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, 22709-22711 [2011-9176]
Download as PDF
<![CDATA[
Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Notices
the authority to sign Federal Register
Notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention, and the Agency for Toxic
Substances and Disease Registry.
Dated: April 15, 2011.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2011–9879 Filed 4–21–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–R–21]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Withholding
Medicare Payments to Recover
Medicaid Overpayments and
Supporting Regulations in 42 CFR
447.31; Form No.: CMS–R–21 (OMB#:
0938–0287); Use: Section 2104 of the
Omnibus Reconciliation Act of 1981
provides CMS with the authority to
withhold Medicare payments to recover
Medicaid overpayments that the
Medicaid State Agency has been unable
to recover. When the CMS Regional
mstockstill on DSKH9S0YB1PROD with NOTICES
AGENCY:
VerDate Mar<15>2010
16:01 Apr 21, 2011
Jkt 223001
Office (RO) receives an overpayment
case from a State Agency, the case file
is examined to determine whether the
conditions for withholding Medicare
payments have been met. If the RO
determines that the case is appropriate
for withholding Medicare payments, the
RO will contact the institution’s
intermediary or individual’s carrier to
determine the amount of Medicare
payments to which the entity would
otherwise be entitled. The RO will then
give notice to the intermediary/carrier to
withhold the entity’s Medicare
payment; Frequency: Occasionally;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
54; Total Annual Responses: 27; Total
Annual Hours: 81. (For policy questions
regarding this collection contact Rory
Howe at 410–786–4878. For all other
issues call 410–786–1326.)
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on May 23, 2011.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov.
Dated: April 19, 2011.
Martique Jones,
Director, Regulations Development Group—
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2011–9846 Filed 4–21–11; 8:45 am]
BILLING CODE 4120–01–P
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
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice.
AGENCY:
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
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
22709
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
E:\FR\FM\22APN1.SGM
22APN1
22710
Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Notices
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.
mstockstill on DSKH9S0YB1PROD with NOTICES
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 30day 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 § 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 speechlanguage pathology services
accreditation standards to our current
Medicare outpatient physical therapy
and speech-language pathology services
conditions of participation (CoPs).
VerDate Mar<15>2010
16:01 Apr 21, 2011
Jkt 223001
• 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 speechlanguage 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 § 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 speechpathology services, nor does AAAASF
have accreditation standards that exceed
the current Medicare requirements.
Response: Regulations at § 488.4 and
§ 488.8 specify the process to be
followed for application, review,
approval and renewal of deeming
authority for AOs. A national AO
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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
§ 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 § 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 speechlanguage pathology services.
• AAAASF modified its policies
regarding timeframes for sending and
E:\FR\FM\22APN1.SGM
22APN1
Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
mstockstill on DSKH9S0YB1PROD with NOTICES
[CMS–2372–N]
Announcement of the Re-Approval of
the American Society of
Histocompatibility and
Immunogenetics (ASHI) as an
Accreditation Organization Under the
Clinical Laboratory Improvement
Amendments of 1988
Centers for Medicare &
Medicaid Services (CMS), HHS.
AGENCY:
VerDate Mar<15>2010
16:01 Apr 21, 2011
Jkt 223001
ACTION:
Notice.
This notice announces the
application of the American Society for
Histocompatibility and Immunogenetics
(ASHI) for re-approval as an
accreditation organization for clinical
laboratories under the Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) program for the
following specialty and subspecialty
areas: General Immunology;
Histocompatibility; and ABO/Rh typing.
We have determined that the ASHI
meets or exceeds the applicable CLIA
requirements. We are announcing the
re-approval and grant ASHI deeming
authority for a period of 5 years.
DATES: Effective Date: This notice is
effective from April 22, 2011 to April
22, 2016.
FOR FURTHER INFORMATION CONTACT:
Penelope Meyers, (410) 786–3366.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background and Legislative
Authority
On October 31, 1988, the Congress
enacted the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) (Pub. L. 100–578). CLIA
amended section 353 of the Public
Health Service Act. We issued a final
rule implementing the accreditation
provisions of CLIA on July 31, 1992 (57
FR 33992). Under those provisions,
CMS may grant deeming authority to an
accreditation organization if its
requirements for laboratories accredited
under its program are equal to or more
stringent than the applicable CLIA
program requirements in 42 CFR part
493 (Laboratory Requirements). Subpart
E of part 493 (Accreditation by a Private,
Nonprofit Accreditation Organization or
Exemption Under an Approved State
Laboratory Program) specifies the
requirements an accreditation
organization must meet to be approved
by CMS as an accreditation organization
under CLIA.
II. Notice of Approval of the ASHI as
an Accreditation Organization
In this notice, we approve ASHI as an
organization that may accredit
laboratories for purposes of establishing
its compliance with CLIA requirements
for the subspecialty of General
Immunology, the specialty of
Histocompatibility, and the subspecialty
of ABO/Rh typing. We have examined
the initial ASHI application and all
subsequent submissions to determine its
accreditation program’s equivalency
with the requirements for approval of an
accreditation organization under
subpart E of part 493. We have
determined that the ASHI meets or
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
22711
exceeds the applicable CLIA
requirements. We have also determined
that the ASHI will ensure that its
accredited laboratories will meet or
exceed the applicable requirements in
subparts H, I, J, K, M, Q, and the
applicable sections of R. Therefore, we
grant the ASHI approval as an
accreditation organization under
subpart E of part 493, for the period
stated in the DATES section of this notice
for the subspecialty of General
Immunology, the specialty of
Histocompatibility, and the subspecialty
of ABO/Rh typing. As a result of this
determination, any laboratory that is
accredited by the ASHI during the time
period stated in the DATES section of this
notice will be deemed to meet the CLIA
requirements for the listed
subspecialties and specialties, and
therefore, will generally not be subject
to routine inspections by a State survey
agency to determine its compliance with
CLIA requirements. The accredited
laboratory, however, is subject to
validation and complaint investigation
surveys performed by CMS, or its
agent(s).
III. Evaluation of the ASHI Commission
Request for Approval as an
Accreditation Organization Under
CLIA
The following describes the process
used to determine that the ASHI
accreditation program meets the
necessary requirements to be approved
by CMS and that, as such, CMS may
approve ASHI as an accreditation
program with deeming authority under
the CLIA program. ASHI formally
applied to CMS for approval as an
accreditation organization under CLIA
for the subspecialty of General
Immunology, the specialty of
Histocompatibility, and the subspecialty
of ABO/Rh typing. In reviewing these
materials, we reached the following
determinations for each applicable part
of the CLIA regulations:
A. Subpart E—Accreditation by a
Private, Nonprofit Accreditation
Organization or Exemption Under an
Approved State Laboratory Program
The ASHI submitted its mechanism
for monitoring compliance with all
requirements equivalent to conditionlevel requirements, a list of all its
current laboratories and the expiration
date of their accreditation, and a
detailed comparison of the individual
accreditation requirements with the
comparable condition-level
requirements. The ASHI policies and
procedures for oversight of laboratories
performing laboratory testing for the
subspecialty of General Immunology,
E:\FR\FM\22APN1.SGM
22APN1
]]>Agencies
[Federal Register Volume 76, Number 78 (Friday, April 22, 2011)]
[Notices]
[Pages 22709-22711]
From the Federal Register Online via the Government Printing 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:
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
[[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
