[Federal Register: July 23, 2004 (Volume 69, Number 141)]
[Notices]
[Page 44027-44029]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jy04-72]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
[CMS-2202-PN]
RIN 0938-ZA52
Medicare and Medicaid Programs; Application by the American
Association for Accreditation of Ambulatory Surgery Facilities, Inc.,
for Continued Deeming Authority for Ambulatory Surgical Centers
AGENCY: Centers for Medicare and Medicaid Services, HHS.
ACTION: Proposed notice.
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SUMMARY: This proposed notice acknowledges the receipt of a renewal
application by the American Association for Accreditation of Ambulatory
Surgery Facilities, Inc. for approval as a national accreditation
program for ambulatory surgical centers that wish to participate in the
Medicare or Medicaid programs. The statute requires that within 60 days
of receipt of an organization's written request, CMS publish a proposed
notice that identifies the national accrediting body making the
request, describing the nature of the request, and providing at least a
30-day public comment period.
DATES: To be assured of consideration, comments must be received at one
of the addresses provided below, no later than 5 p.m. on August 23,
2004.
ADDRESSES: In commenting, please refer to file code CMS-2202-PN.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of three ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on the issues
in this notice to http://www.cms.hhs.gov/regulations/ecomments.
(Attachments should be in Microsoft Word, WordPerfect, or Excel;
however, we prefer Microsoft Word.)
2. By mail. You may mail written comments (one original and two
copies) to the following address ONLY: Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Attention: CMS-2202-
PN, P.O. Box 8018, Baltimore, MD 21244-8018.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-7195 in advance to schedule your arrival
with one of our staff members. Room 445-G, Hubert H. Humphrey Building,
200 Independence Avenue, SW., Washington, DC 20201; or 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 persons 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 indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
FOR FURTHER INFORMATION CONTACT: Milonda H. Mitchell, (410) 786-3511.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on all
issues set forth in this proposed notice to assist us in fully
considering issues and developing policies. You can assist us by
referencing the file code CMS-2202-PN and the specific ``issue
identifier'' that precedes the section on which you choose to comment.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. After the close of the
comment period, CMS posts all
[[Page 44028]]
electronic comments received before the close of the comment period on
its public web site. 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, Yolanda Hayes, (410) 786-7195.
This Federal Register document is 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.gpoaccess.gov/fr/index.html
.
I. Background
[If you choose to comment on issues in this section, please include
the caption ``BACKGROUND'' at the beginning of your comments.]
Under the Medicare program, eligible beneficiaries may receive
covered services in an ambulatory surgical center (ASC), provided the
ASC meets certain requirements. Section 1832(a)(2)(F)(i) of the Social
Security Act (the Act) establishes the authority for the Secretary to
establish distinct criteria for a facility seeking designation as an
ASC. Under this authority, the Secretary has set forth in regulations
minimum requirements that an ASC must meet to participate in Medicare.
The regulations at 42 CFR part 416 (Ambulatory Surgical Services)
specify the conditions under which Medicare makes payments for covered
services provided by an ASC. Types of Medicare payment for ASC services
can be found at Sec. 416.120. Applicable regulations concerning
provider agreements are at part 489 (Provider Agreements and Supplier
Approval) and those pertaining to the survey and certification of
facilities are at part 488 (Survey Certification and Enforcement
Procedures), subpart A (General Provisions) and subpart B (Special
Requirements).
In order for ASC services to be covered under the Medicare program,
the ASC must be licensed by a State agency as an ASC. The licensure
must be in place at the time the ASC is 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 (currently approved under OMB's 0938-
0690 and 0938-0266). There is an alternative, however, to surveys by
State agencies.
As it applies to ASCs, section 1865(b)(1) of the Act permits
``accredited'' provider entities to be exempt from routine surveys by
State survey agencies to determine compliance with Medicare conditions
for coverage. Accreditation by an accreditation organization is
voluntary and is not required for Medicare participation. This section
of the Act provides that, if a provider entity demonstrates through
accreditation that all applicable Medicare conditions are met or
exceeded, CMS shall ``deem'' it as having met the requirements.
If an accreditation organization is recognized in this manner with
respect to a specific facility type (such as an ASC), any facility
accredited by a national accrediting body's approved program is 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 renewal of an accreditation organizations'
deeming authority are set forth at Sec. 488.4 and Sec. 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 if we so determine. Our recognition of the
American Association for Accreditation of Ambulatory Surgery
Facilities, Inc. (AAAASF's) accreditation program for ASCs will
terminate on December 2, 2004.
II. Approval of Deeming Organizations
[If you choose to comment on issues in this section, please include
the caption ``Approval of Deeming Organizations'' at the beginning of
your comments.]
Section 1865 (b)(2) of the Act requires that our findings
concerning review of national accrediting organization's requirements
consider, among other factors, the reapplying accreditation
organization's 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 (currently approved under OMB's 0938-0690 and 0938-
0266).
Section 1865(b)(3)(A) of the Act further requires that we publish,
within 60 days of receipt of an organization's complete reapplication,
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
consideration of AAAASF's request to review its ``deeming authority''
for ASCs. This notice also solicits public comment on the ability of
AAAASF's requirements to meet or exceed the Medicare conditions for
coverage for ASCs.
III. Evaluation of Deeming Authority Request
[If you choose to comment on issues in this section, please include
the caption ``Evaluation of Deeming Authority Request'' at the
beginning of your comments.]
On May 24, 2004, AAAASF submitted all the necessary materials
concerning its request for renewal as a deeming organization for ASCs
to enable us to make a determination. Under section 1865(b)(2) of the
Act and regulations at Sec. 488.8 (Federal review of accreditation
organizations), our review and evaluation of AAAASF will be conducted
in accordance with, but not necessarily limited to, the following
factors:
The equivalency of AAAASF standards for an ASC as compared
with our comparable ASC conditions for coverage.
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 AAAASF's processes to that of State agencies,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities.
--AAAASF's processes and procedures for monitoring providers or
suppliers found out of compliance with AAAASF's program requirements.
These monitoring procedures are used only when AAAASF identifies
noncompliance. If noncompliance is identified through validation
reviews, the survey agency monitors corrections as specified at Sec.
488.7(d).
--AAAASF's capacity to report deficiencies to the surveyed facilities
[[Page 44029]]
and respond to the facility's plan of correction in a timely manner.
--AAAASF'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 AAAASF's staff and other resources, and its financial
viability.
--AAAASF's capacity to adequately fund 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. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995.
V. Response to Comments and Notice Upon Completion of Evaluation
[If you choose to comment on issues in this section, please include
the caption ``Response to Comments and Notice Upon Completion of
Evaluation'' at the beginning of your comments.]
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 public comments we receive by the date and time specified in the
DATES section of this preamble, and when we proceed with a final
notice, we will respond to the public comments in the preamble to the
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 the rights of
States, local, or tribal governments.
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: July 1, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare and Medicaid Services.
[FR Doc. 04-16431 Filed 7-22-04; 8:45 am]
BILLING CODE 4120-01-P