Rules and Regulations. Notice

Agency: Centers for Medicare & Medicaid Services, Health and Human Services (HHS)
Action: Notice
Citation: FR Doc. 2025-16789

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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 on the collection(s) of information must be received by the OMB desk officer by October 2, 2025.

Supplementary Information

Under the Paperwork Reduction Act of 1995 (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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-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 that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare Severity Diagnosis Related Groups Reclassification Request (MS-DRGs); Use: Section 1886(d)(4) of the Act establishes a classification system, referred to as DRGs, for inpatient discharges and adjusts payments under the IPPS based on appropriate weighting factors assigned to each MS-DRG. Section 1886(d)(4)(C)(i) of the Act specifies adjustments to the classification and weighting factors shall occur “at least annually to reflect changes in treatment patterns, technology, and other factors which may change the relative use of hospital resources.” The requests are evaluated in the Division of Coding and DRGs (DCDRG) by the DRG and Coding Team and the clinical advisors (medical officers) in both the Technology, Coding and Pricing Group (TCPG) and the Hospital and Ambulatory Policy Group (HAPG), along with the CMS contractor(s). This team participates via conference calls in the review of MedPAR claims data to analyze and perform clinical review of the requested changes. Based on the examination of claims data and clinical judgment, the team provides recommendations to CMS and HHS leadership for proposed changes. Per the statue, proposed MS-DRG changes and payment adjustments must go through notice and comment rulemaking giving the opportunity for the public to comment. Finalized MS-DRG changes are effective with discharges on and after October 1, consistent with the beginning of the fiscal year. CMS makes the updated MS-DRG Grouper software and related materials that reflects the changes available to the public for free via download at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software. When an application is submitted in MEARIS TM , the DRG and Coding Team in DCDRG will have instant access to the application request and accompanying materials to facilitate a more-timely review of the request, including the ability to efficiently inform other team members involved in the process that information is available for their review and input. Form Number: CMS-10775 (OMB control number 0938-1431); Frequency: Occasionally; Affected Public: Private Sector, Business or other for-profits, Not-for-profits institutions; Number of Respondents: 50; Total Annual Responses: 50; Total Annual Hours: 48,000. (For policy questions regarding this collection contact Marilu Hue at 410-786-4510.) 2. Type of Information Collection Request: Extension of a currently approved collection: * Title of Information Collection: * Medicare Fee-for-Service Prepayment Review of Medical Records; Use: The Medical Review program is designed to prevent improper payments in the Medicare FFS program. Whenever possible, Medicare Administrative Contractors (MACs) are encouraged to automate this process; however, it may require the evaluation of medical records and related documents to determine whether Medicare claims are billed in compliance with coverage, coding, payment, and billing policies. Addressing improper payments in the Medicare fee-for-service (FFS) program and promoting compliance with Medicare coverage and coding rules is a top priority for the CMS. Preventing Medicare improper payments requires the active involvement of every component of CMS and effective coordination with its partners including various Medicare contractors and providers. The information required under this collection is requested by Medicare contractors to determine proper payment, or if there is a suspicion of fraud. Medicare contractors request the information from providers/suppliers submitting claims for payment when data analysis indicates aberrant billing patterns or other information which may present a vulnerability to the Medicare program. Form Number: CMS-10417 (OMB control number: 0938-0969); Frequency: Occasionally; Affected Public: Private Sector, State, Business, and Not-for Profits; Number of Respondents: 489,871; Number of Responses: 489,871; Total Annual Hours: 244,936. (For questions regarding this collection, contact Olufemi Shodeke at 410-786-1649.) 3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetic, Orthotics, and Supplies (DMEPOS); Use: Section 1834(a)(15) of the Social Security Act (the Act) authorizes the Secretary to develop and periodically update a list of DMEPOS that the Secretary determines, on the basis of prior payment experience, are frequently subject to unnecessary utilization and to develop a prior authorization process for these items. Pursuant to this authority, CMS published final rules CMS-6050-F and CMS-1713-F. The information required under this collection is used to determine proper payment and coverage for DMEPOS items. The information requested includes all documents and information that demonstrate the DMEPOS item requested is reasonable and necessary for the beneficiary and meets applicable Medicare requirements. The documentation will be reviewed by trained registered nurses, therapists, or physician reviewers to determine if item(s) or service requested meets all applicable Medicare coverage, coding and payment rules. Form Number: CMS-10524 (OMB control number: 0938-1293); Frequency: Occasionally; Affected Public: Private Sector (Business or other for-profits, Not-for-Profit Institutions); Number of Respondents:; Total Annual Responses: 190,344; Total Annual Hours: 95,172. (For policy questions regarding this collection contact Emily Calvert at (410) 786-4277.) 