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