity. The All-Payer Combination Option does not replace or supersede the Medicare Option; instead, it would allow eligible clinicians to become QPs by meeting the QP thresholds through a pair of calculations that assess Medicare Part B covered professional services furnished through Advanced APMs, and a combination of both Medicare Part B covered professional services furnished through Advanced APMs and services furnished through Other Payer Advanced APMs. We finalized that beginning in payment year 2021, we will conduct QP determinations sequentially so that the Medicare Option is applied before the All-Payer Combination Option (81 FR 77438). An eligible clinician only needs to be a QP under either the Medicare Option or the All-Payer Combination Option to be a QP for the payment year. The All-Payer Combination Option encourages eligible clinicians to participate in payment arrangements with payers other than Medicare that have payment designs that satisfy the Other Payer Advanced APM criteria. It also encourages sustained participation in Advanced APMs across multiple payers.
We finalized that the QP determinations under the All-Payer Combination Option are based on payment amounts or patient counts as illustrated in Tables 46, 47, and Figures K1 and K2 (See 81 FR 77460 through 77461). We also finalized that, in making QP determinations, we will use the Threshold Score that is most advantageous to the eligible clinician toward achieving QP status for the year, or if QP status is not achieved, Partial QP status for the year (81 FR 77475).
Unlike the Medicare Option, where we have access to all of the information necessary to determine whether an APM meets the criteria to be an Advanced APM, we cannot identify whether an other payer arrangement meets the criteria to be an Other Payer Advanced APM without receiving the required information from an external source. Similarly, we do not have the necessary payment amount and patient count information to determine under the All-Payer Combination Option whether an eligible clinician meets the payment amount or patient count threshold to be a QP without receiving the required information from an external source.
We finalized the process that eligible clinicians can use to seek a QP determination under the All-Payer Combination Option (81 FR 77478 through 77480):
• The eligible clinician submits to CMS sufficient information on all relevant payment arrangements with other payers;
• Based upon that information CMS determines that at least one of those payment arrangements is an Other Payer Advanced APM; and
• The eligible clinician meets the relevant QP thresholds by having sufficient payments or patients attributed to a combination of participation in Other Payer Advanced APMs and Advanced APMs.
We address the following topics in this section of the proposed rule: (1) Other Payer Advanced APM Criteria; (2) Determination of Other Payer Advanced APMs; and (3) Calculation of All-Payer Combination Option Threshold Scores and QP Determinations.
Our goal is to align the Advanced APM criteria under the Medicare Option and the Other Payer Advanced APM criteria under the All-Payer Combination Option as permitted by statute and as feasible and appropriate. We believe this alignment will help simplify the Quality Payment Program and encourage participation in Other Payer Advanced APMs.
In the CY 2017 Quality Payment Program final rule, we finalized that, in general, an other payer arrangement with any payer other than traditional Medicare, including Medicare Health Plans, which include Medicare Advantage, Medicaid-Medicaid Plans, 1876 and 1833 Cost Plans, and Programs of All Inclusive Care for the Elderly (PACE) plans, will be an Other Payer Advanced APM if it meets all three of the following criteria:
• The other payer arrangement requires at least 50 percent of participating eligible clinicians in each APM Entity (or each hospital if hospitals are the APM participants) to use Certified EHR Technology (CEHRT) to document and communicate clinical care (81 FR 77464 through 77465);
• The other payer arrangement requires that quality measures comparable to measures under the MIPS quality performance category apply, which means measures that are evidence-based, reliable and valid; and, if available, at least one measure must be an outcome measure (81 FR 77466); and
• The other payer arrangement either: (1) Requires APM Entities to bear more than nominal financial risk if actual aggregate expenditures exceed expected aggregate expenditures (under either the generally applicable or Medicaid Medical Home Model standards for nominal amount of financial risk, as applicable); or (2) is a Medicaid Medical Home Model that meets criteria comparable to Medical Home Models expanded under section 1115A(c) of the Act (81 FR 77466 through 77467).
In the CY 2017 Quality Payment Program final rule we finalized definitions of Medical Home Model and Medicaid Medical Home Model at § 414.1305. The statute does not define “medical homes,” but sections 1848(q)(5)(C)(i), 1833(z)(2)(B)(iii)(II)(cc)(BB), 1833(z)(2)(C)(iii)(II)(cc)(BB), and 1833(z)(3)(D)(ii)(II) of the Act make medical homes an instrumental piece of the Quality Payment Program.
We recognize that there may be medical homes that are operated by other payers that may be appropriately considered medical home models under the All-Payer Combination Option. Examples of these arrangements may include those aligned with the Comprehensive Primary Care Plus (CPC+) model. Therefore, we seek comment on whether we should define the term Other Payer Medical Home Model as an other payer arrangement that is determined by CMS to have the following characteristics:
• The other payer arrangement has a primary care focus with participants that primarily include primary care practices or multispecialty practices that include primary care physicians and practitioners and offer primary care services. For the purposes of this provision, primary care focus means the inclusion of specific design elements related to eligible clinicians practicing under one more of the following Physician Specialty Codes: 01 General Practice; 08 Family Medicine; 11 Internal Medicine; 16 Obstetrics and Gynecology; 37 Pediatric Medicine; 38 Geriatric Medicine; 50 Nurse Practitioner; 89 Clinical Nurse Specialist; and 97 Physician Assistant;
• Empanelment of each patient to a primary clinician; and
• At least four of the following:
++ Planned coordination of chronic and preventive care.
++ Patient access and continuity of care.
++ Risk-stratified care management.
++ Coordination of care across the medical neighborhood.
++ Patient and caregiver engagement.
++ Shared decision-making.
++ Payment arrangements in addition to, or substituting for, fee-for-service payments (for example, shared savings or population-based payments).
Similar to Medical Home Models and Medicaid Medical Home Models, we believe that Other Payer Medical Home Models could be considered unique types of other payer arrangements for purposes of the Quality Payment Program. We anticipate that participants in these arrangements may generally be more limited in their ability to bear financial risk than other entities because they may be smaller and predominantly include primary care practitioners, whose revenues are a smaller fraction of the patients' total cost of care than those of other eligible clinicians. Because of these factors, we believe it may be appropriate to determine whether an Other Payer Medical Home Model satisfies the financial risk criterion by using special Other Payer Medical Home Model financial risk and nominal amount standards, which could be different from the generally applicable Other Payer Advanced APM standards and would be identical to the Medicaid Medical Home Model financial risk and nominal amount standards.
We are particularly interested in, and seek comment on, whether there are payment arrangements that currently exist that would meet this definition. We encourage commenters to note whether such payment arrangements would meet the existing generally applicable Other Payer Advanced APM financial risk and nominal amount standards. We also request comments on any special considerations that might be relevant when establishing a definition for a medical home model standard for payers with payment arrangements that would not fit under the Medical Home Model or Medicaid Medical Home Model definitions, including how the 50 clinician cap discussed in section II.D.4.b.(1) of this proposed rule for the Medical Home Model nominal amount standard would apply.
In the CY 2017 Quality Payment Program final rule we finalized policies to assess whether an other payer arrangement requires participating APM Entities to bear more than nominal financial risk if aggregate expenditures exceed expected aggregated expenditures (more than nominal financial risk for monetary losses). This Other Payer Advanced APM criterion has two components: A financial risk standard and a nominal amount standard. The financial risk standard defines what it means for an APM Entity to bear financial risk if actual aggregate expenditures exceed expected aggregate expenditures under an other payer arrangement. We finalized a generally applicable financial risk standard and a Medicaid Medical Home Model financial risk standard for Other Payer Advanced APMs. (See 81 FR 77466 through 77474).
We finalized that for an other payer arrangement to meet the generally applicable financial risk standard for Other Payer Advanced APMs, if an APM Entity's actual aggregate expenditures exceed expected aggregate expenditures during a specified performance period, the payer must:
• Withhold payment of services to the APM Entity and/or the APM Entity's eligible clinicians;
• Reduce payment rates to APM Entity and/or the APM Entity's eligible clinicians; or
• Require direct payments by the APM Entity to the payer (81 FR 77467).
We also finalized that for a Medicaid Medical Home Model to be an Other Payer Advanced APM, if the APM Entity's actual aggregate expenditures exceed expected aggregate expenditures during a specified performance period, the Medicaid Medical Home Model must:
• Withhold payment of services to the APM Entity and/or the APM Entity's eligible clinicians;
• Reduce payment rates to APM Entity and/or the APM Entity's eligible clinicians;
• Require direct payments by the APM Entity to the payer; or
• Require the APM Entity to lose the right to all or part of an otherwise guaranteed payment or payments (81 FR 77468 through 77469).
The generally applicable nominal amount standard that we finalized in the CY 2017 Quality Payment Program final rule (81 FR 77471) for Other Payer Advanced APMs differs from the generally applicable nominal amount standard for Advanced APMs in two ways.
First, the finalized generally applicable Advanced APM nominal amount standard only requires an APM to meet one measure of risk—total risk (81 FR 77424). The finalized generally applicable Other Payer Advanced APM nominal amount standard involves assessment of the following three measures of risk:
• Marginal risk—the percentage of the amount by which actual expenditures exceed expected expenditures for which an APM Entity would be liable under the payment arrangement.
• Minimum loss rate—a percentage by which actual expenditures may exceed expected expenditures without triggering financial risk.
• Total risk—the maximum potential payment for which an APM Entity could be liable under a payment arrangement.
We note that as described in the CY 2017 Quality Payment Program final rule (81 FR 77426), although we did not formally adopt marginal risk or minimum loss rate criteria for Advanced APMs, we pointed out that all current Advanced APMs would meet these standards, and that we intend that all future Advanced APMs would meet the three measures of risk as well. Therefore, we do not expect the application of the different criteria between Advanced APMs and Other Payer Advanced APMs to produce meaningfully different results in terms of actual risk faced by participants.
Second, the finalized generally applicable Advanced APM nominal amount standard allows for total risk to be defined in one of two ways, based on expected expenditures (the benchmark-based standard) or based on revenue (the revenue-based standard) (81 FR 77427). In contrast, the finalized Other Payer Advanced APM generally applicable nominal amount standard is only based on expected expenditures (81 FR 77471).
In the CY 2017 Quality Payment program final rule, we sought comments on using the expected expenditures approach for the generally applicable Other Payer Advanced APM nominal amount standard.
Table 48 lists the requirements of the generally applicable nominal amount standards as finalized in the CY 2017 Quality Payment Program final rule (81 FR 77427 and 77471).
We do not propose to modify the marginal risk and minimum loss rate requirements as we finalized in the CY 2017 Quality Payment Program final rule as part of the generally applicable nominal amount standard for Other Payer Advanced APMs. We continue to believe that using these measures of risk will ensure that payment arrangements involving other payers and APM Entities or eligible clinicians cannot be engineered in such a way as to provide eligible clinicians an avenue to QP status through an Other Payer Advanced APM that technically meets the financial risk criterion but carries a very low risk of losses based on performance. Because we do not have direct control over the design of Other Payer Advanced APMs, we believe the use of a multi-factor nominal amount standard to assess financial risk provides greater assurance that Other Payer Advanced APMs will involve true financial risk in accordance with statutory requirements. Including marginal risk and a minimal loss rate as components of the nominal amount standard assures that the payment arrangements that we could determine are Other Payer Advanced APMs and could contribute to the attainment of QP status are similarly rigorous to Advanced APMs. We request additional comments on this approach, and on whether there are potential alternative approaches to achieving these goals.
We propose to add a revenue-based nominal amount standard to the generally applicable nominal amount standard for Other Payer Advanced APMs that is parallel to the revenue-based nominal amount standard for Advanced APMs. Specifically, we propose that an other payer arrangement would meet the revenue-based nominal amount standard we are proposing if, under the terms of the other payer arrangement, the total amount that an APM Entity potentially owes the payer or foregoes is equal to at least: For the 2019 and 2020 All-Payer QP Performance Periods, 8 percent of the total combined revenues from the payer of providers and suppliers in participating APM Entities. We would use this standard for other payer arrangements where financial risk is expressly defined in terms of revenue in the payment arrangement. We seek comment on this proposal.
For Advanced APMs, we may determine that an APM still meets the
We propose that under the generally applicable nominal amount standard for Other Payer Advanced APMs, an other payer arrangement would need to meet either the benchmark-based nominal amount standard or the revenue-based nominal amount standard, and need not meet both. We believe this proposed approach to the nominal amount standard would expand the opportunities for other payer arrangements to meet the generally applicable nominal amount standard, and would allow closer alignment between Medicare and other payers as new payment arrangements are introduced and evolve. As with the revenue-based nominal amount standard for Advanced APMs, which we discuss in section II.D.4.b.(2)(a) of this proposed rule, we seek comment on whether we should consider either a lower or higher revenue-based nominal amount standard for the 2019 and 2020 All-Payer QP Performance Periods, and on the amount and structure of the revenue-based nominal amount standard for All-Payer QP Performance Periods 2021 and later.
We also seek comment on whether we should consider a different, potentially lower, revenue-based nominal amount standard only for small practices and those in rural areas that are not participating in a Medicaid Medical Home Model for the 2019 and 2020 All-Payer QP Performance Periods. For the purposes of the Quality Payment Program, we use the definition of small practices and rural areas in § 414.1305. We believe that a different, potentially lower, revenue-based nominal amount standard for the 2019 and 2020 All-Payer QP Performance Periods specifically for small and rural organizations may allow for their increased participation in Advanced APMs, which may help increase the quality and coordination of care beneficiaries receive as a result. Specifically, we seek comment on whether such a standard should apply only to small and, or, rural practices that are participants in an APM, or also to small and/or rural practices that join larger APM Entities to participate in APMs. We also seek comment on how we should decide where a practice is located to determine whether it is operating in a rural area is defined in § 414.1305.
In the CY 2017 Quality Payment Program final rule (81 FR 77472), in addition to the financial risk standard for Medicaid Medical Home Models, we finalized that to be an Other Payer Advanced APM, a Medicaid Medical Home Model must require that the total annual amount that an APM Entity potentially owes or foregoes be at least the following amounts in a given performance year:
• In 2019, 4 percent of the APM Entity's total revenues under the payer.
• In 2020 and later, 5 percent of the APM Entity's total revenues under the payer.
Table 49 lists the requirements of the Medicaid Medical Home Model nominal amount standards as finalized in the CY 2017 Quality Payment Program final rule (81 FR 77428 and 77472).
As we have discussed in section II.D.4.b.(2)(b) of this proposed rule regarding APM Entities in Medical Home Models, we have also received comments that few APM Entities in Medical Home Models and Medicaid Medical Home Models have had experience with financial risk, and that many would be financially challenged to provide sufficient care or even remain a viable business in the event of substantial disruptions in revenue. We understand these concerns that the gradual increase in risk over time may be unmanageable for some APM Entities; however, we still believe that a final Medicaid Medical Home Model nominal amount standard of 5 percent is appropriate and that setting the standard at 5 percent of the APM Entity's total revenue under the payer appropriately reflects the meaning of nominal in the Medicaid Medical Home Model context.
We have reconsidered the incremental annual increases in the standard over several years. Our policy finalized in the CY 2017 Quality Payment Program final rule set forth what we envisioned was a gradually increasing but achievable amount of risk that would apply over time. In general, we still believe this to be true, but recognize that establishing an even more gradual increase in risk for Medicaid Medical Home Models may better suit many APM Entities in Medicaid Medical Home Models that have little experience with risk. To that end, we believe a small reduction of risk in the Medicaid Medical Home Model nominal amount standard beginning in the 2019 All-Payer QP Performance Period may allow for greater flexibility in setting financial risk thresholds that would encourage more participation in Medicaid Medical Home Models and be more sustainable for the type of APM Entities that would potentially participate in Medicaid Medical Home Models.
Therefore, we are proposing that, to be an Other Payer Advanced APM, a Medicaid Medical Home Model must require that the total annual amount that
• For All-Payer QP Performance Period 2019, 3 percent of the APM Entity's total revenue under the payer.
• For All-Payer QP Performance Period 2020, 4 percent of the APM Entity's total revenue under the payer.
• For All-Payer QP Performance Period 2021 and later, 5 percent of the APM Entity's total revenue under the payer.
We seek comment on this proposal.
In summary, we are proposing the following:
• We propose that an other payer arrangement would meet the revenue-based nominal amount standard we are proposing if, under the terms of the other payer arrangement, the total amount that an APM Entity potentially owes the payer or foregoes is equal to at least: for the 2019 and 2020 All-Payer QP Performance Periods, 8 percent of the total combined revenues from the payer of providers and suppliers in participating APM Entities.
• We are proposing that to be an Other Payer Advanced APM, a Medicaid Medical Home Model must require that the total annual amount that an APM Entity potentially owes or foregoes under the Medicaid Medical Home Model must be at least:
++ For All-Payer QP Performance Period 2019, 3 percent of the APM Entity's total revenue under the payer.
++ For All-Payer QP Performance Period 2020, 4 percent of the APM Entity's total revenue under the payer.
++ For All-Payer QP Performance Period 2021 and later, 5 percent of the APM Entity's total revenue under the payer.
In the CY 2017 Quality Payment Program final rule, we established a prospective Advanced APM determination process (81 FR 77408). This prospective approach was implemented to ensure that APM Entities and eligible clinicians were aware of which APMs met the Advanced APM criteria prior to the first QP Performance Period, and because we have a general goal of providing notice, when possible, of which models are Advanced APMs prior to the beginning of the Medicare QP Performance Period. We were able to perform Advanced APM determinations within the time period between the effective date of the CY 2017 Quality Payment Program final rule and the beginning of the first QP Performance Period because we already possessed all of the information necessary.
For other payer arrangements, we specified that an APM Entity or eligible clinician must submit, by a date and in a manner determined by us, information necessary to identify whether a given payment arrangement satisfies the Other Payer Advanced APM criteria (81 FR 77480). We finalized that we will identify Medicaid APMs and Medicaid Medical Home Models that meet the Other Payer Advanced APM criteria before the beginning of the QP Performance Period (81 FR 77478 through 77480). We also sought comment on the overall process for reviewing payment arrangements to determine whether they are Other Payer Advanced APMs, and we also sought comment on whether we should create a separate pathway to identify whether other payer arrangements with Medicaid as a payer meet the Other Payer Advanced APM criteria (81 FR 77463).
We propose to allow certain other payers, including payers with payment arrangements authorized under Title XIX, Medicare Health Plan payment arrangements, and payers with payment arrangements in CMS Multi-Payer Models to request that we determine whether their other payer arrangements are Other Payer Advanced APMs starting prior to the 2019 All-Payer QP Performance Period and each year thereafter. We propose to generally refer to this process as the Payer Initiated Other Payer Advanced APM Determination Process (Payer Initiated Process). We believe that establishing this Payer Initiated Process would be beneficial to APM Entities and eligible clinicians because it would help reduce their reporting burden, and it would provide us with the most complete information on payment arrangements. In addition, we believe the Other Payer Advanced APM determinations made via the Payer Initiated Process could be completed prior to the All-Payer QP Performance Period, and we could therefore provide APM Entities and eligible clinicians with information that may help them plan their participation in Other Payer Advanced APMs.
When referring to Medicare Health Plans in the context of the Payer Initiated Process, we include in the term Medicare Advantage and certain types of plans including Medicare-Medicaid Plans, 1876 and 1833 Cost Plans, and Programs of All Inclusive Care for the Elderly (PACE) Plans.
If a payer requests that we determine whether a payment arrangement authorized under Title XIX, a Medicare Health Plan payment arrangement, or a payment arrangement in a CMS Multi-Payer Model is an Other Payer Advanced APM, and the payer uses the same other payer arrangement in other commercial lines of business, we propose to allow the payer to concurrently request that we determine whether those other payer arrangements are Other Payer Advanced APMs as well. We will make Other Payer Advanced APM determinations for each individual payment arrangement.
We propose that these Other Payer Advanced APM determinations would be in effect for only one year at a time. Payers would need to submit payment arrangement information each year in order for us to make an Other Payer Advanced APM determination in each year. We believe this approach is appropriate since payment arrangements can change from year to year, and also since we may modify aspects of the Other Payer Advanced APM criteria from one year to the next. We seek comment on this approach, and we are exploring ways to streamline this process over time.
We propose to allow remaining other payers, including commercial and other private payers, to request that we determine whether other payer arrangements are Other Payer Advanced APMs starting in 2019 prior to the 2020 All-Payer QP Performance Period and annually each year thereafter. We believe that phasing in the Payer Initiated Process would allow us to gain experience with the determination process on a limited basis with payers where we have the strongest relationships and existing processes that we believe can help facilitate submitting this information. We anticipate making improvements and refinements to this process, which we believe will help us facilitate receiving this information from the remaining other payers.
We propose that the Payer Initiated Process would be voluntary for all payers. We propose that the Payer Initiated Process would generally involve the same steps for each payer type as listed below for each All-Payer QP Performance Period, and we elaborate on details within this framework that are specific to payer type in the following subsections:
We believe that this proposed Payer Initiated Process would encourage greater participation in Other Payer Advanced APMs, particularly because it would allow us to post a list of at least some of the Other Payer Advanced APMs before the start of the All-Payer QP Performance Period as discussed in section II.D.6.d.(2)(a) of this proposed rule. We also believe that payers are well positioned to compile and submit to us the information we require to make Other Payer Advanced APM determinations because they develop other payer arrangements. We seek comment on these proposals.
We note that we will seek OMB approval for the proposed Payer Initiated Submission Form separately from this rulemaking process. In accordance with the Paperwork Reduction Act (PRA), we will publish the required 60-day public notice and 30-day public notice. In addition, the entire information collection request and all associated forms will be made available for public review prior to OMB submission.
In the CY 2017 Quality Payment Program final rule, we finalized that APM Entities and eligible clinicians in payment arrangements with other payers would have an opportunity to request determinations of whether an other payer arrangement(s) is an Other Payer Advanced APM after the QP Performance Period (81 FR 77480). At that time, APM Entities and eligible clinicians would know which payment arrangements they participated in during the preceding QP Performance Period. We clarify that both APM Entities and eligible clinicians may request Other Payer Advanced APM determinations through this process, and we refer to this process as the Eligible Clinician Initiated Process.
We propose that through the Eligible Clinician Initiated Process, APM Entities and eligible clinicians participating in other payer arrangements would have an opportunity to request that we determine for the year whether those other payer arrangements are Other Payer Advanced APMs. The Eligible Clinician Initiated Process could also be used to request determinations before the beginning of an All-Payer QP Performance Period for other payer arrangements authorized under Title XIX, as we discuss in section II.D.6.(c)(2)(b) of this proposed rule. The Eligible Clinician Initiated Process would not be necessary for, or applicable to, other payer arrangements that are already determined to be Other Payer Advanced APMs through the Payer Initiated Process.
We note that APM Entities and eligible clinicians who submit complete Eligible Clinician Initiated Submission Forms by September 1 of the calendar year of the relevant All-Payer QP Performance Period may allow for us to make Other Payer Advanced APM determinations and inform APM Entities or eligible clinicians of those determinations prior to the December 1 QP Determination Submission Deadline. If we determine that an other payer arrangement is not an Other Payer Advanced APM, notifying APM Entities or eligible clinicians of such a determination may help them avoid the burden of submitting payment amount and patient count information for that payment arrangement. We intend to make these early notifications to the extent possible. We propose that APM Entities or eligible clinicians may submit information regarding an other payer arrangement for a subsequent All-Payer QP Performance Period even if we have determined that the other payer arrangement is not an Other Payer Advanced APM for a prior year.
We seek comment on these proposals.
We note that we will seek OMB approval for the proposed Eligible Clinician Initiated Submission Form separately from this rulemaking process. In accordance with the Paperwork Reduction Act (PRA), we will publish the required 60-day public notice and 30-day public notice. In addition, the entire information collection request and all associated forms will be made available for public review prior to OMB submission.
In this section, we discuss how payers, APM Entities, and eligible clinicians may request that we determine whether payment arrangements authorized under Title XIX of the Act are Medicaid APMs or Medicaid Medical Home Models that meet the Other Payer Advanced APM criteria. There are some differences between the determination process for other payer arrangements where Medicaid is the payer and the process for other payer arrangements with other types of payers. These differences stem in part from the requirements specified in sections 1833(z)(2)(B)(ii)(bb) and 1833(z)(2)(C)(ii)(bb) of the Act for the All-Payer Combination Option for QP determinations. We interpret those statutory provisions to direct us, when making QP determinations under the All-Payer Combination Option, to exclude from the calculation of “all other payments” any payments made (or patients under the patient count method) under Title XIX in a state in which there is no available Medicaid APM (which by definition at § 414.1305 meets the Other Payer Advanced APM criteria) or Medicaid Medical Home Model that meets the Other Payer Advanced APM criteria. We believe that our interpretation of the statute to exclude, when appropriate as discussed in section II.D.6.(d)(3)(c) of this proposed rule, Medicaid APMs or Medicaid Medical Home Models that meet the Other Payer Advanced APM criteria, is appropriate to carry out the terms of the statute while avoiding circumstances that could unfairly impact the ability of eligible clinicians to plan ahead and position themselves to attain QP status. Our interpretation leads us to exclude Title XIX payments or patients from the denominator of QP calculations when eligible clinicians had no opportunity to participate in a Medicaid APM or Medicaid Medical Home Model that meets the Other Payer Advanced APM criteria.
To implement this requirement, we need to determine which states have no available Medicaid APMs or Medicaid Medical Home Models that meet the Other Payer Advanced APM criteria during a given All-Payer QP Performance Period as described in section II.D.6.c.(2)(b) of the proposed rule. We believe that it is important for us to make this determination prior to the All-Payer QP Performance Period, and to announce the Medicaid APMs and Medicaid Medical Home Models that meet the Other Payer Advanced APM criteria and the locations where
We propose that any states and territories (which we refer to as states) that have in place a state plan under Title XIX may request that we determine prior to the All-Payer QP Performance Period whether other payer arrangements authorized under Title XIX are Medicaid APMs or Medicaid Medical Home Models that meet the Other Payer Advanced APM criteria, in other words, are Other Payer Advanced APMs, under the Payer Initiated Process. States include the 50 states, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands.
We propose to allow states to request determinations for both Medicaid fee-for-service and Medicaid managed care plan payment arrangements. States often use managed care plan contracts to implement payment arrangements, and a substantial portion of the Medicaid beneficiary population receives their health care services through Medicaid managed care plans. We expect that states would work closely with their managed care plans to identify and collect relevant information. However, we propose to accept requests regarding payment arrangements authorized under Title XIX under the Payer Initiated Process only from the state, not from a Medicaid managed care plan, as states are responsible ultimately for the administration of their Medicaid programs. Details specific to the Payer Initiated Process for payment arrangements authorized under Title XIX are explained below.
We intend to work with states as they prepare and submit Payer Initiated Submission Forms for our review. In completing the Payer Initiated Submission Form, states could refer to information we already possess on their payment arrangements to support their request for a determination. This information could include, for example, submissions that states typically make to us to obtain authorization to modify their Medicaid payment arrangements, such as a State Plan Amendment or an 1115 demonstration's waiver application, Special Terms and Conditions document, implementation protocol document, or other document describing the 1115 demonstration arrangements approved by CMS.
We intend to implement ongoing assistance through existing conversations or negotiations as states design and develop new payment arrangements that may be identified as Other Payer Advanced APMs. As states begin discussions with us regarding the development of other payer arrangements through the different legal authorities available under Title XIX or Title XI of the Act, we would help states consider and address the Other Payer Advanced APM criteria.
We believe that, to appropriately implement the Title XIX exclusions, it is not feasible to allow APM Entities and eligible clinicians to request determinations for Title XIX payment arrangements after the conclusion of the All-Payer QP Performance Period for the year, as we are allowing APM Entities and eligible clinicians to do for other payers. To do so would mean that a single clinician requesting a determination for a previously unknown Medicaid APM or Medicaid Medical Home Model that meets the Other Payer Advanced APM criteria could unexpectedly affect QP threshold calculations for every other clinician in that state (or county) as described in section II.D.6.d.(3) of this proposed rule. Thus, we would be unable to provide timely notice of the presence of a Medicaid APM or Medicaid Medical Home Model that meets the Other Payer Advanced APM criteria to all other eligible clinicians in the state whose QP determinations under the All-Payer Combination Option could be affected. To avoid this scenario, we propose to require that APM Entities and eligible clinicians may request determinations for any Medicaid payment arrangements in which they are participating at an earlier point, prior to the All-Payer QP Performance Period. This would allow all clinicians in a given state or county to know before the beginning of the performance period whether their Title XIX payments and patients would be excluded from the all-payer calculations that are used for QP determinations for the year under the All-Payer Combination Option. Details specific to the Eligible Clinician Initiated Process for payment arrangements authorized under Title XIX are explained below.
The proposed timeline for both the Payer Initiated and Eligible Clinician Initiated Other Payer Advanced APM Determination Processes for payment arrangements authorized under Title XIX are summarized in Table 50.
For purposes of carrying out the Quality Payment Program, we propose to define the term CMS-Multi Payer Model at § 414.1305 of our regulations as an Advanced APM that CMS determines, per the terms of the Advanced APM, has at least one other payer arrangement that is designed to align with the terms of that Advanced APM. Examples of CMS Multi-Payer Models include the Comprehensive Primary Care Plus (CPC+) Model, the Oncology Care Model (OCM) (2-sided risk arrangement), and the Vermont All-Payer ACO Model.
Other payer arrangements that are in a CMS Multi-Payer Model, by definition, are not APMs and thus cannot be Advanced APMs under the Medicare Option. We recognize, though, that these other payer arrangements could be Other Payer Advanced APMs. We therefore propose that beginning in the first All-Payer QP Performance Period, payers with other payer arrangements in a CMS Multi-Payer Model may request that we determine whether those aligned other payer arrangements are Other Payer Advanced APMs.
Because there may be differences among the other payer arrangements that are aligned with an Advanced APM in a CMS Multi-Payer Model, we propose to make separate determinations about each of those other payer arrangements on an individual basis. In other words, an other payer arrangement aligned with an Advanced APM in a CMS Multi-Payer Model is not automatically an Other Payer Advanced APM by virtue of its alignment.
We acknowledge that there can be payment arrangements authorized under Title XIX or Medicare Health Plan payment arrangements that are aligned with a CMS Multi-Payer Model. We propose that payers, APM Entities, or eligible clinicians who want to request that we determine whether those arrangements are Other Payer Advanced APMs would use the processes specified for payment arrangements authorized under Title XIX and Medicare Health Plan payment arrangements discussed in sections II.D.6.c.(2) and II.D.6.c.(4) of this proposed rule.
Details specific to the Payer Initiated Process for payment arrangements in CMS Multi-Payer Models are explained below.
Details specific to the Eligible Clinician Initiated Process for payment arrangements in CMS Multi-Payer Models are explained below.
Some CMS Multi-Payer Models involve an agreement with a state to test an APM and one or more associated other payer arrangements in that state where the state prescribes uniform payment arrangements across state-based payers. As such, we believe it may be appropriate and efficient for states, rather than any other payer, to submit information to us on these payment arrangements for purposes of an Other Payer Advanced APM determination.
We propose that, in CMS Multi-Payer Models where a state prescribes uniform payment arrangements across all payers statewide, the state would submit on behalf of payers in the Payer Initiated Process for Other Payer Advanced APMs; we would seek information for the determination from the state, rather than individual payers. The same Payer Initiated Process and timeline described above for CMS Multi-Payer Models would apply. We seek comment on this proposal. Additionally, we seek comment regarding the effectiveness of taking a similar approach in cases where the state does not require uniform payment arrangements across payers.
The proposed timelines for both the Payer Initiated and Eligible Clinician Initiated Other Payer Advanced APM Determination Processes for payment arrangements in CMS Multi-Payer Models are summarized in Table 51.
The Medicare Option for QP determinations under sections 1833(z)(2)(A), (2)(B)(i), and (2)(C)(i) of the Act, is based only on the percentage of Part B payments for covered professional services, or patients, that is attributable to payments through an Advanced APM. As such, payment amounts or patient counts under Medicare Health Plans, including Medicare Advantage, Medicare-Medicaid Plans, 1876 and 1833 Cost Plans, and Programs of All Inclusive Care for the Elderly (PACE) plans, cannot be included in the QP determination calculations under the Medicare Option. (See 81 FR 77473 through 77474). Instead, eligible clinicians who participate in Other Payer Advanced APMs, including those with Medicare Advantage as a payer, could begin receiving credit for that participation through the All-Payer Combination Option in 2021 based on the performance in the 2019 All-Payer QP Performance Period.
In light of these statutory limitations, we have received feedback in support of creating a way for those participating or who could participate in Advanced APMs that include Medicare Advantage to receive credit for that participation in QP determinations under the Medicare Option. We are considering opportunities to address this issue. We seek comment on such opportunities, including potential models and uses of our waiver and demonstration authorities.
Under the All-Payer Combination Option, eligible clinicians can become QPs based in part on payment amounts or patient counts associated with payer arrangements through Medicare Health Plans, provided that such arrangements meet the criteria to be Other Payer Advanced APMs. We note that the financial relationship between the Medicare Health Plan and CMS is not relevant to the Other Payer Advanced APM determination. Rather, because QP determinations are made for eligible clinicians, only the payment arrangement between a Medicare Health Plan and an eligible clinician is relevant when determining whether a payment arrangement is an Other Payer Advanced APM.
We propose that Medicare Health Plans may request that we determine whether their payment arrangements are Other Payer Advanced APMs prior to the All-Payer QP Performance Period, by submitting information contemporaneously with the annual bidding process for Medicare Advantage contracts (that is., submitted by the first Monday in June of the year prior to the payment and coverage year). Because this is a process in which many Medicare Health Plans currently participate, we believe it will be the least burdensome approach for Medicare Health Plans.
Details specific to the Payer Initiated Process for Medicare Health Plan payment arrangements are explained below.
Details specific to the Payer Initiated Process for Medicare Health Plan payment arrangements are explained below.
The proposed timeline for both the Payer Initiated and Eligible Clinician Initiated Other Payer Advanced APM Determination Processes for Medicare Health Plan payment arrangements are summarized in Table 52.
We propose to allow the remaining other payers not specifically addressed in proposals above, including commercial and other private payers that are not states, Medicare Health Plans or payers with arrangements that are aligned with a CMS Multi-Payer Model, to request that we determine whether other payer arrangements are Other Payer Advanced APMs starting prior to the 2020 All-Payer QP Performance Period and each year thereafter. We seek comment on this proposal, and we also seek comment on potential challenges to these other payers submitting information to us for Other Payer Advanced APM determinations. We intend to discuss this process in more detail in future rulemaking.
We propose that APM Entities and eligible clinicians may request that we determine whether an other payer arrangement with one of these other payers is an Other Payer Advanced APM beginning 2019 All-Payer QP Performance Period as explained below.
We seek comments on these proposals.
The proposed timeline for both the Payer Initiated and Eligible Clinician Initiated Other Payer Advanced APM Determination Processes for payment arrangements for remaining other payers are summarized in Table 53.
The proposed timeline for both the proposed Payer Initiated and Eligible Clinician Initiated Other Payer Advanced APM Determination Processes for all payer types is presented in Table 54.
In the CY 2017 Quality Payment Program final rule, we finalized that to be assessed under the All-Payer Combination Option, APM Entities or eligible clinicians must submit, in a manner and by a date that we specify, payment arrangement information necessary to assess whether the other payer arrangement meets the Other Payer Advanced APM criteria (81 FR 77480).
As we discuss in sections II.D.6.c.(1) through II.D.6.c.(5) of this proposed rule, we propose to allow for certain types of payers as well as APM Entities or eligible clinicians to request that we determine whether certain other payer arrangements are Other Payer Advanced APMs.
We intend to create a Payer Initiated Submission Form that would allow payers to submit the information necessary for us to determine whether a payment arrangement is an Other Payer Advanced APM. We propose that, for each other payer arrangement a payer requests us to determine whether it is an Other Payer Advanced APM, the payer must use, complete, and submit the Payer Initiated Submission Form by the relevant deadline.
For us to make these determinations, we propose to require that payers submit the following information for each other payer arrangement:
• Arrangement name;
• Brief description of the nature of the arrangement;
• Term of the arrangement (anticipated start and end dates);
• Participant eligibility criteria;
• Locations (nationwide, state, or county) where this other payer arrangement will be available;
• Evidence that the CEHRT criterion set forth in § 414.1420(b) is satisfied;
• Evidence that the quality measure criterion set forth in § 414.1420(c) is satisfied; including an outcome measure;
• Evidence that the financial risk criterion set forth in § 414.1420(d) is satisfied; and
• Other documentation as may be necessary for us to determine that the other payer arrangement is an Other Payer Advanced APM.
We propose that the Payer Initiated Submission Form would allow payers to include descriptive language for each of the required information elements. We are proposing to require the name and description of the arrangement, nature of the arrangement, term of the arrangement, eligibility criteria, and location(s) where the arrangement will be available so that we can verify whether eligible clinicians who may tell us that they participate in such arrangements are eligible to do so. We require evidence that all of the Other Payer Advanced APM criteria are met in order for us to determine whether the arrangement is an Other Payer Advanced APM. We propose that a submission for an Other Payer Advanced APM determination submitted by the payer is complete only if all of these information elements are submitted to us.
We propose to require that payers submit documentation that supports the information they provided in the Payer Initiated Submission Form and that is sufficient to enable us to determine whether the other payer arrangement is an Other Payer Advanced APM. Examples of such documentation would include contracts and other relevant documents that govern the other payer arrangement that verify each required information element, copies of their full contracts governing the arrangement, or some other documents that detail and govern the payment arrangement.
We intend to create an Eligible Clinician Initiated Submission Form that would allow for APM Entities or eligible clinicians to submit the information necessary for us to determine whether a payment arrangement is an Other Payer Advanced APM. We propose that, for each other payer arrangement an APM Entity or eligible clinician requests us to determine whether it is an Other Payer Advanced APM, the APM Entity or eligible clinician must use, complete, and submit the Eligible Clinician Initiated Submission Form by the relevant deadline.
For us to make these determinations, we propose to require that the APM Entity or eligible clinician submit the following information for each other payer arrangement:
• Arrangement name;
• Brief description of the nature of the arrangement;
• Term of the arrangement (anticipated start and end dates);
• Locations (nationwide, state, or county) where this other payer arrangement will be available;
• Evidence that the CEHRT criterion set forth in § 414.1420(b) is satisfied;
• Evidence that the quality measure criterion set forth in § 414.1420(c) is satisfied, including an outcome measure;
• Evidence that the financial risk criterion set forth in § 414.1420(d) is satisfied; and
• Other documentation as may be necessary for us to determine whether the other payer arrangement is an Other Payer Advanced APM.
We propose that the Eligible Clinician Initiated Submission Form would allow APM Entities and eligible clinicians to include descriptive language for each of the required information elements. We
We propose to require that APM Entities or eligible clinicians submit documentation that supports the information they provided in the Eligible Clinician Initiated Submission Form and that is sufficient to enable us to determine whether the other payer arrangement is an Other Payer Advanced APM. Examples of such documentation would include contracts and other relevant documents that govern the other payer arrangement that verify each required information element, copies of their full contracts governing the arrangement, or some other documents that detail and govern the payment arrangement. In addition to requesting that we determine whether one or more other payer arrangements are Other Payer Advanced APMs for the year, APM Entities or eligible clinicians may also inform us that they are participating in an other payer arrangement that we determine to be an Other Payer Advanced APM for the year. To do so, we propose that an APM Entity or eligible clinician would indicate, upon submission of Other Payer Advanced APM participation data for purposes of QP determination, which Other Payer Advanced APMs they participated in during the All-Payer QP Performance Period, and include copies of participation agreements or similar contracts (or relevant portions of them) to document their participation in those payment arrangements.
We acknowledge that there is some burden associated with requesting Other Payer Advanced APM determinations. We seek comment on ways to reduce burden on states, payers, APM Entities, and eligible clinicians while still allowing us to receive the information necessary to make such determinations.
We believe that it is important that the information submitted by payers through the Payer Initiated Process is true, accurate, and complete. To that end, we propose to add a new requirement at § 414.1445(d) stating that a payer that submits information pursuant to § 414.1445(c) must certify to the best of its knowledge that the information it submitted to us through the Payer Initiated Process is true, accurate, and complete. Additionally, we propose that this certification must accompany the Payer Initiated Submission Form and any supporting documentation that payers submit to us through this process.
We propose to revise and clarify the monitoring and program integrity provisions at § 414.1460. First, we propose to modify § 414.1460(c) to specify that information submitted by payers for purposes of the All-Payer Combination Option may be subject to audit by us. We anticipate that the purpose of any such audit would be to verify the accuracy of an Other Payer Advanced APM determination. We seek comment on how this might be done with minimal burden to payers. Second, we propose at § 414.1460(e)(1) to require payers who choose to submit information through the Payer Initiated Process to such books, contracts, records, documents, and other evidence as necessary to audit an Other Payer Advanced APM determination. We propose that such information must be maintained for 10 years after submission. We also propose at § 414.1460(e)(3) that such information and supporting documentation must be provided to us upon request. We request comments on this proposal, including comment on the length of time payers typically maintain such information. We also seek comment on how this might be done with minimal burden to payers.
In the CY 2017 Quality Payment Program final rule, we finalized a requirement at § 414.1445(b)(3) that payers must attest to the accuracy of information submitted by eligible clinicians (81 FR 77480). After publication of the final rule, we received comments from stakeholders opposing this requirement. Commenters noted that payers may not have any existing relationship with us, that payers do not have any direct stake in the QP status of eligible clinicians, and that there may be operational and legal barriers to payers attesting to this information. In consideration of these comments, we propose to eliminate the requirement at § 414.1445(b)(3) that payers attest that the information submitted by eligible clinicians is accurate. Instead, as discussed in section II.D.6.c.(7)(b)(i) of this rule, we are proposing that payers must certify only the information they submit directly to us.
In the CY 2017 Quality Payment Program final rule, we finalized a requirement at § 414.1460(c) that eligible clinicians and APM Entities must attest to the accuracy and completeness of data submitted to meet the requirements under the All-Payer Combination Option. We believe this requirement would be more appropriately placed in the regulatory provisions that discuss the submission of information related to requests for Other Payer Advanced APM determinations. Accordingly, we are proposing to remove this requirement at § 414.1460(c) and proposing at § 414.1445(d) that an APM Entity or eligible clinician that submits information pursuant to § 414.1445(c) must certify to the best of its knowledge that the information it submitted to us is true, accurate, and complete. In the case of information submitted by the APM Entity, we propose that the certification be made by a person with the authority to bind the APM Entity. We also propose that this certification accompany the Eligible Clinician Initiated Submission Form and any supporting documentation that eligible clinicians submit to us through this process. We note that under § 414.1460(c), APM Entities or eligible clinicians may be subject to audit of the information and supporting documentation provided under the certification. In section II.D.6.c.(7)(b) of this rule, we discuss our proposal to add a similar certification requirement at § 414.1440(f)(2) for QP determinations. We note that we propose to remove the last sentence of § 414.1460(c) regarding record retention and address the record retention issue only in the maintenance of records provision at § 414.1460(e).
Finally, we are proposing to clarify the nature of the information subject to the record retention requirements at § 414.1460(e). Specifically, we propose that an APM Entity or eligible clinician must maintain such books, contracts, records, documents, and other evidence as necessary to enable the audit of an Other Payer Advanced APM determination, QP determination, and the accuracy of an APM Incentive Payment.
For both Advanced APMs and Other Payer Advanced APMs, we want to encourage the use of outcome measures for quality performance assessment. We also recognize there is a lack of appropriate outcome measures for use
We intend to post, on a CMS Web site, only the following information about other payer arrangements that we determine are Other Payer Advanced APMs: The names of payers with Other Payer Advanced APMs as specified in either the Payer Initiated or Eligible Clinician Initiated Submission Form, the location(s) in which the Other Payer Advanced APMs are available whether at the nationwide, state, or county level, and the names of the specific Other Payer Advanced APMs.
We believe that making this information publicly available is particularly important for Medicaid APMs and Medicaid Medical Home Models so that eligible clinicians can assess whether their Medicaid payments and patients would be excluded in calculations under the All-Payer Combination Option. More generally, we believe that making this information publicly available would help eligible clinicians to identify which of their other payer arrangements are Other Payer Advanced APMs so they can include information on those Other Payer Advanced APMs in their requests for QP determinations; and to learn about, and potentially join, Other Payer Advanced APMs that may be available to them. We seek comment on whether posting this information would be helpful to APM Entities or eligible clinicians.
In the CY 2017 Quality Payment Program final rule, we finalized that, to the extent permitted by federal law, we would maintain confidentiality of certain information that APM Entities or eligible clinicians submit for purposes of Other Payer Advanced APM determinations to avoid dissemination of potentially sensitive contractual information or trade secrets (81 FR 77478 through 77480).
We propose that, with the exception of the specific information we propose to make publicly available as stated above, the information a payer submits to us through the Payer Initiated Process and the information an APM Entity or eligible clinician submits to us through the Eligible Clinician Initiated Process would be kept confidential to the extent permitted by federal law, in order to avoid dissemination of potentially sensitive contractual information or trade secrets.
We seek comment on this proposal.
In the CY 2017 Quality Payment Program final rule, we finalized that to be an Other Payer Advanced APM, the other payer arrangement must require at least 50 percent of participating eligible clinicians in each APM Entity to use Certified EHR Technology (CEHRT) to document and communicate clinical care (81 FR 77465).
We believe that some other payer arrangements, particularly those for which eligible clinicians may request determinations as Other Payer Advanced APMs, may only require CEHRT use at the individual eligible clinician level in the contract the eligible clinician has with the payer. We also believe that it may be challenging for eligible clinicians to submit information sufficient for us to determine that at least 50 percent of eligible clinicians under the other payer arrangement are required to use CEHRT to document and communicate clinical care.
To address this issue, we propose that we would presume that an other payer arrangement would satisfy the 50 percent CEHRT use criterion if we receive information and documentation from the eligible clinician through the Eligible Clinician Initiated Process showing that the other payer arrangement requires the requesting eligible clinician(s) to use CEHRT to document and communicate clinician information. We seek comment on this proposal. We also seek comment on what kind of requirements for CEHRT currently exist in other payer arrangements, particularly if they are written to apply at the eligible clinician level.
In summary, we are proposing the following:
• We propose to allow certain other payers, including payers with payment arrangements authorized under Title XIX, Medicare Health Plan payment arrangements, and payers with payment arrangements in CMS Multi-Payer Models to request that we determine whether their other payer arrangements are Other Payer Advanced APMs starting prior to the 2019 All-Payer QP Performance Period and each year thereafter. We propose to allow remaining other payers, including commercial and other private payers, to request that we determine whether other payer arrangements are Other Payer Advanced APMs starting in 2019 prior to the 2020 All-Payer QP Performance Period, and annually each year thereafter. We propose to generally refer to this process as the Payer Initiated Other Payer Advanced APM Determination Process (Payer Initiated Process), and we propose that the Payer Initiated Process would generally involve the same steps for each payer type for each All-Payer QP Performance Period. If a payer uses the same other payer arrangement in other commercial lines of business, we propose to allow the payer to concurrently request that we determine whether those other payer arrangements are Other Payer Advanced APMs as well.
• We propose that these Other Payer Advanced APM determinations would be in effect for only one year at a time.
• We propose that the Payer Initiated Process would be voluntary for all payers.
• We propose that payers would be required to use the Payer Initiated Submission Form to request that we make an Other Payer Advanced APM determination. We propose that the Submission Period opening date and Submission Deadline would vary by payer type to align with existing CMS processes for payment arrangements authorized under Title XIX, Medicare Health Plan payment arrangements, and payers with payment arrangements in CMS Multi-Payer Models to the extent possible and appropriate.
• We propose that if we determine that the payer has submitted incomplete or inadequate information, we would inform the payer and allow the payer to submit additional information no later than 10 business days from the date we inform the payer. For each other payer arrangement for which the payer does not submit sufficient information, we
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• We propose that through the Eligible Clinician Initiated Process, APM Entities and eligible clinicians participating in other payer arrangements would have an opportunity to request that we determine for the year whether those other payer arrangements are Other Payer Advanced APMs. The Eligible Clinician Initiated Process could also be used to request determinations before the beginning of an All-Payer Payer QP Performance Period for other payer arrangements authorized under Title XIX.
• We propose that APM Entities or eligible clinicians would be required to use the Eligible Clinician Initiated Submission Form to request that we make an Other Payer Advanced APM determination.
• We propose that if we determine that the APM Entity or eligible clinician has submitted incomplete or inadequate information, we would inform the payer and allow the payer to submit additional information no later than 10 business days from the date we inform the APM Entity or eligible clinician. For each other payer arrangement for which the APM Entity or eligible clinician does not submit sufficient information, we would not make a determination in response to that request submitted via the Eligible Clinician Initiated Submission Form.
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• We propose that, for each other payer arrangement a payer requests us to determine whether it is an Other Payer Advanced APM, all payers must complete and submit the Payer Initiated Submission Form by the relevant Submission Deadline. We propose that the Payer Initiated Submission Form would allow payers to include descriptive language for each of the required information elements. We are proposing to require the name and description of the arrangement, nature of the arrangement, term of the arrangement, eligibility criteria, and location(s) where the arrangement will be available so that we can verify whether eligible clinicians who may tell us that they participate in such arrangements are eligible to do so. We propose to require that payers submit documentation that supports the information they provided in the Payer Initiated Submission Form and that is sufficient to enable us to determine whether the other payer arrangement is an Other Payer Advanced APM.
• We propose that, for each other payer arrangement an APM Entity or eligible clinician requests us to determine whether it is an Other Payer Advanced APM, all payers must complete and submit the Eligible Clinician Initiated Submission Form by the relevant deadline. We propose that the Eligible Clinician Initiated Submission Form would allow APM Entities or eligible clinicians to include descriptive language for each of the required information elements. We are proposing to require the name and description of the arrangement, nature of the arrangement, term of the arrangement, eligibility criteria, and location(s) where the arrangement will be available so that we can verify whether eligible clinicians who may tell us that they participate in such arrangements are eligible to do so. We propose to require that APM Entities or eligible clinicians submit documentation that supports the information they provided in the Eligible Clinician Initiated Submission Form and that is sufficient to enable us to determine whether the other payer arrangement is an Other Payer Advanced APM.
• We propose that, for each other payer arrangement a payer requests us to determine whether it is an Other Payer Advanced APM, the payer must complete and submit the Payer Initiated Submission Form by the relevant deadline.
• We propose that, for each other payer arrangement an APM Entity or eligible clinician requests us to determine whether it is an Other Payer Advanced APM, the APM Entity or eligible clinician must complete and submit the Eligible Clinician Initiated Submission Form by the relevant deadline.
• We propose to add a new requirement at § 414.1445(d) stating that a payer that submits information pursuant to § 414.1445(c) must certify to the best of its knowledge that the information submitted to us through the Payer Initiated Process is true, accurate, and complete. Additionally, we propose that this certification must accompany the Payer Initiated Submission Form and any supporting documentation that payers submit to us through this process.
• We also propose to revise the monitoring and program integrity provisions at § 414.1460 to ensure the integrity of the Payer Initiated Process. Specifically, we are proposing to require payers that choose to submit information through the Payer Initiated Process to maintain such books, contracts, records, documents, and other evidence as necessary to audit an Other Payer Advanced APM determination and that such information and supporting documentation must be maintained for 10 years after submission and must be provided to CMS upon request. We also propose to specify that information submitted by payers for purposes of the All-Payer Combination Option may be subject to audit by CMS.
• We are proposing to remove the requirement at § 414.1445(b)(3) that payers must attest to the accuracy of information submitted by eligible clinicians. We are also proposing to remove the attestation requirement at § 414.1460(c) and add a requirement at § 414.1445(d) that an APM Entity or eligible clinician that submits information pursuant to § 414.1445(c) must certify to the best of its knowledge that the information it submitted to us is true, accurate, and complete. We also propose that this certification must accompany the submission.
• We propose to remove the record retention requirement at § 414.1445(c) and only address the record retention issue at § 414.1445(e) stating that APM Entities and eligible clinicians must maintain such books, contracts, records, documents, and other evidence as necessary to enable the audit of an Other Payer Advanced APM determination, QP determination, and the accuracy of an APM Incentive Payment.
• We propose that, with the exception of the specific information we propose to make publicly available as stated above, the information a payer submits to us through the Payer Initiated Process and the information an APM Entity or eligible clinician submits to us through the Eligible Clinician Initiated Process would be kept confidential to the extent permitted by federal law, in order to avoid dissemination of potentially sensitive contractual information or trade secrets.
• We propose that we would initially presume that an other payer arrangement would satisfy the 50 percent CEHRT use criterion if we receive information and documentation from the APM Entity or eligible clinician through the Eligible Clinician Initiated Process showing that the other payer arrangement requires the requesting eligible clinician(s) to use CEHRT to document and communicate clinical information.
In the CY 2017 Quality Payment Program final rule, we finalized our overall approach to the All-Payer Combination Option (81 FR 77463). Beginning in 2021, in addition to the Medicare Option, an eligible clinician may alternatively become a QP through the All-Payer Combination Option, and an eligible clinician need only meet the QP threshold under one of the two options to be a QP for the payment year (81 FR 77459). We finalized that we will conduct the QP determination sequentially so that the Medicare Option is applied before the All-Payer Combination Option (81 FR 77439).
We finalized that we will calculate Threshold Scores under the Medicare Option through both the payment amount and patient count methods,
Sections 1833(z)(2)(B)(ii)(I) and (C)(ii)(I) of the Act specify that the all payer portion of the Threshold Score calculations under the All-Payer Combination Option is based on the sum of payments for Medicare Part B covered professional services furnished by the eligible clinician and, with certain exceptions, all other payments regardless of payer. We finalized that we would include such payments in the numerator and denominator, and we would exclude the following excepted categories of payments made to the eligible clinician and associated patients from the calculations:
• By the Secretary of Defense;
• By the Secretary of Veterans Affairs; and
• Under Title XIX in a state in which no Medicaid Medical Home Model or APM is available under the state plan.
We finalized this exclusion of payments under Title XIX to mean that Medicaid payments and patients should be excluded from the all-payer calculation under the All-Payer Combination Option, unless:
++ A state has in operation at least one Medicaid APM or Medicaid Medical Home Model that is determined to be an Other Payer Advanced APM; and
++ The relevant APM Entity is eligible to participate in at least one of such Other Payer Advanced APMs during the QP Performance Period, regardless of whether the APM Entity actually participates in such Other Payer Advanced APMs.
In the CY 2017 Quality Payment Program final rule, we finalized that the QP Performance Period for both the Medicare Option and the All-Payer Combination Option would begin on January 1 and end on August 31 of the calendar year that is 2 years prior to the payment year (81 FR 77446–77447).
Upon further consideration, we propose to establish a separate QP Performance Period for the All-Payer Combination Option, which would begin on January 1 and end on June 30 of the calendar year that is 2 years prior to the payment year. We propose to define this term in § 414.1305 as the All-Payer QP Performance Period. The QP Performance Period for the Medicare Option will remain the same as previously finalized, so it would begin on January 1 and end on August 31 of the calendar year that is 2 years to the payment year. We propose to define this term in § 414.1305 as the Medicare QP Performance Period.
We are proposing to establish the All-Payer QP Performance Period because, to make QP determinations under the All-Payer Combination Option, we first need to collect information on eligible clinicians' payments and patients with all other payers. In order to provide eligible clinicians with timely QP determination that would enable them to make their own timely decisions for purposes of MIPS based on their QP status for the year, we need to collect this information by December 1 of the QP performance year. We are concerned that eligible clinicians would not be able to submit the necessary payment and patient information from all of their other payers for the period from January 1 through August 31 before the December 1 Information Submission Deadline. For the Medicare Option, we allow for a 90 day claims run out period before gathering the necessary payment amount and patient count information. We believe the same claims run out timeframe should be adopted for other payers. If we were to maintain the current QP Performance Period through August 31 eligible clinicians would be required to submit their other payer payment and patient information to us on or very near the end of the 90 day claims run out period leaving them with little or no time to prepare the submission. We also believe that an additional 60 days after the claims run out is a reasonable amount of time for the eligible clinician to collect and submit the payment and patient data. We seek comment on this proposal, specifically as to an appropriate claims run out standard for other payers.
If we retained the current QP Performance Period and instead delayed the submission deadline to allow eligible clinicians time comparable to the time provided under the Medicare Option to fully collect and submit this information, QP determinations under the All-Payer Combination Option would likely not be complete before the end of the MIPS reporting period, which would undermine our goal of giving eligible clinicians information about their QP status prior to the end of the MIPS reporting period.
Alternatively, we are considering whether to establish the All-Payer QP Performance Period from January 1 through March 31 of the calendar year that is 2 years prior to the payment year. We believe this option would provide the most ample time possible for eligible clinicians to prepare and submit information to enable us to make a QP determination under the All-Payer Combination Option. In the CY 2017 Quality Payment Program final rule, we finalized a snapshot approach that allows an eligible clinician to attain QP status based on Advanced APM participation from January 1 through March 31 under the Medicare Option. Since QP determinations under the Medicare Option can be based on participation information for January 1 through March 31 of a year, we believe this alternative performance period under the All-Payer Combination Option would not be inconsistent with the policy that we finalized last year, and seek comment on this alternative approach. We seek comments on the establishment of a January 1 through March 31 All-Payer QP Performance Period and whether additional requirements may be needed to ensure the appropriate inplementation of this proposal.
We seek comment on the proposed All-Payer QP Peformance Period from January 1 through June 30 of the year that is 2 years prior to the payment year, and a possible alternative All-Payer QP Performance Period that would be from January 1 through March 31. If we do not finalize the proposed or alternative All-Payer QP Performance Period, we would retain the QP Performance Period that we finalized in the CY 2017 Quality Payment Program final rule, which is from January 1 through August 31 of the calendar year that is 2 years prior to the payment year. We are particularly concerned about the potential delay or run out from other payers that may affect the ability of APM entities or eligible clinicians to gather and submit the necessary payment amount and patient count information for the applicable All-Payer QP Performance Period by the December 1 All-Payer QP Determination Submission Deadline. At the same time, we recognize the need to balance this concern with the benefit of collecting Other Payer Advanced APM participation information over a meaningful period of time. We seek comment on the feasibility or difficulty in gathering and submitting this information for each of the potential performance period time frames.
In the CY 2017 Quality Payment Program final rule, we finalized that we will make QP determinations under the
Consistent with our proposal to make the All-Payer QP Performance Period from January 1 through June 30 of the calendar year that is 2 years prior to the payment year, we propose to make QP determinations based on eligible clinicians' participation in Advanced APMs and Other Payer Advanced APMs between January 1 through March 31 and January 1 through June 30 under the All-Payer Combination Option.
We also propose that an eligible clinician would need to meet the relevant QP or Partial QP Threshold under the All-Payer Combination Option, and we would use data for the same time periods for Medicare payments or patients and that of other payers. For example, we would not assess an eligible clinician under the All-Payer Combination Option using their Advanced APM payment amount and patient count information from January 1 through March 31 and their Other Payer Advanced APM payment amount and patient count information from January 1 through June 30. We are proposing to align the time period assessed for the for the Medicare and other payer portions of the calculations under the All-Payer Combination Option because we believe that would support the principle that QP determinations should be based on an eligible clinician's performance over a single period of time, and that lack of alignment, comingling participation information from multiple time periods for the purposes of making QP determinations, would not appropriately reflect the structure of QP assessment using the All-Payer Combination Option. We seek comment on this proposal.
Our goal, under both the Medicare Option and the All-Payer Combination Option, is to notify eligible clinicians of their QP status at a time that gives any Partial QPs time to decide whether to report to MIPS and gives those eligible clinicians who are not QPs or Partial QPs sufficient notice of the need to report to MIPS. For the All-Payer Combination Option, we also believe it is important to provide eligible clinicians as much information as possible about their QP status under the Medicare Option prior to the proposed All-Payer Information Submission Deadline, as subsequently discussed in section II.D.6.d.(4)(b) of this proposed rule. We therefore propose to inform eligible clinicians of their QP status under the All-Payer Combination Option as soon as practicable after the proposed All-Payer Information Submission Deadline.
In the CY 2017 Quality Payment Program final rule, we finalized that, similar to the Medicare Option, we will calculate the Threshold Scores used to make QP determinations under the All-Payer Combination Option at the APM Entity group level unless certain exceptions apply (81 FR 77478).
Upon further consideration, we propose to make QP determinations under the All-Payer Combination Option at the individual eligible clinician level only. We believe that there will likely be significant challenges associated with making QP determinations under the All-Payer Combination Option at the APM Entity group level as we finalized through rulemaking last year.
As we explained in the CY 2017 Quality Payment Program final rule, an APM Entity faces the risks and rewards of participation in an Advanced APM as a single unit and is responsible for performance metrics that are aggregated to the APM Entity group level as determined by the Advanced APM unless that APM Entity falls under the exception specified in § 414.1425(b)(1) for eligible clinicians on Affiliated Practitioner Lists. Because of this, we believe it is generally preferable to make QP determinations at the APM Entity level unless we are making QP determinations for eligible clinicians identified on Affiliated Practitioner Lists as specified at § 414.1425(b)(1); or we are making QP determinations for eligible clinicians participating in multiple APM Entities, none of which reach the QP Threshold as a group as specified at § 414.1425(c)(4) (81 FR 77439). However, under the All-Payer Combination Option, we believe in many instances that the eligible clinicians in the APM Entity group we would identify and use to make QP determinations under the Medicare Option would likely have little, if any, common group-level participation in Other Payer Advanced APMs. The eligible clinicians in the same APM Entity group would not necessarily have agreed to share risks and rewards for Other Payer Advanced APM participation as an APM Entity group, particularly when eligible clinicians may participate in Other Payer Advanced APMs at different rates within an APM Entity group (or not at all).
Eligible clinicians may participate in Other Payer Advanced APMs whose participants do not completely overlap, or do not overlap at all, with the APM Entity the eligible clinician is part of. Therefore, we believe that looking at participation in Other Payer Advanced APMs at the individual eligible clinician level may be a more meaningful way to assess their participation across multiple payers. In addition, those risks and rewards associated with participation in Other Payer Advanced APMs may vary significantly among eligible clinicians depending on the Other Payer Advanced APMs in which they participate. Specifically, we are concerned that if we were to make All-Payer Combination Option QP determinations at the APM Entity level, the denominator in QP threshold calculations could include all other payments and patients from eligible clinicians who had no, or limited, Other Payer Advanced APM participation, thereby disadvantaging those eligible clinicians who did have significant Other Payer Advanced APM participation. By contrast, this scenario is unlikely to occur when making QP determinations at the APM Entity level under the Medicare Option because all eligible clinicians in the APM Entity group would be contributing to the APM Entity's performance under the Advanced APM. For these reasons, we believe it would be most appropriate to make all QP determinations under the All-Payer Combination Option at the individual eligible clinician level.
We seek comment on this proposal, specifically on the possible extent to which APM Entity groups in Advanced APMs could agree to be assessed collectively for performance in Other Payer Advanced APMs. We also seek comment on whether there is variation, and the extent of that variation, among eligible clinicians within an APM Entity group in their participation in other payer arrangements that we may determine to be Other Payer Advanced APMs We seek comment on whether there are circumstances in which QP determinations should be made at a group level under the All-Payer Combination Option.
If we were to establish a mechanism for making QP determinations at the APM Entity group level, we anticipate that there could be significant challenges in obtaining the information necessary at the APM Entity group level under the All-Payer Combination
To make QP determinations at the APM Entity group level under the All-Payer Combination Option, we would need to collect for each APM Entity group all of the payment amount and patient count information for all eligible clinicians as discussed in section II.D.6.d.(4)(a) of this proposed rule. We anticipate also needing Participation Lists or similar documentation to identify eligible clinicians within each APM Entity group that participate in an Other Payer Advanced APM. We seek comment on whether APM Entities in Other Payer Advanced APMs could report this information at the APM Entity group level to facilitate our ability to make QP determinations at the group level.
We note that when an Affiliated Practitioner List defines the eligible clinicians to be assessed for QP determination in the Advanced APM, we make QP determinations under the Medicare Option at the individual level only. To promote consistency with the Medicare Option where possible, if in response to comments on this proposed rule we adopt a mechanism to make QP determinations under the All-Payer Combination Option at the APM Entity group level, we propose that eligible clinicians who meet the criteria to be assessed individually under the Medicare Option would still be assessed at the individual level only under the All-Payer Combination Option. We seek comment on whether there are alternative approaches to making QP determinations under the All-Payer Combination Option for eligible clinicians who meet the criteria to be assessed individually under the Medicare Option.
Because we are proposing to make QP determinations at the individual eligible clinician level only, we are proposing to use the individual eligible clinician payment amounts and patient counts for the Medicare calculations in the All-Payer Combination Option. We believe that matching the information we use at the same level for all payment amounts and patient counts for both the Medicare and all-payer calculations under the All-Payer Combination Option is most consistent with sections 1833(z)(2)(B)(ii) and (C)(ii) of the Act because these provisions require calculations that add together the payments or patients from Medicare and all other payers (except those excluded). We note however that we would use the APM Entity group level payment amounts and patient counts for all Medicare Option Threshold Scores, unless we are making QP determinations for Affiliated Practitioner Lists as specified at § 414.1425(b)(1) or we are making QP determinations for eligible clinicians participating in multiple APM Entities, none of which reach the QP Threshold as a group as specified at § 414.1425(c)(4) (81 FR 77439).
If we were to use the APM Entity group level payment amounts and patient counts for Medicare and individual eligible clinician payment amounts and patient counts for other payers, we would combine APM Entity group level Medicare information with individual eligible clinician level other payer information. In most instances this would disproportionately underweight the eligible clinicians' activities in Other Payer Advanced APMs relative to their activities in Advanced APMs when calculating Threshold Scores under the All-Payer Combination Option. We do not believe that this underweighting would be consistent with sections 1833(z)(2)(B)(ii) and (c)(11) of the Act.
We recognize that in many cases an individual eligible clinician's Medicare Threshold Scores would likely differ from Threshold Scores calculated at the APM Entity group level, which would benefit those eligible clinicians whose individual Threshold Scores would be higher than the group Threshold Scores and disadvantage those eligible clinicians whose individual Threshold Scores are equal to or lower than the group Threshold Scores. In situations where eligible clinicians are assessed under the Medicare Option as an APM Entity group, and receive a Medicare Threshold Score at the group level, we believe that the Medicare portion of their All-Payer Combination Option should not be lower than the Medicare Threshold Score that they received by participating in an APM Entity group.
To accomplish this outcome, we propose a modified methodology. When the eligible clinician's Medicare Threshold Score calculated at the individual level would be a lower percentage than the one that is calculated at the APM Entity group level we would apply a weighted methodology. This methodology would allow us to apply the APM Entity group level Medicare Threshold Score (if higher than the individual eligible clinician level Medicare Threshold Score), to the eligible clinician, under either the payment amount or patient count method, but weighted to reflect the individual eligible clinician's Medicare volume.
We would multiply the eligible clinician's APM Entity group Medicare Threshold Score by the total Medicare payments or patients made to that eligible clinician as follows:
As an example of how this weighting methodology would apply under the payment amount method for payment year 2021, consider the following APM Entity group with two clinicians, one of whom participates in Other Payer Advanced APMs and one who does not.
In this example, the APM Entity group Medicare Threshold Score is $300/$1000, or 30 percent. Eligible Clinicians A and B would not be QPs under the Medicare Option, but Clinician B could request that we make a QP determination under the All-Payer Combination Option since the APM Entity group exceeded the 25 percent minimum Medicare payment amount threshold under that option.
If we calculate Clinician B's payments individually as proposed, we would calculate the Threshold Score as follows:
Because Clinician B's Threshold Score is less than the 50 percent QP Payment Amount Threshold, Clinician B would not be a QP based on this result. However, if we apply the weighting methodology, we would calculate the Threshold Score as follows:
Based upon this Threshold Score, Clinician B would be a QP under the All-Payer Combination Option.
We would calculate the eligible clinician's Threshold Scores both individually and with this weighted methodology, and then use the most advantageous score when making a QP determination. We believe that this approach promotes consistency between the Medicare Option and the All-Payer Combination Option to the extent possible. We seek comment on this approach.
Sections 1833(z)(2)(B)(ii)(I)(bb) and 1833(z)(2)(C)(ii)(I)(bb) of the Act direct us to exclude payments made under Title XIX in a state where no Medicaid Medical Home Model or Medicaid APM is available under that state program. To carry out this exclusion, in the CY 2017 Quality Payment Final Rule, we finalized that for both the payment amount and patient count methods, Title XIX payments or patients will be excluded from the numerator and denominator for the QP determination unless:
(1) A state has in operation at least one Medicaid APM or Medicaid Medical Home Model that is determined to be an Other Payer Advanced APM; and
(2) The relevant APM Entity is eligible to participate in at least one of such Other Payer Advanced APMs during the QP Performance Period, regardless of whether the APM Entity actually participates in such Other Payer Advanced APMs (81 FR 77475).
For purposes of the discussion below on the exclusion of Title XIX payments and patients in QP determinations, when we refer to Medicaid APMs or Medicaid Medical Home Models, we mean to refer to those that are Other Payer Advanced APMs. We also discussed that if a state operates such an Other Payer Advanced APM at a sub-state level such that eligible clinicians who do not practice in the area are not eligible to participate, Medicaid payments or patients should not be included in those eligible clinicians' QP calculations because no Medicaid Medical Home Model or Medicaid APM was available for their participation (81 FR 77475).
We propose that we will use the county level to determine whether a state operates a Medicaid APM or a Medicaid Medical Home Model at a sub-state level. We believe that the county level is appropriate as in our experience, the county level is the most common geographic unit used by states when creating payment arrangements under Title XIX at the sub-state level. We believe that applying this exclusion at the county level would allow us to carry out this exclusion in accordance with the statute in a way that would not penalize eligible clinicians who have no Medicaid APMs or Medicaid Medical Home Models available to them. We seek comment on this proposal.
We propose that, in states where a Medicaid APM or Medicaid Medical Home Model only exists in certain counties, we would exclude Title XIX data from an eligible clinician's QP calculations unless the county where the eligible clinician saw the most patients during the relevant All-Payer QP Performance Period was a county where a Medicaid APM or Medicaid Medical Home Model determined to be an Other Payer Advanced APM was available. We would require eligible clinicians to identify and certify the county where they saw the most patients during the relevant All-Payer QP Performance Period. If this county is not in a county where a Medicaid APM or Medicaid Medical Home Model was available during the All-Payer QP Performance Period, then Title XIX payments would be excluded from the eligible clinician's QP calculations. We are proposing this approach to ensure that, before including Title XIX payment or patient count information in calculating QP determinations, eligible clinicians have a meaningful opportunity to participate in a Medicaid APM or Medicaid Medical Home Model determined to be an Other Payer Advanced APM in a manner that would allow for both positive and negative contributions to their QP threshold score under the All-Payer Combination Option. We seek comments on this proposal.
