[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65812-65814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22883]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3399-FN]


Medicare and Medicaid Programs: Application from DNV-GL 
Healthcare USA, Inc. for Continued Approval of its Critical Access 
Hospital Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and 
Human Services (HHS).

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve DNV-GL 
Healthcare USA, Inc. (DNV-GL) for continued recognition as a national 
accrediting organization for critical access hospitals that wish to 
participate in the Medicare or Medicaid programs.

[[Page 65813]]


DATES: The approval announced in this notice is effective December 23, 
2020 through December 23, 2024.

FOR FURTHER INFORMATION CONTACT: Caecilia Blondiaux, (410) 786-2190.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a Critical Access Hospital (CAH) provided certain 
requirements are met. Sections 1820(c)(2)(B), 1820(e) and 1861(mm)(1) 
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 part 42 CFR 485, subpart F, 
specify the conditions of participation (CoPs) that a CAH must meet to 
participate in the Medicare program, the scope of covered services, and 
the conditions for Medicare payment for CAHs. The regulations at part 
42 CFR 485.647 specify that a CAH's psychiatric or rehabilitation 
distinct part unit (DPU), if any, must meet the hospital requirements 
specified in subparts A, B, C, and D of part 482 in order for the CAH 
DPU to participate in the Medicare program.
    Prior to becoming a CAH, to enter into an agreement, a CAH must 
first be certified by a state survey agency as a hospital complying 
with the conditions or requirements at part 482, then can convert to a 
CAH by complying with the conditions or requirements at part 485, 
subpart F. 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. Certification by a nationally recognized accreditation 
program can substitute for ongoing state review.
    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 requirements are met or exceeded, we will deem 
those provider entities as having met such 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 (the Secretary) 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 requirements. A national 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 requirements.
    Our regulations concerning the approval of AOs are at Sec. Sec.  
488.4 and 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 sooner, as determined by CMS. The DNV-GL Healthcare USA, Inc. 
(DNV-GL) current term of approval for their CAH accreditation program 
expires December 23, 2020.

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 May 18, 2020, we published a proposed notice in the Federal 
Register (85 FR 29723), announcing DNV-GL's request for continued 
approval of its Medicare hospital accreditation program. In the May 18, 
2020 proposed notice, we detailed our evaluation criteria. Under 
section 1865(a)(2) of the Act and our regulations at Sec.  488.5, we 
conducted a review of DNV-GL's Medicare CAH accreditation application 
in accordance with the criteria specified by our regulations, which 
include, but are not limited to the following:
     A virtual administrative review of DNV-GL's: (1) Corporate 
policies; (2) financial and human resources available to accomplish the 
proposed surveys; (3) procedures for training, monitoring, and 
evaluation of its surveyors; (4) ability to investigate and respond 
appropriately to complaints against accredited facilities; and, (5) 
survey review and decision-making process for accreditation.
     A comparison of DNV-GL's accreditation to our current 
Medicare CAH conditions of participation (CoPs).
     A documentation review of DNV-GL's survey process to:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and DNV-GL's ability to provide continuing surveyor 
training.
    ++ Compare DNV-GL's processes to those of state survey agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    ++ Evaluate DNV-GL's procedures for monitoring CAH out of 
compliance with DNV-GL's program requirements. The monitoring 
procedures are used only when DNV-GL identifies noncompliance. If 
noncompliance is identified through validation reviews, the state 
survey agency monitors corrections as specified at Sec.  488.7(d).
    ++ Assess DNV-GL's ability to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ Establish DNV-GL'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 staff and other resources.
    ++ Confirm DNV-GL's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm DNV-GL's policies with respect to whether surveys are 
announced or unannounced.
    ++ Obtain DNV-GL'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 Responses to Public Comments on the Proposed Notice

    In accordance with section 1865(a)(3)(A) of the Act, the May 18, 
2020 proposed notice also solicited public comments regarding whether 
DNV-GL's requirements met or exceeded the Medicare CoPs for CAHs. No 
comments were received in response to our proposed notice.

