[Federal Register Volume 78, Number 142 (Wednesday, July 24, 2013)]
[Notices]
[Pages 44569-44571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17821]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10268, CMS-10287, CMS-R-70, CMS-R-72, CMS-R-
247, CMS-10151, CMS-10380, CMS-10286, and CMS-10339]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
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 (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 a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by August 23, 2013.
ADDRESSES: 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: OMB,
Office of Information and Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395-6974, or Email: [email protected].
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 http://www.cms.hhs.gov/PaperworkReductionActof1995.
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: Reports Clearance Office at (410) 786-
1326.
SUPPLEMENTARY INFORMATION: 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 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 that
summarizes the following proposed collection(s) of information for
public comment:
1. Type of Information Collection Request: Reinstatement of a
currently approved collection; Title of Information Collection:
Consolidated Renal Operations in a Web Enabled Network (CROWNWeb)
Third-party Submission Authorization Form; Use: The Consolidated Renal
Operations in a Web Enabled Network (CROWNWeb) Third-Party Submission
Authorization form (CWTPSA) is to be completed by ``Facility
Administrators'' (administrators of CMS-certified dialysis facilities)
if they intend to authorize a third party (a business with which the
facility is associated, or an independent vendor) to submit data to us
to comply with the recently-revised Conditions for Coverage of dialysis
facilities. The CROWNWeb system is the system used as the collection
point of data necessary for entitlement of ESRD patients to Medicare
benefits and for Federal Government monitoring and assessing of the
quality and types of care provided to renal patients. The information
collected through the CWTPSA form will allow us along with our
contractors to receive data from authorized parties acting on behalf of
CMS-certified dialysis facilities. Since February 2009, we have
received 4,160 CWTPSA forms and anticipates that they will continue to
receive no more than 400 new CWTPSA forms annually to address the
creation of new facilities under the current participating ``third
party submitters.'' Form Number: CMS-10268 (OCN: 0938-1052); Frequency:
Occasionally; Affected Public: Private Sector--Business or other for-
profits and Not-for-profit institutions; Number of Respondents: 400;
Total Annual Responses: 400; Total Annual Hours: 34. (For policy
questions regarding this collection contact Michelle Tucker at 410-786-
0736.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicare Quality
of Care Complaint Form; Use: In
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accordance with Section 1154(a)(14) of the Social Security Act, Quality
Improvement Organizations (QIOs) are required to conduct appropriate
reviews of all written complaints submitted by beneficiaries concerning
the quality of care received. The Medicare Quality of Care Complaint
Form will be used by Medicare beneficiaries to submit quality of care
complaints. This form will establish a standard form for all
beneficiaries to utilize and ensure pertinent information is obtained
by QIOs to effectively process these complaints. Form Number: CMS-10287
(OCN: 0938-1102); Frequency: Reporting--Occasionally; Affected Public:
Individuals or Households; Number of Respondents: 3,500; Total Annual
Responses: 3,500; Total Annual Hours: 583. (For policy questions
regarding this collection contact Coles Mercier at 410-786-2112.)
3. Type of Information Collection Request: Reinstatement with a
change of a previously approved collection; Title of Information
Collection: Information Collection Requirements in HSQ-110,
Acquisition, Protection and Disclosure of Peer review Organization
Information and Supporting Regulations in 42 CFR, Sections 480.104,
480.105, 480.116, and 480.134; Use: The Peer Review Improvement Act of
1982 authorizes quality improvement organizations (QIOs), formally
known as peer review organizations (PROs), to acquire information
necessary to fulfill their duties and functions and places limits on
disclosure of the information. The QIOs are required to provide notices
to the affected parties when disclosing information about them. These
requirements serve to protect the rights of the affected parties. The
information provided in these notices is used by the patients,
practitioners and providers to: obtain access to the data maintained
and collected on them by the QIOs; add additional data or make changes
to existing QIO data; and reflect in the QIO's record the reasons for
the QIO's disagreeing with an individual's or provider's request for
amendment.: Form Number: CMS-R-70 (OCN: 0938-0426); Frequency:
Reporting--On occasion; Affected Public: Business or other for-profits;
Number of Respondents: 400; Total Annual Responses: 21,200; Total
Annual Hours: 42,400. (For policy questions regarding this collection
contact Coles Mercier at 410-786-2112.)
4. Type of Information Collection Request: Reinstatement without
change of a previously approved collection; Title of Information
Collection: Information Collection Requirements in 42 CFR 478.18,
478.34, 478.36, 478.42, QIO Reconsiderations and Appeals; Use: In the
event that a beneficiary, provider, physician, or other practitioner
does not agree with the initial determination of a Quality Improvement
Organization (QIO) or a QIO subcontractor, it is within that party's
rights to request reconsideration. The information collection
requirements 42 CFR 478.18, 478.34, 478.36, and 478.42, contain
procedures for QIOs to use in reconsideration of initial
determinations. The information requirements contained in these
regulations are on QIOs to provide information to parties requesting
the reconsideration. These parties will use the information as
guidelines for appeal rights in instances where issues are actively
being disputed. Form Number: CMS-R-72 (OCN: 0938-0443); Frequency:
Reporting--On occasion; Affected Public: Individuals or Households and
Business or other for-profit institutions; Number of Respondents:
2,590; Total Annual Responses: 5,228; Total Annual Hours: 2,822. (For
policy questions regarding this collection contact Coles Mercier at
410-786-2112.)
