[Federal Register Volume 69, Number 141 (Friday, July 23, 2004)]
[Notices]
[Pages 44027-44029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16431]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[CMS-2202-PN]
RIN 0938-ZA52


Medicare and Medicaid Programs; Application by the American 
Association for Accreditation of Ambulatory Surgery Facilities, Inc., 
for Continued Deeming Authority for Ambulatory Surgical Centers

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Proposed notice.

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SUMMARY: This proposed notice acknowledges the receipt of a renewal 
application by the American Association for Accreditation of Ambulatory 
Surgery Facilities, Inc. for approval as a national accreditation 
program for ambulatory surgical centers that wish to participate in the 
Medicare or Medicaid programs. The statute requires that within 60 days 
of receipt of an organization's written request, CMS publish a proposed 
notice that identifies the national accrediting body making the 
request, describing the nature of the request, and providing at least a 
30-day public comment period.

DATES: To be assured of consideration, comments must be received at one 
of the addresses provided below, no later than 5 p.m. on August 23, 
2004.

ADDRESSES: In commenting, please refer to file code CMS-2202-PN. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of three ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on the issues 
in this notice to http://www.cms.hhs.gov/regulations/ecomments. 
(Attachments should be in Microsoft Word, WordPerfect, or Excel; 
however, we prefer Microsoft Word.)
    2. By 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-2202-
PN, P.O. Box 8018, Baltimore, MD 21244-8018.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. 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) 786-7195 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 FURTHER INFORMATION CONTACT: Milonda H. Mitchell, (410) 786-3511.

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-2202-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. After the close of the 
comment period, CMS posts all

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electronic comments received before the close of the comment period on 
its public web site. 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, Yolanda Hayes, (410) 786-7195.
    This Federal Register document is 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.gpoaccess.gov/fr/index.html.

I. Background

    [If you choose to comment on issues in this section, please include 
the caption ``BACKGROUND'' at the beginning of your comments.]
    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) establishes the authority for the Secretary to 
establish distinct criteria for a facility 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 42 CFR part 416 (Ambulatory Surgical Services) 
specify the conditions under which Medicare makes payments for covered 
services provided by an ASC. Types of Medicare payment for ASC services 
can be found at Sec.  416.120. 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 subpart B (Special 
Requirements).
    In order for ASC services to be covered under the Medicare program, 
the ASC must be licensed by a State agency as an ASC. The licensure 
must be in place at the time the ASC is certified by a State survey 
agency as complying with the conditions or requirements set forth in 
part 416 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 (currently approved under OMB's 0938-
0690 and 0938-0266). There is an alternative, however, to surveys by 
State agencies.
    As it applies to ASCs, section 1865(b)(1) of the Act permits 
``accredited'' provider entities to be exempt from routine surveys by 
State survey agencies to determine compliance with Medicare conditions 
for coverage. Accreditation by an accreditation organization is 
voluntary and is not required for Medicare participation. This section 
of the Act provides that, if a provider entity demonstrates through 
accreditation that all applicable Medicare conditions are met or 
exceeded, CMS shall ``deem'' it as having met the requirements.
    If an accreditation organization is recognized in this manner with 
respect to a specific facility type (such as an ASC), any facility 
accredited by a national accrediting body's approved program is 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 organizations' 
deeming authority are set forth at Sec.  488.4 and Sec.  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 if we so determine. Our recognition of the 
American Association for Accreditation of Ambulatory Surgery 
Facilities, Inc. (AAAASF's) accreditation program for ASCs will 
terminate on December 2, 2004.

II. Approval of Deeming Organizations

    [If you choose to comment on issues in this section, please include 
the caption ``Approval of Deeming Organizations'' at the beginning of 
your comments.]
    Section 1865 (b)(2) of the Act requires that our findings 
concerning review of 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 (currently approved under OMB's 0938-0690 and 0938-
0266).
    Section 1865(b)(3)(A) of the Act further requires that we publish, 
within 60 days of receipt of an organization's complete reapplication, 
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 of a 
completed application to publish approval or denial of the application.
    The purpose of this proposed notice is to inform the public of our 
consideration of AAAASF's request to review its ``deeming authority'' 
for ASCs. This notice also solicits public comment on the ability of 
AAAASF's requirements to meet or exceed the Medicare conditions for 
coverage for ASCs.

III. Evaluation of Deeming Authority Request

    [If you choose to comment on issues in this section, please include 
the caption ``Evaluation of Deeming Authority Request'' at the 
beginning of your comments.]
    On May 24, 2004, AAAASF 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 regulations at Sec.  488.8 (Federal review of accreditation 
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 standards for an ASC as compared 
with our comparable ASC conditions for coverage.
     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 that 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 providers or 
suppliers found out of compliance with AAAASF's program requirements. 
These monitoring procedures are used only when AAAASF identifies 
noncompliance. If noncompliance is identified through validation 
reviews, the survey agency monitors corrections as specified at Sec.  
488.7(d).
--AAAASF's capacity to report deficiencies to the surveyed facilities

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and respond to the facility's plan of correction in a timely manner.
--AAAASF'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 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.
--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. 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.

V. Response to Comments and Notice Upon Completion of Evaluation

    [If you choose to comment on issues in this section, please include 
the caption ``Response to Comments and Notice Upon Completion of 
Evaluation'' at the beginning of your comments.]
    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 the rights of 
States, local, or tribal governments.

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

(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: July 1, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare and Medicaid Services.
[FR Doc. 04-16431 Filed 7-22-04; 8:45 am]
BILLING CODE 4120-01-P