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

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