01-6311. 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.

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 through Friday of each week from 8:30 to 5 p.m. (phone: [phone]).

FOR FURTHER INFORMATION CONTACT:

Joan C. Berry, [phone].

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 § 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 § 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.
• 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.