[Federal Register Volume 89, Number 25 (Tuesday, February 6, 2024)]
[Notices]
[Pages 8203-8204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02342]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3454-PN]


Medicare and Medicaid Programs; Application by DNV Healthcare USA 
Inc. (DNV) for Continued CMS Approval of Its Psychiatric Hospital 
Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed notice.

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SUMMARY: This proposed notice acknowledges the receipt of a deeming 
application from DNV Healthcare USA Inc. (DNV) for continued Centers 
for Medicare & Medicaid Services (CMS) approval of its psychiatric 
hospital accreditation program. The statute requires that within 60 
days of receipt of an organization's complete application, CMS must 
publish a notice that identifies the national accrediting body making 
the request, describes the nature of the request, and provides at least 
a 30-day public comment period.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, by March 7, 2024.

ADDRESSES: In commenting, refer to file code CMS-3454-PN.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3454-PN, P.O. Box 8010, 
Baltimore, MD 21244-8010.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3454-PN, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: 
    Joann Fitzell, (410) 786-4280.
    Lillian Williams, (410) 786-8636.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments. CMS will not post on Regulations.gov public 
comments that make threats to individuals or institutions or suggest 
that the commenter will take actions to harm an individual. CMS 
continues to encourage individuals not to submit duplicative comments. 
We will post acceptable comments from multiple unique commenters even 
if the content is identical or nearly identical to other comments.

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services from a psychiatric hospital provided certain 
requirements are met. Section 1861(f) of the Social Security Act (the 
Act), establishes distinct criteria for facilities seeking designation 
as a psychiatric hospital. Regulations concerning provider agreements 
are at 42 CFR part 489 and those pertaining to activities relating to 
the survey and certification of facilities are at 42 CFR part 488. The 
regulations at 42 CFR 482 subpart E specify the minimum conditions that 
a psychiatric hospital must meet to participate in the Medicare 
program, the scope of covered services, and the conditions for Medicare 
payment for psychiatric hospitals.

[[Page 8204]]

    Generally, to enter into an agreement, a psychiatric hospital must 
first be certified by a state survey agency (SA) as complying with the 
conditions or requirements set forth in part 482, subpart E of our 
regulations. Thereafter, the psychiatric hospital is subject to regular 
surveys by an SA to determine whether it continues to meet these 
requirements.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by a Centers for Medicare & Medicaid 
Services (CMS)-approved national accrediting organization (AO) that all 
applicable Medicare conditions are met or exceeded, we will deem those 
provider entities as having met the requirements. Accreditation by an 
AO is voluntary and is not required for Medicare participation.
    If an AO is recognized by the Secretary of the Department of Health 
and Human Services (the Secretary) as having standards for 
accreditation that meet or exceed Medicare requirements, any provider 
entity accredited by the national accrediting body's approved program 
would be deemed to meet the Medicare conditions. A national AO applying 
for approval of its accreditation program under part 488, subpart A, 
must provide CMS with reasonable assurance that the AO requires the 
accredited provider entities to meet requirements that are at least as 
stringent as the Medicare conditions. Our regulations concerning the 
approval of AOs are set forth at Sec. Sec.  488.4 and 488.5. The 
regulations at Sec.  488.5(e)(2)(i) require AOs to reapply for 
continued approval of its accreditation program every 6 years or sooner 
as determined by CMS.
    DNV Healthcare USA Inc.'s (DNV's) current term of approval for 
their psychiatric hospital accreditation program expires July 30, 2024.

II. Approval of Deeming Organization

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.5 
require that our findings concerning review and approval of a national 
AO's requirements consider, among other factors, the applying AO's 
requirements for accreditation; survey procedures; resources for 
conducting required surveys; capacity to furnish information for use in 
enforcement activities; monitoring procedures for provider entities 
found not in compliance with the conditions or requirements; and 
ability to provide CMS with the necessary data for validation.
    Section 1865(a)(3)(A) of the Act further requires that we publish, 
within 60 days of receipt of an organization's complete application, a 
notice identifying the national accrediting body making the request, 
describing the nature of the request, and providing at least a 30-day 
public comment period. The Act provides us 210 days from the receipt of 
a complete application to publish notice of approval or denial of the 
application.
    The purpose of this proposed notice is to inform the public of 
DNV's request for continued approval of its psychiatric hospital 
accreditation program. This notice also solicits public comment on 
whether DNV's requirements meet or exceed the Medicare conditions of 
participation (CoPs) for psychiatric hospitals.

III. Evaluation of Deeming Authority Request

    DNV submitted all the necessary materials to enable us to make a 
determination concerning its request for initial approval of its 
psychiatric hospital accreditation program. This application was 
determined to be complete on January 2, 2024. Under section 1865(a)(2) 
of the Act and our regulations at Sec.  488.5 (Application and re-
application procedures for national accrediting organizations), our 
review and evaluation of the DNV will be conducted in accordance with, 
but not necessarily limited to, the following factors:
     The equivalency of the DNV standards for psychiatric 
hospitals as compared with CMS' psychiatric hospital CoPs.
     The DNV survey process to determine the following:
    ++ The composition of the survey team, surveyor qualifications, and 
the ability of the organization to provide continuing surveyor 
training.
    ++ The comparability of DNV's processes to those of state agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    ++ DNV's processes and procedures for monitoring a psychiatric 
hospital found out of compliance with DNV's program requirements. These 
monitoring procedures are used only when DNV identifies noncompliance. 
If noncompliance is identified through validation reviews or complaint 
surveys, the state SA monitors corrections as specified at Sec.  
488.9(c).
    ++ DNV's capacity to report deficiencies to the surveyed facilities 
and respond to the facility's plan of correction in a timely manner.
    ++ DNV's capacity to provide CMS with electronic data and reports 
necessary for effective validation and assessment of the organization's 
survey process.
    ++ The adequacy of DNV's staff and other resources, and its 
financial viability.
    ++ DNV's capacity to adequately fund required surveys.
    ++ DNV's policies with respect to whether surveys are announced or 
unannounced, to ensure that surveys are unannounced.
    ++ DNV's policies and procedures to avoid conflicts of interest, 
including the appearance of conflicts of interest, involving 
individuals who conduct surveys or participate in accreditation 
decisions.
    ++ DNV's agreement to provide CMS with a copy of the most current 
accreditation survey together with any other information related to the 
survey as CMS may require (including corrective action plans).
    Upon completion of our evaluation, including evaluation of public 
comments received as a result of this notice, we will publish a final 
notice in the Federal Register announcing the result of our evaluation.

IV. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping, or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.).

V. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this 
document, authorizes Vanessa Garcia, who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

Vanessa Garcia,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2024-02342 Filed 2-5-24; 8:45 am]
BILLING CODE 4120-01-P