As we discuss in section II.D.6.c.(3) of this proposed rule, we need to determine whether there are Medicaid APMs and Medicaid Medical Home Models available in each state prior to end of the All-Payer QP Performance Period in order to properly implement the statutory exclusion of Title XIX payments and patients, which is why we finalized in the CY 2017 Quality Payment Program final rule that we will identify Medicaid APMs and Medicaid Medical Home Models that are Other Payer Advanced APMs prior to the QP Performance Period (81 FR 77478).
In addition to excluding payments based on county-level geography, we propose to exclude Title XIX payments and patients from the QP determination calculation when the only Medicaid APMs and Medicaid Medical Home Models available in a given county are not available to the eligible clinician in question based on their specialty. We believe that this proposal is consistent with the statutory requirement to exclude Title XIX data from the calculations when no Medicaid APM or Medicaid Medical Home Model is available. In cases where participation in such a model is limited to eligible clinicians in certain specialties, we do not believe the Medicaid APM or Medicaid Medical Home Model would effectively be available to eligible
We also wish to clarify that payment arrangements offered by Medicare-Medicaid Plans, operating under the Financial Alignment Initiative for Medicare-Medicaid Enrollees, will not be considered to be either Medicaid APMs or Medicaid Medical Home Models, and that the presence of such payment arrangements in a state will not preclude the exclusion of Title XIX payment and patients in the All-Payer Combination Option calculations for eligible clinicians in that state if no Medicaid APM or Medicaid Medical Home Model is otherwise in operation in the state. Medicare-Medicaid Plans are limited to certain Medicare-Medicaid enrollees, and enter into payment arrangements that do not uniformly segregate Title XVIII and Title XIX funds. As such, payments to eligible clinicians in Medicare-Medicaid plans cannot consistently be attributed to funding under either Title XVIII or XIX. Additionally, given that Medicare is generally the primary payer for services furnished by eligible clinicians to dual Medicare-Medicaid enrollees, any possible segregable Title XIX funding for professional services through these payment arrangements would be de minimus. We do not believe it would be appropriate to consider these payment arrangements exclusively focused on this population as Medicaid APMs or Medicaid Medical Home Models.
In the CY 2017 Quality Payment Program final rule, we finalized that we will calculate an All-Payer Combination Option Threshold Score for eligible clinicians in an APM Entity using the payment amount method (81 FR 77476 through 77477). We finalized that the numerator will be the aggregate of all payments from all payers, except those excluded, to the APM Entity's eligible clinicians, or the eligible clinician in the event of an individual eligible clinician assessment, under the terms of all Other Payer Advanced APMs during the QP Performance Period. We finalized that the denominator will be the aggregate of all payments from all payers, except excluded payments, to the APM Entity's eligible clinicians, or the eligible clinician in the event of an individual eligible clinician assessment during the QP Performance Period.
We finalized that we will calculate the Threshold Score by dividing the numerator value by the denominator value, which will result in a percent value Threshold Score. We will compare that Threshold Score to the finalized QP Payment Amount Threshold and the Partial QP Payment Amount Threshold and determine the QP status of the eligible clinicians for the payment year (81 FR 77475).
We propose to maintain the policies we finalized for the payment amount method as finalized, with some proposed modifications. We propose these changes to facilitate the implementation of the payment amount method while providing eligible clinicians with some flexibility in choosing the timeframe for making QP determinations. To carry out our proposal to make QP determinations at the eligible clinician level only, we propose that the numerator would be the aggregate of all payments from all payers, except those excluded, attributable to the eligible clinician only, under the terms of all Advanced APMs and Other Payer Advanced APMs from either January 1 through March 31 or January 1 through June 30 of the All-Payer QP Performance Period. We also propose that the denominator would be the aggregate of all payments from all payers, except excluded payments, to the eligible clinician from either January 1 through March 31, or January 1 through June 30 of the All-Payer QP Performance Period. We seek comment on this approach.
We finalized that the Threshold Score calculation for the patient count method would include patients for whom the eligible clinicians in an APM Entity furnish services and receive payment under the terms of an Other Payer Advanced APM, except for those that are excluded (81 FR 77477 through 77478). We finalized that the numerator would be the number of unique patients to whom eligible clinicians in the APM Entity furnish services that are included in the aggregate expenditures used under the terms of all their Other Payer Advanced APMs during the QP Performance Period plus the patient count numerator for Advanced APMs (81 FR 77477 through 77478). We finalized that the denominator would be the number of unique patients to whom eligible clinicians in the APM Entity furnish services under all payers, except those excluded (81 FR 77477 through 77478). We finalized that we will calculate the Threshold Score by dividing the numerator value by the denominator value, which will result in a percent value Threshold Score (81 FR 77477 through 77478). We will compare that Threshold Score to the finalized QP Patient Count Threshold and the Partial QP Patient Count Threshold and determine the QP status of the eligible clinicians for the payment year (81 FR 77477 through 77478). We finalized that we would count each unique patient one time in the numerator and one time in the denominator (81 FR 77477 through 77478).
We intend to carry out QP determinations using the patient count method as finalized with some proposed modifications. We propose these changes to facilitate the implementation of the patient count method while providing eligible clinicians with some flexibility in choosing the timeframe for making QP determinations. To carry out our proposal to make QP determinations at the eligible clinician level only, we propose to count each unique patient one time in the numerator and one time in the denominator across all payers to align with our finalized policy for patient counts at the eligible clinician level. We propose that the numerator would be the number of unique patients the eligible clinician furnishes services to under the terms of all of their Advanced APMs or Other Payer Advanced APMs from either January 1 through March 31, or January 1 through June 30 of the All-Payer QP Performance Period. We propose that the denominator would be the number of unique patients the eligible clinician furnishes services to under all payers, except those excluded from either January 1 through March 31, or January 1 through June 30 of the All-Payer QP Performance Period. We seek comment on this approach.
In the CY 2017 Quality Payment Program final rule, we finalized that
In order for us to make QP determinations for an eligible clinician under the All-Payer Combination Option, we need information for all of the Other Payer Advanced APMs in which an eligible clinician participated during the All-Payer QP Performance Period. Eligible clinicians can participate in other payer arrangements that we determine are Other Payer Advanced APMs through the Payer Initiated Process, through the Eligible Clinician Initiated Process, or both. We discuss the submission of information that pertains to Other Payer Advanced APM determinations in section II.D.6.c.(7)(a) of this proposed rule.
In order for us to make QP determinations under the All-Payer Combination Option using either the payment amount or patient count method, we would need to receive all of the payment amount and patient count information: (1) Attributable to the eligible clinician through every Other Payer Advanced APM; and (2) for all other payments or patients, except from excluded payers, made or attributed to the eligible clinician during the All-Payer QP Performance Period. We clarify that eligible clinicians will not need to submit Medicare payment or patient information for QP determinations under the All-Payer Combination Option.
To make calculations for the snapshot dates as proposed in section II.D.6.d.(4)(b) of this proposed rule, we will need this payment amount and patient count information from January 1 through June 30 of the calendar year 2 years prior to the payment year. We will need this payment amount and patient count information submitted in a way that allows us to distinguish information from January 1 through March 31 and from January 1 through June 30 so that we can make QP determinations based on the two snapshot dates as discussed above.
To meet the need for information in a way that we believe minimizes reporting burden, we propose to collect this payment amount and patient count information aggregated for the two proposed snapshot time frames: From January 1 through March 31 and from January 1 through June 30. We seek comment on this approach, particularly as to the feasibility of submitting information in this way and suggestions on how to further minimize reporting burden. Alternatively, if we finalize an All-Payer QP Performance Period of January 1 through March 31, we would need payment amount and patient count information only from January 1 through March 31. If we retain the current finalized QP Performance Period, we would need information aggregated for three snapshot timeframes: From January 1 through March 31, January 1 through June 30, and January 1 through August 31.
As we discuss in section II.D.6.d.(3)(a) of this proposed rule, we are proposing to make QP determinations under the All-Payer Combination Option only at the eligible clinician level. As a result, we propose that all of this payment and patient information must be submitted at the eligible clinician level, and not at the APM Entity group level as we finalized in rulemaking last year.
To minimize reporting burden on individual eligible clinicians and to allow eligible clinicians to submit information to us as efficiently as possible, we propose to allow eligible clinicians to have APM Entities submit this information on behalf of any of the eligible clinicians in the APM Entity group at the individual eligible clinician level. We seek comments on these proposals, particularly regarding the feasibility of APM Entities reporting this information for some or all of the eligible clinicians in the APM Entity group.
Additionally, we propose that if an APM Entity or eligible clinician submits sufficient information only for the payment amount or patient count method, but not for both, we will make a QP determination based on the one method for which we receive sufficient information. We believe that this proposal is consistent with our overall approach, particularly because we have finalized that we will use the more advantageous of the Threshold Scores to make QP determinations (81 FR 77475). We clarify that APM Entities or eligible clinicians can submit information to allow us to use both the payment amount and patient count methods.
To facilitate and ease burden for information submissions, we also propose to create a form that APM Entities or eligible clinicians would be able to use to submit this payment amount and patient count information. APM Entities and eligible clinicians would be required to use this form for submitting the payment and patient information.
We seek comment on these proposals.
We propose that APM Entities or eligible clinicians must submit all of the required information about the Other Payer Advanced APMs in which they participate, including those for which there is a pending request for an Other Payer Advanced APM determination, as well as the payment amount and patient count information sufficient for us to make QP determinations by December 1 of the calendar year that is 2 years to prior to the payment year, which we refer to as the QP Determination Submission Deadline.
We believe that December 1 is the latest date in the year that we could receive information, and be able to complete QP determinations and notify eligible clinicians of their QP status in time for them to report to MIPS as needed. We also proposed this date for the QP Determination Submission Deadline to provide eligible clinicians requesting QP determinations under the All-Payer Combination Option as much time as possible to gather and submit information.
In the CY 2017 Quality Payment Program final rule, we finalized that without sufficient information we will not make QP determinations under the All-Payer Combination Option (81 FR 77480). As such, we will not make QP determinations for an eligible clinician under the All-Payer Combination Option if we do not receive information sufficient to make a QP determination under either the payment amount or patient count method by the QP Determination Submission Deadline.
We seek comment on these proposals.
We propose that a new requirement be added at § 414.1440(f)(2) stating that the APM Entity or eligible clinician that submits information to request a QP
We propose to revise the monitoring and program integrity provisions at § 414.1460 to further promote the integrity of the All-Payer Combination Option. In the CY 2017 Quality Payment Program final rule, we finalized at § 414.1460(e) that an APM Entity or eligible clinician that submits information to us under § 414.1445 for assessment under the All-Payer Combination Option must maintain such books contracts records, documents, and other evidence for a period of 10 years from the final date of the QP Performance Period or from the date of completion of any audit, evaluation, or inspection, whichever is later (81 FR 77555). We also finalized at § 414.1460(c) that eligible clinicians and APM Entities must maintain copies of any supporting documentation related to the All-Payer Combination Option for at least 10 years (81 FR 77555). We propose to revise § 414.1460(e) to apply to information submitted to us under § 414.1440 for QP determinations. We also propose to add paragraph (3) to § 414.1460(e) stating that an APM Entity or eligible clinician who submits information to us under § 414.1445 or § 414.1440 must provide such information and supporting documentation to us upon request. We seek comments on these proposals.
In the CY 2017 Quality Payment Program final rule, we finalized that, to the extent permitted by federal law, we will maintain confidentiality of the information and data that APM Entities and eligible clinicians submit to support Other Payer Advanced APM determinations in order to avoid dissemination of potentially sensitive contractual information or trade secrets (81 FR 77479 through 77480).
We believe that it is similarly appropriate for us to maintain the confidentiality of information submitted to us for the purposes of QP determinations to the extent permitted by federal law. Therefore, we propose that, to the extent permitted by federal law, we will maintain confidentiality of the information that APM Entities or eligible clinicians submit to us for purposes of QP determinations under the All-Payer Combination Option, in order to avoid dissemination of potentially sensitive contractual information or trade secrets.
In Tables 56 and 57, we provide examples where an eligible clinician is in a Medicare ACO Model that we have determined to be an Advanced APM, a commercial ACO arrangement, and a Medicaid APM from January 1 through June 30, 2019. We would use the information below to determine that eligible clinician's QP status for payment year 2021.
We would calculate the Threshold Scores for the APM Entity group in the Advanced APM under the Medicare Option. For the payment amount method, as shown in Table 56, the APM Entity group would not attain QP status under the Medicare Option, which for payment year 2021 requires a QP payment amount Threshold Score of 50 percent. The APM Entity group would also fail to attain Partial QP status under the Medicare Option, which for payment year 2021 requires a Partial QP payment amount Threshold Score of 40 percent. For the patient count method, as shown in Table 57, the APM Entity group would not attain QP status under the Medicare Option, which for payment year 2021 requires a QP patient count Threshold Score of 35 percent. The APM Entity group would not attain Partial QP status under the Medicare Option, which for payment year 2021 requires a Partial QP patient count Threshold Score of 25 percent.
The APM Entity group did not attain QP or Partial QP status under either the payment amount or patient count method under the Medicare Option. However, because under both methods of calculation, the APM Entity group meets or exceeds the required Medicare threshold for the year under the All-Payer Combination Option of 25 percent and 20 percent, respectively, eligible clinicians within the APM Entity group would be eligible to obtain QP status through the All-Payer Combination Option. The eligible clinicians in the APM Entity group would have been notified of this as we share information on a regular basis on their QP status under each snapshot. For payment year 2021, the eligible clinicians in this APM Entity group would submit their payment amount or patient count data from all payers to calculate their Threshold Score under the All-Payer Combination Option.
In this example, the eligible clinician score exceeds the QP payment amount Threshold under the All-Payer Combination Option, which for payment year 2021 is 50 percent, but the eligible clinician only exceeds the Partial QP patient count Threshold under the All-Payer Combination Option, which for payment year 2021 is 40 percent. We would use the more advantageous score, so the eligible clinician would be a QP for payment year 2021.
Alternatively, if we were to use the APM Entity weighted methodology for calculation of a Threshold Score using the payment amount method as described in section II.D.6.d.(3)(d) of this proposed rule, we would apply the weighting methodology as follows:
The eligible clinician would obtain a Threshold Score of 58 percent. This would be slightly below the Threshold Score obtained from the individual eligible clinician payment count calculation, but it would still exceed the QP payment amount Threshold of 50 percent under the All-Payer Combination Option. Based upon this Threshold Score, the eligible clinician would be a QP under the All-Payer Combination Option.
In the 2017 Quality Payment Program final rule, we finalized under the Medicare Option that, in the cases where the QP determination is made at the individual eligible clinician level, if the eligible clinician is determined to be a Partial QP, the eligible clinician will make the election whether to report to MIPS and then be subject to MIPS reporting requirements and payment adjustments (81 FR 77449). To promote alignment with the Medicare Option and to simplify requirements when possible, we propose that eligible clinicians who are Partial QPs for the year under the All-Payer Combination Option would make the election whether to report to MIPS and then be subject to MIPS reporting requirements and payment adjustments. We seek comment on this approach.
To summarize, we are proposing the following:
• We propose to establish the All-Payer QP Performance Period, which would begin on January 1 and end on June 30 of the calendar year that is 2 years prior to the payment year.
• We propose to make QP determinations based on eligible clinicians' participation in Advanced APMs and Other Payer Advanced APMs for two time periods: Between January 1 through March 31 and between January 1 through June 30 of the All-Payer QP Performance Period under the All-Payer Combination Option. We propose to use data for the same time periods for Medicare payments or patients and that of other payers. We also propose the eligible clinicians must request QP determinations under the All-Payer Combination Option and must submit to CMS payment amount and patient count data from other payers to support the determination.
• We propose to notify eligible clinicians of their QP status under the All-Payer Combination Option as soon as practicable after the proposed QP Determination Submission Deadline.
• We propose to make QP determinations under the All-Payer Combination Option at the individual eligible clinician level only.
• We propose to use the individual eligible clinician payment amounts and patient counts for Medicare in the All-
• We propose that we will determine whether a state operates a Medicaid APM or a Medicaid Medical Home Model that has been determined to be an Other Payer Advanced APM at a sub-state level. We propose that we will use the county level to determine whether a state operates a Medicaid APM or a Medicaid Medical Home Model an Other Payer Advanced APM at a sub-state level.
• We propose that in a state where we determine there are one or more Medicaid APMs or Medicaid Medical Home Models that are Other Payer Advanced APMs in operation, but only in certain counties, or only for eligible clinicians in certain specialties, we would further evaluate whether those Medicaid APMs or Medicaid Medical Home Models were available to each eligible clinician for whom we make a QP determination under the All-Payer Combination Option. We would identify the county in which the eligible clinician practices by having the eligible clinician submit that information to identify the county where they saw the most patients during the relevant All-Payer QP Performance Period when they request a QP determination. We also propose that if the eligible clinician's practice is in a county, or in a specialty, in which there is no Medicaid APM or Medicaid Medical Home Model in operation, all of that eligible clinician's Medicaid payments and patients would be excluded from the numerator and denominator of the calculations under the payment amount or patient count method, respectively. We also propose to identify Medicaid APM or Medicaid Medical Home Models that are only open to certain specialties through questions asked of states in the Payer Initiated Process and of eligible clinicians in the Eligible Clinician Initiated Process. We would use the method generally used in the Quality Payment Program to identify an eligible clinician's specialty or specialties.
• For the payment amount method we would first make a calculation under the Medicare Option using all Medicare payments for the APM Entity. If the minimum threshold score for the Medicare Option were met, we would make calculations under the All-Payer Combination Option. We propose that under the All-Payer Combination Option the numerator would be the aggregate of all payments from all payers, except those excluded, that are made or attributable to the eligible clinician, under the terms of all Advanced APMs and Other Payer Advanced APMs. We also propose that the denominator would be the aggregate of all payments from all payers, except those excluded, that are made or attributed to the eligible clinician.
• For the patient count method under the All-Payer Combination Option, we propose to count each unique patient one time in the numerator and one time in the denominator across all payers to align with our finalized policy for patient counts at the eligible clinician level. We propose that the numerator would be the number of unique patients the eligible clinician furnishes services to under the terms of all of their Advanced APMs or Other Payer Advanced APMs. We propose that the denominator would be the number of unique patients the eligible clinician furnishes services to under all payers, except those excluded.
• We propose to collect the necessary payment amount and patient count information for QP determinations under the All-Payer Combination Option aggregated for the two proposed snapshot timeframes: From January 1 through March 31 and from January 1 through June 30. We propose that APM Entities may submit this information on behalf of any of the eligible clinicians in the APM Entity group at the individual eligible clinician level.
• We propose that if an APM Entity or eligible clinician submits sufficient information for either the payment amount or patient count method, but not for both, we will make a QP determination based on the one method for which we receive sufficient information.
• We propose that APM Entities or eligible clinicians must submit all of the required information about the Other Payer Advanced APMs in which they participate, including those for which there is a pending request for an Other Payer Advanced APM determination, as well as the payment amount and patient count information sufficient for us to make QP determinations by December 1 of the calendar year that is 2 years to prior to the payment year, which we refer to as the QP Determination Submission Deadline.
• We propose that an APM Entity or eligible clinician who submits information to request a QP determination under the All-Payer Combination Option must certify to the best of its knowledge that the information submitted is true, accurate and complete. In the case of information submitted by the APM Entity, we propose that the certification be made by an executive of the APM Entity. We also propose that this certification must accompany the form that APM Entities or eligible clinicians submit to us when requesting that we make QP determinations under the All-Payer Combination Option.
• We propose that APM Entities and eligible clinicians that submit information to CMS under § 414.1445 for assessment under the All-Payer Combination Option or § 414.1440 for QP determinations must maintain such books, contracts, records, documents, and other evidence as necessary to enable the audit of an Other Payer Advanced APM determination, QP determinations, and the accuracy of APM Incentive Payments for a period of 10 years from the end of the All-Payer QP Performance Period or from the date of completion of any audit, evaluation, or inspection, whichever is later.
• We propose that APM Entities and eligible clinicians that submit information to us under § 414.1445 or § 414.1440 must provide such information and supporting documentation to us upon request.
• We propose that, to the extent permitted by federal law, we will maintain confidentiality of the information that an APM Entity or eligible clinician submits to us for purposes of QP determinations under the All-Payer Combination Option, to avoid dissemination of potentially sensitive contractual information or trade secrets.
• We propose that eligible clinicians who are Partial QPs for the year under the All-Payer Combination Option would make the election whether to report to MIPS and then be subject to MIPS reporting requirements and payment adjustments.
We seek comment on these proposals.
Section 1868(c) of the Act established an innovative process for individuals and stakeholder entities (stakeholders) to propose physician-focused payment models (PFPMs) to the Physician-Focused Payment Model Technical Advisory Committee (PTAC). The PTAC, established under section 1868(c)(1)(A) of the Act, is a federal advisory committee comprised of 11 members that provides advice to the Secretary. A copy of the PTAC's charter, established on January 5, 2016, is available at
Section 1868(c)(2)(C) of the Act requires the PTAC to review stakeholders' proposed PFPMs, prepare comments and recommendations regarding whether such proposed PFPMs meet the PFPM criteria established by the Secretary, and submit those comments and recommendations to the Secretary. Section 1868(c)(2)(D) of the Act requires the Secretary to review the PTAC's comments and recommendations on proposed PFPMs and to post “a detailed response” to those comments and recommendations on the CMS Web site.
In the CY 2017 Quality Payment Program final rule (81 FR 77555), we defined PFPM at § 414.1465 as an Alternative Payment Model in which: Medicare is a payer; eligible clinicians that are eligible professionals as defined in section 1848(k)(3)(B) of the Act are participants and play a core role in implementing the APM's payment methodology; and the APM targets the quality and costs of services that eligible clinicians participating in the Alternative Payment Model provide, order, or can significantly influence.
In the CY 2017 Quality Payment Program final rule (81 FR 77496) we finalized the requirement that PFPMs be tested as APMs with Medicare as a payer. We stated that a PFPM could include other payers in addition to Medicare, but that other payer arrangements and Other Payer Advanced APMs are not PFPMs. Therefore, PFPM proposals would need to include Medicare as a payer.
In this proposed rule, we seek comment on whether to broaden the definition of PFPM to include payment arrangements that involve Medicaid or the Children's Health Insurance Program (CHIP) as a payer, even if Medicare is not included as a payer. A PFPM would then include Medicaid, CHIP, or Medicare (or some combination of these) as a payer. A PFPM might still include other payers in addition to Medicaid, CHIP, or Medicare; however, an other payer arrangement or Other Payer Advanced APM that includes only private payers, including a Medicare Advantage plan, would not be a PFPM. Medicare Advantage and other private plans paid to act as insurers on the Medicare program's behalf are considered to be private payers. The inclusion of Medicaid or CHIP as a payer would not imply the waiver of any requirements under Title XIX or Title XXI; PFPMs with Medicaid or CHIP as a payer would be required to follow all applicable regulations and requirements relevant to the approach they propose except those for which waivers are expressly provided under the terms of the PFPM in the event, and at the time, that the PFPM is implemented.
We believe broadening the definition of PFPM to include payment arrangements with Medicaid and CHIP, even if Medicare is not included in the payment arrangement, may complement the policies we are proposing within this rule for the All-Payer Combination Option. Broadening the definition of PFPM could potentially provide an opportunity for stakeholders to propose PFPMs to the PTAC that could be Other Payer Advanced APMs, and participation in such Other Payer Advanced APMs would contribute to an eligible clinician's ability to become a QP through the All-Payer Combination Option.
The PTAC's charge is to review submitted proposals and provide comments and recommendations to the Secretary regarding whether the proposals meet the PFPM criteria established by the Secretary. The Secretary is then charged with reviewing and posting on the CMS Web site a detailed response to the PTAC's comments and recommendations.
Because the Secretary does not have authority to direct the design or development of payment arrangements that might be tested with private payers, we seek comment on, if we were to broaden the definition of PFPM, including in the scope of PFPMs only payment arrangements or models for which the Secretary and CMS could take subsequent action following the statutory PTAC review process.
We seek comment on whether broadening the definition of PFPMs would be inclusive of potential PFPMs that could focus on areas not generally applicable to the Medicare population, such as pediatric issues or maternal health and whether changing the definition of PFPM may engage more stakeholders in designing PFPMs that include more populations beyond Medicare FFS beneficiaries. We seek comment on how the PFPM criteria could be applied to these payment arrangements. We seek comment on whether including more issues and populations fits within the PTAC's charge and whether stakeholders are interested in the opportunity to allow the PTAC to apply its expertise to a broader range of proposals for PFPMs.
The current definition of PFPM specifies that a PFPM is an APM. In the CY 2017 Quality Payment Program final rule (81 FR 77406), we noted that APM is defined under section 1833(z)(3)(C) of the Act as any of the following: (1) A model under section 1115A of the Act (other than a health care innovation award); (2) the Shared Savings Program under section 1899 of the Act; (3) a demonstration under section 1866C of the Act; or (4) a demonstration required by federal law. If a payment arrangement is a PFPM it must also be an APM. Under our current regulation, a model that does not meet the definition of APM is not a PFPM. However, a payment arrangement with Medicaid or CHIP as the payer, but not Medicare, would not necessarily meet the definition of APM. Therefore, we seek comment on whether we should, in tandem with potentially broadening the scope of PFPMs to include payment arrangements with Medicaid and CHIP, require that a PFPM be an APM or a payment arrangement operated under legal authority for Medicaid or CHIP payment arrangements.
In the CY 2017 Quality Payment Program final rule (81 FR 77494), we stated that we anticipate PFPMs that are recommended by the PTAC and tested by CMS will be tested using section 1115A authority, although a model or payment arrangement does not need to be tested under section 1115A of the Act to be a PFPM. APMs tested under sections 1115A or 1866C of the Act, or demonstrations required by federal law, may include Medicaid or CHIP, but not necessarily Medicare, as a payer. We believe that because Medicaid and CHIP payment arrangements may be operated under other legal authorities than those included in the definition of APM, such as section 1115(a) waivers, section 1915(b) and (c) waivers, and state plan amendments, we may need to consider broadening the PFPM definition beyond APMs to correspond with potentially including Medicaid or CHIP as the only payer. We note that were our policy to change, PFPMs that are Medicaid or CHIP payment arrangements that fall outside the definition of APM would need to follow the processes and meet the requirements associated with the legal authorities on which they are based.
We believe it is important for PFPMs to include innovative payment methodologies. For that reason, we continue to believe that the definition of PFPM, as well as the PFPM criteria we established through rulemaking should apply exclusively to payment arrangements, and not to arrangements focused on care delivery reform without a payment reform component. We believe there are various statutory authorities outside of those specified in the definition of APM that might allow
Section 1868(c) of the Act does not require PFPMs to meet the criteria to be an Advanced APM for purposes of the incentives for participation in Advanced APMs under section 1833(z) of the Act, and we did not define PFPMs solely as Advanced APMs. Stakeholders may therefore propose as PFPMs either Advanced APMs or Medical Home Models, or other APMs. If we were to broaden the definition to include payment arrangements with Medicaid or CHIP but not Medicare as a payer, stakeholders could propose as PFPMs Medicaid APMs, Medicaid Medical Home Models, or other payer arrangements involving Medicaid or CHIP as a payer. We recognize that both stakeholders and the PTAC may want to discuss whether a proposed PFPM would be an Advanced APM in their proposals, comments, and recommendations.
In the CY 2017 Quality Payment Program final rule (81 FR 77491 through 77492), we described the roles of the Secretary, the PTAC, and CMS as they relate to PFPMs and the PTAC's review process. We believe that expanding the definition of PFPM to include Medicaid or CHIP as a payer, even when Medicare is not involved, might encourage innovation in additional areas and that stakeholders and states may benefit from the PTAC's review process.
We intend to continue to give serious consideration to proposed PFPMs recommended by the PTAC. Section 1868(c) of the Act does not require us to test proposals that are recommended by the PTAC. In the CY 2017 Quality Payment Program final rule (81 FR 77491), we explained that without being able to predict the volume, quality, or appropriateness of the proposed PFPMs on which the PTAC will make comments and recommendations, we are not in a position to commit to test all such models. We continue to believe this is the case. In addition, we acknowledge that any PFPMs with Medicaid or CHIP as a payer, as we are seeking comment on, could not be tested without significant coordination and cooperation with the state(s) involved. We could not ensure the agreement of the state(s) for which a PFPM is proposed with Medicaid or CHIP as a payer, and therefore, similar to models with Medicare as the payer, we could not commit to testing these proposed payment arrangements. The Secretary and CMS must retain the ability to make final decisions on which PFPMs, whether they include Medicare as a payer or only include Medicaid or CHIP, are tested using section 1115A or section 1866C authority, and if so, when they are tested. Proposed PFPMs that the PTAC recommends to the Secretary but that are not immediately tested by us may be considered for testing at a later time.
We also could not speak to the length of time it would take a state to implement a PFPM with Medicaid or CHIP as a payer, or whether it would be shorter than the normal process for implementing a payment arrangement using Title XIX, Title XXI, or any other relevant legal authority.
The decision to test a model recommended by the PTAC that includes Medicare, Medicaid, or CHIP as a payer and is tested under section 1115A authority would not require submission of a second proposal to us; we would review the proposal submitted to the PTAC along with comments from the PTAC and the Secretary, and any other resources we believe would be useful. In order to further evaluate or proceed to test a proposed PFPM based on a recommendation from the PTAC under section 1115A authority, we may seek to obtain additional information based on the contents of the proposal. After a PFPM proposal has been recommended by the PTAC, if it is selected for further evaluation or testing under section 1115A authority, we may work with the individual stakeholders who submitted their proposals to consider design elements for testing the PFPM and make changes as necessary, to the extent that we are involved in the design and testing or operation of the PFPM. We note that if a PFPM we select for testing under section 1115A authority requires those interested to apply in order to participate, the stakeholder who submitted the proposal for a model to be established would still have to apply in order to participate in that model. PFPMs with Medicaid or CHIP as a payer operated under legal authority other than 1115A would need to meet the requirements for that legal authority.
We believe that proposed PFPMs that include Medicare as a payer and that meet all of the PFPM criteria and are recommended by the PTAC may need less time to go through the development process; however, we cannot guarantee that the development process would be shortened, or estimate by how much it would be shortened. These processes depend on the nature of the PFPM's design, and any attempt to impose a deadline on them would not benefit stakeholders because it would not allow us to tailor the review and development process to the needs of the proposed PFPM. We could not speak to the length of time it would take a state to implement a PFPM with Medicaid or CHIP as a payer, or whether it would be shorter than the normal process. This would be true for Medicaid or CHIP payment arrangements tested using any legal authorities.
In the CY 2017 Quality Payment Program final rule (81 FR 77496), we finalized the Secretary's criteria for PFPMs as required by section 1868(c)(2)(A) of the Act. The PFPM criteria are for the PTAC's use in discharging its duties under section 1868(c)(2)(C) of the Act to make comments and recommendations to the Secretary on proposed PFPMs.
We seek comment on the Secretary's criteria, including, but not limited to, whether the criteria are appropriate for evaluating PFPM proposals and are clearly articulated. In addition, we seek comment on stakeholders' needs in developing PFPM proposals that meet the Secretary's criteria. In particular, we want to know whether stakeholders believe there is sufficient guidance available on what constitutes a PFPM, the relationship between PFPMs, APMs, and Advanced APMs; and on how to access data, or how to gather supporting evidence for a PFPM proposal.
In summary, we seek comment on changing the definition of PFPM to include payment arrangements with Medicare, Medicaid or CHIP, or any combination of these, as a payer; and we seek comment on revising the definition to require that a PFPM be an APM or a payment arrangement operated under legal authority for Medicaid or CHIP payment arrangements. We also seek comments on the Secretary's criteria more broadly and stakeholders' needs in developing PFPM proposals that meet the Secretary's criteria.
Under the Paperwork Reduction Act of 1995 (PRA), we are required to publish a 60-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our burden estimates.
• The quality, utility, and clarity of the information to be collected.
• Our effort to minimize the information collection burden on the affected public, including the use of automated collection techniques.
We are soliciting public comment on each of the required issues under section 3506(c)(2)(A) of the PRA for the following information collection requirements (ICRs).
The Quality Payment Program aims to do the following: (1) Support care improvement by focusing on better outcomes for patients, decreased clinician burden, and preservation of independent clinical practice; (2) promote adoption of alternative payment models that align incentives across healthcare stakeholders; and (3) advance existing delivery system reform efforts, including ensuring a smooth transition to a healthcare system that promotes high-value, efficient care through unification of CMS legacy programs.
The CY 2017 Quality Payment Program final rule established policies to implement MIPS, a program for certain eligible clinicians that makes Medicare payment adjustments based on performance on quality, cost and other measures and activities, and that consolidates components of three precursor programs—the PQRS, the VM, and the Medicare EHR Incentive Program for eligible professionals. As prescribed by MACRA, MIPS focuses on the following: Quality—including a set of evidence-based, specialty-specific standards; cost; practice-based improvement activities; and use of CEHRT to support interoperability and advanced quality objectives in a single, cohesive program that avoids redundancies.
In the CY 2017 Quality Payment Program final rule, we estimated a reduction in burden hours of 1,066,658 and reduction of burden costs of $7.4 million relative to the legacy programs it replaced (81 FR 77513). The total existing burden for the previously approved information collections related to the CY 2017 Quality Payment Program final rule was approximately 11 million hours and a total labor cost of reporting of $1.311 million. The streamlining and simplification of data submission structures in the transition year resulted in a reduction in burden relative to the approved information collections for the legacy programs (PQRS and EHR Incentive Program for Eligible Professionals), which represented approximately 12 million hours for a total labor cost of reporting of $1.318 million. We estimate that the policies proposed in this rule would result in further reduction of 132,620 burden hours and a further reduction in burden cost of $12.4 million relative to a baseline of continuing the policies in the CY 2017 Quality Payment Program final rule. The Quality Payment Program Year 2 reduction in burden based on this rule reflects several proposed policies, including our proposal for significant hardship or other type of exception, including a new significant hardship exception for small practices for the advancing care information performance category; our proposal to use a shorter version of the CAHPS for MIPS survey; our proposal to allow election of facility-based measurement for applicable MIPS eligible clinicians, thereby eliminating the need for additional quality data submission processes; and our proposal to allow MIPS eligible clinicians to form virtual groups which would create efficiencies in data submission.
In addition to the decline in burden due to the policies proposed in this rule, we anticipate further reduction in burden as a result of policies set forth in the CY 2017 Quality Payment Program final rule, including greater clinician familiarity with the measures and data submission methods set in their second year of participation, operational improvements streamlining registration and data submission, and continued growth in the number of QPs that are excluded from MIPS. This expected growth is due in part to reopening of CPC+ and Next Generation ACO for 2018, and the ACO Track 1+ which is projected to have a large number of participants, with a large majority reaching QP status. We estimate that there will be between 180,000 and 245,000 eligible clinicians that will become QPs for the 2018 performance period compared to 110,159 eligible clinicians that are estimated to become QPs during the 2017 performance period, an increase of between 69,841 and 134,841. This expected growth is due in part to reopening of CPC+ and Next Generation ACO for 2018, and the ACO Track 1+ in response to public comments. These models are projected to have a large number of participants, the majority of whom are expected to reach QP status. Additional enrollees in currently active and new Advanced APMs are both considered in the growth estimate.
Our estimates assume clinicians who participated in the 2015 PQRS and who are not QPs in Advanced APMs in the 2017 Quality Payment Program performance period will continue to submit quality data as either MIPS eligible clinicians or voluntary reporters in the 2018 Quality Payment Program performance period. Our participation estimates are reflected in Table 65 for the quality performance category, Table 76 for the advancing information performance category, and Table 78 for the improvement activities performance category. We estimate that 36 percent of the 975,723 ineligible or excluded clinicians are expected to report voluntarily because they reported under PQRS. We expect them to continue to submit because (a) the collection and submission of quality data has been integrated into their clinician practice; and (b) the clinician types that were ineligible from MIPS in years 1 and 2 may potentially become eligible in the future.
We also assume that previous PQRS participants who are not QPs will also submit under the improvement activities performance category, and will submit under the advancing care information performance category unless they receive a significant hardship or other type of exception, including a new significant hardship exception for small practices or are automatically assigned a weighting of zero percent for the advancing care information performance category. We are excluding the 110,159 QPs identified using a preliminary version of the file used for predictive qualifying Alternative Payment Model participants analysis made available on
Our burden estimates assume that 36 percent of clinicians who do not exceed the low- volume threshold or are not eligible clinician types will voluntarily submit quality data under MIPS because they submitted quality data under the PQRS. Hence, the proposed changes in low-volume threshold will increase our estimate of the proportion of clinicians who will submit data voluntarily, but will not affect the estimated number of respondents. Section II.C.2.c. of this rule proposes a low-volume threshold of less than or equal to $90,000 in allowed Medicare Part B charges or less than or equal to 200 Medicare patients. The CY 2017 Quality Payment Program final rule established a low-volume threshold of less than or equal to $30,000 in allowed Medicare Part B charges or less than or equal to 100 Medicare patients.
The revised MIPS requirements and burden estimates for all ICRs listed below (except for CAHPS for MIPS and virtual groups election) were submitted as a request for revision of OMB control number 0938–1314. The CAHPS for MIPS ICR was submitted as a request for revision of OMB control number 0938–1222. The virtual groups ICR has a 60 data day
To derive wage estimates, we used data from the U.S. Bureau of Labor Statistics' (BLS) May 2016 National Occupational Employment and Wage Estimates for all salary estimates (
As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, there is no practical alternative, and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method. We have selected the occupations in Table 58 based on a study (Casalino et al., 2016) that collected data on the staff in physician's offices involved in the quality data submission process.
In addition, to calculate time costs for beneficiaries who elect to complete the CAHPS for MIPS survey, we have used wage estimates for Civilian, All Occupations, using the same BLS data discussed in this section of the proposed rule. We have not adjusted these costs for fringe benefits and overhead because direct wage costs represent the “opportunity cost” to beneficiaries themselves for time spent completing the survey. To calculate time costs for virtual groups to prepare their written formal agreements, we have used wage estimates for Legal Support Workers, All Others.
Because of the wide range of information collection requirements under MIPS, Table 59 presents a framework for understanding how the organizations permitted or required to submit data on behalf of clinicians varies across the types of data, and whether the clinician is a MIPS eligible clinician, MIPS APM participant, or an Advanced APM participant. As shown in the first row of Table 59, MIPS eligible clinicians that are not in MIPS APMs and other clinicians voluntarily submitting data will submit data either as individuals, groups, or virtual groups to the quality, advancing care information, and improvement activities performance categories. For MIPS APMs, the organizations submitting data on behalf of participating MIPS eligible clinicians will vary across categories of data, and in some instances across APMs. For the 2018 MIPS performance period, the quality data submitted by Shared Savings Program ACOs, Next Generation ACOs, and Other MIPS APMs on behalf of their participant eligible clinicians will fulfill any MIPS submission requirements for the quality performance category.
For the advancing care information performance category, billing TINs will submit data on behalf of participants who are MIPS eligible clinicians. For the improvement activities performance category, we will assume no reporting burden for MIPS APM participants because we will assign the improvement activities performance category score at the MIPS APM level and all APM Entity groups in the same MIPS APM will receive the same score. Advanced APM participants who are determined to be Partial QPs may incur additional burden if they elect to participate in MIPS, which is discussed in more detail in section II.D.5. of this proposed rule.
The policies finalized in the CY 2017 Quality Payment Program final rule and proposed in this rule create some additional data collection requirements
• Self-nomination of new and returning QCDRs and registries (0938–1314).
• CAHPS for MIPS survey completion by beneficiaries (0938–1222).
• Approval process for new and returning CAHPS for MIPS survey vendors.
• Call for new improvement activities.
• Other Payer Advanced APM identification: other payer initiated process.
• Opt out of performance data display on Physician Compare for voluntary reporters under MIPS.
As described in section II.C.4.b. of this proposed rule, virtual groups are defined by a combination of two or more TINs and must report as a virtual group on measures in all quality, improvement activities, and advancing care information performance categories as virtual groups. Virtual groups may submit data through any of the mechanisms available to groups. We refer to section II.C.4. on additional requirements for virtual groups.
We propose an optional 2-stage process for enrollment. In stage 1, MIPS eligible clinicians have the option to request a determination of their eligibility to form a virtual group before they form a group and begin the stage 2 submission of an election to participate in a virtual group. For clinicians or groups that do not choose to participate in stage 1 of the election process, we will make an eligibility determination during stage 2 of the election process. We refer readers to section II.C.4.e. of this proposed rule for a discussion of the proposed virtual group election process.
As proposed in II.C.4.e. of this proposed rule, the submission of a virtual group election must include, at a minimum, detailed information pertaining to each TIN and NPI associated with the virtual group and detailed information for the virtual group representative, as well as confirmation of a written formal agreement between members of the virtual group.
We assume that virtual group participation will be relatively low in the first year because we have heard from stakeholders that they need at least 3–6 months to form groups and establish agreements before signing up. We are not able to give them that much time in the first year, rather closer to 60 days. Because of this we expect the number of virtual groups will be very small in the first year of virtual group implementation. Our assumptions for participation in a virtual group are shown in Table 60. We assume that only those eligible clinicians that reported historically will participate in virtual groups in the first year because of the limited lead time to create processes. Also, while virtual groups may use the same submission mechanisms as groups, we are estimating based on stakeholder feedback that the 16 virtual groups reflected in Table 60 will report by registry. Table 60 also shows that we estimate that approximately 765 MIPS eligible clinicians will decide to join 16 virtual groups for the 2018 MIPS performance period. The virtual groups could range in size from a few clinicians to hundreds of clinicians, as long as each participant is a solo practice or TIN with 10 or fewer eligible clinicians. In order to estimate the number of clinicians available to participate in virtual groups, we used the data prepared to support the 2017 performance period initial determination of clinician eligibility (available via the NPI lookup on
We assume that the virtual election process will require 10 hours per virtual group, similar to the burden of the QCDR or registry self-nomination process finalized in § 414.1400. We assume that 8 hours of the 10 burden hours per virtual group will be computer systems analyst's time or the equivalent with an average labor cost of $88.10/hour, and an estimated cost of $704.80 per virtual group ($88.10/hour × 8 hours). We also assume that 2 hours of the 10 burden hours per virtual group will be legal support services professionals assisting in formulating the written virtual agreement with an average labor cost of $63.62/hour, with a cost of $127.24 per virtual group ($63.62/hour × 2 hours). Therefore, the total burden cost per virtual group associated with the election process is $832.04 ($704.80 + $127.24). We also assume that 16 new virtual groups will go through the election process leading to a total burden of $13,313 ($832.04 × 16 virtual groups). We estimate that the total annual burden hours will be 160 (16 virtual groups × 10 hours).
While the formation of virtual groups will result in a burden for virtual group registration, we also estimate that the formation of virtual groups will result in a decline in burden from other forms of data submission. Because we assume burden is the same for each organization (group, virtual group, or eligible clinician) submitting quality, improvement activities or advancing care information performance category data, virtual groups will reduce burden by reducing the time needed to prepare data for submission, review measure specifications, register or elect to submit data via a mechanism such as QCDR, registry, CMS Web Interface, or EHR. This reduction in burden is described in each of the quality, improvement activities, and advancing care information performance category sections below.
As stated earlier, the information collection request for the virtual group election process will be submitted for OMB review and approval separately from this rulemaking process. Please note that the 60-day
In section II.C.7.a.(4) of this proposed rule, we propose that for the 2020 MIPS payment year (2018 MIPS performance period), we would allow facility-based MIPS eligible clinicians to be given a MIPS score in the quality and cost performance categories that is based on the performance of the facility in which they provide services. We propose at § 414.1380(e)(2)(i) that a MIPS eligible clinician is eligible for facility-based measurement under MIPS if they furnish 75 percent or more of their covered professional services (as defined in section 1848(k)(3)(A) of the Act) in sites of service identified by the place of service codes used in the HIPAA standard transaction as an inpatient hospital, as identified by place of service code 21, and the emergency room, as identified by place of service code 23, based on claims for a period prior to the performance period as specified by CMS.
These MIPS eligible clinicians may elect to participate in facility-based measurement during the performance period. For the 2020 MIPS payment year (2018 MIPS performance period), we will base our assumptions for these eligible clinicians on the Hospital VBP Program.
In Table 61, we estimate participation in facility-based measurement, based on 2015 data from the PQRS and the first 2019 payment year MIPS eligibility and special status file as described in 81 FR 77069 and 77070.
Although the election of facility-based measurement generates burden, it will also result in the reduction of burden in the quality performance category because certain clinicians and groups will no longer be required to submit data for this category. Hence, our burden estimates for the quality performance category consider the reduction in burden for clinicians who practice primarily in the hospital that previously submitted data for this performance category and elected to use facility-based measurement. The reduction in burden is described in the quality performance category section below. We assume that there will be no reduction in burden related to the advancing care information performance category because MIPS eligible clinicians who practice primarily in the hospital are not required to submit data for this performance category.
As shown in Table 62, we estimate that the election to participate via facility-based measurement will take 1 hour of staff time, comparable to the CMS Web Interface registration process. We assume that the staff involved in the election process to participate via facility-based measurement will mainly be billing clerks or their equivalent, who have an average labor cost of $36.12/hour. Therefore, assuming the total burden hours per group or individual clinician associated with the election process is 1 hour, the total annual burden hours are 18,207 (18,207 groups or individual clinicians × 1 hour). We estimate that the total cost to groups and individual clinicians associated with the election process will be approximately $36.12 ($36.12 per hour × 1 hour per group or eligible clinician). We also assume that 18,207 individual clinicians or groups will go through the election process leading to a total burden of $657,637 ($36.12 × 18,207 clinicians).
Under MIPS, quality, advancing care information, and improvement activities performance category data may be submitted via relevant third party intermediaries, such as qualified registries, QCDRs and health IT vendors. The CAHPS for MIPS survey data, which counts as one quality performance category measure, can be submitted via CMS-approved survey vendors. The burdens associated with qualified registry and QCDR self-nomination and the CAHPS for MIPS survey vendor applications are discussed below.
For the 2017 MIPS performance period, 120 qualified registries and 113 QCDRs were qualified to report quality measures data for purposes of the PQRS, an increase from 114 qualified registries and 69 QCDRs in CY 2016.
We estimate that the self-nomination process for qualifying additional qualified registries or QCDRs to submit on behalf of MIPS eligible clinicians or groups for MIPS will involve approximately 1 hour per qualified registry or QCDR to complete the online self-nomination process. The self-nomination form is submitted electronically using a web-based tool. We are proposing to eliminate the option of submitting the self-nomination form via email that was available in the transition year.
In addition to completing a self-nomination statement, qualified registries and QCDRs will need to perform various other functions, such as meeting with CMS officials when additional information is needed. In addition, QCDRs calculate their measure results. QCDRs must possess benchmarking capability (for non-MIPS quality measures) that compares the quality of care a MIPS eligible clinician provides with other MIPS eligible clinicians performing the same quality measures. For non-MIPS measures the QCDR must provide to us, if available, data from years prior (for example, 2016 data for the 2018 MIPS performance period) before the start of the performance period. In addition, the QCDR must provide to us, if available, the entire distribution of the measure's performance broken down by deciles. As an alternative to supplying this information to us, the QCDR may post this information on their Web site prior to the start of the performance period, to the extent permitted by applicable privacy laws. The time it takes to perform these functions may vary depending on the sophistication of the entity, but we estimate that a qualified registry or QCDR will spend an additional 9 hours performing various other functions related to being a MIPS qualified registry or QCDR.
As shown in Table 63, we estimate that the staff involved in the qualified registry or QCDR self-nomination process will mainly be computer systems analysts or their equivalent, who have an average labor cost of
The burden associated with the qualified registry and QCDR submission requirements in MIPS will be the time and effort associated with calculating quality measure results from the data submitted to the qualified registry or QCDR by its participants and submitting these results, the numerator and denominator data on quality measures, the advancing care information performance category, and improvement activities data to us on behalf of their participants. We expect that the time needed for a qualified registry to accomplish these tasks will vary along with the number of MIPS eligible clinicians submitting data to the qualified registry or QCDR and the number of applicable measures. However, we believe that qualified registries and QCDRs already perform many of these activities for their participants. We believe the estimate noted in this section represents the upper bound of QCDR burden, with the potential for less additional MIPS burden if the QCDR already provides similar data submission services.
Based on the assumptions previously discussed, we provide an estimate of total annual burden hours and total annual cost burden associated with a qualified registry or QCDR self-nominating to be considered “qualified” to submit quality measures results and numerator and denominator data on MIPS eligible clinicians.
In the CY 2017 Quality Payment Program final rule (81 FR 77386), we finalized the definition, criteria, required forms, and vendor business requirements needed to participate in MIPS as a survey vendor. For purposes of MIPS, we defined a CMS-approved survey vendor at § 414.1305 as a survey vendor that is approved by us for a particular performance period to administer the CAHPS for MIPS survey and transmit survey measures data to us. At § 414.1400(i), we require that vendors undergo the CMS-approval process each year in which the survey vendor seeks to transmit survey measures data to us. We finalized the criteria for a CMS-approved survey vendor for the CAHPS for MIPS survey.
We estimate that it will take a survey vendor 10 hours to submit the information required for the CMS-approval process, including the completion of the Vendor Participation Form and compiling documentation, including the quality assurance plan,that demonstrates that they comply with Minimum Survey Vendor Business Requirements. This is comparable to the burden of the QCDR and qualified registry self-nomination process. As shown in Table 64, we assume that the survey vendor staff involved in collecting and submitting the information required for the CAHPS for MIPS certification will be computer systems analysts, who have an average labor cost of $88.10/hour. Therefore, assuming the total burden hours per CAHPS associated with the application process is 10 hours, the annual burden hours is 150 (15 CAHPS vendors × 10 hours). We estimate that the total cost to each CAHPS vendor associated with the application process will be approximately $881.00 ($88.10 per hour × 10 hours per CAHPS vendor). We estimate that 15 CAHPS vendors will go through the process leading to a total burden of $13,215 ($881.00 × 15 CAHPS vendors).
Based on the assumptions previously discussed, we provide an estimated number of total annual burden hours and total annual cost burden associated with the survey vendor approval process in Table 64.
Two groups of clinicians will submit quality data under MIPS: those who submit as MIPS eligible clinicians, and other clinicians who opt to submit data voluntarily but will not be subject to MIPS payment adjustments.
Historically, the PQRS has never experienced 100 percent participation; the participation rate for 2015 was 69 percent. For purposes of these analyses, we assume that clinicians who
Our burden estimates for data submission combine the burden for MIPS eligible clinicians and other clinicians submitting data voluntarily. Apart from clinicians who practice primarily in the hospital electing facility-based measurement and clinicians that became QPs in the first QP performance period, we assume that clinicians will continue to submit quality data under the same submission mechanisms that they used under the 2015 PQRS. As discussed in more detail in the section of this proposed rule describing the burden for facility-based measurement (III.D.), we assume that some eligible clinicians who practice primarily in the hospital will elect facility-based measurement, rather than submit quality data via other mechanisms. Further, as discussed in more detail in the section of this proposed rule describing the burden for the virtual group application process (III.C.), we assume that the approximately 80 TINs that elect to form the approximately 16 virtual groups will continue to use the same submission mechanism as under the 2015 PQRS, but the submission will be at the virtual group, rather than group level. Our burden estimates for the quality performance category do not include the burden for the quality data that MIPS APM Entities submit to fulfill the requirements of their models. Sections 3021 and 3022 of the Affordable Care Act state the Shared Savings Program and the testing, evaluation, and expansion of Innovation Center models are not subject to the Paperwork Reduction Act (42 U.S.C. 1395jjj and 42 U.S.C. 1315a(d)(3), respectively).
Table 65 provides our estimated counts of clinicians that will submit quality performance category data as MIPS individual clinicians, groups, or virtual groups in the 2018 MIPS performance period. The first step was to estimate the number of clinicians to submit as an individual clinician or group via each mechanism during the 2017 MIPS performance period using 2015 PQRS data on individuals and groups submitting through various mechanisms and excluding clinicians identified as QPs in a preliminary version of the file used for the predictive qualifying APM participants analysis made available on
Based on these methods, Table 65 shows that in the 2018 MIPS performance period, an estimated 364,002 clinicians will submit as individuals via claims submission mechanisms; 225,569 clinicians will submit as individuals, or as part of groups or virtual groups via qualified registry or QCDR submission mechanisms; 115,241 clinicians will submit as individuals, or as part of groups or virtual groups via EHR submission mechanisms; and 101,939 clinicians will submit as part of groups via the CMS Web Interface.
Our estimated numbers of clinicians to submit as individual clinicians,
Table 65 provides estimates of the number of clinicians to submit quality measures via each mechanism, regardless of whether they decide to submit as individual clinicians or as part of groups or virtual groups. Because our burden estimates for quality data submission assume that burden is reduced when clinicians elect to submit as part of a group or virtual group, we also separately estimate the expected number of clinicians to submit as individuals or part of groups or virtual groups.
Table 66 uses methods similar to those described for Table 65 to estimate the number of clinicians to submit as individual clinicians via each mechanism in Quality Payment Program Year 2. We estimate that approximately 364,002 clinicians will submit as individuals via claims submission mechanisms; approximately 86,046 clinicians will submit as individuals via qualified registry or QCDR submission mechanisms; and approximately 60,253 clinicians will submit as individuals via EHR submission mechanisms. Individual clinicians cannot elect to submit via CMS Web Interface. Consistent with the proposed policy to allow individual clinicians to be scored on quality measures submitted via multiple mechanisms, our columns in Table 66 are not mutually exclusive.
Table 67 provides our estimated counts of groups or virtual groups to submit quality data on behalf of clinicians via each mechanism in the 2018 MIPS performance period and reflects our assumption that the formation of virtual groups will reduce burden. Except for groups who practice primarily in the hospital electing facility-based measurement and groups comprised entirely of QPs, we assume that groups that submitted quality data as groups under the 2015 PQRS will continue to submit quality data either as groups or virtual groups via the same submission mechanisms in the 2018 MIPS performance period. The first step in estimating the numbers of groups or virtual groups to submit via each mechanism in the 2018 MIPS performance period was to estimate the number of groups to submit on behalf of clinicians via each mechanism in the 2017 MIPS performance period. We used 2015 PQRS data on groups submitting on behalf of clinicians via various mechanisms and excluded groups comprised entirely of QPs in a preliminary version of the file used for the predictive qualifying Alternative Payment Model participants analysis made available on
Specifically, we assumed that 2,455 groups and virtual groups will submit data via QCDR/registry submission mechanisms on behalf of 146,676 clinicians; 817 groups and virtual groups will submit via EHR submission mechanisms on behalf of 56,772 eligible clinicians; and 298 groups will submit data via the CMS Web Interface on behalf of 102,914 clinicians. Groups cannot elect to submit via claims submission mechanism.
These burden estimates have some limitations. We believe it is difficult to quantify the burden accurately because clinicians and groups may have different processes for integrating quality data submission into their practices' work flows. Moreover, the time needed for a clinician to review quality measures and other information, select measures applicable to their patients and the services they furnish, and incorporate the use of quality data codes into the office workflows is expected to vary along with the number of measures that are potentially applicable to a given clinician's practice. Further, these burden estimates are based on historical rates of participation in the PQRS program, and the rate of participation in MIPS are expected to differ.
We believe the burden associated with submitting the quality measures will vary depending on the submission method selected by the clinician, group, or virtual group. As such, we break down the burden estimates by clinicians, groups, and virtual groups by the submission method used.
We anticipate that clinicians and groups using QCDR, qualified registry, and EHR submission mechanisms will have the same start-up costs related to reviewing measure specifications. As such, we estimate for clinicians, groups, and virtual groups using any of these three submission mechanisms a total of 7 staff hours needed to review the quality measures list, review the various submission options, select the most appropriate submission option, identify the applicable measures or specialty measure sets for which they can report the necessary information, review the measure specifications for the selected measures or measures group, and incorporate submission of the selected measures or specialty measure sets into the office work flows. Building on data in a recent article, Casalino et al. (2016), we assume that a range of expertise is needed to review quality measures: 2 hours of an office administrator's time, 1 hour of a clinician's time, 1 hour of an LPN/medical assistant's time, 1 hour of a computer systems analyst's time, and 1 hour of a billing clerk's time.
For the claims submission mechanism, we estimate that the start-up cost for a MIPS eligible clinician's practice to review measure specifications is $596.80, including 3 hours of a practice administrator's time (3 hours × $105.16=$315.48), 1 hour of a clinician's time (1 hour × $202.08/hour=$202.08), 1 hour of an LPN/medical assistant's time (1 hour × $43.12), and 1 hour of a billing clerk's time (1 hour × $36.12/hour = $36.12). These start-up costs pertain to the specific quality submission methods below, and hence appear in the burden estimate tables.
For the purposes of our burden estimates for the claims, qualified registry and QCDR, and EHR submission mechanisms, we also assume that, on average, each clinician, group, or virtual group will submit 6 quality measures.
Our estimated number of respondents for the claims and EHR submission mechanisms increased relative to the estimates in the CY 2017 Quality Payment Program final rule because our estimates now reflect the proposed policy to allow individual clinicians and groups to be scored on quality measures submitted via multiple mechanisms. Our estimated number of respondents for the QCDRs and
As noted in Table 65, based on 2015 PQRS data, the data prepared to support the 2017 performance period initial determination of clinician and special status eligibility (available via the NPI lookup on
The total estimated burden of claims-based submission will vary along with the volume of claims on which the submission is based. Based on our experience with the PQRS, we estimate that the burden for submission of quality data will range from 0.22 hours to 10.8 hours per clinician. The wide range of estimates for the time required for a clinician to submit quality measures via claims reflects the wide variation in complexity of submission across different clinician quality measures. As shown in Table 68, we also estimate that the cost of quality data submission using claims will range from $19.38 (0.22 hours × $88.10) to $951.48 (10.8 hours × $88.10). The total estimated annual cost per clinician ranges from the minimum burden estimate of $704.28 to a maximum burden estimate of $1,636.38. The burden will involve becoming familiar with MIPS data submission requirements. As noted in Table 68, we believe that the start-up cost for a clinician's practice to review measure specifications totals 7 hours, which includes 3 hours of a practice administrator's time (3 hours × $105.16 = $315.48), 1 hour of a clinician's time (1 hour × $202.08/hour = $202.08), 1 hour of an LPN/medical assistant's time (1 hour × $43.12 = $43.12), 1 hour of a computer systems analyst's time (1 hour × $88.10 = $88.10), and 1 hour of a billing clerk's time (1 hour × $36.12/hour = $36.12).
Considering both data submission and start-up costs, the total estimated burden hours per clinician ranges from a minimum of 7.22 hours (0.22 + 3 + 1 + 1 + 1 + 1) to a maximum of 17.8 hours (10.8 + 3 + 1 + 1 + 1 + 1). The total estimated annual cost per clinician ranges from the minimum estimate of $704.28 ($19.38 + $315.48 + $88.10 + $43.12 + $36.12 + $202.08) to a maximum estimate of $1,636.38 ($951.48 + $315.48 + $88.10 + $43.12 + $36.12 + $202.08). Therefore, total annual burden cost is estimated to range from a minimum burden estimate of $256,359,329 (364,002 × $704.28) to a maximum burden estimate of $595,645,593 (364,002 × $1,636.38).
Based on the assumptions discussed in this section of the proposed rule, Table 68 summarizes the range of total annual burden associated with clinicians using the claims submission mechanism.
As noted in Table 65 and based on 2015 PQRS data, the data prepared to support the 2017 performance period initial determination of clinician and special status eligibility (available via the NPI lookup on
We estimate that burdens associated with QCDR submissions are similar to the burdens associated with qualified registry submissions. Therefore, we discuss the burden for both data submissions together below. For qualified registry and QCDR submissions, we estimate an additional time burden for respondents (individual clinicians, groups, and virtual groups) to become familiar with MIPS submission requirements and, in some cases, specialty measure sets and QCDR measures. Therefore, we believe that the start-up cost for an individual clinician or group to review measure specifications and submit quality data to total $851.35. For review costs, this total includes 3 hours per respondent to submit quality data (3 hours × $88.10/hour = $264.00), 3 hours of a practice administrator's time (2 hours × $105.16/hour = $210.32), 1 hour of a clinician's time (1 hours × $202.08/hour = $202.08), 1 hour of a computer systems analyst's time (1 hour × $88.10/hour = $88.10), 1 hour of an LPN/medical assistant's time, (1 hour × $43.12/hour = $43.12), and 1 hour of a billing clerk's time (1 hour × $36.12/hour = $36.12). Clinicians, groups, and virtual groups will need to authorize or instruct the qualified registry or QCDR to submit quality measures' results and numerator and denominator data on quality measures to us on their behalf. We estimate that the time and effort associated with authorizing or instructing the quality registry or QCDR to submit this data will be approximately 5 minutes (0.083 hours) per clinician or group (respondent) for a total burden cost of $7.31, at a computer systems analyst's labor rate (.083 hours × $88.10/hour). Hence, we estimate 9.083 burden hours per respondent, with annual total burden hours of 803,855 (9.083 burden hours × 88,501 respondents). The total estimated annual cost per respondent is estimated to be approximately $851.05. Therefore, total annual burden cost is estimated to be $75,318,776 (88,501 × $851.05). Based on these assumptions, we have estimated the burden for these submissions.
As noted in Tables 65, 66 and 67, based on our analysis of 2015 PQRS data, data prepared to support the 2017 performance period initial determination of clinician and special status eligibility (available via the NPI lookup on
Under the EHR submission mechanism, the individual clinician or group may either submit the quality measures data directly to us from their EHR or utilize an EHR data submission vendor to submit the data to us on the clinician's or group's behalf.
To prepare for the EHR submission mechanism, the clinician or group must review the quality measures on which we will be accepting MIPS data extracted from EHRs, select the appropriate quality measures, extract the necessary clinical data from their EHR, and submit the necessary data to the CMS-designated clinical data warehouse or use a health IT vendor to submit the data on behalf of the clinician or group. We assume the burden for submission of quality measures data via EHR is similar for clinicians, groups, and virtual groups who submit their data directly to us from their CEHRT and clinicians, groups, and virtual groups who use an EHR data submission vendor to submit the data on their behalf. To submit data to us directly from their CEHRT, clinicians, groups, and virtual groups must have access to a CMS-specified identity management system which we believe takes less than 1 hour to obtain. Once a clinician or group has an account for this CMS-specified identity management system, they will need to extract the necessary clinical data from their EHR, and submit the necessary data to the CMS-designated clinical data warehouse.
We estimate that obtaining an account on a CMS-specified identity management system will require 1 hour per respondent for a cost of $88.10 (1 hour × $88.10/hour), and that submitting a test data file to us will also require 1 hour per respondent for a cost of $88.10 (1 hour × $88.10/hour). For submitting the actual data file, we believe that this will take clinicians or groups no more than 2 hours per respondent for a cost of submission of $176.20 (2 hours × $88.10/hour). The burden will involve becoming familiar with MIPS submission. We believe that the start-up cost for a clinician or group to submit the test data file and review measure specifications is a total 7 hours, 1 hour for the test data submission and 6 hours for reviewing measuring which includes 2 hours of a practice administrator's time (2 hours × $105.16/hour = $210.32), 1 hour of a clinician's time (1 hour × $202.08/hour = $202.08), 1 hour of a computer systems analyst's time (1 hour × $88.10/hour = $88.10), 1 hour of an LPN/medical assistant's time (1 hour × $43.12/hour = $43.12), and 1 hour of a billing clerk's time (1 hour × $36.12/hour = $36.12). Hence, we estimated 10 total burden hours per respondent with annual total burden hours of 610,700 (10 burden hours × 61,070 respondents). The total estimated annual cost per respondent is estimated to be $932.14. Therefore, total annual burden cost is estimated to be $56,925,790 = (61,070 respondents × $932.14).
Based on the assumptions discussed in this section of the proposed rule, we have estimated the burden for the quality data submission using EHR submission mechanism below.
Based on 2015 PQRS data and as shown in Table 67, we assume that 298 groups will submit quality data via the CMS Web Interface in the 2018 MIPS performance period. We anticipate that approximately 252,808 clinicians will be represented.
The burden associated with the group submission requirements under the CMS Web Interface is the time and effort associated with submitting data on a sample of the organization's beneficiaries that is prepopulated in the CMS Web Interface. Based on experience with PQRS GPRO Web Interface submission mechanism, we estimate that, on average, it will take each group 74 hours of a computer systems analyst's time to submit quality measures data via the CMS Web Interface at a cost of $88.10 per hour, for a total cost of $6,519 (74 hours × $88.10/hour). Our estimate of 74 hours for submission includes the time needed for each group to populate data fields in the web interface with information on approximately 248 eligible assigned Medicare beneficiaries and then submit the data (we will partially pre-populate the CMS Web Interface with claims data from their Medicare Part A and B beneficiaries). The patient data either can be manually entered or uploaded into the CMS Web Interface via a standard file format, which can be populated by CEHRT. Because the CMS API will streamline the measure submission process for many groups, we have reduced our estimate of the computer system's analyst time needed for submission from 79 hours in the CY 2017 Quality Payment Program final rule to 74 hours. Because each group must provide data on 248 eligible assigned Medicare beneficiaries (or all eligible assigned Medicare beneficiaries if the pool of eligible assigned beneficiaries is less than 248), we assume that entering or uploading data for one Medicare beneficiary requires approximately 18 minutes of a computer systems analyst's time (74 hours ÷ 248 patients).
The total annual burden hours are estimated to be 22,052 (298 groups × 74 annual hours), and the total annual burden cost is estimated to be $1,942,662 (298 groups × $6,519).
Based on the assumptions discussed in this section of the proposed rule, we have calculated the following burden estimate for groups submitting to MIPS with the CMS Web Interface.
Under MIPS, groups of two or more clinicians can elect to contract with a CMS-approved survey vendor and use the CAHPS for MIPS survey as one of their six required quality measures. Beneficiaries that choose to respond to the CAHPS for MIPS survey will experience burden.
The usual practice in estimating the burden on public respondents to
Under the 2018 MIPS performance period, we assume that 461 groups will elect to report on the CAHPS for MIPS survey, which is equal to the number of groups reporting via CAHPS for the PQRS for reporting period 2015.
We are proposing to use a shorter version of the CAHPS for MIPS survey with 58 items, as compared to 81 items for the version that will be used in the transition year. The proposed shorter survey is estimated to require an average administration time of 12.9 minutes (or 0.22 hours) in English (at a pace of 4.5 items per minute). We assume the Spanish survey would require 15.5 minutes (assuming 20 percent more words in the Spanish translation). Because less than 1 percent of surveys were administered in Spanish for reporting year 2016, our burden estimate reflects the length of the English survey. Our proposal would reduce beneficiary burden compared to the transition year; we estimate that the 81-item survey requires an average administration time of 18 minutes in English and 21.6 minutes in Spanish. Compared to the survey for reporting year 2016, this is a reduction of 5.1 minutes (18 minutes−12.9 minutes) in administration time for the English version and a reduction of 6.1 (21.6 minutes−15.5 minutes) minutes in administration time for the Spanish version.
Given that we expect approximately 132,307 respondents per year, the annual total burden hours are estimated to be 29,108 hours (132,307 respondents × 0.22 burden hours per respondent). The estimated total burden annual burden cost is $694,612 (132,307 × $5.25).
Groups interested in participating in MIPS using the CMS Web Interface for the first time must complete an on-line registration process. After first time registration, groups will only need to opt out if they are not going to continue to submit via the CMS Web Interface. In Table 73 we estimate that the registration process for groups under MIPS involves approximately 1 hour of administrative staff time per group. We assume that a billing clerk will be responsible for registering the group and that, therefore, this process has an average computer systems analyst labor cost of $88.10 per hour. Therefore, assuming the total burden hours per group associated with the group registration process is 1 hour, we estimate the total cost to a group associated with the group registration process to be approximately $88.10 ($88.10 per hour × 1 hour per group). We assume that approximately 10 groups will elect to use the CMS Web Interface submission mechanism in the 2018 MIPS performance period. The total annual burden hours are estimated to be 10 (10 groups × 1 annual hour), and the total annual burden cost is estimated to be $881.00 (10 groups × $88.10).
Under MIPS, the CAHPS for MIPS survey counts for one measure towards the MIPS quality performance category and, as a patient experience measure, also fulfills the requirement to submit at least one high priority measure in the absence of an applicable outcome measure. Groups that wish to administer the CAHPS for MIPS survey must register by June of the applicable 12-month performance period, and electronically notify CMS of which vendor they have selected to administer the survey on their behalf. In the 2018 MIPS performance period, we assume that 461 groups will enroll in the MIPS for CAHPS survey.
As shown in Table 74, we assume that the staff involved in the group registration for CAHPS for MIPS Survey will mainly be computer systems analysts or their equivalent, who have an average labor cost of $88.10/hour. We assume the CAHPS for MIPS Survey registration burden estimate includes the time to register for the survey as well as select the CAHPS for MIPS Survey vendor. Therefore, assuming the total burden hours per registration is 1 hour and 0.5 hours to select the CAHPS for MIPS Survey vendor that will be used and electronically notify CMS of their selection, the total burden hours for CAHPS for MIPS registration is 1.5. We estimate the total annual burden hours as 692 (461 groups × 1.5 hours). We estimate the cost per group for CAHPS for MIPS Survey registration is $132.15 ($88.10 × 1.5 hours). We estimate that the total cost associated with the registration process is $60,921 ($132.15 per hour × 461 hours per group).
During the 2018 MIPS performance period, clinicians, groups, and virtual groups can submit advancing care information data through qualified registry, QCDR, EHR, CMS Web Interface, and attestation data submission methods. We have worked to further align the advancing care information performance category with other MIPS performance categories. We anticipate that most organizations will use the same data submission mechanism for the advancing care information and quality performance categories, and that the clinicians, practice managers, and computer systems analysts involved in supporting the quality data submission will also support the advancing care information data submission process. Hence, the burden estimate for the submission of advancing care information data below shows only incremental hours required above and beyond the time already accounted for in the quality data submission process. While this analysis assesses burden by performance category and submission mechanism, we emphasize that MIPS is a consolidated program and submission analysis and decisions are expected to be made for the program as a whole.
