[Federal Register Volume 67, Number 212 (Friday, November 1, 2002)]
[Notices]
[Pages 66642-66645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27782]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2141-FN]
Medicare and Medicaid Programs; Approval of the American
Osteopathic Association for Deeming Authority for Ambulatory Surgical
Centers
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice.
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SUMMARY: This final notice announces the approval of the American
Osteopathic Association (AOA) for recognition as a national
accreditation program for ambulatory surgical centers (ASCs) that
request certification to participate in the Medicare or Medicaid
programs. We have found that accreditation of ASCs by this organization
will demonstrate that all Medicare ASC Conditions for Coverage are met
or exceeded, and, thus, ASCs accredited by AOA will be granted deemed
status to participate in the Medicare program.
EFFECTIVE DATE: This final notice is effective January 30, 2003.
FOR FURTHER INFORMATION CONTACT: Laura A. Weber, (410) 786-0227.
SUPPLEMENTARY INFORMATION: Copies: To order copies of the Federal
Register containing this document, send your request to: New Orders,
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faxing to (202) 512-2250. The cost for each copy is $9. As an
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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 website address is: http://www.access.gpo.gov/nara/index.html.
I. Background
Determining Compliance of Ambulatory Surgical Centers-Surveys and
Deeming
Under the Medicare program, eligible beneficiaries may receive
covered services in an ambulatory surgical center (ASC) provided that
the ASC meets certain requirements. Section 1832(a)(2)(F)(i) of the
Social Security Act (the Act) includes requirements that an ASC have an
agreement in effect with the Secretary and that it meet health, safety,
and other standards specified by the Secretary in regulations.
Requirements concerning supplier agreements are located in 42 CFR part
489, and those pertaining to the survey and certification of facilities
are set forth in 42 CFR part 488.
In 42 CFR part 416, we 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.
For an ASC to enter into an agreement, a State survey agency must
first certify that the ASC complies with our conditions or
requirements. Following that certification, the ASC is subject to
routine monitoring by a State survey agency to ensure continuing
compliance. As an alternative to surveys by State agencies, section
1865(b)(1) of the Act provides that, if the Secretary finds that,
through accreditation by a national accreditation body, a provider
entity demonstrates that all of our applicable conditions and
requirements are met or exceeded, the Secretary will deem that the
provider entity has met the applicable Medicare requirements.
In making our finding as to whether the accreditation organization
demonstrates that all Medicare conditions or requirements are met or
exceeded, we consider factors such as the organization's accreditation
requirements, its survey procedures, its ability to provide adequate
resources for conducting required surveys and supplying information for
us in enforcement activities, its monitoring procedures for providers
entities found to be out of compliance with conditions or requirements,
and its ability to provide us with necessary data for validation.
It has been brought to our attention that some ASCs are under the
mistaken impression that, once we have granted deeming authority to an
accreditation organization, then ASCs must be accredited by such an
organization to receive Medicare certification. Accreditation by an
accreditation organization is voluntary, and we do not require that
accreditation for Medicare certification.
The American Osteopathic Association (AOA) was the fourth
accreditation organization to apply for deeming authority for ASCs. The
three other accreditation organizations already granted deeming
authority are the Joint Commission on the Accreditation of Healthcare
Organizations (JCAHO), the Accreditation Association of Ambulatory
Health Care (AAAHC), and The American Association for the Accreditation
of Ambulatory Surgery Facilities, Inc. (AAAASF).
The AOA is defined as a national accrediting body in section
1865(b)(1) of the Act, and was granted deeming authority by us for
hospitals (65 FR 8727, published February 22, 2000). This was taken
into consideration in the evaluation of this application for ASC
deeming authority.
The AOA previously applied to us for deeming authority, which we
announced in the Federal Register on March 14, 2001 (66 FR 14906).
However, the organization withdrew its application before a final
decision was made. We received a revised complete application from AOA
on April 18, 2002 and published notice of that receipt on May 24, 2002
(67 FR 36611).
II. Determining Compliance--Surveys and Deeming
A national accrediting organization may request the Secretary to
recognize its program as employing standards that meet or exceed
Medicare's standards. The Secretary then examines the national
accreditation organization's requirements to determine if they meet or
exceed Medicare standards. If the Secretary recognizes an accreditation
organization in this manner, any provider accredited by the national
accrediting body's program that we have approved for that service will
be ``deemed'' to meet the Medicare Conditions for Coverage.
The regulations specifying the Medicare Conditions for Coverage for
ASCs 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.
III. Provisions of the Proposed Notice
The proposed notice, published on May 24, 2002 (67 FR 36611),
announced the application of AOA for deemed status for its
accreditation program for ASCs. Under section 1865(b)(2) of the Act and
our regulations in Sec. 488.8 (Federal review of accreditation
organizations), our review and evaluation of a national accreditation
organization was conducted in accordance with, but not necessarily
limited to, the following factors:
[sbull] The equivalency of an accreditation organization's
requirements for an entity to our comparable requirements for that
entity.
[sbull] 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 those 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 in 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.
--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.
[sbull] The accreditation organization's agreement to provide us
with a copy of the most current accreditation survey together with any
other information
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related to the survey as we may require (including corrective action
plans).
IV. Analysis of and Responses to Public Comments
We did not receive any comments to the proposed notice published in
the Federal Register (67 FR 36611) on May 24, 2002.
