[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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