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Notice

Agency Information Collection Activities: Proposed Collection; Comment Request

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What is this Federal Register notice?

This is a notice published in the Federal Register by Health and Human Services Department, Centers for Medicare & Medicaid Services. Notices communicate information, guidance, or policy interpretations but may not create new binding obligations.

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Why it matters: This notice communicates agency policy or guidance regarding applicable regulations.

Document Details

Document Number2025-06760
TypeNotice
PublishedApr 21, 2025
Effective Date-
RIN-
Docket IDDocument Identifiers: CMS-10198, CMS-10561, CMS-10572, CMS-10286, CMS-10377 and CMS-460
Text FetchedYes

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Full Document Text (2,094 words · ~11 min read)

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<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <DEPDOC>[Document Identifiers: CMS-10198, CMS-10561, CMS-10572, CMS-10286, CMS-10377 and CMS-460]</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 June 20, 2025. </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. <E T="03">By regular mail.</E> 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: <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> ). <FP SOURCE="FP-1">CMS-10198 Creditable Coverage Disclosure to CMS On-Line Form and Instructions</FP> <FP SOURCE="FP-1">CMS-10561 Essential Community Provider Data Collection to Support QHP Certification</FP> <FP SOURCE="FP-1">CMS-10572 Transparency in Coverage Reporting by Qualified Health Plan Issuers</FP> <FP SOURCE="FP-1">CMS-10286 Notice of Research Exception under the Genetic Information Nondiscrimination Act</FP> <FP SOURCE="FP-1">CMS-10377 Student Health Insurance Coverage</FP> <FP SOURCE="FP-1">CMS-460 Medicare Participating Physician or Supplier Agreement</FP> 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> Reinstatement without change of a previously approved collection; <E T="03">Title of Information Collection:</E> Creditable Coverage Disclosure to CMS On-Line Form and Instructions; <E T="03">Use:</E> Section 1860D-13 of the Social Security Act, as established by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and implementing regulations at 42 CFR 423.56(e), require that entities that offer prescription drug benefits under any of the types of coverage described in 42 CFR 423.56(b) provide a disclosure of creditable coverage to CMS. There are other disclosure and notification requirements to Part D eligible individuals in § 423.56(c), (d), and (f); this PRA covers the requirement in subsection (e). Entities required to make this disclosure state whether their prescription drug coverage meets the actuarial requirements defined in § 423.56(a). Disclosure of whether prescription drug coverage is creditable provides Medicare with important information relating to whether prescription drug benefits offered by an entity to Medicare Part D eligible individuals is expected to pay at least as much as the standard benefits under Medicare Part D. The form is used as a reporting tool where entities offering prescription drug coverage indicate whether the coverage being provided is considered creditable or non-creditable. <E T="03">Form Number:</E> CMS-10198 (OMB control number 0938-1013); <E T="03">Frequency:</E> Yearly; <E T="03">Affected Public:</E> Individuals and Households, Private Sector, State, Local, or Tribal Governments, Federal Government, Business, and Not-for Profits; <E T="03">Number of Respondents:</E> 141,400; <E T="03">Number of Responses:</E> 141,400; <E T="03">Total Annual Hours:</E> 11,786. (For questions regarding this collection contact Tammie Wall at 410-786-3317.) 2. <E T="03">Type of Information Collection Request:</E> Extension of a currently approved collection; <E T="03">Title of Information Collection:</E> Supporting Statement for Essential Community Provider Data Collection to Support QHP Certification; <E T="03">Use:</E> Standards for Essential Community Provider (ECP) requirements are codified at 45 CFR 156.235. Issuers must contract with a certain percentage, as determined by Health and Human Services (HHS), of the available ECPs in the plan's service area. HHS will continue to collect more complete data from such providers so that all issuers are held to a more uniform ECP standard. HHS achieves this outcome by soliciting qualified ECPs throughout the year to complete and submit the ECP application in order to be added to the HHS ECP list or update required data fields to remain on the list. In soliciting updates directly from providers, HHS routinely performs research and outreach to providers on the ECP List to verify information about ECPs collected via the ECP application and annual renewal form. These ongoing efforts will result in a more accurate listing of the universe of available ECPs from which issuers select to satisfy the ECP standard. <E T="03">Form Number:</E> CMS-10561 (OMB control number: 0938-1295); <E T="03">Frequency:</E> Annually; <E T="03">Affected Public:</E> Private Sector—Business or other for-profits and Not-for-profits institutions; <E T="03">Number of Respondents:</E> 19,020; <E T="03">Number of Responses:</E> 19,020; <E T="03">Total Annual Hours</E> 4,914. (For questions regarding this collection, contact Samantha Nguyen Kella at 816-426-6339.) 3. <E T="03">Type of Information Collection Request:</E> Extension of a currently approved collection; <E T="03">Title of Information Collection:</E> Transparency in Coverage Reporting by Qualified Health Plan Issuers; <E T="03">Use:</E> Sections 1311(e)(3)(A)-(C) of the ACA, as implemented at 45 CFR 155.1040(a)-(c) and 156.220, establish standards for qualified health plan (QHP) issuers to submit specific information related to transparency in coverage. QHP issuers are required to post and make data related to transparency in coverage available to the public in plain language and submit this data to the Department of Health and Human Services (HHS), the Exchange, and the state insurance commissioner. Section 2715A of the Public Health Service (PHS) Act as added by the ACA largely extends the transparency provisions set forth in section 1311(e)(3) to non-grandfathered group health plans and health insurance issuers offering group and individual health insurance coverage. <E T="03">Form Number:</E> CMS-10572 (OMB control number: 0938-1310); <E T="03">Frequency:</E> Annually; <E T="03">Affected Public:</E> Private Sector, Business, and Not-for Profits; <E T="03">Number of Respondents:</E> 400; <E T="03">Number of Response</E> s: 400; <E T="03">Total Annual Hours:</E> 22,000. (For questions regarding this collection, contact Jack Reeves at 301-492-5152.) 4. <E T="03">Type of Information Collection Request:</E> Extension of a currently approved collection; <E T="03">Title of Information Collection:</E> Notice of Research Exception under the Genetic Information Nondiscr ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 16k characters. 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