[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Notices]
[Pages 12260-12262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06149]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3369-FN]


Medicare and Medicaid Programs: Application From the American 
Association for Accreditation of Ambulatory Surgery Facilities, Inc. 
(AAAASF) for Its Outpatient Physical Therapy and Speech Language 
Pathology Services 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 
American Association for Accreditation of Ambulatory Surgery 
Facilities, Inc. (AAAASF) for continued recognition as a national 
accrediting organization for clinics, rehabilitation agencies, or 
public health agencies that furnish outpatient physical therapy and 
speech language pathology services that wish to participate in the 
Medicare or Medicaid programs.

DATES: The approval announced in this notice is effective on April 4, 
2019 through April 4, 2025.

FOR FURTHER INFORMATION CONTACT: Erin Imhoff, (410) 786-2337; Monda 
Shaver, (410) 786-3410; or Tara Lemons, (410) 786-3030.

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SUPPLEMENTARY INFORMATION:

I. Background

    Under Section 1861(p) of the Social Security Act (the Act), 
eligible beneficiaries may receive outpatient physical therapy and 
speech language pathology (OPT) services from a provider of services, a 
clinic, rehabilitation agency, a public health agency, or others, 
provided certain requirements are met. Section 1832(a)(2)(C) of the Act 
permits payment for OPT services. 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 485 subpart H, specify the 
conditions that a clinic, rehabilitation agency or public health agency 
(``OPT providers'') must meet in order to participate in the Medicare 
program, the scope of covered services, and the conditions for Medicare 
payment for OPT providers.
    Generally, to enter into an agreement, an OPT provider must first 
be certified by a State survey agency as complying with the conditions 
of participation set forth in part 485, subpart H of our Medicare 
regulations. Thereafter, the OPT provider is subject to regular surveys 
by a state survey agency to determine whether it continues to meet 
these requirements.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by a Centers for Medicare & Medicaid 
Services (CMS) approved national accrediting organization (AO) that all 
applicable Medicare conditions are met or exceeded, we may deem those 
provider entities as having met the requirements. Accreditation by an 
AO is voluntary and is not required for Medicare participation.
    If an AO is recognized by the Secretary of the Department of Health 
and Human Services (the Secretary) as having standards for 
accreditation that meet or exceed Medicare requirements, any provider 
entity accredited by the national accrediting body's approved program 
may be deemed to meet the Medicare conditions. An AO applying for 
approval of its accreditation program under part 488, subpart A, must 
provide CMS with reasonable assurance that the AO requires the 
accredited provider entities to meet requirements that are at least as 
stringent as the Medicare conditions. Our regulations concerning the 
approval of AOs 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 October 30, 2018, we published a proposed notice in the Federal 
Register (83 FR 54591) announcing the American Association for 
Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF's) request 
for continued approval of its Medicare OPT 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 OPT 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 OPT surveyors; (4) ability to investigate and respond 
appropriately to complaints against accredited OPTs; and, (5) survey 
review and decision-making process for accreditation.
     The comparison of AAAASF's Medicare OPT accreditation 
program standards to our current Medicare OPT CoPs.
     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 we require of state survey 
agencies, including periodic resurvey and the ability to investigate 
and respond appropriately to complaints against accredited OPTs.
    ++ Evaluate AAAASF's procedures for monitoring OPTs 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 
OPT and respond to the OPTs 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 October 
30, 2018 proposed notice also solicited public comments regarding 
whether AAAASF's requirements met or exceeded the Medicare CoPs for 
OPTs. 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 OPT accreditation program requirements and 
survey process with the Medicare CoPs at part 485 subpart H, and the 
survey and certification process requirements of parts 488 and 489. Our 
review and evaluation of AAAASF's OPT 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:
     Section 485.701, to ensure AAAASF's standards 
appropriately reference the CMS standards;
     Section 485.703, definition of ``supervision'' at (2)(ii), 
to ensure AAAASF's standards appropriately reference the CMS standards;
     Section 485.705(a), to ensure AAAASF's standards 
appropriately reference the CMS standards;

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     Section 485.705(c)(2) through (c)(6), to ensure AAAASF's 
standards appropriately reference the CMS standards;
     Section 485.719(b)(3), to ensure AAAASF's standards 
appropriately reference the statutory requirements;
     Section 488.5(a)(4)(ii), to ensure that an appropriate 
number of medical records are fully reviewed during the survey process 
and that survey record totals are accurately reflected in the overall 
deficiency statement;
     Section 488.5(a)(4)(iv), to ensure all deficiencies found 
on survey are cited in AAAASF's final survey report;
     Section 488.5(a)(4)(vii), to ensure appropriate monitoring 
of non-compliance correction;
     Section 488.5(a)(11)(ii), to ensure accurate survey 
findings are reported to CMS;
     Section 488.5(a)(13)(ii), to ensure AAAASF notifies CMS 
regarding any decision to revoke, withdraw, or revise the accreditation 
status of a deemed status supplier;
     Section 488.26(b) and (c), to ensure deficiencies are 
cited at the appropriate level based on manner and degree of findings;
     Section 488.28(a), to ensure AAAASF's policies for an 
acceptable plan of correction meet the CMS requirements;
     Section 488.28(d), to ensure that AAAASF's policies for 
correction of deficiencies in OPTs is comparable to CMS requirements, 
requiring that deficiencies normally must be corrected within 60 days; 
and
     Section 489.13(b)(1), to ensure all enrollment 
requirements are met prior to AAAASF surveying an initial applicant.

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 OPTs that request participation in the Medicare 
program, effective April 4, 2019 through April 4, 2025.

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).

    Dated: March 15, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-06149 Filed 3-29-19; 8:45 am]
 BILLING CODE 4120-01-P