[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:
The equivalency of AAAASF's requirements for an ASC to our
comparable requirements for the ASC.
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).
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.
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.
The adequacy of AAAASF's staff and other resources, and
its financial viability.
AAAASF's ability to provide adequate funding for
performing 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. 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