[Federal Register Volume 76, Number 78 (Friday, April 22, 2011)]
[Notices]
[Pages 22709-22711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9176]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2332-FN]


Medicare and Medicaid Programs; Approval of the American 
Association for Accreditation of Ambulatory Surgery Facilities, Inc. 
for Deeming Authority for Organizations That Provide Outpatient 
Physical Therapy and Speech-Language Pathology Services

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces our decision to approve the American 
Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) 
for recognition as a national accreditation program for organizations 
that provide outpatient physical therapy and speech-language pathology 
services seeking to participate in the Medicare or Medicaid programs.

DATES: Effective Date: This final notice is effective April 22, 2011 
through April 22, 2015.

FOR FURTHER INFORMATION CONTACT: Alexis Prete, (410) 786-0375. Patricia 
Chmielewski, (410) 786-6899.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
outpatient physical therapy and speech language pathology covered 
services from a provider of services, a clinic, a rehabilitation 
agency, a public health agency, or by others under an arrangement with 
and under the supervision of such provider, clinic, rehabilitation 
agency, or public health agency (collectively, ``organizations''), 
provided certain requirements are met. Section 1861(p)(4) of the Social 
Security Act (the Act) establishes distinct criteria for organizations 
seeking approval to provide outpatient physical therapy and speech 
language pathology services. The regulations at 42 CFR part 485, 
subpart H specify, among other things, the conditions that an 
organization providing outpatient physical therapy and speech-language 
pathology services must meet to participate in the Medicare program. 
Regulations concerning provider agreements are located at 42 CFR part 
489 (Provider Agreements and Supplier Approval) and those pertaining to 
survey and certification of facilities at 42 CFR part 488.
    Generally, in order to enter into a provider agreement, an 
organization offering outpatient physical therapy and speech language 
pathology services must first be certified by a State survey agency as 
complying with the conditions or requirements set forth in section 
1861(p)(4) of the Act, and 42 CFR part 485, subpart H. Thereafter, the 
organization is subject to ongoing review by a State survey agency to 
determine whether it continues to meet the Medicare requirements. There 
is an alternative, however, to State compliance surveys. Accreditation 
by a nationally-recognized accreditation program can substitute for 
ongoing State review.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national 
accreditation organization (AO) that all applicable Medicare conditions 
are met or exceeded, we may ``deem'' that provider entity as having met 
the requirements. Accreditation by an accreditation organization is 
voluntary and is not required for Medicare

[[Page 22710]]

participation. A national AO applying for deeming authority under part 
488 subpart A, must provide us with reasonable assurance that the AO 
requires the accredited provider entities to meet requirements that are 
at least as stringent as the Medicare conditions.

II. Deeming Application Approval Process

    Section 1865(a)(3)(A) of the Act provides a statutory timetable to 
ensure that our review of applications for deeming authority is 
conducted in a timely manner. The Act provides us 210 calendar days 
after the date of receipt of a complete application, with any 
documentation necessary to make a 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 accreditation 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 and Response to Comments

