[Federal Register Volume 63, Number 231 (Wednesday, December 2, 1998)]
[Notices]
[Pages 66554-66556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32102]
[[Page 66554]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[HCFA-2008-FN]
RIN 0938-AI90
Medicare Program; 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: Final notice.
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SUMMARY: This notice announces the approval of the American Association
for the Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF)
as an accreditation organization acknowledged by the Medicare program.
We have found that AAAASF's standards for ambulatory surgical centers
(ASCs) meet or exceed those established by the Medicare program. ASCs
accredited by AAAASF will receive deemed status under the Medicare
program.
EFFECTIVE DATE: This final notice is effective December 2, 1998,
through December 2, 2004.
FOR FURTHER INFORMATION CONTACT: Joan Berry, (410) 786-7233.
SUPPLEMENTARY INFORMATION:
I. Background
A. Determining Compliance of Ambulatory Surgical Centers--Surveys and
Deeming
In order to participate in the Medicare program, ambulatory
surgical centers (ASCs) must meet conditions for coverage specified in
regulations that implement Title XVIII of the Social Security Act (the
Act). ASCs enter into a Medicare participation agreement but generally
only after they are certified by a State survey agency as complying
with the ASC conditions for coverage set forth in the Act and
regulations. ASCs are subject to routine surveys by State agencies to
determine whether they continue to meet these requirements; an ASC that
does not meet these requirements is considered out of compliance and
risks having its participation in the Medicare program terminated.
Section 1865 of the Act includes a provision that permits ASCs to
be exempt from routine surveys by the State survey agencies to
determine compliance with the Medicare conditions of coverage.
Specifically, section 1865(b) of the Act provides that if we find that
accreditation of a provider entity by a national accrediting body
demonstrates that all Medicare conditions or requirements are met or
exceeded, we would (for certain providers, including ASCs) ``deem''
these entities as meeting the applicable Medicare conditions. In order
to enter the Medicare program under this deeming authority, the
entities must meet the regulatory requirements at 42 CFR 489.13
(``Effective date of agreement or approval''). Under our regulations at
Sec. 416.40 (``Condition for coverage--Compliance with State licensure
law''), an ASC must still meet the State's licensure requirements.
However, certification by Medicare is still required to receive payment
regardless of whether the certification is by us or the accrediting
body.
In making our finding as to whether the standards of an
accreditation body demonstrate comparability with all Medicare
conditions or requirements, we consider factors such as the body's
accreditation requirements, its survey procedures, its ability to
provide adequate resources for conducting required surveys and
supplying information for use in enforcement activities, its monitoring
procedures for provider entities found to be out of compliance with the
conditions or requirements, and its ability to provide us with
necessary data for validation.
As suppliers, ASCs are included by definition of provider entity in
section 1865(b)(4) of the Act. Thus, if we were to recognize an ASC
accreditation organization's program as demonstrating that all the
Medicare ASC conditions of coverage are met, the ASCs accredited under
the approved Medicare program would be considered or ``deemed'' to meet
the same conditions for which the accreditation standards have been
recognized. The American Association for the Accreditation of
Ambulatory Surgery Facilities, Inc. (AAAASF) is the third accreditation
organization that we have approved for ASCs. The other two
accreditation organizations are the Joint Commission on the
Accreditation of Healthcare Organizations (JCAHO) and the Accreditation
Association for Ambulatory Health Care (AAAHC).
It has been brought to our attention that some ASCs are under the
mistaken impression that once deemed authority is granted by HCFA to an
accreditation organization, then ASCs must be accredited by such a body
to receive Medicare certification. Accreditation by an accreditation
organization is voluntary and not required by HCFA for Medicare
certification.
B. Deeming Authority Process
On November 23, 1993, we published a final rule (58 FR 61816) that
set forth the procedure that we would use to review and approve
national accreditation organizations that wish to be recognized as
providing reasonable assurance that Medicare conditions of coverage are
met (Sec. 488.4, ``Application and reapplication procedures for
accreditation organizations''). A national accreditation organization
(Accreditation organization) applying for approval of deeming authority
must furnish to us information and materials listed in our regulations
at Sec. 488.4. Our regulations at Sec. 488.8 (``Federal review of
accreditation organizations'') detail the Federal review and approval
process of applications for deeming authority. On April 26, 1996,
however, new legislation entitled ``Making Appropriations for Fiscal
Year 1996 to Make a Further Down Payment Toward a Balanced Budget and
for Other Purposes (Pub. L. 104-134)'' was enacted.
Section 516 of Public Law 104-134 amended section 1865 of the Act
in a number of ways. The legislation removed the requirements that
accreditation organizations provide reasonable assurance that entities
accredited by them would meet Medicare conditions coverage or
requirements. In revised section 1865(b)(1) of the Act, organizations
are now required to demonstrate that their accredited entities would
meet or exceed all of the applicable Medicare conditions. Section
1865(b)(4) includes suppliers (for example, ASCs) under the provider
entities that we may consider for deemed status. We are required to
publish a proposed notice in the Federal Register 60 days after the
receipt of a written request for deemed status by a national
accreditation body. After review of the national accreditation body's
application, the statute requires that we publish a notice of our
approval or disapproval within 210 days after we receive a complete
package of information and the organization's deeming application.
We received an application from AAAASF on November 18, 1997 and in
accordance with the statute, this final notice should have been
published by June 16, 1998. However, HCFA was waiting for AAAASF to
submit required materials on a quality improvement project for their
training program before approving its deeming authority. AAAASF chose
to delay the publication date, rather than be denied deemed status and
have to reapply for deemed authority. Regulations at Sec. 488.8(c)
[[Page 66555]]
specify that the deeming authority for AAAASF will take effect 90 days
from the publication of this final notice. Thus, AAAASF cannot award
deemed accreditation to a supplier and request HCFA certification
before the end of that 90-day period.
