[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Notices]
[Pages 13130-13132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06081]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10341, CMS-10538, CMS-R-153, CMS-10561 and
CMS-10336]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
ACTION: Notice.
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SUMMARY: 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 (the PRA), federal agencies are required to publish notice
in the Federal Register concerning each proposed collection of
information (including each proposed extension or reinstatement of an
existing collection of information) and to allow 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
DATES: Comments must be received by May 29, 2018.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
http://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number __, Room C4-26-05, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850.
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' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-10341 Affordable Care Act Information and Collection Requirements
for Section 1115 Demonstration Projects
CMS-10538 Hospice Information for Medicare Part D Plans
CMS-R-153 Medicaid Drug Use Review (DUR) Program
CMS-10561 Essential Community Provider Data Collection to Support QHP
Certification for PYs 2021-2023
CMS-10336 Medicare and Medicaid Programs; Electronic Health Record
Incentive Program
Under the 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 requires federal agencies
to publish a 60-day notice in the Federal Register concerning each
proposed collection of information, including each proposed extension
or reinstatement of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, CMS is publishing this notice.
Information Collection
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Section 1115
Demonstration Projects Regulations at 42 CFR 431.408, 431.412, 431.420,
431.424, and 431.428; Use: This collection is necessary to ensure that
states comply with regulatory and statutory requirements related to the
development, implementation and evaluation of demonstration projects.
States seeking waiver authority under Section 1115 are required to meet
certain requirements for public notice, the evaluation of demonstration
projects, and reports to the Secretary on the implementation of
approved demonstrations. Form Number: CMS-10341 (OMB control number
0938-1162); Frequency: Yearly and quarterly; Affected Public: State,
Local, or Tribal Governments; Number of Respondents: 37; Total Annual
Responses: 300; Total Annual Hours: 24,092. (For policy questions
regarding this collection contact Tonya Moore at 410-786-0019.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Hospice
Information for Medicare Part D Plans; Use: The form would be completed
by the prescriber or the beneficiary's hospice, or if the prescriber or
hospice provides the information verbally to the Part D sponsor, the
form would be completed by the sponsor. Information provided on the
form would be used by the Part D sponsor to establish coverage of the
drug under Medicare Part D. Per statute, drugs that are necessary for
the palliation and management of the terminal illness and related
conditions are not eligible for payment under Part D. The standard form
provides a vehicle for the hospice provider, prescriber or sponsor to
document that the drug prescribed is ``unrelated'' to the
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terminal illness and related conditions. It also gives a hospice
organization the option to communicate a beneficiary's change in
hospice status and care plan to Part D sponsors. Form Number: CMS-10538
(OMB control number 0938-1269); Frequency: Occasionally; Affected
Public: Private sector (business or other for-profits); Number of
Respondents: 424; Total Annual Responses: 376,487; Total Annual Hours:
31,374. (For policy questions regarding this collection contact Shelly
Winston at 410-786-3694.)
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicaid Drug Use
Review (DUR) Program; Use: States must provide for a review of drug
therapy before each prescription is filled or delivered to a Medicaid
patient. This review includes screening for potential drug therapy
problems due to therapeutic duplication, drug-disease
contraindications, drug-drug interactions, incorrect drug dosage or
duration of drug treatment, drug-allergy interactions, and clinical
abuse/misuse. Pharmacists must make a reasonable effort to obtain,
record, and maintain Medicaid patient profiles. These profiles must
reflect at least the patient's name, address, telephone number, date of
birth/age, gender, history, e.g., allergies, drug reactions, list of
medications, and pharmacist's comments relevant to the individual's
drug therapy.
The State must conduct RetroDUR which provides for the ongoing
periodic examination of claims data and other records in order to
identify patterns of fraud, abuse, inappropriate or medically
unnecessary care. Patterns or trends of drug therapy problems are
identified and reviewed to determine the need for intervention activity
with pharmacists and/or physicians. States may conduct interventions
via telephone, correspondence, or face-to-face contact.
Annual reports are submitted to CMS for the purposes of monitoring
compliance and evaluating the progress of States' DUR programs. The
information submitted by States is reviewed and results are compiled by
CMS in a format intended to provide information, comparisons and trends
related to States' experiences with DUR. The States benefit from the
information and may enhance their programs each year based on State
reported innovative practices that are compiled by CMS from the DUR
annual reports. Form Number: CMS-R-153 (OMB control number: 0938-0659);
Frequency: Yearly, quarterly, and occasionally; Affected Public: State,
Local, or Tribal Governments; Number of Respondents: 51; Total Annual
Responses: 663; Total Annual Hours: 41,004. (For policy questions
regarding this collection contact Emeka Egwim at 410-786-1092.)