    On November 29, 2010, we published a proposed notice in the Federal 
Register (75 FR 73088) announcing AAAASF's request for approval as a 
deeming organization for organizations that provide outpatient physical 
therapy and speech-language pathology services. In that notice, we 
detailed our evaluation criteria. Under section 1865(a)(2) of the Act 
and in our regulations at Sec.  488.4 (Application and reapplication 
procedures for accreditation organizations), we conducted a review of 
AAAASF's 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 surveyors; (4) ability to investigate and respond 
appropriately to complaints against accredited facilities; and (5) 
survey review and decision-making process for accreditation.
    <bullet> A comparison of AAAASF's outpatient physical therapy and 
speech-language pathology services accreditation standards to our 
current Medicare outpatient physical therapy and speech-language 
pathology services conditions of participation (CoPs).
    <bullet> A documentation review of AAAASF's survey processes 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 of State survey agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    + Evaluate AAAASF's procedures for monitoring organizations 
providing outpatient physical therapy and speech-language pathology 
services found to be out of compliance with AAAASF's program 
requirements. The monitoring procedures are used only when the AAAASF 
identifies noncompliance. If noncompliance is identified through 
validation reviews, the State survey agency monitors corrections as 
specified at Sec.  488.7(d).
    + Assess AAAASF's ability to report deficiencies to the surveyed 
organizations and respond to the facility's plan of correction in a 
timely manner.
    + Establish AAAASF's ability to provide us with electronic data and 
reports necessary for effective validation and assessment of AAAASF's 
survey process.
    + Determine the adequacy of staff and other resources.
    + Review AAAASF's ability to provide adequate funding for 
performing required surveys.
    + Confirm AAAASF's policies with respect to whether surveys are 
announced or unannounced.
    + Obtain AAAASF's agreement to provide us 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 
26, 2010 proposed notice also solicited public comments regarding 
whether AAAASF's requirements meet or exceed the Medicare CoPs for 
outpatient physical therapy and speech-pathology services. We received 
2 comments in response to our proposed notice.
    Comment: One commenter expressed concern that AAAASF does not have 
adequate experience and familiarity with organizations that provide 
outpatient physical therapy and speech-pathology services, nor does 
AAAASF have accreditation standards that exceed the current Medicare 
requirements.
    Response: Regulations at Sec.  488.4 and Sec.  488.8 specify the 
process to be followed for application, review, approval and renewal of 
deeming authority for AOs. A national AO applying for approval of 
deeming authority under part 488, subpart A, must provide CMS with 
reasonable assurance that the AO requires accredited provider entities 
to meet the requirements that are at least as stringent as the Medicare 
conditions. AO standards may, but are not required to, exceed our 
requirements. AAAASF's application was thoroughly reviewed in 
accordance with these requirements and found to meet the Medicare 
requirements.
    Comment: One commenter expressed concern that AAAASF's application 
did not include occupational therapy services.
    Response: The regulations at 42 CFR part 485, subpart H specify, 
among other things, the conditions that an organization providing 
outpatient physical therapy and speech-language pathology services must 
meet to participate in the Medicare program. These regulations do not 
include a requirement for occupational therapy services. Therefore, it 
was not necessary for occupational therapy services to be addressed in 
AAAASF's application.

IV. Provisions of the Final Notice

A. Differences Between AAAASF's Standards and Requirements for 
Accreditation and Medicare's Conditions and Survey Requirements

    We compared AAAASF's outpatient physical therapy and speech-
pathology services accreditation requirements and survey process with 
the Medicare CoPs and survey process as outlined in the State 
Operations Manual (SOM). Our review and evaluation of AAAASF's deeming 
application, which were conducted as described in section III of this 
final notice, yielded the following:
    <bullet> AAAASF revised its standards to ensure social workers meet 
the requirements outlined in 42 CFR part 484 for States that do not 
require licensure.
    <bullet> AAAASF revised its crosswalk to include the requirements 
that all vocational specialists must meet to comply with the 
requirements at Sec.  485.705(c)(7)(i) through (iii).
    <bullet> AAAASF revised its policies to ensure its survey files 
were complete, accurate and consistent with the Medicare requirements 
at Sec.  488.6(a).
    <bullet> AAAASF revised its accreditation decision letters to 
ensure they are accurate and contain all of the elements necessary for 
the CMS Regional Office to render a decision regarding deemed status of 
an organization that provides outpatient physical therapy and speech-
language pathology services.
    <bullet> AAAASF modified its policies regarding timeframes for 
sending and

[[Page 22711]]

receiving a required plan of correction in accordance with the 
requirements at section 2728 of the SOM.

B. Term of Approval

    Based on the review and observations described in section III of 
this final notice, we have determined that AAAASF's requirements for 
organizations providing outpatient physical therapy and speech-language 
pathology services meet or exceed our requirements. Therefore, we 
approve AAAASF as a national accreditation organization for 
organizations that provide outpatient physical therapy and speech-
language pathology services that request participation in the Medicare 
program, effective April 22, 2011 through April 22, 2015.

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. Chapter 35).
    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by the Office of Management and Budget.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program)

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: March 30, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2011-9176 Filed 4-21-11; 8:45 am]
BILLING CODE 4120-01-P