[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44414-44416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20281]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3343-FN]


Medicare and Medicaid Programs; Continued Approval of the 
American Osteopathic Association/Healthcare Facilities Accreditation 
Program's (AOA/HFAP's) Ambulatory Surgical Center Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve the 
American Osteopathic Association/Healthcare Facilities Accreditation 
Program (AOA/HFAP) 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 final notice is effective September 22, 2017 through 
September 22, 2023.

FOR FURTHER INFORMATION CONTACT: Monda Shaver, (410) 786-3410, Erin 
McCoy, (410) 786-2337, or Patricia Chmielewski, (410) 786-6899.

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

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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 of 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 (the Secretary) 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 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 13, 2017, we published a proposed notice (82 FR 27067) in 
the Federal Register, announcing AOA/HFAP'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 AOA/HFAP's Medicare ASC accreditation renewal application in 
accordance with the criteria specified by our regulations, which 
include, but are not limited to the following:
    <bullet> An onsite administrative review of AOA/HFAP'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.
    <bullet> The comparison of AOA/HFAP's Medicare ASC accreditation 
program standards to our current Medicare ASC condition of coverage 
(CfC's).
    <bullet> A documentation review of ASC's survey process to:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and AOA/HFAP's ability to provide continuing surveyor 
training.
    ++ Compare AOA/HFAP'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 AOA/HFAP's procedures for monitoring ASCs found to be 
out of compliance with AOA/HFAP's program requirements. (This pertains 
only to monitoring procedures when AOA/HFAP 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 AOA/HFAP's ability to report deficiencies to the surveyed 
ASC and respond to the ASCs plan of correction in a timely manner.
    ++ Establish AOA/HFAP'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 AOA/HFAP's staff and other resources.
    ++ Confirm AOA/HFAP's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm AOA/HFAP's policies with respect to surveys being 
unannounced.
    ++ Obtain AOA/HFAP's agreement to provide CMS with a copy of the 
most current accreditation survey, along 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 13, 
2017 proposed notice also solicited public comments regarding whether 
AOA/HFAP's requirements met or exceeded the Medicare CfCs for ASCs. We 
received 2 comments in response to our proposed notice. All of the 
comments received expressed unanimous support for AOA/HFAP's ASC 
accreditation program.

IV. Provisions of the Final Notice

A. Differences Between AOA/HFAP's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared AOA/HFAP'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 AOA/HFAP'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, AOA/HFAP has 
revised its standards and certification processes in order to meet the 
requirements at:
    <bullet> Section 416.2, to ensure its standards appropriately 
reference Sec.  416.2 and Part 416 subparts B and C.
    <bullet> Section 416.25, to ensure its standards to require 
facilities meet the definition at Sec.  416.2.
    <bullet> Section 416.41(b)(3)(i), to ensure its standards 
appropriately reference Sec.  416.41(b)(2).
    <bullet> Section 416.41(b)(3)(ii), to ensure its standards 
appropriately reference Sec.  416.41(b)(2).
    <bullet> Section 416.42(b)(2), to ensure its standards 
appropriately reference Sec.  416.42(c)
    <bullet> Section 416.49(b)(2), to ensure standards appropriately 
reference Sec.  416.49(c).
    <bullet> Section 416.50(a), to ensure its standards appropriately 
reference Sec.  416.50.

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    <bullet> Section 416.50(b), to ensure its standards appropriately 
reference Part 420.
    <bullet> Section 488.5(a)(4)(ii), to ensure AOA/HFAP's surveyors 
review the minimum number of medical records as specified by CMS and 
AOA/HFAP policy.
    <bullet> Section 488.5(a)(4)(iv), to ensure each that all 
observations of non-compliance are documented in the survey report.
    <bullet> Section 488.5(a)(7) through (9), to ensure AOA/HFAP 
complies with its policy and criteria for surveyor qualifications, 
education and evaluation system to monitor the performance of surveyors 
and teams.
    <bullet> Section 488.26(b), to ensure AOA/HFAP cites findings of 
observed non-compliance at the appropriate level (condition versus 
standard level).

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we approve AOA/HFAP as a national accreditation 
organization for ASCs that request participation in the Medicare 
program, effective September 22, 2017 through September 22, 2023.

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: September 14, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2017-20281 Filed 9-21-17; 8:45 am]
 BILLING CODE 4120-01-P