Agency Information Collection Activities: Proposed Collection; Comment Request

Issuing agencies

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 191 (Monday, October 5, 2026)</title>
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[Federal Register Volume 91, Number 191 (Monday, October 5, 2026)]
[Notices]
[Pages 63290-63291]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10722 and CMS-10008]


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 December 4, 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

[[Page 63291]]

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: Revision of a currently 
approved collection; Title of Information Collection: Annual State 
Report on CMS Value Based Purchasing Arrangements (VBP) Supplemental 
Rebate Agreements; Use: The reported data is being collected to 
safeguard against unnecessary utilization of such care and services and 
to assure that state payments to providers of Medicaid services are 
consistent with efficiency, economy, and quality of care. CMS will 
collect this data to ensure that VBP programs adopted by states 
continue to meet these standards. The revisions would add Puerto Rico 
and revise the annual report; Form Number: CMS-10722 (OMB control 
number: 0938-1385); Frequency: Yearly; Affected Public: State, Local, 
or Tribal Governments; Number of Respondents: 52; Total Annual 
Responses: 52; Total Annual Hours: 312. (For policy questions regarding 
this collection contact Whitney Swears at 410-786-6543.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Transitional Pass 
through payments related to Drugs, Biologicals, and 
Radiopharmaceuticals to determine eligibility under the Outpatient 
Prospective Payment System; Use: Section 1833(t)(6)(D)(i) of the Act 
sets the payment rate for pass-through eligible drugs and biologicals 
(assuming that no pro rata reduction in pass-through payment is 
necessary) as the amount determined under section 1842(o) of the Act. 
Section 303(c) of Public Law 108-173 amended Title XVIII of the Act by 
adding new section 1847A. This new section establishes the use of the 
average sales price (ASP) methodology for payment for drugs and 
biologicals described in section 1842(o)(1)(C) of the Act furnished on 
or after January 1, 2005. Therefore, as we stated in the November 15, 
2004 Federal Register (69 FR 65776), in CY 2005, we will pay under the 
OPPS for drugs, biologicals and radiopharmaceuticals with pass-through 
status consistent with the provisions of section 1842(o) of the Act as 
amended by Public Law 108-173 at a rate that is equivalent to the 
payment these drugs and biologicals will receive in the physician 
office setting, and established in accordance with the methodology 
described in the CY 2005 Physician Fee Schedule final rule.
    Interested parties such as hospitals, pharmaceutical companies, and 
physicians will apply for transitional pass-through payment for drugs, 
biologicals, and radiopharmaceuticals used with services covered under 
the hospital OPPS. After we receive all requested information, we will 
evaluate the information to determine if the criteria for making a 
transitional pass-through payment are met and if an interim healthcare 
common procedure coding system (HCPCS) code for a new drug, biological, 
or radiopharmaceutical is necessary. We will advise the applicant of 
our decision and update the hospital OPPS during its next scheduled 
quarterly update to reflect any newly approved drug, biological, or 
radiopharmaceutical. Based on experience gained in processing 
transitional pass-through and new technology applications, we have 
reworded some of the statements for clarity and have more clearly 
requested information in a format that will allow us to determine if 
the drug, biological, or radiopharmaceutical meets the cost 
significance test, as well as to estimate the associated pass-through 
payment amount. In addition, we have also eliminated the requirement 
for applicants to obtain a national Level II HCPCS code prior to 
seeking transitional pass-through payment eligibility or provide us 
with a copy of their application for a national HCPCS code, as we 
originally required in the April 7, 2000, final rule.
    Form Number: CMS-10008 (OMB control number: 0938-0802); Frequency: 
Once; Affected Public: Private Sector, Business or other for-profit and 
Not-for-profit institutions; Number of Respondents: 40; Total Annual 
Responses: 40; Total Annual Hours: 640. (For policy questions regarding 
this collection contact Kelcymarie Kelly at 667-290-8463).

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2026-20352 Filed 10-2-26; 8:45 am]
BILLING CODE 4169-69-P


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