[Federal Register Volume 87, Number 171 (Tuesday, September 6, 2022)]
[Notices]
[Pages 54510-54512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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.
     The comparison of DNV's Medicare hospital accreditation 
program standards to our current Medicare hospitals Conditions of 
Participation (CoPs).
     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:
     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.
     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.
     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.
     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.
     Sections 482.24(c)(4)(i)(A) through 482.24(c)(4)(i)(C). 
DNV revised its standards to fully meet CMS requirements.
     Section 482.28(b)(2). DNV revised its language from a 
restrictive requirement to include an all patient diet.
     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.
     Section 482.52(c)(2). DNV clarified the requirement 
regarding deferral to state anesthesia practice standards; its prior 
language was unclear.
     Section 482.53(d). DNV clarified its standard regarding 
nuclear medicine documentation requirements to include signed and dated 
language, showing authorship.
     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.
     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.
     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