Notice2024-12995
Medicare and Medicaid Programs: Application by the DNV Healthcare USA, Inc. for Continued CMS-Approval of Its Critical Access Hospital Accreditation Program
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 13, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 115 (Thursday, June 13, 2024)</title>
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[Federal Register Volume 89, Number 115 (Thursday, June 13, 2024)]
[Notices]
[Pages 50332-50333]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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:
<bullet> The equivalency of DNV's standards for hospitals as
compared with CMS' CAH CoPs.
<bullet> 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
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