[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.

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     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