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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [Document Identifier: CMS-10914, CMS-10237 and CMS-10631]

# 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 December 9, 2024.

# 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:*                     Revision of a currently approved information collection;                     *Title of Information Collection:*                     Reform of Long-Term Care Facilities Requirements for Respiratory Illness Reporting;                     *Use:*                     Sections 1818 and 1919 of the Act (42 U.S.C. 1395i-3 and 42 U.S.C. 1396r, respectively) specify certain requirements that a LTC facility must meet to participate in the Medicare and Medicaid programs. In particular, sections 1819(d)(4)(B) and 1919(d)(4)(B) require that a SNF or NF must meet such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary many find necessary.                

                    Under the authority of sections 1819, 1919, 1128I (b) and (c), and 1150B of the Act, the Secretary proposes to establish in regulation the requirements that an LTC facility must meet to participate in the Medicare and Medicaid programs. We are revising the information collection requirements for the proposed respiratory illness reporting that would replace the current requirement on COVID-19 reporting at § 483.80(g) based on the proposed rule, Medicare Program; Calendar Year (CY) 2025 Home Health Prospective Payment System (HH PPS) Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin (IVIG) Items and Services Rate Update; and Other Medicare Policies (July 2, 2024/89 FR 55312). In this proposed rule, we revised the LTC requirements for COVID-19 reporting to establish a new requirement for respiratory illness reporting that includes COVID-19, RSV, and influenza. The title, OMB Control Number, and CMS identification number for this 30-day notice has been revised. The 60-day FR Notice (89 FR 67442) was inadvertently published with collection identifiers associated with the PRA request which accounts for all of the Requirements for Long-term Care Facilities collections of information (COIs) (CMS-10573/OMB 0938-1363). Since this information collection only addresses the COIs for § 483.80(g) Respiratory Illness Reporting, this                     **Federal Register**                     Notice and the related PRA package have been assigned newly issued identification numbers, specifically OMB Control Number 0938-NEW and CMS-10914.                     *Form Number:*                     CMS-10914 (OMB control number: 0938-NEW);                     *Frequency:*                     Occasionally;                     *Affected Public:*                     Private Sector, Business or other for-profits, Not-for-profits;                     *Number of Respondents:*                     14,926;                     *Number of Responses:*                     14,926;                     *Total Annual Hours:*                     6,253,995. (For policy questions regarding this collection contact Diane Corning at 410-786-8486).                

                    2.                     *Type of Information Collection Request:*                     Revision of a currently approved information collection;                     *Title                               ( print page 88783)                            of Information Collection:*                     Applications for Part C Medicare Advantage, 1876 Cost Plans, and Employer Group Waiver Plans to Provide Part C Benefits;                     *Use:*                     Collection of this information is mandated by the Code of Federal Regulations, MMA, and CMS regulations at 42 CFR part 422, subpart K, in “                    *Application Procedures and Contracts for Medicare Advantage Organizations.*                    ” In addition, the Medicare Improvement for Patients and Providers Act of 2008 (MIPPA) further amended titles XVII and XIX of the Social Security Act.                

                    This information collection includes the process for organizations wishing to provide healthcare services under MA plans. These organizations must complete an application annually (if required), file a bid, and receive final approval from CMS. The MA application process has two options for applicants that include (1) request for new MA product or (2) request for expanding the service area of an existing product. CMS utilizes the application process as the means to review, assess and determine if applicants are compliant with the current requirements for participation in the MA program and to make a decision related to contract award. This collection process is the only mechanism for organizations to complete the required MA application process.                     *Form Number:*                     CMS-10237 (OMB control number: 0938-0935);                     *Frequency:*                     Yearly;                     *Affected Public:*                     Private Sector, Business or other for-profits, not for-profits and Federal Government;                     *Number of Respondents:*                     500;                     *Number of Responses:*                     500;                     *Total Annual Hours:*                     9,173. (For policy questions regarding this collection contact Jackie Ford at 410-786-7767 or                     *Jacqueline.Ford@cms.hhs.gov*).                

                    3.                     *Type of Information Collection Request:*                     Revision of an approved information collection;                     *Title of Information Collection:*                     The PACE Organization Application Process in 42 CFR part 460;                     *Use:*                     The Programs of All-Inclusive Care for the Elderly (PACE) consist of pre-paid, capitated plans that provide comprehensive health care services to frail, older adults in the community who are eligible for nursing home care according to state standards. PACE organizations (PO) must provide all Medicare and Medicaid covered services; financing of this model is accomplished through prospective capitation of both Medicare and Medicaid payments. Upon approval of a PACE application, CMS executes a 3-way program agreement with the applicant entity and the applicable State Administering Agency (SAA). CMS regulations at 42 CFR 460.98(b)(2) require a PO to provide PACE services in at least the PACE center, the home, and inpatient facilities. The PACE center is the focal point for the delivery of PACE services; the center is where the interdisciplinary team (IDT) is located, services are provided, and socialization occurs with staff that is consistent and familiar to participants.                

                    Collection of this information is mandated by statute under sections 1894(f) and 1934(f) of the Act and at 42 CFR part 460, subpart B, which addresses the PO application and waiver process. In general, PACE services are provided through a PO. An entity wishing to become a PO must submit an application to CMS that describes how the entity meets all the requirements in the PACE program. An entity's application must be accompanied by an assurance from the SAA of the State in which the PO wishes to operate its PACE program. CMS accepts applications on a designated date four times per year (                    *i.e.,*                     on a quarterly basis, generally the last Friday of March, June, September and December).                     *Form Number:*                     CMS-10631 (OMB control number: 0938-1326);                     *Frequency:*                     Occasionally;                     *Affected Public:*                     Private Sector, Business or other for-profits, not for-profits and Federal Government State, Local;                     *Number of Respondents:*                     72;                     *Number of Responses:*                     109;                     *Total Annual Hours:*                     7,271. (For policy questions regarding this collection contact Jackie Ford at 410-786-7767 or                     *Jacqueline.Ford@cms.hhs.gov*).                

William N. Parham, III,

Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs.

[FR Doc. 2024-26018 Filed 11-7-24; 8:45 am]

BILLING CODE 4120-01-P