V. Provisions of the Final Notice

A. Differences Between DNV-GL's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements:

    We compared DNV-GL's CAH requirements and survey process with the 
Medicare CoPs and survey process as outlined in the State Operations 
Manual (SOM). Our review and

[[Page 65814]]

evaluation of DNV-GL's CAH application were conducted as described in 
section III of this final notice and has yielded the following areas 
where, as of the date of this notice, DNV-GL has completed revising its 
standards and certification processes in order to--
     Meet the standard's requirements of all of the following 
regulations:
    ++ Section 482.12(c)(1)(i), to include that DNV-GL's comparable 
standard contains the full CMS requirement to not limit the authority 
of a doctor of medicine or osteopathy to delegate tasks to other 
qualified health care personnel to the extent recognized under state 
law or a state's regulatory mechanism.
    ++ Section 482.41(c), to remove reference of the National Fire 
Protection Association (NFPA) 110 references and revise DNV-GL's 
standard language in accordance with the Life Safety Code and NFPA 99, 
Sections 1.3--Application.
    ++ Section 482.45(b)(1), to include language that ``no hospital is 
considered to be out of compliance with section 1138(a)(1)(B) of the 
Act, or with the requirements of this paragraph, unless the Secretary 
has given the Organ Procurement and Transplantation Network (OPTN) 
formal notice that he or she approves the decision to exclude the 
hospital from the OPTN and has notified the hospital in writing.''
    ++ Section 482.52(c)(2), to include comparable language that the 
request for exemption and recognition of state laws regarding the 
practice of certified registered nurse-anesthetists (CRNAs), and the 
withdrawal of the request may be submitted at any time, and are 
effective upon submission.
    In addition to the standards review, CMS also reviewed DNV-GL'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-GL has completed revising its 
survey processes in order to demonstrate that it uses survey processes 
that are comparable to state survey agency processes by:
    ++ Clarifying and providing proof of documentation that in 
accordance with Sec.  488.5(a)(7), DNV-GL's surveyors meet the 
description of the education and experience required. More specifically 
providing verification that the Physical Environment Specialists have 
completed the NFPA 2012 Health Care Facilities Code training.
    ++ Providing clarifications on DNV-GL's process related to non-
conformity and the levels--Category 1 and 2, comparable to CMS standard 
and condition level deficiencies.
    ++ Plan of Corrections/Correction of Deficiencies: Adjusting 
surveyor guidance and survey report language related to DNV-GL's 
process for continued monitoring activities of facilities with 
condition level deficiencies and providing training to surveyors on the 
applicable changes to ensure comparability with Sec.  488.28(d).
    ++ Revising and adjusting DNV-GL's crosswalks and deficiency 
reports related to surveying and referencing Sec.  485.627--Condition 
of Participation: Organizational Structure, when a facility is found 
out of compliance, consistent with the intent at Sec.  488.26(b).
    ++ Adjusting DNV-GL's matching of the CoPs to their comparable 
standards. Specifically, ensuring reference to the correct Medicare 
conditions for the CAH provider as intended at Sec.  488.26(c).
    ++ Providing training and education to DNV-GL's surveyors related 
to the CAH Medicare conditions, including education on surveyor 
documentation principles cross match citations of the DNV-GL comparable 
standard for governing body to the CMS CoPs.

B. Term of Approval

    Based on our review and observations described in section III. and 
section V. of this final notice, we approve DNV-GL as a national AO for 
CAHs that request participation in the Medicare program. The decision 
announced in this final notice is effective December 23, 2020 through 
December 23, 2024 (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 CAH survey observation 
completed by DNV-GL surveyors as part of the application review 
process. The survey observation is one component of the comparability 
evaluation; therefore, we are providing a shorter term of approval for 
DNV-GL. While DNV-GL has taken actions based on the findings annotated 
in section V.A. of this final notice, as authorized at Sec.  488.8, we 
will continue ongoing review of DNV-GL's CAH survey processes and will 
conduct a survey observation once the PHE has expired. In keeping with 
CMS's initiative to increase AO oversight broadly, and ensure that our 
requested revisions by DNV-GL's are completed, CMS expects more 
frequent review of DNV-GL'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. Chapter 35).
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Seema Verma, having reviewed and approved this document, 
authorizes Lynette Wilson, who is the Federal Register Liaison, to 
electronically sign this document for purposes of publication in the 
Federal Register.

    Dated: October 8, 2020.
Lynette Wilson,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2020-22883 Filed 10-13-20; 8:45 am]
BILLING CODE 4120-01-P