As stated in the CY 2017 Quality Payment Program final rule, some MIPS eligible clinicians may not have sufficient measures applicable and available to them for the advancing care information performance category, and as such, they may apply to have the advancing care information category re-weighted to zero in the following circumstances: insufficient internet connectivity, extreme and uncontrollable circumstances, lack of control over the availability of CEHRT (81 FR 77240 through 77243). As described in section II.C.6.f.(7)(a) of this proposed rule, we are proposing to allow MIPS eligible clinicians to apply to have their advancing care information performance category re-weighted to zero through the Quality Payment Program due to a significant hardship exception or exception for decertified EHR technology. We are also proposing that MIPS eligible clinicians who are in small practices (15 or fewer clinicians) may, beginning with the 2018 performance period and 2020 MIPS payment year, request a reweighting to zero for the advancing care information category due to a significant hardship. We are proposing to rely on section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, as our authority for the significant hardship exceptions.
Table 75 shows the estimated annualized burden for clinicians to apply for a reweighting to zero of their advancing care information performance category due to a significant hardship exception or as a result of a decertification of an EHR, as well as an application for significant hardship by small practices. Based on 2016 data from the Medicare EHR Incentive Program and the first 2019 payment year MIPS eligibility and special status file, we assume 50,689 respondents (eligible clinicians, groups, or virtual groups) will submit a request for reweighting to zero of their advancing care information category due to a significant hardship exception, decertification of an EHR or significant hardship for small practices through the Quality Payment Program. We estimate that 6,699 respondents (eligible clinicians, groups, or virtual groups) will submit a request for a reweighting to zero for the advancing care information performance category due to extreme and uncontrollable circumstances or as a result of a decertification of an EHR, and 43,990 respondents will submit a request for a reweighting to zero for the advancing care information performance category as a small practice. The application to request a reweighting to zero for the advancing care information performance category due to significant hardship is a short online form that requires identifying which type of hardship or if decertification of an EHR applies and a description of how the circumstances impair the ability to submit the advancing care information data, as well
A variety of organizations will submit advancing care information data on behalf of clinicians. Clinicians not participating in a MIPS APM can submit as individuals or as part of a group or virtual group. Group TINs may submit advancing care information data on behalf of clinicians in MIPS APMs, or, except for participants in the Shared Savings Program, clinicians in MIPS APMs may submit advancing care information performance category data individually. Because group TINs in APM Entities will be submitting advancing care information data to fulfill the requirements of submitting to MIPS, we have included MIPS APMs in our burden estimate for the advancing care information performance category. Consistent with the list of APMs that are MIPS APMs on the QPP Web site,
As shown in Table 76, based on 2015 data from the Medicare EHR Incentive Program and the data prepared to support the 2017 performance period initial determination of clinician eligibility and special status determination (available via the NPI lookup on
Further, we anticipate that the 480 Shared Savings Program ACOs will submit data at the ACO participant group TIN-level, for a total of 15,945 group TINs. We anticipate that the three APM Entities electing the one-sided track in the CEC model will submit data at the group TIN-level, for an estimated total of 100 group TINs submitting data. We anticipate that the 195 APM Entities in the OCM (one-sided risk arrangement) will submit data at APM Entity level, for an estimated total of 6,478 group TINs. Based on a preliminary version of the file used for the predictive qualifying Alternative Payment Model participants analysis made available on
In Table 76, we estimate that up to approximately 288,721 respondents will be submitting data under the advancing care information performance category, 265,895 clinicians, 301 groups or virtual groups, 15,945 group TINs within the Shared Savings Program ACOs, 100 group TINs within the APM Entity participating in CECs in the one-sided risk track, and 6,478 group TINs within the OCM (one-sided risk arrangement), and 2 CPC+ group TINs. We estimate this is a significant reduction in respondents from the 2017 MIPS performance period as a result of our proposed policy to provide significant hardship exceptions, including for MIPS eligible clinicians in small practices, as well as for situations due to decertification of an EHR, and our proposed policy to allow eligible clinicians to participate as part of a virtual group.
In the CY 2017 Quality Payment Program final rule, our burden estimates assumed all clinicians who submitted quality data would also submit under advancing care information. For this proposed rule, MIPS special status eligibility data were available to model exceptions. The majority (214,302) of the difference in our estimated number of respondents is due to the availability of MIPS special status data to identify clinicians and groups that would also not need to report advancing care information data under transition year policies, including hospital-based eligible clinicians, clinician types eligible for automatic reweighting of their advancing care information performance category score, non-patient facing clinicians, and clinicians facing a significant hardship. The remaining decline in respondents is due to policies proposed in this rule, including 25,881 respondents who would be excluded under the new proposed significant hardship exception for small practices.
Our burden estimates in the CY 2017 Quality Payment Program final rule assumed that during the transition year, 3 hours of clinician time would be required to collect and submit advancing care information performance category data. We anticipate that the year-over-year consistency of data submission processes, measures, and activities and the further alignment of the advancing care information performance category with other performance categories will reduce the clinician time needed under this performance category in the 2018 MIPS performance period. Further, for some practices the staff mix requirements in the 2018 MIPS performance period may be driven more by transition to 2015 CEHRT. Therefore, as shown in Table 77, the total burden hours for an organization to submit data on the specified Advancing Care Information Objectives and Measures is estimated to be 3 incremental hours of a computer analyst's time above and beyond the clinician, practice manager, and computer system's analyst time required to submit quality data. The total estimated burden hours are 866,163 (288,721 respondents × 3 hours). At a computer systems analyst's hourly rate, the total burden cost is $76,308,960 (288,721 × $264.30/hour).
Requirements for submitting improvement activities did not exist in the legacy programs replaced by MIPS, and we do not have historical data which is directly relevant. A variety of organizations and in some cases, individual clinicians, will submit improvement activity performance category data. For clinicians who are not part of APMs, we assume that clinicians submitting quality data as part of a group or virtual group through the
In Table 79, we estimate that approximately 524,488 respondents will be submitting data under the improvement activities performance category. Our burden estimates in the CY 2017 Quality Payment Program final rule assumed that during the transition year, 2 hours of clinician time would be required to submit data on the specified improvement activities. For this proposed rule, our burden estimate has been revised to assume that the total burden hours to submit data on the specified improvement activities will be 1 hour of computer system analyst time in addition to time spent on other performance categories. Our revised estimate is based on feedback from stakeholders that these are activities they have already been doing and tracking so there is no additional development of material needed. Additionally, the same improvement activity may be reported across multiple performance periods so many MIPS eligible clinicians will not have any additional information to develop for the 2018 MIPS performance period. The total estimated burden hours are 524,488 (524,488 responses × 1 hour). At a computer systems analyst's hourly rate, the total burden cost is $46,207,393 (524,488 × $88.10/hour).
For the 2018 MIPS performance period, we are also proposing to allow clinicians, groups, and other relevant stakeholders to nominate new improvement activities using a nomination form provided on the Quality Payment Program Web site at
The cost performance category relies on administrative claims data. The Medicare Parts A and B claims submission process is used to collect data on cost measures from MIPS eligible clinicians. MIPS eligible clinicians are not asked to provide any documentation by CD or hardcopy. Therefore, under the cost performance category, we do not anticipate any new or additional submission requirements for MIPS eligible clinicians.
APM Entities may face a data submission burden under MIPS related to Partial QP elections. Advanced APM participants will be notified about their QP or Partial QP status before the end of the performance period. For Advanced APMs the burden of partial QP election would be incurred by a representative of the participating APM Entity. For the purposes of this burden estimate, we assume that all MIPS eligible clinicians determined to be Partial QPs will participate in MIPS.
Based on our analyses of a preliminary version of the file used for the predictive qualifying Alternative Payment Model participants analysis made available on
As shown in Table 81, we assume that 17 APM Entities will make the election to participate as a partial QP in MIPS. We estimate it will take the APM Entity representative 15 minutes to make this election. Using a computer systems analyst's hourly labor cost, we estimate a total burden cost of just $375 (17 participant × $22.03).
Beginning in Quality Payment Program Year 3, the All-Payer Combination Option will be an available pathway to QP status for eligible clinicians participating sufficiently in Advanced APMs and Other Payer Advanced APMs. The All-Payer Combination Option allows for eligible clinicians to achieve QP status through their participation in both Advanced APMs and Other Payer Advanced APMs. In order to include an eligible clinician's participation in Other Payer Advanced APMs in their QP threshold score, we will need to determine if certain payment arrangements with other payers meet the criteria to be Other Payer Advanced APMs. To provide eligible clinicians with advanced notice prior to the start of the 2019 QP performance period, and to allow other payers to be involved prospectively in the process, we have outlined in section II.D.6.a. of this proposed rule a payer-initiated identification process for identifying payment arrangements that qualify as Other Payer Advanced APMs. This payer-initiated identification process of Other Payer Advanced APMs will begin in CY 2018, and determinations would be applicable for the Quality Payment Program Year 3.
As shown in Table 82, we estimate that 300 other payer arrangements will be submitted (50 Medicaid payers, 150 MA Organizations, and 100 Multi-payers) for identification as Other Payer Advanced APMs. The estimated burden to apply is 10 hours per payment arrangement, for a total annual burden hours of 3,000 (300 × 100). We estimate a total cost per payer of $881.00 using a computer system analyst's rate of $88.10/hour (10 × 81.10). The total annual burden cost for all other payers is $264,300 (300 × $881.00).
We estimate 22,400 clinicians and groups who will voluntarily participate in MIPS but will also elect not to participate in public reporting. Table 83 shows that for these voluntary participants, they may submit a request to opt out which is estimated at 0.25 hours of a computer system analyst's labor rate of $88.10. The total annual burden hours for opting out is estimated at 5,600 hours (22,400 × 0.25). The total annual burden cost for opting out for all requesters is estimated at $493,472 (22,400 × $22.03).
Table 84 includes the total estimated burden of recordkeeping and data submission of the proposed rule 9,391,175 hours with total labor cost of $856,996,819. In order to understand the burden implications of the proposals in this rule, we have also estimated a baseline burden of continuing the policies and information collections set forth in the CY 2017 Quality Payment Program final rule into the 2018 performance period. This estimated baseline burden of 9,523,975 hours and a total labor cost of $869,369,094 is lower than the burden approved for information collection related to the CY 2017 Quality Payment Program final rule
We estimate that the proposed rule will reduce burden by 132,620 hours and $12,372,275 in labor costs relative to the estimated baseline of continued transition year policies. The Quality Payment Program Year 2 reduction in burden based on proposals in this rule reflects several proposed policies, including our proposal for significant hardship or other type of exception, including a new significant hardship exception for small practices for the advancing care information performance category. Our burden estimates also reflect the proposed reduction in the length of the CAHPS survey; our proposal to allow clinicians that practice primarily in the hospital to elect to use facility-based measurements, thereby eliminating the need for additional quality data submission processes; and our proposal to allow MIPS eligible clinicians to form virtual groups, which would create efficiencies in data submission.
We have submitted a copy of this proposed rule to OMB for its review of the rule's information collection and recordkeeping requirements. These requirements are not effective until they have been approved by the OMB.
To obtain copies of the supporting statement and any related forms for the proposed collections discussed in this section of the proposed rule, please visit our Web site at
We invite public comments on these potential information collection requirements. If you wish to comment, please submit your comments electronically as specified in the
We have invited public comments on the virtual group election process under a separate
Because of the large number of public comments we normally receive on
This proposed rule is necessary to make statutorily required policy changes and other policy updates to the Merit-based Incentive Payment System (MIPS) established under MACRA as well as the policies related to the Advanced APM provisions of MACRA, which together are referred to as the Quality Payment Program. As required by MACRA, MIPS consolidates several quality programs, including components of the Medicare Electronic Health Record Incentive Program, the Physician Quality Reporting System (PQRS), and the Physician Value-Based Payment Modifier (VM) and Physician Feedback Program. The MACRA effectively ends these programs after CY 2018 and authorizes MIPS' operation beginning in CY 2019.
The Quality Payment Program is structured to improve care quality over time with input from clinicians, patients, and other stakeholders. We have sought and continue to seek feedback from the health care community through various public avenues such as listening sessions, request for information and rulemaking where we have received feedback that many clinical practices are still working towards implementing the Quality Payment Program. This proposed rule for Quality Payment Program Year 2 reflects this feedback and includes several proposals that extend transition year policies finalized in the CY 2017 Quality Payment Program final rule with comment period; however, we also include policies to begin ramping up to full implementation, since the performance threshold must be based on the mean or median of prior year performance under statute starting in the 2019 MIPS performance period (MIPS payment year 2021). Additionally, we address elements of MACRA that were not included in the first year of the program, including virtual groups, facility-based measurement, and improvement scoring. We also include proposals to continue implementing elements of MACRA that do not take effect in the first or second year of the Quality Payment Program, including policies related to the All-Payer Combination Option for the APM incentive.
We have examined the impact of this proposed rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (February 2, 2013), the Regulatory Flexibility Act (Pub. L. 96–354 enacted September 19, 1980) (RFA), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 14–04 enacted March 22, 1995), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory
Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017. As shown in the discussion of Table 84 in the Collection of Information section of this proposed rule, we estimate that this proposed rule would reduce the ICR burden by 132,620 hours and would result in a further reduction in burden costs of $12.4 million in the Quality Payment Program Year 2 relative to Quality Payment Program Year 1. As shown in the discussion of Regulatory Review Costs in section V.E. of this proposed rule, we estimate that total regulatory review costs associated with the Quality Payment Program would be approximately $4.8 million.
The Regulatory Flexibility Act (RFA) requires agencies to prepare an Initial Regulatory Flexibility Analysis to describe and analyze the impact of the final rule on small entities unless the Secretary can certify that the regulation will not have a significant impact on a substantial number of small entities. The RFA requires agencies to analyze options for regulatory relief of small entities. Note that Small Business Administration (SBA) standards for small entities differ than the definition of a small practice under MIPS finalized in the CY 2017 Quality Payment Program final rule under § 414.1305. The SBA standard for a small business is $11 million in average receipts for an office of clinicians and $7.5 million in average annual receipts for an office of other health practitioners. (For details, see the SBA's Web site at
Approximately 95 percent of practitioners, other providers, and suppliers are considered to be small entities either by nonprofit status or by having annual revenues that qualify for small business status under the SBA standards. There are over 1 million physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS. Because many of the affected entities are small entities, the analysis and discussion provided in this Regulatory Impact Analysis section as well as elsewhere in this proposed rule is intended to comply with the requirement for an Initial Regulatory Flexibility Analysis (IRFA).
As discussed below, approximately 572,000 MIPS eligible clinicians will be required to submit data under MIPS. As shown later in this analysis, however, potential reductions in Medicare Part B payment for MIPS eligible clinicians under the MIPS are a small percentage of their total Medicare Part B paid charges—5 percent in the 2020 payment year—though rising to as high as 9 percent in subsequent years. On average, clinicians' Medicare billings are only approximately 23 percent of their total revenue,
For the 2018 MIPS performance period, this proposed rule has several key proposals that will provide regulatory relief for clinicians and practices and help increase ways for successful participation. These include implementing virtual groups, raising the low volume threshold, continuing to allow the use of 2014 Edition CEHRT (Certified Electronic Health Record Technology), and adding a new significant hardship exception for the advancing care information performance category for MIPS eligible clinicians who are in small practices, as summarized in section I.D.4.c. of this proposed rule.
In addition, section 1102(b) of the Act requires us to prepare an RIA if a rule may have a significant impact on the operations of a substantial number of small hospitals located in rural areas. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small hospital located in a rural area as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this proposed rule would not have a significant impact on the operations of a substantial number of small hospitals located in rural areas.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits on state, local, or tribal governments or on the private sector before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2017, that threshold is approximately $148 million. This proposed rule would impose no mandates on state, local, or tribal governments or on the private sector because participation in Medicare is voluntary and because physicians and other clinicians have multiple options as to how they will participate under MIPS and discretion over their performance. Moreover, HHS interprets UMRA as applying only to unfunded mandates. We do not interpret Medicare
Executive Order 13132 establishes certain requirements that an agency must meet when it issues a proposed rule (and subsequent final rule) that imposes substantial direct effects on state and local governments, preempts state law, or otherwise has Federalism implications. We have outlined in section II.D.6.(a) of this proposed rule a payer-initiated identification process for identifying which payment arrangements qualify as Other Payer Advanced APMs. State Medicaid programs may elect to participate in the payer-initiated identification process. We do not believe any of these policies impose a substantial direct effect on the Medicaid program as participation in the Payer Initiated Determination Process is voluntary and use of the Eligible Clinician Initiated Determination Process is also voluntary.
We have prepared the following analysis, which together with the information provided in the rest of this proposed rule, meets all assessment requirements. The analysis explains the rationale for and purposes of this proposed rule; details the costs and benefits of the rule; analyzes alternatives; and presents the measures we would use to minimize the burden on small entities. As indicated elsewhere in this proposed rule, we are implementing a variety of changes to our regulations, payments, or payment policies to implement statutory provisions. We provide information for each of the policy changes in the relevant sections of this proposed rule. We note that many of the MIPS policies from the CY 2017 Quality Payment Program final rule were only defined for the 2017 MIPS performance period and 2019 MIPS payment year (including the performance threshold, the performance category reweighting policies, and many scoring policies for the quality performance category) which precludes us from developing a baseline for the 2018 MIPS performance period and 2020 MIPS payment year if there were no new regulatory action. We are unaware of any relevant federal rules that duplicate, overlap, or conflict with this proposed rule. The relevant sections of this proposed rule contain a description of significant alternatives if applicable.
Section 101 of the MACRA, (1) repeals the Sustainable Growth Rate (SGR) formula for physician payment updates in Medicare, and (2) requires that we establish MIPS for eligible clinicians under which the Secretary must use a MIPS eligible clinician's final score to determine and apply a MIPS payment adjustment factor to the clinician's Medicare Part B payments for a year.
The largest component of the MACRA costs is its replacement of scheduled reductions in physician payments with payment rates first frozen at 2015 levels and then increasing at a rate of 0.5 percent a year during CYs 2016 through 2019. The estimates in this RIA take those legislated rates as the baseline for the estimates we make as to the costs, benefits, and transfer effects of this proposed regulation, with some proposed data submission provisions for the 2018 MIPS performance period taking effect in 2018 and 2019, and the corresponding positive and negative payment adjustments taking effect in the 2020 MIPS payment year.
As required by the MACRA, overall payment rates for services for which payment is made under the PFS would remain at the 2019 level through 2025, but starting in 2019, the amounts paid to individual MIPS eligible clinicians and other eligible clinicians would be subject to adjustment through one of two mechanisms, depending on whether the clinician achieves the threshold for participation in Advanced APMs to be considered a Qualifying APM Participant (QP) or Partial QP, or is instead evaluated under the MIPS.
From 2019 through 2024, eligible clinicians receiving a sufficient portion of Medicare Part B payments for covered professional services or seeing a sufficient number of Medicare patients through Advanced APMs as required to become QPs would receive a lump-sum APM Incentive Payment equal to 5 percent of their estimated aggregate payment amounts for Medicare covered professional services in the preceding year, as discussed in section II.D. of this proposed rule.
The APM Incentive Payment is separate from, and in addition to, the payment for covered professional services furnished by an eligible clinician during that year. Eligible clinicians who become QPs for a year would not need to report to MIPS and would not receive a MIPS payment adjustment to their Part B payments. Eligible clinicians who do not become QPs, but meet a slightly lower threshold to become Partial QPs for the year, may elect to report to MIPS and would then be scored under MIPS and receive a MIPS payment adjustment, but do not receive the APM Incentive Payment. For the 2018 Medicare QP Performance Period, we define Partial QPs to be eligible clinicians in Advanced APMs who have at least 20 percent, but less than 25 percent, of their payments for Part B covered professional services through an Advanced APM Entity, or furnish Part B covered professional services to at least 10 percent, but less than 20 percent, of their Medicare beneficiaries through an Advanced APM Entity. If the Partial QP elects to be scored under MIPS, they would be subject to all MIPS requirements and would receive a MIPS payment adjustment. This adjustment may be positive or negative. If an eligible clinician does not meet either the QP or Partial QP standards, the eligible clinician would be subject to MIPS, would report to MIPS, and would receive the corresponding MIPS payment adjustment.
Beginning in 2026, payment rates for services furnished by clinicians who achieve QP status for a year would be increased each year by 0.75 percent for the year, while payment rates for services furnished by clinicians who do not achieve QP status for the year would be increased by 0.25 percent. In addition, MIPS eligible clinicians would receive positive, neutral, or negative MIPS payment adjustments to their Part B payments in a payment year based on performance during a prior performance period. Although the MACRA amendments established overall payment rate and procedure parameters until 2026 and beyond, this impact analysis covers only the second payment year (2020) of the Quality Payment Program in detail. After 2020, while overall payment levels will be partially bounded, we have also acknowledged in the preamble that the Department will likely revise its quality and other payment measures and overall payment thresholds and other parameters as clinicians' behavior changes.
We estimate that between 180,000 and 245,000 eligible clinicians will become QPs, therefore be exempt from MIPS, and qualify for lump sum incentive payment based on 5 percent of their Part B allowable charges for covered professional services, which are estimated to be between approximately $11,820 million and $15,770 million in the 2018 Quality Payment Program performance year. We estimate that the
We project the number of eligible clinicians that will be excluded from MIPS as QPs using several sources of information. First, the projections are anchored in the most recently available public information on Advanced APMs. The projections reflect APMs that will be operating in 2018. This proposed rule indicates which APMs would be Advanced APMs under proposed policies, including the Next Generation ACO Model, Comprehensive Primary Care Plus (CPC+) Model, Comprehensive ESRD Care (CEC) Model, Episode Payment Models (EPM), Vermont All-Payer ACO Model,
Certain clinicians may not be eligible to participate or may be excluded from participation in MIPS for various reasons. For example, the MACRA requires us to limit eligibility for the 2019 and 2020 MIPS payment years to specified clinician types. Additionally, we exclude eligible clinicians with billings that do not exceed the low volume threshold as proposed in section II.C.2.c. of this proposed rule: Those with $90,000 or less in Part B allowed charges or 200 or fewer Medicare Part B patients as measured at the TIN/NPI level for individual reporting, the TIN level for group reporting, the APM Entity level for reporting under the APM scoring standard. We also exclude those who are newly enrolled to Medicare and those eligible clinicians who are QPs.
To estimate the number of clinicians that are not in MIPS due to an ineligible clinician type for CY 2018, our scoring model used the first 2019 Payment Year MIPS eligibility file as described in 81 FR 77069 and 77070. The data file included 1.5 million clinicians who had Medicare Part B claims from September 1, 2015 to August 31, 2016 and included a 60-day claim run-out. We limited our analysis to those clinicians identified as MIPS eligible clinician types for the 2020 MIPS payment year: Doctors of medicine, doctors of osteopathy, chiropractors, dentists, optometrists, podiatrists, nurse practitioners, physician assistants, certified registered nurse anesthetists, and clinical nurse specialists.
We estimated the number of clinicians excluded for low volume by comparing the allowed Medicare Part B charges in the first 2019 MIPS payment year eligibility file to the proposed low volume threshold. We used 2015 PQRS reporting data to determine whether clinicians have historically reported as a group and whether to make the low-volume determination at the individual (TIN/NPI) or group (TIN) level. We assumed all Shared Savings Program or Pioneer ACO participants would exceed the low volume threshold because the ACOs have a requirement for a minimum number of assigned beneficiaries.
Because of the lack of available data on which eligible clinicians would elect to participate as part of a virtual group under the policies proposed in section II.C.4 of this proposed rule, the scoring model does not reflect the proposed policies for scoring virtual groups.
We estimated the number of newly enrolled Medicare clinicians to be excluded from MIPS by assuming clinicians (NPIs) are newly enrolled if they have Part B charges in the eligibility file, but no Part B charges in 2015. Because of data limitations, this newly enrolled modeling methodology is different than the one that will be used under the policies finalized under §§ 414.1310 and 414.1315.
To exclude QPs from our scoring model, we used a preliminary version of the file used for the predictive qualifying Alternative Payment Model participants analysis made available on
We have estimated the cumulative effects of these exclusions in Table 85. We estimate that 65 percent of clinicians' $124,029 million in allowed Medicare Part B charges will be included in MIPS. Further, we estimate that approximately 37 percent of 1,548,022 Medicare clinicians billing to Part B will be included in MIPS.
Table 85 also shows the number of eligible clinicians remaining in the scoring model used for this regulatory impact analysis (554,846) is lower than the estimated number of eligible clinicians remaining after exclusions (572,299). The discrepancy is due to our scoring model excluding clinicians that submitted via measures groups under
Our scoring model includes eligible clinicians who will be required to submit MIPS data to us in year 1.
Payment impacts in this proposed rule reflect averages by specialty and practice size based on Medicare utilization. The payment impact for a MIPS eligible clinician could vary from the average and would depend on the mix of services that the MIPS eligible clinician furnishes. The average percentage change in total revenues would be less than the impact displayed here because MIPS eligible clinicians generally furnish services to both Medicare and non-Medicare patients. In addition, MIPS eligible clinicians may receive substantial Medicare revenues for services under other Medicare payment systems that would not be affected by MIPS payment adjustment factors.
To estimate the impact of MIPS on clinicians required to report, we used the most recently available data, including 2014 and 2015 PQRS data, 2014 and 2015 CAHPS for PQRS data, 2014 and 2015 VM data, 2015 and 2016 Medicare and Medicaid EHR Incentive Program data, the data prepared to support the 2017 performance period initial determination of clinician and special status eligibility (available via the NPI lookup on
We estimated the quality performance category score using measures submitted to PQRS for the 2015 performance period. For quality measures submitted via the claims, EHR, qualified registry, QCDR, and CMS-approved survey vendor submission mechanisms, we applied the published benchmarks developed for the 2017 MIPS performance period. For quality measures submitted via Web Interface, we applied the published benchmarks developed for the 2017 Shared Savings Program where available, and did not calculate scores for measures for which Shared Savings Program benchmarks did not exist. For the all-cause hospital readmission measure we used the 2015 VM analytic file, which was the most recent data available, and calculated our own benchmarks based on 2015 data since published benchmarks were not yet available. In order to estimate the impact of improvement for the quality performance category, we estimated a quality performance category percent score using 2014 PQRS data, 2014 CAHPS for PQRS data, and 2014 VM data. Because we lack detailed information on which MIPS eligible clinicians would elect to submit as part of a virtual group and which MIPS eligible clinicians based primarily in inpatient hospital settings or in emergency departments would elect facility-based measurement, the proposed policies regarding virtual groups and facility-based measurement
We propose in section II.C.6.d.(2) of this proposed rule, for the cost performance category to have a zero percent weight and to not contribute to the 2020 MIPS payment year final score. Therefore, we did not include cost measures in this scoring model.
For the advancing care information performance category score, we used data from the 2015 Medicare and Medicaid EHR Incentive Programs. Because the EHR Incentive Programs are based on attestation at the NPI level, the advancing care information performance category scores are assigned to clinicians by their individual national provider identifier (NPI), regardless of whether the clinician was part of a group submission for PQRS. We assigned a score of 100 percent to MIPS eligible clinicians who attested in the 2015 Medicare EHR Incentive Program or received a 2015 incentive payment from the Medicaid EHR Incentive Program (after excluding incentive payments to adopt, implement, and upgrade). While we had attestation information for the Medicare EHR Incentive Program, we did not have detailed attestation information for the Medicaid EHR Incentive Program. Therefore, we used incentive payments (excluding the adopt implement and upgrade incentive payments) as a proxy for attestation in the Medicaid EHR Incentive Program. Our rationale for selecting a 100 percent performance score is that the requirements to achieve a base score of 50 percent in MIPS are lower than the EHR Incentive Program requirements to attest for meaningful use (which determined whether program requirements were met on an all or nothing basis). We anticipate clinicians who met EHR Incentive Program requirements for meaningful use will be able to achieve an advancing care information performance category score of 100 percent. Because the minimum requirements for meaningful use did not allow partial scoring, we believe the clinicians who met the minimum requirements would be able to achieve an advancing care information performance category score of 100 percent. For example, the minimum requirements to attest to Modified Stage 2 objectives and measures for the 2017 Medicare EHR Incentive Program (assuming no measure exceptions and an immunization registry is available) would translate into an advancing care information performance score of 85 percent. Generally, we see that clinicians have performance greater than the minimum requirements, which is the reason we estimated an advancing care information performance category score of 100 percent.
For those clinicians who did not attest in either the 2015 Medicare or Medicaid EHR Incentive Program, we evaluated whether the MIPS eligible clinician could have their advancing care information performance category score reweighted. The advancing care information performance category weight is set equal to zero percent, and the weight is redistributed to quality for non-patient facing clinicians, hospital-based clinicians, ASC-based clinicians, NPs, PAs, CRNAs, or CNSs, or those who request and are approved for a significant hardship or other type of exception, including a new significant hardship exception for small practices, or clinicians who are granted an exception based on decertified EHR technology. We used the non-patient facing and hospital-based indicators and specialty and small practice indicators as calculated in the initial MIPS eligibility run. Due to data limitations, we were not able to reweight the advancing care information performance category scores of ASC-based clinicians in our scoring model. For significant hardship exceptions, we used the 2016 final approved significant hardship file. If a MIPS eligible clinician did not attest and did not qualify for a reweighting of their advancing care information performance category, the advancing care information performance category score was set equal to zero percent.
We modeled the improvement activities performance category score based on 2015 APM participation and historic participation in 2015 PQRS and 2015 Medicare and Medicaid EHR Incentive Programs. Our model identified the 2015 Shared Savings Program participants and assigned them an improvement activity score of 100 percent, consistent with our policy to assign a 100 percent improvement activities performance category score to Shared Savings Program participants in Quality Payment Program Payment Year 2019. Due to limitations in 2015 data, our model did not include 2015 participants in APMs other than the Shared Savings Program.
Clinicians and groups not participating in a MIPS APM were assigned an improvement activities score based on their performance in the quality and advancing care information performance categories. MIPS eligible clinicians whose 2015 PQRS data meets all the MIPS quality submission criteria (for example, submitting 6 measures with data completeness, including one outcome or high priority measures) and had an estimated advancing care information performance category score of 100 percent (if advancing care information is applicable to them) are assigned an improvement activities performance category score of 100 percent. MIPS eligible clinicians who did not participate in 2015 PQRS or the 2015 Medicare or Medicaid EHR Incentive Program (if it was applicable), earned an improvement activity performance category score of zero percent, with the rationale that these clinicians may be less likely to participate in MIPS if they have not previously participated in other programs.
For the remaining MIPS eligible clinicians not assigned an improvement activities performance category score of 0 or 100 percent in our model, we assigned a score that corresponds to submitting one medium-weighted improvement activity. The MIPS eligible clinicians assigned an improvement activity performance category score corresponding to a medium-weighted activity include (a) those who submitted some quality measures under the 2015 PQRS but did not meet the MIPS quality submission criteria or (b) those who did not submit any quality data under the 2015 PQRS who attested under the Medicare EHR Incentive program or received an incentive payment (excluding adopt implement and upgrade payments) from the Medicaid EHR Incentive Program. We assumed that these clinicians may be likely to partially, but not fully participate, in the improvement activities category. For non-patient facing clinicians, clinicians in a small practice (consisting of 15 or fewer professionals), clinicians in practices located in a rural area, clinicians in a geographic healthcare professional shortage area (HPSA) practice or any combination thereof, the medium weighted improvement activity was assigned one-half of the total possible improvement activities performance category score (20 out of a 40 possible points or 50 percent) The remaining MIPS eligible clinicians not assigned an improvement activities performance category score of 0, 50, or 100 points were assigned a score corresponding to one medium-weighted activity (10 out of 40 possible points or 25 percent). Due to lack of available data, we were not able to identify MIPS eligible clinicians in patient-centered medical homes or comparable specialty societies in our scoring model. The
Our model assigns a final score for each TIN/NPI by multiplying each performance category score by the corresponding performance category weight, adding the products together, and multiplying the sum by 100 points. For MIPS eligible clinicians that had their advancing care information performance category score reweighted due to a significant hardship exception or automatic reweighting, the weight for the advancing care information performance category was assigned to the quality performance category.
The scoring model reflects the proposed bonuses for complex patients and small practices in sections II.C.7.b.(1)(b) and II.C.7.b.(1)(c) of this proposed rule. Consistent with the proposal to define complex patients as those with high medical risk, our scoring model adds the average Hierarchical Condition Category (HCC) score across all the MIPS eligible clinician's patients (with a cap of three points) to the final score. We used the average HCC risk score calculated for each NPI in the 2015 Physician and Other Supplier Public Use File. We also generated a group average HCC risk score by weighing the scores for individual clinicians in each group by the number of beneficiaries they have seen. Our scoring model also adds 5 points to the final score for small practices that had a final score greater than 0 points. After adding any applicable bonus for complex patients and small practices, we set any final scores that exceeded 100 points to 100.
We then implemented an exchange function based on the provisions of this proposed rule to estimate the positive or negative MIPS payment adjustment based on the estimated final score and the estimated Medicare Part B paid charges. Due to data limitations, we assumed that the paid amount was 80 percent of Medicare Part B allowed charges. We iteratively modified the parameters of the exchange function distributions of MIPS payment adjustments that meet statutory requirements related to the linear sliding scale, budget neutrality and aggregate exceptional performance payment adjustment amounts (as finalized under § 414.1405). Our model used a 15-point performance threshold and a 70-point additional performance threshold.
With the extensive changes to policy and the flexibility that is allowed under MIPS, estimating impacts of this proposed rule using only historic 2015 participation assumptions would significantly overestimate the impact on clinicians, particularly on clinicians in practices with 1–15 clinicians, which have traditionally had lower participation rates. To assess the sensitivity of the impact to the participation rate, we have prepared two sets of analyses.
The first analysis, which we label as standard participation assumptions, relies on the assumption that a minimum 90 percent of MIPS eligible clinicians will participate in submitting quality performance category data to MIPS, regardless of practice size. Therefore, we assumed that, on average, the categories of practices with 1–15 clinicians would have 90 percent participation in the quality performance category. This assumption is an increase from existing historical data. PQRS participation rates have increased steadily since the program began; the 2015 PQRS Experience Report showed an increase in the participation rate from 15 percent in 2007 to 69 percent in 2015.
To simulate the impact of the standard model assumption, we randomly select a subset of non-participants and substitute the quality and improvement activity scores of randomly selected participants. For example, for a previously non-participating clinician, we substitute the scores of a randomly selected MIPS eligible clinician with a quality score of 73 percent. The improvement activities performance category score is then computed using this alternative quality score. We did not apply the same participation assumptions to the advancing care information performance category because the category applies only to a subset of MIPS eligible clinicians, and, as noted above, would be weighted at zero percent for non-patient facing clinicians, hospital-based clinicians, ASC-based clinicians, NPs, PAs, CRNAs, or CNSs, and those who request and are approved for a significant hardship or other type of exception, including those in small practices. Further, we took into account that advancing care information performance category participation may be affected by the cost and time it may take to acquire and implement certified EHR technology needed to perform in that performance category.
The second analysis, which we label as “alternative participation assumptions,” assumes a minimum participation rate in the quality and improvement activities performance categories of 80 percent. Because the 2015 PQRS participation rates for practices of more than 15 clinicians are greater than 80 percent, this analysis assumes increased participation for practices of 1–15 clinicians only. Practices of more than 15 clinicians are included in the model at their historic participation rates.
Table 86 summarizes the impact on Part B services of MIPS eligible clinicians by specialty for the standard participation assumptions.
Table 87 summarizes the impact on Part B services of MIPS eligible clinicians by specialty under the alternative participation assumptions.
Tables 89 and 90 summarize the impact on Part B services of MIPS eligible clinicians by practice size for the standard participation assumptions (Table 88) and the alternative participation assumptions (Table 89).
Tables 87 and 89 show that under our standard participation assumptions, the vast majority (96.1 percent) of MIPS eligible clinicians are anticipated to receive positive or neutral payment adjustments for the 2020 MIPS payment
The projected distribution of funds reflects this proposed rule's emphasis on increasing more complete reporting of MIPS eligible clinicians for the Quality Payment Program Performance Year 2, which continues the ramp to more robust participation in future MIPS performance years.
We believe that most MIPS eligible clinicians who can report the advancing care information performance category of MIPS have already adopted an EHR during Stage 1 and 2 of the Medicare or Medicaid EHR Incentive Programs, and will have limited additional operational expenses related to compliance with the advancing care information performance category requirements.
MIPS eligible clinicians who did not participate in the Medicare and Medicaid EHR Incentive Programs could potentially face additional operational expenses for implementation and compliance with the advancing care information performance category requirements.
For some MIPS eligible clinicians, the advancing care information performance category will be weighted at zero percent of the final score. We will continue our policy that was finalized in § 414.1375(a) to reweight the advancing care information performance category scores for certain MIPS eligible clinicians, including those who may have been exempt from the Medicare EHR Incentive Program such as hospital-based clinicians, non-patient facing clinicians, PAs, NPs, CNs and CRNAs. Further, as described in section II.6.f.(7)(a)(iv) of this proposed rule, we are proposing to rely on section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, to assign a scoring weight of zero percent for the advancing care information performance category for MIPS eligible clinicians who are determined to be based in ambulatory surgical centers (ASCs). As described in section II.6.f.(7)(a)(i) of this proposed rule, we are proposing to rely on section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, to allow MIPS eligible clinicians to apply for a significant hardship exception and subsequently have their advancing care information performance category reweighted to zero when they are faced with a significant hardship. Relying on this same authority, we are also proposing a significant hardship exception for the advancing care information performance category for MIPS eligible clinicians who are in small practices, as discussed in section II.6.f.7.(a)(ii) of this proposed rule, and are proposing an exception for MIPS eligible clinicians whose CEHRT has been decertified under ONC's Health IT Certification Program as discussed in section II.6.f.7.(a)(v) of this proposed rule. Additionally, we believe most MIPS eligible clinicians who can report the advancing care information performance category of MIPS have already adopted an EHR during Stage 1 and 2 of the Medicare EHR Incentive Program. As we have stated with respect to the Medicare EHR Incentive Program, we believe that future retrospective studies on the costs to implement an EHR and the return on investment (ROI) will demonstrate efficiency improvements that offset the actual costs incurred by MIPS eligible clinicians participating in MIPS and specifically in the advancing care information performance category, but we are unable to quantify those costs and benefits at this time. At present, evidence on EHR benefits in either improving quality of care or reducing health care costs is mixed. This is not surprising since the adoption of EHR as a fully functioning part of medical practice is progressing, with numerous areas of adoption, use, and
A recent RAND report prepared for the ONC reviewed 236 recent studies that related the use of health IT to quality, safety, and efficacy in ambulatory and non-ambulatory care settings and found that—
“A majority of studies that evaluated the effects of health IT on healthcare quality, safety, and efficiency reported findings that were at least partially positive. These studies evaluated several forms of health IT: Metric of satisfaction, care process, and cost and health outcomes across many different care settings. Our findings agree with previous [research] suggesting that health IT, particularly those functionalities included in the Medicare EHR Incentive Program regulation, can improve healthcare quality and safety. The relationship between health IT and [health care] efficiency is complex and remains poorly documented or understood, particularly in terms of healthcare costs, which are highly dependent upon the care delivery and financial context in which the technology is implemented.”
Similarly, the costs for implementation and complying with the improvement activities performance category requirements could potentially lead to higher expenses for MIPS eligible clinicians. Costs per full-time equivalent primary care clinician for improvement activities will vary across practices, including for some activities or certified patient-centered medical home practices, in incremental costs per encounter, and in estimated costs per member per month.
Costs may vary based on panel size and location of practice among other variables. For example, Magill (2015) conducted a study of certified patient-centered medical home practices in two states.
There are a number of changes in this proposed rule that would have an effect on beneficiaries. In general, we believe that the changes may have a positive impact and improve the quality and value of care provided to Medicare beneficiaries. More broadly, we expect that over time clinician engagement in the Quality Payment Program may result in improved quality of patient care, resulting in lower morbidity and mortality. We believe the policies finalized in the CY 2017 Quality Payment Program final rule, as well as policies in this rule will lead to additional growth in the participation of both MIPS APMS and Advanced APMs. APMs promote seamless integration by way of their payment methodology and design that incentivize such care coordination. The policies that are being proposed regarding the All-Payer Combination Option and identification of Other Payer Advanced APMs will help facilitate both the development and participation in alternative payment arrangements in the private and public sectors. Clinicians can focus their efforts around the care transformation in either Advanced APM or MIPS APM models and know that those efforts will be aligned with the Quality Payment Program, either through incentive payments for QPs or through MIPS scores calculated based on performance within the APM assessed at the APM Entity level.
Several Advanced APMs and MIPS APMS have shown evidence of improving the quality of care provided to beneficiaries and beneficiaries' experience of care. For example, the various shared savings initiatives already operating have demonstrated the potential for quality programs to delivers better quality healthcare, smarter spending, and to put beneficiary experience at the center. For example, in August of 2015, we issued 2014 quality and financial performance results showing that ACOs continue to improve the quality of care for Medicare beneficiaries while generating net savings to the Medicare trust fund, if shared savings paid out to these ACOs are not included.
For Pioneer ACOs, the financial and quality results continue to be positive, with several Pioneer ACOs generating greater savings in the model performance year 4 (PY4) (2015) and one ACO generating savings for the first time. While the cohort of Pioneer ACOs decreased between PY3 (2014) and PY4, they still generated total model savings of over $37 million. It is important to note that going into PY4, the benchmarks for the Pioneer ACOs were re-based, and the Model as a whole introduced new financial benchmarking methodologies. Re-basing refers to using a newer set of baseline years to compute financial benchmarks; the new benchmarks are therefore based on ACOs' spending during their initial years of participation in the Pioneer ACO Model.
Quality performance improved considerably from PY3 to PY4 and across all 4 years of the Pioneer ACO Model. Overall quality scores for nine of the 12 Pioneer ACOs were above 90 percent in PY4. All 12 Pioneers improved their quality scores from PY1 (2012) to PY4 by over 21 percentage points. The financial results were that the 12 Pioneer ACOs participating in PY4 were accountable for 461,442 beneficiaries, representing a nearly 24 percent increase in average aligned beneficiaries per ACO (up to 38,454) from PY3. PY4 was the first option year in the Pioneer ACO Model, where Pioneer ACOs were operating under a new financial benchmarking methodology. While the cohort of Pioneer ACOs decreased by nearly a third between PY3 and PY4 with several Pioneer ACOs transitioning to either the Shared Savings Program or the Next Generation ACO model Pioneer ACOs still generated total model savings (inclusive of all Pioneer ACO savings and losses relative to financial benchmarks) of over $37 million. Of the eight Pioneer ACOs that generated savings, six generated savings outside a minimum savings rate and earned shared savings, and of the four Pioneer ACOs that generated losses, one generated losses outside a minimum loss rate and owed shared losses.
The results from the third program year (January through December 2015) of the original CPC Initiative indicate that the from 2013 to 2015 CPC practices transformed their care delivery —with the biggest improvements in risk-stratified care management, expanded access to care, and continuity of care. The CPC also improved patient experience slightly. Over the first 3 years, ED visits increased by 2 percent less for Medicare FFS beneficiaries in CPC practices relative to those in comparison practices.
As the early findings from the original CPC initiative and literature from other medical home models supported by payment suggest, we expect to see improvement in quality and patient experience of care.
While maintaining coverage of Original Medicare services and beneficiary freedom to choose providers, ACOs could potentially enhance care management of the chronically ill aligned population through the adoption of leading-edge technologies, care coordination techniques, and evidence-based benefit enhancements that motivate providers and beneficiaries to optimize care. The evidence discussed here focuses on the Next Generation Model elements of telehealth, home health care, and reduced cost sharing.
The transition from the inpatient setting to home is a critical period for patients, particularly elderly populations. Studies have examined a variety of interventions to help smooth care transitions. Interventions found in the literature include advance practice nurse-led comprehensive discharge planning and home visit follow-up protocols
The study of the potential value and efficacy of telehealth and remote patient monitoring has become more prevalent in recent years as technology has enabled greater utilization of these services.
We estimate that the Quality Payment Program Year 2 will not have a significant economic effect on eligible clinicians and groups and believe that MIPS policies, along with increasing participation in APMs over time may succeed in improving quality and reducing costs. This may in turn result in beneficial effects on both patients and some clinicians, and we intend to continue focusing on clinician-driven, patient-centered care.
We propose several policies for the Quality Payment Program Year 2 to reduce burden. These include raising the low volume threshold so that fewer clinicians in small practices are required to participate in the MIPS starting with the 2018 performance period; including bonus points for clinicians in small practices; adding a new significant hardship exception for the advancing care information performance category for MIPS eligible clinicians in small practices; implementing virtual groups; allowing MIPS eligible clinicians and groups to submit measures and activities using as many submission mechanisms as necessary to meet the requirements of the quality, improvement activities, or advancing care information performance categories; implementing a voluntary facility-based scoring mechanism for the 2018 performance period that aligns with the Hospital Value Based Purchasing (VBP) Program, and extending the ability of MIPS eligible clinicians and groups to use 2014 Edition CEHRT while providing bonus points for the use of the 2015 Edition of CEHRT. Additionally, for vendors, we believe the flexibility to use EHR technology certified to either the 2014 Edition or the 2015 Edition for the Quality Payment Program Year 2 is beneficial as vendors will have additional time to deploy the updated software to their customers, which are the clinicians and other providers. Clinicians will likewise have additional time to upgrade and implement the new functionalities.
In summary, the Quality Payment Program policies are designed to promote the delivery of high-value care for individuals in all practices and areas with a particular focus on clinicians in small and solo practices. We believe each of these proposals will further reduce burdens on clinicians and practices and help increase successful participation. Further, the policies throughout this proposed rule will focus the Quality Payment Program in its second year on encouraging more complete data submission and educating clinicians. The proposed policies will continue a glide path, which began in the transition year, to more robust participation and performance in future years. The proposed policy changes are reflected in the RIA estimates, which show that the risk for negative MIPS payment adjustment is minimal for MIPS eligible clinicians, including small and solo practices that meet the proposed data completeness requirements.
This proposed rule contains a range of policies, including many provisions related to specific statutory provisions. The preceding preamble provides descriptions of the statutory provisions that are addressed, identifies those policies where discretion has been exercised, presents our rationale for our proposed policies and, where relevant, analyzes alternatives that we considered. Comment is sought in section II.C.8.c. of this proposed rule on policies closely related to this Regulatory Impact Analysis, including the performance threshold. We view the performance threshold as one of the most important factors affecting the distribution of payment adjustments under the Program, and the alternatives that we considered focus on that policy.
For example, we discuss above that we modeled the effects of the proposed rule's policies using a 15-point performance threshold and a 70-point additional performance threshold. Additionally, we assumed a minimum 90 percent participation rate in each category of eligible clinicians. We displayed the results of that modeling in Table 86 along with subsequent tables.
We tested two additional models using a performance threshold of 6 points and a performance threshold of 33 points. In both of these cases, we again modeled a 70-point additional performance threshold and a minimum 90 percent participation rate in each category of eligible clinicians in order to focus the results on the differing performance thresholds.
Under the 6-point performance threshold alternative, we estimated that we would make approximately $663.5 million in positive payment adjustments (including $500 million in exceptional performance payments), and conversely, would make approximately $163.5 million in negative payment adjustments. These results represent a roughly $10 million reduction in the aggregate positive adjustments and a roughly $10 million reduction in
Under the 33-point performance threshold alternative, we estimated that we would make approximately $743.7 million in positive payment adjustments (including $500 million in exceptional performance payments), and conversely, would make approximately $243.7 million in negative payment adjustments. These results represent a roughly $70 million increase in aggregate positive payment adjustments and a roughly $70 million increase in aggregate negative payment adjustments compared to the results displayed above in Table 86. Additionally, under the 33-point performance threshold alternative, we estimated that approximately 9.1 percent of eligible clinicians would receive a negative payment adjustment, compared to the approximately 3.9 percent that we estimated in the 15-point model.
We would like to note several limitations to the analyses that estimated MIPS eligible clinicians' eligibility, negative MIPS payment adjustments, and positive payment adjustments for the 2020 MIPS payment year based on the data prepared to support the 2017 performance period initial determination of clinician and special status eligibility (available via the NPI lookup on
The scoring model cannot fully reflect MIPS eligible clinicians' behavioral responses to MIPS. The scoring model assumes higher participation in MIPS quality reporting than under the PQRS. Other potential behavioral responses are not addressed in our scoring model. The scoring model assumes that quality measures submitted and the distribution of scores on those measures would be similar under Quality Payment Program Payment in the 2020 MIPS payment year as they were under the 2015 PQRS program.
The scoring model does not reflect the growth in Advanced APM participation between 2017 and 2018. After applying the other MIPS exclusions, the scoring model excluded approximately 74,920 QPs using preliminary QP data for Quality Payment Program Year 2017, significantly lower than CMS' summary level projected QP counts for Quality Payment Program Year 2018 (180,000–245,000). The methods for the summary level estimates reflect the several new APMs that we anticipate will be Advanced APMs in CY 2018, and that some eligible clinicians will join the successors of APMs already active in early 2017.
There are additional limitations to our estimates. To the extent that there are year-to-year changes in the data submission, volume and mix of services provided by MIPS eligible clinicians, the actual impact on total Medicare revenues will be different from those shown in Tables 86 through 90. Due the limitations above, there is considerable uncertainty around our estimates that is difficult to quantify in detail.
If regulations impose administrative costs on private entities, such as the time needed to read and interpret this proposed rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review this proposed rule, we assume that the total number of commenters on last year's proposed rule will be the number of reviewers of this proposed rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this rule. It is possible that not all commenters reviewed last year's rule in detail, and it is also possible that some reviewers chose not to comment on the proposed rule. For these reasons, we believe that the number of past commenters would be a fair estimate of the number of reviewers of this proposed rule. We welcome any public comments on the approach in estimating the number of entities that will review this proposed rule.
We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this proposed rule. Therefore, for the purposes of our estimate, we assume that each reviewer reads approximately 50 percent of the proposed rule. We are seeking public comments on this assumption.
Using the wage information from the BLS for medical and health service managers (Code 11–9111), we estimate that the cost of reviewing this proposed rule is $105.16 per hour, including overhead and fringe benefits, which we assume are 100 percent of the hourly wage (
As required by OMB Circular A–4 (available at
We have not attempted to quantify the benefits of this proposed rule because of the many uncertainties as to both clinician behaviors and resulting effects on patient health and cost reductions. For example, the applicable percentage for MIPS payment adjustments changes over time, increasing from 4 percent in 2019 to 9 percent in 2022 and subsequent years, and we are unable to estimate precisely how physicians will respond to the increasing payment adjustments. As noted above, in CY 2020, we estimate that we will distribute approximately $173 million in payment adjustments on a budget-neutral basis, which represents the applicable percent for 2020 required under section 1848(q)(6)(B)(i) of the Act and excludes $500 million in additional MIPS payment adjustments for exceptional performance.
Further, the addition of new Advanced APMs and growth in Advanced APM participation over time will affect the pool of MIPS eligible clinicians, and for those that are MIPS eligible clinicians, may change their relative performance. The $500 million available for exceptional performance and the 5 percent APM Incentive Payment for QPs are only available from 2019 through 2024. Beginning in 2026, Medicare PFS payment rates for services furnished by QPs will receive a higher update than for services furnished by non-QPs. However, we are unable to estimate the number of QPs in those years, as we cannot project the number or types of Advanced APMs that will be made available in those years through future CMS initiatives proposed and
The percentage of the final score attributable to each performance category will change over time and we will continue to refine our scoring rules. The improvement activities category represents a new category for measuring MIPS eligible clinicians' performance. We may also propose policy changes in future years as we continue implementing MIPS and as MIPS eligible clinicians accumulate experience with the new system. Moreover, there are interactions between the MIPS and APM incentive programs and other shared savings and incentive programs that we cannot model or project. Nonetheless, even if ultimate savings and health benefits represent only low fractions of current experience, benefits are likely to be substantial in overall magnitude.
Table 90 includes our estimate for MIPS payment adjustments ($173 million), the exceptional performance payment adjustments under MIPS ($500 million), and incentive payments to QPs (using the range described in the preceding analysis, approximately $590–$800 million). However, of these three elements, only the negative MIPS payment adjustments are shown as estimated decreases.
Based on National Health
Table 91 summarizes the regulatory review costs discussed in section V.E. of this proposed rule, and the collection of information burden costs calculated in section III.N. of this proposed rule.
As noted above, we estimate the regulatory review costs of $4.8 million for this proposed rule. In Table 91, we have prepared our analysis of collection of information burden costs to be consistent with guidance in accordance with OMB's April 2017 guidance on EO13771. The Order's guidance directs agencies to measure certain costs, including costs associated with “Medicare quality performance tracking”, using the estimates in the CY 2017 Quality Payment Program final rule as a baseline. The Order notes that regular updates to certain Medicare regulations make assessments of the incremental changes related to “performance tracking” included in a proposed regulation much more useful than a comparison against hypotheticals (such as a program's hypothetical discontinuation).
As shown in section III.N. of this proposed rule, we estimate that this proposed rule will result in approximately $857 million in collection of information-related burden. However, we estimate that the incremental collection of information-related burden associated with this proposed rule is an approximately $12.4 million reduction relative to the baseline burden of continuing the policies and information collections set forth in the CY 2017 Quality Program final rule into CY 2018. Our burden estimates reflect several proposed that would reduce burden, including the proposed reduction in the length of the CAHPS survey; our proposal to allow certain hospital-based clinicians to elect use facility-based measurements, thereby eliminating the need for additional quality data submission processes; and our proposal to allow MIPS eligible clinicians to form virtual groups, which would create efficiencies in data submission; and our proposal for significant hardship or other type of exception, including a new significant hardship exception for small practices for the advancing care information performance category.
Table 91 also shows the expected benefits associated with this proposed rule. We note that these expected benefits are qualitative in nature. We expect that the Quality Payment Program will result in quality improvements and improvements to the patients' experience of care as MIPS eligible clinicians respond to the incentives for high-quality care provided by the Program and implement care quality improvements in their clinical practices. While we cannot quantify these effects specifically at this time because we cannot project eligible clinicians' behavioral responses to the incentives offered under the Quality Payment Program, we nevertheless believe that changes to clinical care will result in care quality improvements for Medicare beneficiaries and other patients treated by eligible clinicians.
Administrative practice and procedure, Biologics, Drugs, Health facilities, Health professions, Diseases, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below:
Secs. 1102, 1871, and 1881(b)(l) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).
The revisions and additions read as follows:
(1) For any calendar year before 2019, EHR technology (which could include multiple technologies) certified under the ONC Health IT Certification Program that meets one of the following:
(iii) The definition for 2019 and subsequent years specified in paragraph (2) of this definition.
(2) For 2019 and subsequent years, EHR technology (which could include multiple technologies) certified under the ONC Health IT Certification Program that meets the 2015 Edition Base EHR definition (as defined at 45 CFR 170.102) and has been certified to the 2015 Edition health IT certification criteria—
(a)
(b)
(c)
(1)
(i) Solo practitioners and groups with 10 or fewer eligible clinicians interested in forming or joining a virtual group have the option to contact their designated technical assistance representative or the Quality Payment Program Service Center, as applicable, in order to obtain information pertaining to virtual groups and/or determine whether or not they are eligible, as it relates to the practice size requirement of a solo practitioner or a group of 10 or fewer eligible clinicians, to participate in MIPS as a virtual group.
(ii) [Reserved]
(2)
(i) TINs comprising a virtual group must establish a written formal agreement between each member of a virtual group prior to an election.
(ii) On behalf of a virtual group, the official designated virtual group representative must submit an election by December 1 of the calendar year prior to the start of the applicable performance period.
(iii) The submission of a virtual group election must include, at a minimum, information pertaining to each TIN and NPI associated with the virtual group and contact information for the virtual group representative.
(iv) Once an election is made, the virtual group representative must contact their designated CMS contact to update any election information that changed during a performance period one time prior to the start of an applicable submission period.
(3)
(i) Expressly state the only parties to the agreement are the TINs and NPIs of the virtual group.
(ii) Be executed on behalf of the TINs and the NPIs by individuals who are authorized to bind the TINs and the NPIs, respectively.
(iii) Expressly require each member of the virtual group (including each NPI under each TIN) to agree to participate in the MIPS as a virtual group and comply with the requirements of the MIPS and all other applicable laws and regulations (including, but not limited to, federal criminal law, False Claims Act, anti-kickback statute, civil monetary penalties law, Health Insurance Portability and Accountability Act, and physician self-referral law).
(iv) Require each TIN within a virtual group to notify all NPIs associated with the TIN regarding their participation in the MIPS as a virtual group.
(v) Set forth the NPI's rights and obligations in, and representation by, the virtual group, including without limitation, the reporting requirements and how participation in the MIPS as a virtual group affects the ability of the
(vi) Describe how the opportunity to receive payment adjustments will encourage each member of the virtual group (including each NPI under each TIN) to adhere to quality assurance and improvement.
(vii) Require each member of the virtual group to update its Medicare enrollment information, including the addition and deletion of NPIs billing through a TIN that is part of a virtual group, on a timely basis in accordance with Medicare program requirements and to notify the virtual group of any such changes within 30 days after the change.
(viii) Be for a term of at least one performance period as specified in the formal written agreement.
(ix) Require completion of a close-out process upon termination or expiration of the agreement that requires the TIN (group part of the virtual group) or NPI (solo practitioner part of the virtual group) to furnish all data necessary in order for the virtual group to aggregate its data across the virtual group.
(d)
(1) Individual eligible clinicians and individual MIPS eligible clinicians who are part of a TIN participating in MIPS at the virtual group level would have their performance assessed as a virtual group.
(2) Individual eligible clinicians and individual MIPS eligible clinicians who are part of a TIN participating in MIPS at the virtual group level would need to meet the definition of a virtual group at all times during the performance period for the MIPS payment year.
(3) Individual eligible clinicians and individual MIPS eligible clinicians who are part of a TIN participating in MIPS at the virtual group level must aggregate their performance data across multiple TINs in order for their performance to be assessed as a virtual group.
(4) MIPS eligible clinicians that elect to participate in MIPS at the virtual group level would have their performance assessed at the virtual group level across all four MIPS performance categories.
(5) Virtual groups would need to adhere to an election process established and required by CMS.
(c) For purposes of the 2021 MIPS payment year and future years, the performance period for:
(1) The quality and cost performance categories is the full calendar year (January 1 through December 31) that occurs 2 years prior to the applicable MIPS payment year.
(2) [Reserved]
(d) For purposes of the 2021 MIPS payment year, the performance period for:
(1) The advancing care information and improvement activities performance categories is a minimum of a continuous 90-day period within CY 2019, up to and including the full CY 2019 (January 1, 2019 through December 31, 2019).
(2) [Reserved]
(c) * * *
(6) A CMS-approved survey vendor for groups that elect to include the CAHPS for MIPS survey as a quality measure. Groups that elect to include the CAHPS for MIPS survey as a quality measure must select from the above data submission mechanisms to submit their other quality information.
(d)
(b) * * *
(2) 60 percent of a MIPS eligible clinician's final score for MIPS payment year 2020.
(a) * * *
(2) * * *
(i) Criteria applicable to groups of 25 or more eligible clinicians, report on all measures included in the CMS Web Interface. The group must report on the first 248 consecutively ranked beneficiaries in the sample for each measure or module.
(a) * * *
(2) At least 50 percent of the MIPS eligible clinician or group's patients that meet the measure's denominator criteria, regardless of payer for the MIPS payment year 2020.
(3) At least 60 percent of the MIPS eligible clinician or group's patients that meet the measure's denominator criteria, regardless of payer for MIPS payment year 2021.
(b) * * *
(2) At least 50 percent of the applicable Medicare Part B patients seen during the performance period to which the measure applies for MIPS payment year 2020.
(3) At least 60 percent of the applicable Medicare Part B patients seen during the performance period to which the measure applies for MIPS payment year 2021.
(b) * * *
(2) 0 percent of a MIPS eligible clinicians' final score for MIPS payment year 2020.
(a) For purposes of the transition year of MIPS and future years MIPS eligible clinicians must submit data on MIPS improvement activities in one of the following manners:
The revisions and additions read as follows:
(b) * * *
(4) * * *
(i)
(e)
(1)
(2) [Reserved]
(f)
(1) If a Shared Savings Program ACO does not report data on quality measures as required by the Shared Savings Program under § 425.508 of this chapter, each ACO participant TIN will be treated as a unique APM Entity for purposes of the APM scoring standard.
(2)
(g) * * *
(1) * * *
(i) * * *
(A)
(B)
(C)
(D) If a Shared Savings Program ACO does not report on quality measures on behalf of its participating eligible clinicians as required by the Shared Savings Program under § 425.508 of this chapter, the ACO participant TINs may report data for the MIPS quality performance category according to the MIPS submission and reporting requirements.
(ii)
(A)
(
(
(
(
(B)
(C)
(2)
(3) * * *
(i) CMS assigns an improvement activities score for each MIPS APM for an APM scoring standard performance period based on the requirements of the MIPS APM. The assigned improvement activities score applies to each APM Entity group for the APM scoring standard performance period. In the event that the assigned score does not represent the maximum improvement activities score, an APM Entity may report additional activities.
(4) * * *
(i) Each Shared Savings Program ACO participant TIN must report data on the Advancing Care Information (ACI) Performance category separately from the ACO, as specified in § 414.1375(b)(2). The ACO participant TIN scores are weighted according to the number of MIPS eligible clinicians in each TIN as a proportion of the total number of MIPS eligible clinicians in the APM Entity group, and then aggregated to determine an APM Entity score for the ACI Performance category.
(ii) For APM Entities in MIPS APMs other than the Shared Savings Program, CMS uses one score for each MIPS eligible clinician in the APM Entity group to derive a single average APM Entity score for the ACI Performance category. The score for each MIPS eligible clinician is the higher of either:
(h)
(1)
(i) For MIPS APMs that require use of the CMS Web Interface: 50 percent.
(ii) For Other MIPS APMs, 0 percent for 2017, 50 percent beginning in 2018.
(3)
(i) For MIPS APMs that require use of the CMS Web Interface: 20 percent.
(ii) For Other MIPS APMs, 25 percent for 2017, 20 percent beginning in 2018.
(4)
(i) For MIPS APMs that require use of the CMS Web Interface: 30 percent.
(ii) For Other MIPS APMs, 25 percent for 2017, 30 percent beginning in 2018.
(5)
(i) If CMS reweights the Quality Performance category to 0 percent, the Improvement Activities Performance category is reweighted to 25 percent and the Advancing Care Information Performance category is reweighted to 75 percent.
(ii) If CMS reweights the Advancing Care Information Performance category to 0 percent, the Quality Performance category is reweighted to 80 percent.
(a)
(b) * * *
(2) * * *
(ii) May claim an exclusion for each measure that includes an option for an exclusion.
(a)
(1)
(ii) For the cost performance category, measures are scored between 1 and 10 points. Performance is measured against a benchmark. Starting with the 2020 MIPS payment year, improvement scoring is available in the cost performance category.
(iii) For the improvement activities performance category, each improvement activity is worth a certain number of points. The points for each reported activity are summed and scored against a total potential performance category score of 40 points.
(iv) For the advancing care information performance category, the performance category score is the sum of a base score, performance score, and bonus score.
(2) [Reserved]
(b)
(1)
(i) Measure benchmarks are based on historical performance for the measure based on a baseline period. Each benchmark must have a minimum of 20 individual clinicians or groups who reported the measure meeting the data completeness requirement and minimum case size criteria and performance greater than zero. Benchmark data are separated into decile categories based on a percentile distribution. We will restrict the benchmarks to data from MIPS eligible clinicians and comparable APM data, including data from QPs and Partial QPs.
(ii) As an exception, if there is no comparable data from the baseline period, CMS would use information from the performance period to create measure benchmarks, as described in paragraph (b)(1)(i) of this section, which would not be published until after the performance period. For the 2017 performance period, CMS would use information from CY 2017 during which MIPS eligible clinicians may report for a minimum of any continuous 90-day period.
(A) CMS Web Interface submission uses benchmarks from the corresponding reporting year of the Shared Savings Program.
(B) [Reserved]
(iii) Separate benchmarks are used for the following submission mechanisms:
(A) EHR submission options;
(B) QCDR and qualified registry submission options;
(C) Claims submission options;
(D) CMS Web Interface submission options;
(E) CMS-approved survey vendor for CAHPS for MIPS submission options; and
(F) Administrative claims submission options.
(iv) Minimum case requirements for quality measures are 20 cases, unless a measure is subject to an exception.
(v) As an exception, the minimum case requirements for the all-cause hospital readmission measure is 200 cases.
(vi) MIPS eligible clinicians failing to report a measure required under this category receive zero points for that measure.
(vii) Subject to paragraph (b)(1)(viii) of this section, MIPS eligible clinicians do not receive zero points if the expected measure is submitted but is unable to be scored because it does not meet the required case minimum or if the measure does not have a measure benchmark for MIPS payment years 2019 and 2020. Instead, these measures receive a score of 3 points in MIPS payment years 2019 and 2020. MIPS eligible clinicians do not receive zero points if the expected measure is submitted but is unable to be scored because it is below the data completeness requirement. Instead, these measures receive a score of 3 points in the 2019 MIPS payment year and a score of 1 point in the 2020 MIPS payment year, except if the measure is submitted by a small practice. Measures below the data completeness requirement submitted by a small practice receive a score of 3 points in the 2020 MIPS payment year.
(viii) As an exception, the administrative claims-based measures and CMS Web Interface measures will not be scored if these measures do not meet the required case minimum. For CMS Web Interface measures, we will recognize the measure was submitted but exclude the measure from being scored. For CMS Web Interface measures: Measures that do not have a measure benchmark and measures that have a measure benchmark but are redesignated as pay for reporting for all Shared Savings Program accountable care organizations by the Shared Savings Program, CMS will recognize the measure was submitted but exclude the measure from being scored as long as the data completeness requirement is met. CMS Web Interface measures that are below the data completeness requirement will be scored and receive 0 points.
(ix) Measures submitted by MIPS eligible clinicians are scored against measure benchmarks using a percentile distribution, separated by decile categories.
(x) For each set of benchmarks, CMS calculates the decile breaks for measure performance and assigns points based on which benchmark decile range the MIPS eligible clinician's measure rate is between.
(xi) CMS assigns partial points based on the percentile distribution.
(xii) MIPS eligible clinicians are required to submit measures consistent with § 414.1335.
(A) MIPS eligible clinicians that submit measures via claims, qualified registry, EHR, or QCDR submission mechanisms, and submit more than the required number of measures are scored on the required measures with the highest measure achievement points. MIPS eligible clinicians that report a measure via more than one submission mechanism can be scored on only one submission mechanism, which will be the submission mechanism with the highest measure achievement points. Groups that submit via these submission options may also submit and be scored on CMS-approved survey vendor for CAHPS for MIPS submission mechanisms.
(B) Groups that submit measures via the CMS Web Interface may also submit and be scored on CMS-approved survey vendor for CAHPS for MIPS submission mechanisms.
(xiii) Topped out quality measures will be identified on an annual basis and may be removed from the measure set for a submission mechanism after the third consecutive year that a given measure has been identified as topped out in connection with that submission mechanism. CMS will identify topped out measures in the benchmarks published for each Quality Payment Program year. Topped out measures that have been removed pursuant to this policy will not be available for reporting after removal.
(A) For the 2018 MIPS performance period (2020 MIPS payment year), selected topped out measures identified by CMS will receive no more than 6 measure achievement points, provided that the measure benchmarks for all submission mechanisms are identified as topped out in the benchmarks published for the 2018 MIPS performance period.
(B) Beginning with the 2019 MIPS performance period (2021 MIPS payment year), a measure, except for measures in the CMS Web Interface, whose benchmark is identified as topped out for 2 or more consecutive years will receive no more than 6 measure achievement points in the second consecutive year it is identified as topped out, and beyond.
(xiv) Measure bonus points are available for measures determined to be high priority measures when two or more high priority measures are reported.
(A) Measure bonus points are not available for the first reported high priority measure which is required to be reported. To qualify for measure bonus points, each measure must be reported with sufficient case volume to meet the required case minimum, meet the required data completeness criteria, and not have a zero percent performance rate. Measure bonus points may be included in the calculation of the quality performance category percent score regardless of whether the measure is included in the calculation of the total measure achievement points.
(B) Outcome and patient experience measures receive two measure bonus points.
(C) Other high priority measures receive one measure bonus point.
(D) Measure bonus points for high priority measures cannot exceed 10 percent of the total available measure achievement points for the 2019 and 2020 MIPS payment years.
(E) If the same high priority measure is submitted via two or more submission mechanisms, the measure will receive high priority measure bonus points only once for the measure.
(xv) One measure bonus point is also available for each measure submitted with end-to-end electronic reporting for a quality measure under certain criteria determined by the Secretary. Bonus points cannot exceed 10 percent of the total available measure achievement points for the 2019 and 2020 MIPS payment years. If the same measure is submitted via 2 or more submission mechanisms, the measure will receive measure bonus points only once for the measure.
(xvi) Improvement scoring is available to MIPS eligible clinicians that demonstrate improvement in performance in the current MIPS performance period compared to performance in the year immediately prior to the current MIPS performance period based on achievement.
(A) Improvement scoring is available when the data sufficiency standard is met, which means when data are available and a MIPS eligible clinician has a quality performance category achievement percent score for the previous performance period.
(B) The improvement percent score may not total more than 10 percentage points.
(C) The improvement percent score is assessed at the performance category level for the quality performance category and included in the calculation of the quality performance category percent score as described in paragraph (b)(1)(xvii) of this section.
(
(
(
(
(
(D) For the purpose of improvement scoring methodology, the term “quality performance category achievement percent score” means the total measure achievement points divided by the total available measure achievement points,
(E) For the purpose of improvement scoring methodology, the term “improvement percent score” means the score that represents improvement for the purposes of calculating the quality performance category percent score as described in paragraph (b)(1)(xvii) of this section.
(F) For the purpose of improvement scoring methodology, the term “fully participate” means the MIPS eligible clinician met all requirements in §§ 414.1330 and 414.1340.
(xvii) A MIPS eligible clinician's quality performance category percent score is the sum of all the measure achievement points assigned for the measures required for the quality performance category criteria plus the measure bonus points in paragraph (b)(1)(xiv) of this section and measure bonus points in paragraph (b)(1)(xv) of this section. The sum is divided by the sum of total available measure achievement points. The improvement percent score in paragraph (b)(1)(xvi) of this section is added to that result. The quality performance category percent score cannot exceed 100 percentage points.
(xviii) Beginning with the 2018 MIPS performance period, measures significantly impacted by ICD–10 updates, as determined by CMS, will be assessed based only on the first 9 months of the 12-month performance period. For purposes of this paragraph, CMS will make a determination as to whether a measure is significantly impacted by ICD–10 coding changes during the performance period. CMS will publish on the CMS Web site which measures require a 9-month assessment process by October 1st of the performance period if technically feasible, but by no later than the beginning of the data submission period at § 414.1325(f)(1).
