[Federal Register: June 28, 2002 (Volume 67, Number 125)]
[Notices]               
[Page 43612-43613]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jn02-73]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2154-PN]

 
Medicare and Medicaid Programs; Application by the Joint 
Commission on Accreditation of Healthcare Organizations for Continued 
Deeming Authority for Ambulatory Surgical Centers

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Proposed notice.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from the Joint Commission on Accreditation of Healthcare 
Organization for continued recognition as a national accreditation 
program for Ambulatory Surgical Centers that wish to participate in the 
Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social 
Security Act requires that within 60 days of receipt of an 
organization's complete application, we publish a notice that 
identifies the national accrediting body making the request, describes 
the nature of the request, and provides at least a 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 July 29, 2002.

ADDRESSES: In commenting, please refer to file code CMS-2154-PN. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission. Mail written comments (1 original and 3 
copies) to the following address: Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Attention: CMS-2154-
PN, P.O. Box 8013, Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be timely 
received in the event of delivery delays.
    If you prefer, you may deliver (by hand or courier) your written 
comments (1 original and 3 copies) to one of the following addresses: 
Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201, or Room C5-14-03, 7500 Security Boulevard, 
Baltimore, MD 21244-1850.
    (Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for commenters wishing to retain a proof of filing by 
stamping in and retaining an extra copy of the comments being filed.)
    Comments mailed to the addresses identified for hand or courier 
delivery may be delayed and could be considered late.
    For information on viewing public comments see the beginning of the 
SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Cindy Melanson, (410) 786-0310.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: Comments 
received timely will be available for public inspection as they are 
received, generally beginning approximately 3 weeks after publication 
of a document, at the headquarters of the Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, 
Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule 
an appointment to view public comments, call (410) 786-7197.
    Copies: Additional copies of the Federal Register containing this 
notice can be made at most libraries designated as Federal Depository 
libraries and at many other public and academic libraries throughout 
the country that receive the Federal Register.
    This Federal Register document is also available from the Federal 
Register online database through GPO Access, a service of the U.S. 
Government Printing Office. The web site address is: http://
www.access.gpo.gov/nara/index.html.

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) authorizes the Secretary to establish distinct 
criteria for facilities seeking designation as an ASC. Regulations 
concerning supplier agreements are at title 42, part 489 of the Code of 
Federal Regulations (CFR) and those pertaining to activities relating 
to the survey and certification of facilities are at 42 CFR part 488. 
The regulations at 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 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 a provider entity 
demonstrates through accreditation that all applicable Medicare 
conditions are met or exceeded, we shall ``deem'' those provider 
entities as having met the requirements. Accreditation by an 
accreditation organization is voluntary and is not required for 
Medicare participation.
    If an accreditation organization is recognized by the Secretary as 
having standards for accreditation that meet or exceed Medicare 
requirements, any provider entity accredited by the national 
accrediting body's approved program would be deemed to meet the 
Medicare conditions. A national accreditation organization applying for 
approval of deeming authority under part 488, subpart A must provide us 
with reasonable assurance that the accreditation organization requires 
the accredited provider entities to meet requirements that are at least 
as stringent as the Medicare conditions. Our regulations concerning 
reapproval of accrediting organizations are set forth at Secs. 488.4 
and 488.8(d)(3). The regulations at Sec. 488.8(d)(3) require 
accreditation organizations to reapply for continued approval of 
deeming authority every 6 years or sooner, as determined by us.
    The Joint Commission on Accreditation of Healthcare Organizations' 
(JCAHO) current term of approval as a recognized accreditation program 
for ASCs expires December 19, 2002.

II. Approval of Deeming Organizations

    Section 1865(b)(2) of the Act and our regulations at Sec. 488.8(a) 
require that our findings concerning review and reapproval of a 
national accrediting organization's requirements consider, among other 
factors, the reapplying accreditation organization's

[[Page 43613]]

requirements for accreditation; survey procedures; resources for 
conducting required surveys; capacity to furnish information for use in 
enforcement activities; monitoring procedures for provider entities 
found not in compliance with the conditions or requirements; and 
ability to provide us with the necessary data for validation.
    Section 1865(b)(3)(A) of the Act further requires that we publish, 
within 60 days of receipt of an organization's complete 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. We have 210 days from our receipt of a completed 
application to publish approval or denial of the application.
    The purpose of this proposed notice is to inform the public of our 
receipt of JCAHO's request for approval of continued deeming authority 
for ASCs. This notice also solicits public comment on the ability of 
JCAHO requirements to meet or exceed the Medicare conditions for 
coverage for ASCs.

III. Evaluation of Deeming Authority Request

    On April 15, 2002, JCAHO submitted all the necessary materials 
concerning its request for reapproval as a deeming organization for 
ASCs to enable us to make a determination. 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 JCAHO will 
be conducted in accordance with, but not necessarily limited to, the 
following factors:
     The equivalency of JCAHO standards for an ASC as compared 
with our comparable ASC conditions of coverage.
     JCAHO'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 JCAHO processes to those of State agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
--JCAHO's processes and procedures for monitoring providers or 
suppliers found out of compliance with JCAHO program requirements. 
These monitoring procedures are used only when JCAHO identifies 
noncompliance. If noncompliance is identified through validation 
reviews, the survey agency monitors corrections as specified at 
Sec. 488.7(d).
--JCAHO's capacity to report deficiencies to the surveyed facilities 
and respond to the facility's plan of correction in a timely manner.
--JCAHO's capacity 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 JCAHO's staff and other resources, and its financial 
viability.
--JCAHO's capacity to adequately fund required surveys.
--JCAHO's policies with respect to whether surveys are announced or 
unannounced.
--JCAHO'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. Response to Public Comments and Notice Upon Completion of 
Evaluation

    Because of the large number of items of correspondence 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 the public comments in the 
preamble to that document.
    Upon completion of our evaluation, including evaluation of comments 
received as a result of this notice, we will publish a final notice in 
the Federal Register announcing the result of our evaluation.
    In accordance with the provisions of Executive Order 12866, the 
Office of Management and Budget did not review this proposed notice.
    In accordance with Executive Order 13132, we have determined that 
this proposed notice would not have a significant effect on the rights, 
roles, or responsibilities of States, local, or tribal governments.

    Authority: Sec. 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: June 19, 2002.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 02-15970 Filed 6-27-02; 8:45 am]
BILLING CODE 4120-01-P