[Federal Register Volume 87, Number 54 (Monday, March 21, 2022)]
[Notices]
[Pages 16003-16005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05910]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3416-FN]


Medicare and Medicaid Programs; Continued Approval of the 
American Association for Accreditation of Ambulatory Surgery 
Facilities' Rural Health Clinic Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services, Department of Health 
and Human Services (HHS).

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve 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.

DATES: The decision in this final notice is effective March 23, 2022, 
through March 23, 2026.

FOR FURTHER INFORMATION CONTACT: Lillian Williams, (410) 786-8636, or 
Shonte Carter, (410) 786-3532.

SUPPLEMENTARY INFORMATION: 

I. Background

    A healthcare provider may enter into an agreement with Medicare to 
participate in the program as a Rural Health Clinic (RHC) provided 
certain requirements are met. Section 1861(aa)(2) and 1905(l)(1)of the 
Social Security Act (the Act), establish distinct criteria for 
facilities seeking designation as RHCs for Medicare and Medicaid, 
respectively. Regulations concerning Medicare provider agreements are 
at 42 CFR part 489 and those pertaining to the survey and certification 
for Medicare participation of certain providers and suppliers are at 42 
CFR part 488. The regulations at 42 CFR part 491 specify the conditions 
that a facility must meet to participate in the Medicare program as an 
RHC.
    Generally, to enter into a Medicare provider agreement, an RHC must 
first be certified by a State survey agency as complying with the 
conditions set forth in part 491 of our Medicare regulations. 
Thereafter, the RHC is subject to periodic surveys by a State survey 
agency to determine whether it continues to meet these conditions. 
However, there is an alternative to certification surveys by State 
agencies. Accreditation by an approved, nationally recognized Medicare 
accreditation program may substitute for both initial and ongoing 
review.
    Section 1865(a)(1) of the Act provides that, if the Secretary of 
the Department of Health and Human Services finds that accreditation of 
a provider entity by an approved national accreditation organization 
demonstrates that all applicable Medicare conditions or requirements 
are met or exceeded, we will deem those provider entities as having met 
such requirements. Accreditation by an accrediting organization is 
voluntary and is not required for Medicare participation.
    Subpart A of part 488 requires in part that a national accrediting 
organization applying for approval of its Medicare accreditation 
program provide us with reasonable assurance that the accrediting 
organization requires its

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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. 
Section 488.5(e)(2)(i) requires an accrediting organization to reapply 
for continued approval of its Medicare accreditation program every 6 
years or sooner as determined by CMS. The American Association for 
Accreditation of Ambulatory Surgery Facilities' (AAAASF) current term 
of approval for their RHC accreditation program expires March 23, 2022.

II. Application Approval Process

    Section 1865(a)(3)(A) of the Act requires that we publish, within 
60 days of receipt of an organization's complete application, a notice 
identifying the national accreditation body making the request, 
describing the nature of the request, and providing at least a 30-day 
public comment period. We have 210 days after the date of receipt of a 
complete application to publish a notice announcing our approval or 
denial of an application.

III. Provisions of the Proposed Notice

    On October 15, 2021, we published a proposed notice in the Federal 
Register (86 FR 57429) entitled ``Application from the American 
Association for Accreditation of Ambulatory Surgery Facilities for 
Continued Approval of its Rural Health Clinic (RHC) Accreditation 
Program'' announcing AAAASF's request for continued approval of its 
Medicare RHC accreditation program. In that notice, we detailed our 
evaluation criteria. Under section 1865(a)(2) of the Act and per 
Sec. Sec.  488.5 and 488.8(h), we conducted a review of AAAASF's 
application in accordance with the criteria authorized by our 
regulations, which include, but are not limited to the following:
     An administrative review of AAAASF's: (1) Corporate 
policies; (2) financial and human resources available to accomplish the 
proposed surveys; (3) procedures for training, monitoring, and 
evaluation of its RHC surveyors; (4) ability to investigate and respond 
appropriately to complaints against accredited RHCs; and, (5) survey 
review and decision-making process for accreditation.
     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 survey training.
    ++ 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 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.
    In accordance with section 1865(a)(3)(A) of the Act, the October 
15, 2021 proposed notice also solicited public comments regarding 
whether AAAASF's requirements met or exceeded the Medicare conditions 
for certification for RHCs. The comments we received support the 
approval of AAAASF for continued recognition as a national accrediting 
organization for RHCs. We did not receive any comments opposing the 
approval.

