[Federal Register Volume 89, Number 136 (Tuesday, July 16, 2024)]
[Notices]
[Pages 57900-57901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15519]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3454-FN]


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

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

ACTION: Notice.

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SUMMARY: This notice acknowledges the approval of an application from 
DNV Healthcare USA Inc. for continued CMS approval as a national 
accrediting organization for its psychiatric hospitals that wish to 
participate in the Medicare or Medicaid programs.

DATES: This notice is applicable on July 30, 2024 through July 30, 
2028.

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

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services from a psychiatric hospital provided certain 
requirements established by the Secretary of the Department of Health 
and Human Services (the Secretary) are met. Section 1861(f) of the 
Social Security Act (the Act) establishes distinct criteria for 
facilities seeking designation as a psychiatric hospital under 
Medicare. Regulations concerning provider agreements and supplier 
approval 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 part 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.
    Generally, to enter into a provider agreement with the Medicare 
program, a psychiatric hospital must first be certified by a State 
Survey Agency as complying with the conditions or requirements set 
forth in part 482 subpart E of CMS regulations. Thereafter, the 
psychiatric hospital is subject to regular surveys by a State Survey 
Agency to determine whether it continues to meet the Medicare 
requirements. There is an alternative, however, to surveys by State 
agencies. Certification by a nationally recognized accreditation 
program can substitute for ongoing State review.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national accrediting 
organization (AO) that all applicable Medicare conditions are met or 
exceeded, we may treat the provider entity as having met those 
conditions, that is, we may ``deem'' the provider entity 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 as having standards for 
accreditation that meet or exceed Medicare requirements, any provider 
entity accredited by the national accrediting body's approved program 
may 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.  488.5. The regulations at Sec.  
488.5(e)(2)(i) require the AO to reapply for continued approval of its 
accreditation program every 6 years or sooner as determined by CMS.

II. Application Approval Process

    Section 1865(a)(2) of the Act and CMS regulations at Sec.  488.5 
require that our findings concerning review and approval of an 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 
that were not in compliance with the conditions or requirements; and 
their ability to provide CMS with the necessary data for validation.
    Section 1865(a)(3)(A) of the Act provides a statutory timetable to 
ensure that our review of applications for CMS-approval of an 
accreditation program is conducted in a timely manner. The Act provides 
CMS 210 days after the date of receipt of a complete application, with 
any documentation necessary to make the determination, to complete our 
survey activities and application process. Within 60 days after 
receiving a complete application, CMS must publish a notice in the 
Federal Register that identifies the national accrediting body making 
the request, describes the request, and provides no less than a 30-day 
public comment period. At the end of the 210-day period, CMS must 
publish a notice in the Federal Register approving or denying the 
application.

III. Provisions of the Proposed Notice

    In the February 6, 2024 Federal Register (89 FR 8203), we published 
a proposed notice announcing DNV's request for approval of its Medicare 
psychiatric hospital accreditation program. In the proposed notice, we 
detailed our evaluation criteria. Under section 1865(a)(2) of the Act 
and in our regulations at Sec.  488.5, we conducted a review of DNV's 
Medicare psychiatric hospital accreditation application in accordance 
with the criteria specified by

[[Page 57901]]

our regulations, which include, but are not limited to the following:
     An onsite administrative review of DNV's: (1) Corporate 
policies; (2) financial and human resources available to accomplish the 
proposed surveys; (3) procedures for training, monitoring, and 
evaluation of its psychiatric hospital surveyors; (4) ability to 
investigate and respond appropriately to complaints against accredited 
psychiatric hospitals; and (5) survey review and decision-making 
process for accreditation.
     The comparison of DNV's Medicare psychiatric hospital 
accreditation program standards to our current Medicare hospitals 
Conditions of Participation (CoPs) and psychiatric hospital special 
CoPs.
     A documentation review of DNV's psychiatric hospital 
survey process to do the following:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and DNV's ability to provide continuing surveyor 
training.
    ++ Compare DNV's processes to those we require of State Survey 
Agencies, including periodic re-survey and the ability to investigate 
and respond appropriately to complaints against accredited psychiatric 
hospitals.
    ++ Evaluate DNV's procedures for monitoring psychiatric hospitals 
it has found to be out of compliance with DNV's program requirements. 
(This pertains only to monitoring procedures when DNV identifies non-
compliance. If noncompliance is identified by a State Survey Agency 
through a validation survey, the State Survey Agency monitors 
corrections as specified at Sec.  488.9(c)(1)).
    ++ Assess DNV's ability to report deficiencies to the surveyed 
hospital and respond to the psychiatric hospital's plan of correction 
in a timely manner.
    ++ Establish DNV's ability to provide CMS with electronic data and 
reports necessary for effective validation and assessment of the 
organization's survey process.
    ++ Determine the adequacy of DNV's staff and other resources.
    ++ Confirm DNV's ability to provide adequate funding for performing 
required surveys.
    ++ Confirm DNV's policies with respect to surveys being 
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.
    ++ Obtain 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 we may require, including corrective action 
plans.
    ++ As authorized under 488.8(h), CMS reserves the right to conduct 
onsite observations of accrediting organization operations at any time 
as part of the ongoing review and continuing oversight of an AO's 
performance.
    In accordance with section 1865(a)(3)(A) of the Act, the February 
6, 2024, proposed notice also solicited public comments regarding 
whether DNV's requirements met or exceeded the Medicare CoPs for 
psychiatric hospitals. No comments were received in response to our 
proposed notice.

IV. Provisions of the Final Notice

A. Differences Between DNV's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared DNV's psychiatric hospital accreditation program 
requirements and survey process with the Medicare CoPs at 42 CFR part 
482 subpart E, and the survey and certification process requirements of 
parts 488 and 489. Our review and evaluation of DNV's psychiatric 
hospital application, which were conducted as described in section III. 
of this final notice, yielded the following areas where, as of the date 
of this notice, DNV has completed revising its standards and 
certification processes in order to meet the requirements at:
     Section 482.41(c)(2), to address the requirements 
regarding the Health Care Facilities Code waiver allowance.
     Section 488.5(4)(ii), to address the requirements to 
include the requirement for Life Safety Specialist to have training or 
experience in the Health Care Facilities Code.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we have determined that DNV's psychiatric hospital 
accreditation program requirements meet or exceed our requirements, and 
its survey processes are also comparable. Therefore, we approve DNV as 
a national accreditation organization for psychiatric hospitals that 
request participation in the Medicare program, effective July 30, 2024 
through July 30, 2028.

V. 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.).
    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. 2024-15519 Filed 7-15-24; 8:45 am]
BILLING CODE 4120-01-P