(2)
(i) Cost measure benchmarks are based on the performance period. Cost measures must have a benchmark to be scored.
(ii) A MIPS eligible clinician must meet the minimum case volume specified by CMS to be scored on a cost measure.
(iii) A MIPS eligible clinician cost performance category percent score is the sum of the following, not to exceed 100 percent:
(A) The total number of achievement points earned by the MIPS eligible clinician divided by the total number of available achievement points; and
(B) The cost improvement score, as determined under paragraph (iv).
(iv) Cost improvement scoring is available to MIPS eligible clinicians that demonstrate improvement in performance in the current MIPS performance period compared to their performance in the immediately preceding MIPS performance period.
(A) The cost improvement score is determined at the measure level for the cost performance category.
(B) The cost improvement score is calculated only when data sufficient to measure improvement is available. Sufficient data is available when a MIPS eligible clinician or group participates in MIPS using the same identifier in 2 consecutive performance periods and is scored on the same cost measure(s) for 2 consecutive performance periods. If the cost improvement score cannot be calculated because sufficient data is not available, then the cost improvement score is zero.
(C) The cost improvement score is determined by comparing the number of measures with a statistically significant change (improvement or decline) in performance; a change is determined to be significant based on application of a t-test. The number of cost measures with a significant decline is subtracted from the number of cost measures with a significant improvement, with the result divided by the number of cost measures for which the MIPS eligible clinician or group was scored for two consecutive performance periods. The resulting fraction is then multiplied by the maximum improvement score.
(D) The cost improvement score cannot be lower than zero percentage points.
(E) The maximum cost improvement score for the 2020 MIPS payment year is zero percentage points.
(v) A cost performance category percent score is not calculated if a MIPS eligible clinician is not attributed any cost measures because the clinician or group has not met the case minimum requirements for any of the cost measures or a benchmark has not been created for any of the cost measures that would otherwise be attributed to the clinician or group.
(3)
(i) CMS assigns credit for the total possible category score for each reported improvement activity based on two weights: Medium-weighted and high-weighted activities.
(ii) Improvement activities with a high weighting receive credit for 20 points, toward the total possible category score.
(iii) Improvement activities with a medium weighting receive credit for 10 points toward the total possible category score.
(iv) A MIPS eligible clinician or group in a practice that is certified or recognized as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, receives full credit for performance on the improvement activities performance category. A practice is certified or recognized as a patient-centered medical home if it meets any of the following criteria:
(A) The practice has received accreditation from one of four accreditation organizations that are nationally recognized;
(
(
(
(
(B) The practice is participating in a Medicaid Medical Home Model or Medical Home Model.
(C) The practice is a comparable specialty practice that has received the NCQA Patient-Centered Specialty Recognition.
(D) The practice is a participant or in a control group in the CPC+ model.
(E) The practice has received accreditation from other certifying bodies that have certified a large number of medical organizations and meet national guidelines, as determined by the Secretary. The Secretary must determine that these certifying bodies must have 500 or more certified member practices, and require practices to include the following:
(
(
(
(
(
(v) CMS compares the points associated with the reported activities against the highest potential category score of 40 points.
(vi) A MIPS eligible clinician or group's improvement activities category score is the sum of points for all of their reported activities, which is capped at 40 points, divided by the highest potential category score of 40 points.
(vii) Non-patient facing MIPS eligible clinicians and groups, small practices, and practices located in rural areas and geographic HPSAs receive full credit for improvement activities by selecting one high-weighted improvement activity or two medium-weighted improvement activities. Non-patient facing MIPS eligible clinicians and groups, small practices, and practices located in rural areas and geographic HPSAs receive half credit for improvement activities by selecting one medium-weighted improvement activity.
(viii) For the transition year, to receive full credit as a certified or recognized patient-centered medical home or comparable specialty a TIN that is reporting must include at least one practice site which is a certified patient-centered medical home or comparable specialty practice.
(ix) MIPS eligible clinicians participating in APMs that are not patient-centered medical homes for a performance period shall earn a minimum score of one-half of the highest potential score for the improvement activities performance category.
(x) For the 2018 MIPS performance period and future periods, to receive full credit as a certified or recognized patient-centered medical home or comparable specialty practice, CMS requires that at least 50 percent of the practice sites within the TIN must be recognized as a patient-centered medical home or comparable specialty practice.
(4)
(A) A MIPS eligible clinician earns a base score by reporting the numerator (of at least one) and denominator or a yes/no statement or an exclusion; as applicable, for each required measure.
(B) A MIPS eligible clinician earns a performance score by reporting on certain measures specified by CMS. MIPS eligible clinicians may earn up to 10 or 20 percentage points as specified by CMS for each measure reported for the performance score.
(C) A MIPS eligible clinician may earn the following bonus scores:
(1) A bonus score of 5 percentage points for reporting to one or more additional public health agencies or clinical data registries.
(2) A bonus score of 10 percentage points for attesting to completing one or more improvement activities specified by CMS using CEHRT.
(3) For the 2020 MIPS payment year, a bonus score of 10 percentage points for submitting data for the measures for the base score and the performance score generated solely from 2015 Edition CEHRT.
(c)
Final score = [(quality performance category percent score × quality performance category weight) + (cost performance category percent score × cost performance category weight) + (improvement activities performance category score × improvement activities performance category weight) + (advancing care information performance category score × advancing care information performance category weight)] × 100 + [the complex patient bonus + the small practice bonus], not to exceed 100 points.
(1)
(i) Quality performance category weight is defined under § 414.1330(b).
(ii) Cost performance category weight is defined under § 414.1350(b).
(iii) Improvement activities performance category weight is defined under § 414.1355(b).
(iv) Advancing care information performance category weight is defined under § 414.1375(a).
(2)
(i) CMS determines there are not sufficient measures and activities applicable and available to MIPS eligible clinicians pursuant to section 1848(q)(5)(F) of the Act.
(ii) CMS estimates that the proportion of eligible professionals who are meaningful EHR users is 75 percent or greater pursuant to section 1848(q)(5)(E)(ii) of the Act.
(iii) A significant hardship exception or other type of exception is granted to a MIPS eligible clinician for the advancing care information performance category pursuant to section 1848(o)(2)(D) of the Act.
(3)
(i) For MIPS eligible clinicians and groups, the complex patient bonus is equal to the average HCC risk score assigned to beneficiaries (pursuant to the HCC risk adjustment model established by CMS pursuant to section 1853(a)(1) of the Act) seen by the MIPS eligible clinician or seen by clinicians in a group.
(ii) For MIPS APMs and virtual groups, the complex patient bonus is equal to the beneficiary weighted average HCC risk score for all MIPS eligible clinicians and TINs for models and virtual groups which rely on complete TIN participation within the APM entity or virtual group, respectively.
(iii) The complex patient bonus cannot exceed 3.0.
(4)
(d)
(e)
(1)
(i) For the 2018 MIPS performance period, the facility-based measures available are the measures adopted for the FY 2019 Hospital Value-Based Purchasing Program as authorized by section 1886(o) of the Act and codified in our regulations at § 412.160 through § 412.167.
(ii) For the 2020 MIPS payment year, the scoring methodology applicable for MIPS eligible clinicians electing facility-based measurement is the Total Performance Score methodology adopted for the Hospital Value-Based Purchasing Program.
(2)
(i)
(ii)
(3)
(4)
(5)
(6)
(i)
(ii)
(iii)
(iv)
(v)
(A)
(B) [Reserved]
(b)
(c)
(d)
(a)
(b)
(c)
(d)
The revisions and additions read as follows:
(a) * * *
(1) MIPS data may be submitted by third party intermediaries on behalf of a MIPS eligible clinician, group or virtual group by:
(5) All data submitted to CMS by a third party intermediary on behalf of a
(b)
(e)
(3) CAHPS for MIPS survey. Although the CAHPS for MIPS survey is included in the MIPS measure set, we consider the changes that need to be made to the CAHPS for MIPS survey for reporting by individual MIPS eligible clinicians (and not as a part of a group) significant enough as to treat the CAHPS for MIPS survey as a QCDR quality measure for purposes of individual MIPS eligible clinicians reporting the CAHPS for MIPS survey via a QCDR.
(f)
(1) For QCDR quality measures, the quality measure specifications must include the following for each measure: name/title of measures, NQF number (if NQF-endorsed), descriptions of the denominator, numerator, and when applicable, denominator exceptions, denominator exclusions, risk adjustment variables, and risk adjustment algorithms. The narrative specifications provided must be similar to the narrative specifications we provide in our measures list.
(2) For MIPS quality measures, the QCDR only needs to submit the MIPS measure numbers or specialty-specific measure sets (if applicable). CMS expects that QCDRs reporting on MIPS measures, retain and use the MIPS measure specifications as they exist under the program year.
(g)
(i)
(j) * * *
(2) The entity must retain all data submitted to CMS for purposes of MIPS for a minimum of 10 years from the end of the MIPS Performance Period.
(b)
(1) CMS updates the Advanced APM list on its Web site at intervals no less than annually.
(2) CMS will include notice of whether a new APM is an Advanced APM in the first public notice of the new APM.
(c)
(2)
(3) * * *
(i) * * *
(A) For Medicare QP Performance Periods 2017, 2018, 2019, and 2020, 8 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities; or
(4)
(A) For Medicare QP Performance Period 2017, 2.5 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
(B) For Medicare QP Performance Period 2018, 2 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities;
(C) For Medicare QP Performance Period 2019, 3 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
(D) For Medicare QP Performance Period 2020, 4 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
(E) For Medicare QP Performance Periods 2021 and later, 5 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
(ii) [Reserved]
(a)
(3) * * *
(i) Requires APM Entities to bear more than nominal financial risk if actual aggregate expenditures exceed expected aggregate expenditures as described in paragraph (d) of this section; or
(ii) Is a Medicaid Medical Home Model that meets criteria comparable to Medical Home Models expanded under section 1115A(c) of the Act as described in paragraph (d) of this section.
(c)
(2) At least one of the quality measures used in the payment arrangement must have an evidence-based focus, be reliable and valid, and meet at least one of the following criteria:
* * *
(3) To meet the quality measure use criterion, a payment arrangement must use an outcome measure if there is an applicable outcome measure on the MIPS quality measure list.
(d)
(1)
(3)
(i) 8 percent of the total revenue from the payer of providers and suppliers participating in each APM Entity in the payment arrangement if financial risk is expressly defined in terms of revenue; or
(ii) At least 3 percent of the expected expenditures for which an APM Entity is responsible under the payment arrangement.
(4)
(i) For All-Payer QP Performance Period 2019, 3 percent of the APM Entity's total revenue under the payer.
(ii) For All-Payer QP Performance Period 2020, 4 percent of the APM Entity's total revenue under the payer.
(iii) For All-Payer QP Performance Periods 2021 and later, 5 percent of the APM Entity's total revenue under the payer.
The revisions and addition read as follows:
(a)
(2) For Advanced APMs in which APM Entities do not include eligible clinicians on a Participation List but do include eligible clinicians on an Affiliated Practitioner List, the Affiliated Practitioner List is used to identify the eligible clinicians for purposes of QP determinations.
(3) For Advanced APMs in which some APM Entities may include eligible clinicians on a Participation List and other APM Entities may only include eligible clinicians on an Affiliated Practitioner List depending on the type of APM Entity, paragraph (a)(1) of this section applies to APM Entities that may include eligible clinicians on a Participation List, and paragraph (a)(2) of this section applies to APM Entities that only include eligible clinicians on an Affiliated Practitioner List.
(b)
(2)
(3)
(c) * * *
(3) An eligible clinician is a QP for a year under the Medicare Option if the eligible clinician is in an APM Entity group that achieves a Threshold Score that meets or exceeds the corresponding QP payment amount threshold or QP patient count threshold for that Medicare QP Performance Period as described in § 414.1430(a)(1) and (3). An eligible clinician is a QP for the year under the All-Payer Combination Option if the individual eligible clinician achieves a Threshold Score that meets or exceeds the corresponding QP payment amount threshold or QP patient count threshold for that All-Payer QP Performance Period as described in § 414.1430(b)(1) and (3).
(4) * * *
(i) The eligible clinician is included in more than one APM Entity group and none of the APM Entity groups in which the eligible clinician is included meets the QP payment amount threshold or the QP patient count threshold, or the eligible clinician is an Affiliated Practitioner; and
(ii) CMS determines that the eligible clinician individually achieves a Threshold Score that meets or exceeds the QP payment amount threshold or the QP patient count threshold; unless
(iii) Any of the APM Entities in which the eligible clinician participates voluntarily or involuntarily terminates from the Advanced APM before the end of the Medicare QP Performance Period.
(6)
(ii) For QP determinations specified under paragraph (c)(4) of this section and Partial QP determinations under paragraph (d)(2) of this section, QP determinations are made using claims data for the full Medicare QP Performance Period even if the eligible clinician participates in one or more Advanced APMs that start or end during the Medicare QP Performance Period.
(d) * * *
(1) An eligible clinician is a Partial QP for a year under the Medicare Option if the eligible clinician is in an APM Entity group that achieves Threshold Score that meets or exceeds the corresponding Partial QP payment amount threshold or Partial QP patient count threshold for that Medicare QP Performance Period as described in § 414.1430(a)(2) and (4). An eligible clinician is a Partial QP for the year under the All-Payer Combination Option if the individual eligible clinician achieves a Threshold Score that meets or exceeds the corresponding Partial QP payment amount threshold or Partial QP patient count threshold for that All-Payer QP Performance Period as described in § 414.1430(b)(2) and (4).
(2) Notwithstanding paragraph (d)(1) of this section, an eligible clinician is a Partial QP for a year if:
(i) The eligible clinician is included in more than one APM Entity group and none of the APM Entity groups in which the eligible clinician is included meets the corresponding QP or Partial QP threshold, or the eligible clinician is an Affiliated Practitioner; and
(ii) CMS determines that the eligible clinician individually achieves a Threshold Score that meets or exceeds the corresponding Partial QP Threshold; unless
(iii) Any of the APM Entities in which the eligible clinician participates voluntarily or involuntarily terminates from the Advanced APM before the end of the Medicare QP Performance Period.
(a)
(1)
(2)
(b) * * *
(1)
(2)
(3)
(4)
(c) * * *
(3) When it is not operationally feasible to use the final attributed beneficiary list, the attributed beneficiary list will be taken from the Advanced APM's most recently available attributed beneficiary list at the end of the Medicare QP Performance Period.
(d)
(a) * * *
(2) Payments and associated patient counts under paragraph (a)(1) of this section, are included in the numerator and denominator as specified in paragraphs (b)(2) and (3) of this section for an eligible clinician if CMS determines that there is at least one Medicaid APM or Medicaid Medical Home Model that is an Other Payer Advanced APM available in the county where the eligible clinician sees the most patients during the All-Payer QP Performance Period, and that the eligible clinician is eligible to participate in the Other Payer Advanced APM based on their specialty.
(b)
(2)
(3)
(c)
(2)
(3)
(d)
(2) If the Medicare Threshold Score for an eligible clinician is higher when calculated for the APM Entity group than when calculated for the individual eligible clinician, CMS makes the QP determination under the All-Payer Combination Option using a weighted Medicare Threshold Score that will be factored into an All-Payer Combination Option Threshold Score calculated at the individual eligible clinician level.
(e)
(2) To request a QP determination under the All-Payer Combination Option, for each payment arrangement submitted as set forth in paragraph (e)(1), the APM Entity or eligible clinician must include the amount of revenue for services furnished through the payment arrangement, the total revenue received from the all payers except those excluded as provided in paragraph (a)(2) of this section, the number of patients furnished any service through the arrangement, and the total number of patients furnished any services, except those excluded as provided in paragraph (a)(2) of this section, during the All-Payer QP Performance Period.
(f)
(2)
(g)
(a)
(b)
(2)
(i) CMS will not determine that a payment arrangement is a Medicaid APM or a Medicaid Medical Home Model that meets the Other Payer Advanced APM criteria after the end of the All-Payer QP Performance Period.
(ii) [Reserved]
(c)
(2) If an eligible clinician submits information showing that a payment arrangement requires that the eligible clinician must use CEHRT as defined in § 414.1305 to document and communicate clinical care, CMS will presume that CEHRT criterion in § 414.1420(b) is satisfied for that payment arrangement.
(3) If a payment arrangement has no outcome measure, the payer, APM Entity, or eligible clinician submitting payment arrangement information to request a determination of whether a payment arrangement meets the Other Payer Advanced APM criteria must certify that there is no available or applicable outcome measure on the MIPS list of quality measures.
(d)
(e)
(f)
(a)
(b)
(1) Any of the information CMS relied on in making the QP determination was inaccurate or misleading.
(2) The QP is terminated from an Advanced APM or Other Payer Advanced APM during the Medicare QP Performance Period, All-Payer QP Performance Period or Incentive Payment Base Period; or
(3) The QP is found to be in violation of the terms of the relevant Advanced APM or any Federal, State, or tribal statute or regulation during the Medicare QP Performance Period, All-Payer Performance Period or Incentive Payment Base Period.
(c)
(d)
(1) CMS may reduce or deny an APM Incentive Payment to an eligible clinician
(i) Who CMS determines is not in compliance with all Medicare conditions of participation and the terms of the relevant Advanced APM in which they participate during the Medicare QP Performance Period, All-Payer QP Performance Period, or Incentive Payment Base Period;
(ii) Who is terminated by an APM or Advanced APM during the Medicare QP Performance Period, All-Payer QP Performance Period, or Incentive Payment Base Period; or
(iii) Whose APM Entity is terminated by an APM or Advanced APM for non-compliance with any Medicare condition of participation or the terms of the relevant Advanced APM in which they participate during the Medicare QP Performance Period, All-Payer QP Performance Period, or Incentive Payment Base Period.
(2) CMS may reopen, revise, and recoup an APM Incentive Payment that was made in error in accordance with procedures similar to those set forth at §§ 405.980 through § 405.986 and §§ 405.370 through 405.379 of this chapter or as established under the relevant APM.
(e)
(2) An APM Entity or eligible clinician that submits information to CMS under § 414.1445 for assessment under the All-Payer Combination Option or § 414.1440 for QP determinations must maintain such books, contracts, records, documents, and other evidence as necessary to enable the audit of an Other Payer Advanced APM determination, QP determinations, and the accuracy of APM Incentive Payments for a period of 10 years from the end of the All-Payer QP Performance Period or from the date of completion of any audit, evaluation, or inspection, whichever is later, unless:
(i) CMS determines there is a special need to retain a particular record or group of records for a longer period and notifies the APM Entity or eligible clinician at least 30 days before the formal disposition date; or
(ii) There has been a termination, dispute, or allegation of fraud or similar fault against the APM Entity or eligible clinician, in which case the APM Entity or eligible clinician must retain records for an additional 6 years from the date of any resulting final resolution of the termination, dispute, or allegation of fraud or similar fault.
(3) A payer, APM Entity or eligible clinician that submits information to CMS under §§ 414.1440 or 414.1445 must provide such information and supporting documentation to CMS upon request.
For previously finalized MIPS quality measures, we refer readers to Table A in the Appendix of the CY 2017 Quality Payment Program final rule (81 FR 77558). For previously finalized MIPS specialty measure sets, we refer readers to Table E in the Appendix of the CY 2017 Quality Payment Program final rule (81 FR 77686). Except as otherwise proposed below, previously finalized measures and specialty measure sets would continue to apply for the Quality Payment Program year 2 and future years.
We propose to include these additional improvement activities in the Improvement Activities Inventory for the Quality Payment Program Year 2 and future years based on guidelines discussed in the CY 2017 Quality Payment Program final rule at (81 FR 77190) and proposed in section II.C.6.e.(7)(b) of this proposed rule. These may include one or more of the following criteria:
• Relevance to an existing improvement activities subcategory (or a proposed new subcategory);
• Importance of an activity toward achieving improved beneficiary health outcome;
• Importance of an activity that could lead to improvement in practice to reduce health care disparities;
• Aligned with patient-centered medical homes;
• Activities that may be considered for an advancing care information bonus;
• Representative of activities that multiple individual MIPS eligible clinicians or groups could perform (for example, primary care, specialty care);
• Feasible to implement, recognizing importance in minimizing burden, especially for small practices, practices in rural areas, or in areas designated as geographic HPSAs by HRSA;
• CMS is able to validate the activity; or
• Evidence supports that an activity has a high probability of contributing to improved beneficiary health outcomes.
Fish and Wildlife Service, Interior.
Final rule; availability of final Grizzly Bear Recovery Plan Supplement: Revised Demographic Criteria.
The best available scientific and commercial data indicate that the Greater Yellowstone Ecosystem (GYE) population of grizzly bears (
Concurrent to this final rule, we are appending the Grizzly Bear Recovery Plan Supplement: Revised Demographic Criteria to the 1993 Recovery Plan. Moreover, prior to publication of this final rule, the Yellowstone Ecosystem Subcommittee finalized the 2016 Conservation Strategy that will guide post-delisting monitoring and management of the grizzly bear in the GYE. Additionally, the U.S. Forest Service finalized in 2006 the Forest Plan Amendment for Grizzly Bear Conservation for the GYE National Forests and made a decision to incorporate this Amendment into the affected National Forests' Land Management Plans. Yellowstone National Park and Grand Teton National Park appended the habitat standards to their Park Superintendent's Compendia, thereby ensuring that these national parks would manage habitat in accordance with the habitat standards. The States of Idaho, Montana, and Wyoming have signed a Tri-State Memorandum of Agreement and enacted regulatory mechanisms to ensure that State management of mortality limits is consistent with the demographic recovery criteria.
This final rule becomes effective July 31, 2017.
Comments and materials received, as well as supporting documentation used in preparation of this final rule, are available for inspection, by appointment, during normal business hours, at the Grizzly Bear Recovery Office, University Hall, Room #309, University of Montana, Missoula, Montana 59812. To make arrangements, call 406–243–4903.
Dr. Hilary Cooley, Grizzly Bear Recovery Coordinator, U.S. Fish and Wildlife Service, University Hall, Room #309, University of Montana, Missoula, MT 59812; telephone 406–243–4903; facsimile 406–329–3212. For Tribal inquiries, contact Roya Mogadam, Deputy Assistant Regional Director, External Affairs, U.S. Fish and Wildlife Service; telephone: 303–236–4572. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service at 800–877–8339.
Section 4 of the Act and its implementing regulations in part 424 of title 50 of the Code of Federal Regulations (50 CFR part 424) set forth the procedures for revising the Federal Lists of Endangered and Threatened Wildlife and Plants. Rulemaking is required to remove a species from these lists. Accordingly, we are issuing this final rule to identify the Greater Yellowstone Ecosystem (GYE) grizzly bear distinct population segment (DPS) and revise the List of Endangered and Threatened Wildlife by removing the DPS from the List. The population is stable (
On September 21, 2009, the U.S. District Court for the District of Montana vacated and remanded the Service's previous final rule establishing and delisting this DPS. The Ninth Circuit Court of Appeals affirmed the district court finding that the Service had not adequately analyzed the effects of whitebark pine as a food source for this DPS, but reversed the district court finding that the Service had permissibly and appropriately considered the 2007 Conservation Strategy under section 4 of the Act.
This action is authorized by the Act. We are amending 50 CFR 17.11(h) by revising the listing for “Bear, grizzly” under “Mammals” in the List of Endangered and Threatened Wildlife to remove the GYE grizzly bear DPS.
We have not analyzed the costs or benefits of this rulemaking action because the Act precludes consideration of such impacts on listing and delisting determinations. Instead, listing and delisting decisions are based solely on the best scientific and commercial data available regarding the status of the subject species.
The Greater Yellowstone Ecosystem (GYE) refers to the larger ecological system containing and surrounding Yellowstone National Park (YNP). The GYE includes portions of five National Forests; YNP, Grand Teton National Park (GTNP), and the John D. Rockefeller Memorial Parkway (JDR; administered by GTNP); and State, Tribal, and private lands. The GYE is generally defined as those lands surrounding YNP with elevations greater than 1,500 meters (m) (4,900 feet (ft)) (see USDA FS 2004, p. 46; Schwartz
On July 28, 1975, we published a rule to designate the grizzly bear as threatened in the conterminous (lower 48) United States (40 FR 31734). Accordingly, we developed a Grizzly Bear Recovery Plan (U.S. Fish and Wildlife Service 1982) and updated that plan as necessary (72 FR 11376, March 13, 2007; U.S. Fish and Wildlife Service 1993, 2007
The Service appealed the District Court decision, and on November 15, 2011, the Ninth Circuit Court of Appeals issued an opinion affirming in part and reversing in part the district court's decision vacating and remanding the final rule delisting grizzly bears in the Greater Yellowstone Ecosystem (
On March 11, 2016, we proposed to designate the GYE population of grizzly bears as a DPS and to remove (delist) this DPS from the Federal List of Endangered and Threatened Wildlife (81 FR 13174). In addition, our proposed rule included a notice announcing the availability of the draft Grizzly Bear Recovery Plan Supplement: Revised Demographic Criteria and the draft 2016 Conservation Strategy. The proposed rule was followed by a 60-day comment period, during which we held two open houses and two public hearings (81 FR 13174, March 11, 2016). The public comment period was later reopened for an additional 30 days in light of the receipt of five peer reviews and the States of Idaho, Montana, and Wyoming finalizing regulatory mechanisms to manage human-caused mortality of grizzly bears (81 FR 61658, September 7, 2016). Please refer to the proposed rule for more detailed information on previous Federal actions (81 FR 13174, March 11, 2016).
Grizzly bears (
Adult grizzly bears are normally solitary except when females have dependent young (Nowak and Paradiso 1983, p. 971), but they are not territorial and home ranges of adult bears frequently overlap (Schwartz
Grizzly bears are extremely omnivorous, display great diet plasticity—even within a population (Edwards
Grizzly bears use a variety of habitats in the GYE (LeFranc
For detailed information on the biology of this species, see the “Taxonomy and Species Description, Behavior and Life History, Nutritional Ecology, and Habitat Management” sections of the March 11, 2016, proposed rule Removing the Greater Yellowstone Ecosystem Population of Grizzly Bears from the Federal List of Endangered and Threatened Wildlife; proposed rule (81 FR 13176–13186).
The scientific discipline that informs decisions about most wildlife population management is population
While population size is a well-known and easily understood metric, it only provides information about a population at a single point in time. Wildlife managers often want to know how a population is changing over time and why. Population trend is determined by births, deaths, and how many animals move into or out of the population (
In its simplest form, population trend is driven by births and deaths. Survival and reproduction are the fundamental demographic vital rates driving whether the grizzly bear population increases, decreases, or remains stable. When wildlife biologists refer to demographic vital rates, they are referring to all of the different aspects of reproduction and survival that cumulatively determine a population's trend (
No population can grow forever because the resources it requires are finite. This understanding led ecologists to develop the concept of carrying capacity (expressed as the symbol “K”). This is the maximum number of individuals a particular environment can support over the long term without resulting in population declines caused by resource depletion (Vandermeer and Goldberg 2003, p. 261; Krebs 2009, p. 148). Classical studies of population growth occurred under controlled laboratory conditions where populations of a single organism, often an insect species or single-celled organism, were allowed to grow in a confined space with a constant supply of food (Vandermeer and Goldberg 2003, pp. 14–17). Under these conditions, K is a constant value that is approached in a predictable way and can be described by a mathematical equation. However, few studies of wild populations have demonstrated the stability and constant population size suggested by this equation. Instead, many factors affect carrying capacity of animal populations in the wild, and carrying capacity itself typically varies over time. Populations usually fluctuate above and below carrying capacity, resulting in relative population stability over time (
When a population is at or near carrying capacity, mechanisms that regulate or control population size fall into two broad categories: Density-dependent effects and density-independent effects. Generally, factors that limit population growth more strongly as population size increases are density-dependent effects, or intrinsic factors, usually expressed through individual behaviors, physiology, or genetic potential (McLellan 1994, p. 15). Extrinsic factors, such as drought or fire that kill individuals regardless of how many individuals are in a population, are considered density-independent effects (Colinvaux 1986, p. 172). These extrinsic factors may include changes in resources, predators, or human impacts and may cause carrying capacity to vary over time. Population stability (
As a result of these sometimes similar indicators, determining whether a population is affected more strongly by density-dependent or density-independent effects can be a complex undertaking. For long-lived mammals such as grizzly bears, extensive data collected over decades are needed to understand if and how these factors are operating in a population. We have these data for the GYE grizzly bear population, and the IGBST examined some of these confounding effects to find that density-dependent effects are the likely cause of the recent slowing in population growth factors. The slowing of population growth since the early 2000s was primarily a function of lower survival of dependent young and moderate reproductive suppression (IGBST 2012, p. 8). Survival of cubs-of-the-year and reproduction were lower in areas with higher grizzly bear densities but showed no association with estimates of decline in whitebark pine tree cover, suggesting that density-dependent factors contributed to the change in population growth (van Manen
Population viability analyses (PVAs) are another tool population ecologists often use to assess the status of a population by estimating its likelihood of persistence in the future. Boyce
Prior to the arrival of Europeans, the grizzly bear occurred throughout the western half of the contiguous United States, central Mexico, western Canada, and most of Alaska (Roosevelt 1907, pp. 27–28; Wright 1909, pp. vii, 3, 185–186; Merriam 1922, p. 1; Storer and Tevis 1955, p. 18; Rausch 1963, p. 35; Herrero 1972, pp. 224–227; Schwartz
By the 1950s, with little or no conservation effort or management directed at maintaining grizzly bears anywhere in their range, the GYE population had been reduced in numbers and was restricted largely to the confines of YNP and some surrounding areas (Craighead
Grizzly bear recovery has required, and will continue to require, cooperation among numerous government agencies and the public for a unified management approach. To this end, there are three interagency groups that help guide grizzly bear management in the GYE. The IGBST, created in 1973, provides the scientific information necessary to make informed management decisions about grizzly bear habitat and conservation in the GYE. Since its formation in 1973, the published work of the IGBST has made the GYE grizzly bear population the most studied in the world. The wealth of biological information produced by the IGBST over the years includes 30 annual reports, hundreds of articles in peer-reviewed journals, dozens of theses, and other technical reports (see:
The second interagency group guiding grizzly bear conservation efforts is the Interagency Grizzly Bear Committee (IGBC). Created in 1983, its members coordinate management efforts and research actions across multiple Federal lands and States to recover the grizzly bear in the lower 48 States (USDA and USDOI 1983, entire). One of the objectives of the IGBC is to change land management practices to more effectively provide security and maintain or improve habitat conditions for the grizzly bear (USDA and USDOI 1983, entire). IGBC members include upper level managers from the Service, USFS, USGS, Bureau of Land Management (BLM), and the States of Idaho, Montana, Washington, and Wyoming (USDA and USDOI 1983, entire). The IGBST Team Leader, the National Carnivore Program Leader, and the Service Grizzly Bear Recovery Coordinator are advisors to the subcommittee providing all the scientific information on the GYE grizzly bear population and its habitat.
The third interagency group guiding management of the GYE grizzly bear is a subcommittee of the IGBC: The Yellowstone Ecosystem Subcommittee (YES). Formed in 1983 to coordinate recovery efforts specific to the GYE, the YES includes mid-level managers and representatives from the Service; the five GYE National Forests (the Shoshone, Beaverhead-Deerlodge, Bridger-Teton, Custer Gallatin, and Caribou-Targhee); YNP; GTNP; the Wyoming Game and Fish Department (WGFD); the Montana Department of Fish, Wildlife, and Parks (MFWP); the Idaho Department of Fish and Game (IDFG); the BLM; county governments from each affected State; and the Shoshone Bannock, Northern Arapahoe, and Eastern Shoshone Tribes (USDA and USDOI 1983). The IGBST Team Leader and the Service Grizzly Bear Recovery Coordinator are advisors to the subcommittee providing all the scientific information on the GYE grizzly bear population and its habitat. Upon implementation of the 2016 Conservation Strategy, the Yellowstone Grizzly Bear Coordinating Committee (YGCC) will replace the YES.
In accordance with section 4(f)(1) of the Act, the Service completed a Grizzly Bear Recovery Plan (Recovery Plan) in 1982 (USFWS 1982, p. ii). Recovery plans serve as road maps for species recovery—they lay out where we need to go and how to get there through specific actions. Recovery plans are not regulatory documents and are instead intended to provide guidance to the Service, States, and other partners on methods of minimizing threats to listed species and on criteria that may be used to determine when recovery is achieved.
The Recovery Plan identified six recovery ecosystems within the conterminous United States thought to support grizzly bears. Today, current
In 1993, the Service completed revisions to the Recovery Plan to include additional tasks and new information that increased the focus and effectiveness of recovery efforts (USFWS 1993, pp. 41–58). In 1996 and 1997, we released supplemental chapters to the Recovery Plan to direct recovery in the Bitterroot and North Cascades Recovery Zones, respectively (USFWS 1996; USFWS 1997). In the GYE, we updated both the habitat and demographic recovery criteria in 2007 (72 FR 11376, March 13, 2007). We proposed revisions to the demographic recovery criteria in 2013 (78 FR 17708, March 22, 2013) and proposed additional revisions concurrent with the proposed rule (81 FR 13174, March 11, 2016) to reflect the best available science. Although it is not necessary to update recovery plans prior to delisting, the
In 1979, the IGBST developed the first comprehensive “Guidelines for Management Involving Grizzly Bears in the Greater Yellowstone Area” (hereafter referred to as the Guidelines) (Mealey 1979, pp. 1–4). We determined in a biological opinion that implementation of the Guidelines by Federal land management agencies would promote conservation of the grizzly bear (USFWS 1979, p. 1). Beginning in 1979, the five affected National Forests (Beaverhead-Deerlodge, Bridger-Teton, Caribou-Targhee, Custer Gallatin, and Shoshone), YNP and GTNP, and the BLM in the GYE began managing habitats for grizzly bears under direction specified in the Guidelines.
In 1986, the IGBC modified the Guidelines to more effectively manage habitat by mapping and managing according to three different management situations (USDA FS 1986, pp. 35–39). In areas governed by “Management Situation One,” grizzly bear habitat maintenance and improvement and grizzly bear-human conflict minimization received the highest management priority. In areas governed by “Management Situation Two,” grizzly bear use was important, but not the primary use of the area. In areas governed by “Management Situation Three,” grizzly bear habitat maintenance and improvement were not management considerations.
The National Forests and National Parks delineated 18 different bear management units (BMUs) within the GYE Recovery Zone to aid in managing habitat and monitoring population trends. Each BMU was further subdivided into subunits, resulting in a total of 40 subunits contained within the 18 BMUs (see map at
On June 17, 1997, we held a public workshop in Bozeman, Montana, to develop and refine habitat-based recovery criteria for the grizzly bear, with an emphasis on the GYE. This workshop was held as part of the settlement agreement in
There is no published method to deductively calculate minimum habitat values required for a healthy and recovered population. Grizzly bears are long-lived opportunistic omnivores whose food and space requirements vary depending on a multitude of environmental and behavioral factors and on variation in the experience and knowledge of each individual bear. Grizzly bear home ranges overlap and change seasonally, annually, and with reproductive status. While these factors make the development of threshold habitat criteria difficult, these may be established by assessing what habitat factors in the past were compatible with a stable to increasing grizzly bear population, and then using these habitat conditions as threshold values to be maintained to ensure a healthy population (
The habitat-based recovery criteria established objective, measurable values
Additionally, we developed several monitoring items that may help inform management decisions or explain population trends: (1) Trends in the location and availability of food sources such as whitebark pine (
Because we used easily recognized boundaries to delineate the boundaries of the GYE grizzly bear DPS, it includes both suitable and unsuitable habitat (figure 1). For the purposes of this final rule, “suitable habitat” is considered the area within the DPS boundaries capable of supporting grizzly bear reproduction and survival now and in the foreseeable future. We have defined “suitable habitat” for grizzly bears as areas having three characteristics: (1) Being of adequate habitat quality and quantity to support grizzly bear reproduction and survival; (2) being contiguous with the current distribution of GYE grizzly bears such that natural recolonization is possible; and (3) having low mortality risk as indicated through reasonable and manageable levels of grizzly bear mortality.
Our definition and delineation of suitable habitat is built on the widely accepted conclusions of extensive research (Craighead 1980, pp. 8–11; Knight 1980, pp. 1–3; Peek
For our analysis of suitable habitat, we considered the Middle Rockies ecoregion, within which the GYE is contained (Omernik 1987, pp. 120–121; Woods
Grizzly bear presence in these drier, grassland habitats was associated with rivers and streams where grizzly bears used bison carcasses as a major food source (Burroughs 1961, pp. 57–60; Herrero 1972, pp. 224–227; Stebler 1972, pp. 297–298; Mattson and Merrill 2002, pp. 1128–1129). Most of the short-grass prairie on the east side of the Rocky Mountains has been converted into agricultural land (Woods
Although there are historical records of grizzly bears throughout the GYE DPS, evidence suggests that grizzly bears were less common in prairie habitats (Rollins 1935, p. 191; Wade 1947, p. 444). Bears in these peripheral areas will not establish self-sustaining, year-round populations due to a lack of suitable habitat, land ownership patterns, and the lack of traditional, natural grizzly bear foods (
Human-caused mortality risk also can impact which habitat might be considered suitable. Some human-caused mortality is unavoidable in a dynamic system where hundreds of bears inhabit large areas of diverse habitat with several million human visitors and residents. The negative impacts of humans on grizzly bear survival and habitat use are well documented (Harding and Nagy 1980, p. 278; McLellan and Shackleton 1988, pp. 458–459; Aune and Kasworm 1989, pp. 83–103; McLellan 1989, pp. 1862–1864; McLellan and Shackleton 1989, pp. 377–378; Mattson 1990, pp. 41–44; Mattson and Knight 1991, pp. 9–11; Mace
As human population densities increase, the frequency of encounters between humans and grizzly bears also increases, resulting in more human-caused grizzly bear mortalities due to a perceived or real threat to human life or property (Mattson
Because urban sites and sheep allotments possess high mortality risks for grizzly bears, we did not include these areas as suitable habitat (Knight
Finally, dispersal capabilities of grizzly bears were considered in our determination of which potential habitat areas might be considered suitable. Although the Bighorn Mountains west of I–90 near Sheridan, Wyoming, are grouped within the Middle Rockies ecoregion, they are not connected to the current distribution of grizzly bears via suitable habitat or linkage zones, nor are there opportunities for such linkage. The Bighorn Mountains comprise 6,341 km
Some areas that do not meet our definition of suitable habitat may still be used by grizzly bears (4,635 km
According to the habitat suitability criteria described above, the GYE contains approximately 46,035 km
The 1993 Recovery Plan and subsequent supplements to it identified three demographic criteria to objectively measure and monitor recovery in the GYE (USFWS 1993, pp. 20–21; USFWS 2007
In 2013, we proposed to change two of the recovery criteria for the Yellowstone Ecosystem in the Grizzly Bear Recovery Plan (78 FR 17708, March 22, 2013). The proposed changes were: (1) Update demographic recovery criterion 1 to maintain a minimum population of 500 animals and at least 48 females with cubs-of-the-year, and to eliminate this criterion's dependence on a specific counting method; (2) revise the area where the demographic recovery criteria apply; and (3) update the sustainable mortality rates for independent females to 7.6 percent (IGBST 2012). We chose to revise the criteria because they no longer represented the best scientific data or the best technique to assess recovery of the GYE grizzly bear DMA population (78 FR 17708, March 22, 2013). Specifically, these criteria warranted revision because: (1) Updated demographic analyses for 2002–2011 indicated that the rate of growth seen during the 1983–2001 period has slowed and sex ratios have changed; (2) there was consensus among scientists and statisticians that the area within which we apply total mortality limits should be the same area we use to estimate population size; and (3) the population had basically stabilized inside the DMA since 2002, with an average population size between 2002–2014 of 674 using the model-averaged Chao2 population estimator (see
We released these proposed revisions related to population size and total mortality limits for public comment in 2013 (78 FR 17708, March 22, 2013) but did not finalize them so that we could consider another round of public comments on these revisions in association with the comments on the proposed rule (81 FR 13174, March 11, 2016). Further proposed revisions to the Recovery Plan Supplement: Revised Demographic Criteria and the draft 2016 Conservation Strategy for the Grizzly Bear in the GYE were made available for public review and comment concurrent with the proposed rule (81 FR 13174, March 11, 2016). The first two proposed changes were the same as those proposed in 2013: (1) Update demographic recovery criterion 1 to maintain a minimum population of 500 animals and at least 48 females with cubs-of-the-year, and to eliminate this criterion's dependence on a specific counting method; and (2) revise the area where the demographic recovery criteria apply. The third change is to update the mortality limits for independent females, independent males, and dependent young to maintain the population within the DMA around the 2002–2014 population size. After review and incorporation of appropriate public comments, we are releasing a final Grizzly Bear Recovery Plan Supplement: Revised Demographic Criteria (USFWS 2017, entire) and announcing the availability of the 2016 Conservation Strategy for the Grizzly Bear in the GYE concurrent with this final rule.
Below, we summarize relevant portions of the demographic analyses contained in the IGBST's 2012 report (IGBST 2012, entire) and compare them with the previous results of Schwartz
The model-averaged Chao2 population estimator is currently the best available science to derive annual estimates of total population size in the GYE. The basis for the estimation is an annual count of female grizzly bears with cubs-of-the-year, based on sightings on aerial surveys and ground observations. Those sightings are clustered into those estimated to be from the same family group (
Annual estimates of females with cubs-of-the-year based on Chao2 have been reported by IGBST since 2005, accompanied by the derivation of total population estimates. The model-averaged Chao2 estimates of females with cubs-of-the-year and derived total population estimates have been applied and reported by the IGBST since 2007.
As the grizzly bear population has increased, the model-averaged Chao2 population estimates have become increasingly conservative (
Schwartz
Mortality reduction is a key part of any successful management effort for grizzly bears; however, some mortality, including most human-caused mortality, is unavoidable in a dynamic system where hundreds of bears inhabit large areas of diverse habitat with several million human visitors and residents. Adult female mortality influences the population trajectory more than mortality of males or dependent young (Eberhardt 1977, p. 210; Knight and Eberhardt 1985, p. 331; Schwartz
The most current demographic criteria were appended to the 1993 Recovery Plan in 2007, and proposed revisions to those were released for public comment in 2013, though not finalized, as explained above. Further revisions to the demographic criteria were released for public comment concurrent with the proposed rule (81 FR 13174, March 11, 2016). Below, we detail each recovery criterion that is appended to the Recovery Plan concurrent with this final rule and included in the 2016 Conservation Strategy.
To achieve mortality management in the area appropriate to the long-term conservation of the GYE population and to assure that the area of mortality management was the same as the area where the population estimates are made, the Service, based on recommendations in an IGBST report (2012), has modified the area where mortalities are counted against the total mortality limits to be the same area that is monitored for unique adult female grizzly bears with cubs-of-the-year (see
A minimum population size of at least 500 animals within the DMA will ensure short-term genetic health (Miller and Waits 2003, p. 4338) and is not a population goal. Population size will be quantified by methods established in published, peer-reviewed scientific literature and calculated by the IGBST using the most updated protocol, as posted on their Web site. Five hundred is a minimum population threshold and will ensure the short-term fitness of the population is not threatened by losses in genetic diversity in such an isolated population. The goal is to maintain the population well above this threshold to ensure that genetic issues are not a detriment to the short-term genetic fitness of the GYE grizzly bear population. The Service will initiate a formal status review if the total population estimate is less than 500 inside the DMA in any year or if counts of females with cubs-of-the-year fall below 48 for 3 consecutive years.
The population had stabilized during the period of 2002–2014, and the mean model-averaged Chao2 population estimate over that time period was 674 (95% CI = 600–747), which is very close to the population size of 683 when the GYE population was previously delisted in 2007 (72 FR 14866, March 29, 2007). The population naturally stabilized because of reduced survival of dependent young and subadults, and lower reproduction in areas with higher grizzly bear densities, suggesting density-dependent population effects associated with the population approaching carrying capacity. The existence of lower subadult survival and occupancy by grizzly bears in almost all suitable habitat inside the DMA has been demonstrated by van Manen
In order to document the regulatory mechanisms and coordinated management approach necessary to ensure the long-term maintenance of a recovered population, the Recovery Plan calls for the development of “a conservation strategy to outline habitat and population monitoring that will continue in force after recovery” (Recovery Plan Task Y426) (USFWS 1993, p. 55). To accomplish this goal, a Conservation Strategy Team was formed in 1993. This team included biologists and managers from the Service, NPS, USFS, USGS, IDFG, WGFD, and MFWP.
In March 2000, a draft Conservation Strategy for the GYE was released for public review and comment (65 FR 11340, March 2, 2000). Also in 2000, a Governors' Roundtable was organized to provide recommendations from the perspectives of the three States that would be involved with grizzly bear management after delisting. In 2003, the draft Final Conservation Strategy for the Grizzly Bear in the GYE was released, along with drafts of State grizzly bear management plans (all accessible at
Revisions were made to the Conservation Strategy, and a draft 2016 Conservation Strategy was presented for public comment concurrent with the proposed rule to delist the GYE grizzly bear DPS (81 FR 13174, March 11, 2016). The 2016 Conservation Strategy was finalized on December 16, 2016 (available at
The 2016 Conservation Strategy will guide post-delisting management of the GYE grizzly bear population for the foreseeable future, beyond the minimum 5-year post-delisting monitoring period required by the Act. The purposes of the 2016 Conservation Strategy and associated State, Tribal, and Federal implementation plans are to: (1) Describe, summarize, and implement the coordinated efforts to manage the grizzly bear population and its habitat to ensure continued conservation of the GYE grizzly bear population; (2) specify and implement the population/mortality management, habitat, and conflict bear standards to maintain a recovered grizzly bear population for the future; (3) document specific State, Tribal, and Federal regulatory mechanisms and legal authorities, policies, management, and monitoring programs that exist to maintain the recovered grizzly bear population; and (4) document the actions that participating agencies have agreed to implement (YES 2016a, pp. 1–12).
Implementation of the 2016 Conservation Strategy by all agency partners will coordinate management and monitoring of the GYE grizzly bear population and its habitat after delisting. The 2016 Conservation Strategy summarizes the regulatory framework that Federal and State agencies will use for management of the GYE grizzly bear population after delisting. The 2016 Conservation Strategy also identifies and defines adequate post-delisting monitoring to maintain a healthy GYE grizzly bear population (YES 2016a, pp. 33–85). The 2016 Conservation Strategy has objective, measurable habitat and population standards, with clear State and Federal management responses if deviations occur (YES 2016a, pp. 100–103). It represents 20 years of a collaborative, interagency effort among the members of the YES. State grizzly bear management plans were developed in all three affected States (Idaho, Montana, and Wyoming) and are incorporated into the final 2016 Conservation Strategy as appendices (accessible at
The 2016 Conservation Strategy identifies and provides a framework for managing habitat within the PCA and managing demographic parameters within the DMA (see figure 1). The PCA contains adequate seasonal habitat components for a portion of the recovered GYE grizzly bear population for the future and to allow bears to continue to expand outside the PCA. The PCA includes approximately 51 percent of suitable grizzly bear habitat within the GYE, and approximately 75 percent of the population of female grizzly bears with cubs-of-the-year spent part or all of the year within the PCA (Haroldson 2014a,
The 2016 Conservation Strategy will be implemented and funded by Federal, Tribal, and State agencies within the GYE. The signatories to the final 2016 Conservation Strategy have a demonstrated track record of funding measures to ensure recovery of this grizzly bear population for more than 3 decades. Post delisting, mortality management will be the responsibility of State fish and wildlife agencies. In general, the USFS and NPS will be responsible for habitat management to reduce the risk of human-caused mortality to grizzly bears, while the NPS, and State and Tribal wildlife agencies, will be responsible for managing the population within specific total mortality limits within their respective areas of responsibility. The USFS and NPS collectively manage approximately 98 percent of lands inside the PCA. Specifically, YNP; GTNP; and the Shoshone, Beaverhead-Deerlodge, Bridger-Teton, Caribou-Targhee, and Custer Gallatin National Forests are the Federal entities responsible for implementing the 2016 Conservation Strategy. Affected National Forests and National Parks have incorporated the habitat standards and criteria into their Forest Plans and National Park management plans and/or Superintendent's Compendia via appropriate amendment processes so that they are legally applied to these public lands within the GYE (USDA FS 2006b, p. 4; YNP 2014b, p. 18; GTNP and JDR 2016, p. 3). Outside of the PCA, grizzly bear habitat is well protected via Wilderness Area designation (Wilderness or Wilderness Study Area (WSA)) or Forest Plan direction, and demographic standards will protect the population throughout the DMA.
When this final rule goes into effect, the YGCC will replace the YES as the interagency group coordinating implementation of the 2016 Conservation Strategy's habitat and population standards, and monitoring (YES 2016a, pp. 96–98). Similar to the YES, the YGCC members include representatives from YNP, GTNP, the five affected National Forests, BLM, USGS, IDFG, MFWP, WGFD, one member from local county governments within each State, and one member from the Shoshone Bannock, Northern Arapahoe, and Eastern Shoshone Tribes. Through this action, the Service is transferring primary management authority from the Service to the States, other Federal agencies, and the Tribes; therefore, the Service is not a member of the YGCC. The Service Grizzly Bear Recovery Coordinator and the IGBST Team Leader will serve as advisors to the YGCC as they did to the YES. All meetings will be open to the public. Besides coordinating management, research, and financial needs for successful conservation of the GYE grizzly bear population, the YGCC will review the IGBST Annual Reports and review and respond to any deviations from habitat or population standards. As per the implementation section of the 2016 Conservation Strategy, the YGCC will coordinate management and implementation of the 2016 Conservation Strategy and work together to rectify problems and to ensure that the habitat and population standards and total mortality limits will be met and maintained.
The 2016 Conservation Strategy is an adaptive, dynamic document that establishes a framework to incorporate new and better scientific information as it becomes available or as necessary in response to environmental changes. The signatories to the 2016 Conservation Strategy have agreed that any changes and updates to the 2016 Conservation Strategy will occur only if they are based on the best available science, and subject to public comment before being implemented by the YGCC (YES 2016a, pp. 2, 18).
Section 4 of the Act and its implementing regulations (50 CFR part 424) set forth the procedures for listing species, reclassifying species, or removing species from listed status. “Species” is defined by the Act as including any species or subspecies of fish or wildlife or plants, and any distinct vertebrate population segment of fish or wildlife that interbreeds when mature (16 U.S.C. 1532(16)). We, along with the National Marine Fisheries Service (NMFS) (now the National Oceanic and Atmospheric Administration—Fisheries), developed the Policy Regarding the Recognition of Distinct Vertebrate Population Segments (DPS policy) (61 FR 4722, February 7, 1996), to help us in determining what constitutes a distinct population segment (DPS). Under this policy, the Service considers two factors to determine whether the population segment is a valid DPS: (1) Discreteness of the population segment in relation to the remainder of the taxon to which it belongs; and (2) the significance of the population segment to the taxon to which it belongs. If a population meets both tests, it is a DPS, and the Service then evaluates the population segment's conservation status according to the standards in section 4 of the Act for listing, delisting, or reclassification (
As of April 11, 2017, of the 439 native vertebrate listings, 97 are listed as less than an entire taxonomic species or subspecies (henceforth referred to in this discussion as populations) under one of several authorities, including the “distinct population segment” language in the Act's definition of species (section 3(16)). Twenty-three of these 97 populations, which span 5 different taxa, predate either the 1978 amendments to the ESA which revised the definition of “species” to include DPSs of vertebrate fish and wildlife or the 1996 DPS Policy; as such, the final listing determinations for these populations did not include formal policy-based analyses or expressly designate the listed entity as a DPS. In several instances, however, the Service and NMFS have established a DPS and revised the List of Endangered and Threatened Wildlife in a single action, as shown in several of the following examples (see proposed rule for further details, 81 FR 13174, March 11, 2016) for the brown pelican (
Our authority to make these determinations and to revise the list accordingly is a reasonable interpretation of the language of the Act, and our ability to do so is an important component of the Service's program for the conservation of endangered and threatened species. Our authority to revise the existing listing of a species (the grizzly bear in the lower 48 States) to identify a GYE DPS and determine
On December 12, 2008, a formal opinion was issued by the Solicitor, “U.S. Fish and Wildlife Service Authority Under Section 4(c)(1) of the Endangered Species Act to Revise Lists of Endangered and Threatened Species to `Reflect Recent Determinations'” (M–37018, U.S. DOI 2008). The Service fully agrees with the analysis and conclusions set out in the Solicitor's Memorandum opinion. This final action is consistent with the opinion. The complete text of the Solicitor's opinion can be found at
We recognize that our interpretation and use of the DPS policy to revise and delist distinct population segments has been challenged in
In the 1993 Grizzly Bear Recovery Plan, the Service identifies six grizzly bear ecosystems and identifies unique demographic recovery criteria for each one (see map at
Under our DPS Policy, a population of a vertebrate taxon may be considered discrete if it satisfies either one of the following conditions: (1) It is markedly separated from other populations of the same taxon (
Although the DPS Policy does not allow State or other intra-national governmental boundaries to be used as the basis for determining the discreteness of a potential DPS, an artificial or human-made boundary may be used to clearly identify the geographic area included within a DPS designation. Easily identified human-made objects, such as the center line of interstate highways, Federal highways, and State highways are useful for delimiting DPS boundaries. Thus, the GYE grizzly bear DPS consists of: that portion of Idaho that is east of Interstate Highway 15 and north of U.S. Highway 30; that portion of Montana that is east of Interstate Highway 15 and south of Interstate Highway 90; and that portion of Wyoming that is south of Interstate Highway 90, west of Interstate Highway 25, west of Wyoming State Highway 220, and west of U.S. Highway 287 south of Three Forks (at the 220 and 287 intersection, and north of Interstate Highway 80 and U.S. Highway 30) (see DPS boundary in figure 1). Due to the use of highways as easily described boundaries, large areas of unsuitable habitat are included in the DPS boundaries.
The core of the GYE grizzly bear DPS is the Yellowstone PCA (24,000 km
The GYE grizzly bear population is the southernmost population remaining in the conterminous United States and has been physically separated from other areas where grizzly bears occur for at least 100 years (Merriam 1922, pp. 1–2; Miller and Waits 2003, p. 4334). The nearest population of grizzly bears is found in the NCDE approximately 115 km (70 mi) to the north. Although their current range continues to expand north (Bjornlie
Genetic data also support the conclusion that grizzly bears from the GYE are separated from other grizzly bears. Genetic studies estimating heterozygosity (which provides a measure of genetic diversity) show 60 percent heterozygosity in the GYE grizzly bears compared to 67 percent in the NCDE grizzly bears (Haroldson
Based on the best available scientific data about grizzly bear locations and movements, we find that the GYE grizzly bear population and other remaining grizzly bear populations are markedly, physically separated from each other. Therefore, the GYE grizzly bear population meets the criterion of discreteness under our DPS Policy. Occasional movement of bears from other grizzly bear populations into the GYE grizzly bear population would be beneficial to its long-term persistence (Boyce
If we determine that a population segment is discrete under one or more of the conditions described in the Service's DPS policy, its biological and ecological significance will then be considered in light of Congressional guidance that the authority to list DPS's be used “sparingly” while encouraging the conservation of genetic diversity (see Senate Report 151, 96th Congress, 1st Session). In carrying out this examination, we consider available scientific evidence of the population's importance to the taxon (
As specified in the DPS policy (61 FR 4722, February 7, 1996), this consideration of the population segment's significance may include, but is not limited to, the following: (1) Persistence of the discrete population segment in an ecological setting unusual or unique for the taxon; (2) evidence that loss of the discrete population segment would result in a significant gap in the range of the taxon; (3) evidence that the discrete population segment represents the only surviving natural occurrence of a taxon that may be more abundant elsewhere as an introduced population outside its historic range; or (4) evidence that the discrete population segment differs markedly from other populations of the species in its genetic characteristics. To be considered significant, a population segment needs to satisfy only one of these conditions, or other classes of information that might bear on the biological and ecological importance of a discrete population segment, as described in the DPS policy (61 FR 4722, February 7, 1996). Below we address Factors 1, 2, and 4. Factor 3 does not apply to the GYE grizzly bear population because there are several other naturally occurring populations of grizzly bears in North America.
In the 2007 final rule, we concluded that the GYE was a unique ecological setting because GYE grizzly bears were more carnivorous than in other ecosystems where the taxon occurs and they still used whitebark pine seeds extensively while other populations no longer did. New research shows that meat constitutes approximately the same percentage of annual grizzly bear diets in the NCDE (38 and 56 percent for females and males, respectively) (Teisberg
In addition to the unique combination of food sources available in the GYE, there is a gradient of foraging strategies across the ecosystem with bears in different parts of the GYE having access
Although grizzly bears in other ecosystems consume meat in similar quantities as the GYE, grizzly bears in the GYE are unique in their consumption of bison (Mattson 1997, p. 167; Fortin
In light of these new data indicating that grizzly bears in the GYE consume a unique combination of food sources compared to other grizzly bear populations, where we have considerable information about the taxon's diet, we consider the GYE grizzly bear population to meet the DPS policy standard for significance based on its persistence in an ecological setting unusual or unique for the taxon.
Historically, grizzly bears were distributed throughout the North American Rockies from Alaska and Canada, and south into central Mexico. Grizzly bears have been extirpated from most of the southern portions of their historic range and the Canadian plains (Schwartz
Several studies have documented some level of genetic differences between grizzly bears in the GYE and other populations in North America (Paetkau
In summary, while we no longer consider the GYE grizzly bear population to be significant due to marked genetic differences, we still conclude that the GYE grizzly bear population is significant due to its persistence in an ecological setting unique for the taxon and because the loss of this population would result in a significant gap in the range of the taxon.
Based on the best scientific and commercial data available, as described above, we find that the GYE grizzly bear population is discrete from other grizzly bear populations and significant to the remainder of the taxon (
Section 4 of the Act and its implementing regulations (50 CFR part 424) set forth the procedures for listing species, reclassifying species, or removing species from listed status. “Species” is defined by the Act as including any species or subspecies of fish or wildlife or plants, and any distinct vertebrate population segment
A recovered species is one that no longer meets the Act's definition of endangered or threatened. A species is endangered for purposes of the Act if it is in danger of extinction throughout all or a significant portion of its range (SPR) and is threatened if it is likely to become endangered in the foreseeable future throughout all or a significant portion of its range. The word “range” in “significant portion of its range” refers to the range in which the species currently exists at the time of this status review. Determining whether a species is recovered requires consideration of the same five categories of threats specified in section 4(a)(1) of the Act. For species that are already listed as endangered or threatened, this analysis of threats is an evaluation of both the threats currently facing the species and the threats that are reasonably likely to affect the species in the foreseeable future following the removal of the Act's protections. For the purposes of this analysis, we first evaluate the status of the species throughout all of its range, then consider whether the species is in danger of extinction or likely to become so in any significant portion of its range.
In considering what factors might constitute threats, we must look beyond the exposure of the species to a particular factor to evaluate whether the species may respond to the factor in a way that causes actual impacts to the species. If there is exposure to a factor and the species responds negatively, the factor may be a threat, and during the five-factor threats analysis, we attempt to determine how significant a threat it is. The threat is significant if it drives or contributes to the risk of extinction of the species such that the species warrants listing as endangered or threatened as those terms are defined by the Act. However, the identification of factors that could affect a species negatively may not be sufficient to justify a finding that the species warrants listing. The information must include evidence sufficient to suggest that the potential threat is likely to materialize and that it has the capacity (
Habitat destruction and modification were contributing factors leading to the listing of the grizzly bear as a threatened species under the Act in 1975 (40 FR 31734, July 28, 1975). Both the dramatic decreases in historical range and land management practices in formerly secure grizzly bear habitat led to the 1975 listing (40 FR 31734, July 28, 1975). For consideration under the Act's listing provisions in this final rule, the word range applies to where the species currently exists. To address this source of population decline, the IGBST was created in 1973, to collect, manage, analyze, and distribute science-based information regarding habitat and demographic parameters upon which to base management and recovery. Then, in 1983, the IGBC was created to coordinate management efforts across multiple Federal lands and different States within the various ecosystems ultimately working to achieve recovery of the grizzly bear in the lower 48 States. Its objective was to change land management practices on Federal lands that supported grizzly bear populations at the time of listing to provide security and maintain or improve habitat conditions for the grizzly bear. Since 1986, National Forest and National Park plans have incorporated the Interagency Grizzly Bear Guidelines (USDA FS 1986, pp. 1–2) to manage grizzly bear habitat in the Yellowstone PCA.
Management improvements made as a result of the Interagency Grizzly Bear Guidelines include, but are not limited to: (1) Federal and State agency coordination to produce nuisance bear guidelines that allow a quick response to resolve and minimize grizzly bear-human confrontations; (2) reduced motorized access route densities through restrictions, decommissioning, and closures; (3) highway design considerations to facilitate population connectivity; (4) seasonal closure of some areas to all human access in National Parks that are particularly important to grizzly bears; (5) closure of many areas in the GYE to oil and gas leasing, or implementing restrictions such as no surface occupancy; (6) elimination of six active and four vacant sheep allotments on the Caribou-Targhee National Forest since 1998, resulting in an 86 percent decrease in total sheep animal months inside the Yellowstone PCA; and (7) expanded information and education (I&E) programs in the Yellowstone PCA to help reduce the number of grizzly bear mortalities caused by big-game hunters (outside National Parks). Overall, adherence to the Interagency Grizzly Bear Guidelines has changed land management practices on Federal lands to provide security and to maintain or improve habitat conditions for the grizzly bear. Implementation of these guidelines has led to the successful rebound of the GYE grizzly bear population, allowing it to significantly increase in size and distribution since its listing in 1975.
In December 2016, the YES released the final 2016 Conservation Strategy for the grizzly bear in the GYE to guide management and monitoring of the habitat and population of GYE grizzly bears after delisting. The 2016 Conservation Strategy is the most recent iteration of the Conservation Strategy, which was first published in final form in 2007 (see our notice of availability published on March 13, 2007, at 72 FR
As per the 2016 Conservation Strategy and the habitat-based recovery criteria discussed above, the PCA will be a core secure area for grizzly bears where human impacts on habitat conditions will be maintained at or below levels that existed in 1998 (YES 2016a, pp. 54–73). Specifically, the amount of secure habitat will not decrease below 1998 levels while the number and capacity of developed sites and the number and acreage of livestock allotments will not increase above 1998 levels. The majority of land, all suitable habitat, within the PCA is managed by the NPS (39.4 percent (9,409 of 23,853 km
Motorized access affects grizzly bears primarily through increased human-caused mortality risk (Schwartz
“Administrative sites” are those sites or facilities constructed for use primarily by government employees to facilitate the administration and management of public lands. Administrative sites are counted toward developed sites, and examples include headquarters, ranger stations, patrol cabins, park entrances, Federal employee housing, and other facilities supporting government operations. In contrast to developed or administrative sites, “dispersed sites” are those not associated with a developed site, such as a front-country campground. These sites are typically characterized as having no permanent agency-constructed features, are temporary in
The primary concern related to developed sites is direct mortality from bear-human encounters and unsecured attractants. Secondary concerns include temporary or permanent habitat loss and displacement due to increased length of time of human use and increased human disturbance to surrounding areas. In areas of suitable habitat inside the PCA, the NPS and the USFS enforce food storage rules aimed at decreasing grizzly bear access to human foods (YES 2016a, pp. 30–31, 84–85). These regulations will continue to be enforced and are in effect for nearly all currently occupied grizzly bear habitat within the GYE grizzly bear DPS boundaries (YES 2016a, pp. 30–31, 84–85). Developed sites inside the PCA do not currently constitute a threat to the GYE grizzly bear DPS. Additionally, because the National Parks and National Forests within the PCA will continue to manage developed sites at 1998 levels within each bear management subunit, with some exceptions as per the application rules (YES 2016a, pp. 65–67), and because food storage rules will be enforced on these public lands, we do not expect developed sites inside the PCA to pose a threat to the GYE grizzly bear DPS in the foreseeable future.
Approximately 14 percent (45 of 311) of all human-caused grizzly bear mortalities in the GYE between 2002 and 2014 were due to management removal actions associated with livestock depredations. This human-caused mortality is the main impact to grizzly bears in the GYE associated with livestock. Increased chances of grizzly bear conflict related to livestock have been minimized through requirements to securely store and/or promptly remove attractants associated with livestock operations (
The Recovery Plan Supplement: Habitat-based Recovery Criteria for the Yellowstone Ecosystem (USFWS 2007
A total of 106 livestock allotments existed inside the PCA in 1998. Of these 1998 allotments, there were 72 active and 13 vacant cattle allotments and 11 active and 10 vacant sheep allotments, with a total of 23,090 sheep animal months (YES 2016b, Appendix E). Sheep animal months are calculated by multiplying the permitted number of animals by the permitted number of months. Any use of vacant allotments will be permitted only if the number and net acreage of allotments inside the PCA does not increase above the 1998 baseline (YES 2016a, p. 68). Since 1998, the Caribou-Targhee National Forest has closed six sheep allotments within the PCA, while the Shoshone National Forest has closed two sheep allotments and the Gallatin National Forest has closed four (Greater Yellowstone Area Grizzly Bear Habitat Modeling Team 2015, p. 86). This situation has resulted in a reduction of 21,120 sheep animal months, a 91 percent reduction, from the total calculated for 1998 within the PCA, and is a testament to the commitment that land management agencies have to the ongoing success of the grizzly bear population in the GYE. As of 2014, there is only one active sheep allotment within the PCA, on the Caribou-Targhee National Forest.
The mandatory restriction on creating new livestock allotments and the voluntary phasing out of livestock allotments with recurring conflicts further ensure that the PCA will continue to function as source habitat. Although it is possible to reopen closed allotments, such an action would be subject to NEPA and the majority of allotments would have a low probability of reopening because the rationale behind closing them is still applicable (
Under the conditions of the 2016 Conservation Strategy, any new oil, gas, or mineral project will be approved only if it conforms to secure habitat and developed site standards (USFWS 2007
Recreation in the GYE can be divided into six basic categories based on season of use (winter or all other seasons), mode of access (motorized or non-motorized), and level of development (developed or dispersed) (USDA FS 2006a, p. 187). Inside the PCA, the vast majority of lands available for recreation are accessible through non-motorized travel only (USDA FS 2006a, p. 179). Motorized recreation during the summer, spring, and fall inside the PCA will be limited to existing roads as per the standards in the 2016 Conservation Strategy that restrict increases in roads or motorized trails. Current and projected levels of non-motorized recreation, including mountain biking, do not occur at a level that requires limitations. Recreation at developed sites such as lodges, downhill ski areas, and campgrounds will be limited by the developed sites habitat standard described in the 2016 Conservation Strategy. Ongoing I&E efforts are an important contributing factor to successful grizzly bear conservation and will continue under the 2016 Conservation Strategy (YES 2016a, pp. 92–95). The number and capacity of existing developed sites on Federal lands has not increased from the 1998 baseline and will not increase once delisting occurs. For a more complete discussion of projected increases in recreation in the GYE National Forests, see the Final Environmental Impact Statement for the Forest Plan Amendment for Grizzly Bear Habitat Conservation for the GYE National Forests (USDA FS 2006a, pp. 176–189).
In conclusion, because the few motorized access routes inside the PCA will not increase, because the number and capacity of developed sites on public lands within the PCA will not increase, and because the National Parks and National Forests within the PCA will continue to educate visitors on their lands about how to recreate safely in bear country and avoid grizzly bear-human conflicts, the current level of recreation does not currently constitute a threat to the GYE grizzly bear DPS, and we do not expect recreation to constitute a threat in the foreseeable future.
Disturbance in the den could result in increased energetic costs (increased activity and heart rate inside the den) and possibly den abandonment, which, in theory, could ultimately lead to a decline in physical condition of the individual or even cub mortality (Swenson
Swenson
In summary, the available data about the potential for disturbance while denning and den abandonment from nearby snowmobile use are extrapolated from studies examining the impacts of other human activities and are identified as “anecdotal” in nature (Swenson
Conversely, vegetation management may result in positive effects on grizzly bear habitat once the project is complete, provided key habitats such as riparian areas and known food production areas are maintained or enhanced. For instance, tree removal for thinning or timber harvest and prescribed burning can result in localized increases in bear foods through increased growth of grasses, forbs, and berry-producing shrubs (Zager
Changes in the distribution, quantity, and quality of cover are not necessarily detrimental to grizzly bears as long as they are coordinated on a BMU or subunit scale to ensure that grizzly bear needs are addressed throughout the various projects occurring on multiple jurisdictions at any given time. Although there are known, usually temporary, impacts to individual bears from timber management activities, these impacts have been adequately mitigated using the Interagency Grizzly Bear Guidelines in place since 1986, and will continue to be managed at levels acceptable to the grizzly bear population under the 2016 Conservation Strategy. Therefore, we do not expect that vegetation management inside the PCA will constitute a threat to the GYE grizzly bear DPS now, or in the foreseeable future.
Potential advantages of this data collection requirement include reduction of grizzly bear mortality due to vehicle collisions, access to seasonal habitats, maintenance of traditional dispersal routes, and decreased risk of fragmentation of individual home ranges. For example, work crews will place temporary work camps in areas with lower risk of displacing grizzly bears, and food and garbage will be kept in bear-resistant containers. Highway planners will incorporate warning signs and crossing structures such as culverts or underpasses into projects when possible to facilitate safe highway crossings by wildlife. Additionally, the conflict prevention, response, and outreach elements of the 2016 Conservation Strategy play an important role in preventing habitat fragmentation by keeping valleys that are mostly privately owned from becoming mortality sinks to grizzly bears attracted to human sources of foods. In conclusion, because these activities that combat habitat fragmentation will continue to occur under the 2016 Conservation Strategy, we do not expect that fragmentation within the GYE grizzly bear DPS boundaries will constitute a threat to the GYE grizzly bear DPS now, or in the foreseeable future.
In suitable habitat outside of the PCA within the DPS boundaries, the USFS, BLM, and State wildlife agencies will monitor habitat and population criteria to prevent potential threats to habitat, ensuring that the measures of the Act continue to be unnecessary (Idaho's Yellowstone Grizzly Bear Delisting Advisory Team 2002, pp. 2–3; MFWP 2013, p. 5; USDA FS 2006a, pp. 44–45; WGFD 2016, p. v; YES 2016a, pp. 1–12). Factors impacting suitable habitat outside of the PCA in the future are similar to those inside the PCA and may include projects that involve road construction, livestock allotments, developed sites, and increased human-caused grizzly bear mortality risk.