4. Type of Information Collection Request: Extension of a currently
approved information collection; Title of Information Collection:
Essential Community Provider Data Collection to Support QHP
Certification for PYs 2021-2023; Use: For plan years beginning on or
after January 1, 2021, Health and Human Services (HHS) intends to
continue collecting more complete provider data for inclusion on the
HHS Essential Community Provider (ECP) list to ensure a more accurate
reflection of the universe of qualified available ECPs in a given
service area that can be counted toward an issuer's satisfaction of the
ECP standard. HHS intends to continue collecting these data on
qualified and available ECPs directly from providers through the online
ECP petition. Providers will submit an ECP petition to be added to the
HHS ECP list or update required data fields to remain on the list. Form
Number: CMS-10561 (OMB Control Number: 0938-1295); Frequency: Annually;
Affected Public: Private sector (Business or other for-profits and Not-
for-profit Institutions); Number of Respondents: 14,260; Total Annual
Responses: 14,260; Total Annual Hours: 7,468. (For policy questions
regarding this collection contact Deborah Hunter at (202) 309-1098).
5. Type of Information Collection Request: Extension of a currently
approved information collection; Title of Information Collection:
Medicare and Medicaid Programs; Electronic Health Record Incentive
Program; Use: The American Recovery and Reinvestment Act of 2009
(Recovery Act) (Pub. L. 111-5) was enacted on February 17, 2009. The
Recovery Act includes many measures to modernize our nation's
infrastructure, and improve affordable health care. Expanded use of
health information technology (HIT) and certified electronic health
record (EHR) technology will improve the quality and value of America's
health care. Title IV of Division B of the Recovery Act amends Titles
XVIII and XIX of the Social Security Act (the Act) by establishing
incentive payments to eligible professionals (EPs), eligible hospitals
and critical access hospitals (CAHs), and Medicare Advantage (MA)
organizations participating in the Medicare and Medicaid programs that
adopt and successfully demonstrate meaningful use of certified EHR
technology. These Recovery Act provisions, together with Title XIII of
Division A of the Recovery Act, may be cited as the ``Health
Information Technology for Economic and Clinical Health Act'' or the
``HITECH Act.''
The HITECH Act creates incentive programs for EPs and eligible
hospitals, including CAHs, in the Medicare Fee-for-Service (FFS), MA,
and Medicaid programs that successfully demonstrate meaningful use of
certified EHR technology. In their first payment year, Medicaid EPs and
eligible hospitals may adopt, implement or upgrade to certified EHR
technology. It also, provides for payment adjustments in the Medicare
FFS and MA programs starting in FY 2015 for EPs and eligible hospitals
participating in Medicare that are not meaningful users of certified
EHR technology. These payment adjustments do not pertain to Medicaid
providers.
The first final rule for the Medicare and Medicaid EHR Incentive
Program, which was published in the Federal Register on July 28, 2010
(CMS-0033-F), specified the initial criteria EPs, eligible hospitals
and CAHs, and MA organizations must meet in order to qualify for
incentive payments; calculation of incentive payment amounts; payment
adjustments under Medicare for covered professional services and
inpatient hospital services provided by EPs, eligible hospitals and
CAHs failing to demonstrate meaningful use of certified EHR technology
beginning in 2015; and other program participation requirements. On the
same date, the Office of the National Coordinator of Health Information
Technology (ONC) issued a closely related final rule (45 CFR part 170,
RIN 0991-AB58) that specified the initial set of standards,
implementation specifications, and certification criteria for certified
EHR technology. ONC has also issued a separate final rule on the
establishment of certification programs for health information
technology (HIT) (45 CFR part 170, RIN 0991-AB59). The functionality of
certified EHR technology should facilitate the implementation of
meaningful use. Subsequently, final rules have been issued by CMS (77
FR 53968) and ONC (77 FR 72985) to create a Stage 2 of meaningful use
criteria and other changes to the CMS EHR Incentive Programs and the
2014 Edition Certification Criteria for EHR technology.
The information collection requirements contained in this
information collection request are needed to implement the HITECH Act.
In order to avoid duplicate payments, all EPs are enumerated through
their National Provider Identifier (NPI), while all eligible hospitals
and CAHs are
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enumerated through their CMS Certification Number (CCN). State Medicaid
agencies and CMS use the provider's tax identification number and NPI
or CCN combination in order to make payment, validate payment
eligibility and detect and prevent duplicate payments for EPs, eligible
hospitals and CAHs. Form Number: CMS-10336 (OMB Control Number: 0938-
1158); Frequency: Occasionally; Affected Public: Private sector; Number
of Respondents: 214,694; Total Annual Responses: 214,694; Total Annual
Hours: 2,034,740. (For policy questions regarding this collection
contact Steven Johnson at (410) 786-3332).
Dated: March 22, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2018-06081 Filed 3-26-18; 8:45 am]
BILLING CODE 4120-01-P