[Federal Register Volume 63, Number 83 (Thursday, April 30, 1998)]
[Notices]
[Pages 23790-23791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11491]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[HCFA-2008-PN]
RIN 0938-AI90


Medicare and Medicaid Programs; Recognition of the American 
Association for Accreditation of Ambulatory Surgery Facilities, Inc. 
for Ambulatory Surgical Centers Program

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Proposed notice.

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SUMMARY: In this notice we announce the receipt of an application from 
the American Association for Accreditation of Ambulatory Surgery 
Facilities, Inc. (AAAASF) for recognition as a national accreditation 
program for ambulatory surgical centers that wish to participate in the 
Medicare or Medicaid programs. The Social Security Act requires that 
the Secretary publish a notice identifying the national accreditation 
body making the request, describing the nature of the request, and 
providing a 30 day public comment period.

DATES: Comments will be considered if we receive them at the 
appropriate address, as provided below, no later than 5:00 pm on June 
1, 1998.

ADDRESSES: Mail written comments (1 original and 3 copies) to the 
following address: Health Care Financing Administration, Department of 
Health and Human Services, Attention: HCFA-2008-PN, P.O. Box 26688, 
Baltimore, MD 21207-5178.
    If you prefer, you may deliver your written comments (1 original 
and 3 copies) to one of the following addresses:

Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201, or
Room C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    Because of staffing and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code HCFA-1885-P. Comments received timely will be available 
for public inspection as they are received, generally beginning 
approximately 3 weeks after publication of a document, in Room 309-G of 
the Department's offices at 200 Independence Avenue, SW., Washington, 
DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m. 
(phone: (202) 690-7890).

FOR FURTHER INFORMATION CONTACT: Joan C. Berry (410) 786-7233.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in an ambulatory surgical center (ASC) provided 
certain requirements are met. Section 1832 (a)(2)(F) of the Social 
Security Act (the Act) includes the requirements that an ASC have an 
agreement in effect with the Secretary and meet health, safety, and 
other standards specified by the Secretary in regulations. Regulations 
concerning supplier 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 416 
specify the conditions that an ASC must meet in order to participate in 
the Medicare program, the scope of covered services, and the conditions 
for Medicare payment for facility services.
    Generally, in order to enter into an agreement, an ASC must first 
be 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

[[Page 23791]]

to determine whether it continues to meet these requirements. There is 
an alternative, however, to surveys by State agencies.
    Section 1865(b) of the Act permits ``accredited'' ASCs to be exempt 
from routine surveys by State survey agencies to determine compliance 
with Medicare requirements. Section 1865(b)(1) of the Act provides that 
if the Secretary finds that accreditation of a provider entity by a 
national accreditation body demonstrates that all of the applicable 
conditions and requirements are met, the Secretary would deem those 
provider entities as meeting the applicable Medicare requirements. 
Hence, if the Secretary finds that the accreditation of an ASC by a 
national accreditation body demonstrates that all the Medicare 
conditions and standards are met or exceeded, then the Secretary 
``deems'' the requirements to be met by the ASC. Our regulations 
concerning approval of accrediting organizations are at Secs. 488.4, 
488.6, and 488.8. A national accrediting organization starts the 
process by requesting that the Secretary recognize its accreditation 
program. To date, two organizations have been recognized with deeming 
authority for their ASC programs: the Joint Commission on Accreditation 
of Healthcare Organizations and the Accreditation Association for 
Ambulatory Health Care.

II. Approval of Accreditation Organization

    The purpose of this notice is to notify the public of the request 
of the American Association for Accreditation of Ambulatory Surgery 
Facilities, Inc. (AAAASF) for approval of its request that the 
Secretary find its accreditation program for ambulatory surgical 
centers meets or exceeds the Medicare conditions. This notice also 
solicits public comment on the ability of this body's requirements to 
meet or exceed the Medicare conditions for coverage.
    Section 1865(b)(2) of the Act requires that the Secretary's 
findings consider the applying accreditation organization's 
requirements for accreditation, its survey procedures, its ability to 
provide adequate resources for conducting required surveys and ability 
to supply information for use in enforcement activities, its monitoring 
procedures for provider entities found out of compliance with the 
conditions or requirements, and its ability to provide the Secretary 
with necessary data for validation.
    Section 1865(b)(3)(A) of the Act requires that the Secretary 
publish within 60 days of the receipt of a completed 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. In addition, the Secretary has 210 days from the 
receipt of the request to publish a finding of approval or denial of 
the application.
    This notice also solicits public comment on the ability of this 
body's requirements to meet or exceed the Medicare conditions of 
coverage.

III. Evaluation of Deeming Request

    On November 18, 1997, the AAAASF submitted all the necessary 
information concerning their request for a finding by the Secretary 
that its accreditation program met or exceeded the Medicare conditions. 
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 AAAASF is being conducted in accordance with, but not 
necessarily limited to, the following factors:
    <bullet> The equivalency of AAAASF's requirements for an ASC to our 
comparable requirements for the ASC.
    <bullet> 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 its processes to that of State agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
--The organization's procedures for monitoring providers or suppliers 
found by the organization to be out of compliance with program 
requirements. These monitoring procedures are used only when the 
organization identifies noncompliance. If noncompliance is identified 
through validation reviews, the survey agency monitors corrections as 
specified at Sec. 488.7(b)(3).

    <bullet> The ability of the organization to report deficiencies to 
the surveyed facilities and respond to the facility's plan of 
correction in a timely manner.
    <bullet> The ability of AAAASF to provide us with electronic data 
in ASCII comparable code and reports necessary for effective validation 
and assessment of the organization's survey process.
    <bullet> The adequacy of AAAASF's staff and other resources, and 
its financial viability.
    <bullet> AAAASF's ability to provide adequate funding for 
performing required surveys.
    <bullet> AAAASF's policies with respect to whether surveys are 
announced or unannounced.
    <bullet> 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. Notice Upon Completion of Evaluation

    Upon completion of our evaluation, including evaluation of comments 
received as a result of this notice, we will publish a notice in the 
Federal Register announcing the result of our evaluation.

V. Responses to Public Comments

    Because of the large number of comments 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 
comments we receive by the date and time specified in the DATES section 
of this preamble and will respond to them in a forthcoming rulemaking 
document.

(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: April 6, 1998.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.
[FR Doc. 98-11491 Filed 4-29-98; 8:45 am]
BILLING CODE 4120-01-M