Agency Information Collection Activities: Proposed Collection; Comment Request

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <DEPDOC>[Document Identifiers: CMS-R-305 and CMS-367a-e]</DEPDOC> <SUBJECT>Agency Information Collection Activities: Proposed Collection; Comment Request</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Medicare & Medicaid Services, Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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 <E T="04">Federal Register</E> 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. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Comments must be received by February 20, 2026. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> 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. <E T="03">Electronically.</E> You may send your comments electronically to <E T="03">http://www.regulations.gov.</E> Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments. 2. By <E T="03">regular mail.</E> You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, <E T="03">Attention:</E> 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: <E T="03">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</E> . <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> William N. Parham at (410) 786-4669. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Contents</HD> 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 <E T="02">ADDRESSES</E> ). 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 <E T="04">Federal Register</E> 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. <HD SOURCE="HD1">Information Collections</HD> 1. <E T="03">Type of Information Collection Request:</E> Revision of a currently approved collection; <E T="03">Title of Information Collection:</E> External Quality Review (EQR) of Medicaid and Children's Health Insurance Program (CHIP) Managed Care, EQR Protocols, and Supporting Regulations; <E T="03">Use:</E> Most contracts between a state Medicaid agency and their managed care plan must provide for an annual External Quality Review (EQR). The annual EQR is conducted by an independent external quality review organization (EQRO). States must provide the EQRO with information obtained through methods consistent with the protocols specified by CMS. The information is used by the EQRO to determine the quality of care furnished by the managed care plans in the state. The publicly posted EQR results allows Medicaid/CHIP enrollees and potential enrollees to make informed choices regarding the selection of their providers. It also provides advocacy organizations, researchers, and other interested parties access to information on the quality of care provided to Medicaid beneficiaries enrolled in Medicaid/CHIP managed care. States use the information during their oversight of these organizations. <E T="03">Form Number:</E> CMS-R-305 (OMB control number: 0938-0786); <E T="03">Frequency:</E> Annually and one-time; <E T="03">Affected Public:</E> Private sector and State, Local or Tribal Governments; <E T="03">Number of Respondents:</E> 681; <E T="03">Number of Responses:</E> 7,236; <E T="03">Total Annual Hours:</E> 887,086. (For policy questions regarding this collection contact Carrie Hanlon at 410-786-1660.) 2. <E T="03">Type of Information Collection Request:</E> Extension of a currently approved collection; <E T="03">Title of Information Collection:</E> Medicaid Drug Program; <E T="03">Use:</E> Labelers transmit drug product and pricing data to CMS within 30 days after the end of each calendar month and quarter. CMS calculates the unit rebate amount (URA) and the unit rebate offset amount (UROA) for each new drug application (NDC) and distributes to all State Medicaid agencies. States use the URA to invoice the labeler for rebates and the UROA to report onto CMS-64. The monthly data is used to calculate Federal Upper Limit (FUL) prices for applicable drugs and for states that opt to use this data to establish their pharmacy reimbursement methodology. <E T="03">Form Number:</E> CMS-367a-e (OMB control number: 0938-0578); <E T="03">Frequency:</E> Monthly, quarterly, and on occasion; <E T="03">Affected Public:</E> Private sector; <E T="03">Number of Respondents:</E> 840; <E T="03">Total Annual Responses:</E> 16,160; <E T="03">Total Annual Hours:</E> 606,932. (For policy questions regarding this collection contact Robert Giles at 667-290-8626.) <SIG> <NAME>William N. Parham, III,</NAME> Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs. </SIG> </SUPLINF> <FRDOC>[FR Doc. 2025-23507 Filed 12-19-25; 8:45 am]</FRDOC> </NOTICE>