[Federal Register Volume 67, Number 125 (Friday, June 28, 2002)]
[Notices]
[Pages 43610-43612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15969]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2155-PN]


Medicare and Medicaid Programs; Application by the Accreditation 
Association for Ambulatory Health Care, Inc. for Continued Deeming 
Authority for Ambulatory Surgical Centers

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Proposed notice.

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SUMMARY: This proposed notice acknowledges the receipt of a renewal 
application by the Accreditation Association for Ambulatory Health 
Care, Inc. for continued recognition as a national accreditation 
program for ambulatory surgical centers that wish to participate in the 
Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social 
Security Act requires that within 60 days of receipt of an 
organization's complete application we publish a proposed 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: We will consider comments if we receive them at the appropriate 
address, as provided below, no later than 5 p.m. on July 29, 2002.

ADDRESSES: In commenting, please refer to file code CMS-2155-PN. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission. Mail written comments (1 original and 3 
copies) to the following address: Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Attention: CMS-2155-
PN, P.O. Box 8013, Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be timely 
received in the event of delivery delays.
    If you prefer, you may deliver (by hand or courier) your written 
comments (1 original and 3 copies) to one of the following addresses: 
Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201, or Room C5-14-03, 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 commenters 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 identified for hand or courier 
delivery may be delayed and could be considered late.
    For information on viewing public comments see the beginning of the 
SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Milonda Mitchell, (410) 786-3511.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: Comments 
received timely will 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, call (410) 786-7197.
    Copies: Additional copies of the Federal Register containing this 
proposed notice can be made at most libraries designated as Federal 
Depository libraries and at many other public and academic libraries 
throughout the country that receive the Federal Register.
    This Federal Register document is also available from the Federal 
Register online database through GPO Access, a service of the U.S. 
Government Printing Office. The web site address is: http://www.access.gpo.gov /nara/index.html.

SUPPLEMENTARY INFORMATION:   

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in an ambulatory surgical center (ASC) provided the 
ASC meets certain requirements. Section 1832(a)(2)(F)(i) of the Social 
Security Act (the Act) authorizes the Secretary to establish distinct 
criteria for facilities seeking designation as an ASC. Under this 
authority, the Secretary has set forth in regulations minimum 
requirements that an ASC must meet to participate in Medicare. The 
regulations at title 42, part 416 (Ambulatory Surgical Services) of the 
Code of Federal Regulations (CFR)

[[Page 43611]]

determine the basis and scope of covered services provided by an ASC, 
and Conditions for Medicare payment for ASCs. Applicable regulations 
concerning provider agreements are at part 489 (Provider Agreements and 
Supplier Approval) and those pertaining to the survey and certification 
of facilities are at part 488 (Survey Certification and Enforcement 
Procedures), subpart A (General Provisions) and B (Special 
Requirements).
    In order for an ASC to be approved for participation in the 
Medicare program, the ASC must comply with State licensure 
requirements. The ASC must be certified by a State survey agency as 
complying with the conditions or requirements, as set forth in 
Sec. 416.26(b) of our regulations. Then, the ASC 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 surveys 
by State agencies.
    Section 1865(b)(1) of the Act permits provider entities that are 
accredited by CMS-approved accrediting organizations to be exempt from 
routine surveys by State survey agencies to determine compliance with 
Medicare conditions of coverage. Accreditation by an accreditation 
organization is voluntary and is not required of ASCs for Medicare 
participation. Section 1865(b)(1) of the Act provides that, if an ASC 
demonstrates through accreditation that all applicable Medicare 
conditions are met or exceeded, we shall ``deem'' those ASCs as having 
met the requirements.
    If an accreditation 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 accreditation organization applying for 
approval of deeming authority under part 488, subpart A must provide us 
with reasonable assurance that the accreditation organization requires 
the accredited provider entities to meet requirements that are at least 
as stringent as the Medicare conditions. Our regulations concerning 
renewal of an accreditation organization's deeming authority are set 
forth at Secs. 488.4 and 488.8(d)(3). The regulations at 
Sec. 488.8(d)(3) require accreditation organizations to reapply for 
continued approval of deeming authority every 6 years or sooner, as 
determined by us. Our current recognition of the Accreditation 
Association for Ambulatory Health Care Inc.'s (AAAHC) accreditation 
program for ASCs will terminate on December 19, 2002.

II. Approval of Deeming Organizations

    Section 1865(b)(2) of the Act requires that our findings concerning 
review of a national accrediting organization's requirements consider, 
among other factors, the reapplying accreditation 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 us with the necessary data for validation.
    Section 1865(b)(3)(A) of the Act further requires that we publish, 
within 60 days of receipt of an organization's complete application, a 
notice identifying the national accreditation body making the request, 
describing the nature of the request, and providing at least a 30-day 
public comment period. We have 210 days from our receipt to publish 
approval or denial of the application.
    The purpose of this proposed notice is to inform the public of our 
receipt of the AAAHC's request for renewal and continuation of its 
deeming authority for ASCs. This notice also solicits public comment on 
the ability of AAAHC requirements to meet or exceed the Medicare 
conditions for coverage for ASCs.

II. Evaluation of Deeming Authority Request

    On April 18, 2002, AAAHC submitted all the necessary materials 
concerning its request for renewal as a deeming organization for ASCs 
to enable us to make a determination. Under section 1865(b)(2) of the 
Act and our regulations at Sec. 488.8 (Federal review of accreditation 
organizations), our review and evaluation of AAAHC will be conducted in 
accordance with, but not necessarily limited to, the following factors:
     The equivalency of AAAHC standards for an ASC as compared 
with our comparable ASC conditions of coverage.
     AAAHC'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 AAAHC's processes to those of State agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
--AAHC's processes and procedures for monitoring providers or suppliers 
found out of compliance with AAAHC's program requirements. These 
monitoring procedures are used only when AAAHC identifies 
noncompliance. If noncompliance is identified through validation 
reviews, the survey agency monitors corrections as specified at 
Sec. 488.7(d).
--AAAHC's capacity to report deficiencies to the surveyed facilities 
and respond to the facility's plan of correction in a timely manner.
--AAAHC's capacity to provide us with electronic data in ASCII 
comparable code, and reports necessary for effective validation and 
assessment of the organization's survey process.
--The adequacy of AAAHC's staff and other resources, and its financial 
viability.
--AAAHC's capacity to adequately fund required surveys.
--AAAHC's policies with respect to whether surveys are announced or 
unannounced.
--AAAHC'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 and Notice Upon Completion of Evaluation

    Because of the large number of items of correspondence we normally 
receive on Federal Register documents published for comment, we are not 
able to acknowledge or respond to them individually. We will consider 
all public comments we receive by the date and time specified in the 
DATES section of this preamble, and when we proceed with a final 
notice, we will respond to the public comments in the preamble to the 
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.
    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, 
roles, and responsibilities of States, local, or tribal governments.

    Authority: Section 1865 of the Social Security Act (42 U.S.C. 
1395bb)


[[Page 43612]]


(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: June 19, 2002.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 02-15969 Filed 6-27-02; 8:45 am]
BILLING CODE 4120-01-P