[Federal Register Volume 85, Number 96 (Monday, May 18, 2020)]
[Notices]
[Pages 29723-29724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10632]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3399-PN]


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), HHS.

ACTION: Notice with request for comment.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from DNV-GL Healthcare USA, Inc. for continued recognition 
as a national accrediting organization for critical access hospitals 
that wish to participate in the Medicare or Medicaid programs.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on June 17, 2020.

ADDRESSES: In commenting, please refer to file code CMS-3399-PN
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov . Follow the ``submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3399-PN, P.O. Box 8010, 
Baltimore, MD 21244-8010.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3399-PN, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    [Submission of comments on paperwork requirements. You may submit 
comments on this document's paperwork requirements by following the 
instructions at the end of the ``Collection of Information 
Requirements'' section in this document.]
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

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

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following website as soon as possible after they have been 
received: http://www.regulations.gov . Follow the search instructions 
on that website to view public comments.

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a critical access hospital (CAH), provided that 
certain requirements are met by the CAH. Section 1861(mm) 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 42 CFR part 485, subpart F specify the 
conditions that a CAH must meet to participate in the Medicare program, 
the scope of covered services, and the conditions for Medicare payment 
for CAHs.
    Generally, to enter into an agreement, a CAH must first be 
certified by a state survey agency as complying with the conditions or 
requirements set forth in part 485 of our regulations. 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. 
Section 1865(a)(1) of the Act states, if a provider entity demonstrates 
through accreditation by an approved national accrediting organization 
(AO) that all applicable Medicare conditions are met or exceeded, we 
will 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 Centers for Medicare & Medicaid 
Services (CMS) 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 conditions. A national AO applying for approval of its 
accreditation program

[[Page 29724]]

under part 488, subpart A, must provide us 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 AO are set forth at Sec.  
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 as 
determined by CMS.
    The DNV-GL Healthcare USA, Inc. (DNV-GL) current term of approval 
for their hospital accreditation program expires December 23, 2020.

II. Approval of Accreditation Organizations

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.5 
require that our findings concerning review and approval of a national 
AO's requirements consider, among other factors, the applying AO's 
requirements for accreditation; survey procedures; resources for 
conducting required surveys; capacity to furnish information for use in 
enforcement activities; monitoring procedures for provider entities 
found not in compliance with the conditions or requirements; and 
ability to provide CMS with the necessary data for validation.
    Section 1865(a)(3)(A) of the Act further requires that we publish, 
within 60 days of receipt of an organization's complete application, a 
notice identifying the national accrediting body making the request, 
describing the nature of the request, and providing at least a 30-day 
public comment period. We have 210 days from the receipt of a complete 
application to publish notice of approval or denial of the application.
    The purpose of this proposed notice is to inform the public of DNV-
GL's request for continued approval of its CAH accreditation program. 
This notice also solicits public comment on whether the DNV-GL's 
requirements meet or exceed the Medicare conditions of participation 
(CoPs) for CAHs.

III. Evaluation of Deeming Authority Request

    DNV-GL submitted all the necessary materials to enable us to make a 
determination concerning its request for continued approval of its CAH 
accreditation program. This application was determined to be complete 
on March 17, 2020. Under 1865(a)(2) of the Act and our regulations at 
Sec.  488.5 (Application and re-application procedures for national 
AO), our review and evaluation of the DNV-GL will be conducted in 
accordance with, but not necessarily limited to, the following factors:
     The equivalency of the DNV-GL's standards for hospitals as 
compared with CMS' CAH CoPs.
     The DNV-GL'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 the DNV-GL's processes to those of state 
agencies, including survey frequency, and the ability to investigate 
and respond appropriately to complaints against accredited facilities.
    ++ DNV-GL's processes and procedures for monitoring a CAH found out 
of compliance with DNV-GL's program requirements. These monitoring 
procedures are used only when the DNV-GL identifies noncompliance. If 
noncompliance is identified through validation reviews or complaint 
surveys, the state survey agency monitors corrections as specified at 
Sec.  488.9.
    ++ DNV-GL's capacity to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ DNV-GL's capacity to provide CMS with electronic data and 
reports necessary for effective validation and assessment of the 
organization's survey process.
    ++ The adequacy of the DNV-GL's staff and other resources, and its 
financial viability.
    ++ DNV-GL's capacity to adequately fund required surveys.
    ++ DNV-GL's policies with respect to whether surveys are announced 
or unannounced, to assure that surveys are unannounced.
    ++ DNV-GL'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-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. 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 3501 et seq.).

V. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Seema Verma, having reviewed and approved this document, 
authorizes Evell J. Barco Holland, who is the Federal Register Liaison, 
to electronically sign this document for purposes of publication in the 
Federal Register.

    Dated: May 7, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2020-10632 Filed 5-15-20; 8:45 am]
BILLING CODE 4120-01-P