Of the 22,783 km
Specifically, the Wilderness Act of 1964 (16 U.S.C. 1131
Wilderness Study Areas (WSAs) (Wilderness Study Act of 1977) have been designated by Congress as areas having wilderness characteristics and warranting further study by Federal land management agencies (
Inventoried Roadless Areas (IRAs) currently provide 4,891 km
Based on the amount of Wilderness, WSA, and IRA, an estimated 71 percent (12,396 of 17,291 km
Additional protections occur on suitable habitat on Federal (BLM and NPS) and Tribal lands outside of the PCA but inside the DMA. The BLM manages an additional 22 percent (5,064 km
Federal, State, and Tribal agencies are committed to managing habitat so that the GYE grizzly bear DPS remains recovered and is not likely to become endangered throughout all or a significant portion of its range in the foreseeable future (Idaho's Yellowstone Grizzly Bear Delisting Advisory Team 2002, pp. 2–3; USDA FS 2006b, entire; Eastern Shoshone and Northern Arapaho Tribes 2009, p. 11; MFWP 2013, p. 6; YNP 2014b, p. 18; GTNP and JDR 2016, p. 3; WGFD 2016, p. v; YES 2016a, pp. 54–85). In suitable habitat outside of the PCA, restrictions on human activities are more flexible, but the USFS, BLM, and Tribal and State wildlife agencies will still carefully manage these lands, monitor bear-human conflicts in these areas, and respond with management as necessary to reduce such conflicts to account for the complex needs of both grizzly bears and humans (Idaho's Yellowstone Grizzly Bear Delisting Advisory Team 2002, pp. 16–17; USDA FS 2006b, pp. A1–A27; Eastern Shoshone and Northern Arapaho Tribes 2009, pp. 9–11; MFWP 2013, pp. 53–59; WGFD 2016, pp. 20–25; YES 2016a, pp. 86–91).
By and large, habitat management on Federal public lands is directed by Federal land management plans, not State management plans. However, the three State grizzly bear management plans recognize the importance of areas that provide security for grizzly bears in suitable habitat outside of the PCA within the DPS boundaries on Federal lands. For example, the Montana and Wyoming plans recommend limiting average road densities to 1.6 km/2.6 km
In 2004, there were roughly 150 active cattle allotments and 12 active sheep allotments in suitable habitat outside the PCA within the DPS boundaries (USDA FS 2004, p. 129). The Targhee National Forest closed two of these sheep allotments in 2004, and there have not been any new allotments created since then (USDA FS 2006a, p. 168; Landenburger 2014,
There are over 500 developed sites on the five National Forests in the areas identified as suitable habitat outside the PCA within the DPS boundaries (USDA FS 2004, p. 138). While grizzly bear-human conflicts at developed sites on public lands do occur, the most frequent reason for management removals are conflicts on private lands (Servheen
According to current Forest Plan direction, less than 19 percent (3,213 km
Ultimately, the five affected National Forests (the Beaverhead-Deerlodge, Bridger-Teton, Caribou-Targhee, Custer Gallatin, and Shoshone) will manage the number of roads, livestock allotments, developed sites, timber harvest projects, and oil and gas wells outside of the PCA in the DMA to allow for a recovered grizzly bear population. Under the National Forest Management Act of 1976, the USFS will consider all potential impacts of projects to the GYE grizzly bear population in the NEPA planning process and then ensure that activities will provide appropriate habitat to maintain the population's recovered status.
Rapidly accelerating growth of human populations in some areas outside of the PCA continues to define the limits of grizzly bear range, and will likely limit the expansion of the GYE grizzly bear population onto private lands in some areas outside the PCA. Urban and rural sprawl (low-density housing and associated businesses) has resulted in increasing numbers of grizzly bear-human conflicts with subsequent increases in grizzly bear mortality rates. Private lands account for a disproportionate number of bear deaths and conflicts (USFWS 2007
In summary, the following factors warranted consideration as possible threats to the GYE grizzly bear DPS under
Within suitable habitat, different levels of management and protection are applied to areas based on their level of importance. Within the PCA, habitat protections for grizzly bear conservation are in place across the current range where 75 percent of the females with cubs-of-the-year live most or all of the time (Schwartz
Suitable habitat outside the PCA provides additional ecological resiliency and habitat redundancy to allow the population to respond to environmental changes. Habitat protections specifically for grizzly bear conservation are not necessary here because other binding regulatory mechanisms are in place for nearly 60 percent of the area outside the PCA. In these areas, the Wilderness Act, the Roadless Areas Conservation Rule, and National Forest Land Management Plans limit development and motorized use. Management of individual projects on public land outside the PCA will continue to consider and minimize impacts on grizzly bear habitat. Efforts by NGOs and Tribal, State, and county agencies will seek to minimize bear-human conflicts on private lands (YES 2016a, pp. 86–91). These and other conservation measures ensure threats to the GYE grizzly bear population's suitable habitat outside the PCA will continue to be ameliorated and will not be a threat to this population's long-term persistence (USDA FS 2006b).
Other management practices on Federal lands have been changed to provide security and to maintain or improve habitat conditions for grizzly bears. All operating plans for oil and gas leases must conform to secure habitat and developed site standards, which require mitigation for any change in secure habitat. Recreation inside the GYE is limited through existing road and developed site standards. Additionally, I&E campaigns educate visitors about how to recreate safely in bear country and avoid bear-human conflicts. There are no data available on the impacts of snowmobiling on grizzly bears to suggest an effect on grizzly bear survival or recovery of the population. Although vegetation management may temporarily impact individual grizzly bears, these activities are coordinated on a BMU or subunit scale according to the Interagency Grizzly Bear Guidelines to mitigate for any potentially negative effect. As a result of vegetation management, there may also be positive effects on grizzly bears where key habitats are maintained or enhanced. The habitat changes that are predicted under climate change scenarios are not expected by most grizzly bear biologists to directly threaten grizzly bears. The potential for changes in the frequency and timing of grizzly bear-human interactions is discussed below under
In summary, the factors discussed under
Excessive human-caused mortality, including “indiscriminate illegal killing” and management removals, was the primary factor contributing to grizzly bear decline during the 19th and 20th centuries (Leopold 1967, p. 30; Koford 1969, p. 95; Servheen 1990, p. 1; Servheen 1999, pp. 50–52; Mattson and Merrill 2002, pp. 1129, 1132; Schwartz
From 1980 to 2002, 66 percent (191) of the 290 known grizzly bear mortalities were human-caused (Servheen
We define poaching as intentional, illegal killing of grizzly bears. People may kill grizzly bears for several reasons, including a general perception that grizzly bears in the area may be dangerous, frustration over livestock depredations, or to protest land-use and road-use restrictions associated with grizzly bear habitat management (Servheen
State and Federal law enforcement agents have cooperated to ensure consistent enforcement of laws protecting grizzly bears. Currently, State and Federal prosecutors and enforcement personnel from each State and Federal jurisdiction work together to make recommendations to all jurisdictions, counties, and States on uniform enforcement, prosecution, and sentencing relating to illegal grizzly bear kills. This cooperation means illegal grizzly bear mortalities are often prosecuted under State statutes instead of the Act. We have a long record of this enforcement approach being effective, and no reason to doubt its effectiveness in the absence of the Act's additional layer of Federal protections.
When this final rule becomes effective, all three affected States and the Eastern Shoshone and Northern Arapaho Tribes of the WRR will classify grizzly bears in the GYE as game animals, which cannot be taken without authorization by State or Tribal wildlife agencies (W.S. 23–1–101(a)(xii)(A); W.S. 23–3–102(a); MCA 87–2–101(4); MCA 87–1–301; MCA 87–1–304; MCA 87–5–302; IC 36–2–1; IDAPA 13.01.06.100.01(e); IC 36–1101(a); Idaho's Yellowstone Grizzly Bear Delisting Advisory Team 2002, pp. 18–21; MFWP 2013, p. 6; Eastern Shoshone and Northern Arapahoe Tribes 2009, p. 9; WGFD 2016, p. 9; YES 2016a, pp. 104–116). In other words, it will still be illegal for private citizens to kill grizzly bears unless it is in self-defense (as is currently allowed under the Act's protections), or if they have a hunting license issued by State or Tribal wildlife agencies.
In addition, in the Montana portion of the DPS, a grizzly bear may be killed if it is caught in the act of attacking or killing livestock (87–6–106 MCA). With respect to this exception, there must be injured or dead livestock associated with any grizzly bear killed in defense of livestock in Montana. There are no documented cases of livestock owners or herders actually observing a grizzly bear depredating on livestock since records began to be kept in 1975. Before that time, it would have been legal for a livestock operator to kill a grizzly bear just for being present. A similar exception that occurs in the Idaho portion of the DPS allows a grizzly bear to be killed if it is “molesting or attacking livestock or domestic animals” (Senate Bill 1027: Section 7: 36–1107(d)). Because Idaho contains only 6.6 percent of the DMA and has experienced low numbers of conflicts and management removals from 2002 to 2014 (9.9 and 0.3 per year, respectively, inside the DMA), we do not expect Idaho Senate Bill 1027 to be a significant source of mortality to the GYE grizzly bear.
The States will continue to enforce, prosecute, and sentence poachers as they do for any game animal such as elk, black bears, and cougars (W.S. 23–3–102(d); W.S. 23–6–202; W.S. 23–6–206; W.S. 23–6–208; MCA 87–6–301; IC 36–1404). Although it is widely recognized that poaching still occurs, this illegal source of mortality is not significant enough to hinder population stability for the GYE grizzly bear population (IGBST 2012, p. 34) or range expansion (Pyare
I&E campaigns (described in detail in
From 2002 to 2014, 31 percent (97) of human-caused grizzly bear mortalities in the GYE were self-defense or defense of other persons kills (Haroldson 2014b,
Another primary source of human-caused mortality is agency removal of conflict bears following grizzly bear-
Conflicts at developed sites (on either public or private lands) were responsible for 90 of the 135 agency removals between 2002 and 2014. These conflicts usually involve attractants, such as garbage, human foods, pet/livestock/wildlife foods, livestock carcasses, and wildlife carcasses, but also are related to attitudes, understanding, and tolerance toward grizzly bears. Mandatory food storage orders on public lands decrease the change of conflicts while State and Federal I&E programs reduce grizzly bear-human conflicts on both private and public lands by educating the public about potential grizzly bear attractants and how to store them properly. Accordingly, the majority of grizzly bear budgets of the agencies responsible for implementing the 2016 Conservation Strategy and managing the GYE grizzly bear population post-delisting is for grizzly bear-human conflict management, outreach, and education. To address public attitudes and knowledge levels, I&E programs present grizzly bears as a valuable public resource while acknowledging the potential dangers associated with them and ways to avoid conflicts (for a detailed discussion of I&E, see
Agency removals due to grizzly bear conflicts with livestock accounted for nearly 33 percent (45/135) of agency removals (Haroldson 2014b,
The 2016 Conservation Strategy and State grizzly bear management plans will guide decisions about agency removals of conflict bears post-delisting and keep this source of human-caused mortality within the total mortality limits for each age/sex class as per tables 2 and 3. The 2016 Conservation Strategy is consistent with current protocols (USDA FS 1986, pp. 53–54), emphasizing the individual's importance to the entire population. Females will continue to receive a higher level of protection than males. Location, cause of incident, severity of incident, history of the bear, health, age, and sex of the bear, and demographic characteristics are all considered in any relocation or removal action. Upon delisting, State, Tribal, and NPS bear managers will continue to coordinate and consult with each other and relevant Federal agencies (
Overall, we consider agency management removals a necessary component of grizzly bear conservation. Conflict bears can become a threat to human safety and erode public support if they are not addressed. Without the support of the people that live, work, and recreate in grizzly bear country, conservation will not be successful. Therefore, we do not consider management removals a threat to the GYE grizzly bear population now, or in the foreseeable future. However, we recognize the importance of managing these sanctioned removals within sustainable levels, and Federal, Tribal, and State management agencies are committed to working with citizens, landowners, and visitors to address unsecured attractants to reduce the need for grizzly bear removals.
Humans kill grizzly bears unintentionally in a number of ways. From 2002 to 2014, there were 34 accidental mortalities and 23 mortalities associated with mistaken identification (totaling 18 percent of human-caused mortality for this time period) (Haroldson 2014b,
Mistaken identification of grizzly bears by black bear hunters is a manageable source of mortality. The 2016 Conservation Strategy identifies I&E programs targeted at hunters that emphasize patience, awareness, and correct identification of targets to help reduce grizzly bear mortalities from inexperienced black bear and ungulate hunters (YES 2016a, pp. 92–95). Beginning in license year 2002, the State of Montana required that all black bear hunters pass a Bear Identification Test before receiving a black bear license (see
The IGBST prepares annual reports analyzing the causes of conflicts, known and probable mortalities, and proposed management solutions (Servheen
No grizzly bears have been removed from the GYE since 1975 for commercial, recreational, scientific, or educational purposes. While there have been some mortalities related to research trapping since 1975, these were accidental as discussed above. The only commercial or recreational take anticipated post-delisting is a limited, controlled hunt, discussed below.
The population has stabilized inside the DMA since 2002, with the model-averaged Chao2 population estimate for 2002–2014 being 674 (95% CI = 600–747). This stabilization over 13 years is strong evidence that the population is exhibiting density-dependent population regulation inside the DMA, and this has recently been documented (van Manen
Accordingly, the agencies implementing the 2016 Conservation Strategy have decided that the population in the DMA will be managed to maintain the population around the long-term average population size for 2002–2014 of 674 (95% CI = 600–747) (using the model-averaged Chao2 population estimate), consistent with the revised demographic recovery criteria (USFWS 2017, entire) and the Tri-State Memorandum of Agreement (MOA) (Wyoming Game and Fish Commission
When this final rule is made effective, grizzly bears will be classified as a game species throughout the GYE DPS boundaries outside National Parks and the WWR in the States of Wyoming, Montana, and Idaho (W.S. 23–1–101 (a)(xii)(A); MCA 87–2–101 (4); IC 36–2–1; IDAPA 13.01.06.100.01(e); Idaho's Yellowstone Grizzly Bear Delisting Advisory Team 2002, pp. 18–21; MFWP 2013, p. 6; Eastern Shoshone and Northern Arapahoe Tribes 2009, p. 9; WGFD 2016, p. 9; YES 2016a, pp. 104–116). While the States may choose to institute a carefully regulated hunt with ecosystem-wide coordinated total mortality limits (Wyoming Game and Fish Commission
The States have enacted the following regulatory mechanisms by law and regulations that address human-caused mortality, including mortality from hunting. The State regulatory mechanisms include: Grizzly Bear Management Hunting Regulations; Wyoming Game and Fish Commission Chapter 67 Grizzly Bear Management Regulation; Proclamation of the Idaho Fish and Game Relating to the Limit of the Take of Grizzly Bear in the Greater Yellowstone Ecosystem; Montana Fish, Wildlife & Parks Grizzly Bear Montana Hunting Regulations; and the Memorandum of Agreement Regarding the Management and Allocation of Discretionary Mortality of Grizzly Bears in the Greater Yellowstone Ecosystem (the Tri-State MOA) (in their entirety: Idaho Fish and Game Commission 2016; MFWP 2016; Montana Fish and Wildlife Commission Resolution, July 13, 2016, pp. 753–761; approving the Tri-State MOA; Wyoming Game and Fish Commission 2016; Wyoming Game and Fish Commission
• Suspend all discretionary mortality inside the DMA, except if required for human safety, if the model-averaged
• Suspend grizzly bear hunting inside the DMA if total mortality limits for any sex/age class (as per tables 2 and 3) are met at any time during the year (Montana Fish and Wildlife Commission Resolution, July 13, 2016, pp. 753–761; approving the Tri-State MOA; Tri-State MOA: Section IV(2)(c), Section IV(4)(a), Section IV(6); Chapter 67 of WY Game and Commission Regulations: Section 4(d); Idaho Fish and Game Commission Proclamation: Section 5);
• Prohibit hunting of female grizzly bears accompanied by young (Montana Fish and Wildlife Commission Resolution, July 13, 2016, pp. 753–761; approving the Tri-State MOA; Tri-State MOA: Section IV(4)(b); MT State Hunting Regulations pp. 4, 7; Chapter 67 of WY Game and Commission Regulations: Section 4(e); Idaho Fish and Game Commission Proclamation: Section 4);
• In a given year, discretionary mortality will be allowed only if non-discretionary mortality does not meet or exceed total mortality limits for that year (Montana Fish and Wildlife Commission Resolution, July 13, 2016, pp. 753–761; approving the Tri-State MOA; Tri-State MOA: Section IV(2)(c), Section IV(4)(a), Section IV(6); Chapter 67 of WY Game and Commission Regulations: Section 4(d), Section 4(k); Idaho Fish and Game Commission Proclamation: Section 5); and
• Any mortality that exceeds allowable total mortality limits in any year will be subtracted from that age/sex class allowable total mortality limit for the following year to ensure that long-term mortality levels remain within prescribed limits inside the DMA (Montana Fish and Wildlife Commission Resolution, July 13, 2016; approving the Tri-State MOA; Tri-State MOA: Section IV(2)(c); Chapter 67 of WY Game and Commission Regulations: Section 4(g), Section 4(k), and Section 4(l); Idaho Fish and Game Proclamation: Section 6).
The Tri-State MOA was signed by Idaho, Montana, and Wyoming wildlife agencies in July/August 2016. In it, the three States commit to manage grizzly bears consistent with the 2007 Conservation Strategy and all revisions associated with delisting (which includes the 2016 Conservation Strategy approved by all three States), to use the best science to collectively manage grizzly bears, and to manage discretionary mortality consistent with the model-average Chao2 population estimate from 2002 to 2014. The Service believes the Tri-State MOA will be implemented because all parties have approved it. In addition to their signatures on the MOA, the States have either adopted the entire MOA or key parts of it via regulatory mechanisms. The Idaho Fish and Game Commission adopted a proclamation agreeing to the MOA mortality limits (Idaho Fish and Game Commission 2016; Trever 2017,
The States' authorities to implement important aspects of the Tri-State MOA are set forth in Attachment B of the Tri-State MOA. These regulatory mechanisms include the authority to suspend hunting seasons, prohibit the take of females with young, and to enact emergency closures for other reasons,
In addition to the regulatory mechanism above, the IGBST will complete a Biology and Monitoring Review to evaluate the impacts of these total mortality levels on the population and present it to the YGCC and the public if any of the following conditions are met: (1) Exceeding independent female mortality limits in 3 consecutive years, or (2) exceeding independent male mortality limits in 3 consecutive years, or (3) exceeding dependent young mortality limits in 3 consecutive years (YES 2016a, pp. 100–102). The States will coordinate via the Tri-State MOA to manage total mortalities within the DMA to be within the age/sex mortality limits as per tables 2 and 3.
The number of grizzly bears available for discretionary mortality in a given year is based on the model-averaged Chao2 population estimate inside the DMA from the previous year, the total annual allowable mortality rate (see table 2), the total annual allowable mortality numbers, and the non-discretionary mortality from the previous year. Total annual allowable mortality numbers are calculated each year by multiplying the total annual mortality rate by the size of each sex/age cohort, which varies with population size, from the previous year. Total mortality includes documented known and probable grizzly bear mortalities from all causes, including but not limited to: management removals, illegal kills, mistaken identity kills, self-defense kills, vehicle kills, natural mortalities, undetermined-cause mortalities, grizzly bear hunting, and a statistical estimate of the number of unknown/unreported mortalities (Cherry
This example serves to explain the process that the States will use to determine allowable discretionary mortality. State fish and wildlife agencies, or their Wildlife Commissions, have discretion to determine whether they intend to propose a grizzly bear hunting season in any year and, if so, how much discretionary mortality they will authorize to allocate to discretionary mortality while remaining within the limits that maintain a recovered population.
Other regulations, such as timing and location of hunting seasons, should seasons be implemented, would be devised by the States to minimize the possibility of exceeding total mortality limits of independent females within the DMA (Idaho's Yellowstone Grizzly Bear Delisting Advisory Team 2002, p. 20; MFWP 2013, p. 61; WGFD 2016, p. 16).
To ensure that the distribution criterion (16 of 18 bear management units within the Recovery Zone must be occupied by females with young, with no 2 adjacent bear management units unoccupied, during a 6-year sum of observations) is maintained, the IGBST will annually monitor and report the current distribution of reproducing females. If the necessary distribution of reproducing females is not met for 3 consecutive years, the IGBST will complete a Biology and Monitoring Review to evaluate the impacts of reduced distribution of reproducing females on the population and present it to the YGCC. This Biology and Monitoring Review will consider the significance of the reduced distribution of reproducing females and make recommendations to increase their current distribution as necessary.
The Service will initiate a formal status review and could emergency re-list the GYE grizzly bear population until the formal status review is complete under any of the following conditions:
(1) If there are any changes in Federal, State, or Tribal laws, rules, regulations, or management plans that depart significantly from the specifics of population or habitat management detailed in this final rule or the 2016 Conservation Strategy that would significantly increase the threat to the GYE grizzly bear population. The Service will promptly conduct such an evaluation of any change in a State or Federal agency's regulatory mechanisms to determine if such a change represents a threat to the GYE grizzly bear population. As the Service has done for the Rocky Mountain DPS of gray wolf, such an evaluation will be documented for the record and acted upon if necessary.
(2) If the population falls below 500 in any year using the model-averaged Chao2 population estimator, or counts of females with cubs-of-the-year fall below 48 for 3 consecutive years.
(3) If fewer than 16 of 18 bear management units are occupied by females with young for 3 consecutive 6-year sums of observations. Monitoring and status review provisions are discussed in detail later in this final rule.
In areas of the GYE grizzly bear DPS outside the DMA boundaries, respective States and Tribes may establish hunting seasons independent of the total mortality limits inside the DMA. Hunting mortality outside the DMA boundary would not threaten the GYE grizzly bear DPS because total mortality limits are in place as per tables 2 and 3 for the source population within the DMA boundary.
To increase the likelihood of occasional genetic interchange between the GYE grizzly bear population and the NCDE grizzly bear population, the State of Montana has indicated they will manage discretionary mortality in this area in order to retain the opportunity for natural movements of bears between ecosystems (MFWP 2013, p. 9). Maintaining the presence of non-conflict grizzly bears in areas between the NCDE management area and the DMA of the GYE, such as the Tobacco Root and Highland Mountains, would likely facilitate periodic grizzly bear movements between the NCDE and GYE.
To ensure total mortality rates remain consistent with population objectives after delisting, the IGBST will conduct a demographic review of population vital rates (table 3, item #7) at least every 5 to 10 years for the foreseeable future. The results of these reviews will be used to make appropriate adjustments to ensure that the population remains recovered in accordance with the recovery criteria. The 5- to 10-year time interval was selected based on life-history characteristics of bears and methodologies in order to obtain estimates with acceptable levels of uncertainty and statistical rigor (Harris
In the period 2002–2014, 76 percent of known or probable grizzly bear mortalities in the GYE DMA (311/410) were human-caused (Haroldson 2014b,
Although grizzly bears have been documented with a variety of bacteria
Grizzly bears are occasionally killed by other wildlife. Adult grizzly bears kill dependent young, subadults, or other adults (Stringham 1980, p. 337; Dean
In summary, the following factors warranted consideration as possible threats to the GYE grizzly bear DPS under
Overall, from 2002 to 2014, the GYE grizzly bear population incurred an average of 23.9 human-caused mortalities per year (Haroldson 2014b,
If grizzly bear hunting occurs, hunting mortality would be within the total mortality limits for independent females and males noted in tables 2 and 3 that ensure the population remains recovered within the DMA as measured by adherence to total mortality limits and annual population estimates. Hunting will not occur if other sources of mortality exceed the total mortality limits (see table 3). The States have incorporated the total mortality limits for each age/sex class based on annual IGBST model-averaged Chao2 population estimates set forth in table 2 in the Tri-State MOA and State regulations (Idaho Fish and Game Commission 2016; MFWP 2016; Wyoming Game and Fish Commission 2016; Wyoming Game and Fish Commission
In addition, as discussed above, the Service will initiate a status review with possible emergency re-listing pursuant to the Act if: (1) There are any changes in Federal, State, or Tribal laws, rules, regulations, or management plans that depart significantly from the specifics of population or habitat management detailed in this final rule or the 2016 Conservation Strategy that would significantly increase the threat to the GYE grizzly bear population. The Service will promptly conduct such an evaluation of any change in a State or Federal agencies change in regulatory mechanisms to determine if such a change represents a threat to the GYE grizzly bear population. As the Service has done for the Rocky Mountain DPS of gray wolf, such an evaluation will be documented for the record and acted upon if necessary; or (2) the population falls below 500 in any year using the model-averaged Chao2 population estimator, or counts of females with cubs-of-the-year fall below 48 for 3 consecutive years; or (3) fewer than 16 of 18 bear management units are occupied by females with young for 3 consecutive 6-year sums of observations.
These commitments have been implemented into regulations and ameliorate impacts related to potential commercial and recreational hunting
Therefore, based on the best available scientific and commercial information, detailed State and Federal regulatory and other commitments, application of mortality management detailed in this final rule and the 2016 Conservation Strategy, and the expectation that these bear management practices will continue into the foreseeable future, we conclude that natural disease, predation, and human-caused mortality do not constitute threats to the GYE grizzly bear DPS now and are not anticipated to constitute threats in the foreseeable future.
Under this factor, we examine the stressors identified within the other factors as ameliorated or exacerbated by any existing regulatory mechanism or conservation effort designed to address threats to a species or pertain to the overall State management of a species. Section 4(b)(1)(A) of the Act requires that the Service take into account “those efforts, if any, being made by any State or foreign nation, or any political subdivision of a State or foreign nation, to protect such species. . . .” We consider relevant Federal, State, and Tribal laws, regulations, and other binding legal mechanisms that may ameliorate or exacerbate any of the threats we describe in threat analyses under the other four factors or otherwise enhance the species' conservation. Our consideration of regulatory mechanisms is described in detail within the discussion of each of the threats or stressors to the species (
The following existing regulatory mechanisms are specifically considered and discussed as they relate to the stressors, under the applicable Factors, affecting the GYE grizzly bear DPS. Under
• 2006 Forest Plan Amendment for Grizzly Bear Habitat Conservation for the Greater Yellowstone Area National Forests,
• Wilderness Act of 1964, the 2001 Roadless Rule, and
• YNP and GTNP Compendia implemented under the National Park Service Organic Act. The Organic Act of 1916, 16 U.S.C. Section 1, created the NPS and assigned it the responsibility to manage the national parks. The Organic Act requires the NPS to manage park units to conserve scenery, natural and historic objects within parks, and wildlife, and to provide for their enjoyment in a manner that leaves them unimpaired for the enjoyment of future generations.
• State of Idaho Yellowstone Grizzly Bear Management Plan,
• Proclamation of the Idaho Fish and Game Commission Relating to the Limit of the Take of Grizzly Bear in the Greater Yellowstone Ecosystem,
• Grizzly Bear Management Plan for Southwestern Montana,
• Montana Hunting Regulations for Grizzly Bear,
• Montana Fish and Wildlife Commission Resolution approving the Tri-State MOA (July 13, 2016),
• Wyoming Grizzly Bear Management Plan,
• Wyoming Game and Fish Commission Chapter 67 Grizzly Bear Management Regulation, and
• Memorandum of Agreement Regarding the Management and Allocation of Discretionary Mortality of Grizzly Bears in the GYE.
Therefore, based on the best available information and on continuation of current regulatory commitment, we do not consider inadequate regulatory mechanisms to constitute a threat to the GYE grizzly bear DPS now or in the foreseeable future.
The isolated nature of the GYE grizzly bear population was identified as a potential threat when listing occurred in 1975. Declines in genetic diversity are expected in isolated populations (Allendorf
Effective population size is a metric used by geneticists to distinguish between total population size and the actual number of individuals available to reproduce at any given time. For example, many individuals in a population may be too young to reproduce and, therefore, are not part of the “effective population size.” For short-term fitness (
To further ensure this minimum number of animals in the population necessary for genetic health is always maintained, the revised demographic recovery criteria as well as the 2016
While this current estimated effective population size of approximately 469 animals (Kamath
Based on Miller and Waits (2003, p. 4338), the 2007 Conservation Strategy recommended that if no movement or successful genetic interchange was detected by 2020, grizzly bears from the NCDE would be translocated into the GYE grizzly bear population to achieve the goal of two effective migrants every 10 years (
To increase the likelihood of occasional genetic interchange between the GYE grizzly bear population and the NCDE grizzly bear population, the State of Montana has indicated they will manage discretionary mortality in this area in order to retain the opportunity for natural movements of bears between ecosystems. Translocation of bears between these ecosystems will be a last resort and will be implemented only if there are demonstrated effects of lowered heterozygosity among GYE grizzly bears or other genetic measures that indicate a decrease in genetic diversity, as monitored by the IGBST (WGFD 2016, p. 13).
To document natural connectivity between the GYE and the NCDE, Federal and State agencies will continue to monitor bear movements on the northern periphery of the GYE grizzly bear DPS boundaries and the southern edges of the NCDE using radio-telemetry and will collect genetic samples from all captured or dead bears to document possible gene flow between these two ecosystems (YES 2016a, pp. 51–53). These genetic samples will detect migrants using an “assignment test” to identify the area from which individuals are most likely to have originated based on their unique genetic signature (Paetkau
In summary, genetic concerns are not currently a threat to the GYE grizzly bear population (Miller and Waits 2003, p. 4338; Kamath
A comprehensive study of the GYE grizzly bear diet documented over 266 distinct plant and animal species ranging from grasses, fungi, berries, and seeds, to fish, carrion, and other meat sources (
Grizzly bears consume elk and bison as winter-killed carrion in the early spring, kill calves opportunistically, consume hunter-killed carcasses or gut piles, and prey upon adults weakened during the fall breeding season. Ungulate populations are threatened by brucellosis (
A decline in the Yellowstone cutthroat trout population has resulted from a combination of factors: the introduction of nonnative lake trout (
Army cutworm moths aggregate on remote, high-elevation talus slopes where grizzly bears forage on them from mid- to late summer. Grizzly bears could potentially be disturbed by backcountry visitors (White
More details on the specific ways in which changes in ungulates, cutthroat trout, and army cutworm moths could affect the GYE grizzly bear population are discussed in detail in the 2007 final rule (72 FR 14866, March 29, 2007, 14928–14933). Our analysis focuses on the potential impacts that the loss of whitebark pine could have on the GYE grizzly bear population. While we discussed notable declines in whitebark pine due to mountain pine beetle in the 2007 final rule, the data used to estimate population growth only went through 2002. The Ninth Circuit Court of Appeals questioned our conclusions about future population viability based on data gathered before the sharp decline in whitebark pine began (
The threats to whitebark pine reported in our 2007 final rule and reiterated in our 12-month finding for whitebark pine are currently being analyzed in a Species Status Assessment (76 FR 42631, July 19, 2011). Whitebark pine is currently warranted for protected status under the Act, but that action is precluded by higher priority actions. This status is primarily the result of direct mortality due to white pine blister rust and mountain pine beetles but also less obvious impacts from climate change and fire suppression. For more details on the status of whitebark pine, please see the 2013 candidate notice of review (78 FR 70104, November 22, 2013).
Whitebark pine is a masting species, which means it produces large seed crops in some years and poor crops in other years. In the GYE, a good seed crop occurs approximately every 2 to 3 years. During years of low availability of whitebark pine seeds, grizzly bear-human conflicts tend to increase as bears use lower elevations, and when those areas are within less secure habitats (Gunther
Using data from 2002 to 2011, the IGBST documented an average annual population growth rate for the GYE grizzly bear population between 0.3 and 2.2 percent (IGBST 2012, p. 34). Although the population was still increasing in this more recent time period, it was increasing at a slower rate than in the previous time period (1983–2001) and coincided with the rapid decline of whitebark pine that began in the early 2000s. Therefore, the IGBST examined the potential influence of whitebark pine decline on the change in population growth rate. Because extrinsic, density-independent factors (
For the Food Synthesis Report, the IGBST developed a comprehensive set of research questions and hypotheses to evaluate grizzly bear responses to changes in food resources. Specifically, the IGBST asked eight questions:
(1) How diverse is the diet of GYE grizzly bears?
(2) Has grizzly bear selection of whitebark pine habitat decreased as tree mortality increased?
(3) Has grizzly bear body condition decreased as whitebark pine declined?
(4) Has animal matter provided grizzly bears with an alternative food resource to declining whitebark pine?
(5) Have grizzly bear movements increased during the period of whitebark pine decline (2000–2011)?
(6) Has home range size increased as grizzly bears sought alternative foods, or has home-range size decreased as grizzly bear density increased?
(7) Has the number of human-caused grizzly bear mortalities increased as whitebark pine decreased?
(8) Are changes in vital rates during the last decade associated more with decline in whitebark pine resources than increases in grizzly bear density?
The preliminary answers to these questions are contained in the Synthesis Report and the final results have been (or will be) published in peer-reviewed journals (in their entirety: Bjornlie
Key findings of the Synthesis Report are summarized below. To address the first question about how diverse diets of grizzly bears in the GYE are, Gunther
In response to the fourth research question, in years with poor whitebark pine seed production, grizzly bears shifted their diets and consumed more meat (Schwartz
In response to the seventh question, while land managers have little influence on how calories are spread across the landscape, we have much more influence on human-caused mortality risk. Consistent with findings from earlier studies, the IGBST (2013, p. 24) found that grizzly bear mortalities increased in poor compared to good whitebark pine seed production years. Assuming the poorest observed whitebark pine cone production, the IGBST (2013, p. 25) predicted an increase of 10 annual mortalities ecosystem-wide of independent females comparing 2000 with 2012, encompassing the period that coincided with whitebark pine decline (IGBST 2013, p. 25). The greatest increase in predicted mortality occurred outside the PCA, which may be partially attributable to range expansion and continued population increase (IGBST 2013, p. 25). However, increased mortality numbers during poor whitebark pine cone production years have not led to a declining population trend (IGBST 2012, p. 34), and total mortality will be maintained within the total allowable mortality limits set forth in table 3.
In response to the eighth question, the IGBST found that while whitebark pine seed production can influence reproductive rates the following year, the overall fecundity rates during the last decade (2002–2011) did not decline when compared with data from 1983–2001 (IGBST 2013, p. 32). This is important because fecundity rates are a function of both litter size and the likelihood of producing a litter, the two ways in which whitebark pine seed production may affect reproduction. Although Schwartz
In contrast to previous studies that concluded increased mortality in poor whitebark pine cone production years led to population decline in those years (Pease and Mattson 1999, p. 964), the IGBST found the population did not decline despite increased mortality in poor whitebark pine cone production years. Therefore, we determined that the conclusions of Pease and Mattson (1999, p. 964) are inaccurate. First and foremost, estimating population growth for individual, non-consecutive years, as Pease and Mattson (1999, p. 962) did, is “not legitimate” and results in an “incorrect estimate” (Eberhardt and Cherry 2000, p. 3257). Even assuming their methods of separating out individual, non-consecutive years of data for a species whose reproduction and survival are inextricably linked to multiple, consecutive years (
The findings of Schwartz
Earlier studies suggested that increased grizzly bear mortalities in poor whitebark pine cone production years are a result of bears roaming more widely in search of foods and exposing themselves to higher mortality risk in roaded habitats at lower elevations. However, Costello
Evidence suggests that observed changes in population vital rates were driven by density-dependent effects and have resulted in a relatively flat population trajectory (van Manen 2016a,
We recognize that changes in food resources can also influence population vital rates. These research questions and results do not refute that possibility, but the preponderance of evidence supports the conclusion that bears so far are finding alternative food resources and that those resources are sufficient to maintain body mass and body condition (IGBST 2013, p. 20; Costello
While there was some concern that the rapid loss of whitebark pine could result in mortality rates similar to those experienced after the open-pit garbage dumps were closed in the early 1970s (Schwartz
GYE grizzly bears have high diet diversity (Gunther
The IGBST will continue to monitor annual production of common foods, grizzly bear-human conflicts, survival rates, reproductive rates, and the causes and locations of grizzly bear mortality, as detailed in the 2016 Conservation Strategy (YES 2016a, pp. 33–91). These data provide the 2016 Conservation Strategy's signatory agencies with the scientific information necessary to inform and implement adaptive management (Holling 1978, pp. 11–16) actions in response to ecological
Grizzly bears are resourceful omnivores that will make behavioral adaptations regarding food acquisition (Schwartz
The GYE grizzly bear population has been coping with the unpredictable nature of whitebark pine seed production for millennia. Grizzly bears are not dependent upon whitebark pine seeds for survival, nor do they have a diet that is specialized on consumption of these seeds. While we know whitebark pine seed production can influence reproductive and survival rates, it has not caused a negative population trend, as evidenced by a relatively constant population size between 2002 and 2014 (IGBST 2012, p. 34; van Manen 2016a,
In
Second, the court noted that the Service's data on long-term population growth came from 2002, before the pine beetle epidemic began. The population growth rate slowed from the 4 to 7 percent that occurred from 1983 to 2001 (Eberhardt
Fourth, the Ninth Circuit observed that the Service contradicted itself by stating that the entire PCA was necessary to support a recovered population, yet acknowledged that whitebark pine would persist in only a small part of the PCA. New data show that, despite the decline in whitebark pine, the GYE population has been relatively constant, is close to carrying capacity, and is exhibiting density-dependent regulation inside the DMA (van Manen
In summary, the best scientific and commercial data available regarding grizzly bear responses to food losses suggest this issue is not a threat to the GYE grizzly bear population and is not an impediment to long-term population persistence. Therefore, we conclude that changes in food resources do not constitute a threat to the GYE grizzly bear DPS now, nor are such changes anticipated to constitute a threat in the foreseeable future.
Our analyses under the Act include consideration of observed or likely environmental changes resulting from ongoing and projected changes in climate. As defined by the Intergovernmental Panel on Climate Change (IPCC), the term “climate” refers
Scientific measurements spanning several decades demonstrate that changes in climate are occurring. In particular, warming of the climate system is unequivocal, and many of the observed changes in the last 60 years are unprecedented over decades to millennia (IPCC 2013b, p. 4). The current rate of climate change may be as fast as any extended warming period over the past 65 million years and is projected to accelerate in the next 30 to 80 years (National Research Council 2013, p. 5). Thus, rapid climate change is adding to other sources of extinction pressures, such as land use and human-caused mortality, which will likely place extinction rates in this era among just a handful of the severe biodiversity crises observed in Earth's geological record (American Association for the Advancement of Sciences 2014, p. 17).
Examples of various other observed and projected changes in climate and associated effects and risks, and the bases for them, are provided for global and regional scales in recent reports issued by the IPCC (in their entirety: 2013b, 2014), and similar types of information for the United States and regions within it are available via the National Climate Assessment (Melillo
Scientists use a variety of climate models, which include consideration of natural processes and variability, as well as various scenarios of potential levels and timing of greenhouse gas emissions, to evaluate the causes of changes already observed and to project future changes in temperature and other climate conditions. Model results yield very similar projections of average global warming until about 2030, and thereafter the magnitude and rate of warming vary through the end of the century depending on the assumptions about population levels, emissions of greenhouse gases, and other factors that influence climate change. Thus, absent extremely rapid stabilization of greenhouse gas emissions at a global level, there is strong scientific support for projections that warming will continue through the 21st century, and that the magnitude and rate of change will be influenced substantially by human actions regarding greenhouse gas emissions (IPCC 2013b, p. 19; IPCC 2014, entire).
Global climate projections are informative, and, in some cases, the only or the best scientific information available for us to use. However, projected changes in climate and related impacts can vary substantially across and within different regions of the world (in their entirety: IPCC 2013b, 2014), and within the U.S. (Melillo
The hydrologic regime in the Rocky Mountains has changed and is projected to change further (Bartlein
The effects related to climate change may result in a number of changes to grizzly bear habitat, including a reduction in snowpack levels, shifts in denning times, shifts in the abundance and distribution of some natural food sources, and changes in fire regimes. Most grizzly bear biologists in the United States and Canada do not expect habitat changes predicted under climate change scenarios to directly threaten grizzly bears (Servheen and Cross 2010, p. 4). These changes may even make habitat more suitable and food sources more abundant (Servheen and Cross 2010, Appendix D). However, these ecological changes may affect the timing and frequency of grizzly bear-human interactions and conflicts (Servheen and Cross 2010, p. 4).
Because timing of den entry and emergence is at least partially influenced by food availability and weather (Craighead and Craighead 1972, pp. 33–34; Van Daele
The effects related to climate change could create temporal and spatial shifts in grizzly bear food sources (Rodriguez
Fire regimes can affect the abundance and distribution of some vegetative bear foods (
Here we analyze a number of possible catastrophic events including fire, volcanic activity, and earthquake. Fire is a natural part of the GYE system; however, 20th century forest management, which included extensive wildfire suppression efforts, promoted heightened potential for a large fire event. The 1988 fires, the largest wildfires in YNP's recorded history, burned a total of 3,213 km
The GYE has also experienced several exceedingly large volcanic eruptions in the past 2.1 million years. Super eruptions occurred 2.1 million, 1.3 million, and 640,000 years ago (Lowenstern
More likely to occur is a nonexplosive lava flow eruption or a hydrothermal explosion. There have been 30 nonexplosive lava flows in YNP over the last 640,000 years, most recently 70,000 years ago (Lowenstern
Earthquakes also occur in the region. The most notable earthquake in YNP's recent history was a magnitude 7.5 in 1959 (Lowenstern
We considered catastrophic and stochastic (random probability) events that might reasonably occur in the GYE within the foreseeable future, to the extent possible. Most catastrophic events discussed above are unpredictable and unlikely to occur within the foreseeable future. Other events that might occur within the foreseeable future would likely cause only localized and temporary impacts that would not threaten the GYE grizzly bear population.
Public support is paramount to any successful large carnivore conservation program (Servheen 1998, p. 67). Historically, human attitudes played a primary role in grizzly bear population declines by promoting a culture and government framework that encouraged excessive, unregulated, human-caused mortality. Through government-endorsed eradication programs and perceived threats to human life and economic livelihood, humans settling the Western United States were able to effectively eliminate most known grizzly bear populations after only 100 years of westward expansion.
We have seen a change in public perceptions and attitudes toward the grizzly bear in the last several decades. The same government that once financially supported active extermination of the bear now uses its resources to protect the great symbol of American wildness. This change in government policy and practice is a product of changing public attitudes about the grizzly bear. Although attitudes about grizzly bears vary geographically and demographically, there has been a revival of positive attitudes toward the grizzly bear and its conservation (Kellert
Public outreach presents a unique opportunity to effectively integrate human and ecological concerns into comprehensive programs that can modify societal beliefs about, perceptions of, and behaviors toward grizzly bears. Attitudes toward wildlife are shaped by numerous factors including basic wildlife values, biological and ecological understanding of species, perceptions about individual species, and specific interactions or experiences with species (Kellert 1994, pp. 44–48; Kellert
Traditionally, residents of the GYE involved in resource extraction industries, such as loggers, miners, livestock operators, and hunting guides, were opposed to land-use restrictions that were perceived to place the needs of the grizzly bear above human needs (Kellert 1994, p. 48; Kellert
Ultimately, the future of the grizzly bear will depend on the people who live, work, and recreate in grizzly bear habitat and the willingness and ability of these people to learn to coexist with the grizzly bear and to accept this animal as a cohabitant of the land. Other management strategies are unlikely to succeed without effective and innovative public I&E programs. The objective of the I&E is to proactively address grizzly bear-human conflicts by informing the public about the root causes of these conflicts and providing suggestions on how to prevent them (YES 2016a, pp. 92–95). By increasing awareness of grizzly bear behavior and biology, we hope to enhance public involvement and appreciation of the grizzly bear. In addition to public outreach programs, the States have implemented other programs to help reduce conflicts with the people that are directly affected by grizzly bears. These efforts include livestock carcass removal programs, electric fencing subsidies for apiaries and orchards, and sharing costs of bear-resistant garbage bins where appropriate.
Although some human-caused grizzly bear mortalities are unintentional (
From 1980 through 2002, at least 36 percent (72 out of 196) of human-caused mortalities may have been avoided if relevant I&E materials had been presented, understood, and used by involved parties (Servheen
Outside the PCA, State wildlife agencies recognize that the key to preventing grizzly bear-human conflicts is providing I&E to the public. State grizzly bear management plans also acknowledge that this is the most effective long-term solution to grizzly bear-human conflicts and that adequate public outreach programs are paramount to ongoing grizzly bear survival and successful coexistence with humans in the GYE so that the measures of the Act continue not to be necessary. All three States have been actively involved in I&E outreach for over a decade, and their respective management plans contain chapters detailing efforts to continue current programs and expand them when possible. For example, the WGFD created a formal grizzly bear-human conflict management program in July 1990 and has coordinated an extensive I&E program since then. Similarly, since 1993, MFWP has implemented countless public outreach efforts to minimize bear-human conflicts, and the
Compensating ranchers for losses caused by grizzly bears is another approach to build support for coexistence between livestock operators and grizzly bears. In cases of grizzly bear livestock depredation that have been verified by USDA Animal and Plant Health Inspection Service's Wildlife Services, IDFG, MFWP, or WGFD, affected livestock owners are compensated. Since 1997, compensation in Montana and Idaho has been provided primarily by private organizations, principally Defenders of Wildlife. Since the program's inception in 1997, the Defenders of Wildlife Grizzly Bear Compensation Trust paid over $400,000 to livestock operators in the northern Rockies for confirmed and probable livestock losses to grizzly bears (Edge 2013, entire). In 2013, the State of Montana passed legislation establishing a compensation program for direct livestock losses caused by grizzly bears (MCA 2–15–3113). In light of this legislation, Defenders of Wildlife stopped their compensation program in Montana and redirected funds to other conflict prevention programs.
In Wyoming, compensation has always been paid directly by the State. Upon delisting, both Idaho and Wyoming's grizzly bear management plans call for State funding of compensation programs (Idaho's Grizzly Bear Delisting Advisory Team 2002, p. 16; WGFD 2016, pp. 53–55). In Idaho, compensation funds would come from the secondary depredation account, and the program would be administered by the appropriate IDFG Regional Landowner Sportsman Coordinators and Regional Supervisors (Idaho's Grizzly Bear Delisting Advisory Team 2002, p. 16). In Wyoming, the WGFD will pay for all compensable damage to agricultural products as provided by State law and regulation (WGFD 2016, p. 58). The WGFD will continue efforts to establish a long-term funding mechanism to compensate property owners for livestock and apiary losses caused by grizzly bears. In Montana, long-term funding to compensate livestock owners for direct kills has been secured through the general fund. A long-term funding source has not been identified for conflict prevention projects but is being actively pursued. Based on the analysis provided above, we conclude that, through the positive influence of the I&E program, public support and attitude does not constitute a threat to the GYE grizzly bear DPS now, nor is it anticipated to in the foreseeable future.
Because the GYE grizzly bear population has increased or remained relatively constant in size during declines in whitebark pine seed production and other high-calorie foods since the early 1990s, there is no evidence that changes in food resources will become substantial impediments to the long-term persistence of the GYE grizzly bear population. Changing climate conditions have the potential to affect grizzly bear habitat with subsequent implications for grizzly bear-human conflicts. While we do not consider the effects of climate change to be a direct threat to grizzly bear habitat in the GYE, it could influence the timing and frequency of some grizzly bear-human conflicts with possible increases in grizzly bear mortality. This possible increase in grizzly bear mortality risk is not expected to be a threat because of coordinated total mortality limits within the DMA (see table 3 and
Essentially, the management response to all of these potential threats would be to limit human-caused mortality through conflict prevention and management to limit discretionary mortality (see table 3 and
Many of the threats faced by grizzly bears are interrelated and could be synergistic. Principal threats discussed above include habitat loss through road building and the resulting increased human access to grizzly bear habitat, human-caused mortality of grizzly bears, and the legal mechanisms that direct habitat and population management. The principal threats assessed in previous sections may cumulatively impact the GYE grizzly bear population beyond the scope of each individual threat. For example, the loss of whitebark pine could lead to lower survival rates at the same time of the year when grizzly bears are vulnerable to human-caused mortality from elk hunting. Alternatively, expected increases in human populations across the Western United States and climate change both have the potential to increase grizzly bear conflicts and human-caused mortality. Historically, each of these factors impacted grizzly bears in the GYE and cumulatively acted to reduce their range and abundance over time. Today, these stressors have been adequately minimized and ameliorated and do not impact the GYE grizzly bear population with the same intensity.
While these numerous stressors on grizzly bear persistence are challenging to conservation, our experience demonstrates that it is possible for large carnivore conservation to be compatible with them (Linnell
The primary factors related to past habitat destruction and modification have been reduced through changes in management practices that have been formally incorporated into regulatory documents. Maintenance of the 1998 baseline values for secure habitat, developed sites on public lands, and livestock allotments inside the PCA will adequately ameliorate the multitude of stressors on grizzly bear habitat such that they do not become threats to the GYE grizzly bear population in the foreseeable future. We expect many of the threats discussed under
Upon delisting, the GYE National Forests and National Parks will continue to implement and maintain the 1998 baseline. Together, these two Federal agencies manage 98 percent of lands within the PCA and 88 percent of all suitable habitat within the DPS boundaries. Suitable habitat outside the PCA provides additional ecological resiliency and habitat redundancy to allow the population to respond to environmental changes. Habitat protections specifically for grizzly bear conservation are not necessary here because other regulatory mechanisms that limit development and motorized use are already in place for nearly 60 percent of suitable habitat outside the PCA. These and other conservation measures discussed in the USFS's Record of Decision (2006b) ensure threats to the GYE grizzly bear population's habitat outside the PCA will not become substantial enough to threaten this population's long-term persistence. Therefore, based on the best available information and expectation that current management practices will continue into the foreseeable future, we conclude that the present or threatened destruction, modification, or curtailment of its habitat or range does not constitute a threat to the GYE grizzly bear DPS and is not expected to become a threat in the foreseeable future.
When grizzly bears were listed in 1975, we identified human-caused mortality, mainly “indiscriminate illegal killing” and management removals, as threats to the population under
The importance of regulatory mechanisms and effective wildlife management infrastructure to large carnivore conservation cannot be understated, as described under
Other factors under
Many of the threats faced by grizzly bears are interrelated and could cumulatively impact the GYE grizzly bear population through excessive grizzly bear mortality. While these numerous stressors on grizzly bear persistence are challenging to conservation, our experience demonstrates it is possible for large carnivore conservation to be compatible with them (Linnell
In the proposed rule published on March 11, 2016 (81 FR 13174), we requested that all interested parties submit written comments on the proposal by May 10, 2016. We also
A number of commenters, including peer reviewers, Federal agencies, and the States, provided new information or clarifications on information presented in the GYE proposed delisting rule (81 FR 13174, March 11, 2016) and its supporting documents. Categories of new or clarified information include corrections of discrepancies between the proposed rule and draft 2016 Conservation Strategy (
While we respect the values and opinions of all commenters, the Act does not allow us to factor ethical objections to hunting into our delisting decision. Section 4(a)(1) of the Act specifies that we shall determine whether any species is threatened or endangered because of any of the following factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. Section 4(b)(1)(A) further specifies that we shall make such determinations based solely on the best scientific and commercial data available.
The best scientific and commercial data available indicate that the GYE grizzly bear population is recovered and no longer meets the definition of a threatened or endangered species. However, we acknowledge tolerance of grizzly bears remains a concern in some areas. The 2016 Conservation Strategy contains a strong Information and Education (I&E) program component that will continue efforts to improve local tolerance towards the species.
The public comment period on the proposed rule was open for a total of 90 days, during which time we received more than 665,000 comments. We offered a variety of options for submitting comments; the public could submit their comments electronically, using a specified Web site, or in hard copy, via U.S. mail or hand delivery.
As mentioned above, we also held two public meetings and public hearings in Cody, WY, and Bozeman, MT, where verbal or written comments could be submitted. These two cities were selected because of their proximity to the GYE. We declined to hold additional public hearings because we satisfied section 4(b)(5)(E)'s statutory requirement that we hold at least one public hearing and the substantial cost associated with conducting public hearings. Although we appreciate the public's desire to give public testimony, oral and written comments are given the same consideration in our process. We again provided access information for persons using a telecommunications device. In our notifications of comment periods, meetings, and hearings, we stated that persons with disabilities wanting to participate in a public meeting or hearing, including the need for American Sign Language or English as a second language interpreter, could be accommodated.
The Act requires the Service to make a decision based solely on the best available scientific and commercial information available (section 4(b)(1)(A)) when determining if a species meets the definition of endangered or threatened. Substantive comments raising scientific, legal, and policy issues are the most relevant for consideration in our determination. We focused our attention on unique comments that provide substantive feedback on potential errors or oversights in our analyses. We appreciate and consider additional data or substantive remarks, with supporting documentation, that broaden our understanding of whether grizzly bears meet the definition of a threatened or endangered species under the Act. We considered all scientific and commercial information included in the public comments, and incorporated this information into this final rule as appropriate.
The Service appreciates the long-standing efforts of all of our partners in the GYE's recovery; however, the decision on whether or not to list, delist, or reclassify species under the Act remains the sole regulatory responsibility of our agency. The NPS only has jurisdiction to manage natural resources within the Park boundaries, but often collaborates with adjacent landowners on wildlife-specific issues. NPS manages approximately 39 percent of lands within the PCA. Please see Issue 65 for a discussion about hunting on and adjacent to NPS lands and Issue 82 about inclusion of the NPS in annual meetings with the States allocating discretionary mortality.
Accordingly, it is appropriate that they would be responsible for articulating their post-delisting management plans. Likewise the Federal land management agencies will be responsible for habitat management. Our role is to analyze these commitments and ensure they will allow the species to remain recovered. Please see Issue 5 for further discussion about the processing and consideration of public comments.
Second, commenters expressed concern about peer reviewer selection and suggested we had not adequately disclosed this process. Some commenters suggested that our peer reviewers had a conflict of interest because the Service's contractor who facilitated their selection works in the oil and gas industry rather than wildlife science, while other commenters suggested that the peer reviewers had a conflict of interest since they all hunt or trap. Some commenters claimed that documents released under the Freedom of Information Act indicated we “hand-picked reviewers” to ensure a favorable review, subverting the validity and independence of the peer review process, and that we purposefully selected reviewers that were not grizzly bear experts, since the majority of grizzly bear experts would have been opposed to our proposed action, according to a survey from Ohio State University. Another commenter suggested that we could not legally use a contractor for the peer review process because: (1) The contractor is not disclosing the process to the public; (2) we cannot outsource the preparation of the Administrative Record; and (3) it violates a 2004 OMB policy, “Final Information Quality Bulletin for Peer Review” (70 FR 2664, January 14, 2005), and a 1994 Service policy, “Interagency Policy for Peer Review in ESA Activities” (59 FR 34270, July 1, 1994). One commenter suggested that only a National Academy of Sciences panel would be adequate for performing review of the rule.
Third, commenters stated that we did not follow up with the peer reviewers to ask them additional questions, noting that not doing so suggested that we did not give the peer review or our delisting decision enough thought. Another commenter suggested that this situation implied the need for another round of peer review (see Issue 4). Fourth, one commenter took issue with the fact that we did not share with the public which peer reviewer authored each review. Finally, one commenter thought we did not give the peer reviewers enough time to review the proposed rule and associated documents.
We chose to contract the peer review out due to the controversial nature of our decision. Nothing in the current Service peer review guidance and policy prohibits the Service from doing so. As part of this process, we drafted a statement of work to the peer-review contractor, which included criteria: “The independent peer reviewers shall be experienced senior-level ecologists, bear biologists, or population modelers, and bear managers who have previously conducted similar reviews or regularly provided reviews of research and conservation articles for the scientific literature. Reviewers must be well-versed in the demographic management of mammals, preferably bears or other carnivores.” We also identified potential conflicts of interest, including: employment or affiliation with the Service, the States of Montana, Wyoming, or Idaho, the IGBST, or the Western Governors Association; those who have offered a public opinion or a statement either for or against delisting; and those who are directly or indirectly employed by or associated in any way with any organization that has either litigated the Federal Government concerning grizzly bears or wolves or taken a position on one side or the other about recovery and delisting of grizzly bears or wolves. Our statement of work also included topics and questions for the reviewers to consider and deliverables, including a proposed timeline, original scientific reviews, and a Complete Official Record.
The contractor then selected the reviewers based on our statement of work. We do not know why any particular person was not chosen, such as Dr. David Mattson; however, we do know that those reviewers chosen did meet the above criteria. Neither we nor the contractor handpicked reviewers hoping to get a favorable review, as that would be counterproductive to the Act's requirements that we base our decisions based on the best available data.
Peer reviewers are generally selected for their expertise on the particular species, closely related species, relevant threats or conservation actions, or other relevant topics (
The peer reviewers were asked to provide comments within the open public comment period to allow for the public to access and comment on, should they choose, the peer reviewers' comments. No peer reviewers requested additional time for review. The peer reviewer comments were posted in regulations.gov under the docket for this rulemaking. As previously noted, the first comment period was open for 60 days, and a second comment period was open for an additional 30 days, which provided ample time for the public to review the proposed rule and supplemental documents and provide comments. Once the process is complete, we take into consideration the context of all comments, including those from peer reviewers, in our evaluation of the substantive information provided.
Using a contractor for peer review does not indicate we are outsourcing the administrative record for this decision, as the administrative record comprises many documents throughout the listing determination process and compilation of the administrative record remains the Service's obligation. The Service is maintaining the decision file and will be preparing an administrative record per the Department of the Interior's guidance for compiling decision files and administrative records (282 FW 5).
Lastly, some commenters suggested that the delisting decision was a “political stunt to weaken the Endangered Species Act,” referencing recently proposed legislation that would prevent litigation from overturning delisting decisions, thus “denying opponents [of delisting] due process.” On the other hand, one commenter suggested that delisting the grizzly bears was a stunt to save the Act from legislative destruction.
Conversely, a number of commenters expressed support for the Service's scientific integrity and the validity and breadth of the data the Service used in the decision-making process.
First, commenters claimed that the Service's Director and State governors used “under the table agreements” to set the mortality limits in the rule, recovery plan supplement, and 2016 Conservation Strategy. The mortality limits are set in the recovery plan supplement (demographic recovery criterion #3) and carried over into this rule and the 2016 Conservation Strategy. Section 4 of the Act provides direction for developing and implementing endangered species recovery. The Section gives the Service the ability to procure the services of appropriate public and private agencies and institutions, and other qualified persons. We discussed mortality limits with the States because they are the agencies that will be directly responsible for implementing them. More importantly, the mortality limits in the recovery criteria are scientifically defensible and will insure that the GYE grizzly bear population within the DMA will be maintained around the 2002 to 2014 population size (see Issue 66 for further discussion on the mortality rates). Throughout the more than 40 years of grizzly bear recovery, the Service has collaborated closely with state agencies to ensure positive conservation outcomes for grizzly bears and effective, coordinated management. This collaboration is partly responsible for a recovered GYE grizzly bear population. This collaboration continued throughout the delisting process to ensure effective post-delisting management and will persist after delisting through the Yellowstone Grizzly Bear Coordinating Committee.
Second, commenters suggested that the former grizzly bear coordinator's studies were biased and not open to peer or public review and that he was unable to be objective regarding the delisting. The delisting determination used the best available scientific and commercial data to come to the conclusion that grizzly bears should be removed from the list of threatened and endangered wildlife and plants. The Service relied on literature from a broad range of scientists; this literature included peer-reviewed studies from Dr. Chris Servheen, former grizzly bear recovery coordinator for the Service, but also research from other scientists. This broad range of peer-reviewed sources indicated that grizzly bears in the GYE were recovered and would remain so after delisting.
Third, commenters claimed that Service managers bullied staff biologists to delist the GYE grizzly bear population. Commenters provided no evidence of any alleged “bullying” of staff biologists. The Service acknowledges that its former grizzly bear coordinator, Dr. Chris Servheen, may have concluded that the Service did not always agree with his recommendations. However, there was no “bullying.” The delisting recommendation came from staff biologists. There were a number of issues worked out between Serve staff and management. Internal agency disagreement and debate are expected with a delisting rule for a controversial species like grizzly bears. The decision to delist the GYE population of grizzly bears was based on the best available scientific and commercial data available. Service biologists presented this information, including data on grizzly population trends and State management regulations, to Service leadership to inform their decision-making about the status of grizzly bears in the GYE. The Service's decision-making process provides opportunity for staff biologists who are species experts to outline all relevant information, ask questions, and provide recommendations.
Fourth, commenters claimed that there was political interference with the 2015 IGBST report on grizzly bear mortality because publication of the report was delayed. There is no annual due date for this report, and while it is usually published midsummer, sometimes there are delays. The delays in the release of the 2015 IGBST report on grizzly bear mortality were not a result of political interference but a combination of the IGBST team leader being on detail as the Acting Center Director of the USGS Northern Rocky Mountain Science Center for three months, transitions within the IGBST, and scientific presentations, which delayed finalization of the report. We had all relevant data from this report available to inform our decision-making process about the status of grizzly bears. Considering the relevant content of this report, we believe that grizzly bears are recovered and will remain so for the foreseeable future.
Fifth, commenters suggested that the Service is a pro-hunting organization and Service staff involved in the delisting process have ties to hunting organizations, oil and gas companies, or initiatives working to exterminate wolves. The Service supports hunting as a form of wildlife-dependent recreation and as a useful element in a suite of management strategies. However, the Service is not an agency whose purpose is to promote hunting or hunting interests; the Service mission is working with others to conserve, protect, and enhance fish, wildlife, plants, and their habitats for the continuing benefit of the American people. While hunting can be an essential element of conserving wildlife and their habitats and can be a benefit that wildlife provide to the American people, the Service considers a broad range of factors and benefits when managing species and making decisions supportive of this mission. Furthermore, very little of the Service's budget and none of the Endangered Species program's budget comes from hunting revenue. While many Service staff support or contribute to a variety of causes in their personal capacity, Service ethics rules and guidelines (for example, 212 FW 1 through11), Departmental Regulations (for example, 5 CFR 3501.105), and government-wide laws and regulations (for example, 18 U.S.C. Sections 201–209; 5 CFR 2635.502) ensure these affiliations do not impact or bias their decision-making and management.
Sixth, commenters claimed that the States pressured the Service to use population estimates that produce the maximum number of bears. This unsupported accusation is false. The population estimates the Service used in its delisting determination (the model-averaged Chao2 population estimator) is based on the best available commercial and scientific data available and not States' individual preferences. Moreover, the model-averaged Chao2 population estimator is a relatively conservative estimate of the number of bears on the landscape in the GYE and likely underestimates the actual number of bears (Schwartz
Seventh, commenters claimed that the Service is only proposing to delist the GYE population (and not the “larger northern population”) because of the influence of hunting, oil, gas, mining, and property development lobbies. The recovery of grizzly bears has always been focused around six different recovery zones. Each recovery zone has different recovery needs and criteria based on the biology of the species in that area and the relevant stressors. Thus, delisting of the bears in each recovery zone may occur on a different timeline as the populations meet unique recovery criteria. Based purely on the best available scientific and commercial data available, the population of grizzly bears in the GYE was the first to achieve recovery and warrant delisting. As other populations achieve this milestone, as determined by the best available scientific and commercial data
Eighth, commenters suggested that industrial interests on the YES/YGCC inappropriately influenced the delisting proposal and will inappropriately influence any future changes to the 2016 Conservation Strategy. The Service has regularly coordinated with a wide variety of stakeholders through the more than 40 years of the grizzly bear recovery program. Please see the
Ninth, commenters referenced a 2015 Union of Concerned Scientists Report, which suggested a dearth of “scientific integrity” at the FWS due to “political interference.” The Union of Concerned Scientists surveyed scientists at four federal agencies, including the Service, on “the state of scientific integrity at their agencies, their ability to communicate with colleagues and the public, and overall agency effectiveness” (Union of Concerned Scientists 2015, p. 4). This survey included biologists Service wide and did not include information on the particular work being conducted by survey participants. It did not directly address grizzly bears. The Service has a rigorous policy on scientific integrity that guides the agency's work and decision-making (212 FW 7). The policy states, “Scientific and scholarly information that we consider in our decision-making must be robust, of the highest quality, and the result of the most rigorous scientific and scholarly processes as can be achieved. Most importantly, it must be trustworthy. We must establish and maintain integrity in our scientific and scholarly activities because this information is a critical factor for making public policies.” In addition, delisting decisions are subject to scientific peer review according to the Service's peer review policy set forth in the Office of Management and Budget “Final Information Quality Bulletin for Peer Review” (70 FR 2664, January 14, 2005). The Service is committed to using the best available scientific and commercial data available in our delisting decisions, as required by the Endangered Species Act. For all of these reasons, the Service does not believe a scientific integrity review is needed.
The Service has been considering delisting of the GYE grizzly bear population for over a decade and previously published a final rule to delist this population in 2007 (72 FR 14866, March 29, 2007). As described in the Background section, that final determination was vacated by the Montana district court in
To the extent that this comment requests consideration of threats outside of the suitable habitat, we respond as follows (considering Factors A, B, C, D, and E). Although grizzly bears once occurred throughout the area within the GYE DPS boundaries (Stebler 1972, pp. 297–299), records indicate that even in the early 19th century, grizzly bears were less common in these eastern prairie habitats than in mountainous areas to the west and south (Rollins 1935, p. 191; Wade 1947, p. 444). Today, these habitats are no longer biologically suitable for grizzly bears as they lack adequate natural food resources and land use changes have altered the suitability of the habitat for grizzly bear persistence (considering Factors A, B, C, D, and E). These marginal, peripheral areas are either unoccupied or might in some instances have limited occupancy due to dispersal from core source population within the PCA, DMA, and suitable habitat. While grizzly bears that do establish or move into these unsuitable habitats will face a reduced probability of persistence (considering Factors A, B, C, D, and E), these bears will constitute a small percentage of the population and, thus, are of minimal importance to the sustainability of the overall population. Such peripheral impacts will not compromise the viability of the GYE population. Impacts to GYE bears in unsuitable habitat will not and do not singularly, or in combination with other factors, cause the GYE population to become in danger of extinction nor likely to become so within the foreseeable future in all or a significant portion of its range.
We regularly work with directly affected Tribes as active participants in recovery and management of the GYE grizzly bear. The Northern Arapahoe and Eastern Shoshone Tribes are participants in the YES of the IGBC as they manage nearly 4 percent of suitable habitat (1,360 km
Beginning in April 2014, the Service sent consultation invitation letters via registered mail to the four Tribes having treaty interests in the proposed GYE grizzly bear delisting area: The Northern Arapaho, Eastern Shoshone, Northwestern Band of the Shoshone Nation, and Shoshone-Bannock Tribes. Over the next year the Service was made aware of many more Tribes having an interest in the GYE grizzly bear and expanded our efforts in explaining the
On February 17, 2015, the Service sent letters offering government-to-government consultation to 26 Tribes. On June 15, 2015, the Service sent out a second round of letters to 48 tribes, offering another opportunity for consultation, followed by personal phone calls or emails from Service leadership to the 48 tribes, personally inviting them to engage in government-to-government consultation. On August 13, 2015, the Service met with the Rocky Mountain Tribal Leaders Council in Billings, Montana and invited tribal representative to engage in consultation concerning the GYE grizzly bear.
On October 29, 2015, the Service sent letters to 53 tribes, which included all Tribes, Tribal Councils, and First Nations in Canada that have contacted the Service regarding the GYE grizzly bear population. The letters invited all Federal Tribes to engage in government-to-government consultation. In addition, the letter invited Tribes to participate in an informational webinar and conference call held on November 13, 2015.
On March 3, 2016, the Service announced its proposal to delist grizzly bears in the GYE. The announcement was disseminated to all Tribes west of the Mississippi River with Tribes being notified by both email and hard copy mail. In addition, the Service announced two consultation meeting opportunities in the
On March 10, 2016, the Service hosted a tribal conference call to provide an overview of the proposed delisting and discuss any questions or concerns. It was not considered government-to-government consultation. The announcement for this call was included in the March, 3rd notifications sent to Tribes.
To date, the Service has conducted ten Tribal consultations with the following Tribes: June 10, 2015: Confederated Salish and Kootenai Tribes; June 18, 2015: Blackfeet Nation Wildlife Committee; July 21, 2015: Northern Arapahoe Tribal Council; July 21, 2015: Eastern Shoshone Tribal Council; July 30, 2015: Shoshone Bannock Tribal Council; April 28, 2016: Bozeman Montana (Tribes Present at meeting: Shoshone Bannock Tribes, Northern Cheyenne Tribe, Eastern Shoshone Tribe, Northwest Band of the Shoshone); May 5, 2016: Rapid City, South Dakota (Northern Arapaho, Rosebud Sioux); November 2, 2016: Eastern Shoshone Tribe; November 16, 2016: Shoshone Bannock Tribe; April 07, 2017: Northern Cheyenne Tribal Council.
We considered issues of cultural, spiritual, and ecological importance that Tribes raised and we are sensitive to those concerns. However, the Act requires the Service to make decisions based on the biological status of the species as informed solely by the best scientific and commercial data available. That said, once this action becomes effective, Tribes will have the right to manage grizzly bears on their Tribal lands in accordance with their spiritual, cultural, and historic traditions.
Criteria #1 and #2 are important as they set forth minimums by which to measure genetic health and adequate distribution of females with young to maintain a recovered population. The 2016 Conservation Strategy commits to using the model-averaged Chao2 population estimator, for the foreseeable future, to measure the population size for criterion #3 (see Issue 28 for details regarding the Chao2 method and Issue 31 for discussion on the implementation of a new population estimator). We specify that criterion #1 is no longer dependent on a single population estimate method. Despite these updates, we note here that, as discussed above, delisting determinations are based solely on an evaluation of whether the species meets the definition of endangered or threatened due to one or more of the five factors as per section 4(a) of the Act, and while recovery criteria can inform that analysis, we do not need to update a species' recovery plan prior to the species' delisting. However, we have revised the Demographic Recovery Criteria for the GYE grizzly bear population concurrent with this final rule.
If the population estimate falls below 500 in any year, the Service will conduct a status review to determine if re-listing may be warranted. The 2016 Conservation Strategy establishes a process through which corrections to population and habitat management can be made if any new scientific information or change in status arise that suggests the need to revise. The IGBST will conduct demographic reviews of the vital rates for the GYE grizzly bear population every 5 to 10 years and be able to detect if decreased reproduction occurred as a result of a stabilized population. Upon completion of a demographic review, the IGBST will provide the information to the YGCC, who will revise or amend the 2016 Conservation Strategy (2016 YES, p. 96) based on the best biological data and the best available science. Any such amendments will be subject to public review. In the 2007 revision to the Yellowstone demographic recovery criteria, YES advised the Service that maintaining a minimum population size of 500 individuals would be a conservative approach to ensure that the population stayed above the minimum of 400 bears recommended by Miller and Waits (2003, p. 4338) for genetic health.
