[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]
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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.
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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:
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.
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).
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:
AAAASF revised its standards to ensure social workers meet
the requirements outlined in 42 CFR part 484 for States that do not
require licensure.
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).
AAAASF revised its policies to ensure its survey files
were complete, accurate and consistent with the Medicare requirements
at Sec. 488.6(a).
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.
AAAASF modified its policies regarding timeframes for
sending and
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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