[Federal Register Volume 89, Number 156 (Tuesday, August 13, 2024)]
[Notices]
[Pages 65914-65915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18031]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10239]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

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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 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.

DATES: Comments must be received by October 7, 2024.

ADDRESSES: When commenting, please reference the document identifier or 
Office of Management and Budget (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 
https://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

[[Page 65915]]

and associated materials (see ADDRESSES).

CMS-10239 Conditions of Participation for Critical Access Hospitals 
(CAH) and Supporting Regulations

    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain 
approval from 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: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Conditions of Participation for Critical Access Hospitals 
(CAH) and Supporting Regulations; Use: The purpose of this package is 
to request from the Office of Management and Budget (OMB) the approval 
to reinstate, with changes, the information collection request, 
associated with OMB Control Number 0938-1043, titled ``Critical Access 
Hospital (CAH) Conditions of Participation (CoPs) and Supporting 
Regulations.''
    Sections 1820 and 1861(mm) of the Social Security Act provide that 
CAHs participating Medicare meet certain specified requirements. The 
regulations containing the information collection requirements are 
located at 42 CFR part 485, subpart F. These regulations implement 
sections 1102, 1138, 1814(a)(8), 1820(a-f), 1861(mm), 1864, and 1871 of 
the Act.
    This is a reinstatement of the information collection request that 
expired on March 31, 2024. The previous iteration of this OMB No. 0938-
1043 (approved March 25, 2021) had a burden of 33,905 annual hours. For 
this requested reinstatement, with changes, the estimated total annual 
burden hours for the industry is 898,332 hours and the estimated annual 
burden costs are $74,020,673.
    The increase in burden hours from the prior package is primarily 
due to new information collections associated with new CoPs for CAHs 
outlined in the two CMS rules referenced below. The new CoPs include 
multiple information collection requirements that are one-time burdens 
for developing new policies and protocols and ongoing reporting 
requirements, such as daily or biweekly reporting of respiratory 
illnesses as well as maternal deaths. The reasons for the increased 
information collections are discussed in more detail in the rules and 
are summarized in the information collection request.
    (1) Obstetrical services included in the proposed rule, Medicare 
and Medicaid Programs: Hospital Outpatient Prospective Payment and 
Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, 
Including the Hospital Inpatient Quality Reporting Program; Health and 
Safety Standards for Obstetrical Services in Hospitals and Critical 
Access Hospitals; Prior Authorization; Requests for Information; 
Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four 
Walls Exceptions; Individuals Currently or Formerly in Custody of Penal 
Authorities; Revision to Medicare Special Enrollment Period for 
Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On 
Payment for High-Cost Drugs Provided by Indian Health Service and 
Tribal Facilities, 89 FR 59186 (July 22, 2024) (hereinafter referred to 
as the ``July 2024 Proposed Rule'').
    (2) Reporting of acute respiratory illnesses in the interest of 
public health and ensuring resiliency in the U.S. health care system 
included in the Final rule: Medicare and Medicaid Programs and the 
Children's Health Insurance Program; Hospital Inpatient Prospective 
Payment Systems for Acute Care Hospitals and the Long-Term Care 
Hospital Prospective Payment System and Policy Changes and Fiscal Year 
2025 Rates; Quality Programs Requirements; and Other Policy Changes. 
The aforementioned final rule, CMS-1808-F (RIN 0938-AV34), is currently 
on display at the Office of the Federal Register and scheduled for 
publication on August 28, 2024 (hereinafter referred to as the ``August 
2024 Final Rule'').
    The change in total burden hours is also due to prior information 
collection requests are exempt from the PRA because the requirements 
are customary and usual industry practice and would take place in the 
absence of the Medicare and Medicaid programs. Form Number: CMS-10239 
(OMB control number: 0938-1043); Frequency: Yearly; Affected Public: 
Private Sector (Business or other for-profit); Number of Respondents: 
1,245; Total Annual Responses: 9,145; Total Annual Hours: 898,332 (For 
policy questions regarding this collection contact Claudia Molinar at 
410-786-8445).

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-18031 Filed 8-8-24; 4:15 pm]
BILLING CODE 4120-01-P