[Billing Code: 4120-01-P]

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.
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 [INSERT DATE 30 DAYS AFTER DATE OF
PUBLICATION IN THE FEDERAL REGISTER].
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 § 488.5. The
regulations at § 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 § 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 § 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

•

DNV’s survey process to determine the following:

CoPs.

++ 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 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 § 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: 6/12/2024 8:45 am; Publication Date: 6/13/2024]