Notice2025-22203
Medicare and Medicaid Programs: Approval of Application by DNV Healthcare, Inc. for Initial CMS Approval of Its Ambulatory Surgical Center (ASC) Accreditation Program
Primary source
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Published
December 8, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This notice acknowledges the approval of an application from DNV Healthcare, Inc. for initial CMS approval of its Ambulatory Surgical Centers as a national accrediting organization that wishes to participate in the Medicare or Medicaid programs.
Full Text
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<title>Federal Register, Volume 90 Issue 233 (Monday, December 8, 2025)</title>
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[Federal Register Volume 90, Number 233 (Monday, December 8, 2025)]
[Notices]
[Pages 56766-56768]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22203]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3474-FN]
Medicare and Medicaid Programs: Approval of Application by 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.
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SUMMARY: This notice acknowledges the approval of an application from
DNV Healthcare, Inc. for initial CMS approval of its Ambulatory
Surgical Centers as a national accrediting organization that wishes to
participate in the Medicare or Medicaid programs.
DATES: The decision announced in this notice is applicable from
December 8, 2025 to December 10, 2029.
FOR FURTHER INFORMATION CONTACT:
Joy Webb (410) 786-1667.
Kristin Shifflett (410) 786-4133.
SUPPLEMENTARY INFORMATION:
I. Background
Ambulatory Surgical Centers (ASCs) are distinct entities that
operate 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 in order 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.
488.5.
This is DNV Healthcare, Inc.'s (DNV's) initial application and does
not
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have a current term for the ASC program.
II. Application Approval Process
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
us 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, we 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, we must
publish a notice in the Federal Register approving or denying the
application. Due to the federal lapse in appropriated funding, certain
parts of CMS operations were temporarily halted on September 30, 3025.
This lapse in funding led to a government shutdown, and operations in
particular areas have remained non-operational. Therefore, this notice
was impacted and did not publish on or before October 15, 2025 (the
210-day statutory requirement).
III. Provisions of the Proposed Notice
On April 28, 2025, CMS published a proposed notice in the Federal
Register (90 FR 17599), announcing DNV's request for initial approval
of its Medicare ASC accreditation program. In the April 28, 2025,
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 initial ASC accreditation application in
accordance with the criteria specified by our regulations, which
include, but are not limited to the following:
<bullet> An 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
ASC surveyors; (4) ability to investigate and respond appropriately to
complaints against accredited ASCs; and (5) survey review and decision-
making process for accreditation.
<bullet> The equivalency of DNV's standards for ASCs as compared
with Medicare's Conditions for Coverage (CfCs) for ASCs.
<bullet> 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. Analysis of and Responses to Public Comments on the Proposed Notice
In accordance with section 1865(a)(3)(A) of the Act, the April 28,
2025, proposed notice also solicited public comments regarding whether
DNV's requirements met or exceeded the Medicare CfCs for ASCs. No
comments were received in response to our proposed notice.
V. 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 ASC accreditation requirements and survey process
with the Medicare CfCs at 42 CFR part 416, and the survey and
certification process requirements of parts 488 and 489. Our review and
evaluation of DNV's ASC 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 do all of the
following:
<bullet> Meet the standard's requirements of all of the following
regulations:
++ Section 416.42(a)(1)(ii) to clarify as defined at Sec.
410.69(b) who must examine the patient for anesthesia risk.
++ Section 416.42(c)(1) to revise to include an attestation from
the State's Governor to opt-out of the physician supervision
requirements.
++ Sections 416.43(a)(2) and (c)(2) to revise to include how the
ASC will measure, analyze and track adverse patent events.
++ Section 416.43(c)(3) to revise that staff are familiar with the
ASC's preventive strategies.
++ Section 416.44(b)(1) to ensure ASCs meet the provisions
applicable to Ambulatory Health Care Occupancies and address the Life
Safety Code (LSC) Tentative Interim Amendments (TIAs), TIA 12-2, TIA
12-3, and TIA 12-4 requirements.
++ Section 416.44(c) to incorporate the requirement for ASCs to
comply with Health Care Facilities Code (HCFC) NFPA 99, and Tentative
Interim Amendments (TIAs), TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5 and
TIA 12-6 and remove for Ambulatory Health Care Occupancies for
consistency.
++ Section 416.44(d) to clarify LSC policies to include the
requirement that the ASC medical staff and governing body coordinates,
develops, and revises ASC policies and procedures to specify the types
of emergency equipment required for use in the ASC's operating room.
++ Section 416.44(e) to clarify policies to include the requirement
that personnel trained in the use of emergency equipment and in
cardiopulmonary resuscitation must be available whenever there is a
patient in the ASC.
++ Section 416.45(a) to revise polices to allow the ASC's governing
body to make privileging decisions and to solicit recommendations from
qualified medical personnel.
++ Section 416.50(d)(5) to ensure that the ASC investigates all
grievances made by the patient, patient representative and patient
surrogate.
++ Section 416.51(a) to specify that infection control standards
adhere to
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professionally acceptable standards of practice.
++ Section 416.51(b)(3) to ensure that the ASC's infection control
program provides a plan of action for infections and communicable
diseases and immediately implements corrective and preventive measures.
++ Section 416.52 to ensure that each patient has the appropriate
pre-surgical and post-surgical assessments completed and that all
elements of the discharge requirements are done.
We also reviewed DNV's comparable survey processes, which were
conducted as described in section III. of this final notice, and
yielded the following areas where, as of the date of this notice, DNV
has completed revising its survey processes in order to demonstrate
that it uses survey processes that are comparable to state survey
agency processes by:
++ Ensuring DNV's policies allow for the survey team to include at
least one RN or Physician with hospital or ASC survey experience.
++ Updating DNV's policy and procedures to include 488.26(b) for
determining manner and degree, when evaluating multiple standards and
elevating to a higher deficiency level.
++ Providing clarification to DNV's policy on timeframes for
notifying CMS of terminations and withdrawals.
++ A process to ensure that during survey, an Infection Control
Worksheet is completed to confirm safe injection practices.
B. Term of Approval
Based on our review described in section III. and section V. of
this final notice, we approve DNV as an initial national accreditation
organization for ASCs that request participation in the Medicare
program. The decision announced in this final notice is effective
December 8, 2025 to December 10, 2029. In accordance with Sec.
488.5(e)(2)(i) the term of the approval will not exceed 6 years.
Generally, when an AO is seeking an initial approval for a specific
program type, CMS may approve for a term no greater than 4 years.
VI. Collection of Information and Regulatory Impact Statement
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), Mehmet Oz, 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, Center for Medicare & Medicaid Services.
[FR Doc. 2025-22203 Filed 12-5-25; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on December 8, 2025.
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