Notice2021-20722
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 24, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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 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.
Full Text
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<title>Federal Register, Volume 86 Issue 183 (Friday, September 24, 2021)</title>
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[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Pages 53059-53060]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-20722]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10531 and CMS-10501]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
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 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 on the collection(s) of information must be received by
the OMB desk officer by October 25, 2021.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html</a>.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
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: Revision of a currently
approved collection; Title of Information Collection: Transcatheter
Valve Therapy (TVT) Registry; Use: The data collection is required by
the Centers for Medicare & Medicaid Services (CMS) National Coverage
Determination (NCD) entitled, ``Transcatheter Edge-to-Edge Repair
(TEER) for Mitral Valve Regurgitation'' and was previously entitled
``Transcatheter Mitral Valve Repair (TMVR)''. Effective January 19,
2021, CMS updated this NCD to expand coverage to functional mitral
regurgitation (MR). Previously, coverage was limited to degenerative
MR. To more precisely define the treatment addressed in this NCD, we
replaced the term TMVR with TEER. The TEER device is only covered when
specific conditions are met including that the heart team and hospital
are submitting data in a prospective, national, audited registry. The
data includes patient, practitioner and facility level variables that
predict outcomes such as all-cause mortality and quality of life. In
order to remove the data collection requirement under this coverage
with evidence development (CED) NCD or make any other changes to the
existing policy, we must formally reopen and reconsider the policy. We
are continuing to review and analyze the data collected since the
original NCD was effective in 2014 and following the update in 2021.
The data collected and analyzed in the TVT Registry will be used by
CMS to determine if TEER is reasonable and necessary (e.g., improves
health outcomes) for Medicare beneficiaries
[[Page 53060]]
under Section 1862(a)(1)(A) of the ACT. Furthermore, data from the
Registry will assist the medical device industry and the Food and Drug
Administration (FDA) in surveillance of the quality, safety and
efficacy of new medical devices to treat MR. Form Number: CMS-10531
(OMB control number: 0938-1274); Frequency: Annually; Affected Public:
Private sector (Business or other for-profits); Number of Respondents:
8,649; Total Annual Responses: 34,596; Total Annual Hours: 12,974. (For
policy questions regarding this collection contact Sarah Fulton at 410-
786-2749.)
2. Title of Information Collection: Healthcare Fraud Prevention
Partnership (HFPP) Data Sharing and Information Exchange; Type of
Information Collection Request: Revision; Use: Section 1128C(a)(2) of
the Social Security Act (42 U.S.C. 1320a-7c(a)(2)) authorizes the
Secretary and the Attorney General to consult, and arrange for the
sharing of data with, representatives of health plans for purposes of
establishing a Fraud and Abuse Control Program as specified in Section
1128(C)(a)(1) of the Social Security Act. The result of this authority
has been the establishment of the HFPP. The HFPP was officially
established by a Charter in the fall of 2012 and signed by HHS
Secretary Sibelius and US Attorney General Holder. In December 2020,
President Trump signed into law H.R.133--Consolidated Appropriations
Act, 2021, which amended Section 1128C(a) of the Social Security Act
(42 U.S.C. 1320a-7c(a)) providing explicit statutory authority for the
Healthcare Fraud Prevention Partnership including the potential
expansion of the public-private partnership analyses.
Data sharing within the HFPP primarily focuses on conducting
studies for the purpose of combatting fraud, waste, and abuse. These
studies are intended to target specific vulnerabilities within the
payment systems in both the public and private healthcare sectors. The
HFPP and its committees design and develop studies in coordination with
the TTP. The core function of the TTP is to manage and execute the HFPP
studies within the HFPP. Form Number: CMS-10501 (OMB control number:
0938-1251); Frequency: Occasionally; Affected Public: Private sector
(Business or other for-profits); Number of Respondents: 28; Number of
Responses: 28; Total Annual Hours: 120. (For questions regarding this
collection, contact Marnie Dorsey at (410-786-5942).
Dated: September 21, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2021-20722 Filed 9-23-21; 8:45 am]
BILLING CODE 4120-01-P
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