[Federal Register Volume 89, Number 115 (Thursday, June 13, 2024)]
[Notices]
[Pages 50332-50333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12995]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3460-PN]


Medicare and Medicaid Programs: Application by the DNV Healthcare 
USA, Inc. for Continued CMS-Approval of Its Critical Access Hospital 
Accreditation Program

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

ACTION: Notice with request for comment.

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SUMMARY: This notice acknowledges the receipt of an application from 
the DNV Healthcare USA, Inc. for continued recognition as a national 
accrediting organization for critical access hospitals that wish to 
participate in the Medicare or Medicaid programs.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on July 15, 2024.

ADDRESSES: In commenting, please refer to file code CMS-3460-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-3460-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-3460-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: Caecilia Andrews, (410) 786-2190.

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.

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a critical access hospital (CAH), provided that 
certain requirements are met by the CAH. Section 1861(mm) of the Social 
Security Act (the Act), establishes distinct criteria for facilities 
seeking designation as a CAH. 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 part 485, subpart F specify the 
conditions that a CAH must meet to participate in the Medicare program.
    Generally, to enter into an agreement, a CAH must first be 
certified by a state survey agency as complying with the conditions or 
requirements set forth in part 485 of our regulations. Thereafter, the 
CAH is subject to regular surveys by a state survey agency to determine 
whether it continues to meet these requirements.
    However, there is an alternative to surveys by state agencies. 
Section 1865(a)(1) of the Act states, if a provider entity demonstrates 
through accreditation by an 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 Centers for Medicare & Medicaid 
Services (CMS) 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 us 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 an AO to reapply for continued approval of its accreditation 
program every 6 years or as determined by CMS.
    The DNV Healthcare USA, Inc.'s (DNV's) current term of approval for 
their critical access hospital accreditation program expires December 
23, 2024.

II. Approval of Accreditation Organizations

    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. We have 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 CAH accreditation program. 
This notice also solicits public comment on whether the DNV 
requirements meet or exceed the Medicare conditions of participation 
(CoPs) for CAHs.

III. Evaluation of Deeming Authority Request

    DNV submitted all the necessary materials to enable us to make a 
determination concerning its request for continued approval of its CAH 
accreditation program. This application was determined to be complete 
on March 1, 2024. Under 1865(a)(2) of the Act and our regulations at 
Sec.  488.5 (Application and re-application procedures for national 
AO), our review and evaluation of the DNV CAH accreditation program 
will be conducted in accordance with, but not necessarily limited to, 
the following factors:
     The equivalency of DNV's standards for hospitals as 
compared with CMS' CAH CoPs.
     DNV's survey process to determine the following:
    ++ The composition of the survey team, surveyor qualifications, and 
the

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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 CAH 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 
survey agency monitors corrections as specified at Sec.  488.9.
    ++ 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 assure 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 we may require (including corrective action plans).

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. Chapter 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. 2024-12995 Filed 6-12-24; 8:45 am]
BILLING CODE 4120-01-P