[Federal Register Volume 89, Number 152 (Wednesday, August 7, 2024)]
[Notices]
[Pages 64463-64465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17484]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-R-48]


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

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(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 
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 
http://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 and associated 
materials (see ADDRESSES).

CMS-R-48 Hospital Conditions of Participation (CoPs) and Supporting 
Regulations

    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 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: Hospital Conditions of Participation (CoPs) and Supporting 
Regulations; Use: The purpose of this package is to request from the 
Office of Management and Budget (OMB) approval of the reinstatement 
with change of the information collection request associated with OMB 
control number: 0938-0328.
    The information collection requirements described herein are needed 
to implement the Medicare and Medicaid Conditions of Participation 
(CoPs) for a total of 5,132 facilities that includes: 4,994 accredited 
and non-accredited hospitals and 138 Critical Access Hospitals (CAHs) 
with Distinct Part Units (DPUs); specifically, 119 CAHs with 
psychiatric DPUs and 19 CAHs with rehabilitation DPUs. The information 
collection requirements for the 1,245 CAHs without DPUs (1,383 total 
CAHs less 138 CAHs with DPUs) are covered under OMB control number: 
0938-1043 (CMS-10239).
    As previous stated, this notice is related to a reinstatement of 
the information collection request that expired on 11/30/2017. The 
previous iteration of this OMB control number 0938-0328 (approved 
November 14, 2014) had a burden of 14,424,655 annual hours. For this 
requested reinstatement, with changes, the adjusted annual hourly 
burden for industry is 3,566,521 hours at an annual cost of 
$310,989,894. The decrease in burden hours is primarily due to the fact 
that many of the information collections that were previously required 
as CoPs by CMS are now customary and usual industry practice and would 
take place in the absence of the Medicare and Medicaid programs. In 
addition, where possible, CMS reduced the burden of CoPs with prior 
information collections. For example, the burden for individual 
hospitals that are part of a multi-hospital system was reduced by 
allowing a multi-hospital system, which represent approximately 70% of 
hospitals today, to develop a unified Quality Assessment and 
Performance Improvement (QAPI) program rather than requiring each 
hospital in the system to maintain separate programs and reporting 
requirements.
    This reinstatement also reflects a change in how the annual burden 
costs for information collection requirements for Hospital CoPs are 
calculated. In prior submissions, the fully loaded wage estimates 
applied only an additional 33% to the hourly wage to account for fringe 
benefits. This reinstatement applies an additional 100% to the median 
hourly wage to reflect the costs more accurately to hospitals for 
compliance with the current CoPs.
    Additional changes reflected in this reinstatement are some of the 
information collections were placed on participating hospitals as CoPs 
during the recent COVID-19 Public Health Emergency (PHE), specifically 
regarding collecting and reporting data on incidents and hospital 
management of infection diseases. The burden of many of these 
information collections were accounted for in other OMB submissions, 
such as the ``Unified Hospital Data Surveillance System (U.S. 
Healthcare COVID-19 Collection'' (OMB control number 0990-0478), and 
some of these collections ended or were revised after HHS declared the 
end of the COVID-19 PHE in April 2024. As a result, this reinstatement 
does not include information collection requirements that have expired, 
and only includes the annual burden and costs to participating 
hospitals and CAHs with DPUs for information collections that have 
remained as CoPs after the COVID-19 PHE ended. In addition, in 
anticipation of an upcoming final rule titled ``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,'' this package includes burden

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estimates for additional information collection requirements that CMS 
is adding as CoPs in the interest of public health and ensuring 
resiliency in the U.S. health care system. The aforementioned final 
rule, CMS-1808-F (RIN 0938-AV34), is currently on public display at the 
Office of the Federal Register and scheduled for publication on August 
28, 2024.
    Finally, this reinstatement incorporates additional information 
collection requirements associated with a number of new CoPs for 
hospitals and CAHs regarding obstetrical services which are outlined in 
detail in the July 2024 proposed rule titled ``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). Form Number: CMS-R-48 (OMB control 
number: 0938-0328); Frequency: Yearly; Affected Public: Private Sector 
(Business or other for-profit); Number of Respondents: 4,664; Total 
Annual Responses: 2,647,647; Total Annual Hours: 3,566,521 (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. 2024-17484 Filed 8-2-24; 4:15 pm]
BILLING CODE 4120-01-P