[Federal Register Volume 80, Number 74 (Friday, April 17, 2015)]
[Notices]
[Pages 21244-21245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-08917]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3305-FN]


Medicare and Medicaid Programs; Continued Approval of the 
American Association for Accreditation of Ambulatory Surgery 
Facilities' Accreditation Program for Organizations That Provide 
Outpatient Physical Therapy and Speech Language Pathology Services

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 Association for Accreditation of Ambulatory Surgery Facilities 
for continued recognition as a national accrediting organization for 
organizations that provide outpatient physical therapy and speech 
language pathology (OPT) services that wish to participate in the 
Medicare or Medicaid programs. An OPT that participates in Medicaid 
must also meet the Medicare Conditions of Participation.

DATES: This final notice is effective April 22, 2015 through April 22, 
2019.

FOR FURTHER INFORMATION CONTACT: Cindy Melanson, (410) 786-0310, or 
Patricia Chmielewski, (410) 786-6899.

SUPPLEMENTARY INFORMATION:

I. Background

    A healthcare provider may enter into an agreement with Medicare to 
participate in the program as an outpatient physical therapy and speech 
language pathology (OPT) provided certain requirements are met. Section 
1861(p)(4) of the Social Security Act (the Act), establish distinct 
criteria for facilities seeking designation as an OPT. Regulations 
concerning Medicare provider agreements are at 42 CFR part 489 and 
those pertaining to the survey and certification for Medicare 
participation of providers and certain types of suppliers are at 42 CFR 
part 488. The regulations at 42 CFR part 485, subpart H specify the 
specific conditions that a provider must meet to participate in the 
Medicare program as an OPT.
    Generally, to enter into a Medicare provider agreement, a facility 
must first be certified by a State Survey Agency as complying with the 
conditions or requirements set forth in part 485, subpart H of our 
Medicare regulations. Thereafter, the OPT 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 national 
Medicare accreditation program approved by the Center for Medicare & 
Medicaid Services (CMS) may substitute for both initial and ongoing 
state agency 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 
accreditation organization meets or exceeds all applicable Medicare 
conditions or requirements, 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 its accredited provider entities 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. Sec.  488.4 and 488.8(d)(3). The regulations at 
Sec.  488.8(d)(3) require an accrediting organization to reapply for 
continued approval of its Medicare accreditation program every 6 years 
or sooner as determined by the CMS. The American Association for 
Accreditation of Ambulatory Surgery Facilities (AAAASF's) current term 
of approval as a Medicare accreditation program for OPTs expires April 
22, 2015.

II. Application Approval Process

    Section 1865(a)(3)(A) of 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 of receipt of an organization's 
complete application, we must publish a notice that identifies the 
national accrediting body making the request, describes the nature of 
the request, and provide at least a 30-day public comment period. At 
the end of the 210-day period, we must publish a notice announcing our 
approval or denial of an application.

III. Provisions of the Proposed Notice

    On November 21, 2014, we published a proposed notice in the Federal 
Register (79 FR 69481) entitled ``Application from the American 
Association for Accreditation of Ambulatory Surgery Facilities for 
Continued Approval of its Accreditation Program for Organizations that 
Provide Outpatient Physical Therapy and Speech Language Pathology 
Services'' announcing AAAASF's request for continued approval of its 
Medicare OPT accreditation program. In that notice, we detailed our 
evaluation criteria. Under section 1865(a)(2) of the Act and in our 
regulations at Sec.  488.4 and Sec.  488.8, we conducted a review of 
AAAASF's Medicare OPT accreditation 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 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.
    <bullet> The comparison of AAAASF's Medicare accreditation program 
standards to our current Medicare OPT Conditions of Participation 
(CoPs).
    <bullet> A documentation review of AAAASF's survey process to:
    ++ Determine the composition of the survey team, surveyor 
qualifications,

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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.  488.7(d).
    ++ Assess AAAASF's ability to report deficiencies to the surveyed 
OPT and respond to the OPT's 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 November 
21, 2014 proposed notice also solicited public comments regarding 
whether AAAASF's requirements met or exceeded the Medicare CoPs for 
OPTs. We received no public 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 requirements and survey 
process with the Medicare CoPs of 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 completed 
revising its standards and certification processes in order to meet the 
requirements at:
    <bullet> Section 488.4(a)(3)(ii), to ensure surveyors are provided 
the necessary tools to evaluate compliance with the Medicare 
conditions.
    <bullet> Section 488.4(a)(3)(iii), to ensure the accreditation 
review process and accreditation decision making process meets the 
Medicare requirements, the following was modified:
    ++ Policy related to how AAAASF verifies an organization without a 
CMS certification number (CCN) seeking an initial survey has completed 
the Medicare enrollment application prior to receiving an accreditation 
survey;
    ++ Policy for establishing an effective date for renewal surveys;
    ++ Policy for withdrawals and terminations; and
    ++ Guidance and instructions on how plans of correction are handled 
when they are not adequate.
    <bullet> Section 488.4(a)(6), to address the requirement where 
complaints that do not rise to the level of requiring an onsite 
investigation are tracked and trended for potential focus areas during 
the next onsite survey.
    <bullet> Section 488.9, to address the number of medical records 
reviews that must be completed onsite.
    <bullet> Section 488.26(b), to ensure survey reports contain the 
appropriate level of deficiency (that is, standard versus condition).
    <bullet> Section 488.28(a), to ensure plans of correction correct 
the cited deficiencies, include thresholds of compliance and are sent 
timely.

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 22, 2015 through April 22, 2019.

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.

    Dated: April 13, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-08917 Filed 4-16-15; 8:45 am]
BILLING CODE 4120-01-P