V. Provisions of the Final Notice
A. Deeming Approval Review and Evaluation
We evaluated the AOA's standards and survey process to determine if
facilities accredited by AOA met Medicare Conditions for Coverage. We
did a standard-by-standard comparison of the applicable conditions or
requirements to determine which of them met or exceeded Medicare
requirements.
We compared the standards contained in the AOA's ``Ambulatory
Surgical Center (ASC) Manual'' and its survey process in the
``Ambulatory Surgical Center Surveyor Handbook'' with the Medicare ASC
Conditions for Coverage and our State and Regional Operations Manual.
Our review and evaluation of AOA's deeming application, which were
conducted as described in this notice, yielded the following
clarifications:
[sbull] AOA provided an updated listing of its accredited ASC
facilities.
[sbull] AOA adjusted language to refer consistently to the entities
as ASCs as opposed to hospitals in its documents.
[sbull] AOA modified its standards to meet fully the requirements
of the Medicare Conditions for Coverage.
[sbull] AOA modified its survey policy to ensure that ASC surveys
are unannounced.
[sbull] AOA modified its requirements to indicate that any ASC
seeking to participate in Medicare by virtue of an AOA accreditation
must meet the ``Accreditation with Medicare Certification,'' which
requires that all State licensure requirements are satisfied in
addition to meeting all AOA standards.
[sbull] AOA adjusted its standards to require written confirmation
of primary source verifications with regard to medical staff
credentialing.
[sbull] AOA adjusted its standard to conform with all applicable
requirements of each State Nurse Practice Act to specify what duties a
registered nurse may be allowed to perform in the area of
pharmaceutical services.
[sbull] AOA agrees to notify us of all accreditation decisions
made.
Review of AOA's application raised issues concerning the
comparability of the AOA's ASC accreditation standards with the
Medicare Conditions for Coverage for ASCs. We requested that the AOA
demonstrate compliance with the Medicare ASC Conditions for Coverage
and submit supplemental information to clarify its policies and
procedures. Upon our final review of this information, we have
determined that the AOA's ASC accreditation program meets the Medicare
Conditions for Coverage for ASCs.
B. Term of Approval
Based on the review and observations described in this final
notice, we have determined that AOA's requirements for ASCs meet or
exceed our requirements. We reserve the right to observe an AOA ASC
survey to determine the compliance of AOA surveyors to the policies and
procedures, as there were none scheduled during the review of this
application. In addition, the AOA must seek approval of all standards
pertaining to the Life Safety Code (LSC) when we move to the LSC 2000
Edition, which we intend to implement in Spring 2003. We therefore
recognize the AOA as a national accreditation organization for ASCs
that request participation in the Medicare program, effective for a 6-
year period beginning January 30, 2003.
VI. Collection of Information Requirements
This final notice does not impose any information collection and
record keeping requirements subject to the Paperwork Reduction Act
(PRA). Consequently, it does not need to be reviewed by the Office of
Management and Budget (OMB) under the authority of the PRA. The
requirements associated with granting and withdrawal of deeming
authority to national accreditation organizations, codified in 42 CFR
part 488, ``Survey, Certification, and Enforcement Procedures,'' are
currently approved by OMB under OMB approval number 0938-0690.
VII. Regulatory Impact Statement
We have examined the impact of this notice as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354),
section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects; distributive impacts; and equity).
The RFA requires agencies to analyze options for regulatory relief
for small businesses, nonprofit organizations, and government agencies.
Most hospitals and most other providers and suppliers are small
entities, either by nonprofit status or by having revenues of $6
million to $29 million or less in any 1 year (for details, see the
Small Business Administration's publication that set forth size
standards for health care industries at 65 FR 69432). Approximately 73
percent of ASCs are considered small businesses with total revenues of
$8.5 million or less according to the Small Business Administration's
data. For purposes of the RFA, States and individuals are not
considered small entities.
Also, section 1102(b) of the Act requires the Secretary to prepare
a regulatory impact analysis for any notice that may have a significant
impact on the operations of a substantial number of small rural
hospitals. Such an analysis must conform to the provisions of section
604 of the RFA. For purposes of section 1102(b) of the Act, we consider
a small rural hospital as a hospital that is located outside of a
Metropolitan Statistical Area and has fewer than 100 beds.
This notice merely recognizes AOA as a national accreditation
organization that has requested approval for deeming authority for ASCs
that are participating in the Medicare program. Since these provider
entities must be routinely monitored to determine compliance with
Medicare requirements, we believe that this organization's
accreditation program has the potential to reduce both the regulatory
and administrative burdens associated with the Medicare program
requirements.
This notice is not a major rule as defined in Title 5, United
States Code, section 804(2) and is not an economically significant rule
under Executive Order 12866.
Therefore, we have determined, and the Secretary certifies, that
this final notice will not result in a significant impact on small
entities and will not have an effect on the operations of small rural
hospitals. Therefore, we are not preparing analyses for either the RFA
or section 1102(b) of the Act.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in expenditure in any 1 year by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $110 million. This
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notice will have no consequential effect on State, local, or tribal
governments. We believe the private sector costs of this notice will
fall below this threshold as well.
In accordance with Executive Order 13132, this notice will not
significantly affect the rights of States and will not significantly
affect State authority.
In accordance with the provisions of Executive Order 12866, this
notice was reviewed by the Office of Management and Budget.
Authority: Section 1865(b)(3)(A) of the Social Security Act (42
U.S.C. 1395bb(b)(3)(A)).
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program; and No. 93.774, Medicare--Supplementary Medical
Insurance Program)
Dated: October 7, 2002.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 02-27782 Filed 10-31-02; 8:45 am]
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