# Agency Information Collection Activities: Submission for OMB Review; Comment Request
**AGENCY:**
Centers for Medicare & Medicaid Services, Health and Human Services (HHS).
**ACTION:**
Notice.
**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 September 29, 2025.
**ADDRESSES:**
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to *www.reginfo.gov/public/do/PRAMain.* Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
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 Parham at (410) 786-4669.
**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:* Reinstatement with change of a previously approved collection; *Title of Information* Collection: Medicare and Medicaid Programs: Conditions of Participation for Hospices; *Use:* Under the Medicare program, eligible beneficiaries may receive covered services in a hospice, provided that certain requirements are met by the hospice. Hospice care means a comprehensive set of services identified and coordinated by an interdisciplinary group to provide for the physical, psychosocial, spiritual and emotional needs of a terminally ill patient and/or family members, as delineated in a specific patient plan of care.
The information collection requirements (ICRs) described herein are needed to implement the Medicare Conditions of Participation (CoPs) for Medicare-participating hospices. The CoPs help assure an adequate level of patient health and safety in participating hospices and help ensure that Medicare hospice eligibility requirements are being met. CMS originally published the Hospice Conditions of Participation on June 5, 2008 (hereinafter “2008 Final Rule”). The regulations containing the information collection requirements are located at 42 CFR part 418 of the Code of Federal Regulations, Subparts B, C and D.
This is a reinstatement of the information collection request that expired on March 31, 2024. The previous iteration of this OMB Control Number: 0938-1067 (approved March 23, 2021) had an annual burden of 3,639,215 hours and annual costs of $273,001,454. For this requested reinstatement, with changes, the total annual burden hours for industry is 4,032,329 hours and the annual burden costs are $350,449,922. The 10.8% increase in hours is primarily due to the increase in the number of hospices since the last iteration.
Since the last reinstatement was approved in March 2021, CMS revised one of the hospice CoPs at 42 CFR 418.76 in the proposed rule, *Medicare Program: FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements* published on April 14, 2021 (86 FR 19700). As CMS addressed in the final rule (CMS-1754-F) published on August 4, 2021 (86 FR 42528), the comments received supported the proposed revisions and did not require any changes to the original burden estimates in this PRA package. This reinstatement incorporates the policy changes made to Section 418.76 through this rule and updates the associated burden estimates based on the original assumptions.
In November 2021, CMS required hospices to develop policies and procedures as a CoP to ensure all staff were fully vaccinated and the burden requirements were detailed in OMB Control Number: 0938-0266. However, CMS removed this requirement and related burden for hospices (and other facilities) in June 2023. *Form Number:* CMS-10277 (OMB control number: 0938-1067); *Frequency:* Yearly; *Affected Public:* Private sector (Business or other for-profit and Not-for-profit institutions); *Number of Respondents:* 7,356; *Total Annual Responses:* 9,209,893; *Total Annual Hours:* 4,032,329. (For policy questions regarding this collection contact Claudia Molinar at 410-786-8445.)
2. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* Blueprint for Approval of State-based Exchange; *Use:* The Patient Protection and Affordable Care Act (ACA) and its implementing regulations provide states with flexibility in the design and operation of Exchanges to ensure states are implementing Exchanges that best meet the needs of their consumers. States can choose to establish and operate a State-based Exchange (SBE) or a State-based Exchange on the Federal Platform (SBE-FP). To ensure a state can operate a successful and compliant SBE or SBE-FP, it is critical that states provide CMS with a complete and thorough Exchange Blueprint Application, Declaration of Intent Letter, and attest to demonstrate operational readiness. The information collected from states will be used by CMS, IRS, SSA and reviewed by other Federal agencies to determine if a state can implement a complete and fully operational Exchange. *Form Number:* CMS-10416 (OMB control number: 0938-1172); *Frequency:* Annually; *Affected Public:* State, Local, or Tribal governments; *Number of Respondents:* 2; *Total Annual Responses:* 21; *Total Annual Hours:* 106. (For policy questions regarding this collection contact Tiffany Y. Animashaun at *[email protected].* )
William N. Parham, III
Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs.