90 FR 122 pgs. 27540-27542 - Agency Information Collection Activities: Proposed Collection; Comment Request
Type: NOTICEVolume: 90Number: 122Pages: 27540 - 27542
Pages: 27540, 27541, 27542Docket number: [Document Identifiers: CMS-10328 and CMS-10148]
FR document: [FR Doc. 2025-11980 Filed 6-26-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Medicare & Medicaid Services
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10328 and CMS-10148]
Agency Information Collection Activities: Proposed Collection; Comment Request
AGENCY:
Centers for Medicare & Medicaid Services, Health and Human Services (HHS).
ACTION:
Notice.
SUMMARY:
[top] 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
DATES:
Comments must be received by August 26, 2025.
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, please access the CMS PRA website by copying and pasting the following web address into your web browser: 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-10328 Medicare Self-Referral Disclosure Protocol
CMS-10148 HIPAA Administrative Simplification (Non-Privacy/Security) Complaint Form
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: Revision of a currently approved collection; Title of Information Collection: Medicare Self-Referral Disclosure Protocol; Use: Section 6409 of the ACA requires the Secretary to establish a voluntary self-disclosure process that allows providers of services and suppliers to self-disclose actual or potential violations of section 1877 of the Act. The SRDP is a voluntary self-disclosure process that allows providers of services and suppliers to disclose actual or potential violations of section 1877 of the Act. For purposes of the SRDP, a person submitting a disclosure to the SRDP will be referred to as a "disclosing party." CMS analyzes the disclosed conduct to determine compliance with section 1877 of the Act and the application of the exceptions to the physician self-referral prohibition.
Specifically, under the proposal a physician practice disclosing group practice noncompliance will submit an SRDP form consisting of the following components: (1) the SRDP Disclosure Form, (2) a single Group Practice Information Form covering all the physicians in the practice who made prohibited referrals to the practice, and (3) a Financial Analysis Worksheet. All other entities will continue to submit disclosures using the SRDP Disclosure Form, separate Physician Information Forms for each physician covered in the self-disclosure, and a Financial Analysis Worksheet. Form Number: CMS-10328 (OMB control number: 0938-1106); Frequency: Yearly; Affected Public: Private Sector (Business or other for-profits, Not-for-Profit Institutions); Number of Respondents: 100; Total Annual Responses: 100; Total Annual Hours: 4,950. (For policy questions regarding this collection contact Caitlin Bailey at 410-786-9768.)
2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: HIPAA Administrative Simplification (Non-Privacy/Security) Complaint Form; Use: The Secretary of Health and Human Services (HHS), hereafter known as "The Secretary," codified 45 CFR parts 160 and 164 Administrative Simplification provisions that apply to the enforcement of the Health Insurance Portability and Accountability Act of 1996 Public Law 104-191 (HIPAA). The provisions address rules relating to the investigation of non-compliance of the HIPAA Administrative Simplification code sets, unique identifiers, operating rules, and transactions. 45 CFR 160.306, Complaints to the Secretary, provides for investigations of covered entities by the Secretary. Further, it outlines the procedures and requirements for filing a complaint against a covered entity.
Anyone can file a complaint if he or she suspects a potential violation. Persons believing that a covered entity is not utilizing the adopted Administrative Simplification provisions of HIPAA are voluntarily requested to file a complaint with CMS via the Administrative Simplification Enforcement and Testing Tool (ASETT) online system, by mail, or by sending an email to the HIPAA mailbox at hipaacomplaint@cms.hhs.gov. Information provided on the standard form will be used during the investigation process to validate non-compliance of HIPAA Administrative Simplification provisions.
This standard form collects identifying and contact information of the complainant, as well as the identifying and contact information of the filed against entity (FAE). This information enables CMS to respond to the complainant and gather more information if necessary, and to contact the FAE to discuss the complaint and CMS' findings. Form Number: CMS-10148 (OMB control number: 0938-0948); Frequency: Occasionally; Affected Public: Private sector, Business or Not-for-profit institutions, State, Local, or Tribal Governments, Federal Government, Not-for-profits institutions; Number of Respondents: 400; Total Annual Responses: 400; Total Annual Hours: 400. (For policy questions regarding this collection contact Kevin Stewart at 410-786-6149).
[top] 3. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Drug Price
Negotiation Data Elements: The statute requires that CMS consider certain data from Primary Manufacturers as part of the negotiation process. To the extent that more than one entity meets the statutory definition of manufacturer (specified in section 1193(a)(1) of the Act) for a selected drug for purposes of initial price applicability year 2028, CMS will designate the entity that holds the New Drug Application(s) (NDA(s))/Biologics License Application(s) (BLA(s)) for the selected drug to be "the manufacturer" of the selected drug (hereinafter the "Primary Manufacturer"). The Primary Manufacturer's data submissions include the non-Federal average manufacturer price and related data for selected drugs for the purpose of establishing a ceiling price, as outlined in section 1193(a)(4)(A) of the Act, and information that the Secretary requires, pertaining to the negotiation factors outlined in section 1194(e)(1) of the Act, for the purpose of formulating offers and counteroffers pursuant to section 1193(a)(4)(B) of the Act. Some of these data are held by the Primary Manufacturer and are not currently available to CMS. Data described in sections 1194(e)(1) and 1193(a)(4) of the Act must be submitted by the Primary Manufacturer.
Section 1194(e)(2) of the Act requires CMS to consider certain data on selected drugs and their alternative treatments. Because the statute does not specify where these data come from, CMS will allow for optional submission from Primary Manufacturers and the public for drugs selected for negotiation or renegotiation. CMS will additionally review existing literature, conduct internal analyses, and consult subject matter and clinical experts on the factors listed in section 1194(e)(2) of the Act. Manufacturers may optionally submit this information as part of their Negotiation Data Elements Information Collection Request Form. The public may also optionally submit evidence about the selected drugs and their alternative treatments.
Drug Price Negotiation and Renegotiation Process: Any MFPs that are negotiated or renegotiated for these selected drugs will apply beginning in initial price applicability year 2028. For initial price applicability year 2028, the negotiation and renegotiation period begins on the earlier of the date that the Primary Manufacturer enters into a Medicare Drug Price Negotiation Program Agreement or February 28, 2026.
Section 1194(b)(2)(C) of the Act provides that if the Primary Manufacturer does not accept CMS' written initial offer, the Primary Manufacturer may submit an optional written counteroffer no later than 30 days after the date of receipt of CMS' written initial offer. If the Primary Manufacturer chooses to develop and submit a written counteroffer to CMS' written initial offer during the drug price negotiation or renegotiation process for initial price applicability year 2028, the Primary Manufacturer must submit the Counteroffer Form. Form Number: CMS-10849 (OMB control number: 0938-1452); Frequency: Once; Affected Public: Private sector, Business or other for-profit; Number of Respondents: 405; Number of Responses: 405; Total Annual Hours: 51,940. (For questions regarding this collection, contact Elisabeth Daniel at 667-290-8793.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-11980 Filed 6-26-25; 8:45 am]
BILLING CODE 4120-01-P