5. Type of Information Collection Request: Reinstatement with a
change of a previously approved collection; Title of Information
Collection: Expanded Coverage for Diabetes Outpatient Self-Management
Training Services and Supporting Regulations Contained in 42 CFR
410.141, 410.142, 410.143, 410.144, 410.145, 410.146, 414.63; Use:
According to the National Health and Nutrition Examination Survey
(NHANES), as many as 18.7 percent of Americans over age 65 are at risk
for developing diabetes. The goals in the management of diabetes are to
achieve normal metabolic control and reduce the risk of micro- and
macro-vascular complications. Numerous epidemiologic and interventional
studies point to the necessity of maintaining good glycemic control to
reduce the risk of the complications of diabetes. Despite this
knowledge, diabetes remains the leading cause of blindness, lower
extremity amputations and kidney disease requiring dialysis. Diabetes
and its complications are primary or secondary factors in an estimated
9 percent of hospitalizations (Aubert, RE, et al., Diabetes-related
hospitalizations and hospital utilization. In: Diabetes in America. 2nd
ed. National Institutes of Health, National Institute of Diabetes and
Digestive and Kidney Disease, NIH, Pub. No 95-1468-1995: 553-570).
Overall, beneficiaries with diabetes are hospitalized 1.5 times more
often than beneficiaries without diabetes. HCFA-3002-F provided for
uniform coverage of diabetes outpatient self-management training
services. These services include educational and training services
furnished to a beneficiary with diabetes by an entity approved to
furnish the services. The physician or qualified non-physician
practitioner treating the beneficiary's diabetes would certify that
these services are needed as part of a comprehensive plan of care. This
rule established the quality standards that an entity would be required
to meet in order to participate in furnishing diabetes outpatient self-
management training services. It set forth payment amounts that have
been established in consultation with appropriate diabetes
organizations. It implements section 4105 of the Balanced Budget Act of
1997. Form Number: CMS-R-247 (OCN: 0938-0818); Frequency: Recordkeeping
and Reporting--Occasionally; Affected Public: Business or other for-
profit institutions; Number of Respondents: 5327; Total Annual
Responses: 63,924; Total Annual Hours: 197,542. (For policy questions
regarding this collection contact Kristin Shifflett at 410-786-4133.)
6. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Data Collection for Medicare Beneficiaries Receiving
Implantable Cardioverter-Defibrillators for Primary Prevention of
Sudden Cardiac Death; Use: We provide coverage for implantable
cardioverter-defibrillators (ICDs) for secondary prevention of sudden
cardiac death based on extensive evidence showing that use of ICDs
among patients with a certain set of physiologic conditions are
effective. Accordingly, we consider coverage for ICDs reasonable and
necessary under Section 1862 (a) (1) (A) of the Social Security Act.
However, evidence for use of ICDs for primary prevention of sudden
cardiac death is less compelling for certain patients.
To encourage responsible and appropriate use of ICDs, we issued a
``Decision Memo for Implantable Defibrillators'' on January 27, 2005,
indicating that ICDs will be covered for primary prevention of sudden
cardiac death if the beneficiary is enrolled in either an FDA-approved
category B IDE clinical trial (42 CFR 405.201), a trial under the CMS
Clinical Trial Policy (NCD Manual Sec. 310.1) or a qualifying
prospective data collection system (either a practical clinical trial
or prospective systematic data collection, which is sometimes referred
to as a registry). Form Number: CMS-10151 (OMB: 0938-0967);
Frequency: Occasionally; Affected Public: Private
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Sector; Business or other for-profits, Not-for-profit institutions;
Number of Respondents: 1,702; Total Annual Responses: 82; Total Annual
Hours: 139,356. (For policy questions regarding this collection contact
JoAnna Baldwin at 410-786-7205.)
7. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Reporting
Requirements for Grants to Support States in Health Insurance Rate
Review and Pricing Transparency--Cycles I, II, and III; Use: Under the
Section 1003 of the Affordable Care Act (ACA) (Section 2794 of the
Public Health Service Act), the Secretary, in conjunction with the
states and territories, is required to establish a process for the
annual review, beginning with the 2010 plan year, of unreasonable
increases in premiums for health insurance coverage. Section 2794(c)
requires the Secretary to establish the Rate Review Grant Program to
States to assist states to implement this provision. In addition,
Section 2794(c) requires the Rate Review Grant Program to assist states
in the establishment and enhancement of ``Data Centers'' that collect,
analyze, and disseminate health care pricing data to the public.
