2024-17484. Agency Information Collection Activities: Proposed Collection; Comment Request

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Department of Health and Human Services

Centers for Medicare & Medicaid Services

1. [Document Identifiers: CMS-R-48]

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 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 [phone].

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 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.