[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