Notice2026-11638
Agency Information Collection Activities: Proposed Collection; Comment Request
Primary source
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Published
June 10, 2026
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 (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 91 Issue 111 (Wednesday, June 10, 2026)</title>
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[Federal Register Volume 91, Number 111 (Wednesday, June 10, 2026)]
[Notices]
[Pages 35215-35216]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11638]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10697 and CMS-10302]
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 August 10, 2026.
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, please access
the CMS PRA website by copying and pasting the following web address
into your web browser: <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).
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: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Medicare Coverage of Items and Services for Coverage with
Evidence Development; Use: This is a reinstatement package. In general,
in order for an item or service to be covered under Medicare, it must
meet the standard described in section 1862(a)(1)(A) of the Act--that
is, it must be reasonable and necessary for the diagnosis or treatment
of illness or injury or to improve the functioning of a malformed body
member.
When the available evidence is insufficient to demonstrate that the
items and services are reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the functioning of a
malformed body member under section 1862(a)(1)(A) of the Act, CED has
been used to support evidence development for certain items and
services that are likely to show benefit for the Medicare population.
CED relies primarily on the statutory exception in section
1862(a)(1)(E) of the Act, which effectively permits Medicare payment
for items and services that are reasonable and necessary to carry out
research conducted pursuant to section 1142 of the Act. Items and
services that are not reasonable and necessary to carry out that
research are excluded.
CED has been a pathway whereby, after a CMS and AHRQ review,
Medicare covers items and services on the condition that they are
furnished in the context of approved clinical studies or with the
collection of additional clinical data. Any approved CED study
submission should satisfy each of the criteria ``1-17'' provided in the
CMS Coverage with Evidence Development guidance document. Form Number:
CMS-10697 (OMB control number 0938-1387); Frequency: Annually; Affected
Public: Private sector--Not-for-profit institutions and Businesses or
other for-profits; Number of Respondents: 15; Total Annual Responses:
15; Total Annual Hours: 1,500. (For policy questions regarding this
collection, contact Lori Ashby at 410-786-6322.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of
[[Page 35216]]
Information Collection: Collection Requirements for Compendia for
Determination of Medically-accepted Indications for Off-label Uses of
Drugs and Biologicals in an Anti-cancer Chemotherapeutic Regimen; Use:
Section 182(b) of the Medicare Improvement of Patients and Providers
Act (MIPPA) amended section 1861(t)(2)(B) of the Social Security Act
(42 U.S.C. 1395x(t)(2)(B)) by adding at the end the following new
sentence: `On and after January 1, 2010, no compendia may be included
on the list of compendia under this subparagraph unless the compendia
has a publicly transparent process for evaluating therapies and for
identifying potential conflicts of interest.' CMS implemented this
statutory provision that compendia have a ``publicly transparent
process for evaluating therapies and for identifying potential
conflicts of interests'' by amending 42 CFR 414.930 to include the
MIPPA requirements and by defining the key components of publicly
transparent processes for evaluating therapies and for identifying
potential conflicts of interests.
All compendia were required to comply with these provisions as of
January 1, 2010, to remain on the list of recognized compendia. In
addition, any compendium that is the subject of a future request for
inclusion on the list of recognized compendia will be required to
comply with these provisions. No compendium can be on the list if it
does not fully meet the standard described in section 1861(t)(2)(B) of
the Act, as revised by section 182(b) of the MIPPA. Form Number: CMS-
10302 (OMB control number: 0938-1078); Frequency: Annually; Affected
Public: Business and other for-profits and Not-for-profit institutions;
Number of Respondents: 845; Total Annual Responses: 900; Total Annual
Hours: 5,135. (For policy questions regarding this collection contact
Sarah Fulton at 410-786-2749.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2026-11638 Filed 6-9-26; 8:45 am]
BILLING CODE 4120-01-P
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