Commenters suggested that Waples and Yokota (2007, entire) and Luikart
A number of commenters provided suggestions for how to change this criterion, including: (1) Making exceedance of mortality limits independent of a population minimum; (2) eliminating the 3-year wait between the population dropping below 612 and determining that the criterion is not met; (3) using an annual index of observed females with cubs-of-the-year to total observed mortality instead of proposed population measurement methods; (4) raising the average around which the population will be maintained (to be more precautionary); (5) halting discretionary mortality at populations of 674 bears, rather than 600 bears; (6) allowing the States more management flexibility for bear removal at populations below 600 (
We recognize the confusion created by the multiple numbers in criterion #3. In this final rule, the 2016 Conservation Strategy, and the revised demographic recovery criteria, we clarify that the criterion calls for maintaining the population within the DMA around the 2002 to 2014 model-averaged Chao2 population estimate (average = 674; 95% confidence interval (CI) = 600–747; 90% CI = 612–735). The lower bounds of the 90% and the 95% CIs are presented as the thresholds at which management changes would occur (
Some have criticized the population objectives in the Conservation Strategy and proposed rule because the States could in theory manage below the long-term model-averaged Chao2 estimate from 2002 to 2014 of 674 bears. Importantly, this criticism misses the intent of criterion #3 as outlined in the 2016 Conservation Strategy and in the Recovery Plan Supplement (USFWS 2017, p. 5). The long-term model-averaged Chao2 estimate, 674 bears, is not a minimum recovery threshold. Rather, this number represents a population level that is at or near carrying capacity (van Manen
The adjustable mortality limits set forth in table 2 provide a mechanism for maintaining the population within this confidence interval and serve as a buffer to ensure the population does not drop and remain below the lower bound of 600 bears. For example, a population estimate of fewer than 674 would trigger mortality limits of less than 7.6 percent for independent females. The best available science indicates that this population will increase in size at a mortality limit of less than 7.6 percent. Thus, if the population is estimated to be fewer than 600 bears, there would be no discretionary mortality, likely producing a total mortality rate less than 7.6 percent, which means the population would increase in size and return to the 95 percent confidence interval (600–747).
The Service recognizes it is at least theoretically possible that, even with a mortality limit of 7.6 percent, a population could drop below 600 bears for a certain amount of time while the population is increasing in size; however, we do not anticipate that it will remain below 600 bears for an extended length of time during this rebuilding period because of the other mechanisms (
Further buffering our recovery criteria is the fact that the Service and the States agreed on a counting methodology, the model-averaged Chao2 estimate, that is conservative,
We provided additional safety margins to assure that the recovery criteria will be met. Four scenarios could lead us to initiate a status review and analysis of threats to determine if re-listing is warranted including: (1) If there are any changes in Federal, State, or Tribal laws, rules, regulations, or management plans that depart
The Service has reviewed and revised the GYE grizzly bear demographic recovery criteria to ensure they are adequate under the requirements of the Act and that they have been fully achieved, and determined that a population at or above 600 individuals, by managing for a safety margin of 674 bears, together with criterions #1 and 2, is biologically recovered. States have committed to maintain the GYE population to within these goals. Collectively, these commitments indicate that the entire GYE population is likely to remain recovered.
Although there were many suggestions of slight modifications to this criterion, peer reviewers were supportive that this recovery criterion was scientifically sound and would maintain a recovered grizzly bear population. The mortality limit for dependent young is based only on human-caused mortality, which is what is currently measured and reported in the IGBST Annual Reports. The 2016 Conservation Strategy, this final rule, and the supplement to the Recovery Plan now consistently reflect each other and the Tri-State MOA: At population levels less than or equal to 674, independent female mortality would be less than 7.6 percent.
We disagree with comments that request we remove mention of the agreement to halt discretionary mortality at populations less than 600 bears because listing actions (including this final rule) are required to describe threats and the measures that address those threats. Discretionary mortality is a potential threat to grizzly bears, and we must explain how that threat has been addressed in this final rule. The main threat of human-caused mortality has been addressed through carefully monitored and controlled total mortality limits established in the Grizzly Bear Recovery Plan and incorporated into the 2016 Conservation Strategy (YES 2016a, pp. 33–53) and into State regulations as per tables 2 and 3 and
One peer reviewer recommended that the population goals be periodically reevaluated to allow for consideration of natural and anthropogenic changes in the ecosystem. Another commenter suggested starting with a very protective management objective that can be made more liberal if State management proves to be effective.
The Service and the States understand that the actual population will vary around 674, and that mortality will be managed to ensure that the population does not drop and remain below 600. In our best professional judgement, management within this range will maintain recovery, as required by the Act, and a large, robust, healthy and viable population. We further conclude that the ecosystem can and will continue to support such populations. Put another way, habitat quality and management (discussed further under
With this as the backdrop, we set human-caused mortality limits that the best scientific and commercial information available indicated would help maintain the population around the 2002–2014 average. With more liberal mortality rates above 674, and more restrictive mortality rates below that, the population should fluctuate around that average. We anticipate that managers will further limit mortality the closer they get to 600 grizzly bears, as measured by the model-averaged Chao2 population estimator, at which point all discretionary mortality would be halted except as necessary for human safety. For further discussion, see Issue 19.
While some expressed concern that managing for stability may preclude population expansion and connectivity with other ecosystems, the State of Montana has indicated that they will manage discretionary mortality in the area between the GYE and the NCDE to maintain the opportunity for natural movement between the ecosystems (MFWP 2013, p. 9). Please see Issues 50
We recognize that some parties support continued population growth in perpetuity. We conclude that this is impractical, that the system has biological limits, that the average population estimate for the period of stability likely approximates or approaches those limits, that expansion into unsuitable habitat is largely unsustainable, and that continued population growth goes beyond the requirements of the Act for delisting. That is, the population no longer meets the definition of threatened or endangered even without population growth in perpetuity.
At any population level below 674, mortality limits would be low, and thus, hunting or other discretionary mortality would be managed within these limits. In addition, all discretionary mortality would be halted if the population within the DMA dropped to 600, except as necessary for human safety. This increases the likelihood of maintaining a stable population around 674 bears. See Issues 19 and 66 for more information.
Conversely, other commenters presented reasons for disagreeing with our conclusions regarding recovery, including: (1) Confusion regarding our definition of “recovered” and our determination of how the GYE population has met demographic recovery criteria; (2) suggestions that higher grizzly bear numbers (ranging from 700–5,000 bears) are more indicative of a stable, recovered GYE population and that a metapopulation in the lower 48 States of 2,500–5,000 bears is necessary before recovery is achieved; (3) determination of recovery should consider age and sex structure, in addition to the number of bears; (4) concern that grizzly bears currently inhabit less than two percent of their historical range and that populations are less than three percent of their historical abundance; thus, we must further expand their range, connect to other healthy grizzly bear populations, and conduct additional reintroductions/reestablishment of populations before we can declare recovery; (5) the GYE population still meets the criteria to be listed as “vulnerable” by the IUCN Red List, and thus cannot be considered recovered; and (6) assertions, based on mortality rates exceeding mortality limits and the need to transplant bears, that threats have not been adequately addressed. In addition, some commenters suggested that recovery will not be achieved until carrying capacity is met, while one State suggested that carrying capacity is not a proper metric for assessing recovery.
Although grizzly bears historically occurred throughout the area of the proposed GYE grizzly bear DPS (Stebler 1972, pp. 297–298), many of these habitats are not, today, biologically suitable for grizzly bears because of land conversion and a lack of natural food sources (
We disagree with the suggestion that there must be 2,500 to 5,000 grizzly bears throughout the lower 48 States for recovery to be achieved in the GYE, and the United States District Court, District of Montana agreed with us, stating “it would be nonsensical to require the Service to consider the grizzly bears' historic range throughout the United States as significant in relation to the Yellowstone grizzly bear” if the GYE DPS does not remain threatened by these historical losses within its own boundaries (
We measure the demographic recovery criteria as set out in the current revisions to the Recovery Plan, Demographic Recovery Criteria for the GYE (USFWS 2017, entire). The IGBST will conduct demographic reviews of the vital rates (including sex ratio and survival) for the GYE grizzly bear population every 5 to 10 years. Upon completion of a demographic review, the IGBST would provide the information to the YGCC who could then advise States and Federal land management partners if modifications to the 2016 Conservation Strategy are necessary. We disagree with the claim that we have focused only on demographic recovery. While demographic factors such as mortality control and population monitoring are critical to recovery, we have also established habitat-based recovery criteria to address habitat security (
As previously stated, under section 4 of the Act, a species shall be delisted if it does not meet the definition of a threatened or endangered species, considering solely the best available scientific and commercial data. We may not adopt the conservation classification criteria of other agencies or organizations, such as the IUCN. However, we do evaluate and consider the underlying data other agencies or organizations have relied upon in making their own conservation classifications. While it is true the GYE grizzly bear population meets one of the IUCN criteria for vulnerable (population size estimated at less than 1,000 mature individuals), our recovery and post-delisting management goals were designed to provide for the long-term conservation of the GYE grizzly bear population by ensuring sufficient control of human-caused mortality and maintenance of suitable habitat.
Finally, regarding carrying capacity, this has never been one of our recovery criteria. While there are multiple lines of evidence suggesting the population is at or near carrying capacity (
There is disagreement among geneticists as to the conclusion that the genetic evidence suggests four different evolutionarily significant units (ESU) in North America (Waits
In the event that a taxonomic change is eventually accepted as the best available science based on genetic differentiation between brown bears in North America (Waits
Conversely, other commenters asserted that delisting: (1) Was premature because we based it primarily on population size or “social carrying capacity,” or on insufficient time to measure success, public input, and inadequate or unreliable data; (2) contradicts the precautionary approach to wildlife management mandated under the Act, especially considering potential threats from climate change, implementation of hunting, and the low reproductive rates of bears; (3) contradicts opinions of grizzly bear biologists cited in an Ohio State University study; and (4) could lead to population declines or extinction of the GYE grizzly bear. Other commenters suggested that Federal protections be increased, rather than removed, while another suggested that excess bears should be culled rather than be delisted. Some commenters asserted that the goal of the Act is to recover a species, not delist it: We should ensure that re-listing will not be necessary in the foreseeable future, rather than delisting as soon as a population meets minimum goals.
Many commenters recommended delaying delisting until we can demonstrate successful reproduction outside of National Parks and effective dispersal and connection between grizzly populations.
Some commenters opposed delisting because they suggested that management would revert to the States and hunting would likely follow, with bears classified as predators and then shot, poisoned, or killed on sight. One commenter thought that proposed State replacements for section 7 consultations, section 9 take prohibitions, and an ability to bring legal challenge against management actions were inadequate. Another commenter asserted that, after the 2007 delisting, GYE grizzly bears were placed back on the List of Endangered and Threatened Wildlife because we failed to protect the species. One commenter suggested delisting could not be justified given the intrinsic values of the species.
To be clear, the Act does not contain a mandate or requirement that we institute a “precautionary approach to wildlife management.” Instead, the Act mandates that we make decisions about conservation status based on the best available scientific and commercial data, which informs the Act's definitions of threatened and endangered species. We remain confident that this population has long been recovered and will remain so after delisting.
Furthermore, this final rule, the 2016 Conservation Strategy, and the protective measures in Montana, Wyoming, and Idaho implement a conservative management approach by establishing science-based population criteria tied to the demographic recovery criteria, while also maintaining distributional recovery criteria. In addition, the adaptive management system in the 2016 Conservation Strategy incorporates the results from intensive monitoring of population vital rates, habitat standards, and major foods into management decisions and ensures the GYE grizzly bear DPS will remain recovered under the management frameworks now in place in Wyoming, Idaho, and Montana. In short, the regulatory frameworks now in place give us great confidence that this success story for American conservation and the Act will be maintained and that future generations will be able to see and enjoy grizzly bears in the GYE.
Strict regulations and regulatory mechanisms within State statute or codified regulation are in place to protect grizzly bears within the DPS boundaries. The States of Wyoming, Montana, and Idaho have classified grizzly bears throughout the entire GYE DPS boundaries as a game animal and have never suggested they will be classified as predators (W.S. 23–1–101(a)(xii)(A); W.S. 23–3–102(a); MCA 87–2–101(4); MCA 87–1–301; MCA 87–1–304; MCA 87–5–302; IC 36–2–1; IDAPA 13.01.06.100.01(e); IC 36–1101(a)). Game animal status is much more protective than predator status. Any grizzly bear found outside of the DPS boundaries would be protected under the Act as a threatened species. If any of the three States decided to classify grizzly bears as predators (an outcome that has not been proposed or even discussed to our knowledge), we would consider this a significant departure from current State laws and regulations and we would immediately initiate a status review.
Lastly, while we respect the moral and ethical reasons some members of the public may have for disapproving of this decision, delisting is the appropriate decision based on the current status of the DPS and the statutory requirements of the Act.
The IGBST approach to scientific studies involves extensive collaborations and contracts with independent academic and agency researchers who do not serve on the IGBST. Data used to calculate population size are available in the tables provided by Keating
As discussed under Issue 10, we have followed our peer review policies. Peer review is a widely accepted approach within the scientific community to maintain the highest standards of quality and provide credibility. It is designed to detect biases and flawed assumptions by allowing objective and anonymous reviewers, when appropriate and applicable, to examine the methods, results, interpretation, and conclusions of colleagues to identify weaknesses and suggest improvements before publication. Peer review provides a critical evaluation of the subject work by similarly qualified experts and constitutes a form of self-regulation by qualified members of a profession within the relevant field. In short, peer review is an integral part of the scientific process, and publication in a peer-reviewed journal is often a key consideration in our assessment of what constitutes best available science. The GYE grizzly bear population is the most studied in the world, and the peer-reviewed scientific journal articles used in the proposed and final rules represent the best available science.
Models are never perfect, but are crucial to the scientific process. Models can be reliable and informative as we consider the best scientific and commercial data available. Modeling typically requires a set of assumptions and can be prone to error, including Type II errors. Incorrect inputs or failure to account for certain variables or assumptions can result in inaccurate outputs and conclusions. By design, scientific peer review identifies and corrects potential concerns with modeling. Models used by IGBST and other scientists are based on commonly used and broadly accepted approaches in wildlife science. To suggest that models should not be used or relied upon is too generalized a conclusion and, in our view, unfounded. Not using scientific inference from modeling would reject the role of science. Ignoring available modeling could be directly counter to the Act's requirement that we base our decisions on the best available science.
We are aware of and considered ideas that are contrary to our conclusions, including those of Dr. David Mattson, who contends that the population is declining due to declining food sources, drought, invasive species, and habitat loss. However, the peer-reviewed research does not support this idea. Please see
Opinions vary regarding what criteria should be evaluated (
The GYE proposed rule clearly cautioned the reader that the analyses of Boyce
Commenters also cast doubt on the accuracy and reliability of the Chao2 population estimation method, especially considering the research of Doak and Cutler (2014a, 2014b). These concerns included: (1) Concerns that Chao2 becomes less accurate with time; (2) confusion about the wide range of estimated population sizes (according to Thuermer (2016), the number of bears, based on the Chao2 method, could range anywhere from 552 bears to 1,110 bears); (3) suggestions that 40 percent variance (the apparent variance associated with the Chao2 estimate) is unacceptable; and (4) suspicions about the fact that, in 2007, the population estimate jumped from the long-time estimate of 260–600 bears to 700 bears because delisting was under consideration. One commenter wondered how the raw counts and Chao2 estimates of females with cubs differ in Keating
Several comments were concerned with the measurement and interpretation of unique females with cubs, and how potential biases in these counts could lead to overestimation of the Chao2 population estimate (which is based on counts of females with cubs). The first source of bias commenters cited stems from increased sightability; over time, as bears have increased their use of moth sites, which are easier to monitor, it has become easier to find and count individual bears. These commenters claimed that the increasing trend of the number of females with cubs in IGBST monitoring data could stem from the fact that it has become easier to count bears and not from the fact that there are actually more bears in the GYE. The second source of bias commenters cited relates to increased unreliability of unique sightings of females with cubs. Based on the guidelines for how the IGBST counts females with cubs, females sighted with differing numbers of cubs are considered unique (
Commenters raised concerns about other sources of bias in the Chao2 estimator. First, some commented that the population estimate is influenced and potentially biased by the multipliers used for dependent young, pre-reproductive independent females, and independent males, and by changing survival rates (
We have provided clarifications in the final rule (see
The derivation of total population size introduces additional uncertainty into the total population estimate, but we have no data that suggest that bias would increase. Indeed, the vital rates (
The survival estimates are not inflated and, in fact, may be underestimates because IGBST assigns the month of death as the last month an individual bear was known to be active when a bear was lost from monitoring and the date of death was unknown. If some of these individuals were lost the following month, the overall estimate of survival would be higher (Haroldson
Thus, while population growth indeed slowed down, a given estimate of the number of females with cubs-of-the-year based on 2002–2011 vital rates translates into a larger total population compared to 1983–2001 data because of the greater proportion of independent males in the population. These observations are not an indicator of the
In response to doubts on the accuracy and reliability of the Chao2 population estimation method: (1) We acknowledge an underestimation bias in Chao2 that increases as the population grows (
Schwartz
The critique of increased search effort and sightability were addressed in substantial detail in the response by van Manen
The suggestion that we continue the current method of population monitoring indefinitely, including intensity, distribution, and design, is addressed in this final rule (see
The rule set used in the Chao2 estimate for identifying unique females with cubs-of-the-year is conservative and becomes increasingly conservative with greater numbers of unique females with cubs-of-the-year (
Several commenters suggested additional or alternative methods to apply in detecting the population trend including: (1) Comparing the annual uncertainty in the population estimates to long-term averages; and (2) using capture-recapture data to estimate population trend rather than the trapping effort data used by van Manen
One commenter expressed concern with our population trend projections from Harris
The IGBST is currently investigating the power of the current population estimation protocol to detect a declining trend. Primary findings will be submitted to a peer-reviewed journal later in 2017. An overview of how cumulative uncertainty in the population models are carried over into final uncertainty of estimated population growth is provided in table 2.1 of the IGBST's Demographic Workshop Report (2012, p. 20). In a rebuttal to the critique by Doak and Cutler (2014a, 2014b), van Manen
For large vertebrate populations, lag effects can occur, if there is indeed
The IGBST investigated the influence of “anchoring” the time series in 1983 versus 2002. The difference in model-averaged Chao2 estimates was negligible. For example, the 2014 estimate of females with cubs-of-the-year using the time series of 1983–2014 was 60, whereas the 2002–2014 time series resulted in an estimate of 57 for 2014. Similarly, the 2015 estimate of females with cubs-of-the-year based on the 1983–2015 time series was 56, whereas the 2002–2015 time series produced an estimate of 54 (van Manen 2016b,
In response to the comment that suggests we use additional methods to detect population trend and size, although the proposed rule (81 FR 13174, March 11, 2016) describes use of only the Chao2 method to detect population size, the IGBST uses three additional and independent methods: (1) Mark-Resight estimator (
The IGBST's primary estimates of population trajectory (
Some public commenters requested that any new population estimation methodology be open to public comment prior to implementation. Some commenters and peer-reviewers were concerned that implementation of a new method could make interpretation of estimates and trends difficult and raised questions about how new estimates would be reconciled with previous estimates that used the Chao2 methodology, including a need to calibrate the mortality limits, population estimates, status review triggers, and population objectives. Commenters worried that, without this recalibration, adoption of a more accurate population estimation method would allow the States to kill hundreds of bears, while other commenters noted that new population estimation methodology should not be used to re-define what the recovered bear numbers are for future management decisions.
We received several comments about the recalibration language in Appendix C of the draft 2016 Conservation Strategy, some suggested that the same language needed to not only remain in Appendix C of the 2016 Conservation Strategy but also be included in the MOA and State plans, while others were concerned that it restricted the adaptability of future management by dictating how a new population estimator would be applied. Some commenters expressed that the lack of recalibration language in the State regulations and plans meant that adequate regulatory mechanisms were not in place.
The final 2016 Conservation Strategy commits to using the model-averaged Chao2 population estimator for the foreseeable future to maintain the population around the average population size from 2002 to 2014. The implementation of a new method to estimate population size within the GYE DMA would be evaluated by the IGBST and constitute a change to the Conservation Strategy, which requires approval by the YGCC and a public comment period.
The recalibration language in Appendix C was removed because it was determined to be too prescriptive as it would require data from 2002 to 2014, the period for which the model-averaged Chao2 population estimate is used as the population objective. It is likely that any new method would require data that are not currently collected, and, therefore, retroactive estimation using the new method would not be possible. The States have made a number of clearly articulated commitments through the 2016 Conservation Strategy and Tri-State MOA to maintain a recovered bear population as measured by the established demographic recovery criteria. For example, in the Tri-State MOA (Wyoming Game and Fish Commission
Some commenters suggested that the definitions and example calculations (
Commenters also expressed concern about “background mortality” including that background mortality must take into account unknown and unreported mortalities, that we need to account for the uncertainty in the calculation of background mortality, and that we need to define the period over which the moving average of background mortality will be calculated.
Some commenters expressed concern about our ability to accurately track natural death and predation, claiming that most cub and yearling deaths are due to predation and are undocumented. One commenter disagreed with the estimates of natural death and predation provided in the proposed rule; but did not provide alternative supporting documentation.
While there is uncertainty around estimates of unknown/unreported mortality, there is no inherent bias. The cause of death is indeed important. For example, the IGBST makes the reasonable assumption that deaths of radio-collared bears and those due to management removals are known with certainty and thus can be excluded from the Bayesian procedure that is used to estimate unknown/unreported mortalities from those documented mortalities that are discovered and reported (again excluding management removals and loss of radio-marked bears). The IGBST capture and radio-collaring efforts have been very consistent over time; while sampling this large ecosystem with its many remote and inaccessible areas is challenging, the combined effort of IGBST partner agencies is based on a well-distributed spatial sample with very little variation in annual effort over several decades of sampling. The sex ratio in the overall population is 50M:50F, and since 2002, the sex ratio for mortalities of independent-aged bears within the Recovery Zone is 51M:49F, which statistically is not different from 50M:50F (IGBST, unpublished data). However, the sex ratio of mortalities outside the Recovery Zone is biased towards males (70M:30F) and reflects the fact that range expansion is driven by males. The overall average M:F mortality ratio for the ecosystem is approximately 59M:41F and is appropriate when assigning sex to documented mortalities for which sex of the animal could not be determined.
Natural deaths of cubs and yearlings (
Regarding natural deaths of independent-aged bears, the IGBST accounts for four sources in the estimate of total mortality: (1) Documented natural mortality from radio telemetry; (2) reported natural mortality; (3) a portion of the estimated unknown/unreported mortality previously described; and (4) a portion of reported grizzly bear mortalities for which a specific cause of death was undetermined but are likely from natural causes. These mortalities from undetermined causes are also used for the estimation of unknown/unreported mortalities, which is then included in the annual estimate of total mortality.
Annual estimates of total mortality for independent female and male bears are subsequently used to assess annual mortality rates for each of those two segments of the population. Since 2010, annual estimated mortality rates (as derived from the Chao2 estimator) averaged 7.5 percent and 9.8 percent for independent female and male bears, respectively, in the DMA. These estimates are slightly higher than the average mortality rates of 5 to 6 percent derived from known-fate monitoring of radio-marked bears (IGBST 2012). The difference is likely attributable to the fact that mortality rates derived from Chao2 estimates are biased low. Using an unbiased population estimator, such as the Mark-Resight method, would result in lower mortality rates that are more in line with those derived from known-fate monitoring, suggesting that estimates of total mortality are reasonable and, therefore, estimates of natural mortalities are also reasonable.
Commenters also expressed concerns about our measurement of total mortality including: (1) That the IGBST reports do not include confidence intervals on mortality rates; (2) that the IGBST does not include natural deaths in their mortality estimations; (3) that the method the IGBST uses to calculate total deaths underestimates the number of total deaths with an unknown and inconsistent degree of bias; (4) that actual total mortality is twice as high as reported levels because analysts are not accurately capturing mortality from unreported poaching and road kills; and (5) that emigration out of the DMA does not, but should, count towards total allowable mortality in the DMA or towards background mortality when calculating allowable discretionary mortality limits. One commenter suggested we use the upper bound of the 95 percent confidence interval to determine the value of unreported
Other commenters requested that the rule include information on geographic locations of factors associated with mortality risk (
The IGBST does not report credible intervals for estimates of unknown/unreported mortalities, which includes natural deaths, because it would substantially complicate implementation (see Issue 33 for further discussion). The IGBST includes all sources of mortality, including natural deaths, in their calculations of total mortality for independent females and males. Although the method used for estimating unknown/unreported mortalities slightly underestimates mortality, it is inconsequential because other estimations associated with calculation of mortality rates are conservative (in their entirety: Knight
We did not find it necessary to include detailed geographic locations of factors associated with mortality risk in the proposed or final rule because the IGBST maintains the GYE grizzly bear mortality database, which is available at
Commenters also suggested that 2016 mortality levels are “unsustainable” and could exceed the 2015 records, which reduces public confidence that mortality levels will improve upon delisting. One commenter contended that mortality could approach 200 bears annually after delisting, if bears are also killed in trophy hunts. Commenters worried if bears could withstand this additional mortality from hunting considering current high mortality levels without a hunt; many thought any additional mortality could lead to population decline. Commenters asserted that if the grizzly bear population has stabilized since 2002 while mortality rates have simultaneously increased, then the bear population is actually declining.
Many commenters also expressed concerns that the IGBST is no longer reporting violations of mortality thresholds, which the Service is required to publicly announce.
Regarding concerns over the level of mortality in 2015, the estimated number of annual mortalities was 25
Total mortality from any cause, including hunting, shall not exceed thresholds as defined in the final rule and 2016 Conservation Strategy; therefore, if hunting was allowed, it would be an inclusive instead of additive source of mortality. Although independent male mortality was higher in 2016 than in 2015 (37 individuals v. 32, respectively), the mortality rate (15.5 percent (Haroldson and Frey,
The assertion that the bear population may be actually declining is not supported by data. See Issue 29 for additional detail.
The IGBST did not include in their Annual Report for 2015 whether mortality thresholds were exceeded because the demographic recovery criteria were under revision. They will report if mortality rates are under or over sustainable rates, as measured by the revised demographic recovery criteria, in future annual reports, which will be available at
There is a lag time between when a change in trend occurs and when it may be detected. However, the current monitoring system effectively identified that a change in the population trajectory had occurred, which triggered the IGBST to conduct a comprehensive biology and monitoring review; this review led to the finding that cub and yearling survival and a reproductive parameter had declined, which led to further investigations about the potential causes for these changes. Those potential causes were investigated in detail as part of the IGBST's Food Synthesis project and indicated associations with bear density (cub survival and reproductive transition decreased as bear density increased), but not with decline of whitebark pine. Regardless, the issues of trend detection are important. The IGBST is currently investigating the ability to detect (based on the Chao2 estimator) when population estimates have reached specific population thresholds and the degree to which population thresholds may be exceeded, both in time and population size, before they are detected. Reproductive parameters in wildlife populations, including bear populations, typically co-vary and often in a non-linear manner. Depending on the complexity of these relationships, the covariance of parameters may be difficult to accurately estimate.
Some commenters questioned whether carrying capacity has been reached since (1) grizzly bears occupy only 25 percent of the GYE; (2) there is inherent difficulty in calculating carrying capacity; and (3) a population that is increasing at a rate of 3 to 4 percent per year and for which harvest needs to be adjusted to maintain mortality levels at 10 to 22 percent are not parameters characteristic of a population at carrying capacity. In addition, a few commenters questioned if our conclusion that the GYE grizzly bear population has reached carrying capacity applied within the PCA, the DMA, or the entire GYE. Conversely, other commenters expressed support that carrying capacity has been reached based on: (1) The preponderance of the best available science; (2) the stability of reproduction inside YNP; and (3)
One commenter and several peer-reviewers suggested alternative hypotheses to our claim that the GYE population is approaching carrying capacity: (1) That a decrease in food availability (as mentioned in van Manen
While one commenter noted that grizzly bears occupy only 25 percent of the GYE, we note that suitable habitat is roughly 24 percent of the total area within the GYE DPS boundaries, of which grizzly bears occupy 90 percent (see Issue 22). We acknowledge in the proposed rule the inherent difficulty in calculating carrying capacity. As the population has approached carrying capacity, the population growth rate has naturally slowed with the most recent trajectory using the Chao2 estimator showing no statistical trend within the DMA for the period 2002 to 2014 (van Manen 2016a,
Studies by the IGBST provide strong support for a density-dependent effect for the leveling off of the population. Discussion of the Food Synthesis Report (see
If bears were responding to a decline in carrying capacity, however, we would have expected home-range size and movements to have increased (McLoughlin
The IGBST data does not support the alternative hypothesis that human social carrying capacity has been reached and is contributing to the slowing of population growth. On average, total mortality rates over the last 10 to 15 years have not exceeded established mortality thresholds and there is no evidence of an increase in poaching, which has remained low for several decades. The DMA is based on an IGBT assessment of an area “sufficiently large to support a viable population in the long term” (IGBST 2012, p. 42). The 2016 Conservation Strategy incorporates adaptive management and monitoring of population vital rates, habitat standards, and major foods into management decisions to ensure that the GYE grizzly bear DPS remains recovered.
Commenters also raised concerns about the factors we used to evaluate the relative influence of density-independent and density-dependent effects on grizzly bear population dynamics in the GYE, suggesting: (1) That of the four factors we analyzed, only one factor (home range size) differed between the analyses of density-dependence and density-independence, and, therefore, the other three factors (decreased cub and yearling survival, increased age of first reproduction, and decreased reproduction) cannot be used to distinguish between the influence of density-dependent and density-independent effects; (2) that we only explained one of these four factors (cub survival); and (3) that we did not account for temporal changes in the abundance of key foods and habitat. Commenters thus questioned the causal link we suggested between density-dependence and declining vital rates, and one peer-reviewer suggested we review our use of any words suggesting causality, as opposed to association, in our density-dependence analysis.
(1) The number of females with cubs-of-the-year in YNP showed a gradual but steady increase from 1973 through 2015, while the number of females with cubs-of-the-year observed outside of YNP increased at a much higher rate starting in the late 1980s (IGBST, unpublished data) (see figure 4 in the 2016 Conservation Strategy).
(2) Home-range and movement data do not support the interpretation that bears are leaving the core of the
(3) Recent range expansion has occurred beyond the DMA, and thus beyond the area where the IGBST conducts population monitoring. However, we believe the population is close to carrying capacity inside the DMA and expect continued range expansion through bear dispersal.
(4) The IGBST uses four independent methods to estimate population size and/or trend (see Issue 29).
In regard to the density index, it was peer-reviewed (contrary to the comment submitted that it was not), published, and presented in detail in both Bjornlie
In response to comments about our conclusions from our analysis of density-independent and density-dependent effects on grizzly bear population dynamics in the GYE we added clarifying language in this rule (see
In response to the comment suggesting we review our use of words suggesting “causality” as opposed to “association” in our density-dependent analysis, we clarified that density-dependent effects are the likely cause of the recent slowing in population growth factors rather than “associated with”.
The IGBST used the average annual activity radii of independent female grizzly bears to buffer and smooth the boundaries of suitable habitat so that the DMA would encompass areas outside of suitable habitat that were likely to be used by grizzly bears on a regular basis. This is the process by which areas such as the Upper Green River were included within the DMA boundaries. Conversely, because this quantitative technique smoothed the boundaries of suitable habitat and did not attempt to define suitable habitat itself, it is also the reason some areas in the southern Wind River Range were not included in the DMA even though they are found within Wilderness Areas. These were areas that did not meet the definition of suitable habitat because they possessed high mortality risk due to large, contiguous blocks of sheep allotments. The Service adopted the IGBST's recommended DMA boundaries in the Revised Demographic Criteria (USFWS 2017, entire). The Big Sandy and Popo Agie areas are included in the DMA because we consider most of the Wind River Range to be suitable habitat for grizzly bears in the GYE due to the large percentage of Wilderness. Lastly, recovery plans are not regulatory documents and are instead intended to provide guidance to Federal agencies, States, and other partners on criteria that may be used to determine when recovery is achieved.
In addition, other commenters were uncertain as to how we defined unsuitable habitat and wondered if unsuitable habitat was “non-habitat,” “edge habitat,” habitat with a certain number of human-bear conflicts, areas where “reasonable levels of bear/human conflict precautions do not suffice to prevent the death of a substantial fraction of bears entering this area,” or areas that are population sinks. One commenter suggested that the Service makes unsupported claims that bears in unsuitable habitat are more “transient” and did not define “transient.” Commenters requested demographic data on each area of unsuitable habitat, presuming these areas are sinks, as well as information on the methods managers used to determine the number of bears in unsuitable habitat and how much time each bear spent in unsuitable habitat. Other commenters worried that declaring habitat unsuitable because of the high risk of mortality would become a “self-fulfilling prophecy” and that
One commenter requested two additional visuals: (1) A map that overlays locations of bear deaths with habitat suitability, the “range” of viable populations, and the home ranges of the dead bears; and (2) a map that shows which unsuitable habitat does not meet grizzly bear needs because of concerns about mortality risk and which unsuitable habitat does not meet grizzly bear needs for other reasons. Another commenter asked for further details on what levels and kinds of management to reduce conflicts would be considered “reasonable and manageable,” specifically: I&E; efforts to reduce the availability of attractants; live-trapping and removal of conflict bears; and aversive conditioning of conflict bears.
Our determination that large, contiguous blocks of sheep allotments were not suitable for grizzly bears was biologically based on mortality rates. Scattered, small, and isolated sheep allotments were included in suitable habitat and considered in our threats analysis under
The presence of grizzly bears in places with high levels of human activity and human occupancy results in biological effects to grizzly bears in terms of increased mortality risk and displacement. The level of this effect is directly related to the location and numbers of humans, their activities, and their attitudes and beliefs about grizzly bears. The consideration of human activities is fundamental to the management of grizzly bears and their habitat. While it is true that the current distribution of grizzly bears extends outside of the DMA into unsuitable habitat, the records of grizzly bears in these areas are generally due to recorded grizzly bear-human conflicts or to transient animals, not reproductive females with offspring. For instance, between 1985 and 2014, only 2.1 percent of all sightings of unduplicated females with cubs-of-the-year were outside of the DMA (Haroldson 2016,
Our definition of suitable habitat is biologically based on the best available science and not on “social intolerance.” The 2016 Conservation Strategy specifies strategies to manage grizzly bear-human conflicts, and for ongoing I&E programs, both of which foster social tolerance (YES 2016a, pp. 86–95). The adaptive management approach described in the 2016 Conservation Strategy will allow management agencies to make changes, if necessary, to I&E efforts and conflict management in response to potential impacts of changes in social tolerance.
Our analysis of suitable habitat was a quantitative, broad-scale habitat assessment. As such, its purpose was to provide an understanding of the broad trends in habitat distribution, not to address the nuances of changing food sources or dynamic mortality risk as “spatially dynamic boundaries” would. While we appreciate this commenter's suggestion, we conclude that the spatially explicit survival modeling done by the IGBST is adequate to address these concerns (see Schwartz
The Act does not require us to quantify the proportion of suitable habitat that is “core” versus “edge” habitat; however, we did consider edge effects in our analysis and chose not to include isolated patches and strips of land as suitable habitat because of the potential for higher mortality. The IGBST tracks mortality and associated causes (see Issue 34). Historically, increased human-caused mortality risk was associated with motorized access routes, which led to implementation of motorized access route standards (YES 2016a, pp. 54–71;
The IGBST's annual reports include maps of mortality locations that show
Schwartz
Although Boyce
Appendix E of the 2016 Conservation Strategy explains why the CEM is no longer the best available science and that the Motorized Access Model, established concurrently with the CEM, will be the tool used to project impact analysis (YES 2016b). The Motorized Access Model calculates and monitors secure habitat and motorized route density. The 2016 Conservation Strategy incorporates the IGBST's long-term monitoring data of population vital rates, habitat standards, and major foods and will be used to inform management decisions on maintaining a recovered GYE population. Although lag effects can occur in large vertebrate populations affected by habitat declines, there is little evidence of a lag effect at the grizzly bear population or individual level in response to changes in food resources. The IGBST's current monitoring system effectively identified a change in the species' population trajectory, which subsequently triggered the IGBST to conduct a comprehensive biology and monitoring review. See Issue 36 for further discussion on lag effects, vital rates, and habitat features.
Commenters and peer-reviewers provided the following alternative means of defining secure habitat: (1) Defining “microscale” security areas as approximately 28.3 km
Peer-reviewers and commenters provided suggestions on the management of secure habitat, including that: (1) Any future changes to secure habitat, and subsequent mitigation efforts, need to ensure that secure habitat is distributed across the landscape in a way that does not cause habitat fragmentation and that facilitates movements of bears both within and between bear management units (from a peer-reviewer); (2) the 2016 Conservation Strategy's guidelines for road construction on secure habitat, signage, and crossing structures are vague, especially about who monitors road density, makes decisions about additional roads, and pursues mitigation; (3) the proposed rule and the 2016 Conservation Strategy were not consistent in how they discussed USFS maintenance of secure habitat; and (4) the 2016 Conservation Strategy's provisions that allow only temporary reductions in the amount of secure habitat seem to apply only to Federal projects and leave open what could happen to secure habitat affected by State or county road projects (especially if they are emergency projects or broad-scale projects that could affect more than one BMU).
Lakes are not automatically considered secure habitat. Instead, secure habitat is based on the presence or absence of motorized access. Lakes larger than 2.6 km
We do not think it is necessary to modify our definition of secure habitat to exclude areas within 500 m (1,640 ft) of high human use. Federal agencies lack sufficient resources and data needed to measure the intensity of human-use for every road and trail throughout the ecosystem. Instead, for grizzly bear purposes, motorized access is a surrogate measure of human presence on the landscape and one that can be reliably tracked via GIS. Research indicates that non-motorized trails do not significantly affect grizzly bear survival, and that survival was better explained by the presence of motorized routes (Schwartz
We agree with the comment that any changes to secure habitat should ensure it is distributed across the landscape in a way that does not cause habitat fragmentation. The 2016 Conservation Strategy directs that, on the rare occasions when there are projects inside the PCA that require the construction of new roads (
The NPS and the USFS manage the majority of lands within the GYE and are responsible for managing road construction on their lands, including monitoring road density, making decisions about additional roads and pursuing mitigation. Land and resource management plans for National Forests and National Parks in the GYE have incorporated additional habitat standards and other relevant provisions of the 2016 Conservation Strategy (USDA FS 2006b, entire; YNP 2014, p. 18; GTNP and JDR 2016, p. 3) and will guide decisions about road management. The allowance for temporary reductions in secure habitat applies only to areas inside the PCA, of which 97.9 percent of the land is Federally owned. With only 2.1 percent of the land in private and other ownerships, we conclude that any future State or county road projects would not substantially affect secure habitat. Additional specificity and timelines will be provided in State grizzly bear management plans, forest plans, and other appropriate planning documents for areas outside the PCA.
Regarding the comment suggesting managers should develop plans to control important habitat components, the GYE National Forests and National Parks have incorporated the habitat components outlined in the Conservation Strategy into their compendia, and the National Forests' 2006 Forest Plan Amendment will go into effect upon delisting, as stated in the amendment (see Issue 95 for more details on the Forest Plan Amendment). Their 15-year implementation history gives us confidence that they will do so. Additionally, the Conservation Strategy was signed by State agencies and Federal land management agencies in December 2016 and is currently in place. See Issue 48 for more information about which habitat components, including the abundance of ungulates, will be monitored. The IGBST will continue demographic monitoring of the GYE grizzly bear population and the habitat criteria set forth in the 2016 Conservation Strategy; therefore, the IGBST would be able to detect if changes in vital rates occurred and evaluate whether they were a result of changes in habitat quality or quantity. Upon completion of a demographic review, the IGBST will provide the information to the YGCC, who will decide if modifications to the 2016 Conservation Strategy are necessary.
However, we disagree that temporary projects should not be allowed on public lands inside the PCA. In general, it is reasonable and biologically sound to provide management flexibility and discretion to land management agencies so they can fulfill their mandates of balancing and accommodating multiple uses (USFS) and providing for public recreation while conserving resources (NPS). These allowances for temporary changes to secure habitat were based on known levels of project activities occurring during the 1990s, a time during which the GYE grizzly bear population was known to be increasing (Harris
There is no exception to the 1998 baseline regarding administrative use of roads that are closed to the public. All roads, even if only open for administrative purposes, are considered open roads and are included in the 1998 baseline (YES 2016a, p. 61). There is a very specific statement in the 2016 Conservation Strategy (YES 2016a, p. 64) that allows administrative use on existing routes for the purposes of power line/utility maintenance. These roads are not open to the public, have no obvious footprint, and are used very rarely. As such, we continue to conclude that allowing access for power line and utility maintenance is not a threat to the GYE grizzly bear.
For developed sites on public lands, expansion of existing administrative sites is allowed if these are “deemed necessary for enhancement of public land management and other viable alternatives are not available” (YES 2016a, p. 66). This does not allow new developed sites for administrative purposes, only expansion in capacity or acreage of existing administrative sites. In general, administrative sites are occupied by trained personnel of the National Forests or National Parks, contain strictly enforced requirements for securing attractants from grizzly bears, and prohibit most personnel from carrying firearms. As such, administrative sites do not pose the same level of risk to grizzly bear survival as sites occupied by the general public, so it is reasonable to allow some expansion of capacity at these existing sites.
The allowance for temporary projects that include low-level helicopter flights and temporary road construction during the grizzly bear denning season (December 1–February 28) is also biologically sound and reasonable. While no studies have been conducted documenting impacts of low-level helicopter flights on grizzly bears during the denning season, as discussed in the
A notable number of improvements in route density since 1998 have taken place on subunits that are partially or completely contained within the Gallatin National Forest. The documented decreases in motorized route density can be directly attributed to implementation of the 2006 Gallatin National Forest (NF) Travel Plan and reflects an overall goal to manage motorized access in a manner that allows for recovery of threatened species such as the grizzly bear. In areas of suitable habitat outside the PCA, we do not anticipate any significant increases in road densities because of other existing plans and designations (
Temporary roads are extremely limited by the application rules described in the 2016 Conservation Strategy and associated National Park and National Forest management plans. See Issues 44 and 45 for additional information.
While there are not two distinct grizzly bear populations inside and outside of the PCA, the single GYE grizzly bear population experiences different growth rates in these areas. When the population was growing at 4 to 7 percent per year in the 1990s (Harris
We maintain that suitable habitat outside the PCA provides additional ecological resiliency to the population. Unlike inside the PCA, there are areas of suitable habitat outside the PCA that are not currently occupied and that contain large stands of healthy whitebark pine (
The multiple indices used to monitor both bear foods and bear vital rates provide a dynamic and intensive data source that allows the agencies to respond in a timely manner to results that might indicate problems. The GYE monitoring system under the 2016 Conservation Strategy (YES 2016a, pp. 33–85) is one of the most detailed and comprehensive monitoring systems developed for any wildlife species. Specific habitat variables that will be monitored include: Amount and location of secure habitat, open motorized route densities, total motorized route densities, developed sites, relative abundance of ungulates, cutthroat trout abundance and use, grizzly bear use of army cutworm moth sites, whitebark pine abundance, and grizzly bear distribution and mortality. Since we will be monitoring a suite of demographic vital rates including survival of radio-collared bears, home range size, mortality of all bears from all causes in all areas, causes and locations of grizzly bear-human conflicts, body condition, and reproductive statistics like litter size, litter interval, generation time, and age of first reproduction, we are confident that we will be able to detect the consequences of significantly reduced habitat productivity soon enough to respond with changes to management approaches.
For the habitat components that are part of the 1998 baseline (
Finally, we are not able to commit to reviewing land management activities on public lands every 3 years. However, we do commit to monitoring secure habitat and motorized access route density, developed sites, livestock grazing, and grizzly bear foods according to the protocol outlined in the Conservation Strategy (YES 2016a, pp. 68–73).
There were several comments regarding whether or not the 1998 habitat baseline has been maintained in the past or could be maintained into the future. Peer-reviewers and several commenters asked: (1) For additional detail on changes in habitat, roads, and developments from the past 40 years (especially since 1998), even if the amount of secure habitat has not changed, as these specifics could shed light on the feasibility and appropriateness of the 1998 baseline; and (2) whether agencies have been, and can remain, in compliance with the 1998 baseline; and, in particular, the three BMU subunits in the Targhee and Gallatin NF, which needed improvements in secure habitat in 2007. Some commenters expressed concern with the 2006 Gallatin Travel Management Plan implementation and questioned if it was approved; commenters expressed confusion as to “why the Service is not enforcing the Gallatin NF to decommission motorized routes and develop sites to comply with the 1998 baselines as all other forests have done.”
A number of commenters presented alternatives to the 1998 baseline including: (1) Using current conditions for the baseline, since bears are recovered under current conditions; and (2) using the “moving window analysis” from Mace and Waller (1996), which recommends open motorized route densities, total motorized route densities, and core amounts of habitat for each BMU. A peer-reviewer suggested using a defining period of 1988 to 2005, unless there were unique habitat features that were stable between 1988 and 1998. And lastly, many commenters worried that negotiations around the 2016 Conservation Strategy have already changed the 1998 baseline, and we have not adjusted our explanation of secure habitat or threats analysis accordingly.
We recognize that the 1988 fires and other natural events may alter habitat, including the distribution and abundance of foods across the landscape, in the GYE. However, there is no evidence that fires detrimentally affect grizzly bears (see Issue 61). We agree that mortality risk is not static within secure habitat. Schwartz
For a discussion on overestimation of population growth estimation and Pease and Mattson (1999), please refer to
Habitat conditions relating to the habitat standards described in the 2016 Conservation Strategy (YES 2016a, pp. 54–85) have either remained stable or improved from the 1998 baseline levels of secure habitat, site developments, and livestock allotments. The Grizzly Bear Annual Habitat Monitoring Report includes changes and corrections to the 1998 baseline and is included in the IGBST Annual Reports. The 1998 baseline: (1) Was not developed to address specific projects such as oil and gas development or timber harvest; (2) does not contain threshold values for any of the major foods due to the natural annual variability in their abundance and distribution; and (3) attempted to establish realistic habitat standards that ensure adequate habitat security and minimum livestock conflicts within the PCA. Therefore, we consider the establishment of habitat thresholds for human population growth, food sources, and specific projects to be unrealistic and that the 1998 baseline will adequately address these issues through access management and limitations on site development.
As the commenters point out, the moving window analysis approach represents the best available science and is the method used for measuring route densities on public lands in the GYE. Motorized route densities and percentages of secure (“core”) habitat within the GYE are calculated using a suite of GIS geospatial tools that are packaged as the
Although no specific standards are directly imposed on motorized route densities, road construction is significantly curtailed by imposing a no-net-decrease in secure habitat per bear management subunit inside the PCA. The commenter refers to the NCDE provision for core area amounts (68 percent/2,500 acres). It is true that
The Gallatin NF Management Plan was approved in 2006 and has implemented the 1998 baseline. The three subunits identified by the 2007 Conservation Strategy that were in need of improvement were on the Targhee and Gallatin NFs, although the portions of these subunits that were identified as in need of improvement were within the Gallatin NF. The high road density values and subsequently low levels of secure habitat in these subunits is primarily due to motorized access on private land (USFWS 2007
Commenters suggested several remaining threats to connectivity warrant further discussion in the rule, including: (1) The 150 miles of farmland and roads that separate GYE grizzly bears from their northern neighbors; (2) proposed hunting (especially along NP boundaries), combined with high mortality rates (as much as 47 percent) outside the DMA could preclude future connectivity; and (3) large-scale and long-term effects of road construction, like fragmentation, can jeopardize connectivity. Peer-reviewers asked us to explain the relevance of food storage orders to the issue of connectivity and to more fully address remaining barriers to movement, such as topography or manmade structures, including a suggestion to provide scientific evidence of grizzly bear use of crossing structures to strengthen our promotion of these structures as a management tool.
Due to the habitat protections, population standards, mortality control, outreach efforts, and the adaptive management approach described in the 2016 Conservation Strategy, we conclude that isolation is not a threat to the GYE grizzly bear population and, therefore, does not preclude delisting. Based on estimated grizzly bear distribution in the NCDE (Costello
We have added a discussion of catastrophic events to this rule under
For Montana, public commenters were concerned that the State's: (1) Plan and regulations are noncommittal or unclear on the subject of connectivity,
Other commenters suggested that State plans must manage for connectivity rather than managing toward a minimum population level and should have comprehensive management plans, not just for the GYE, that integrate all of the grizzly bear populations in their State and discuss how to facilitate connectivity between them. Overall, commenters expressed that States must provide more explicit and robust commitments to ensuring connectivity for delisting to be justified and that the final rule must “commit to connectivity and coordinated management.” Without these commitments, commenters asserted that the delisting would violate Service regulations, the National Forest Management Act, NEPA, the APA, and § 219.9 of the 2012 Forest Planning Rule.
Conversely, the States commented that: (1) Their discussions of connectivity in plans and regulations were sufficient to ensure the continued recovery of the GYE grizzly bear population to which one public commenter agreed with Montana; (2) the proposed rule may be too prescriptive on the subject of connectivity and movement between ecosystems; and (3) the Service should remove references to bear occupancy outside the DMA in the recovery supplement because the best available science indicates genetic connectivity is not a threat to the GYE population and the recovery criteria “are conservative in recognition of the GYE DPS' relative isolation.”
As stated in the proposed rule, connectivity/linkage, while desirable, is not required to maintain the GYE DPS. Published information indicates the genetic variability and viability of the GYE DPS is strong, and lack of connectivity is not a threat to the existence of the GYE DPS (in their entirety: Kamath
For Recovery Zones outside the GYE DPS, the Act's protections will continue. The 2016 Conservation Strategy describes actions for habitat connectivity. Although connectivity with other Recovery Zones is not required for recovery or delisting of the GYE DPS, the 2016 Conservation Strategy and Montana's State management plan include a long-term goal of allowing grizzly bear populations in southwestern and western Montana to reconnect through the maintenance of non-conflict grizzly bears in areas between the ecosystems. The State of Montana has indicated that, while discretionary mortality may occur, the State will manage discretionary mortality to retain the opportunity for natural movements of bears between ecosystems. Grizzly bears have recently been documented in the Elkhorn Mountains, near Butte, Mill Creek, near Avon, and in the Big Hole, demonstrating that bears are moving into the area between the GYE and the NCDE and that natural connectivity is likely forthcoming; however, only the grizzly bears from near Butte and Mill Creek were confirmed as originating from the NCDE, and the ecosystem of origination for the other bears is unknown (pers. comm., M Haroldson). Montana's approved hunting regulations incorporate areas outside the DMA into hunting districts, and apply a quota to the whole hunting district based on the portion of the district within the DMA. This approach will better allow bears to occupy suitable habitat outside the DMA.
Although the Idaho Management Plan does not allow translocation of bears from the PCA to unoccupied areas within Idaho, it does allow for natural expansion into areas that are biologically suitable and socially acceptable. While the Wyoming Management Plan discourages occupation of areas outside of the DMA that are prone to conflict, it does not discourage occupancy of any sort as is implied by reviewer comment. The DMA was developed as an area within the GYE DPS to maintain consistent monitoring while providing large-scale suitable habitat sufficient in size to maintain a recovered grizzly bear population in perpetuity. However, this does not imply that bears cannot occur outside the DMA (as they currently do now) or into the future.
Commenters explained that the Service and its partners lack sufficient plans that will effectively ameliorate the threats from livestock allotments because: (1) Phasing out of livestock allotments is not, and has not been, an effective measure to reduce conflicts with wildlife; (2) there are currently no requirements to securely store or remove attractants, including livestock carcasses and feed, on private lands in the PCA; (3) current methods for
Commenters suggested methods to more effectively ameliorate the threats from livestock allotments and reduce conflict with livestock, including: (1) Conducting NEPA examination of all grazing allotments on public land and section 7 consultations before issuing any livestock allotment permits; (2) removing the livestock instead of the bear in cases of repeated conflicts; (3) encouraging landowners who have livestock allotment permits on Federal land to accept grizzly bear depredation of livestock, rather than expect retaliatory action towards grizzly bears; (4) instead of delisting, increasing support for programs that compensate landowners for livestock losses in place of retaliatory killing of grizzly bears; (5) requiring that livestock permits contain nonlethal conflict prevention measures before grizzly bear removal can occur; (6) including stronger, perhaps mandatory, language on livestock allotment phase-out, especially, according to one peer-reviewer, where conflicts are common, and including commitments to work with third parties to buy out allotments; (7) withdrawing most or all grazing rights on NF Land; and (8) removing leases from public lands that are “edge areas” important for connectivity or from all grizzly bear habitat. In addition, while some commenters suggested that the U.S. Sheep Experiment Station needs to be closed, others suggest that it has effectively used such nonlethal techniques to protect sheep from grizzly bears.
Conversely, some commenters worried about heightened negative impacts to ranchers if management of livestock allotments is made more stringent because compensation for relinquishing allotments is insufficient to cover the lost revenue to those ranchers. These commenters also suggested that the impact to livestock growers as a result of closing livestock allotments is disproportionate to the threat that these allotments pose, arguing that livestock allotments (especially sheep) are a comparatively small source of grizzly bear mortality (
Livestock permits are regulated through National Forest Land Management Plans, Livestock Grazing Permits, and/or Annual Operating Instructions. The USFS controls the number of permits and allotments, herd size, and season of use. In addition, permits contain carcass disposal requirements and enforce USFS food storage orders, which include livestock feed (for more details on food storage orders see YES 2016a, pp. 84–85). Existing permits within grizzly bear habitat, either under a programmatic review or for each allotment, have undergone section 7 analysis and any significant changes to these plans (
Federal and State management agencies emphasize preventative measures and nonlethal techniques whenever possible (Idaho's Yellowstone Grizzly Bear Delisting Advisory Team 2002, pp. 15–16; MFWP 2016, pp. 51–53; WGFD 2005, pp. 21–26). Inside the PCA, numerous sheep allotments have been retired or relocated to other, less-conflict-prone areas to accommodate grizzly bears (USDA FS 2006a, p. 170). As of 2006, there is only one remaining active sheep allotment inside the PCA (USDA FS 2006a, p. 168). Management removal will be used only as a last resort inside the PCA. The respective State wildlife agency's grizzly bear management plan will guide management of grizzly bear conflicts with livestock grazing on public lands outside of the PCA. Thus, removals as a result of these conflicts will remain within the sustainable mortality limits established in the 2016 Conservation Strategy. As such, this source of mortality will not threaten the GYE grizzly bear population.
The Service must make its decisions based on the best available scientific data. Therefore, we focus on whether or not grizzly bear mortalities resulting from conflicts with livestock affect the overall population trajectory. Grizzly bear mortalities associated with livestock depredations have mostly been eliminated within the PCA as most livestock allotments have been closed or retired. However, as the grizzly bear population expands beyond the PCA and beyond the DMA where livestock allotments remain, mortalities have again increased as a result of this range expansion. Mortality rates will remain within the biologically sustainable mortality rates in the demographic recovery criteria and the 2016 Conservation Strategy (see Issues 19 and 66). The Service has established conflict bear guidelines that are strategic in nature and provide managers with a framework to assess conflicts on a case-by-case basis. Grizzly bears depredating on lawfully present livestock on public lands may or may not be removed from the population, depending on several factors such as location of the conflict, severity of the incident, age and sex of the bear, and conflict history of the bear (YES 2016a, Chapter 4). While not required by the Act, State, Tribal, and Federal managers will continue to use a combination of management options in order to reduce grizzly bear-human conflicts, including nonlethal forms (Bangs
Some commenters thought we needed stronger language making the phase-out of livestock allotments necessary. The Service has established a management system in the 2016 Conservation Strategy (YES 2016a, pp. 67–68, 72–73) that balances livestock grazing on public lands with the needs of grizzly bears. The vast majority of public lands in grizzly bear habitat in the GYE are managed with no livestock grazing. There is no livestock grazing on any of the National Parks in the GYE; the last livestock allotment in GTNP was closed in 2006. While livestock grazing allotments are a legitimate use of some public lands, we recognize that such grazing, especially sheep grazing, can lead to some grizzly bear mortality. In light of this understanding, and past management experience, the Service endorses an approach that includes minimizing livestock allotments with recurring conflicts.
The USFS's multiple-use mandate guides management to maintain a healthy forest while providing opportunities for wildlife and goods and services, such as livestock forage. Therefore, the USFS focuses on whether or not grizzly bear mortalities resulting from conflicts with livestock affect recovery of the population. The USFS has stated that, “Inside the PCA, no new active commercial livestock grazing allotments would be created and there would be no increases in permitted sheep AMs from the identified 1998 baseline. Existing sheep allotments would be monitored, evaluated, and phased out as opportunities arise with willing permittees. Inside the PCA, cattle allotments or portions of cattle allotments with recurring conflicts that cannot be resolved through modification of grazing practices may be retired as opportunities arise with willing permittees. Outside the PCA in areas identified in State management plans as biologically suitable and socially acceptable for grizzly bear occupancy, livestock allotments or portions of allotments with recurring conflicts that cannot be resolved through modification of grazing practices may be retired as opportunities arise with willing permittees” (USDA FA 2006a, pp. 36–37).
We conclude that this approach to livestock grazing is a logical and responsive way to manage grizzly bear-livestock conflicts. In some cases, the offer of financial incentives through nongovernmental organizations has been successful in retiring sheep allotments on public lands with willing participants (Gunther
The Final EIS for the Forest Plan Amendment for Grizzly Bear Habitat Conservation for the Greater Yellowstone Area National Forests includes an analysis of the potential economic impacts of implementing the 2007 Conservation Strategy, including the strategy surrounding livestock allotments (USDA FS 2006a, pp. 242–254). This Final EIS concludes that the negative economic impacts of implementing the 2007 Conservation Strategy would be minimal to livestock operators and do not outweigh the positive effects to grizzly bears (USDA FS 2006a, pp. 251–252).
Lastly, we disagree that the U.S. Sheep Experiment Station needs to be closed in order to conserve grizzly bears. The Station is located 6 miles north of Dubois, Idaho, and is 113 km
Commenters suggested that these oil, gas, and mineral activities, especially those adjacent to USFS lands, will affect grizzly bear habitat and lead to population declines post delisting, since: (1) Mitigation is voluntary; (2) NEPA will be inadequate to “curb harmful activities;” (3) the 1872 General Mining Law could restrain abilities to limit any new mining developments; (4) areas associated with oil and gas boom towns have an increased incidence of poaching (Berger and Daneke 1988); (5) the effects of honoring existing oil, gas, and other mineral leases are unclear; (6) denning bears, particularly females, have decreased fitness when disturbed by forest cutting, mining, oil and gas exploration, and human recreation; and (7) delisting will “lift” restrictions on oil, gas, and mineral leases in the GYE. A peer-reviewer also noted that it is unclear what actions land managers will take to mitigate for potential impacts from existing leases given the current language that land managers are “striving” to meet the application rules for changes to secure habitat.
Commenters requested additional plans and assurances to adequately explain amelioration of this threat such as: (1) More explicit plans for monitoring and mitigation; (2) complete removal, or at a minimum, commitments for no new oil, gas, or mining projects within the PCA after delisting; and (3) clarity on whether
The potential for future increases in oil and gas leasing inside the PCA on National Forest lands is guided by the 2016 Conservation Strategy and its limitations on road density and development (YES 2016a, pp. 60–72). We do not anticipate a dramatic increase in resource extraction outside of the PCA either due to the quantity of National Forest land designated as Wilderness (6,799 km
The proposed rule (81 FR 13196, March 11, 2017) accurately stated that, “Additionally, 1,354 preexisting mining claims were located in 10 of the subunits inside the PCA (YES 2016b, Appendix E), but only 28 of these mining claims had operating plans. These operating plans are included in the 1998 developed site baseline.” Activity on these 28 claims in both the PCA and suitable habitat range from small intermittent operations to 2 large mines producing platinum and palladium on the Custer-Gallatin National Forests. While claimants under the 1872 General Mining Law have a right to explore for and develop valuable mineral deposits on their claims, the USFS develops appropriate mitigations for these claims through analysis and the NEPA process (42 U.S.C. 4321–4347.1970, as amended). Please see the 2016 Conservation Strategy (YES 2016a, pp. 62–67) for additional details on required mitigation. The proposed Montanore Mine in the Cabinet Mountains is outside the scope of this rulemaking because it is not located in the GYE. Mitigation of mineral activity on BLM-managed lands requires NEPA, and the effects analysis helps determine the appropriate mitigation.
State agencies are authorized to permit and determine appropriate mitigation for operations on private and State lands. The Wyoming Department of Environmental Quality's Land Quality Division (LQD) permits and licenses to “ensure that land disturbances resulting from mining are minimal, and that affected areas are properly restored once mining is complete” (Wyoming Department of Environment Quality–Land Quality Division 2017). The Idaho Department of Lands permits surface and placer mining operations from beginning through reclamation. The Montana Department of Environmental Quality permits and licenses mining in Montana. The Idaho and Wyoming Oil and Gas Conservation Commissions and the Montana Board of Oil and Gas Conservation are the agencies authorized to permit and regulate oil and gas wells. The State agencies also have a role in permitting on the Federal lands. Operators proposing projects to develop federally owned minerals have to get both Federal approvals and the appropriate State permits, licenses, or approvals. While it varies by State, additional State agencies may be responsible for a variety of resources such as water discharge permits or air quality permits whether the proposed operations are on Federal or non-Federal lands.
The level of exploration and development on Federal lands has remained relatively constant over approximately 20 years. Mineralized areas with a history of exploration and development particularly occur on the Custer-Gallatin NF. Activity has remained within the level described in the 1998 developed site list. To the fullest extent of its regulatory authority, the USFS will minimize effects on grizzly bear habitat from those activities based in statutory rights (
Under the 2016 Conservation Strategy, any new oil, gas, or mineral project will be approved only if it conforms to secure habitat and developed site standards (YES 2016a, pp. 54–85). For instance, any oil, gas, or mineral project that permanently reduces the amount of secure habitat will have to provide replacement secure habitat of similar habitat quality (based on our scientific understanding of grizzly bear habitat). Any change in developed sites will require mitigation equivalent to the type and extent of the impact, and such mitigation must be in place prior to project initiation or be provided concurrently with project development as an integral part of the project plan (YES 2016a, pp. 54–85). For projects that temporarily change the amount of secure habitat, only one project is allowed in any subunit at any time (YES 2016a, pp. 54–85). Mitigation of any project will occur within the same subunit and will be proportional to the type and extent of the project (YES 2016a, pp. 54–85). In conclusion, because any new mineral or energy development will continue to be approved only if it conforms to the secure habitat and developed site standards set forth in the 2016 Conservation Strategy, we conclude that such development inside the PCA will not constitute a threat to the GYE grizzly
Since 2002, we have consulted with all of the GYE National Forests at least once regarding the effect of snowmobiles on denning grizzly bears (Caribou-Targhee NF 2004, p. 15; Dixon 2016,
As we stated in the proposed rule (81 FR 13174, March 11, 2016), the available data about the potential for disturbance while denning and den abandonment from nearby snowmobile use are extrapolated from studies examining the impacts of other human activities and are identified as “anecdotal” in nature (Swenson
Inside YNP, the use of an avalanche management system is limited to Sylvan Pass to prevent avalanches from covering the road, and the Superintendent has the ability to consider the location of wintering wildlife and close Sylvan Pass. Furthermore, there have been no documented mortalities or disturbances of denning grizzly bears as a result of avalanche control. Avalanche control for snowmobiling does not occur on any of the National Forests within the DMA. Therefore, we conclude that avalanche control activities are not a threat now, or in the foreseeable future, to GYE population.
Commenters also proposed potential management responses that could alleviate these impacts including: (1)
A survey of grizzly bear experts showed that research on the potential impacts of habituation as a result of human recreational activities should be a high priority (Fortin
Section 7 of the Act will no longer apply to the GYE population upon finalization of this rule. However, the Service considers the establishment of habitat thresholds for human population growth and limits on levels of human recreation to be unrealistic and concludes that the 1998 baseline will adequately address these issues through access management, limitations on site development, and I&E efforts. See Issues 45, 54, and 108 for additional information. Under the 2016 Conservation Strategy, a multi-agency effort will be conducted to determine the best long-term solutions for alleviating the pressures of increased visitation and the potential need for increased infrastructure.
Public comments provided varied perspectives on the impacts of logging on grizzly bears including: (1) Grizzly bears avoid recently logged forests (McClellan and Hovey 2001; Apps
Commenters also suggested that future management may worsen these impacts, including that: (1) The USFS could ignore habitat protections for grizzly bears that limit logging as previously occurred in Targhee NF; and (2) timber harvest lands adjacent to YNP (and in wildlife migration routes) will be designated Farm Bill priority lands, resulting in a less rigorous review. Suggestions on how to minimize these impacts included: (1) Mitigation for projects that impact secure habitat should not include land that has already been disturbed (
Timber is the primary resource extracted in grizzly bear habitat. Habitat quality (as a function of road density and timber harvest) has improved as a result of declining timber harvest, decreasing road construction, and increasing road decommissioning since the mid-1990s (USDA FS 2006a, pp. 156, 200). Timber harvest volumes and road construction have declined since the mid-1990s. Under the 1998 level of secure habitat, the GYE grizzly bear population has tripled in size and has stabilized from 2002–2014 as it has reached carrying capacity (Haroldson
Please see the
Concerns from commenters on management strategies for bear conservation on private lands included: (1) Questions as to how “take” prohibitions will apply to degradation of bear habitat on private lands since “take” includes habitat destruction, in addition to killing and harassing endangered animals; (2) suggestions to apply a “no net loss” policy for grizzly bear habitat on private lands; (3) suggestions that the Federal Government should use public lands to mitigate for impacts to grizzly bears that occur on private lands; and (4) suggestions that we need to consider how implementation of the 2016 Conservation Strategy will impact private landowners in the DMA, potentially adversely, since the process for meeting damage claims on real and personal property could be mired in delays. A peer-reviewer emphasized that education and mitigation will be key strategies in reducing the likelihood of “attractant sinks” (
In regard to potential privatization of Federal public land posing a threat to grizzly bears in the GYE, while changes to the protected status of grizzly bear habitat on these public lands is theoretically possible, such an outcome is highly improbable, especially at the scale that would be necessary to affect the viability of the GYE grizzly bear population. Although Doak and Cutler (2014a, p. 313) graph the increase in rural population trends from 1975 to 2005, they do not include rural population trends in their modeling of population trends in the GYE (see Issues 28 and 29 for discussion on a rebuttal to Doak and Cutler 2014a).
Suitable habitat excludes areas of increased mortality risk (
Limits on developing private lands to reduce conflicts with resident wildlife are the responsibility of the counties and the States, both of which have representatives on the YGCC; the Service has no direct authority over private lands. As previously stated, section 9 take prohibitions of the Act will no longer apply after this final rule goes into effect. Because a disproportionate number of grizzly bear-human conflicts occur at site developments on private lands (see Servheen
Conversely, substantive comments in opposition to hunting covered a range of issues, including that: (1) There is a lack of scientific data to support hunting and discount it as a substantial threat because it will be adding to the current levels of human-caused mortality that will not decline after delisting; (2) we did not adequately consider how hunting could impact the grizzly bear population given the species' slow reproductive cycles; (3) we should institute a 5- to 10-year moratorium on hunting after delisting to allow the grizzly bear population to reach at least 850 to 1,000 bears and there is a self-sustaining population outside the DMA, to see how State management impacts populations, and to allow for additional research on the potential impacts of a hunt; (4) hunting could cause an increase in immigration of new males that result in female avoidance via the use of less suitable habitat and thus smaller litter sizes, as well as those males committing infanticide, further depressing population numbers; (5) hunting could negatively impact grizzly bear behavior including orphaning of young and the disruption of activity patterns during denning; (6) hunting is an ineffective management tool, noting that it could lead to inbreeding and eventual extinction, hunters are likely to target the largest, fittest animals, rather than conflict bears, and that there is no evidence that hunting bears will increase grizzly bears' fear of humans; (7) States will have incentive to allow regular exceedance of grizzly bear mortality limits in order to maximize numbers of moose and elk for ungulate hunters; and (8) hunting could erode support for wildlife recovery.
We appreciate that many commenters have concerns regarding hunting of grizzly bears. Hunting is a discretionary mortality source that will occur only if mortality limits from all other causes have not been exceeded (YES 2016a, pp. 33–50). Because the sustainable mortality limits for independent males and females include mortalities from all sources (YES 2016a, p. 36), including hunting, and are applied within the DMA, hunting should never threaten the GYE grizzly bear population. Hunting permits will not be issued by the States if mortality limits are exceeded.
Hunting is regulated by the States who will again have management authority and jurisdiction to regulate any future hunting when this final rule goes into effect as discussed in
The limited hunting that may occur in the GYE if States choose to institute a hunt will be carefully controlled and would be unlikely to affect population dynamics. Some evidence of infanticide has been found in North American and European brown bear populations (McLellan 1994, pp. 15–16; Swenson
Although disturbances caused by hunting during denning may have negative effects on individual survival and reproduction (Swenson
In regard to hunting being an ineffective management tool, research by Swenson (1999, pp. 159–160) showed that brown bears were more wary of humans in areas where brown bear hunting occurred. To our knowledge, there is no data or information that hunting would decrease the overall fitness of individuals in the GYE grizzly bear population. Hunting can be used as a compensatory mortality source, targeting bears that would otherwise be removed by management action. However, as explained above, States will authorize hunting only as long as the overall mortality limits are not exceeded. The IGBST and State agencies collect data on grizzly bear-human conflicts and will continue to do so after delisting. These data are reported and displayed spatially in the IGBST's Annual Report. Any changes in the frequency, location, or nature of grizzly bear-human conflicts would be detected. State regulations (see
See Issue 40 for the definition of secure habitat; the risk of human-grizzly bear conflicts is reduced in secure habitat as a result of habitat management. However, hunting may occur in secure habitat where authorized by applicable Federal and State laws and will be limited by the applicable annual mortality thresholds (see table 1). Hunt areas and hunt area boundaries outside NPS and Tribal lands will be addressed in State hunting regulations, which are under the purview of the State Fish and Game Commissions. See
The total annual mortality limits inside the DMA by definition include any grizzly bear legally harvested on NPS inholdings. Any grizzly bears occupying private land inholdings within NPS boundaries are inside the DMA and are a part of both the annual population estimate and annual mortality limits, and as such, were explicitly considered during the analysis conducted in the preparation of this final rule.
