[Federal Register Volume 90, Number 80 (Monday, April 28, 2025)]
[Notices]
[Pages 17599-17601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07247]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3474-PN]
Medicare and Medicaid Programs: Application From DNV Healthcare,
Inc. for Initial CMS-Approval of Its Ambulatory Surgical Center (ASC)
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
DNV Healthcare Inc. for initial recognition as a national accrediting
organization for Ambulatory Surgical Centers that wish to participate
in the Medicare or Medicaid programs.
DATES: To be assured consideration, comments must be received at one of
the addresses discussed later in this section, no later than 5 p.m. on
May 28, 2025.
ADDRESSES: In commenting, refer to file code CMS-3474-PN. Due to staff
and resource limitations, we cannot accept comments by facsimile (FAX)
transmission.
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-3474-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-3474-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: Joy Webb, (410) 786-1667, or Danielle
Adams, (410) 786-8818.
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
at http://www.regulations.gov. Follow the search instructions on that
website to view public comments. The Centers for Medicare & Medicaid
Services (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
Ambulatory Surgical Centers (ASCs) are distinct entities that
operate
[[Page 17600]]
exclusively for the purpose of furnishing outpatient surgical services
to patients. Under the Medicare program, eligible beneficiaries may
receive covered services from an ASC provided certain requirements are
met. Section 1832(a)(2)(F)(i) of the Social Security Act (the Act)
establishes distinct criteria for a facility seeking designation as an
ASC. 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 416 specify the conditions that an ASC must meet to
participate in the Medicare program, the scope of covered services, and
the conditions for Medicare payment for ASCs.
Generally, to enter into an agreement, an ASC must first be
certified by a state survey agency (SA) as complying with the
conditions or requirements set forth in part 416 of our Medicare
regulations. Thereafter, the ASC 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 may deem that
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 of the Department of Health
and Human Services 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. The 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.
This is DNV Healthcare, Inc.'s (DNV's) initial application and does
not have a current term of approval for its ASC program.
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 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
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 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. 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 initial CMS-approval of its ASC accreditation
program. This notice also solicits public comment on whether DNV's
requirements meet or exceed the Medicare conditions for coverage (CfCs)
for ASCs.
III. Evaluation of Deeming Authority Request
DNV submitted all the necessary materials to enable us to make a
determination concerning its request for initial CMS-approval of its
ASC accreditation program. This application was determined to be
complete on March 21, 2025. Under section 1865(a)(2) of the Act and
Sec. 488.5, our review and evaluation of DNV will be conducted in
accordance with, but not necessarily limited to, the following factors:
The equivalency of DNV's standards for ASCs as compared
with Medicare's CfCs for ASCs.
DNV's 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 an ASC 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(c)(1).
++ 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 the 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).
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 Public 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), Mehmet Oz, having reviewed and approved this document,
authorizes Vanessa Garcia, who is the Federal Register Liaison, to
electronically sign
[[Page 17601]]
this document for purposes of publication in the Federal Register.
Vanessa Garcia,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2025-07247 Filed 4-25-25; 8:45 am]
BILLING CODE 4120-01-P