[Federal Register Volume 66, Number 50 (Wednesday, March 14, 2001)]
[Notices]
[Pages 14906-14908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6311]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[HCFA-2079-PN]
Medicare and Medicaid Programs; Recognition of the American
Osteopathic Association 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 Osteopathic Association (AOA), 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 at least 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 April 13, 2001.
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-2079-PN, P.O. Box 8013, Baltimore, MD
21244-8013.
To ensure that mailed comments are received in time for us to consider
them, please allow for possible delays in delivering them.
If you prefer, you may deliver your written comments (1 original
and 3 copies) to one of the following addresses:
Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue,
SW., Washington, DC 20201, or Room C5-16-03, 7500 Security
Boulevard, Baltimore, MD 21244-8013.
Comments mailed to the above addresses may be delayed and received
too late for us to consider them.
Because of staff and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commenting, please refer
to file code HCFA-2079-PN. 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 443-G of
the Department's office at 200 Independence Avenue, SW., Washington,
DC, on Monday
[[Page 14907]]
through Friday of each week from 8:30 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)(i) 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 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 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 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 or exceeded, the Secretary shall deem those
provider entities as meeting the applicable Medicare requirements.
Section 1865(b)(2) of the Act further 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 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.
II. Determining Compliance--Surveys and Deeming
Providers of health care services participate in Medicare and
Medicaid programs pursuant to provider agreements with HCFA (for
Medicare) and State Medicaid agencies (for Medicaid). Generally, in
order to enter into a provider agreement, an entity must first be
certified by a State survey agency as complying with the conditions or
standards set forth in Federal law and regulations. Providers are
subject to regular surveys by State survey agencies to determine
whether the provider continues to meet these requirements.
A provider deemed through accreditation is one that has voluntarily
applied for and been accredited by a national accreditation program
that HCFA has determined applies and enforces standards that meet or
exceed the applicable Medicare conditions or requirements. Section
1865(b) of the Act essentially permits these deemed providers of
services to be exempt from routine surveys by State survey agencies to
determine compliance with Medicare requirements. If the Secretary finds
that the accreditation of the provider by the national accreditation
body demonstrates that all the Medicare conditions and standards are
met or exceeded, then the Secretary would ``deem'' the requirements to
be met by the provider entity.
A national accrediting organization may request the Secretary to
recognize its program. The Secretary then examines the national
accreditation organization's accreditation requirements to determine if
they meet or exceed the Medicare conditions as HCFA would have applied
them. If the Secretary recognizes an accreditation organization in this
manner, any provider accredited by the national accrediting body's HCFA
approved program for that service will be ``deemed'' to meet the
Medicare conditions of coverage. To date, three such organizations have
been recognized to have deeming authority for their ambulatory surgical
programs: the Joint Commission on Accreditation of Health
Organizations, the Accreditation Association for Ambulatory Health
Care, and the American Association for Accreditation of Ambulatory
Surgery Facilities, Inc.
The purpose of this notice is to notify the public of the request
of American Osteopathic Association (AOA) for approval of its request
that the Secretary find its accreditation program for ambulatory
surgical centers meet or exceed the Medicare conditions. This notice
also solicits public comments on the ability of this organization to
develop and apply standards to ASCs which meet or exceed the Medicare
conditions for coverage. Our regulations concerning approval of
accrediting organizations are at 42 CFR 488.4, 488.6, and 488.8.
III. Ambulatory Surgical Center Conditions for Coverage and
Requirements
The regulations specifying the Medicare conditions for coverage for
ambulatory surgical centers are located in 42 CFR part 416. These
conditions implement section 1832(a)(2)(F)(i) of the Act, which
provides for Medicare Part B coverage of facility services furnished in
connection with surgical procedures specified by the Secretary under
section 1833(i)(1)(a) of the Act.
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 a national accreditation organization will be
conducted in accordance with, but not necessarily limited to, the
following factors:
The equivalency of an accreditation organization's
requirements for an entity to our comparable requirements for the
entity.
The organization'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(d).
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 the organization to provide us with
electronic data in ASCII comparable code, and reports necessary for
effective validation and assessment of the organization's survey
process.
[[Page 14908]]
The adequacy of staff and other resources, and its
financial viability.
The organization's ability to provide adequate funding for
performing required surveys.
The organization's policies with respect to whether
surveys are announced or unannounced.
The accreditation organization'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.
In accordance with the provisions of Executive Order 12866, this
notice was not reviewed by the Office of Management and Budget.
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: February 2, 2001.
Michael McMullan,
Acting Deputy Administrator, Health Care Financing Administration.
[FR Doc. 01-6311 Filed 3-13-01; 8:45 am]
BILLING CODE 4120-01-P