[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Notices]
[Pages 76079-76081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26156]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10443, CMS-10558 and CMS-287-21]


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 December 28, 2020.

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 website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html

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    2. Call the Reports Clearance Office at (410) 786-1326.

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: Extension 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: 37,221; Total 
Annual Responses: 148,884; Total Annual Hours: 47,765. (For policy 
questions regarding this collection contact Sarah Fulton at 410-786-
2749.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Information 
Collection for Machine Readable Data for Provider Network and 
Prescription Formulary Content for FFM QHPs; Use: Under 45 CFR 
156.122(d)(1)(2), 156.230(b), and 156.230(c), and in the final rule, 
Patient Protection and Affordable Care Act; HHS Notice of Benefit and 
Payment Parameters for 2018 (CMS-9934-F), standards for qualified 
health plan (QHP) issuers (including Small Business Health Options 
Program (SHOP) issuers and stand-alone dental plans (SADP) issuers) are 
established for the submission of provider and formulary data in a 
machine- readable format to the Department of Health and Human Services 
(HHS) and for posting on issuer websites. These standards provide 
greater transparency for consumers, including by allowing software 
developers to access formulary and provider data to create innovative 
and informative tools. The Centers for Medicare and Medicaid Services 
(CMS) is continuing an information collection request (ICR) in 
connection with these standards. Form Number: CMS-10558 (OMB control 
number 0938-1284); Frequency: Annually; Affected Public: Private 
Sector, State, Business, and Not-for Profits; Number of Respondents: 
376; Number of Responses: 376; Total Annual Hours: 10,495. (For 
questions regarding this collection, contact Joshua Van Drei at 410-
786-1659).
    3. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Home Office Cost Statement; Use: The primary function of 
the home office cost statement is to provide the documentary support 
required for a Medicare provider to claim reimbursement for HO/CO costs 
in their Medicare cost report. A HO/CO must submit an acceptable home 
office cost statement directly to the servicing contractors for its 
providers that received a home office cost allocation for reimbursement 
determinations. Section 1874A of the Act describes the functions of the 
contractor.
    The home office cost statement schedules collect the cost data 
required to support home office costs claimed in a provider's Medicare 
cost report. The Schedule S includes the certification statement where 
the HO/CO attests to the accuracy of the information and allows the HO/
CO the opportunity to electronically sign and electronically submit the 
home office cost statement. The Schedule S-1 collects identifying data 
about the home office and key officers/employees of the home office. 
The Schedule S-2 collects identifying information for healthcare 
provider components, non-healthcare components, and region/division 
components of the HO/CO, and provides the structure for reporting

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costs for those components throughout the cost statement. The A series 
of schedules collects the HO/CO trial balance of expenses, 
reclassifications, and adjustments, for allocation of the HO/CO costs 
to its components. On the B series of schedules, the home office 
directly allocates costs directly attributable to specific components. 
On the C and D series of schedules, the HO/CO functionally allocates 
costs to components in a manner that reasonably relates to the services 
provided to the components. On the E series of schedules, the HO/CO 
allocates pooled costs (costs not directly assigned or functionally 
allocated) to the components. On the F series of schedule, the HO/CO 
summarizes the cost allocations by component. On the G series of 
schedules, the HO/CO reports financial data from their balance sheet 
and income statement. Form Number: CMS-287-21 (OMB control number 0938-
0202); Frequency: Annually; Affected Public: Private Sector, State, 
Business, and Not-for Profits; Number of Respondents: 1,626; Number of 
Responses: 1,626; Total Annual Hours: 757,716. (For questions regarding 
this collection, contact Gail Duncan at 410-786-7278.)

    Dated: November 20, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-26156 Filed 11-25-20; 8:45 am]
BILLING CODE 4120-01-P