[Federal Register Volume 89, Number 175 (Tuesday, September 10, 2024)]
[Notices]
[Pages 73420-73421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20400]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10141, CMS-10913, CMS-R-290 and CMS-10443]


Agency Information Collection Activities: Proposed Collection; 
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 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 November 12, 2024.

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, please access 
the CMS PRA website by copying and pasting the following web address 
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

FOR FURTHER INFORMATION CONTACT: William N. 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-10141 Medicare Prescription Drug Benefit Program
CMS-10913 Medicare Part C Utilization Management Annual Data Submission 
and Audit Protocol Data Request
CMS-R-290 Medicare Program: Procedures for Making National Coverage 
Decisions
CMS-10443 Transcatheter Valve Therapy (TVT) Registry

    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 Collections

    1. Type of Information Collection Request: Revision of a currently 
approved information collection; Title of Information Collection: 
Medicare Prescription Drug Benefit Program; Use: CMS will use this 
information from plan sponsors and States to approve contract 
applications, monitor compliance with contract requirements, make 
proper payment to plans, and ensure that correct information is 
disclosed to potential and current enrollees. Form Number: CMS-10141 
(OMB control number: 0938-0964); Frequency: Annually; Affected Public: 
Private Sector, State, Local, or Tribal Governments; Number of 
Respondents: 4,633,032; Total Annual Responses: 87,014,803; Total 
Annual Hours: 25,409,037. (For policy questions regarding this 
collection contact Chad Buskirk at 410-786-1630 or 
[email protected]).
    2. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Medicare Part C Utilization Management Annual Data Submission and Audit 
Protocol Data Request; Use: Section 1857(d) of the Act, added by the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 
and implementing regulations at 42 CFR 422.503 and 422.504 state that 
CMS must oversee an MA organization's continued compliance with the 
requirements for a MA organization. Additionally, per Sec.  422.516(a), 
MA organizations are required to compile and report to CMS information 
related to the utilization of services, and other matters as CMS may 
require.
    The information gathered during this annual data collection and 
audit will be used by the Medicare Parts C and D Oversight and 
Enforcement Group (MOEG) within the Center for Medicare (CM) to assess 
Sponsoring organizations' compliance with Medicare UM requirements. CMS 
will utilize the data submitted during the annual data submission to 
assess the number of items and services that have associated internal 
coverage criteria, and to develop a landscape of items and services 
across the nation to assess

[[Page 73421]]

trends related to the development and utilization of internal coverage 
criteria. Additionally, CMS will use the annual submission to select a 
number of Sponsoring organizations to undergo UM audits each year, and 
to select specific items and services to audit. Annual UM data 
submissions, for all Sponsoring organizations, will be due to CMS by 
January 31 of each calendar year. Form Number: CMS-10913 (OMB control 
number: 0938-new); Frequency: Yearly; Affected Public: Private Sector, 
Business or other for-profits, Not-for-profits institutions; Number of 
Respondents: 179; Total Annual Responses: 179; Total Annual Hours: 
19,180. (For policy questions regarding this collection contact 
Caroline Zeman at 410-786-1564).
    3. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title: Medicare Program: 
Procedures for Making National Coverage Decisions; Use: This collection 
is required by a notice (78 FR 48164-69) published on August 7, 2013 
which delineates the process for making a national coverage 
determination (NCD) including information for external parties to 
submit a formal request for a new NCD or a reconsideration of an 
existing NCD. An NCD is defined in 1862(l) of the Social Security Act 
(the Act) as ``a determination by the Secretary with respect to whether 
or not a particular item or service is covered nationally under this 
title.'' This information collection will assist us in obtaining the 
information we require to make a national coverage determination in a 
timely manner and ensuring that the Medicare program continues to meet 
the needs of its beneficiaries. Form Number: CMS-R-290 (OMB control 
number: 0938-0776); Frequency: Annual; Affected Public: Private Sector: 
Business or other for-profits; Number of Respondents: 30; Total Annual 
Responses: 30; Total Annual Hours: 1,200. (For policy questions 
regarding this collection contact Lori M. Ashby at 410-786-6322.)
    4. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection: Title of Information 
Collection: Transcatheter Valve Therapy (TVT) Registry; Use: The data 
collection is required by the Centers for Medicare and Medicaid 
Services (CMS) National Coverage Determination (NCD) entitled, 
``Transcatheter Aortic Valve Replacement (TAVR)''. The TAVR 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. CMS finds that the Society of Thoracic Surgery/
American College of Cardiology Transcatheter Valve Therapy (STS/ACC 
TVT) Registry, one registry overseen by the National Cardiovascular 
Data Registry, meets the requirements specified in the NCD on TAVR. The 
TVT Registry will support a national surveillance system to monitor the 
safety and efficacy of the TAVR technologies for the treatment of 
aortic stenosis.
    The data will also include the variables on the eight item Kansas 
City Cardiomyopathy Questionnaire (KCCQ-10) to assess heath status, 
functioning and quality of life. In the KCCQ, an overall summary score 
can be derived from the physical function, symptoms (frequency and 
severity), social function and quality of life domains. For each 
domain, the validity, reproducibility, responsiveness and 
interpretability have been independently established. Scores are 
transformed to a range of 0-100, in which higher scores reflect better 
health status.
    The conduct of the STS/ACC TVT Registry and the KCCQ-10 is in 
accordance with section 1142 of the Social Security Act (the Act) that 
describes the authority of the Agency for Healthcare Research and 
Quality (AHRQ). Under section 1142, research may be conducted and 
supported on the outcomes, effectiveness, and appropriateness of health 
care services and procedures to identify the manner in which disease, 
disorders, and other health conditions can be prevented, diagnosed, 
treated, and managed clinically. Section 1862(a)(1)(E) of the Act 
allows Medicare to cover under coverage with evidence development (CED) 
certain items or services for which the evidence is not adequate to 
support coverage under section 1862(a)(1)(A) and where additional data 
gathered in the context of a clinical setting would further clarify the 
impact of these items and services on the health of beneficiaries.
    The data collected and analyzed in the TVT Registry will be used by 
CMS to determine if the TAVR 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 aortic stenosis. For purposes of the TAVR NCD, 
the TVT Registry has contracted with the Data Analytic Centers to 
conduct the analyses. In addition, data will be made available for 
research purposes under the terms of a data use agreement that only 
provides de-identified datasets. Form Number: CMS-10443 (OMB control 
number: 0938-1202); Frequency: Annual; Affected Public: Individuals, 
Households and Private Sector; Number of Respondents: 49,704; Total 
Annual Responses: 198,816; Total Annual Hours: 63,790. (For policy 
questions regarding this collection contact Nina Arya at 667-290-9456).

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-20400 Filed 9-9-24; 8:45 am]
BILLING CODE 4120-01-P