[Federal Register Volume 86, Number 197 (Friday, October 15, 2021)]
[Notices]
[Pages 57429-57431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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-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: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments. CMS will not post on Regulations.gov 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:
     The equivalency of AAAASF's standards for RHCs as compared 
with CMS' RHC CoPs.
     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.

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    ++ 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