Notice2021-22506
Medicare and Medicaid Programs; Application From the American Association for Accreditation of Ambulatory Surgery Facilities for Continued Approval of Its Rural Health Clinic (RHC) Accreditation Program
Primary source
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Published
October 15, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This proposed notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for continued recognition as a national accrediting organization for rural health clinics (RHCs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare and Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Full Text
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<title>Federal Register, Volume 86 Issue 197 (Friday, October 15, 2021)</title>
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[Federal Register Volume 86, Number 197 (Friday, October 15, 2021)]
[Notices]
[Pages 57429-57431]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-22506]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3416-PN]
Medicare and Medicaid Programs; Application From the American
Association for Accreditation of Ambulatory Surgery Facilities for
Continued Approval of Its Rural Health Clinic (RHC) Accreditation
Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed notice.
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SUMMARY: This proposed notice acknowledges the receipt of an
application from the American Association for Accreditation of
Ambulatory Surgery Facilities (AAAASF) for continued recognition as a
national accrediting organization for rural health clinics (RHCs) that
wish to participate in the Medicare or Medicaid programs. The statute
requires that within 60 days of receipt of an organization's complete
application, the Centers for Medicare and Medicaid Services (CMS)
publish a notice that identifies the national accrediting body making
the request, describes the nature of the request, and provides at least
a 30-day public comment period.
[[Page 57430]]
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on November 15,
2021.
ADDRESSES: In commenting, please refer to file code CMS-3416-PN.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of three ways (please choose only
one of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
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-3416-PN, P.O. Box 8016,
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-3416-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:
Shonte Carter, (410) 786-3532.
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: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on that website to
view public comments. CMS will not post on <a href="http://Regulations.gov">Regulations.gov</a> public
comments that make threats to individuals or institutions or suggest
that the individual will take actions to harm the individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services from a rural health clinic (RHC), provided certain
requirements are met. Sections 1861(aa) of the Social Security Act (the
Act) establish distinct criteria for an entity seeking designation as
an RHC. Regulations concerning provider agreements are at 42 CFR part
489 and those pertaining to activities relating to the survey and
certification of facilities and other entities are at 42 CFR part 488.
The regulations at 42 CFR part 491, subpart A, specify the minimum
conditions that an RHC must meet to participate in the Medicare
program.
Generally, to enter into a provider agreement with the Medicare
program, an RHC must first be certified by a state survey agency as
complying with the conditions or requirements set forth in 42 CFR part
491, subpart A of our Medicare regulations. Thereafter, the RHC 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 provides that, if a provider entity
demonstrates through accreditation by an approved national accrediting
organization that all applicable Medicare conditions are met or
exceeded, we will deem those provider entities as having met the
requirements. Accreditation by an accrediting organization is voluntary
and is not required for Medicare participation.
If an accrediting organization is recognized by the Secretary 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 would be deemed to
meet the Medicare conditions. A national accrediting organization
applying for CMS approval of their accreditation program under 42 CFR
part 488, subpart A must provide CMS with reasonable assurance that the
accrediting organization requires the accredited provider entities to
meet requirements that are at least as stringent as the Medicare
conditions. Our regulations concerning the approval of accrediting
organizations are set forth at Sec. 488.5. The regulations at Sec.
488.5(e)(2)(i) require accrediting organizations to reapply for
continued approval of their accreditation program every 6 years or
sooner as determined by CMS.
The American Association for Accreditation of Ambulatory Surgery
Facilities (AAAASF's) term of approval for their RHC accreditation
program expires March 23, 2022.
II. Approval of Deeming 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
accrediting organization's requirements consider, among other factors,
the applying accrediting organization'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 us 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
AAAASF's request for continued approval for its RHC accreditation
program. This notice also solicits public comment on whether AAAASF's
requirements meet or exceed the Medicare conditions of participation
(CoPs) for RHCs.
III. Evaluation of Deeming Authority Request
AAAASF submitted all the necessary materials to enable us to make a
determination concerning its request for continued approval of its RHC
accreditation program. This application was determined to be complete
on August 25, 2021. 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
AAAASF will be conducted in accordance with, but not necessarily
limited to, the following factors:
<bullet> The equivalency of AAAASF's standards for RHCs as compared
with CMS' RHC CoPs.
<bullet> AAAASF'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.
[[Page 57431]]
++ The comparability of AAAASF's processes to those of state
agencies, including survey frequency, and the ability to investigate
and respond appropriately to complaints against accredited RHCs.
++ AAAASF's processes and procedures for monitoring RHCs found out
of compliance with AAAASF's program requirements. These monitoring
procedures are used only when AAAASF 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).
++ AAAASF's capacity to report deficiencies to the surveyed RHCs
and respond to the RHC's plan of correction in a timely manner.
++ AAAASF's capacity to provide us with electronic data and reports
necessary for effective validation and assessment of the organization's
survey process.
++ The adequacy of AAAASF's staff and other resources, and its
financial viability.
++ AAAASF's capacity to adequately fund required surveys.
++ AAAASF's policies with respect to whether surveys are announced
or unannounced, to assure that surveys are unannounced.
++ AAAASF'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.
++ AAAASF's agreement to provide us 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
Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. chapter 35).
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 notice.
Upon completion of our evaluation, including evaluation of comments
received as a result of this notice, we will publish a final notice in
the Federal Register summarizing our response to comments and
announcing the result of our evaluation.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this
document, authorizes Lynette Wilson, who is the Federal Register
Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Dated: October 12, 2021.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2021-22506 Filed 10-14-21; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on October 15, 2021.
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