The management of conflict bears within the GYE grizzly bear DPS boundaries will be based upon existing laws and authorities of State wildlife agencies and Federal land management agencies, and directed by protocols established in the 2016 Conservation Strategy and State management plans. Wyoming has indicated that they intend to “emphasize harvest in high conflict areas which typically occur a significant distance from National Park boundaries” (Mead 2016,
A number of commenters requested additional clarification in our mortality limits, such as: (1) An explanation on uncertainty around estimated mortality limits; (2) “what point within the 95 percent confidence interval the population size estimate refers” when discussing mortality rates; (3) what the mortality rate would be at population levels less than 674 bears (
Commenters worried that the proposed mortality limits could be easily exceeded (especially with hunting) and could lead to population declines because: (1) Undetected population declines could result from male bears being killed nearly twice as often as female bears; (2) models run by commenters show high probabilities of population decline below 500 bears with our proposed mortality limit framework, declines that could go undetected because of our insensitive population estimates based on females with cubs-of-the-year; (3) it will be difficult to close the hunting season when total mortality limits are reached because as many as half of grizzly bear mortalities occur in non-telemetered bears and are unknown (McLellan
We received several comments from the public suggesting adjustments to our proposed mortality limits including: (1) Mortality limits should be more conservative to account for bias associated with the population size and trend and potential threats from an expanding urban-wildland interface; (2) mortality limits should be set at the lower end of the confidence interval because the use of average estimates for vital rates, mortality rates, and population size means there is a 50 percent chance that mortality limits are too high and unsustainable; (3) cumulative annual mortality should be indexed monthly or seasonally to alert managers if mortality limits may be exceeded, with a trigger to stop discretionary mortality for the year; (4) discretionary mortality should cease when the population estimate is less than 674 rather than less than 600 bears; (5) if discretionary mortality is allowed at less than 674 bears, then total human-caused mortality should be at the threshold proposed in the 2007 Recovery Plan: Supplement to the Demographic Recovery Criteria; (6) hunting should halt when the lower bound of the 95 percent confidence interval of the population estimate is less than 600 bears; and (7) only a fraction of the estimated population available for discretionary mortality should be harvested to avoid overharvest due to uncertainty in population size, a strategy known as proportional threshold harvesting. Peer-reviewers also proposed how to adjust mortality limits in the future, including: (1) Discretionary mortality should change in response to potential changes in sex-age classes; and (2) hunting limits should consider annual changes in environmental conditions (
Whereas the IGBST is currently investigating the power of the Chao2 technique to assess how soon we can detect a change in population trend may be reached under the 9 percent and 10 percent scenarios, and how far the population may already be below the objective of 674 when this is detected, the premise for this adaptive management approach is well established in the literature. There is uncertainty around the mortality estimates due to unknown/unreported mortalities, but YES managers expressed a desire to rely on the central tendency of the data rather than reporting credible intervals as it would substantially complicate implementation of mortality monitoring (see Issue 33). Given that the Chao2 estimator underestimates population size, particularly at higher densities (Schwartz
On the issue of the 50 percent chance that mortality limits are unsustainable, this is correct if mortality limits are reached every year. Decisions whether to set the mortality limits at the lower end of the confidence interval on the population estimate or based on the point estimate itself are mostly policy issues; from a scientific standpoint, however, there is justification for basing management decisions on the central tendency of the data,
In response to comments about the potential to overshoot the population objective, see Issue 19. There is indeed a lag time and, thus, the potential for the population to drop below the long-term average of 674. The States have indicated that they will manage the population around the long-term average, and we recognize that the population abundance will vary above and below that point estimate. IGBST is currently investigating the power to detect when a population objective has been reached and by the time it is detected, the degree to which the population objective may be exceeded in terms of time and population size. The determination of when mortality thresholds are reached is based on total mortality, which includes a statistical estimate of the number of unknown/unreported mortalities. The IGBST uses a similar method as McLellan
In response to the suggestion of a monthly or seasonal mortality index, the IGBST already summarize mortalities on a continuous basis (
In response to concerns that the population estimate will not detect a decline because males will be killed at nearly twice the rate as female bears and that population estimates will be based on the entire ecosystem while hunting occurs only outside of National Parks, the IGBST uses multiple techniques for monitoring, including Chao2. Although the model-averaged Chao2 technique would not detect changes in the male subpopulation, the rates and ratios we use to derive a total population estimate are based on our known-fate analyses. The sample of radio-monitored bears (females and males) will allow the IGBST to update these rates and ratios if they change, which would be reflected in the total population estimate. If male survival declines, this would lead to lower estimates of a total population size through changes in the sex ratio, which would eventually change mortality thresholds as specified in this final rule and the 2016 Conservation Strategy. Whereas hunting mortality would occur only outside the parks, mortality management is based on the notion that grizzly bears in the GYE population form a single population, within which densities vary naturally due to differences in habitat quality, habitat security, etc. Thus, some areas currently already experience different levels of mortality. If hunting is added as a mortality source, it may change these spatial patterns, potentially changing source-sink dynamics, but total mortality would be managed so that it remains sustainable for the population as a whole. This system provides management flexibility, as it provides agencies with a mechanism to address, for example, conflict issues in certain areas while allowing potential connectivity in other areas.
Several of the more detailed assessments proposed by commenters, including the idea of an EIS, are difficult to achieve given current data. Assessing the impacts of different mortality thresholds on dispersal, for example, would be a substantial challenge and require new, concerted research efforts. Whereas such analyses would provide interesting ecological
From 2002 to 2014, hunting would have been allowed for independent males in 10 out of 13 years and for independent females in 7 out of 13 years. The average annual allowable allocation for discretionary mortality would have been 19 independent males and 4 independent females. Edits were made to all three documents for consistency in the mortality limits and to clarify that they apply annually. All three documents were updated to reflect that at an estimated population size of less than or equal to 674 bears the mortality limit for independent females and dependent young is less than 7.6 percent and not less than or equal to 7.6 percent.
Annually, mortality limits will be applied as set forth in table 2 of this final rule based on the previous year's population estimate. Mortality limits will be adjusted in the future based on reviews of vital rates by the IGBST every 5 to 10 years, or at any point a Biology and Monitoring Review is required. The current State regulations to maintain the mortality limits within those in table 2 will compensate for annual fluctuations in natural or other causes of mortality. These regulations include: Suspending grizzly bear hunting within the DMA if total mortality limits for any sex/age class are met at any time during the year; in a given year, discretionary mortality will be allowed only if non-discretionary mortality does not meet or exceed allowable total mortality limits for that year; and any mortality that exceeds allowable total mortality limits in any year will be subtracted from that age/sex class allowable total mortality limits for the following year.
While we respect concerns from commenters about the spatial distribution of discretionary mortality, it is outside of the scope of our decision-making authority. Hunt areas will be developed by the States in order to direct harvest where appropriate, if hunting occurs (YES 2016a, p. 20; WGFD 2016, p. 16); see Issues 64 and 65 for further discussion. There are a number of ways in which population mortality thresholds can be set and measured. The IGBST has spent considerable effort to develop the current system, with a number of workshops over the past decade and associated scientific documents (
In response to suggestions to change the mortality limits and management framework, we recognize that it is unrealistic to expect to manage down to a single individual. The States agreed to manage the GYE grizzly bear population within the DMA, to
A few commenters weighed in on whether they thought the act of delisting would increase or decrease conflict.
Many commenters believed we presented an inadequate discussion of methods to manage and reduce conflict; they suggested the following improvements or additions prior to delisting: (1) Improved education programs that aim to change attitudes and behaviors of people living in grizzly bear country in order to increase risk tolerance and improve willingness to share habitat (see Issue 108); (2) limits on, or elimination of, ungulate hunting to reduce defense of life and property kills; (3) incentives for hunters to retreat from downed game; (4) additional law enforcement and field staff; (5) encouragement and funding of alternatives to lethal control of bears (including additional discussion of such methods in State management plans) since lethal control does not increase public tolerance or promote avoidance of future conflict; (6) preparation of a Grizzly Bear Management Relocation Plan with pre-arranged relocation sites; (7) discussion on how managers should resolve conflicts on Tribal lands; and (8) managing for higher wild ungulate populations to decrease livestock depredation. A peer-reviewer suggested funding for programs that reduce bear attractants on public and private lands.
Commenters also provided suggestions on how to revise State management plans or the 2016 Conservation Strategy to better address conflict management, such as: (1) Explaining the 33 recommendations to abate grizzly bear conflicts in a 2006 IGBST report and incorporating these into Wyoming's grizzly bear management plan; (2) including in the 2016 Conservation Strategy the admonition that managers and citizens should not “reward” or “encourage” bears around roads, campgrounds, cities, or landfills; and (3) changes to the nuisance bear standards.
Peer-reviewers also presented a number of additional analyses that could bolster our discussion of human-bear conflict, including: (1) A review of “the social aspects of managing large predators;” (2) using NDVI data (satellite imagery) to understand bear distribution and how these distributions relate to human-bear conflict; (3) tracking of relocated animals to assess the efficacy of relocating problem bears; and (4) additional analysis on how to change mortality management techniques as the number of people living in and recreating in the GYE increases. Peer-reviewers also requested an explanation of how conflict bears will be treated inside versus outside the PCA.
It is not unexpected that the number of conflicts would increase as bears increasingly encounter humans and livestock outside the PCA, where human access is generally greater than within the PCA. However, there is no evidence that bears are leaving the core of the ecosystem as a result of changes in food resources (see Issue 38 for further discussion). Areas with a high risk of grizzly bear mortality due to repeated conflict with humans or livestock were not considered suitable habitat and are not included in our quantification of habitat available to meet the needs of a recovered grizzly bear population (see Issue 40). The IGBST 2009 report (p. 3) identifies three main causes for increased known and probable mortalities, predation, hunting (defense of life and mistaken identity), and management removal as a result of cattle depredation. The States have invested considerable resources in hunter education to reduce mortalities as a result of mistaken identity and defense of life (see Issue 108 for further details). In addition, increased I&E efforts have been made to reduce attractants (YES 2016a, pp. 86–95). The IGBST maintains a database of known and probable GYE grizzly bear mortalities, including cause (see Issue 34). In addition, potential changes in verified conflicts will continue to be documented and evaluated, as well as annual evaluations of the population and mortality, and the YGCC can make modifications to the 2016 Conservation Strategy if they deem it is necessary to maintain a recovered grizzly bear population within the GYE.
We agree that nonlethal control of grizzly bears is the preferred option for managing human-bear conflict. However, no single management tool can resolve all issues associated with human-bear conflict. Therefore, State, Tribal, and Federal managers will continue to use a combination of management options, including nonlethal forms of management. The current methods we use to reduce human-caused grizzly bear mortality by preventing and addressing conflicts in a systematic, fair, and prompt manner have accommodated an increasing GYE grizzly bear population and range since 2002.
As previously noted, the 2016 Conservation Strategy identifies, defines, and requires adequate post-delisting monitoring to maintain a healthy GYE grizzly bear population, with clear State and Federal management responses if deviations occur. Agreed-upon total mortality limits will ensure that mortality will continue to be managed in accordance with recovery criteria. Notably, more than two-thirds of all suggested funding to implement the 2016 Conservation Strategy is designated to managing conflicts and conducting outreach to minimize conflicts, especially by decreasing attractants on private lands. Nonlethal means of addressing conflict such as relocation of conflict bears are included in the 2016 Conservation Strategy.
The 2016 Conservation Strategy prioritizes I&E programs to minimize human-bear conflicts. These programs work to change human perceptions, and beliefs about grizzly bears and Federal regulation of public lands. For example, hunter education courses and other educational materials strongly encourage hunters to carry bear spray, and information and education programs educate the public about potential grizzly bear attractants and how to properly store them. A stable to increasing GYE grizzly bear population, despite large increases in people living and recreating in the GYE over the last
In addition to public I&E, the States have implemented programs to help reduce conflicts with people including: Livestock carcass removal, electric fencing subsidies for apiaries and orchards, and cost-sharing for bear-resistant garbage bins. Removal of conflict bears is still sometimes necessary. Removal is lethal to the individual bear, but it minimizes illegal killing of bears that might otherwise occur if people are encouraged to “take matters into their own hands,” and it thus serves a long-term conservation purpose. Bear removal also provides an opportunity to educate the public about how to avoid conflicts and thus limits removals in the future. It encourages tolerance of grizzly bears by responding promptly and effectively when bears pose a threat to public safety.
Human-grizzly bear conflicts are reported by jurisdiction in the IGBST annual reports. The IGBST continues to conduct research on many aspects of the GYE grizzly bear and their ecosystem. Problem bears are radio-tracked when they are relocated, and the IGBST plans to assess the efficacy of relocating problem bears in the near future. The lower survival rates of relocated bears suggests that relocation should be used conservatively; however, relocated female bears have contributed to the population and should be used as a viable management alternative to removal from the population (Brannon 1987, p. 572; Blanchard and Knight 1995, p. 564). The 2016 Conservation Strategy (YES 2016a, pp. 86–91) and the State management plans detail the conflict bear standards to be applied to the GYE grizzly bear DPS once delisted. Inside the PCA, grizzly bears will be given a higher priority whereas “outside the PCA and National Park lands more consideration will be given to existing human uses.” Conflict bear removals will be counted against the mortality limits set forth in this rule and the 2016 Conservation Strategy.
The specific statement by the commenter about bears that could be incidentally killed is in regard to an “Incidental Take Statement” that is a projected potential mortality to grizzly bears that could occur within a project area, and rather is not something that is suggested or purported to occur. Regardless, Incidental Take Statements would no longer apply after the bear is delisted.
The Convention is an international treaty designed to regulate international trade in certain animal and plant species that are now, or potentially may become, threatened with extinction. Under this treaty, countries work together to regulate the international trade of species and ensure that this trade is not detrimental to the survival of wild populations. Species are listed in one of three Appendices to CITES, each conferring a different level of regulation and requiring CITES permits or certificates. Any trade in protected plant and animal species should be sustainable, based on sound biological understanding and principles. An Appendix I species is one “threatened with extinction and provides the greatest level of protection, including restrictions on commercial trade.” An Appendix II species is one “although currently not threatened with extinction, may become so without trade controls.” An Appendix III species is one for which a range country has asked other countries to help in controlling international trade. See
All international trade in brown bears is restricted by either CITES Appendix I (in parts of central Asia) or CITES Appendix II. All U.S. and Canadian populations are included in Appendix II. Even populations not at risk (
The McKittrick Policy requires proof of intent, that the individual knowingly killed a listed species under the Act, for Federal prosecution. However, intent is not necessary for prosecution under State law. During an investigation, the investigative officers usually meet with both local and Federal attorneys to decide if prosecution will be more successful under State or Federal jurisdiction. In most situations where the U.S. Attorney has declined prosecution conflicts, the States have taken over those prosecutions through State courts. There have been successful prosecutions under both Federal and State laws. For example, in 2015 a man knowingly shot at a grizzly bear in the Cabinet-Yaak ecosystem, was prosecuted in Federal court, and was sentenced to 6 months in Federal prison. Under Idaho State jurisdiction, a man was successfully prosecuted in a 2014 grizzly bear killing after making a false claim of self-defense and was assessed a penalty of a $1,400 fine and civil penalties ($500 of which was suspended), 30 days suspended jail time, 1 year revocation of his hunting license, and 2 years unsupervised probation. H.R. 4751, The Local Enforcement for Local Lands Act of 2016, was not enacted. And lastly, law enforcement officers cannot comment on ongoing cases; therefore, it is not appropriate to publicly share the details of grizzly bear mortalities that are under investigation.
Another commenter noted that YNP currently includes the outdated 2007 Conservation Strategy in its Superintendent's Compendium; this commenter requested additional clarity on whether the 2016 Superintendent's Compendium would incorporate the provisions in the revised 2016 Conservation Strategy. Other commenters questioned whether land use plans, State management plans, MOAs, and conservation strategies qualify as regulatory mechanisms since they are not binding and enforceable.
On-the-ground habitat protections for GYE grizzly bears have not changed since the 2011 decision, and the GYE bear population has stabilized. The NPS and the USFS continue to manage 98 percent of the land within the Primary Conservation Area. These regulatory mechanisms have been proven to be effective. The habitat management standards detailed in the 2016 Conservation Strategy (YES 2016a, pp. 54–85) to reduce human-caused mortality have already been implemented through National Park Compendia (YNP 2014b, p. 18; GTNP and JDR 2016, p. 3) and the 2006 Forest Plan Amendment (USDA FS 2006b, entire). Changes to both the Compendia and the Forest Plan amendments per the revised 2016 Conservation Strategy are considered minor and of little biological significance and, therefore, largely the same as previous regulatory mechanisms. For example, the method to measure motorized route densities was updated, based on the best available science, so that the moving window approach calculates the total route length instead of the previous method of absence or presence of motorized routes, which often over- or under-estimated total routes (for further details see YES 2016b, Appendix E). Both agencies are signatories to the 2016 Conservation Strategy, which means that current habitat management standards will be taken into account in decision-making and that human-caused mortality will be monitored and controlled.
Section 4(b)(1)(A) of the Act requires us to make listing determinations based on the best available scientific and commercial data after taking into account the efforts of States and foreign nations, whether through predatory control, protection of habitat and food supply, or other conservation practices. The Ninth Circuit did not determine whether the 2007 Conservation Strategy was a “regulatory mechanism” under
In terms of regulatory mechanisms to manage mortality, we are confident that the GYE grizzly bear population will be managed according to the demographic recovery criteria set forth in the 2016 Conservation Strategy and agreed to by the States in their Tri-State MOA. This framework ensures that mortality from all sources will be monitored and controlled by the States to ensure consistency with recovery criteria. Idaho, Montana, and Wyoming have capably managed other big game species (
As to the comment that existing regulatory mechanisms must be both final and “proven to be effective,” please see our response above regarding the effectiveness of NPS and USFS. The Service's Policy for the Evaluation of Conservation Efforts when Making Listing Decisions is not applicable to delisting determinations (68 FR 15100, March 28, 2003).
Commenters supportive of State management expressed confidence in the States' commitment and abilities to maintain a recovered population of grizzly bears, and State management will be more nimble, efficient, adaptive, and responsive to local stakeholder needs than Federal management. The State agencies themselves, in addition to public commenters, expressed confidence in their abilities to maintain a recovered population of grizzly bears, citing financial and staffing commitments to do so.
Ongoing review and evaluation of the effectiveness of the Strategy is the responsibility of the State, Tribal, and Federal managers in the GYE and will occur at least every 5 years, allowing public comment in the updating process. Any significant departure from agreed-upon Federal and/or State management plans will trigger a status review, and, if data indicate that grizzly bears in the GYE are in need of protection under the Act, we can initiate listing procedures, including, if appropriate, emergency listing.
In response to concerns about the ordinances, regulations, or resolutions passed by county governments in Wyoming regarding the presence or distribution of grizzly bears in these counties, we requested a letter from the Wyoming Attorney General's office clarifying the authority of counties in Wyoming to legislate in the area of grizzly bear management. The Wyoming Attorney General's office's response, dated August 8, 2006, states on p. 2, “ ‘* * * as an arm of the State, the county has only those powers expressly granted by the constitution or statutory law or reasonably implied from the powers granted.’
Commenters also suggested the Service require additional content in State regulations prior to proceeding with a delisting rule, such as that: (1) An “independent panel of ecological researchers” determine the total number of limited hunting permits; (2) managers use a lottery system to distribute these few licenses; (3) all three States require 12-hour reporting requirements as opposed to 24-hour reporting requirements; (4) establishment of prohibitions on the killing of any bear accompanied by other bears; (5) inclusion of provisions shutting down all hunting for the season once quotas for female grizzly bears are met; (6) States coordinate season dates through the YGCC and time seasons to minimize risks to females; (7) inclusion of provisions requiring proper food storage and handling of hunter-killed carcasses; (8) provision of subsidies for bear-proof garbage containers to increase affordability and use; and (9) State quotas should not change with intra-annual fluctuations in local population levels. On the other hand, another commenter suggested that the Service would fail to honor State wildlife laws if additional provisions are required in relation to grizzly bears.
The State agencies took issue with the fact that the proposed rule prematurely assumed the three States would establish hunting seasons and suggested that the Act does not “require states to establish hunting seasons before delisting can occur.” They thought that, by requiring specific provisions in State hunting regulations, the Service “created a public expectation that hunting will occur as soon as delisting is finalized.”
Conversely, some commenters believed these five requirements were reasonable and adequate. These commenters referred especially to our fourth requirement as a key safeguard in ensuring the continued recovery of grizzly bears and preventing exceedance of mortality limits; this requirement ensures that the number of grizzly bears available for hunting fluctuates depending on the number of bears that have already died.
While State regulations include no prohibition on the taking of females or the taking of cubs, regulations do impose mortality limits on the numbers of females, males, and total bears taken, and prohibit the taking of female grizzly bears with dependent young. Mortality limits take into account all forms of mortality, including management removals, illegal kills, self-defense, calculated unknown/unreported mortalities, natural mortalities, and other causes such as vehicle collisions.
Under State management, any open hunting season will be closed within 24 hours of the total mortality limit being met by Idaho and Wyoming (Idaho Fish and Game Commission 2016, p. 2; Wyoming Game and Fish Commission 2016, p. 67–2) and of the harvest limits being met by Montana (MFWP 2016, p. 4). If a hunter kills a female by mistake and causes an exceedance of the total allowable mortality limits for female bears, managers will subtract this mortality from the total allowable number of kills in the subsequent year, ensuring the number of female grizzly bear mortalities stays in check. Any reported cubs orphaned due to the human-caused mortality of the mother are counted as probable mortalities in the mortality database maintained by IGBST and will count towards the dependent mortality threshold. We conclude that the provisions outlined in the 2016 Conservation Strategy and the Tri-State MOA are adequate to ensure that the three States coordinate regularly to reconcile mortality statistics, plan appropriate conservation actions, adapt management, and generally ensure the continued recovery of grizzly bears in the GYE. Please see Issues 68 and 89, as well as
We agree with States' comments that the Act does not require States to establish hunting seasons before delisting can occur, and we regret any false expectations our proposed rule may have established. However, our intent in requesting the hunting regulations prior to delisting was to clearly demonstrate adequate regulatory mechanisms that would ameliorate such a potential threat if the States chose to establish hunting seasons, and to ensure that the GYE grizzly bear population will remain recovered if States decided to implement hunting seasons. The willingness on the part of the three States to implement regulations prior to a final decision on their part to implement hunting seasons is further testament to their commitment to manage the species in a way to ensure it remains recovered post delisting.
In
Since then the population has increased in abundance and distribution, and additional regulatory mechanisms have been adopted by State agencies to manage the GYE DPS at the ecosystem level, to ensure communication is facilitated annually to improve management, and to regulate any future hunting in a way that would ensure the species remains recovered. The Tri-State MOA (Wyoming Game and Fish Commission
• The Parties (referring to the three States) will support the IGBST in the annual monitoring of the GYE grizzly bear population.
• The Parties will meet annually in the month of January to review population monitoring data supplied by IGBST and collectively establish discretionary mortality limits for regulated harvest for each jurisdiction (MT, ID, WY) in the DMA, so DMA thresholds are not exceeded, based upon the following allocation protocol (YES 2016a, p. 46).
• The Parties will confer with the NPS and USFS annually. The Parties will invite representatives of both GYE National Parks, the NPS regional office, and GYE USFS Forest Supervisors to attend the annual meeting.
• The Parties will monitor mortality throughout the year, and will communicate and coordinate with each other and with Federal land management agencies as appropriate to minimize the likelihood of exceeding mortality limits.
It is true that States cannot compel Federal agencies to manage their lands in accordance with their State plans. However, as participants in the 2016 Conservation Strategy, both State and Federal agencies have agreed to carry out all its provisions, including the appended State plans. The Tri-state MOA directly incorporates the 2007 Conservation Strategy instead of the 2016 Conservation Strategy. The reason for this is that the MOA was signed before the 2016 Conservation Strategy was complete, but the MOA incorporates aspects of the 2016 Conservation Strategy. In addition, the MOA states that “The Parties intend this MOA to be consistent . . . with revisions to these documents made in conjunction with the delisting process.”
Commenters worried that no entity is required to act if States exceed mortality limits and that States are not compelled to monitor the grizzly bear population. To enhance enforcement of mortality limits, commenters suggested making the 2016 Conservation Strategy mandatory and not “voluntary” and instituting penalties for States if they “exceed reasonable mortality thresholds.”
Many commenters provided detailed concerns about the content of regulatory mechanisms (though these concerns were not specific to any State regulation in particular). These included that: (1) Spring hunts are irresponsible since “it is impossible to know how many bears will be killed later in the year through management removals, poaching, accidents or natural causes;” (2) hunters would be able to kill hibernating grizzly bears due to provisions in the Sportsmen's Heritage and Recreational Enhancement (SHARE) Act of 2015; (3) States have not considered “what to do with the wounded bears that will escape;” (4) plans do not explain how the various entities will monitor mortality, revise limits, and prevent decreases in the levels of “scientific oversight” of the population; and (5) regulations lacked safeguards to prevent hunters, outfitters, or poachers from using radio collar frequencies to find collared bears.
One commenter suggested that the grizzly bear hunting regulations are too stringent and that normal licensing and hunting procedures should apply to any grizzly bear hunt (
Commenters also noted the need for bans on bear trapping and bear hunting with hounds in all three States (both within and outside the PCA) prior to delisting. Commenters worried that hunting with dogs leads to conflicts between dogs and grizzly bears and can attract grizzly bears to people. Commenters also expressed that trapping endangers humans and can cause severe damage to bears; this commenter asked if there is an Animal Care and Use Committee that has recently reviewed trapping in the GYE. One State suggested that a restriction on bear trapping should not be a foundation for grizzly bear delisting and that we remove the language in the rule that discusses bear trapping.
Commenters questioned whether each State had regulatory mechanisms that met the elements that we identified in our proposed rule as necessary for delisting if the States decide to establish hunting seasons. State agencies commented that the Service exceeded our authority by identifying these requirements before the States decided whether to establish hunting seasons.
Commenters claimed various State regulatory mechanisms were inadequate based on public notice or involvement, or because they were the subject of litigation. Commenters took issue with the contents of State regulatory mechanisms, claiming they did not explicitly limit discretionary mortality, they allowed preemptive or unlicensed killing of bears, or they allowed killing bears causing conflict with livestock. Commenters questioned the State Commission's qualifications to set management objectives and their commitment to honoring limits, claiming prior Commission actions had harmed grizzly bears or other wildlife, such as wolves and bison.
Commenters claimed that the Tri-State MOA was inadequate, stating that it was voluntary, did not reflect all revisions in the 2016 Conservation Strategy, or otherwise did not adequately monitor bears or limit mortality.
Commenters claimed that Idaho's proclamation was not a regulatory mechanism and that various aspects of Idaho's, Montana's, or Wyoming's hunting frameworks were not final. Commenters questioned the States' abilities to enforce hunting closures and violations. Commenters questioned the timing and location of potential hunts, including their relationship to National Park boundaries, cutworm moth sites, connectivity, vulnerability of cubs and attending females, vulnerability during other big game hunts, or bear movement between hunt areas.
Commenters claimed that Montana, Idaho, or Wyoming management plans were flawed because they contained outdated factual information, did not include recent science, did not include the most current population and mortality information, had inconsistencies with other documents, did not reflect all revisions in the 2016 Conservation Strategy, or did not fully commit to the 2016 Conservation Strategy. Commenters criticized Montana's plan for not supporting the State's claim of the importance of hunting for increasing human safety. Commenters criticized Idaho's plan for not mentioning the DMA. Commenters criticized Wyoming's management plan because its hunting fees were too low, because it had not defined the term “human habituated” to ensure that only those bears posing a safety risk (and not merely bears near developed areas) will be subject to removal, and because it had not explicitly described how it would deal with orphaned cubs. One commenter suggested Wyoming adopt a “once-in-a-lifetime” limitation for grizzly bear hunting.
We reached the conclusion that State regulatory mechanisms are adequate to protect the recovered population of GYE grizzly bears and that they do contain the general elements we required in our proposed delisting rule. Our analysis is set forth in the final rule, and we refer commenters to that discussion under
To the extent that commenters objected to public notice and comment procedures utilized by the States in adopting their respective regulatory frameworks, we refer the commenters to the administrative procedural requirements that each State must follow under State law. Responding to the specific comment about Idaho's proclamations, we note that Idaho Fish and Game proclamations, orders, and director orders carry the force and effect of law under Idaho Code 36–105(3) and 36–106(6)(D).
As to the comment that hunting regulations are not final, we would not expect all State hunting regulations to be final because no decisions have been made to authorize hunting seasons in Idaho, Montana, or Wyoming. Furthermore, the process set forth in the
The States are governed by the Tri-State MOA and have agreed in writing to follow the 2016 Conservation Strategy. The Service's review of State actions is dependent on compliance with the regulatory measures required of each State (set forth in the proposed rule), and adherence to the population objectives in the Tri-State MOA and 2016 Conservation Strategy. Outside these requirements, States will have considerable latitude to design hunting seasons based on their own knowledge and expertise. The States have an incentive to manage bears based upon recovery criteria and the associated mortality limits in both the recovery criteria and the Conservation Strategy and are, therefore, expected to take into account the biological requirements necessary for successful management, including the locations of food sources, travel corridors, connectivity, NPS boundaries, etc. Recovery of the GYE DPS would not have occurred without the active participation, support, and leadership of Idaho, Montana, and Wyoming.
The Service has analyzed and reviewed State management of other species, like elk, deer, and black bears. Over decades, the States have demonstrated responsible and professional wildlife management of these species and have a proven track record of managing these and other species to population goals and unit targets. In the many discussions with our State partners, the Service has not encountered any situation or data that evidences an intent to deviate from these established wildlife management practices. This historical evaluation of other species informs the Service's conclusion that the suite of management principles and commitments can be reasonably considered in our overall delisting determination.
State management plans are useful because they help guide the State wildlife agencies in achieving management objectives, including population goals. The Service duly considers them in its analysis of a State's regulatory framework, as it is required to do under the Act. But management plans are not the only source of State management and control of wildlife populations. State management plans are just one of the many mechanisms the Service considered here. We understand that some commenters are disappointed that some State management plans for grizzly bears lack current data, but we look to other measures that are current and that will guide population management into the future. These include the State regulatory requirements, the Tri-State MOA, and the 2016 Conservation Strategy.
Other commenters provided input on the content of the 2016 Conservation Strategy, in addition to the suggestions and concerns raised in other issues (
Commenters also suggested potential additions to the 2016 Conservation Strategy, including: (1) Reiteration of the five elements our proposed rule stated must be in State regulation; (2) inclusion of frequently cited documents (
Commenters expressed particular concern about the States' financial and administrative capacity to manage and monitor grizzly bears after delisting. Concerns about adequacy of State funding included: (1) A reminder that any Federal financial support would run dry after 5 years post-delisting; (2) confusion as to where States would find funds to make up this difference; (3) claims that delisting would cost an additional $1.2 million per year on top of current expenditures on recovery and would preclude States from pursuing certain funding opportunities (like Section 6 grants); (4) claims that funds generated from the sale of grizzly bear hunting licenses will not provide adequate funding to the States to manage grizzly bears; (5) worries that the Hicks Bill would relieve Wyoming of any obligation to pay to protect bears from illegal mortality; and (6) suggestions that States currently lack sufficient funds to combat poaching and this will only worsen in a delisted environment. Some commenters expressed concern that the States do not have sufficient staff to respond to hunting violations in a timely manner, close hunting seasons immediately upon meeting mortality thresholds, enforce adequate penalties on poachers, and conduct research and monitoring on grizzly bears to ensure effective adaptive management.
Commenters provided suggestions for ways to enhance confidence in State financial capacity for grizzly bear conservation, including: (1) State plans should clearly identify how they will fund grizzly bear monitoring, conservation, conflict management, and connectivity facilitation; (2) the Federal Government should provide sufficient financial support for State field biologists, State management of grizzly bears, and programs to minimize bear conflict; (3) decision-makers should develop a means to share tourism dollars with State wildlife managers; and (4) managers should revive the idea of an endowment fund for the 2016 Conservation Strategy and post-delisting management, which had been part of recovery and delisting discussions for more than 20 years.
The 2016 Conservation Strategy reflects the States' commitment to future management and monitoring of grizzly bears. The States have been funding and performing the majority of grizzly bear recovery, management, monitoring, and enforcement efforts within their jurisdictions for decades; for example, the WGFD has expended more than $40,000,000 for grizzly bear recovery from 1980 to 2015. There is not a reasonable basis to believe the States will not adequately fund grizzly bear management of a delisted population. Claims that it would cost an additional $1.2 million/year are not supported by empirical data.
On April 12, 2017, the Secretary of the Interior issued a Memorandum, “Managing Grants, Cooperative Agreements, and Other Significant Decisions” establishing a new review process for Wildlife and Sport Fish Restoration Program grants in the amount of $100,000 or more. This new process may affect States, however, we do not think this memorandum will affect the capacity to conduct grizzly bear post-delisting monitoring because these procedures are temporary and do not reduce the amount of funding available for assistance.
The best available information does not support commenters' claims that the States lack the ability to monitor, manage, and respond to violations as States' have long demonstrated their expertise in managing wildlife within their borders. For example, Idaho successfully prosecuted a violation for unlawful take of grizzly bears in the GYE under State law even while the grizzly bear was listed; see
By signing the 2016 Conservation Strategy, participating agencies have committed to implementing the protective features that are within their discretion and authority, and to secure adequate funding for implementation. Lack of adequate funding to carry out the 2016 Conservation Strategy grizzly bear management commitments could trigger a status review for possible re-listing under the Act.
We received a few comments on the first Service Status Review trigger in the proposed rule, including: (1) It is unclear what “significantly” means in this trigger; (2) this trigger could reduce the “flexibility that any management of any ecosystem requires” by constraining the ability of States to update and adapt management plans and strategies; and (3) it is important to keep this trigger, despite State desires to remove it, “so that future changes cannot lead to a decline in the grizzly bear population.”
Many commenters suggested increasing the population size in the second Service Status Review trigger so we would initiate a Service Status Review if the Chao2 population estimate fell below 600 bears in any given year. Other commenters suggested that the Service should determine whether the lower bound of the 95 percent confidence interval for the annual population estimate violates these requirements when assessing this trigger (as opposed to using the average).
Commenters also weighed in on the
Additional suggested triggers for a Service Status Review included those related to: A lack of funding; habitat standards/habitat degradation and monitoring protocols, including food monitoring (Johnson
Some commenters expressed concern about the meaningfulness of our triggers, whether the Service would be willing to re-list the grizzly bear, should it become necessary, and whether the Service could re-list in a timely manner before populations decline further (given the usually lengthy process required for a listing determination). Some commenters expressed concern that the triggers do not require the Service or any other parties to act if they are violated. One commenter suggested that re-listing should be automatic to avoid these delays or failures to act. One commenter asked what recourse the Service had if other agencies did not abide by the agreements. One commenter asked how the Service would determine whether a status review is “warranted” if an individual, organization, or YGCC were to petition for such a status review. Another commenter warned that the Service cannot use “the possibility of relisting as a justification for delisting,” based on past court decisions.
In response to comments on the
In response to comments on the
In response to the comments on the
In response to the comments requesting for additional triggers based on habitat or food monitoring, we consider the establishment of habitat thresholds for food sources to be unrealistic. As discussed in Issue 99, due to the natural annual variation in abundance and distribution in the four major food sources, there is no known way to calculate minimum threshold values for grizzly bear foods. The 1998 baseline will address these issues adequately through access management and limitations on site development. Managers will use an adaptive management approach that addresses poor food years with responsive management actions such as limiting grizzly bear mortality, increasing (I&E) efforts, and long-term habitat restoration (
The multiple indices used to monitor both bear foods and bear vital rates provide a dynamic and intensive data source to allow the agencies to respond to potential problems. The monitoring and adaptive management system described in the 2016 Conservation Strategy (YES 2016a, entire) ensures the maintenance of a recovered grizzly bear population in the GYE.
We agree that the mere possibility of re-listing is not an adequate regulatory mechanism. Re-listing cannot be an automatic function if the GYE grizzly bear population declines to the point where the protections of the Act become necessary because we are obligated to conduct rulemaking procedures, which include, among other things, an evaluation of threats as outlined in the Act and the APA. However, listing may be expedited if necessary through the Act's emergency listing procedures. Be that as it may, we remain confident that these provisions will not be necessary due to the species' current and foreseeable viability, as managed and monitored by the 2016 Conservation Strategy and Tri-State MOA.
While official reviews will be conducted only every 5 to 10 years, the IGBST will closely monitor the population annually, including estimating population size using the model-averaged Chao2 method, monitoring and reporting the distribution of reproducing females, and monitoring and reporting mortalities. Habitat variables will also be monitored annually, including livestock grazing, food availability, and ungulate populations, Yellowstone cutthroat trout, moth aggregation sites, and whitebark pine cone production and health. The IGBST could at any time recommend a Biology and Monitoring Review to the YGCC if they deem necessary based on annual monitoring results. Additionally, the Strategy outlines specific triggers for an IGBST Biology and Monitoring Review as well as a Service-initiated status review.
Many commenters and a peer-reviewer requested additional information on the adaptive process for revising the 2016 Conservation Strategy during its duration should the best available science indicate changes are warranted. One commenter hoped authors could include specific provisions in the 2016 Conservation Strategy requiring review and updating every 5 years or including language in the preamble explaining that the 2016 Conservation Strategy will evolve as new science becomes available.
Commenters also varied in their perspective on the proper Service role after delisting. Some commenters suggested the Service should have little to no role after delisting; one stated that after delisting “the Service must monitor, but not dictate, the state's or Tribes' management methodologies.” One commenter requested that we clarify that the 2016 Conservation Strategy is a cooperative agreement and that the Service's role is not to oversee management but to evaluate the five factors under the Act should it be necessary. Others suggested the proposed rule did not allow enough Federal involvement after delisting and urged more Service engagement in independent monitoring. Some commenters went so far as to suggest “management should continue to be the responsibility of the USFWS” and that the Service should use the preemption clause of the Constitution to invalidate any State or local laws that jeopardize grizzly bears. Another commenter simply requested that we explain and clarify the Service's role in grizzly bear management within the GYE after delisting.
Under the Act, we are required to show that threats to listed species have
For grizzly bears, our analysis under
We conclude that the Service's involvement in grizzly bear management, as described in this final rule, is appropriate in scope and is consistent with statutory requirements. After the delisting of grizzly bears in the GYE, the regulatory protections of the Act will be withdrawn but the Service will continue to evaluate the species' status through post-delisting monitoring as described in the interagency 2016 Conservation Strategy. Post-delisting monitoring will continue to include data collected by various State, Tribal, and Federal agencies under the 2016 Conservation Strategy; we are confident that such monitoring can continue to provide valid data on grizzly bear status, and conclude that monitoring programs do not need to be funded and implemented separately by the Service. Because grizzly bears are vulnerable to excessive human-caused mortality, the 2016 Conservation Strategy recognizes the need for active management under the jurisdiction and authority of the various Federal, State, and Tribal agencies to implement conservation measures intended to address the source of such mortality.
With continuing interagency cooperation in implementing the 2016 Conservation Strategy, we fully expect partners will maintain healthy grizzly bear populations in the GYE without the protections of the Act. As is the case for any non-listed species, the Service can conduct a status review at any time and is required to consider petitions for re-listing if ever received. Such a review will be triggered if population and mortality targets in the 2016 Conservation Strategy are consistently not met. Furthermore, although we conclude this will likely not be necessary, Section 4(g)(2) of the Act directs the Service to make prompt use of its emergency listing authority if necessary to prevent a significant risk to the well-being of the recovered population.
We anticipate that the Federal Government will continue to be involved in grizzly bear management after delisting. As discussed in the proposed rule, the NPS, USFS, and BLM are responsible for land management over much of the GYE, and will continue to be actively involved in interagency groups implementing the 2016 Conservation Strategy. Similarly, Federal scientists, such as those employed by the USGS, will continue to monitor the GYE grizzly bear population. The Service plans to remain informed about grizzly bear status and population trends, and to remain engaged with partners as the 2016 Conservation Strategy is implemented.
As discussed in the proposed rule, we conclude that limited and well-regulated harvest of grizzly bears can be compatible with meeting mortality targets under the 2016 Conservation Strategy, and thus maintaining a healthy population that does not require the Act's protections. The suggestion to designate grizzly bears as non-game and prohibit regulated harvest altogether is not necessary, nor is it within Federal control for most unlisted species. For example, brown bear hunting is a common and sustainable practice globally. When managed correctly, as discussed in the final rule, carefully regulated harvest can be a part of the greater conservation strategy.
Others suggested the 2016 Conservation Strategy should stay in place for much longer than 5 years. One commenter recommended a post-delisting monitoring period of 18 years based on grizzly bears' slow reproduction and vulnerability to habitat change, noting previous precedents for monitoring periods up to 20 years. One commenter stated that “it is critically important that the IGBST continue to be involved” with GYE grizzly bear recovery GYE for 10 or more years after delisting. Several commenters expressed that the Conservation Strategy should be in place “in perpetuity.”
Other commenters referenced revisions to the 2016 Conservation Strategy that clarify how it would remain in effect for the “foreseeable future.” In light of the above, commenters requested that we clarify how long the 2016 Conservation Strategy would remain in effect, how long monitoring would continue, and what would happen after that point. One commenter requested a definition of “foreseeable future.” Another commenter stated that common usage for “foreseeable future” was 100 years, similar to the timeframe of a forest rotation, and recommended monitoring over two rotations to allow their effects to manifest. Another commenter agreed that management was required over the foreseeable future because the grizzly bear is a conservation-reliant species.
Section 4(g), added to the Act in the 1988 reauthorization, requires the Service to implement a system in cooperation with the States to monitor for not less than 5 years the status of all species that have recovered and been removed from the list of threatened and endangered plants and animals (USFWS and NMFS 2008, p. 1–1). The legislative history of section 4(g) indicates that Congress intended to give the Services and States latitude to determine the extent and intensity of post-delisting monitoring that is needed and appropriate (USFWS and NMFS 2008, p. 1–1). According to our 2008 Post-Delisting Monitoring (PDM) Plan Guidance, decisions regarding frequency and duration of effective monitoring should appropriately reflect the species' biology and residual threats (USFWS and NMFS 2008, p. 4–4).
Delisting criteria and the formal rulemaking process for removal from the list are designed to provide reasonable confidence that the species will remain secure for the foreseeable future, and post-delisting monitoring provides an additional “check” on projections that the species will remain secure after removal of the Act's protections (USFWS and NMFS 2008, p. 4–3). There are no absolute guarantees against future declines, but if the species appears to remain secure, conclusion of post-delisting monitoring is appropriate (USFWS and NMFS 2008, p. 4–3).
We agree that it is unrealistic and is beyond what is required by the Act to expect any single version of the Conservation Strategy and intensive Federal oversight to remain in effect in perpetuity. Therefore, the 2016 Conservation Strategy was revised to remain in effect for the foreseeable future as this is the time horizon that we must consider as we evaluate the species' status relative to the Act's definition of a threatened species.
In making our determination, we considered what the “foreseeable future” means in the context of GYE grizzly bear biology and the factors potentially affecting bear viability. To determine whether a species is likely to become endangered in the foreseeable future, the Service must consider the period over which it can make reliable predictions. It cannot speculate. Solicitor's Opinion M–37021,
The partners managing the GYE grizzly population have, as discussed above, successfully reduced or eliminated the negative trends that led to the listing of the bear in the first place. In addition, we anticipate no particular future events that will lead to the DPS becoming in danger of extinction in the future. Future implementation of the 2016 Conservation Strategy and its management objectives have also been expressly tied to the statutory concept of the foreseeable future. Under these circumstances, with a stable and protected population extending into the indefinite future, there is no need to more precisely define a particular period as being the “foreseeable future” for the bear. In other words, we cannot reliably predict on any human timescale that the status of the bear will deteriorate at all, much less that it will become in danger of extinction in the future.
However, there is not an expectation that the 2016 Conservation Strategy will remain static during its lifespan. In fact, the YGCC (the body that will coordinate management and promote the exchange of information about the GYE grizzly bear population after delisting) can revise or amend the 2016 Conservation Strategy based on the best biological data and best available science (YES 2016a, chapter 6). Any such amendments will be subject to public review and comment and approved by YGCC (YES 2016a, p. 96). More meaningful changes will need to be evaluated by the Service to determine whether they would depart significantly from previous commitments or represent a significant threat to the population and thus trigger a status review.
Periodic status reviews are consistent with Service practice for other species. For example, the Service has a history of conducting such reviews during the Northern Rocky Mountain gray wolf post-delisting monitoring period. Specifically, during this 5-year post-delisting monitoring period, we conducted six annual evaluations of status (in their entirety: Bangs 2010,
Whereas minor differences in the application rules and monitoring requirements indicate that the plans will need administrative change, amendment, or revision, these differences do not impact the adequate regulatory mechanisms in current forest plans (Schmid 2017,
A few commenters suggested potential additional analysis and modeling to consider in our analysis of genetic viability such as: (1) Models of the rate of allele loss due to genetic drift at various population sizes (though the long-term fitness implications of changes in allelic diversity are not well understood); and (2) projections of the evolutionary health of the GYE grizzly bear population.
Several comments raised concerns over the scientific basis for our lower limit of 500 bears for genetic viability, saying this threshold ensures only short-term genetic fitness and is based on outdated science (Franklin 1980) when more recent critical assessments of this standard are available (Frankham
Other commenters took issue with our calculation and analysis of effective population size. A few commenters thought the actual effective population size was lower than the 469 bears we reported and thus not yet at the long-term viable population criterion of more than 500 bears because: (1) “effective population size is approximately 25–27 percent of total population size,” suggesting a true effective population size of only 179 bears given recent population estimates (Allendorf
Conversely, one commenter stated that the scope of the discussion of genetics in the proposed rule was too broad and that the Service should instead clearly state that “current genetic diversity sufficiently supports the delisting decision and that future management of genetic diversity after delisting is a separate matter to be managed as described in the Conservation Strategy.”
Several public commenters raised concerns over connectivity and how genetic connections between grizzly bear populations could become more challenging to facilitate in a post-delisting environment (see Issue 50 for a more detailed discussion of public and peer-reviewer concerns about connectivity). Commenters claimed that lack of connectivity to other grizzly bear populations, habitat fragmentation, and habitat loss present a “long-term genetic risk for Yellowstone grizzlies” (Haroldson
Many commenters weighed in on potential transplant programs. One commenter asked us to provide more justification behind our assertion that one to two immigrants or transplants per generation is an adequate level of gene flow into the GYE (Miller and Waits 2003). Some commenters suggested that managers would need to transplant anywhere from 7 to 15 bears
Because it is generally accepted that isolated populations are at greater risk of extinction over the long term, the 2016 Conservation Strategy (YES 2016a, pp. 82–84) identifies and commits to a protocol to encourage natural habitat connectivity between the GYE and other grizzly bear ecosystems. Although natural connectivity is the best possible scenario, isolation does not constitute a threat to the GYE grizzly bear in the foreseeable future because of intensive monitoring and adaptive management strategies that will remain in effect post-delisting. Based on the best available science (Miller and Waits 2003, p. 4338), the Service concludes that the genetic diversity of the GYE grizzly bear population will be adequately maintained by the immigration or relocation of one to two effective migrants from the NCDE every 10 years. Effective migrant is defined as a bear from another ecosystem that breeds with GYE bears and successfully reproduces. Thus, immigration of more than 1 or 2 bears may be needed, depending on survival and reproductive success of the migrants. See YES (2016a, pp. 51–53) and discussion under
Connectivity between the GYE and the NCDE is a long-term goal for the State of Montana, as set out in their Grizzly Bear Management Plan for Southwestern Montana (MFWP 2013, pp. 41–44). This connectivity would provide the desired gene flow for long-term genetic fitness of the GYE population. Frankham
Our analysis of N
Although the current N
The high ratio of effective population size to census population size (N
Indicators of fitness in the GYE population demonstrate that the current levels of genetic heterozygosity are adequate, as evidenced by measures such as litter size, little evidence of disease, high survivorship, an equal sex ratio, normal body size and physical characteristics, and a stable to increasing population. None of these
Other commenters worried about the defensibility of the IGBST's models analyzing the effects of food availability on grizzly bear populations; these commenters noted that much of the IGBST's data for these models comes from observational studies, which makes it difficult to isolate the effects of individual variables or rule out other confounding drivers of birth and death rates, such as spatial and temporal correlations. Finally, one commenter claimed that the three IGBST papers (Bjornlie
We contend that a key point regarding female body condition, changes in food resources, and reproduction has been overlooked: Female grizzly bears without adequate nutrition to support reproduction, especially in YNP where bear densities are high and from where the fall sample of female percent body fat is taken, would not support the trend in counts of females with cubs-of-the-year within YNP, or the entire ecosystem (see YES 2016a, figures 3 and 4). For example, the highest counts of females with cubs-of-the-year were in 2013 and 2014, approximately 6 to 7 years after the peak of whitebark decline and more than a decade after the start of decline. Additionally, compared with the body fat data, the inference based on vital rates (
The vital rates that showed the greatest change, and caused the slowing of population growth since the early 2000s, are lower cub and yearling survival (
There were no compelling reasons to investigate the
Rather than use such a compounded uncertainty approach, the management system outlined in the 2016 Conservation Strategy (YES 2016a, pp. 33–85) depends on monitoring of multiple indices including production and availability of the four high-caloric foods; and monitoring of grizzly bear vital rates including survival, age at first reproduction, reproductive rate, cub survival, mortality cause and location, dispersal, and human-bear conflicts. The IGBST will annually report to the YGCC on the monitoring results of food production, bear mortality, and females with cubs-of-the-year. In addition, the IGBST will conduct a demographic monitoring review of the population vital rates every 5 to 10 years. The relationships between these factors will detect any impacts of changes in foods on bear viability in the ecosystem and will be the basis for an adaptive management response by the YGCC to address poor food years with responsive actions such as limiting grizzly bear mortality, increasing I&E efforts, and long-term habitat restoration (
Future studies will be directed to address further questions regarding grizzly bear responses to changing food resources and changing environmental conditions. Female home ranges decreased in size from the period of 1989 to 1999 and 2007 to 2012 with the decrease being greater in areas with higher grizzly bear densities, supporting evidence that the population is reaching carrying capacity (Bjornlie
It is impossible to calculate with any degree of certainty the extent to which natural foods will change across the landscape and any resulting effects on bears. With the exception of whitebark pine, there are no documented relationships among grizzly bear demographic rates and the consumption of other grizzly bear foods, such as cutthroat trout, army cutworm moths, or ungulates. It is important to note that the annual abundance and distribution of whitebark pine seeds, as well as other food sources, vary naturally, annually and spatially, and are not predictable. Thus, it is not biologically possible to define “baseline” levels for various foods, and the monitoring system discussed above is a more robust approach. During years with little or no whitebark pine seed production, grizzly bears switch to alternative foods. Indeed, the effect of whitebark pine crops on survival of independent-aged grizzly bears is relatively minor: For example, based on Haroldson
The caveat of food source monitoring “as budgets allow” has been removed from the 2016 Conservation Strategy. Please see Issue 85 for further discussion on funding being a trigger for a status review.
Commenters noted that the nutritional value (
While we agree that the extent to which grizzly bears might be able to compensate for the loss of one of the four major foods is unknown, the final rule discusses and relies upon the best scientific and commercial data available. Future food source availability and the possible grizzly bear reaction to those possible future changes are discussed under
The use of the four high-caloric foods should not be interpreted that these foods are essential for a sustainable grizzly bear population in the GYE. In the 2013 Food Synthesis Report, the IGBST suggested a paradigm shift may be needed in reference to the importance of whitebark pine to grizzly bears (see IGBST 2013). When comparing one food item to another, it is unrealistic to expect that any alternative food is fully comparable in the factors mentioned above (
Although we agree that, in general, to a bear “a grass is a grass,” grizzly bears feed on multiple species in each phylogenetic kingdom including: 162 plant species (4 aquatics, 4 ferns and fern allies, 85 forbs, 31 graminoids, 31 shrubs, and 7 trees); 7 fungi species; 70 animal species (1 amphibian, 3 birds, 4 fish, 26 mammals, 33 insects, 1 mollusk, 1 segmented worm, and 1 spider); and 1 protista (algae). Within the plant kingdom, energy content may be as high as 2.52 kilocalories/gram (kcal/g) for grasses and sedges to 4.83 kcal/g for clover (whitebark pine seeds are 3.24 kcal/g); protein content may be as high as 21.1 percent for bear grass to 39 percent for the pre-flowering foliage of spring beauty; fat content may be as high as 15.6 percent for bear grass to 30.5 percent for whitebark pine seeds; and carbohydrate content averaged 55 percent for berry species and was as high as 88.8 percent for onion grass
We do not dispute that bear densities vary widely between ecosystems depending on habitat productivity, as it is one factor that may change carrying capacity in an ecosystem; however, the ability of grizzly bears to survive in such a variety of habitat types with large differences in available food sources (
Peer-reviewers and commenters also provided input on potential management of declining food sources. A peer-reviewer disagreed with our statement that “land managers have little influence on how calories are spread across the landscape” and suggested a few examples of management actions that affect food distribution, including: “increasing ungulate densities through improving habitat and controlling hunting harvest; improving fish stocks and habitat; controlling invasive species to protect native food resources desired by grizzly bears;” and increasing bison populations by limiting lethal control of bison as a means of managing brucellosis. One commenter suggested that the grizzly bear should not be delisted because its food sources are declining and it has restricted access to additional food sources outside a protected range.
Several of the suggestions for management of declining food sources are already being implemented (
Commenters maintained that we did not account for the effect of increasing moth use on birth and death rates and, without this analysis, we cannot determine “future effects of losses of this food on the population.” Commenters suggested reasons to worry about recent declines in and the future abundance of moths, and the associated health of grizzly bears, including: (1) Concerns about the unknown responses of moths if up to 90 percent of the subalpine and alpine habitat upon
There is no accurate method available to monitor moth numbers across thousands of square kilometers of alpine habitat. The current, best available method quantifies bear use of moth sites as an index of moth presence and distribution. Although it is known that moth abundance fluctuates in the spring on agricultural lands on the plains (Burton
Several comments stated that there has been a substantial decrease (almost 90 percent) in the cutthroat population due to predation by nonnative lake trout, declines in winter snowfall, total lack of spawning in all tributaries of Yellowstone Lake, increased drought, and subsequent reductions of in-stream flows; commenters suggested that these negative population trends are likely to continue, especially as warmer temperatures could increase incidence of whirling disease. One commenter recommended that more information be provided regarding future populations of trout including impacts to cutthroat trout from lake trout, future management of lake trout, future vulnerability of cutthroat trout to pathogens, and future impacts from climate change.
Commenters suggested that cutthroat trout declines have affected, and will continue to affect, GYE grizzly bears because: (1) The loss of cutthroat trout has left a seasonal gap in the diet of grizzly bears, which bears have filled by consuming elk calves and lower quality vegetation (Fortin
As stated previously, trout consumption by female grizzly bears was quite low in the late nineties and continued at similarly low levels into the late 2000s (Felicetti
The Service encourages ongoing efforts to control the lake trout population in Yellowstone Lake. Recent streamside counts indicate that numbers of spawning cutthroat trout are increasing on some tributary streams (Gunther
Commenters also disagreed on whether potential whitebark pine declines would negatively affect grizzly bear populations. Most peer-reviewers and some commenters did not believe these declines represented a threat to the GYE population because: (1) The IGBST provided a report in 2013 (which YES accepted) showing that declines in the availability of whitebark pine seeds would not lead to declines in grizzly bear populations; (2) the population has increased since 2001, concurrent with whitebark pine population decline; and (3) whitebark pine is not present within the home ranges of approximately one-third of all GYE grizzly bears and thus should be considered an opportunistic food source rather than a fall staple. However, another commenter questioned whether this absence of whitebark pine was natural, or a result of beetles and blister rust). Conversely, other commenters suggested that the decline in whitebark pine is a more serious stressor on the GYE grizzly bear population than we acknowledged in our proposed rule because: (1) Whitebark pine is the most important food source for GYE grizzly bear; (2) we overlooked how whitebark pine die-offs and grizzly bear vital rates declined simultaneously; (3) despite current positive grizzly bear population growth rates, the threat of declining whitebark pine could still be substantial and the grizzly bear population may be unhealthy; (4) contrary to our analysis in the proposed rule, the GYE population of grizzly bears may not adapt to losses of whitebark pine simply because the NCDE population of grizzly bears has continued to grow in the absence of whitebark pine; (5) low whitebark pine production results in grizzly bears seeking food sources associated with humans, leading to increased conflict between bears and humans; (6) “Nearly 20% of females handled during 2008–2013 had season-specific body fat levels low enough to put them at risk for reproductive failure, whereas prior to 2004, no females assessed were so clearly deficient in body fat;” and (7) the most severe losses in whitebark pine have occurred too recently to detect long-term population impacts, especially considering grizzly bear's slow reproductive rate.
A few commenters expressed concerns over the methods of our analysis, including: (1) Concern that our analysis of whitebark pine availability did not account for the loss of whitebark pine that occurred in a 1988 fire and the subsequent lack of regeneration; (2) a request that we provide additional detail on the protocol we use to monitor the location and availability of whitebark pine, suggesting that our protocol may be inadequate or outdated; (3) concern that the three IGBST papers analyzing whitebark pine (Bjornlie
A number of commenters suggested we consider additional analyses, such as: (1) The creation of a cone availability index to more accurately assess availability; (2) analysis of the fungi that grow symbiotically with whitebark pine, since the health and survival of the pine and the fungi are closely related; (3) monitoring of additional transects in wilderness areas southeast, east, north, and west of YNP; (4) statistical analysis to determine whether GYE grizzly bear mortality correlates more closely with annual variation in whitebark pine abundance or with management practices; and (5) evaluation of the abundance and behavior of red squirrels regarding pine nut storage and the subsequent consumption of those nuts by grizzly bears. A peer-reviewer suggested analyses comparing the vital rates of grizzly bears that feed on whitebark pine to the vital rates of those that do not.
Approximately 75 percent of mature, cone-producing whitebark pine trees have experienced mortality since 2002, according to an opportunistic sample based on cone production transects conducted by the IGBST since 1980 (see
The IGBST conducted a comprehensive study, using available data, to address eight relevant research questions regarding the potential effects of whitebark pine decline on grizzly bears. Several of those questions also addressed issues related to other foods, as well as the ultimate measure of how individuals are responding to changes in food resources, body mass and body condition. See Issue 99. While there will always be new research questions to address and the IGBST is currently pursuing several new hypotheses associated with this theme, many of the commenters' suggestions cannot be addressed with current data, are not relevant, or do not seem to use the scientific principle of “preponderance of evidence.” For example, the suggestion regarding the 1988 fires ignores the observation that the period of most robust grizzly bear population growth (4 to 7 percent) occurred shortly after the fires, through the entire decade of the 1990s (see Issue 61).
The changes in vital rates actually started prior to or at the start of whitebark pine decline, as documented in van Manen
The interpretation that Costello
The comment about potential future impacts of higher human-caused mortality to grizzly bears in years of low whitebark pine production has received much attention but is misleading. Costello
Several of the suggestions for additional analyses are useful. However, the symbiotic connections between fungi and whitebark pine, although of interest, would best be studied by forest ecologists, rather than IGBST. The IGBST previously examined (Schwartz
We received many comments from both the public and peer-reviewers regarding recent declines in the availability of ungulates as a food source, and potential effects on grizzly bear populations, which we inadequately considered in our proposed rule. These comments included that: (1) All elk herds in the GYE (except the Upper Madison herd) have declined due to increased calf depredation, drought, chronic wasting disease, and human hunters; (2) effects on elk from hunters are synergistic because hunters preferentially target top breeding individuals (Vucetich
Commenters also expressed concerns regarding the potential side-effects of grizzly bear reliance on ungulates as a food source, such as: (1) Declines in cub and yearling survival rates due to more deadly confrontations with other predators, including adult male grizzly bears; (2) increased conflicts with ranchers and hunters; and (3) consumption of food sources that are unsuitable for meeting female grizzly bear reproductive needs.
Commenters also suggested we include additional monitoring and analysis, such as: (1) Data on the numbers of elk and bison in various ecosystem herds; and (2) information on the historical, current, and future effects of predation by grizzly bears and wolves, winter severity, disease, and habitat availability on ungulate abundance. Peer-reviewers suggested that we should (1) conduct an analysis of cub survival from 2002 to 2014 to assess predator-prey relationships, which may have a time-lag in detectability; and (2) estimate the amount of biomass left by ungulate hunters and available to grizzly bears instead of counting the number of hunters.
The GYE grizzly bear consumes bison primarily as winter-killed carrion, but also opportunistically kills calves and weakened adults. The Yellowstone bison population size has remained within the IBMP's recommended range of 2,500 to 4,500 bison since the year 2000, with the exception of 2005 and 2007 years when numbers exceeded 4,500. Therefore, we do not anticipate that bison as a potential food source will be a limiting factor for GYE grizzly bears in the future. Please see Issue 100 and the
Areas with a high risk of grizzly bear mortality due to repeated conflict with humans or livestock are not considered suitable habitat and are not included in our quantification of habitat available to meet the needs of a recovered grizzly bear population. See Issue 40.
As previously stated, the 2016 Conservation Strategy will continue monitoring multiple indices, including production and availability of all major foods and grizzly bear vital rates—survival, age at first reproduction, reproductive rate, mortality cause and location, dispersal, and human-bear conflicts. These data will allow managers to use an adaptive management approach that addresses poor food years with responsive management actions such as limiting grizzly bear mortality, increasing I&E efforts, and long-term habitat restoration as appropriate. The continued monitoring of these multiple indices will maintain the recovered population.
The extent to which natural foods will change across the landscape and the resulting effects on bears is impossible to calculate with any degree of certainty. See Issue 98. Future food source availability and the possible grizzly bear reaction to those possible future changes are discussed under
Commenters mentioned the many potential ways climate change could continue to affect grizzly bears and increase human-bear conflicts (Servheen and Cross 2010), including: (1) Reduction of snowpack and shortening of the winter season, which could affect the timing and success of denning, potentially reducing reproductive success and increasing conflict; (2) less snowpack could result in fewer avalanche chutes, preferred spring and summer habitat for grizzly bears; (3) the effect of drought on death rates; (4) increased frequency and extent of fire could alter plant and animal composition (Westerling
Commenters and peer-reviewers suggested that several issues related to climate change require monitoring, such as: (1) Monitoring and modeling potential impacts of climate change on habitat suitability and the abundance and distribution of grizzly bear food in relation to temperature and moisture dependence; (2) monitoring possible effects of climate change on grizzly bear vital rates; and (3) monitoring for emerging diseases since the frequency of diseases and parasites will likely change in the context of climate change.
The 2016 Conservation Strategy prioritizes outreach and education, and the State plans also contain direction on ways, to minimize grizzly bear-human conflicts (Idaho's Yellowstone Grizzly Bear Delisting Advisory Team 2002, p. 15; MFWP 2013, pp. 65–69; YES 2016a, pp. 86–95; WGFD 2016, pp. 26–27). Although the States do not currently require hunters to carry pepper spray, it is strongly encouraged in hunter education courses and other educational materials. Elk hunters in GTNP are required to carry bear spray, and this may prove to be a research opportunity to quantify how much, if any, this requirement reduces grizzly bear conflicts with elk hunters.
Between 2002 and 2014, 37 percent (115 of 311) of human-caused grizzly bear mortalities were related to hunting (defense of self or others and mistaken identity kills) (Haroldson 2014a, 2017c,
Public outreach presents a unique opportunity to effectively integrate human dimensions of wildlife management into comprehensive programs that can modify societal beliefs about, perceptions of, and behaviors toward grizzly bears. Attitudes toward wildlife are shaped by numerous factors including basic wildlife values, biological and ecological understanding of species, perceptions of individual species, and specific interactions or experiences with species (in their entirety: Kellert 1994; Kellert
The I&E programs teach visitors and residents about grizzly bear biology, ecology, and behavior, which enhances appreciation for this large predator by dispelling myths about its temperament and feeding habits. Effective I&E programs have been an essential factor contributing to grizzly bear conservation since its listing in 1975. Being aware of specific values common to certain user groups allows I&E materials and workshops to be tailored to their specific concerns and perceptions. By providing general information to visitors and targeting specific user groups living and working in grizzly bear country, coexistence between grizzly bears and humans can be accomplished. Traditionally, people involved in resource extraction industries (
State wildlife agencies recognize that the key to preventing grizzly bear-human conflicts is providing I&E to the public and connecting the public with the right resources to prevent conflicts (Idaho's Yellowstone Grizzly Bear Delisting Advisory Team 2002, pp. 13–14; MFWP 2013, pp. 49–51, 65–68; WGFD 2016, pp. 26–27; YES 2016a, pp. 92–95). This outreach is the most effective long-term solution to grizzly bear-human conflicts and is paramount to ongoing grizzly bear survival and successful coexistence with humans so that the measures of the Act are no longer necessary. All three affected States wildlife agencies (IDFG, MFWP, and WGFD) and associated partners (
States are committed to continuing these public outreach and conflict response efforts to help maintain and expand that tolerance. Compensation programs are another tool that helps with this effort, since livestock producers who suffer losses from bears are likely to be more tolerant of them if they are compensated for losses caused by grizzly bears. Based on recent experiences with wolves in Idaho and Montana, social tolerance for wolves improved as both States implemented an adaptive management approach to managing conflict during the post-delisting monitoring period. By building and maintaining social tolerance, the recovered bear population will continue to be maintained.
Ultimately, the future of the grizzly bear will be based on the people who live, work, and recreate in grizzly bear habitat and the willingness and ability of these people to learn to coexist with the grizzly bear and to accept this animal as a cohabitant of the land. Other management strategies are unlikely to succeed without effective and innovative public I&E programs. The primary goals of public outreach programs are to proactively address grizzly bear-human conflicts by educating the public about the root causes of these conflicts and providing options to prevent them. By continuing to increase awareness about grizzly bear behavior and biology, we are confident that the current and planned I&E efforts will reduce the negative outcomes of human-grizzly bear encounters such that the GYE grizzly bear population is no longer threatened by these activities, nor likely to become so in the foreseeable future.
Overall, the GYE grizzly bear population's current and expected abundance and geographic distribution (occurring both inside and outside the DMA and occurring across multiple management jurisdictions) provides the GYE grizzly bear population with substantial representation, resiliency, and redundancy (see
Second, a few commenters seemed to have misunderstood our analysis. One stated that our conclusion that the GYE DPS does not qualify as an endangered or threatened species meant that the GYE DPS does not qualify as a “species” under the Act. Another suggested that because the grizzly bear is currently listed as a DPS (lower 48 States) we cannot designate the GYE population as a DPS because this would be creating a DPS of a DPS.
Third, commenters weighed in on the geographic scope of our DPS designation. Some commenters thought we drew the DPS boundary appropriately. Others thought we should have defined it more broadly to include: (1) Additional unsuitable habitat where bears from the GYE population might roam; and (2) additional suitable habitat deemed necessary for connectivity to other populations of grizzly bears. Still others thought we should have conducted additional analyses to evaluate the importance of unsuitable habitat to GYE grizzly bears including information on: (1) How much time grizzly bears spend in unsuitable habitat; (2) why grizzly bears spend time in unsuitable habitat; (3) how much time researchers spend looking for bears in unsuitable habitat; and (4) the extent to which bears need this habitat as corridors between areas of suitable habitat. Another commenter suggested that the DPS should include all grizzly bears in Montana since all grizzly bears in the State of Montana should be removed from the lists of threatened and endangered species.
Fourth, several commenters wanted greater certainty about our intentions for grizzly bear recovery in the remainder of the listed entity (lower 48 States outside of the GYE DPS). Some stated that, prior to taking action on any individual population, the Service must designate multiple DPSs encompassing the entire range of the subspecies, set recovery goals for each DPS, and evaluate the status of each DPS for listing. Others recommended that we explain our intentions for the remainder of the grizzly bear listed entities in a notice of proposed rulemaking, which should set forth a timeline for initiating and completing such reevaluation and allow solicitation of public comment on possible ways the remainder of the listed entity could be reclassified.
Because the GYE grizzly bear population is a DPS based on the “discreteness” and “significance” qualifications, we must then evaluate the DPS's conservation status in relation to the Act's standards for determining whether the DPS is endangered or threatened. The authority and standards for conducting this status determination comes directly from section 4(a)(1) of the Act and the Service's implementing regulations, not the DPS policy. In other words, the outcome of the discreteness and significance analyses determines if a population is a DPS. Then the outcome of the section 4 analysis on that DPS determines if the DPS warrants protections under the Act. This final rule adheres to all of the required analyses for identifying the GYE grizzly bear population as a DPS. And, therefore, per section 4 of the Act, we have the authority to consider if the GYE grizzly bear DPS is endangered or threatened; and if it is neither, as we have determined here, to revise the lower-48 grizzly bear listing to remove the DPS from Federal protection.
Our recognition of the GYE grizzly bear DPS does not create a DPS of a DPS. A population's discreteness and significance determinations are based on its discreteness and significance to the taxon (species or subspecies) to which it belongs; in this case the taxon is the subspecies
As stated in the proposed and final rules, when delineating the boundary of the GYE grizzly bear DPS, we focused on including sufficient habitat that was capable of supporting grizzly bear reproduction and survival now and in the foreseeable future. We have defined
For more than 30 years, the Service has strived to maintain transparency in our grizzly bear recovery program. The Service's grizzly bear Recovery Plan, first approved in 1982 and revised in 1993, and its supplemental documents (USFWS 1982, 1993, 2007
We refer to genetic studies estimating heterozygosity in our consideration of discreteness to further support the conclusion that grizzly bears from the GYE are markedly,
Based on public comments, we reevaluated our assessment of the “unique or unusual ecological setting” for the GYE grizzly bear and revised our discussion in this final rule. In this case, we determined that the GYE grizzly bear population is significant due to its persistence in an ecological setting unique for the taxon and that loss of the population would result in a significant gap in the range of the taxon (
Again, the Service's analysis to determine if a species “is in danger of extinction” throughout all or a significant portion of its range denotes a present-tense condition of being at risk of a current or future undesired event. To say a species “is in danger” in an area where it no longer exists—
Finally, in our SPR analysis we set forth the standard by which a portion of a species' range may be considered significant. It is the Service's position that a portion of the range of a species is significant if the species is not currently endangered or threatened throughout all of its range, but the portion's contribution to the viability of the species is so important that, without the members in that portion, the species would be in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range. We have applied this standard in our final rule.
As stated in our response to Issue 116 above, it is the Service's standard practice to consider the effects of lost historical range on the species when we evaluate the status of the species in its current range. In the case of the GYE DPS, we address historical range in our analysis of suitable habitat. In our discussion we acknowledge that bears historically occurred, although were probably not evenly distributed, throughout the area of the GYE DPS. Many of these habitats are no longer biologically suitable for bears (see Issue 40).
