[Federal Register Volume 85, Number 41 (Monday, March 2, 2020)]
[Notices]
[Pages 12306-12307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04137]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3388-PN]


Medicare and Medicaid Programs; Application From DNV-GL 
Healthcare USA Inc. for Initial CMS Approval of Its Psychiatric 
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 the DNV-GL Healthcare USA Inc. (DNV-GL) for initial 
recognition as a national accrediting organization (AO) for psychiatric 
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 April 1, 2020.

ADDRESSES: In commenting, refer to file code CMS-3388-PN. Because of 
staff and resource limitations, we cannot accept comments by facsimile 
(FAX) transmission.
    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-3388-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-3388-PN, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:
Joann Fitzell, (410) 786-4280.
Lillian Williams, (410) 786-8636.

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 from a psychiatric hospital, provided certain 
requirements are met. Section 1861(f) of the Social Security Act (the 
Act) establishes distinct criteria for facilities seeking designation 
as a psychiatric 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 part 42 CFR part 482 subpart E specify the minimum 
conditions that a psychiatric hospital must meet to participate in the 
Medicare program, the scope of covered services and the conditions for 
Medicare payment for psychiatric hospitals.
    Generally, to enter into an agreement, a psychiatric hospital must 
first be certified by a state survey agency as complying with the 
conditions or requirements set forth in part 482 subpart E of our 
regulations. Thereafter, the psychiatric hospital 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 
may treat the provider entity as having met those conditions, that is, 
we may deem those provider entities as having met the requirements. 
Accreditation by an AO is voluntary and is not required for Medicare 
participation.

[[Page 12307]]

    If an AO is recognized by the Center 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 may be deemed to meet the 
Medicare conditions. An 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 conditions. 
Our regulations concerning the approval of AOs are set forth at Sec.  
488.5.

II. Approval of Accreditation Organizations

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.5 
require that findings concerning review and approval of an 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 the 
DNV-GL Healthcare USA Inc. (DNV-GL) request for initial approval of its 
psychiatric hospital 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 psychiatric hospitals.

III. Evaluation of Deeming Authority Request

    DNV-GL submitted all the necessary materials to enable us to make a 
determination concerning its request for initial approval of its 
psychiatric hospital accreditation program. This application was 
determined to be complete on January 2, 2020. Under section 1865(a)(2) 
of the Act and our regulations at Sec.  488.5 (Application and re-
application procedures for national accrediting organizations), 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 standards for psychiatric 
hospitals as compared with CMS' psychiatric hospital CoPs.
     The DNV-GL 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.
    ++ The DNV-GL's processes and procedures for monitoring a 
psychiatric hospital found out of compliance with the 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(c).
    ++ The DNV-GL's capacity to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ The 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.
    ++ The DNV-GL's capacity to adequately fund required surveys.
    ++ The DNV-GL's policies with respect to whether surveys are 
announced or unannounced, to assure that surveys are unannounced.
    ++ The 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.
    ++ The 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 CMS may require (including corrective action 
plans).
    Upon completion of our evaluation, including evaluation of public 
comments received as a result of this notice, we will publish a final 
notice in the Federal Register announcing the result of our evaluation.

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. 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.

    Dated: February 13, 2020.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2020-04137 Filed 2-28-20; 8:45 am]
 BILLING CODE 4120-01-P