The U.S. Department of Health and Human Services (HHS) released the
Rate Review Grants Cycle I funding opportunity twice--first to states
(and the District of Columbia) in June 2010 and then to the territories
and the five states that did not apply during the first release,
(http://www.hhs.gov/ociio/initiative/final_premium_review_grant_solicitation.pdf). The second release was due to the decision that the
territories were subject to provisions of the ACA and hence eligible
for the Rate Review Grants. Forty-five (45) states, 5 U.S. territories,
and the District of Columbia were awarded grants. On February 24, 2011,
HHS released the Funding Opportunity Award (FOA) for Cycle II Rate
Review Grants. On December 21, 2012, Cycle II of the Rate Review Grant
Program was amended in order to include an additional application date.
Thirty (30) states, the District of Columbia, and three territories
were awarded grants in Cycle II.
On May 8, 2013, CMS published the Cycle III Funding Opportunity
Announcement, ``Grants to Support States in Health Insurance Rate
Review and Pricing Transparency''. On July 12, 2013, the Funding
Opportunity Announcement for Cycle III of the Rate Review Grants
Program was amended in order to extend the deadline for submission of
Letters of Intent. Concurrent with the publication of the Funding
Opportunity Announcement for Cycle III, CMS published associated
grantee reporting requirements consisting of: (4) quarterly reports,
(5) rate review transaction data reports (quarterly and annual), (1)
annual report, and (1) final report from all grantees. This information
collection is required for effective monitoring of grantees and to
fulfill statutory requirements under section 2794(b)(1)(A) of the ACA
that requires grantees, as a condition of receiving a grant authorized
under section 2794(c) of the ACA, to report to the Secretary
information about premium increases. Form Number: CMS-10380 (OCN: 0938-
1121); Frequency: Annually; On Occasion; Affected Public: Public
Sector--State and Territory Governments; Number of Respondents: 56;
Total Annual Responses: 1,001; Total Annual Hours: 31,378; (For policy
questions regarding this collection contact Sarah Norman at 301-492-
4185.)
8. Type of Information Collection Request: Reinstatement with
change of a previously approved information collection; Title of
Information Collection: Notice of Research Exception under the Genetic
Information Nondiscrimination Act; Use: Under the Genetic Information
Nondiscrimination Act of 2008 (GINA), a plan or issuer may request (but
not require) a genetic test in connection with certain research
activities so long as such activities comply with specific
requirements, including: (i) The research complies with 45 CFR part 46
or equivalent Federal regulations and applicable State or local law or
regulations for the protection of human subjects in research; (ii) the
request for the participant or beneficiary (or in the case of a minor
child, the legal guardian of such beneficiary) is made in writing and
clearly indicates that compliance with the request is voluntary and
that non-compliance will have no effect on eligibility for benefits or
premium or contribution amounts; and (iii) no genetic information
collected or acquired will be used for underwriting purposes. The
Secretary of Labor or the Secretary of Health and Human Services is
required to be notified if a group health plan or health insurance
issuer intends to claim the research exception permitted under Title I
of GINA. Nonfederal governmental group health plans and issuers solely
in the individual health insurance market or Medigap market will be
required to file with the Centers for Medicare & Medicaid Services
(CMS). The Notice of Research Exception under the Genetic Information
Nondiscrimination Act is a model notice that can be completed by group
health plans and health insurance issuers and filed with either the
Department of Labor or CMS to comply with the notification requirement.
Form Number: CMS-10286 (OCN: 0938-1077); Frequency: On Occasion;
Affected Public: State, Local, or Tribal Governments, Private Sector;
Number of Respondents: 2; Total Annual Responses: 2; Total Annual
Hours: 1; (For policy questions regarding this collection contact Usree
Bandyopadhyay at 410-786-6650.)
9. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Pre-Existing
Health Insurance Plan and Supporting Regulations; Use: On March 23,
2010, the President signed into law H.R. 3590, the Patient Protection
and Affordable Care Act (Affordable Care Act), Public Law 111-148.
Section 1101 of the law establishes a ``temporary high risk health
insurance pool program'' (which has been named the Pre-Existing
Condition Insurance Plan, or PCIP) to provide health insurance coverage
to currently uninsured individuals with pre-existing conditions. The
law authorizes HHS to carry out the program directly or through
contracts with states or private, non-profit entities.
We are requesting an extension of this package because this
information is needed to assure that PCIP programs are established
timely and effectively. This request is being made based on regulations
and guidance that have been issued and contracts which have been
executed by HHS with states or an entity on their behalf participating
in the PCIP program. PCIP is also referred to as the temporary
qualified high risk insurance pool program, as it is called in the
Affordable Care Act, but we have adopted the term PCIP to better
describe the program and avoid confusion with the existing state high
risk pool programs. Form Number: CMS-10339 (OMB: 0938-1100);
Frequency: Reporting--On occasion; Affected Public: state governments;
Number of Respondents: 51; Total Annual Responses: 2,652; Total Annual
Hours: 36,924. (For policy questions regarding this collection contact
William Brice at 410-786-1777.)
Dated: July 19, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2013-17821 Filed 7-23-13; 8:45 am]
BILLING CODE 4120-01-P