[Federal Register Volume 85, Number 101 (Tuesday, May 26, 2020)]
[Notices]
[Pages 31511-31513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11234]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3397-PN]
Medicare and Medicaid Programs; Application From The Joint
Commission (TJC) for Continued CMS-Approval of Its Ambulatory Surgical
Center (ASC) Accreditation Program
AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS.
[[Page 31512]]
ACTION: Notice with request for comment.
-----------------------------------------------------------------------
SUMMARY: This proposed notice acknowledges the receipt of an
application from The Joint Commission for continued recognition as a
national accrediting organization for Ambulatory Surgical Centers 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 25, 2020.
ADDRESSES: In commenting, refer to file code CMS-3397-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-3397-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-3397-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:
Erin Imhoff, (410) 786-2337.
Joy Webb, (410) 786-1667.
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
Ambulatory Surgical Centers (ASCs) are distinct entities that
operate exclusively for the purpose of furnishing outpatient surgical
services to patients. Under the Medicare program, eligible
beneficiaries may receive covered services from an ASC provided certain
requirements are met. Section 1832(a)(2)(F)(i) of the Social Security
Act (the Act) establishes distinct criteria for a facility seeking
designation as an ASC. 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 416 specify the conditions that an ASC must
meet in order to participate in the Medicare program, the scope of
covered services, and the conditions for Medicare payment for ASCs.
Generally, to enter into an agreement, an ASC must first be
certified by a State survey agency (SA) as complying with the
conditions or requirements set forth in part 416 of our Medicare
regulations. Thereafter, the ASC is subject to regular surveys by an SA
to determine whether it continues to meet these requirements.
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 conditions are met or exceeded, we may deem that
provider entity 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 Secretary of the Department of Health
and Human Services 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. The 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.
The Joint Commission's (TJC's) current term of approval for its ASC
program expires December 20, 2020.
II. Approval of Deeming Organization
Section 1865(a)(2) of the Act and Sec. 488.5 require that our
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
TJC's request for continued CMS-approval of its ASC accreditation
program. This notice also solicits public comment on whether TJC's
requirements meet or exceed the Medicare conditions for coverage (CfCs)
for ASCs.
III. Evaluation of Deeming Authority Request
TJC submitted all the necessary materials to enable us to make a
determination concerning its request for continued CMS-approval of its
ASC accreditation program. This application was determined to be
complete on March 24, 2020. Under section 1865(a)(2) of the Act and
Sec. 488.5, our review and evaluation of TJC will be conducted in
accordance with, but not necessarily limited to, the following factors:
[ballot] The equivalency of TJC's standards for ASCs as compared
with Medicare's CfCs for ASCs.
[ballot] TJC'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 TJC's processes to those of State agencies,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities.
++ TJC's processes and procedures for monitoring an ASC found out
of compliance with TJC's program requirements. These monitoring
procedures are used only when TJC identifies noncompliance. If
noncompliance is identified through
[[Page 31513]]
validation reviews or complaint surveys, the State survey agency
monitors corrections as specified at Sec. 488.9(c)(1).
++ TJC's capacity to report deficiencies to the surveyed facilities
and respond to the facility's plan of correction in a timely manner.
++ TJC's capacity to provide CMS with electronic data and reports
necessary for the effective validation and assessment of the
organization's survey process.
++ The adequacy of TJC's staff and other resources, and its
financial viability.
++ TJC's capacity to adequately fund required surveys.
++ TJC's policies with respect to whether surveys are announced or
unannounced, to ensure that surveys are unannounced.
++ TJC'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.
++ TJC'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).
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 Public 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.
Upon completion of our evaluation, including our evaluation of
comments received as a result of this notice, we will publish a final
notice in the Federal Register announcing the result of our evaluation.
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. 2020-11234 Filed 5-22-20; 8:45 am]
BILLING CODE 4120-01-P