```

[Federal Register: November 29, 2010 (Volume 75, Number 228)]
[Notices]               
[Page 73088-73089]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no10-94]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[CMS-2332-PN]

 
Medicare Program; Application by the American Association for 
Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for 
Deeming Authority for Providers of Outpatient Physical Therapy and 
Speech-Language Pathology Services.

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Proposed notice.

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

SUMMARY: This proposed notice acknowledges the receipt of a deeming 
application from the American Association for Accreditation of 
Ambulatory Surgery Facilities (AAAASF) for recognition as a national 
accrediting organization for providers of outpatient physical therapy 
and speech-language pathology services that wish to participate in the 
Medicare or Medicaid programs. Section 1865(a)(3)(A) of the Social 
Security Act requires that within 60 days of receipt of an 
organization's complete application, the Secretary of the Department of 
Health and Human Services publish a notice that identifies the national 
accrediting body making the request, describes the nature of the 
request, and provides at least a 30-day public comment period.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on December 29, 
2010.

ADDRESSES: In commenting, please refer to file code CMS-2332-PN. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on specific 
issues in this regulation to http://www.regulations.gov. Click on the 
link ``Submit electronic comments on CMS regulations with an open 
comment period.'' (Attachments should be in Microsoft Word, 
WordPerfect, or Excel; however, we prefer Microsoft Word.)
    2. By regular mail. You may mail written comments (one original and 
two copies) to the following address ONLY: Centers for Medicare & 
Medicaid Services, Department of Health and Human Services, Attention: 
CMS-2332-PN, P.O. Box 8010, Baltimore, MD 21244-8010.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments (one 
original and two copies) to the following address ONLY:
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-2332-PN, Mail Stop C4-26-05, 7500 
Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original and two copies) before the 
close of the comment period to one of the following addresses. If you 
intend to deliver your comments to the Baltimore address, please call 
telephone number (410) 786-9994 in advance to schedule your arrival 
with one of our staff members.
    Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, 
SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 
21244-1850.
    (Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for persons wishing to retain a proof of filing by stamping 
in and retaining an extra copy of the comments being filed.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

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

SUPPLEMENTARY INFORMATION:
    Submitting Comments: We welcome comments from the public on all 
issues set forth in this proposed notice to assist us in fully 
considering issues and developing policies. You can assist us by 
referencing the file code CMS-2332-PN and the specific ``issue 
identifier'' that precedes the section on which you choose to comment.
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following Web 
site as soon as possible after they have been received: http://www.regulations.gov. Click on the link ``Electronic Comments on CMS 
Regulations'' on that Web site to view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
outpatient physical therapy services (OPT) 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 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. Our regulations at 42 CFR part 
485, subpart H specify the conditions that an organization providing 
OPT services must meet in order to participate in the Medicare program.
    Generally, in order to enter into a provider agreement with the 
Medicare program, an organization offering OPT services must first be 
certified by a State survey agency as complying with the applicable 
conditions or requirements set forth in part 42 CFR part 485.

[[Page 73089]]

Thereafter, the organization is subject to regular surveys by a State 
survey agency to determine whether it continues to meet these 
requirements.
    There is an alternative, however, to State certification and 
surveys by State agencies, as a means to enter into a Medicare provider 
agreement. Section 1865(a)(1) of the Act provides that, if a provider 
entity demonstrates through accreditation by a national accrediting 
organization approved by the Secretary, that all applicable Medicare 
conditions are met or exceeded, we will deem those provider entities as 
having met the requirements. Accreditation by an accrediting 
organization is voluntary and is not required for Medicare 
participation.
    If an accrediting organization is recognized by 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 would be deemed to meet the 
Medicare conditions. A national accrediting organization applying for 
deeming authority under part 488, subpart A must provide us with 
reasonable assurance that the accrediting organization requires the 
accredited provider entities to meet requirements that are at least as 
stringent as the Medicare conditions of participation. The regulations 
at Sec.  488.8(d)(3) require accrediting organizations to reapply for 
continued deeming authority every six years or sooner, as determined by 
the Secretary.

II. Approval of Deeming Organizations

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.8(a) 
require that our findings concerning review and approval of a national 
accrediting organization's Requirements consider, among other factors, 
the applying accrediting organization's: Requirements for 
accreditation; survey procedures; resources for conducting required 
surveys; capacity to furnish information for use in enforcement 
activities; monitoring procedures for provider entities found not in 
compliance with the conditions or requirements; and ability to provide 
the Secretary with the necessary data for validation.
    Section 1865(a)(3)(A) of the Act further requires that the 
Secretary publish, within 60 days of receipt of an organization's 
complete application, a notice identifying the national accrediting 
body making the request, describing the nature of the request, and 
providing at least a 30-day public comment period. The Secretary has 
210 days from the receipt of a complete application to publish notice 
of approval or denial of the application.
    The purpose of this proposed notice is to inform the public of 
AAAASF's request for deeming authority for organizations providing OPT 
services. This notice also solicits public comment on whether AAAASF's 
requirements meet or exceed the Medicare conditions for participation 
for such organizations.

III. Evaluation of Deeming Authority Request

    AAAASF submitted all the necessary materials to enable us to make a 
determination concerning its request for approval as a deeming 
organization for organizations providing OPT services. This application 
was determined to be complete on October 15, 2010. Under Section 
1865(a)(2) of the Act and our regulations at Sec.  488.8 (Federal 
review of accrediting organizations), our review and evaluation of 
AAAASF will be conducted in accordance with, but not necessarily 
limited to, the following factors:
     The equivalency of AAAASF's standards for an organization 
providing OPT services, as compared with CMS' OPT organizations' 
conditions of participation.
     AAAASF's survey process to determine the following:
--The composition of the survey team, surveyor qualifications, and the 
ability of the organization to provide continuing surveyor training.
--The comparability of AAAASF's processes to those of State agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
--AAAASF's processes and procedures for monitoring OPTs found out of 
compliance with the AAAASF's program requirements. These monitoring 
procedures are used only when AAAASF identifies noncompliance. If 
noncompliance is identified through validation reviews, the State 
survey agency will monitor corrections as specified at Sec.  488.7(d).
--AAAASF's capacity to report deficiencies to the surveyed facilities 
and respond to the facility's plan of correction in a timely manner.
--AAAASF's capacity to provide the Secretary with electronic data and 
reports necessary for effective validation and assessment of the 
organization's survey process.
--The adequacy of AAAASF's staff and other resources, and its financial 
viability.
--AAAASF's capacity to adequately fund required surveys.
--AAAASF's policies with respect to whether surveys are announced or 
unannounced, to assure that surveys are unannounced.
--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).

IV. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.
    Upon completion of our evaluation, including evaluation of comments 
received as a result of this notice, we will publish a final notice in 
the Federal Register announcing the result of our evaluation.

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. 35).

VI. Regulatory Impact Statement

    In accordance with the provisions of Executive Order 12866, the 
Office of Management and Budget did not review this proposed notice.
    In accordance with Executive Order 13132, we have determined that 
this proposed notice would not have a significant effect on the rights 
of States, local or tribal governments.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program; 
and No. 93.774, Medicare--Supplementary Medical Insurance Program)

    Dated: November 17, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-29966 Filed 11-26-10; 8:45 am]
BILLING CODE 4120-01-P
```