[Federal Register Volume 87, Number 66 (Wednesday, April 6, 2022)]
[Notices]
[Pages 19957-19958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
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, 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.

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]
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