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-10328 and CMS-10148]</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 August 26, 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. 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, 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-10328 Medicare Self-Referral Disclosure Protocol</FP> <FP SOURCE="FP-1">CMS-10148 HIPAA Administrative Simplification (Non-Privacy/Security) Complaint Form</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> Revision of a currently approved collection; <E T="03">Title of Information Collection:</E> Medicare Self-Referral Disclosure Protocol; <E T="03">Use:</E> 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. <E T="03">Form Number:</E> CMS-10328 (OMB control number: 0938-1106); <E T="03">Frequency:</E> Yearly; <E T="03">Affected Public:</E> Private Sector (Business or other for-profits, Not-for-Profit Institutions); <E T="03">Number of Respondents:</E> 100; <E T="03">Total Annual Responses:</E> 100; <E T="03">Total Annual Hours:</E> 4,950. (For policy questions regarding this collection contact Caitlin Bailey at 410-786-9768.) 2. <E T="03">Type of Information Collection Request:</E> Revision of a currently approved collection; <E T="03">Title of Information Collection:</E> HIPAA Administrative Simplification (Non-Privacy/Security) Complaint Form; <E T="03">Use:</E> 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 <E T="03">hipaacomplaint@cms.hhs.gov.</E> 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. <E T="03">Form Number:</E> CMS-10148 (OMB control number: 0938-0948); <E T="03">Frequency:</E> Occasionally; <E T="03">Affected Public:</E> Private sector, Business or Not-for-profit institutions, State, Local, or Tribal Governments, Federal Government, Not-for-profits institutions; <E T="03">Number of Respondents:</E> 400; <E T="03">Total Annual Responses:</E> 400; <E T="03">Total Annual Hours:</E> 400. (For policy questions regarding this collection contact Kevin Stewart at 410-786-6149). 3. <E T="03">Type of Information Collection Request:</E> Revision of a currently approved collection; <E T="03">Title of Information Collection:</E> Drug Price Negotiation for Initial Price Applicability Year 2028 under Sections 11001 and 11002 of the Inflation Reduction Act Information Collection Request (ICR) (CMS-10849, OMB 0938-1452); <E T="03">Use:</E> Under the authority in sections 11001 and 11002 of the Inflation Reduction Act of 2022 (Pub. L. 117-169), the Centers for Medicare & Medicaid Services (CMS) is implementing the Medicare Drug Price Negotiation Program, codified in sections 1191 through 1198 of the Social Security Act (“the Act”). The Act establishes the Negotiation Program to negotiate maximum fair prices (“MFPs”), defined at 1191(c)(3) of the Act, for certain high expenditure, single source selected drugs covered under Medicare Part B and Part D. For the third cycle of the Negotiation Program, the Secretary of Health and Human Services (the “Secretary”) will select up to 15 high expenditure, single source drugs payable under Part B and/or covered under Part D for negotiation. In accordance with section 1194(f)(4) of the Act, CMS will also renegotiate MFPs for drugs selected for renegotiation, if any, for initial price applicability year 2028. <E T="03">Negotiation Data Elements:</E> The statu ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 14k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━