Agency Information Collection Activities: Submission for OMB Review; Comment Request

AGENCY:

Centers for Medicare & Medicaid Services, Health and Human Services (HHS).

ACTION:

Notice.

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 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).