Notice2022-19099
Medicare and Medicaid Program; Approval of Application From Det Norske Veritas for Continued Hospital Accreditation Program
Primary source
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Published
September 6, 2022
Effective
September 26, 2026
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This final notice announces our decision to approve Det Norske Veritas for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.
Full Text
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<title>Federal Register, Volume 87 Issue 171 (Tuesday, September 6, 2022)</title>
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[Federal Register Volume 87, Number 171 (Tuesday, September 6, 2022)]
[Notices]
[Pages 54510-54512]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-19099]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3424-FN]
Medicare and Medicaid Program; Approval of Application From Det
Norske Veritas for Continued Hospital Accreditation Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice.
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SUMMARY: This final notice announces our decision to approve Det Norske
Veritas for continued recognition as a national accrediting
organization for hospitals that wish to participate in the Medicare or
Medicaid programs.
DATES: The decision announced in this final notice is effective through
September 26, 2026.
FOR FURTHER INFORMATION CONTACT:
Joy Webb, (410) 786-1667.
Lillian Williams, (410) 786-8636.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services from a hospital, provided that certain requirements
are met. Section 1861(e) of the Social Security Act (the Act),
establishes distinct criteria for facilities seeking designation as a
hospital. 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 482 specify the minimum conditions that a hospital must
meet to participate in the Medicare program.
Generally, to enter into an agreement, a hospital must first be
certified by a State survey agency as complying with the conditions or
requirements set forth in part 482 of our regulations. Thereafter, the
hospital is subject to regular surveys by a State survey agency 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 an approved national accrediting
organization (AO) that all applicable Medicare conditions are met or
exceeded, we may 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 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. A national AO applying for approval of its
accreditation program under part 488, subpart A, must provide the
Centers for Medicare and Medicaid Services (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 accrediting organizations
are set forth at Sec. 488.5. The regulations at Sec. 488.5(e)(2)(i)
require AOs to reapply for continued approval of its accreditation
program every 6 years or sooner as determined by CMS. Det Norske
Veritas's (DNV's) current term of approval for their hospital
accreditation program expires September 26, 2022.
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.
III. Provisions of the Proposed Notice
On April 18, 2022, we published a proposed notice in the Federal
Register (87 FR 22894), announcing DNV's request for continued approval
of its Medicare hospital accreditation program. In the 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 Medicare hospital accreditation renewal 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
hospital surveyors; (4)
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ability to investigate and respond appropriately to complaints against
accredited hospitals; and (5) survey review and decision-making process
for accreditation.
<bullet> The comparison of DNV's Medicare hospital accreditation
program standards to our current Medicare hospitals Conditions of
Participation (CoPs).
<bullet> A documentation review of DNV's survey process to do the
following:
++ Determine the composition of the survey team, surveyor
qualifications, and DNV's ability to provide continuing surveyor
training.
++ Compare DNV's processes to those we require of state survey
agencies, including periodic resurvey and the ability to investigate
and respond appropriately to complaints against accredited hospitals.
++ Evaluate DNV's procedures for monitoring accredited hospitals it
has found to be out of compliance with DNV's program requirements.
(This pertains only to monitoring procedures when DNV identifies non-
compliance. If noncompliance is identified by a state survey agency
through a validation survey, the state survey agency monitors
corrections as specified at Sec. 488.9(c)).
++ Assess DNV's ability to report deficiencies to the surveyed
hospital and respond to the hospital's plan of correction in a timely
manner.
++ Establish DNV's ability to provide CMS with electronic data and
reports necessary for effective validation and assessment of the
organization's survey process.
++ Determine the adequacy of DNV's staff and other resources.
++ Confirm DNV's ability to provide adequate funding for performing
required surveys.
++ Confirm DNV's policies with respect to surveys being
unannounced.
++ Confirm 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.
++ Obtain 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. Analysis of and Response to Public Comments on the Proposed Notice
In accordance with section 1865(a)(3)(A) of the Act, the April 18,
2022 proposed notice also solicited public comments regarding whether
DNV's requirements met or exceeded the Medicare CoPs for hospitals. We
received one comment in response to our proposed notice. The comment
received expressed support for DNV's hospital accreditation program.