Limited gene flow, as suggested here, would not compromise the required level of discreteness for DPS status, as the DPS policy does not require complete separation of one DPS from other populations, but instead requires “marked separation.”
As stated previously, it is the Service's standard practice to consider the effects of lost historical range on the species when we evaluate the status of the species in its current range. See discussion under
Our SPR analysis is consistent with current agency practice. After careful examination of the GYE grizzly bear population in the context of our definition of “significant portion of its range,” we determined areas on the periphery of the range warranted further consideration because human-caused mortality risk threats are geographically concentrated there. After identifying these areas, we evaluated whether they were significant and determined they were not significant because, even without the grizzly bears in these areas, the GYE grizzly bear DPS would not be in danger of extinction, or likely to become so in the foreseeable future. These areas will likely never contribute meaningfully to the GYE grizzly bear population because of lack of suitable habitat and loss of traditional grizzly bear foods (
An assessment of the need for a species' protection under the Act is based on whether a species is in danger of extinction or likely to become so because of any of five factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. As required by section 4(a)(1) of the Act, we conducted a review of the status of this species and assessed the five factors to evaluate whether the GYE grizzly bear DPS is endangered or threatened throughout all of its range. We examined the best scientific and commercial information available regarding the past, present, and foreseeable future threats faced by the species.
In considering what factors might constitute threats, we must look beyond the mere exposure of the species to the factor to determine whether the exposure causes actual impacts to the species. If there is exposure to a factor and the species responds negatively, the factor may be a threat and we then attempt to determine how significant the threat is. If the threat is significant, it may drive, or contribute to, the risk of extinction of the species such that the species warrants listing as endangered or threatened as those terms are defined by the Act. Alternatively, some threats may be significant enough to contribute to the risk of extinction but are adequately ameliorated through active conservation and management efforts so that the risk is low enough that it does not mean the species is in danger of extinction or likely to become so in the foreseeable future.
As demonstrated in our five-factor analysis, threats to this population and its habitat have been sufficiently minimized and the GYE grizzly bear DPS is a biologically recovered population. Multiple, independent lines of evidence support this interpretation. Counts of females with cubs-of-the-year have increased. Since at least 2001, the demographic recovery criterion that requires 16 of the 18 BMUs to be occupied with females with young has been met. The Recovery Plan target for a minimum population size of 500 animals inside the DMA to ensure genetic health has been met since at least 2007, using the conservative model-averaged Chao2 population estimator. Calculations of population trajectory derived from radio-monitored female bears showed an increasing population trend at a rate of 4 to 7 percent per year from 1983 through 2001 (Eberhardt
Occupied grizzly bear range has more than doubled since 1975 (Basile 1982, pp. 3–10; Blanchard
Grizzly bears occupied 92 percent of suitable habitat within the DPS boundaries as of 2014 (Fortin-Noreus 2015,
During our analysis, we did not identify any factors alone or in combination that reach a magnitude that threatens the continued existence of the species now or in the foreseeable future. Significant threats identified at the time of listing that could have resulted in the extirpation of the population have been eliminated or reduced since listing. We conclude that known impacts to the GYE grizzly bear population from the loss of secure habitat and development on public lands (
Having determined that the GYE grizzly bear DPS is not in danger of extinction or likely to become so in the foreseeable future throughout all of its range, we next consider whether there are any significant portions of its range in which the GYE grizzly bear DPS is in danger of extinction or likely to become so. The phrase “significant portion of its range” (SPR) is not defined by the Act, and we have never addressed it in our regulations: (1) The outcome of a determination that a species is either in danger of extinction or likely to become so in the foreseeable future throughout a significant portion of its range, but not throughout all of its range; or (2) what qualifies a portion of a range as “significant.”
Two district court decisions have addressed whether the SPR language allows the Service to list or protect less than all members of a defined “species”:
Consistent with that interpretation, and for the purposes of this rule, we interpret the phrase “significant portion of its range” in the Act's definitions of “endangered species” and “threatened species” to provide an independent basis for listing a species in its entirety; thus there are two situations (or factual bases) under which a species would qualify for listing: A species may be in danger of extinction or likely to become so in the foreseeable future throughout all of its range; or a species may be in danger of extinction or likely to become so throughout a significant portion of its range. If a species is in danger of extinction throughout an SPR, it, the species, is an “endangered species.” The same analysis applies to “threatened species.” Therefore, the consequence of finding that a species is in danger of extinction or likely to become so throughout a significant portion of its range is that the entire species will be listed as an endangered species or threatened species, respectively, and the Act's protections will be applied to all individuals of the species wherever found.
We conclude, for the purposes of this rule, that interpreting the SPR phrase as providing an independent basis for listing is the best interpretation of the Act because it is consistent with the purposes and the plain meaning of the key definitions of the Act; it does not conflict with established past agency practice (
Although there are potentially many ways to determine whether a portion of a species' range is “significant,” we conclude, for the purposes of this rule, that the significance of the portion of the range should be determined based on its biological contribution to the conservation of the species. For this reason, we describe the threshold for “significant” in terms of an increase in the risk of extinction for the species. We conclude that a biologically based definition of “significant” best conforms to the purposes of the Act, is consistent with judicial interpretations, and best ensures species' conservation. Thus, for the purposes of this rule, a portion of the range of a species is “significant” if the species is not currently endangered or threatened throughout all of its range, but the portion's contribution to the viability of the species is so important that, without the members in that portion, the species would be in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range.
We evaluate biological significance based on the principles of conservation biology using the concepts of redundancy, resiliency, and representation.
For the purposes of this rule, we determine if a portion's biological contribution is so important that the portion qualifies as “significant” by asking whether,
We recognize that this definition of “significant” establishes a threshold that is relatively high. On the one hand, given that the outcome of finding a species to be in danger of extinction or likely to become so in an SPR would be listing all individuals of the species wherever found, it is important to use a threshold for “significant” that is robust. It would not be meaningful or appropriate to establish a very low threshold whereby a portion of the range can be considered “significant” even if only a negligible increase in extinction risk would result from its loss. Because nearly any portion of a species' range can be said to contribute some increment to a species' viability, use of such a low threshold would require us to impose restrictions and expend conservation resources disproportionately to conservation benefit: Listing would be rangewide, even if only a portion of the range of minor conservation importance to the species is imperiled. On the other hand, it would be inappropriate to establish a threshold for “significant” that is too high. This would be the case if the standard were, for example, that a portion of the range can be considered “significant” only if threats in that portion result in the entire species' being currently endangered or threatened. Such a high bar would not give the SPR phrase independent meaning, as the Ninth Circuit held in
The definition of “significant” used in this rule carefully balances these concerns. By setting a relatively high threshold, we minimize the degree to which restrictions would be imposed or
In implementing this interpretation, the first step in our analysis of the status of a species is to determine its status throughout all of its range. If we determine that the species is in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range, we determine the species is an endangered species (or threatened species) and no SPR analysis will be required. If the species is neither in danger of extinction nor likely to become so throughout all of its range, we next determine whether the species is in danger of extinction or likely to become so throughout a significant portion of its range. If it is, we determine the species is an endangered species or threatened species, respectively; if it is not, we conclude that the species is neither an endangered species nor a threatened species.
The range of a species can theoretically be divided into portions in an infinite number of ways. However, there is no purpose to analyzing portions of the range that have no reasonable potential to be significant
Applying the process described above, we first evaluated the current range of the GYE grizzly bear DPS to determine if any area could be considered a significant portion of its 50,280 km
The Service has identified the PCA as a secure area for grizzly bears, with population and habitat condition maintained to ensure a recovered population is maintained and to allow bears into suitable habitat. This is likely to be significant (
After determining there are no natural divisions delineating separate portions of the GYE grizzly bear population, or other important areas that warrant further consideration, we next examined whether any stressors are geographically concentrated in some way that would indicate the species could be in danger of extinction, or likely to become so, in that area. Through our review of potential threats, we identified greater mortality risk in the areas on the periphery of the population's current range. More grizzly bear mortality occurs toward the periphery of its range, as evidenced by lower population growth rates in these areas (Schwartz
Because we identified areas on the periphery of the current range as warranting further consideration due to the geographic concentration of mortality risk there, we then evaluated whether these areas are significant to the GYE grizzly bear population such that, without the members in that portion, the entire population would be in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range.
The core population inside the DMA is resilient, and its current range provides the necessary redundancy to offset loss of individual bears in peripheral areas. The areas that may experience higher mortality rates represent a very small proportion of the range, and an even smaller proportion of the total number of animals in the GYE grizzly bear population. Moreover, if bears in these peripheral areas were in fact lost, that loss would not significantly affect the long-term viability of the GYE grizzly bear population, much less cause the population in the remainder of its range to be in danger of extinction or likely to become so. Therefore, there is not substantial information indicating that the peripheral portions of the GYE grizzly bear population's range are significant to the rest of the population.
After careful examination of the GYE grizzly bear population in the context of our definition of “significant portion of its range,” we determined areas on the periphery of the range warranted further consideration because human-caused mortality risk is geographically concentrated there. After identifying these areas, we evaluated whether they were significant and determined they were not significant because, even without the grizzly bears in these areas, the GYE grizzly bear DPS would not be in danger of extinction, or likely to become so in the foreseeable future. These areas will likely never contribute meaningfully to the GYE grizzly bear population because of lack of suitable habitat and loss of traditional grizzly bear foods (
We are aware of the March 28, 2017, Arizona District Court ruling in
This final rule revises 50 CFR 17.11(h) by establishing a DPS and removing the GYE grizzly bear DPS from the Federal List of Endangered and Threatened Wildlife. The prohibitions and conservation measures provided by the Act, particularly through sections 7 and 9, would no longer apply to this DPS. Federal agencies would no longer be required to consult with the Service under section 7 of the Act in the event that activities they authorize, fund, or carry out may affect the GYE grizzly bear population. However, actions within the DPS would still be managed by State, Tribal, and Federal laws, regulations, policies, and management plans ensuring enforcement of the 2016 Conservation Strategy. Delisting the GYE grizzly bear DPS is expected to have positive effects in terms of management flexibility to the States and local governments. The full protections of the Act, including section 4(d) (50 CFR 17.40), would still continue to apply to grizzly bear populations in other portions of the lower-48 States outside the GYE grizzly bear DPS' boundaries. Those grizzly bears outside the GYE DPS will remain fully protected by the Act.
Section 4(g)(1) of the Act requires us to implement a system, in cooperation with the States, to monitor for at least 5 years all delisted and recovered species. The primary purpose of this requirement is to ensure that the recovered species does not deteriorate, and if an unanticipated decline is detected, to take measures to halt the decline to avoid re-listing. If data indicate that protective status under the Act should be reinstated, we will initiate listing procedures, including, if appropriate, emergency listing.
For the GYE grizzly bear population, the 2016 Conservation Strategy serves as the post-delisting monitoring plan. The 2016 Conservation Strategy will remain in effect for the foreseeable future, beyond the 5-year monitoring period required by the Act due to their low resiliency to excessive human-caused mortality and the manageable nature of this threat. These management actions are detailed in the 2016 Conservation Strategy and will be evaluated by the management agencies every 5 years, allowing for public comment should updates to the Conservation Strategy be made in the future.
To ensure the long-term conservation of grizzly bear habitat and continued recovery of the GYE grizzly bear population, several monitoring programs and protocols have been developed and integrated into land management agency planning documents. The 2016 Conservation Strategy and appended State grizzly bear management plans satisfy the requirements for having a post-delisting monitoring plan for the GYE grizzly bear population. Monitoring programs and a coordinated approach to management would continue for the foreseeable future. Monitoring programs will focus on assessing whether demographic and
Within the PCA, the IGBST will continue to monitor habitat standards and adherence to the 1998 baseline. The IGBST will report on levels of secure habitat, developed sites, and livestock allotments annually, and these will not be allowed to deviate from 1998 baseline values unless changes were to be beneficial to grizzly bears (USDA FS 2006b, entire; YNP 2014b, p. 18). The IGBST, with participation from YNP, the USFS, and State and Tribal wildlife agencies, also will continue to monitor the abundance and distribution of common grizzly bear foods. This system allows managers some degree of predictive power to anticipate and avoid grizzly bear-human conflicts related to a shortage of one or more foods in a given season.
Within the DMA, the IGBST will continue to document population trends, current distribution, survival and birth rates, and the presence of alleles from grizzly bear populations outside the GYE grizzly bear DPS boundaries to document gene flow into the population. Throughout the DPS boundaries, locations of grizzly bear mortalities on private lands will be provided to the IGBST for incorporation into their annual report. To examine reproductive rates, survival rates, causes of death, and overall population trends, the IGBST will radio-collar and monitor a minimum of 25 adult female grizzly bears every year and a similar representative sample of adult males. The objective will be to maintain a radio-marked sample of bears that are spatially distributed throughout the ecosystem so they provide a representative sample of the entire population inside the DMA. Mortalities throughout the GYE DPS will be monitored and reported annually and evaluated in accordance with the DMA total mortality limits and population objectives in table 3.
Outside of the PCA, the GYE National Forests will monitor agreed-upon habitat parameters in suitable habitat and will calculate secure habitat values outside of the PCA every 2 years and submit these data for inclusion in the IGBST's annual report (USDA FS 2006b, p. 6). The GYE National Forests also will monitor and evaluate livestock allotments for recurring conflicts with grizzly bears in suitable habitat outside the PCA (USDA FS 2006b, p. 6). The Greater Yellowstone Whitebark Pine Monitoring Group will continue to monitor whitebark pine occurrence, productivity, and health both inside and outside the PCA (USDA FS 2006b, p. 7). Members of the IGBST will monitor grizzly bear vital rates and population parameters within the entire DMA. Finally, State wildlife agencies will provide known mortality information to the IGBST, which will annually summarize these data with respect to location, type, date of incident, and the sex and age of the bear for the entire DPS area.
In the 2007 final rule (72 FR 14866, March 29, 2007), we reported habitat quality and effectiveness values for 1998 using the Cumulative Effects Model and associated 1998 habitat data (USFWS 2007
While the inverse relationship between whitebark pine seed production and grizzly bear conflicts in the GYE has been documented (Mattson
To address the possible “lag effect” associated with slow habitat degradation taking a decade or more to translate into detectable changes in population size (see Doak 1995), the IGBST will monitor a suite of indices simultaneously to provide a highly sensitive system to monitor the health of the population and its habitat and to provide a sound scientific basis to respond to any changes or needs with adaptive management actions (Holling 1978, pp. 11–16). This “lag effect” is a concern only if the sole method to detect changes in habitat is monitoring changes in total population size (see Doak 1995, p. 1376). The monitoring systems in the 2016 Conservation Strategy (YES 2016a, pp. 33–85) are far more detailed and sophisticated and would detect changes in vital rates in response to habitat changes sooner than the system described by Doak (1995, pp. 1371–1372). The IGBST will be monitoring a suite of vital rates including survival of radio-collared bears, mortality of all bears, reproductive success, litter size, litter interval, number of females with cubs-of-the-year, distribution of females with young, and overall population trajectory, in addition to the physical condition of bears by monitoring body mass and body fat levels of each bear handled. Because of the scope of monitoring, we feel confident that we will be able to detect the consequences of significant changes in habitat within a reasonable timeframe that would allow for appropriate management response.
Monitoring systems in the 2016 Conservation Strategy allow for adaptive management (Holling 1978, pp. 11–16) as environmental issues change. The agencies have committed in the 2016 Conservation Strategy to be responsive to the needs of the grizzly bear through adaptive management (Holling 1978, pp. 11–16) actions based on the results of detailed annual population and habitat monitoring. These monitoring efforts would reflect the best scientific and commercial data and any new information that has become available since the delisting determination. The entire process would be dynamic so that when new science becomes available it
The YGCC will use the IGBST's monitoring results and annual reports to determine if the population and habitat standards are being adhered to. The States, Tribes, and National Parks will use the IGBST's annually produced model-averaged Chao2 population estimates to set and establish total mortality limits within the DMA as per tables 2 and 3. The 2016 Conservation Strategy signatories have agreed that if there are deviations from certain population or habitat standards, the IGBST will conduct a Biology and Monitoring Review as described under
In addition to the scenarios described under
An IGBST Biology and Monitoring Review examines habitat management, population management, or monitoring efforts of participating agencies with an objective of identifying the source or cause of failing to meet a habitat or demographic goal. This review also will provide management recommendations to correct any such deviations. A Biology and Monitoring Review could occur if funding becomes inadequate to the implementation of the 2016 Conservation Strategy to such an extent that it compromised the recovered status of the GYE grizzly bear population. If the review is triggered by failure to meet a population goal, the review would involve a comprehensive review of vital rates including survival rates, litter size, litter interval, grizzly bear-human conflicts, and mortalities. The IGBST will attempt to identify the reason behind any variation in vital rates such as habitat conditions, poaching, excessive roadkill, etc., and determine if these compromise the recovered status of the population. Similarly, if the review was triggered by failure to meet a habitat standard, the review would examine what caused the failure, whether this situation requires that the measures of the Act are necessary to ensure the recovered status of the population, and what actions may be taken to correct the problem. The IGBST would complete this review and release it to the public within 6 months of initiation and make it available to the YGCC and the public.
The YGCC responds to a Biology and Monitoring Review with actions to address deviations from habitat standards or, if the desired population and habitat standards specified in the 2016 Conservation Strategy cannot be met in the opinion of the YGCC, the YGCC could recommend that the Service consider re-listing of the GYE grizzly bear DPS (YES 2016a, pp. 96–103). Because the YGCC possesses substantial information about the population's status, the Service would respond by conducting a status review to determine if re-listing is warranted.
The Service can also initiate a status review independent of the IGBST or the YGCC should the total mortality limits be exceeded by a significant margin or routinely violated or if substantial management changes occur significant enough to raise concerns about population-level impacts. Emergency re-listing of the population is an option we can and will use, if necessary, in accordance with section 4(g)(2) of the Act, to prevent a significant risk to the well-being of the grizzly bears (16 U.S.C. 1533(g)). Such an emergency re-listing would be effective the day the rule is published in the
Upon delisting of the GYE grizzly bear population, we will use the information in IGBST annual reports and adherence to total mortality limits as per tables 2 and 3 to determine if a formal status review is necessary. Because we anticipate that the YGCC and IGBST are fully committed to maintaining GYE grizzly bear population management and habitat management through implementation of the 2016 Conservation Strategy and State and Federal management plans, and to correct any problems through the process established in the 2016 Conservation Strategy and described in the preceding section, we created a threshold for criteria that would trigger a formal Service status review that is higher than that for a Biology and Monitoring Review. Specifically, any of the following scenarios would result in a formal status review by the Service:
(1) If there are any changes in Federal, State, or Tribal laws, rules, regulations, or management plans that depart significantly from the specifics of population or habitat management detailed in this final rule or the 2016 Conservation Strategy that would significantly increase the threat to the GYE grizzly bear population. The Service will promptly conduct such an evaluation of any change in a State or Federal agency's regulatory mechanisms to determine if such a change represents a threat to the GYE grizzly bear population. As the Service has done for the Rocky Mountain DPS of gray wolf, such an evaluation will be documented for the record and acted upon if necessary.
(2) A total population estimate is less than 500 inside the DMA in any year using the model-averaged Chao2 population estimator, or counts of females with cubs-of-the-year fall below 48 for 3 consecutive years.
(3) If fewer than 16 of 18 bear management units are occupied by females with young for 3 consecutive 6-year sums of observations.
(4) If the Service determines a petition to re-list from an individual or organization is substantial.
In addition to these four criteria for a status review, the Service may conduct a status review at any time that the best scientific information indicates a review may be necessary or if population and mortality targets in the 2016 Conservation Strategy are consistently not met. Upon completion of a formal status review, a notice of availability would be published in the
Status reviews and re-listing decisions would be based on the best available scientific and commercial data available. If a status review is triggered, the Service would evaluate the status of the GYE grizzly bear population to determine if re-listing is warranted. We would make prompt use of the Act's emergency listing provisions if necessary to prevent a significant risk to the well-being of the GYE grizzly bear population. We have the authority to emergency re-list at any time, and a completed status review is not necessary to exercise this emergency re-listing authority.
We have determined that environmental assessments and environmental impact statements, as defined under the authority of the NEPA of 1969 (42 U.S.C. 4321
This rule does not contain any new collections of information other than those already approved under the Paperwork Reduction Act (44 U.S.C. 3501
Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. As this rule is not expected to significantly affect energy supplies, distribution, or use, this action is not a significant energy action and no Statement of Energy Effects is required.
In accordance with the President's memorandum of April 29, 1994, Government-to-Government Relations with Native American Tribal Governments (59 FR 22951), E.O. 13175, and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that Tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes.
Beginning in April 2014, the Service sent consultation invitation letters via registered mail to the four Tribes having treaty interests in the proposed GYE grizzly bear delisting area: the Northern Arapaho, Eastern Shoshone, Northwestern Band of the Shoshone Nation, and Shoshone-Bannock Tribes. Over the next year the Service was made aware of many more Tribes having an interest in the GYE grizzly bear and expanded our efforts in explaining the status of the bear and offering government-to-government consultation to Tribes.
On February 17, 2015, the Service sent letters offering government-to-government consultation to 26 Tribes. On June 15, 2015, the Service sent out a second round of letters to 48 tribes, offering another opportunity for consultation, followed by personal phone calls or emails from Service leadership to the 48 tribes, personally inviting them to engage in government-to-government consultation. On August 13, 2015, the Service met with the Rocky Mountain Tribal Leaders Council in Billings, Montana and invited tribal representative to engage in consultation concerning the GYE grizzly bear.
On October 29, 2015, the Service sent letters to 53 tribes, which included all Tribes, Tribal Councils, and First Nations in Canada that have contacted the Service regarding the GYE grizzly bear population. The letters invited all Federal Tribes to engage in government-to-government consultation. In addition, the letter invited Tribes to participate in an informational webinar and conference call held on November 13, 2015.
On March 3, 2016, the Service announced its proposal to delist grizzly bears in the GYE. The announcement was disseminated to all Tribes west of the Mississippi River with Tribes being notified by both email and hard copy mail. In addition, the Service announced two consultation meeting opportunities in the
On March 10, 2016, the Service hosted a tribal conference call to provide an overview of the proposed delisting and discuss any questions or concerns. It was not considered government-to-government consultation. The announcement for this call was included in the March, 3rd notifications sent to Tribes.
To date, the Service has conducted ten Tribal consultations with the following Tribes: June 10, 2015: Confederated Salish and Kootenai Tribes; June 18, 2015: Blackfeet Nation Wildlife Committee; July 21, 2015: Northern Arapahoe Tribal Council; July 21, 2015: Eastern Shoshone Tribal Council; July 30, 2015: Shoshone Bannock Tribal Council; April 28, 2016: Bozeman Montana (Tribes Present at meeting: Shoshone Bannock Tribes, Northern Cheyenne Tribe, Eastern Shoshone Tribe, Northwest Band of the Shoshone); May 5, 2016: Rapid City, South Dakota (Northern Arapaho, Rosebud Sioux); November 2, 2016: Eastern Shoshone Tribe; November 16, 2016: Shoshone Bannock Tribe; April 07, 2017: Northern Cheyenne Tribal Council. Government-to-Government consultation is not open to the public or media. This process involves consultation with Tribal members speaking on behalf of their Tribe and as a representative of their Tribe (see
A complete list of all references cited in this final rule is available at
The primary authors of this final rule are staff members of the Service's Grizzly Bear Recovery Office (see
Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.
Accordingly, we hereby amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations as set forth below:
16 U.S.C. 1361–1407; 1531–1544; and 4201–4245, unless otherwise noted.
(h) * * *
Environmental Protection Agency (EPA).
Final rule; administrative change.
The Environmental Protection Agency (EPA) is revising the format for materials that are made part of the Illinois State Implementation Plan (SIP) through the process of incorporation by reference (IBR). The regulations and materials affected by this format change have all been previously submitted by Illinois and approved by EPA as part of the SIP.
This action is effective June 30, 2017.
EPA has established a docket for this action under Docket ID No. EPA–R05–OAR–2016–0599. SIP materials which are incorporated by reference into 40 CFR part 52 are available for inspection at the following locations: Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604 and the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to:
Christos Panos, Environmental Engineer, Attainment Planning and Maintenance Section, Air Programs Branch (AR 18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 353–8328,
Throughout this document, wherever “we,” “us” or “our” is used, it is intended to refer to EPA. Information is organized as follows:
Each state has a SIP containing, among other things, the control measures and strategies used to attain and maintain the national ambient air quality standards (NAAQS). The SIP is extensive, containing such elements as air pollution control regulations, emission inventories, monitoring networks, attainment demonstrations, and enforcement mechanisms.
Each state must formally adopt the control measures and strategies to attain and maintain the NAAQS after the public has had an opportunity to comment on them. The states then submit them to EPA as SIP revision requests upon which EPA must formally act. EPA evaluates these submissions to determine whether they meet CAA requirements. If and when these control measures and strategies are approved by EPA, after notice and comment rulemaking, EPA uses the IBR process to make them part of the Federally approved SIP. IBR is a method of incorporating material into EPA regulations in the CFR by referencing the original document(s) without publishing the full text of the material. In this case, the SIP rules are identified in part 52 (Approval and Promulgation of Implementation Plans), title 40 of the Code of Federal Regulations (40 CFR part 52). These rules are approved by EPA with a specific effective date, but are not reproduced in their entirety in 40 CFR part 52. This format allows both EPA and the public to identify which regulations are contained in a given SIP and to help determine whether the state is enforcing those regulations. This format also assists EPA and the public in taking enforcement action, should a state not enforce its SIP-approved regulations.
The SIP is periodically revised as necessary to address the unique air pollution problems in the state. Therefore, EPA must periodically take action on state SIP submissions containing new and/or revised regulations and other materials; if approved, they become part of the SIP. On May 22, 1997 (62 FR 27968), EPA revised the formatting procedures of 40 CFR part 52 for incorporating by reference Federally approved SIP revisions. These procedures include: (1) A revised SIP document for each state that would use the IBR process under the provisions of title 1 CFR part 51; (2) a revised mechanism for announcing EPA approval of revisions to an applicable SIP and updating both the document that has gone through the IBR process and the CFR; and (3) a revised format of the “Identification of plan” sections for each applicable subpart in 40 CFR part 52 to reflect these revised IBR procedures. The description of the revised SIP document, IBR procedures, and “Identification of plan” format are discussed in further detail in the May 22, 1997
The Federally-approved regulations, source-specific requirements, and nonregulatory provisions (entirely or portions of) submitted by each state agency have been compiled by EPA into a “SIP compilation.” The SIP compilation contains the updated regulations, source-specific requirements, and nonregulatory provisions approved by EPA through previous rulemaking actions in the
Each SIP compilation contains three parts. Part one contains the regulations, part two contains the source-specific requirements, and part three contains nonregulatory provisions. Each state's SIP compilation contains a table for each of the three parts that identifies each SIP-approved regulation, source-specific requirement, and nonregulatory provision. In this action, EPA is publishing the SIP compilation tables that summarize the applicable SIP requirements for Illinois and that will be codified at 40 CFR 52.720. The effective dates in the table indicate the date of the most recent revision to an approved regulation. EPA Regional Offices have the primary responsibility for updating the state SIP compilations and ensuring their accuracy.
EPA Region 5 has developed and will maintain the SIP compilation for Illinois. A copy of the full text of Illinois's regulatory and source-specific SIP compilation will also be maintained at NARA.
In order to better serve the public, EPA revised the organization of the section titled “Identification of plan” at 40 CFR 52.720 and included additional information to clarify the enforceable elements of the SIP. The revised format does not affect Federal enforceability of the SIP and is consistent with the requirements of Section 110(h)(1) of the CAA concerning comprehensive SIP publication.
The revised Identification of plan section contains five subsections: (a) Purpose and scope, (b) Incorporation by reference, (c) EPA approved regulations, (d) EPA approved source specific requirements, and (e) EPA approved nonregulatory and quasi-regulatory provisions.
All new requirements and revisions to the applicable SIP become Federally enforceable as of the effective date of the revisions to paragraphs (c), (d), or (e) of the applicable Identification of plan section found in each subpart of 40 CFR part 52.
To facilitate enforcement of previously approved SIP provisions and provide a smooth transition to the new SIP processing system, EPA will retain the original Identification of plan section, previously appearing in the CFR as the first or second section of part 52 for each state subpart. The original Identification of plan section will be moved to Section 52.750 of part 52 for Illinois. After an initial two-year period, EPA will review its experience with the new SIP processing system and decide whether to retain the original Identification of plan section for some further period.
We are revising the format of 40 CFR part 52 “Identification of plan” section for Illinois regarding incorporation by reference, by adding Section 52.720(c)(d) and (e), to be consistent with the format described above and in 62 FR 27968 (May 22, 1997). We are adding Section 52.720(b)(1) to further clarify that all SIP revisions listed in Section 52.720(c) and (d), regardless of inclusion in the most recent “update to the SIP compilation,” are Federally enforceable under sections 110 and 113 of the Clean Air Act (CAA) as of the effective date of the final rulemaking in which EPA approved the SIP revision. We are adding Section 52.720(b)(2) to certify that the materials provided by EPA at the addresses in paragraph (b)(3) are an exact duplicate of the official state rules/regulations. We are adding Section 52.720(b)(3) to update address and contact information. Additionally, we are removing sections 52.729 “Control strategy: Carbon monoxide”, 52.745 “Section 110(a)(2) infrastructure requirements” and 52.746 “Control strategy: Lead (Pb)” because the information within those sections is being incorporated into the tables at Section 52.720 and is, therefore, no longer necessary.
This action constitutes a recordkeeping and organizational exercise to ensure that all revisions to the state programs that have occurred are accurately reflected in 40 CFR part 52. State SIP revisions are controlled by EPA regulations at 40 CFR part 51.
EPA has determined that this action falls under the “good cause” exemption in sections 553(b)(3)(B) and 553(d)(3) of the Administrative Procedures Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation and allows an agency to make a rule effective immediately, thereby avoiding the 30-day delayed effective date otherwise provided for in the APA. This action simply reformats and codifies provisions which are already in effect as a matter of law in Federal and approved state programs. Under section 553(b)(3)(B) of the APA, an agency may find good cause where notice and public procedure are “impractical, unnecessary, or contrary to the public interest.” Public comment is unnecessary for this action because EPA is reformatting and codifying existing law. Immediate notice in the CFR benefits the public by removing outdated citations and making the IBR format clearer and more user-friendly.
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Illinois Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available electronically through
Under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011), this action is not a “significant regulatory action” and is therefore not subject to review by the Office of Management and Budget. This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866. Because the agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the Administrative Procedure Act or any other statute as indicated in the
The Congressional Review Act (5 U.S.C. 801
EPA has also determined that the provisions of section 307(b)(1) of the Clean Air Act pertaining to petitions for judicial review are not applicable to this action. Prior EPA rulemaking actions for each individual component of the Illinois SIP compilations had previously afforded interested parties the opportunity to file a petition for judicial review in the United States Court of Appeals for the appropriate circuit within 60 days of such rulemaking action. Thus, EPA sees no need in this action to reopen the 60-day period for filing such petitions for judicial review for these “Identification of plan” reorganization actions for Illinois.
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur dioxide, Volatile organic compounds.
Part 52 of chapter I, title 40 of the Code of Federal Regulations, is amended as follows:
42 U.S.C. 7401
(a) This section identified the original “Air Quality Implementation Plan for the State of Illinois” and all revisions submitted by Illinois that were Federally-approved prior to June 1, 2017.
(a)
(b)
(1) Material listed in paragraphs (c) and (d) of this section with an EPA approval date prior to December 31, 2016, was approved for incorporation by reference by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Entries in paragraphs (c) and (d) of this section with the EPA approval dates after December 31, 2016, have been approved by EPA for inclusion in the State implementation plan and for incorporation by reference into the plan as it is contained in this section, and will be considered by the Director of the Federal Register for approval in the next update to the SIP compilation.
(2) EPA Region 5 certifies that the materials provided by EPA at the addresses in paragraph (b)(3) of this section are an exact duplicate of the officially promulgated state rules/regulations which have been approved as part of the state implementation plan as of the dates referenced in paragraph (b)(1).
(3) Copies of the materials incorporated by reference into the SIP may be inspected at the Region 5 EPA Office at 77 West Jackson Boulevard, Chicago, IL 60604. To obtain the material, please contact the person identified in the
(c)
(d)
(e)
Nuclear Regulatory Commission.
Final rule.
The U.S. Nuclear Regulatory Commission (NRC) is amending the licensing, inspection, special project, and annual fees charged to its applicants and licensees. These amendments are necessary to implement the Omnibus Budget Reconciliation Act of 1990 as amended (OBRA–90), which requires the NRC to recover approximately 90 percent of its annual budget through fees.
This final rule is effective on August 29, 2017.
Please refer to Docket ID NRC–2016–0081 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
Michele Kaplan, Office of the Chief Financial Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, telephone: 301–415–5256, email:
The NRC's fee regulations are governed primarily by two laws: (1) The Independent Offices Appropriations Act of 1952 (IOAA) (31 U.S.C. 9701), and (2) OBRA–90. The OBRA–90 statute requires the NRC to recover approximately 90 percent of its budget authority through fees; this fee-recovery requirement may exclude amounts appropriated for Waste Incidental to Reprocessing, generic homeland security activities, $5 million for advanced reactor regulatory infrastructure, and Inspector General (IG) services for the Defense Nuclear Facilities Safety Board. The OBRA–90 statute first requires the NRC to use its IOAA authority to collect user fees for NRC work that provides specific benefits to identifiable applicants and licensees (such as licensing work, inspections, special projects). The regulations at part 170 of title 10 of the
The NRC is issuing the FY 2017 final fee rule based on the Consolidated Appropriations Act, 2017 (Pub. L. 115–31), in the amount of $917.1 million, a decrease of $85.0 million from FY 2016. As explained previously, certain portions of the NRC's total budget are excluded from the NRC's fee-recovery amount—specifically, these exclusions include: $1.3 million for waste-incidental-to-reprocessing activities, $1.0 million for IG services for the Defense Nuclear Facilities Safety Board, and $15.8 million and for generic homeland security activities. Also, for the first time, the enacted budget includes $5 million for advanced reactor infrastructure, which is required to be excluded from the fee base. Additionally, OBRA–90 requires the NRC to recover only approximately 90 percent of the remaining budget authority, leaving the remaining 10 percent to be funded by a congressional appropriation.
After accounting for the OBRA–90 exclusions, this 10-percent appropriation, and net billing adjustments (the sum of unpaid current year invoices (estimated) minus payments for prior year invoices) the NRC must bill approximately $805.9 million in FY 2017 to licensees. Of this amount, the NRC estimates that $297.3 million will be recovered through 10 CFR part 170 user fees, which leaves approximately $508.6 million to be recovered through 10 CFR part 171 annual fees. Table I summarizes the fee-recovery amounts for the FY 2017 final fee rule using the enacted budget and taking into account excluded activities, the 10-percent appropriation, and net billing adjustments (individual values may not sum to totals due to rounding). The FY 2017 appropriation includes access to $23.0 million in carryover funds. The use of carry over funds allows the NRC to accomplish the work needed without additional costs to licensees because fees are calculated based on the new appropriation and not carryover funds.
The NRC uses an hourly rate to assess fees for specific services provided by the NRC under 10 CFR part 170. The hourly rate also helps determine flat fees (which are used for the review of certain types of license applications). This rate would be applicable to all activities for which fees are assessed under §§ 170.21 and 170.31.
The NRC's hourly rate is derived by adding the budgeted resources for: (1) Mission-direct program salaries and benefits;
For FY 2017, the NRC is decreasing the hourly rate from $265 to $263. The 0.8 percent decrease in the FY 2017 hourly rate is due primarily to the decline in total budgetary resources and an increase in productive hours worked, offset by a decline in mission-direct FTE from FY 2016 to FY 2017. The FY 2017 estimated annual direct hours per staff is 1,500 hours, up from 1,440 hours in FY 2016. The productive-hours assumption reflects the average number of hours that a mission-direct employee spends on mission-direct work in a given year. This excludes hours charged to annual leave, sick leave, holidays, training and general administration tasks. Table II shows the hourly rate calculation methodology. The FY 2016 amounts are provided for comparison.
The NRC is amending the flat application fees that it charges to applicants for import and export licenses, applicants for materials licenses and other regulatory services, and holders of materials in its schedule of fees in §§ 170.21 and 170.31, to reflect the revised hourly rate of $263. The NRC calculates these flat fees by multiplying the average professional staff hours needed to process the licensing actions by the proposed professional hourly rate for FY 2017. The NRC analyzes the actual hours spent performing licensing actions and then estimates the average professional staff hours that are needed to process licensing actions as part of its biennial review of fees, which is required by Section 902 of the Chief Financial Officers Act of 1990 (31 U.S.C. 902(8)). The NRC performed this review in FY 2017 and will perform this review again in FY 2019. For the most part, application fees decreased due to a lower hourly rate along with efficiencies achieved in the licensing and inspection programs. Please see the final fee rule work papers (ADAMS Accession No. ML17164A283) for more
The NRC rounds these flat fees in such a way that ensures both convenience for its stakeholders and that any rounding effects are minimal. Accordingly, fees under $1,000 are rounded to the nearest $10, fees between $1,000 and $100,000 are rounded to the nearest $100, and fees greater than $100,000 are rounded to the nearest $1,000.
The licensing flat fees are applicable for import and export licensing actions (see fee categories K.1. through K.5. of § 170.21), as well as certain materials licensing actions (see fee categories 1.C. through 1.D., 2.B. through 2.F., 3.A. through 3.S., 4.B. through 5.A., 6.A. through 9.D., 10.B., 15.A. through 15.L., 15.R., and 16 of § 170.31). Applications filed on or after the effective date shown in the
As previously noted, OBRA–90 requires the NRC to recover only approximately 90-percent of its budget authority. The remaining 10 percent that is not recovered through fees is applied by the NRC to offset certain budgeted activities—see Table III for a full listing. These activities are referred to as “fee-relief” activities. Any difference between the 10-percent non-fee-recoverable amount and the budgeted amount of these fee-relief activities results in a fee adjustment (either an increase or decrease) to all licensees' annual fees, based on their percentage share of the NRC's budget.
In FY 2017, the NRC's budgeted fee-relief activities exceeded the 10-percent threshold—therefore, the NRC assessed a fee-relief adjustment (
Table IV shows how the NRC allocates the $12.1 million fee-relief adjustment (surcharge) to each license fee class.
In addition to the fee-relief adjustment, the NRC also assesses a generic LLW surcharge of $3.2 million. Disposal of LLW occurs at commercially operated LLW disposal facilities that are licensed by either the NRC or an Agreement State. There are four existing LLW disposal facilities in the United States that accept various types of low-level waste. All are in Agreement States and, therefore, regulated by the State authority. The NRC allocates this surcharge to its licensees based on data available in the DOE Manifest Information Management System. This database contains information on total LLW volumes and NRC usage information from four generator classes: Academic, industry, medical, and utility. The ratio of utility waste volumes to total LLW volumes over a period of time is used to estimate the portion of this surcharge that should be allocated to the power reactors, fuel facilities, and materials fee classes. The materials portion is adjusted to account for the fact that a large percentage of materials licensees are licensed by the Agreement States rather than the NRC.
Table IV shows the surcharge, and its allocation across the various fee classes.
In accordance with SECY–05–0164, “Annual Fee Calculation Method,” dated September 15, 2005 (ADAMS Accession No. ML052580332), the NRC re-baselines its annual fees every year. Re-baselining entails analyzing the budget in detail and then allocating the budgeted costs to various classes or subclasses of licensees. It also includes updating the number of NRC licensees in its fee calculation methodology.
The NRC revised its annual fees in §§ 171.15 and 171.16 to recover approximately 90 percent of the NRC's FY 2017 budget authority (less non-fee amounts and the estimated amount to be recovered through 10 CFR part 170 fees). The total estimated 10 CFR part 170 collections for this final rule are $297.3 million, a decrease of $35.4 million from the FY 2016 final rule. The NRC, therefore, must recover $508.6 million through annual fees from its licensees, which is a decrease of $42.1 million from the FY 2016 final rule.
Table V shows the re-baselined fees for FY 2017 for a representative list of categories of licensees. The FY 2016 amounts are provided for comparison.
Paragraphs a. through h. of this section describe budgetary resources allocated to each class of licensees and the calculations of the re-baselined fees. For more information about detailed fee calculations for each class, please consult the accompanying work papers.
The NRC will collect $33.9 million in annual fees from the fuel facility class.
In FY 2017, the fuel facilities budgetary resources decreased due to continued construction delays at multiple sites (including the Shaw Mixed Oxide Fuel Fabrication and the International Isotope facilities) and efficiencies achieved within the licensing and inspection programs, offset by declining estimated 10 CFR part 170 billings for license renewals and amendments, and a reduction of one licensee in the fee class—Centrus Energy Corporation Lead Cascade Gas Centrifuge Enrichment Demonstration facility. Due to the proration rules in our regulation, this licensee will remain for the FY 2017 final fee rule calculation, and be removed from the fee rule for FY 2018.
The NRC allocates annual fees to individual fuel facility licensees based on the effort/fee determination matrix developed in the FY 1999 final fee rule (64 FR 31447; June 10, 1999). To briefly recap, that matrix groups licensees into various categories. The NRC's fuel facility project managers determine the effort levels associated with regulating each category. This is done by assigning separate effort factors for the safety and safeguards activities associated with each category (for more information about this matrix, see the work papers). These effort levels are reflected in Table VII.
For FY 2017, the total budgeted resources for safety activities are $13.8 million. To calculate the annual fee, the NRC allocates this amount to each fee category based on its percent of the total regulatory effort for safety activities. Similarly, the NRC allocates the budgeted resources for safeguards activities, $12.1 million, to each fee category based on its percent of the total regulatory effort for safeguards activities. Finally, the fuel facility fee class' portion of the fee-relief adjustment/LLW surcharge—$2.5 million—is allocated to each fee category based on its percent of the total regulatory effort for both safety and safeguards activities. The annual fee per licensee is then calculated by dividing the total allocated budgeted resources for the fee category by the number of licensees in that fee category. The fee for each facility is summarized in Table VIII.
In comparison to FY 2016, the FY 2017 budgetary resources for uranium recovery licensees increased due to increased work expected for additional safety and environmental reviews associated with new licensing actions and increased hearing activities. In addition, the NRC regulates DOE's Title I and Title II activities under the Uranium Mill Tailings Radiation Control Act (UMTRCA).
Estimated 10 CFR part 170 fees increased due to the Ludeman expansion, Kennecott safety evaluation report, and the Marsland environmental assessment. For the UMTRCA program, 10 CFR part 170 fees decreased due to delays in the submission of the Monument Valley groundwater correction action plan, the Lakeview long-term surveillance plan, and the completion of the review of the Durango site evaporation pond decommissioning plan.
The NRC will collect approximately $1.0 million in annual fees from the uranium recovery facilities fee class for both DOE and non-DOE licensees, an increase of about eight percent from FY 2016. In comparison with FY 2016, non-DOE licensees annual fees will remain flat for most licensees and decrease for some. The NRC computes the 10 CFR part 171 annual fee for the uranium recovery fee class by dividing the total annual fee recovery amount between DOE and the other licensees in this fee class. The final annual fee assessed to DOE includes the costs specifically budgeted for the NRC's UMTRCA Title
Further, for the non-DOE licensees, the NRC uses a matrix to determine the effort levels associated with conducting the generic regulatory actions for the different (non-DOE) licensees in this fee class; this is similar to the NRC's approach for fuel facilities, described previously.
The matrix methodology for uranium recovery licensees first identifies the licensee categories included within this fee class (excluding DOE). These categories are: Conventional uranium mills and heap leach facilities; uranium
Applying these factors to the approximate $369,178 in budgeted costs to be recovered from non-DOE uranium recovery licensees results in the total annual fees for each fee category. The annual fee per licensee is calculated by dividing the total allocated budgeted resources for the fee category by the number of licensees in that fee category, as summarized in Table XII.
The NRC will collect $426.5 million in annual fees from the power reactor fee class in FY 2017, as shown in Table XIII. The FY 2016 values and percentage change are shown for comparison.
Compared with FY 2016, 10 CFR part 170 fees decreased due to completion of actions to address the licensing actions backlog, and the transition of Fort Calhoun to decommissioning status in November 2016.
The budgeted costs are divided equally among the 99 currently operating power reactors, resulting in a final 10 CFR part 171 annual fee of $4,308,000 per reactor. Additionally, each licensed power reactor is assessed the FY 2017 spent fuel storage/reactor decommissioning 10 CFR part 171 annual fee of $188,000 (see the discussion that follows). The combined FY 2017 annual fee for power reactors is, therefore, $4,496,000 which is a decrease from the combined FY 2016 10 CFR part 171 annual fee of $4,856,000.
On May 24, 2016 (81 FR 32617), the NRC published a final rule that amended its licensing, inspection, and annual fee regulations to establish a variable annual fee structure for light-water small modular reactors (SMRs). Under the variable annual fee structure, effective June 23, 2016, an SMR's annual fee would be calculated as a function of its licensed thermal power rating. Currently, there are no operating SMRs; therefore, the NRC will not assess an annual fee in FY 2017 for this type of licensee.
To collect the budgeted resources for spent fuel storage/reactor decommissioning, the NRC will collect $23.0 million in annual fees from 10 CFR part 50 power reactors and from 10 CFR part 72 licensees who do not hold a 10 CFR part 50 license.
In comparison to FY 2016, the decrease in annual fee is mainly the result of a decrease in budgetary resources for storage licensing and rulemaking activities and an increase in 10 CFR part 170 estimated billings due to the application for a consolidated interim storage facility for Holtec/Eddy Lea Energy and the technical review of an application submitted by Waste Control Specialists.
The required annual fee recovery amount is divided equally among 122 licensees, resulting in an FY 2017 annual fee of $188,000 per licensee.
The NRC will collect $0.326 million in annual fees from the research and test reactor licensee class.
In FY 2017, the research and test/non-power reactors budgetary resources decreased due to a decrease in the NRC's workload for licensing medical isotope utilization and production facilities. Accordingly, the estimated 10 CFR part 170 billings decreased for the medical isotope production review. For research and test reactors, in comparison to FY 2016, the 10 CFR part 171 annual fee remained flat. The required annual fee-recovery amount is divided equally among the four research and test reactors subject to annual fees and results in an FY 2017 annual fee of $81,400 for each licensee.
The application for a rare-earth facility has been placed on hold until late FY 2017. Therefore, the NRC has not allocated any budgetary resources to this fee class and will not assess an annual fee in FY 2017 for this fee class.
The NRC will collect $35.4 million in annual fees from materials users licensed under 10 CFR parts 30, 40, and 70.
To equitably and fairly allocate the $35.4 million in FY 2017 budgeted costs among approximately 2,700 diverse materials users licensees, the NRC calculates the annual fees for each fee category within this class based on the 10 CFR part 170 application fees and estimated inspection costs for each fee category. Because the application fees and inspection costs are indicative of the complexity of the license, this approach provides a proxy for allocating the generic and other regulatory costs to the diverse categories of licenses based on the NRC's cost to regulate each category. This fee-calculation method also considers the inspection frequency (priority), which is indicative of the safety risk and resulting regulatory cost associated with each category of license.
The annual fee for these categories of materials users' licenses is developed as follows:
Annual fee = Constant × [Application Fee + (Average Inspection Cost/Inspection Priority)] + Inspection Multiplier × (Average Inspection Cost/Inspection Priority) + Unique Category Costs.
For FY 2017, the constant multiplier necessary to recover approximately $25.9 million in general costs (including allocated generic transportation costs) is 1.46 (see work papers for more detail). The average inspection cost is the average inspection hours for each fee category multiplied by the hourly rate of $263. The inspection priority is the interval between routine inspections, expressed in years. The inspection multiplier is the multiple necessary to recover approximately $8.4 million in inspection costs, and is 1.65 for FY 2017. The unique category costs are any special costs that the NRC has budgeted for a specific category of licenses. For FY 2017, approximately $275,000 in budgeted costs for the implementation of revised 10 CFR part 35, “Medical Use of Byproduct Material” (unique costs), has been allocated to holders of NRC human-use licenses.
The annual fee assessed to each licensee also includes a share of the fee-relief surcharge assessment of approximately $430,421 allocated to the materials users fee class (see Table IV, “Allocation of Fee-Relief Adjustment and LLW Surcharge, FY 2017,” in Section III, “Discussion,” of this document), and for certain categories of these licensees, a share of the approximately $442,000 LLW surcharge costs allocated to the fee class. The annual fee for each fee category is shown in § 171.16(d).
The NRC will collect $5.8 million in annual fees to recover generic transportation budgeted resources. The FY 2016 values are shown for comparison.
In comparison to FY 2016, the total budgetary resources for generic transportation activities decreased due to a reduction in rulemaking activities involving revisions to transportation safety requirements and compatibility with International Atomic Energy Agency Transportation Standards, hence reducing all fee class generic transportation annual fees. The 10 CFR part 170 estimated billings are expected to decrease due in part to a reduction in activities for Areva Federal Services and NAC International.
Consistent with the policy established in the NRC's FY 2006 final fee rule (71 FR 30721; May 30, 2006), the NRC recovers generic transportation costs unrelated to DOE as part of existing annual fees for license fee classes. The NRC assesses a separate annual fee under § 171.16, fee category 18.A. for DOE transportation activities. The amount of the allocated generic resources is calculated by multiplying the percentage of total Certificates of Compliance (CoCs) used by each fee class (and DOE) by the total generic transportation resources to be recovered. The DOE annual fee increase is mainly due to the elimination of a prior year credit totaling approximately $220,000 from FY 2016, as well as a rise in CoCs by 4, or 22 percent.
This resource distribution to the licensee fee classes and DOE is shown in Table XVIII. Specifically, for the research and test reactors fee class, the NRC allocates the distribution to only the licensees that are subject to annual fees. Four CoCs benefit the entire research and test reactor class, but only 4 out of 31 research and test reactors are subject to annual fees. The number of CoCs used to determine the proportion of generic transportation resources allocated to research and test reactors annual fees is adjusted to 0.6 so that the licensees subject to annual fees are charged a fair and equitable portion of the total. For more information see the work papers.
The NRC assesses an annual fee to DOE based on the 10 CFR part 71 CoCs it holds. The NRC, therefore, does not allocate these DOE-related resources to other licensees' annual fees because these resources specifically support DOE.
The NRC makes three administrative changes:
The hourly rate in 10 CFR part 170 is calculated by dividing the cost per direct FTE by the number of mission-direct hours per direct FTE in a year. “Mission-direct hours” are hours charged to mission-direct activities in the Nuclear Reactor Safety Program and Nuclear Materials and Waste Safety Program. The FY 2016 final fee rule used 1,440 hours per direct FTE in the hourly rate calculations. During the FY 2017 budget formulation process, the NRC staff reviewed and analyzed time and labor data from FY 2016 to determine whether it should revise the direct hours per FTE. In FY 2016, the total mission-direct hours charged by direct employees increased due to increased accuracy in coding time to direct work in the time and labor system, as well as decreased time coded for training. The increase in mission-direct hours was apparent in all mission business lines. To reflect this increase in productivity as demonstrated by the time and labor data, the NRC staff determined that the number of mission-direct hours per FTE should increase to 1,500 hours for FY 2017.
In accordance with NRC policy, in 2017 the NRC staff conducted a biennial review of small entity fees to determine whether the NRC should change those fees. The NRC staff used the fee methodology, developed in FY 2009, which applies a fixed percentage of 39 percent to the prior 2-year weighted
The NRC modifies the description under 10 CFR 171.19, “Payment,” to include fee category 3G in the description as the annual fee is below $100,000. These licensees in fee category 3G should now be billed annual fees on their anniversary month due to the annual fee being less than $100,000. This change resulted from a decrease in budgeted resources allocated to this fee class for the final rule caused by a decrease in the final appropriation.
In a January 30, 2015, paper to the Commission (SECY–15–0015, “Project Aim 2020 Report and Recommendations” (ADAMS Accession No. ML15012A594)), the NRC staff recommended that the Office of the Chief Financial Officer (OCFO) undertake an effort to: (1) Simplify how the NRC calculates its fees, (2) improve transparency, and (3) improve the timeliness of the NRC's communications about fee changes. These recommendations were similar to stakeholder comments the staff received during outreach on the NRC's fees and fee development process. In addition, an interoffice steering committee of NRC staff evaluated the current fee process to identify potential; solutions for concerns raised by NRC stakeholders. Based on comments received from the public and input from steering committee members, the staff developed over 40 process and policy improvements to be implemented over the next 4 years that addressed concerns with the current fee process. On August 15, 2016, the Chief Financial Officer (CFO) submitted a paper for Notation Vote (SECY–16–0097 (ADAMS Accession No. ML16194A365)) to the Commission. This memorandum identified 14 process improvements in six categories that the staff would implement in FY 2017 and requested Commission approval to further analyze four improvements as policy issues. The Commission disapproved the policy issues with the exception of a voluntary pilot initiative to explore whether a flat fee structure could be established for routine licensing matters in the area of uranium recovery policy issues. The Commission also directed staff to accelerate the process improvements for future consideration including transition to an electronic billing system.
Currently, 10 of the 14 process improvements for FY 2017 have been completed and the NRC is well-positioned to complete the remaining 4 process improvements by the end of the fiscal year. In addition, 3 of the 9 improvements for FY 2018 have been accelerated and completed. The voluntary pilot project for uranium recovery flat fees and activities to support electronic invoicing are underway. For more information on our fees transformation initiative, please see our License Fees Web site at
The NRC published the FY 2017 proposed fee rule in the
The NRC also held a public meeting on February 16, 2017, to provide more transparency regarding fees in relation to the budget process and fulfill its commitment to external stakeholders to address NRC program processes and inefficiencies mentioned in the comments submitted for the FY 2016 proposed fee rule. During the public meeting, the NRC received no comments on the FY 2017 proposed fee rule. The public meeting transcript is available as indicated in Section XIV, Availability of Documents, of this document.
The NRC received four written comment submissions for the proposed rule. A comment submission for the purpose of this rule is defined as a communication or document submitted to the NRC by an individual or entity with one or more distinct comments addressing a subject or an issue. A comment, on the other hand, refers to a statement made in the submission addressing a subject or issue. In general, the commenters were supportive of the specific proposed regulatory changes, although most commenters expressed concerns about broader fee-policy issues related to transparency and fairness.
The commenters are listed in Table XIX, and are classified as follows: One member of the uranium industry (Wyoming Mining Association (WMA)); one nuclear power plant operator (Exelon); one private citizen; and one industry trade group (Nuclear Energy Institute (NEI)).
Information about obtaining the complete text of the comment submissions is available in Section XIV, “Availability of Documents,” of this document.
The NRC has carefully considered the public comments received. The comments have been organized by topic followed by the NRC response.
Further, for the FY 2017 final fee rule, the annual fee for non-DOE uranium recovery licensees will remain flat for most licensees. This change from the projected 8 percent increase in the proposed rule is due to a decrease in budgetary resources and an increase in non-DOE 10 CFR part 170 estimated billings. For additional information, refer to the uranium recovery section of this final rule.
No change was made to the final rule in response to this comment.
In addition, as part of the fees transformation initiative, the NRC is beginning a voluntary pilot to explore whether a flat fee structure could be established for routine licensing matters in the area of uranium recovery. As part of this pilot the NRC will engage with stakeholders to solicit feedback on the proposed strategy before a final decision is made.
No change was made to the final rule in response to this comment.
Response: Costs related to specific projects are recovered through hourly charges and do not increase fees for all licensees. The part of the FY 2017 fee rule discussion being questioned by the commenter is only a general description of the business environment affecting the 10 CFR part 170 user fees (
No change was made to the final rule in response to this comment.
Further, for the FY 2017 final fee rule, the annual fee for non-DOE uranium recovery licensees will remain flat for most licensees. This change from the projected 8 percent increase in the proposed rule is due to a decrease in budgetary resources and an increase in non-DOE 10 CFR part 170 estimated billings. For additional information, refer to the uranium recovery section of this final rule.
As part of our Wyoming transition initiative, the NRC will explore alternative methods of developing the fee schedule to support a continued fair and equitable assessment of fees to recover the budgetary resources associated with contested hearings. The alternative methods may include seeking an appropriation off the fee base, developing an alternate fee class structure, or classifying the resources as fee relief. The NRC will evaluate these changes and the associated impacts across the various fee classes and categories in a future fee rule.
No change was made to the final rule in response to this comment.
The NRC would not be able to provide specific information on contracts since it is proprietary in nature. However, as part of the fees transformation initiative, project managers are providing enhanced licensee outreach to increase awareness of general contract activities and costs.
No change was made to the final rule in response to this comment.
The amount not included under international fee relief activities represents international resources that the NRC assigned to each mission-direct fee class in the work papers. Specifically, these resources represent international cooperation activities that benefit a specific fee class (rather than international assistance activities or technical cooperation activities whose benefits range across several classes of licensees). These fee-recoverable cooperation activities provide direct input to the NRC's regulations and the NRC's oversight of its licensees and, therefore, benefit a group of NRC licensees. For example, international cooperative activities involve sharing information, knowledge, and technical expertise with the NRC's international regulatory counterparts. These international cooperative activities enhance the NRC's regulatory programs by providing direct input into the NRC's regulation and oversight of its licensees. International cooperation activities also provide other benefits to NRC licensees, such as collaborative research that is relevant to the NRC's regulatory programs. The NRC continuously assesses and, where relevant, incorporates international operating experience and research insights into the NRC's domestic regulatory program. As an example of the relevance of international cooperation work to the NRC's nuclear safety mission, power reactor licensees benefit from international efforts to exchange information on operational events, regulatory experience, and expertise on construction, startup, and the operation of nuclear power plants.
Changes were made to the final rule work papers in response to this comment.
Unrelated to the calculation of 10 CFR part 170 estimates, the NRC is currently developing estimates for services to be posted on our Web site as part of our Fee Transformation initiative.
No change was made to the final rule in response to this comment.
No change was made to the final rule in response to this comment.
The WMA considers the proportion of hours (28%) spent on non-mission-direct work to be excessive and that a much smaller portion of time should be devoted to non-mission-direct work. (WMA)
In the final fee rule for FY 2005 (70 FR 30526, May 26, 2005), the NRC revised its estimate of the number of mission-direct hours per FTE to use a realistic estimate based on time and labor data for program employees who perform activities directly associated with the programmatic mission of the NRC. The NRC periodically reviews time and labor data to assess changes in the average number of productive hours from year to year and determines a realistic estimate of direct hours per FTE based on the most recent data. The estimate does not include time for administration, training, and other activities a mission-direct program FTE may perform that, while relevant to consider for certain costing purposes, would more accurately be considered overhead rather than mission-direct time for purposes of calculating a rate per hour of direct activities. When the NRC calculates the fees required to recover the budget enacted by Congress, this estimate of mission-direct hours per FTE is used to calculate the hourly rate.
The estimate of 1,500 hours per FTE used in the fee rule calculation for FY 2017 was based on an analysis of actual time and labor data from FY 2016. Use of an updated, realistic estimate of mission-direct hours per FTE helps ensure that the hourly rate accurately reflects the current cost of providing 10 CFR part 170 services, allowing the NRC to more fully recover the costs of these services through 10 CFR part 170 fees.
No change was made to the final rule in response this comment.
No change was made to the final rule in response to this comment.
No change was made to the final rule in response to this comment.
No change was made to the final rule in response to this comment.
No change was made to the final rule in response to this comment.
In its comments dated May 4, 2016 on the Request for Information—Fees Development and Communications—(
The WMA believes that a substantial problem with the agency's invoicing is the lack of predictability in the invoice amounts. This could be mitigated to some extent by flat fee invoicing for some items however for others, it would require that the agency prepare a nonbinding estimate of cost to complete the review. (WMA)
Additionally, as directed in SRM–SECY–16–0097, “Fee Setting Improvements and Fiscal Year 2017 Proposed Fee Rule,” dated October 19, 2016, (ADAMS Accession No. ML16293A902) the NRC staff is exploring whether a flat fee structure could be established for routine licensing matters in the area of uranium recovery. In addition, staff is also evaluating the level of detail to be provided in invoices.
No change was made to the final rule in response to this comment.
As part of the fees transformation direction from the Commission, SRM–SECY–16–0097: Fee Setting Improvements and Fiscal Year 2017 Proposed Fee Rule (ML16293A902) the Commission directed staff to review the 2015 fee rule revised methodology of charging overhead time for project managers and resident inspectors and modify it for more clarity. As part of this initiative, the NRC will consider alternate strategies for recovery of the resources allocated to administrative time for project managers and resident inspectors and develop a new approach to be implemented by October 2018.
No change was made to the final rule in response to this comment.
No change was made to the final rule in response to this comment.
For Category 1A(2)(c), program code 31133 is not in our system. We assume the commenter meant program code 21133. The NRC added program code 21133 to Category 1A(2)(c).
The NRC notes that, in calculating the percentage of mission-direct program activities, the commenter does not take into account all mission-direct resources contained in the total budget authority presented in the FY 2017 proposed fee rule. The $340.5 million referenced by the commenter includes only mission-direct salaries and benefits—it does not include the mission-direct amount for contract support, which is an additional $125.3 million. Although not included within the hourly rate, mission-direct contract support is a significant component of the direct costs within the agency's total budget authority. Total mission-direct program activities in the proposed rule—including salaries, benefits, and contract support—equaled $465.8 million. Further, the $136.7 million that the NRC budgeted for mission-indirect program support in the proposed rule brings the NRC's total budgeted mission costs to $602.5 million, or 65 percent of the total budget authority less excluded fee items. The remaining 35 percent for Agency Support in the proposed rule included resources for the NRC's Office of the Inspector General, which is not included when calculating corporate support.
No change was made to the final rule in response to this comment.
Some comments suggested that the NRC implement a number of recommendations to streamline the regulatory process, review the changing technical guidance to licensees, and consider risk when executing regulatory oversight activities.
All of these matters are outside the scope of this rulemaking. The primary purpose of the NRC's annual fee recovery rulemaking is to update the NRC's fee schedules to recover approximately 90 percent of the appropriations that the NRC received for the current fiscal year, and to make other necessary corrections or appropriate changes to specific aspects of the NRC's fee regulations in order to ensure compliance with OBRA–90, as amended.
The NRC takes very seriously the importance of examining and improving the efficiency of its operations and the prioritization of its regulatory activities. Recognizing the importance of continuous reexamination and improvement of the way the agency does business, the NRC has undertaken, and continues to undertake, a number of significant initiatives aimed at improving the efficiency of NRC operations and enhancing the agency's approach to regulating.
As required by the Regulatory Flexibility Act of 1980, as amended (RFA),
Under OBRA–90, the NRC is required to recover approximately 90 percent of its budget authority in FY 2017. The NRC established fee methodology guidelines for 10 CFR part 170 in 1978, and established additional fee methodology guidelines for 10 CFR part 171 in 1986. In subsequent rulemakings, the NRC has adjusted its fees without changing the underlying principles of its fee policy to ensure that the NRC
In this rulemaking, the NRC continues this long-standing approach. Therefore, the NRC did not identify any alternatives to the current fee structure guidelines and did not prepare a regulatory analysis for this rulemaking.
The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to this final rule and that a backfit analysis is not required. A backfit analysis is not required because these amendments do not require the modification of, or addition to, systems, structures, components, or the design of a facility, or the design approval or manufacturing license for a facility, or the procedures or organization required to design, construct, or operate a facility.
The Plain Writing Act of 2010 (Pub. L. 111–274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883). The NRC requests comment on this final rule with respect to the clarity and effectiveness of the language used.
The NRC has determined that this rule will amend NRC's administrative requirements in 10 CFR part 170 and 10 CFR part 171. Therefore, this action is categorically excluded from needing environmental review as described in 10 CFR 51.22(c)(1). Consequently, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule.
This final rule does not contain new or amended information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.
This final rule is a rule as defined in the Congressional Review Act of 1996 (5 U.S.C. 801–808). The Office of Management and Budget has found it to be a major rule as defined in the Congressional Review Act.
The National Technology Transfer and Advancement Act of 1995, Public Law 104–113, requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this final rule, the NRC proposes to amend the licensing, inspection, and annual fees charged to its licensees and applicants, as necessary, to recover approximately 90 percent of its budget authority in FY 2017, as required by OBRA–90, as amended. This action does not constitute the establishment of a standard that contains generally applicable requirements.
The Small Business Regulatory Enforcement Fairness Act requires all Federal agencies to prepare a written compliance guide for each rule for which the agency is required by 5 U.S.C. 604 to prepare a regulatory flexibility analysis. The NRC, in compliance with the law, prepared the “Small Entity Compliance Guide” for the FY 2017 final fee rule. The compliance guide was developed when the NRC completed the small entity biennial review for FY 2017. This document is available as indicated in Section XIV, Availability of Documents, of this document.
The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.
Byproduct material, Import and export licenses, Intergovernmental relations, Non-payment penalties, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Source material, Special nuclear material.
Annual charges, Approvals, Byproduct material, Holders of certificates, Intergovernmental relations, Nonpayment penalties, Nuclear materials, Nuclear power plants and reactors, Registrations, Source material, Special nuclear material.
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR parts 170 and 171.
Atomic Energy Act of 1954, secs. 11, 161(w) (42 U.S.C. 2014, 2201(w)); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); 42 U.S.C. 2214; 31 U.S.C. 901, 902, 9701; 44 U.S.C. 3504 note.
Fees for permits, licenses, amendments, renewals, special projects, 10 CFR part 55 re-qualification and replacement examinations and tests, other required reviews, approvals, and inspections under §§ 170.21 and 170.31 will be calculated using the professional staff-hour rate of $263 per hour.
Atomic Energy Act of 1954, secs. 11, 161(w), 223, 234 (42 U.S.C. 2014, 2201(w), 2273, 2282); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); 42 U.S.C. 2214; 44 U.S.C. 3504 note.
(b)(1) The FY 2017 annual fee for each operating power reactor which must be collected by September 30, 2017, is $4,496,000.
(2) The FY 2017 annual fees are comprised of a base annual fee for power reactors licensed to operate, a base spent fuel storage/reactor decommissioning annual fee, and associated additional charges (fee-relief adjustment). The activities comprising the spent storage/reactor decommissioning base annual fee are shown in paragraphs (c)(2)(i) and (ii) of this section. The activities comprising the FY 2017 fee-relief adjustment are shown in paragraph (d)(1) of this section. The activities comprising the FY 2017 base annual fee for operating power reactors are as follows:
(c)(1) The FY 2017 annual fee for each power reactor holding a 10 CFR part 50 license that is in a decommissioning or possession-only status and has spent fuel onsite, and for each independent spent fuel storage 10 CFR part 72 licensee who does not hold a 10 CFR part 50 license, is $188,000.
(2) The FY 2017 annual fee is comprised of a base spent fuel storage/reactor decommissioning annual fee (which is also included in the operating power reactor annual fee shown in paragraph (b) of this section) and a fee-relief adjustment. The activities comprising the FY 2017 fee-relief adjustment are shown in paragraph (d)(1) of this section. The activities comprising the FY 2017 spent fuel storage/reactor decommissioning re-baselined annual fee are:
(d)(1) The fee-relief adjustment allocated to annual fees includes a surcharge for the activities listed in paragraph (d)(1)(i) of this section, plus the amount remaining after total budgeted resources for the activities included in paragraphs (d)(1)(ii) and (iii) of this section are reduced by the appropriations the NRC receives for these types of activities. If the NRC's appropriations for these types of activities are greater than the budgeted resources for the activities included in paragraphs (d)(1)(ii) and (iii) of this section for a given fiscal year, annual fees will be reduced. The activities comprising the FY 2017 fee-relief adjustment are as follows:
(2) The total FY 2017 fee-relief adjustment allocated to the operating power reactor class of licenses is an $11,074,000 fee-relief surcharge, not including the amount allocated to the spent fuel storage/reactor decommissioning class. The FY 2017 operating power reactor fee-relief adjustment to be assessed to each operating power reactor is approximately a $111,863 fee-relief surcharge. This amount is calculated by dividing the total operating power reactor fee-relief surplus adjustment, $11,074,000, by the number of operating power reactors (99).
(3) The FY 2017 fee-relief adjustment allocated to the spent fuel storage/reactor decommissioning class of licenses is a $467,500 fee-relief assessment. The FY 2017 spent fuel storage/reactor decommissioning fee-relief adjustment to be assessed to each operating power reactor, each power reactor in decommissioning or possession-only status that has spent fuel onsite, and to each independent spent fuel storage 10 CFR part 72 licensee who does not hold a 10 CFR part 50 license, is a $3,832 fee-relief assessment. This amount is calculated by dividing the total fee-relief adjustment costs allocated to this class by the total number of power reactor licenses, except those that permanently ceased operations and have no fuel onsite, and 10 CFR part 72 licensees who do not hold a 10 CFR part 50 license.
(f) The FY 2017 annual fees for licensees authorized to operate a research or test (non-power) reactor licensed under 10 CFR part 50, unless the reactor is exempted from fees under § 171.11(a), are as follows:
(c) A licensee who is required to pay an annual fee under this section, in addition to 10 CFR part 72 licenses, may qualify as a small entity. If a licensee qualifies as a small entity and provides the Commission with the proper certification along with its annual fee payment, the licensee may pay reduced annual fees as shown in the following table. Failure to file a small entity certification in a timely manner could result in the receipt of a delinquent invoice requesting the outstanding
(d) The FY 2017 annual fees are comprised of a base annual fee and an allocation for fee-relief adjustment. The activities comprising the FY 2017 fee-relief adjustment are shown for convenience in paragraph (e) of this section. The FY 2017 annual fees for materials licensees and holders of certificates, registrations, or approvals subject to fees under this section are shown in the following table:
(e) The fee-relief adjustment allocated to annual fees includes the budgeted resources for the activities listed in paragraph (e)(1) of this section, plus the total budgeted resources for the activities included in paragraphs (e)(2) and (3) of this section, as reduced by the appropriations the NRC receives for these types of activities. If the NRC's appropriations for these types of activities are greater than the budgeted resources for the activities included in paragraphs (e)(2) and (3) of this section for a given fiscal year, a negative fee-relief adjustment (or annual fee reduction) will be allocated to annual fees. The activities comprising the FY 2017 fee-relief adjustment are as follows:
(d) Annual fees of less than $100,000 must be paid as billed by the NRC. Materials license annual fees that are less than $100,000 are billed on the anniversary date of the license. The materials licensees that are billed on the anniversary date of the license are those covered by fee categories 1.C., 1.D., 1.F., and 2.A.(2) through 9.D.
For the Nuclear Regulatory Commission.