IV. Provisions of the Final Notice

A. Differences Between AAAASF's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared AAAASF's RHC accreditation requirements and survey 
process with the Medicare conditions for certification of 42 CFR part 
491 and the survey and certification process requirements of parts 488 
and 489. Our review and evaluation of AAAASF's RHC application, which 
were conducted as described in section III. of this final notice, 
yielded the following areas where, as of the date of this notice, 
AAAASF has completed revising its standards and survey processes in 
order to meet the requirements at:
     Section 491.7(a)(1) to ensure that their crosswalk and 
standards included the requirement that an RHC must have a health care 
staff that meets the requirements of Sec.  491.8.
     Section 491.8(a)(2) to ensure that their crosswalk and 
standards include the correct reference that a physician member of the 
staff may be the owner of the RHC, an employee of the clinic or center, 
or under agreement with the clinic or center to carry out the 
responsibilities required under this section.
     Section 491.9(b)(4) to include the correct reference to 
Sec.  491.9(b)(2), identifying the group of professional personnel.
     Section 491.9(c)(2) to include a reference to 42 CFR part 
493.
     Revised and clarified survey processes and organizational 
policies, consistent with Sec.  488.5(a)(4)(i), to ensure all surveys 
are unannounced. AAAASF clarified its organizational policies to 
reflect that surveys are not conducted based on the availability of 
administrators, clinic directors, or any other individual of authority, 
and for the same reasons, are not delayed.
    In accordance with comparability requirements to those of the State 
Survey Agency at Sec.  488.5(a)(4)(ii), AAAASF's revised its policies, 
procedures and survey processes to include:
     Revising policies to ensure the sample of the medical 
records used in surveyor guidance is consistent with the type of 
medical records to be reviewed.
     Providing a corrective action plan and clarifications to 
AAAASF's policies to ensure that documentation of patient and staff 
observations and record reviews include separate identifier keys used 
to ensure the security of patients and staff.
     Developing additional policies and procedures and surveyor 
guides to clarify deficiency citations, specifically how surveyors 
determine the appropriateness of the level of citation is assessed 
during an RHC survey for compliance (that is, condition level v. 
standard level deficiency citation) and in accordance with Sec.  
488.26(b).
     Section 488.5(a)(5) describing the method AAAASF uses for 
determining

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the size and composition of the RHC survey team and AAAASF's comparable 
criteria on determining the parameters for each survey to be comparable 
to those of the State Survey Agency as outlined per Sec.  488.5(a)(4).

B. Term of Approval

    Based on our review and observations described in section III. of 
this final notice, we approve AAAASF as a national accreditation 
organization for RHCs that request participation in the Medicare 
program. The decision announced in this final notice is effective March 
23, 2022 through March 23, 2026. Due to travel restrictions and the 
reprioritization of survey activities brought on by the 2019 Novel 
Coronavirus Disease (COVID-19) Public Health Emergency (PHE), CMS was 
unable to observe an RHC survey completed by AAAASF surveyors as part 
of the application review process, which is typically one component of 
the comparability evaluation. Therefore, we are providing AAAASF with a 
shorter period of approval. Based on our discussions with AAAASF and 
the information provided in its application, we are confident that 
AAAASF will continue to ensure that its accredited RHCs will continue 
to meet or exceed the required standards. While AAAASF has taken 
actions based on the findings noted in section IV. of this final notice 
(Differences Between AAAASF's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements), as 
authorized under Sec.  488.8, we will continue ongoing review of 
AAAASF's RHC survey processes and will conduct a survey observation 
once the COVID-19 PHE has expired.

V. 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 35).
    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: March 16, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2022-05910 Filed 3-18-22; 8:45 am]
BILLING CODE 4120-01-P