The proposed notice described CMS' process and oversight activities
in Section III., Evaluation of Deeming Authority Request, which
highlighted the evaluation CMS conducts before granting deeming
authority to an AO. In Section V. of this final notice, CMS is
highlighting areas, which were identified to have discrepancies or lack
of clarity within DNV's standards and survey processes. We note that
DNV corrected these discrepancies prior to renewal of their deeming
authority for their CMS-approved hospital accreditation program. CMS
continues to strive for increased oversight of AOs.
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 hospital accreditation program requirements and
survey process with the Medicare CoPs at 42 CFR part 482, and the
survey and certification process requirements of parts 488 and 489. Our
review and evaluation of DNV's hospital 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
revised its standards and certification processes in order to meet our
requirements at:
<bullet> Section 482.13(e)(8)(i)(A) through (C). DNV clarified the
specific age-based limits with respect to applicable to the amount of
time a patient could spend in restraint and seclusion in hospitals;
these limits would supersede any conflicting state law.
<bullet> Section 482.15(a)(1). DNV changed its standard to include
community-based risk assessment in its requirements and all-hazards
definition in interpretive guidelines.
<bullet> Section 482.15(b)(7). DNV addressed the requirement that
states make arrangements with others hospitals and other providers to
receive patients in the event of limitation or cessation of operations,
in order to maintain the continuity of services to hospital patients.
<bullet> Section 482.23(b)(4). DNV addressed our concerns
pertaining to nursing assessment and care plan, to ensure that the
requirements are comparable with CMS' requirement.
<bullet> Sections 482.24(c)(4)(i)(A) through 482.24(c)(4)(i)(C).
DNV revised its standards to fully meet CMS requirements.
<bullet> Section 482.28(b)(2). DNV revised its language from a
restrictive requirement to include an all patient diet.
<bullet> Section 482.41(c). DNV revised language regarding the
applicability of National Fire Protection Association (NFPA) to
correspond to 2012 NFPA 99, Section 1.3 Application.
<bullet> Section 482.52(c)(2). DNV clarified the requirement
regarding deferral to state anesthesia practice standards; its prior
language was unclear.
<bullet> Section 482.53(d). DNV clarified its standard regarding
nuclear medicine documentation requirements to include signed and dated
language, showing authorship.
<bullet> Section 482.57. DNV revised its respiratory care standards
to include language reflecting ``the needs of the patients'' in order
to fully reflect CMS' requirement.
<bullet> Section 482.58. DNV clarified its standards to include the
governing body of the hospital bears the responsibility of assuring
medical staff has written policies.
<bullet> Section 482.58(b)(1). DNV revised the standard to be more
specific and to fully meet the regulatory requirement. DNV's standard
had not made it clear that the patients have the right to be informed
of total health status in the language they can understand, but rather
focused on rules, regulations, and facility responsibilities during
facility stay.
B. Term of Approval
Based on our review and observations described in Sections III. and
V. of this final notice, we approve DNV as a national accreditation
organization for hospitals that request participation in the Medicare
program. The decision announced in this final notice is effective
September 26, 2022 through September 26, 2026 (4 years). In accordance
with Sec. 488.5(e)(2)(i), the term of the approval will not exceed 6
years. Due to travel restrictions and the reprioritization of survey
activities brought on by the 2019 Novel Coronavirus Disease (COVID-19)
Public Health Emergency (PHE), CMS was unable to observe a hospital
survey completed by DNV surveyors as part of the application review
process, which is typically one component of the comparability
evaluation. Therefore, we are providing DNV with a shorter period of
approval. Based on our discussions with DNV and the information
provided in its application, we are confident that DNV will continue to
ensure that its deemed hospitals continue to meet or
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exceed our required standards. While DNV has taken actions based on the
findings noted in section V.A. of this final notice (Differences
Between TJC's Standards and Requirements for Accreditation and Medicare
Conditions and Survey Requirements), as authorized under Sec. 488.8,
we will continue ongoing review of DNV's hospital surveys. In keeping
with CMS's initiative to broadly increase AO oversight, and to ensure
that our requested revisions by DNV are completed, CMS expects to
perform more frequent review of DNV's activities in the future.
VI. 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.).
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this
document, authorizes Trenesha Fultz-Mimms, who is the Federal Register
Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Trenesha Fultz-Mimms,
Federal Register Liaison, Center for Medicare & Medicaid Services.
[FR Doc. 2022-19099 Filed 9-2-22; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on September 6, 2022.
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