Notice2022-05910
Medicare and Medicaid Programs; Continued Approval of the American Association for Accreditation of Ambulatory Surgery Facilities' Rural Health Clinic Accreditation Program
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Published
March 21, 2022
Effective
March 23, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 54 (Monday, March 21, 2022)</title>
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[Federal Register Volume 87, Number 54 (Monday, March 21, 2022)]
[Notices]
[Pages 16003-16005]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> 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.
<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 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:
<bullet> 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.
<bullet> 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.
<bullet> Section 491.9(b)(4) to include the correct reference to
Sec. 491.9(b)(2), identifying the group of professional personnel.
<bullet> Section 491.9(c)(2) to include a reference to 42 CFR part
493.
<bullet> 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:
<bullet> 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.
<bullet> 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.
<bullet> 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).
<bullet> 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
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</html>Indexed from Federal Register on March 21, 2022.
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