Medicare and Medicaid Programs: Approval of the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC) Application for Continued Approval of Its Ambulatory Surgical Center Accreditation Program
| Published date | 21 December 2018 |
| Record Number | 2018-27592 |
| Court | Centers For Medicare & Medicaid Services |
Federal Register, Volume 83 Issue 245 (Friday, December 21, 2018)
[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Pages 65676-65677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27592]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3362-FN]
Medicare and Medicaid Programs: Approval of the Accreditation
Association for Ambulatory Health Care, Inc. (AAAHC) Application for
Continued Approval of Its Ambulatory Surgical Center Accreditation
Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice.
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SUMMARY: This final notice announces our decision to approve the
Accreditation Association for Ambulatory Health Care, Inc. for
continued recognition as a national accrediting organization for
ambulatory surgical centers that wish to participate in the Medicare or
Medicaid programs.
DATES: Applicable Date: December 20, 2018 through December 20, 2024.
FOR FURTHER INFORMATION CONTACT: Lillian Williams, (410) 786-8636,
Monda Shaver, (410) 786-3410, or Renee Henry, (410) 786-7828.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services in an Ambulatory Surgical Center (ASC) provided
certain requirements are met. Sections 1832(a)(2)(F)(i) of the Social
Security Act (the Act) establishes distinct criteria for facilities
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 as complying with the conditions set forth in part 416 and
recommended to the Centers for Medicare & Medicaid Services (CMS) for
participation by a state survey agency. Thereafter, the ASC 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 a nationally
recognized Medicare accreditation program approved by CMS may
substitute for both initial and ongoing state 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 accrediting organization
meets or exceeds all applicable Medicare conditions or requirements, we
may deem the provider entity as having met those conditions or
requirements. Accreditation by an accrediting organization is voluntary
and is not required for Medicare participation.
A national accrediting organization applying for approval of its
Medicare accreditation program under part 488, subpart A, must provide
CMS with reasonable assurance that the accrediting organization
requires its 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. 488.4.
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 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 a notice of approval or denial of the
application.
III. Provisions of the Proposed Notice
On July 26, 2018, we published a proposed notice entitled
``Application from the Accreditation Association for Ambulatory Health
Care, Inc. (AAAHC) for Continued Approval of its Ambulatory Surgical
Center Accreditation Program'' in the Federal Register (83 FR 35486)
announcing AAAHC's request for continued approval of its Medicare ASC
accreditation program. In the proposed notice, we detailed our
evaluation criteria. Under section 1865(a)(2) of the Act and in our
regulations at Sec. 488.5, we conducted a review of AAAHC's Medicare
ASC accreditation renewal application in accordance with the criteria
specified by our regulations, which include, but are not limited to the
following:
An onsite administrative review of AAAHC's: (1) Corporate
policies; (2) financial and human resources available to accomplish the
proposed surveys; (3) procedures for training, monitoring, and
evaluation of its ASC surveyors; (4) ability to investigate and respond
appropriately to complaints against accredited ASCs; and, (5) survey
review and decision-making process for accreditation.
The comparison of AAAHC's Medicare ASC accreditation
program standards to our current Medicare ASC conditions for coverage
(CfCs).
A documentation review of AAAHC's survey process to:
++ Determine the composition of the survey team, surveyor
qualifications, and AAAHC's ability to provide continuing surveyor
training.
++ Compare AAAHC's processes to those we require of state survey
agencies, including periodic resurvey and the ability to investigate
and respond appropriately to complaints against accredited ASCs.
++ Evaluate AAAHC's procedures for monitoring ASCs it has found to
be out of compliance with AAAHC's program requirements. (This pertains
only to monitoring procedures when AAAHC identifies non-compliance. If
noncompliance is identified by a state survey agency through a
validation survey, the state survey agency monitors corrections as
specified at Sec. 488.9(c).)
++ Assess AAAHC's ability to report deficiencies to the surveyed
ASC and respond to the ASCs plan of correction in a timely manner.
[[Page 65677]]
++ Establish AAAHC's ability to provide CMS with electronic data
and reports necessary for effective validation and assessment of the
organization's survey process.
++ Determine the adequacy of AAAHC's staff and other resources.
++ Confirm AAAHC's ability to provide adequate funding for
performing required surveys.
++ Confirm AAAHC's policies with respect to surveys being
unannounced.
++ Obtain AAAHC's agreement to provide CMS 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 July 26,
2018 proposed notice also solicited public comments regarding whether
AAAHC's requirements met or exceeded the Medicare CfCs for ASCs. We
received no comments in response to our proposed notice.
IV. Provisions of the Final Notice
A. Differences Between AAAHC's Standards and Requirements for
Accreditation and Medicare Conditions and Survey Requirements
We compared AAAHC's ASC accreditation program requirements and
survey process with the Medicare CfCs at part 416, and the survey and
certification process requirements of parts 488 and 489. Our review and
evaluation of AAAHC's ASC 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, AAAHC has revised its
standards and certification processes in order to meet the requirements
at:
Sec. 416.44(b)(1), to ensure its standards appropriately
reference Life Safety Code requirements;
Sec. 416.44(c), to ensure its standards appropriately
reference Life Safety Code requirements;
Sec. 416.44(c)(1)(iv), to ensure its standards
appropriately reference Life Safety Code requirements;
Sec. 488.5(a)(4)(ii), to ensure comparability of AAAHC's
survey process and surveyor guidance to those required for state survey
agencies conducting federal Medicare surveys for the same provider or
supplier type;
Sec. 488.5(a)(4)(iv), to ensure all identified areas of
non-compliance are clearly documented and cited appropriately in the
final survey report.
Sec. 488.5(a)(7) through (9), to ensure its surveyors are
appropriately qualified, trained and maintain competence during
extended periods of time without conducting a survey;
Sec. 488.5(a)(11)(ii), to ensure accurate survey findings
are reported to CMS;
Sec. 488.5(a)(12), to ensure complaints are triaged
appropriately and surveyed within the required timeframes;
Sec. 488.18(a), to ensure that the findings are
documented and written within the principles of documentation.
Sec. 488.26(b), to ensure deficiencies are cited at the
appropriate level based on manner and degree of findings; and
Sec. 488.28(d), to ensure that its policies for
correction of deficiencies in ASCs is comparable to CMS requirements,
requiring that deficiencies normally must be corrected within 60 days.
Sec. 489.13(c), to ensure that all accreditation
requirements have been met before granting accreditation and making a
recommendation for participation or continued participation in the
Medicare program comparable to CMS requirements, requiring that
deficiencies normally must be corrected within 60 days.
B. Term of Approval
Based on our review and observations described in section III of
this final notice, we approve AAAHC as a national accreditation
organization for ASCs that request participation in the Medicare
program, effective December 20, 2018 through December 20, 2024.
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. 3501 et seq.).
Dated: December 14, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-27592 Filed 12-20-18; 8:45 am]
BILLING CODE 4120-01-P
