[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]
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