Notice2022-07314
Agency Information Collection Activities: Proposed Collection; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 6, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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 (the 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.
Full Text
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<title>Federal Register, Volume 87 Issue 66 (Wednesday, April 6, 2022)</title>
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[Federal Register Volume 87, Number 66 (Wednesday, April 6, 2022)]
[Notices]
[Pages 19957-19958]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-07314]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier CMS-10511 and CMS-10440]
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 (the 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 June 6, 2022.
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
<a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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, you may make
your request using one of following:
1. Access CMS' website address at website address at <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>.
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-10511 Medicare Coverage of Items and Services in FDA
Investigational Device Exemption Clinical Studies--Revision of Medicare
Coverage
CMS-10440 Data Collection to Support Eligibility Determinations for
Insurance Affordability Programs and Enrollment through Health
Insurance Marketplaces, Medicaid and Children's Health Insurance
Program Agencies
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 Collection
1. Type of Information Collection Request: Reinstatement without
change; Title of Information Collection: Medicare Coverage of Items and
Services in FDA Investigational Device Exemption Clinical Studies--
Revision of Medicare Coverage; Use: Section 1862(m) of the Social
Security Act (and regulations at 42 CFR Subpart B (sections 405.201-
405.215) allows for payment of the routine costs of care furnished to
Medicare beneficiaries in a Category A investigational device exemption
(IDE) study and authorizes the Secretary to establish criteria to
ensure that Category A IDE trials conform to appropriate scientific and
ethical standards. Medicare does not cover the Category A device itself
because Category A (Experimental) devices do not satisfy the statutory
requirement that Medicare pay for devices determined to be reasonable
and necessary. Medicare may cover Category B (Non-experimental)
devices, and associated routine costs of care, if they are considered
reasonable and necessary and if all other applicable Medicare coverage
requirements are met.
Under the current centralized review process, interested parties
(such as study sponsors) that wish to seek Medicare coverage related to
Category A or B IDE studies have a centralized point of contact for
submission, review and determination of Medicare coverage IDE study
requests. In order for CMS (or its designated entity) to determine if
the Medicare coverage criteria are met, as described in our
regulations, CMS (or its designated entity) must review documents
submitted by interested parties or study sponsors. Such information
submitted will be a FDA IDE approval letter, IDE study protocol, IRB
approval letter, National Clinical Trials (NCT) number, and Supporting
materials as needed. Form Number: CMS-10511 (OMB control number:
[[Page 19958]]
0938-1250); Frequency: Yearly; Affected Public: Private Sector
(Business or other for-profits, Not-for-Profit Institutions); Number of
Respondents: 116; Total Annual Responses: 116; Total Annual Hours: 232.
(For policy questions regarding this collection contact Xiufen Sui at
410-786-3136.)
2. Type of Information Collection Request: Reinstatement without
change; Title of Information Collection: Medicare Coverage of Items and
Services in FDA Investigational Device Exemption Clinical Studies--
Revision of Medicare Coverage; Use: Section 1413 of the Affordable Care
Act directs the Secretary of Health and Human Services to develop and
provide to each state a single, streamlined application form that may
be used to apply for coverage through a Marketplace and for APTC/CSR,
Medicaid, and CHIP (which we refer to collectively as insurance
affordability programs). The application must be structured to maximize
an applicant's ability to complete the form satisfactorily, taking into
account the characteristics of individuals who may qualify for the
programs by developing materials at appropriate literacy levels and
ensuring accessibility.
45 CFR 155.405(a) provides more detail about the application that
must be used by Marketplaces to determine eligibility and to collect
information necessary for enrollment. Eligibility standards for the
Marketplace are set forth in 45 CFR 155.305. The information will be
required of each applicant upon initial application, with some
subsequent information collections for the purposes of confirming
accuracy of previous submissions and for changes in an applicant's
circumstances. 42 CFR 435.907 and 457.330 establish the standards for
state Medicaid and CHIP agencies related to the use of the application.
CMS has designed a dynamic electronic application that will tailor the
amount of data required from an applicant based on the applicant's
circumstances and responses to particular questions in the FFM (please
note SBM implementations may vary but the essence of the data
collection must adhere to the same parameters). The paper version of
the application will not be tailored in the same way but will require
only the data necessary to determine eligibility.
Information collected by the Marketplace, Medicaid or CHIP agency
will be used to determine eligibility for coverage through the
Marketplace and insurance affordability programs (i.e., Medicaid, CHIP,
and APTC), and assist consumers in enrolling in a QHP if eligible.
Applicants include anyone who may be eligible for coverage through any
of these programs. Form Number: CMS-10440 (OMB control number: 0938-
1191); Frequency: Annually; Affected Public: Private Sector (Business
or other for-profits, Not-for-Profit Institutions); Number of
Respondents: 4,884,000; Total Annual Responses: 4,884,000; Total Annual
Hours: 2,205,614.
(For policy questions regarding this collection contact Anne
Pesto at 410-786-3492.)
Dated: April 1, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2022-07314 Filed 4-5-22; 8:45 am]
BILLING CODE P
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