[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)]
[Notices]
[Pages 58253-58254]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25013]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3358-FN]


Medicare and Medicaid Programs: Application From the American 
Association for Accreditation of Ambulatory Surgery Facilities, Inc. 
(AAAASF) for Continued Approval of Its Ambulatory Surgical Center 
Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

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SUMMARY: This final notice announces our decision to approve the 
American Association for Accreditation of Ambulatory Surgery 
Facilities, Inc. (AAAASF) for continued recognition as a national 
accrediting organization for ambulatory surgical centers (ASCs) that 
wish to participate in the Medicare or Medicaid programs.

DATES: This notice is applicable November 27, 2018 through November 27, 
2024.

FOR FURTHER INFORMATION CONTACT: Erin McCoy, (410) 786-2337, 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, we may treat the 
provider entity as having met those conditions, that is, we may 
``deem'' the provider entity to be in compliance. Accreditation by an 
accrediting organization is voluntary and is not required for Medicare 
participation.
    Part 488, subpart A, implements the provisions of section 1865 of 
the Act and requires that a national accrediting organization applying 
for approval of its Medicare accreditation program 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.  488.5.

II. Application Approval Process

    Section 1865(a)(3)(A) of the Act provides a statutory timetable to 
ensure that our review of applications for CMS-

[[Page 58254]]

approval of an accreditation program is conducted in a timely manner. 
The Act provides us 210 days after the date of receipt of a complete 
application, with any documentation necessary to make the 
determination, to complete our survey activities and application 
process. Within 60 days after receiving a complete application, we must 
publish a notice in the Federal Register that identifies the national 
accrediting body making the request, describes the request, and 
provides no less than a 30-day public comment period. At the end of the 
210-day period, we must publish a notice in the Federal Register 
approving or denying the application.

III. Provisions of the Proposed Notice

    On June 22, 2018, we published a proposed notice in the Federal 
Register (83 FR 29120) announcing the American Association for 
Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF'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 AAAASF'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 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 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 AAAASF's Medicare ASC accreditation 
program standards to our current Medicare ASC Conditions for Coverage 
(CfCs).
     A documentation review of AAAASF's survey process to:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and AAAASF's ability to provide continuing surveyor 
training.
    ++ Compare AAAASF's processes to those CMS require of state survey 
agencies, including periodic resurvey and the ability to investigate 
and respond appropriately to complaints against accredited ASCs.
    ++ Evaluate AAAASF's procedures for monitoring ASCs it has found to 
be out of compliance with AAAASF's program requirements. (This pertains 
only to monitoring procedures when AAAASF 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 AAAASF's ability to report deficiencies to the surveyed 
ASC and respond to the ASCs plan of correction in a timely manner.
    ++ Establish AAAASF'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 AAAASF's staff and other resources.
    ++ Confirm AAAASF's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm AAAASF's policies with respect to surveys being 
unannounced.
    ++ Obtain AAAASF'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 June 22, 
2018 proposed notice also solicited public comments regarding whether 
AAAASF'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 AAAASF's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared AAAASF's ASC accreditation program requirements and 
survey process with the Medicare CfCs at 42 CFR part 416, and the 
survey and certification process requirements of Parts 488 and 489. Our 
review and evaluation of AAAASF'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, AAAASF has revised its 
standards and certification processes in order to meet the requirements 
at:
     Sec.  416.2, to ensure its standards appropriately 
reference Sec.  416.2 subparts B and C;
     Sec.  416.44(b)(1) to ensure its standards appropriately 
reference Life Safety Code requirements;
     Sec.  416.44(b)(2) to ensure its standards appropriately 
reference that only Life Safety Code deficiencies may request a time-
limited waiver as part of the ASC's plan of correction;
     Sec.  416.47(b)(4) to ensure its standards appropriately 
address each required element of Sec.  416.47(b)(4);
     Sec.  416.47(b)(5) to ensure its standards appropriately 
address Sec.  416.47(b)(5);
     Sec.  416.52(a)(1) through (3) to ensure its standards 
appropriately address the requirements for a comprehensive medical 
history and physical assessment;
     Sec.  488.5(a)(4)(i) to ensure that its policies clearly 
support and convey the unannounced nature of Medicare deemed status 
surveys;
     Sec.  488.5(a)(4)(ii) to ensure comparability of AAAASF'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)(iii) to ensure that copies of AAAASF's 
guidelines and instructions to surveyors appropriately address Medicare 
requirements;
     Sec.  488.5(a)(7) through (9) to ensure its surveyors are 
qualified and evaluated on performance;
     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.  488.26(b) and (c) 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.

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 ASCs that request participation in the Medicare 
program, effective November 27, 2018 through November 27, 2024.

V. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 35).

    Dated: November 7, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-25013 Filed 11-16-18; 8:45 am]
 BILLING CODE 4120-01-P