4. Type of Information Collection Request: Revision of currently approved collection; Title: Healthcare Fraud Prevention Partnership (HFPP) Data Sharing and Information Exchange; Use: Section 1128C(a)(2) of the Social Security Act (42 U.S.C. 1320a-7c(a)(2)) authorizes the Secretary and the Attorney General to consult, and arrange for the sharing of data with, representatives of health plans for purposes of establishing a Fraud and Abuse Control Program as specified in Section 1128(C)(a)(1) of the Social Security Act. The result of this authority has been the establishment of the HFPP. The HFPP was officially established by a Charter in the fall of 2012 and signed by HHS Secretary Sibelius and U.S. Attorney General Holder. In December 2020, President Trump signed into law H.R.133—Consolidated Appropriations Act, 2021, which amended Section 1128C(a) of the Social Security Act (42 U.S.C. 1320a-7c(a)) providing explicit statutory authority for the Healthcare Fraud Prevention Partnership including the potential expansion of the public-private partnership analyses. Data sharing within the HFPP primarily focuses on conducting studies for the purpose of combatting fraud, waste, and abuse. These studies are intended to target specific vulnerabilities within the payment systems in both the public and private healthcare sectors. The HFPP and its committees design and develop studies in coordination with the TTP. The core function of the TTP is to manage and execute the HFPP studies within the HFPP. Form Number: CMS-10501 (OMB control number: 0938-1251); Frequency: Occasionally; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 28; Number of Responses: 28; Total Annual Hours: 120. (For questions regarding this collection, contact Maricruz Bonfante at (410-786-5086). 5. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Minimum Essential Coverage; Use: The final rule titled “Patient Protection and Affordable Care Act; Exchange Functions: Eligibility for Exemptions; Miscellaneous Minimum Essential Coverage Provisions,” published July 1, 2013 (78 FR 39494) designates certain types of health coverage as minimum essential coverage. Other types of coverage, not statutorily designated and not designated as minimum essential coverage in regulation, may be recognized by the Secretary of Health and Human Services (HHS) as minimum essential coverage if certain substantive and procedural requirements are met. To be recognized as minimum essential coverage, the coverage must offer substantially the same consumer protections as those enumerated in Title I of the Affordable Care Act relating to non-grandfathered, individual health insurance coverage to ensure consumers are receiving adequate coverage. The final rule requires sponsors of other coverage that seek to have such coverage recognized as minimum essential coverage to adhere to certain procedures. Sponsoring organizations must submit to HHS certain information about their coverage and an attestation that the plan substantially complies with the provisions of Title I of the Affordable Care Act applicable to non-grandfathered individual health insurance coverage. Sponsors must also provide notice to enrollees informing them that the plan has been recognized as minimum essential coverage. Form Number: CMS-10465 (OMB control number: 0938-1189); Frequency: Occasionally; Affected Public: Private Sectors; State, Local or Tribal Governments; Number of Respondents: 10; Total Annual Responses: 10; Total Annual Hours: 53. (For policy questions regarding this collection contact Russell Tipps at 301-492-4371.) 6. Type of Information Collection Request: Reinstatement with change of a previously approved collection; Title of Information Collection: Hospice Request for Certification in the Medicare Program; Use: This is a request to reinstate the CMS-417 form, which was approved under OMB control number 0938-0313 and the current approval expired on 11/30/2024. We have made several changes to the CMS-417 form that make it easier to read, understand and complete. For example, we made the data fields larger to provide more space in which to provide responses. We have also reformatted the data fields and available responses to make them easier to understand and complete. In addition, we have added a new data field to collect the title of the person signing the CMS-417 form. We believe it is important to collect this information to ensure that the person completing and signing the form has the proper authority to do so. Finally, we made the instruction more comprehensive. We have submitted a change crosswalk that provides a detailed explanation of all the changes made to the CMS-417 form. The CMS-417 form is an identification and screening form used to initiate the certification process for new hospices. The CMS-417 form is also completed by existing hospices at the time of their recertification surveys, to update their certification information. The form collects data that is used to determine if the provider has sufficient personnel to participate in the Medicare program. If a hospice provider meets these preliminary staffing requirements, a survey is scheduled to determine if the provider complies with the conditions of participation (CoPs) required by the Medicare program. The data provided by the hospice on the CMS-417 form serve as a basis for the survey inspection. The facility is only required to complete certain items on the certification forms as indicated by the instructions included with the form. Form Number: CMS-417 (OMB Control number: 0938-0313); Frequency: Annually; Affected Public: Private Sector—Business or other for-profits; Number of Respondents: 3,418; Total Annual Responses: 3,418; Total Annual Hours: 2,564. (For policy questions regarding this collection contact Caroline Gallaher at 410-786-8705.) William N. Parham, III, Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2025-16789 Filed 8-29-25; 8:45 am]