[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Pages 53059-53060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 www.reginfo.gov/public/do/PRAMain. 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: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

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