C. Ambulatory Surgical Center Conditions for Coverage and Requirements
The regulations specifying the Medicare conditions for coverage for
ASCs are located in 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 us under section 1833(i)(1) of the Act.
II. Provisions of the Proposed Notice
The proposed notice announced the application of AAAASF for deemed
status for its accreditation program only to the extent that it
accredits ASCs.
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 this national accreditation organization was
conducted in accordance with, but was not necessarily limited to, the
following factors:
The equivalency of an accreditation organization's
requirements for an entity to be certified compared to our requirements
for certification.
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 the organization's process 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 to be out of compliance with program requirements. If
noncompliance is identified through validation reviews, the survey
agency monitors corrections as specified at Sec. 488.7(b)(2).
* 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.
* 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 that we may require (including
corrective action plans).
We met with representatives of AAAASF to evaluate its accreditation
standards and survey process to determine if the organization
demonstrated that its accredited facilities met Medicare conditions. We
did a standard by standard comparison of the applicable conditions or
requirements to determine which of them met or exceeded Medicare
requirements. The representatives responded to our concerns by
proposing to change the organization standards for its member ASCs
needing Medicare certification. We subsequently received revised survey
guidelines and amended standards for their member ASCs requesting
Medicare certification.
A. Differences Between the American Association for the Accreditation
of Ambulatory Surgery Facilities, Inc. and Medicare Conditions and
Survey Requirements
We compared the standards contained in the AAAASF's 1994 Standards
Manual for accreditation of ambulatory surgery facilities and its
survey process in the 1994 Inspectors Manual to the Medicare ASC
conditions and survey procedures. In 18 areas the AAAASF has made the
following revisions:
Exclusivity Requirement--AAAASF has included a statement
on ASC surgical exclusivity as an integral part of its application
package.
Unannounced Surveys--AAAASF has added language to the on-
site inspection information to include a declaration that all surveys
will be unannounced. In order to accommodate the need to assure that
key staff are on hand for surveys without notification of the facility,
AAAASF has agreed to request that the facility send staffing schedules
on a regular basis once their application is complete.
Frequency of Surveys--AAAASF resurveys an ASC every 3
years. Our original requirement was to survey ASCs every year. In
practice, our resurveys have been averaging almost 3 years. Both the
JCAHO and AAAHC have 3-year resurvey cycles. Therefore, we accept
AAAASF's 3-year resurvey cycle.
State and Local Laws--AAAASF has agreed to assure that
out-of-state inspectors receive adequate information on certification,
licensure, and scope of practice requirements of that State.
Reasonable Assurance--AAAASF has agreed to modify its
process to build in a review of the past history of facilities that
already have Medicare certification through the State.
Fraud and Abuse--AAAASF has agreed to require that its
inspectors report any suspected instances of fraud and abuse to the
appropriate HCFA Regional Office.
Hearing Schedules and Appeals--AAAASF has specified the
dates and locations for its Accreditation Committee hearings over the
next 4 years.
Hospitalization--AAAASF has inserted the word ``local'' to
indicate those hospitals eligible to receive immediate transfers for
patients requiring emergency medical care beyond the capabilities of
the ASC.
Anesthetic Risk and Evaluation--AAAASF has added language
to indicate that a physician must examine each patient immediately
before surgery to evaluate the risk of anesthesia and the procedure to
be performed.
Recovery Room and Waiting Area--AAAASF has specified that
an ASC must have a separate recovery room and waiting area.
Emergency Personnel--AAAASF has added the requirement that
personnel trained in the use of emergency equipment and cardiopulmonary
resuscitation must be available whenever a patient is in the facility.
Other Practitioners--AAAASF has added the requirement that
if certified operating room technicians are employed that their
certification or licensure must be current. Furthermore, if uncertified
or unlicensed operating room technicians are used, it must be
permissible under State law and the technician must be personally
trained by the employing surgeon.
Organization and staffing--AAAASF has added the
requirement that a registered nurse must be available for emergency
treatment whenever a patient is in the facility.
Oral Orders--AAAASF has added a standard that requires
that oral orders for drugs and biologicals must be followed by a
written order and signed by the prescribing physician.
Laboratory and Radiologic Services--AAAASF has added the
requirement that radiologic services be obtained from a Medicare-
approved facility and that ASC laboratories must meet requirements of
part 493.
[[Page 66556]]
Furthermore, if the ASC does not provide its own laboratory services,
it must have procedures for obtaining routine and emergency laboratory
services from a certified laboratory in accordance with part 493. Any
referral laboratory must be certified in the appropriate specialties
and subspecialties of service to perform the referred tests in
accordance with the requirements of part 493.
Life Safety Code: Surgical Procedures--AAAASF agreed to
require facilities to meet State and local requirements, or the
National Fire Prevention Association (NFPA) Standards for Health Care
Facilities (NFPA 99), and Life Safety Code (NFPA 101) Chapters 12 and
13 (and appropriate references), whichever is more stringent. Language
was added to specify that their regular inspections for installation
and maintenance of surgical equipment will be at least annually. In
conformity with the NFPA requirements, AAAASF has made standby
generator as the mandatory source of emergency power and reduced the
time for such generators to reach full power from 30 to 10 seconds.
Life Safety Code: Environment--AAAASF has specified that
fire drills must be held once a month for each shift and has made smoke
detectors mandatory for all office-based ASCs.
Life Safety Code: Standards Addendum--AAAASF has specified
that facilities must be inspected at least annually by the local or
State fire control agency if this service is available. If not, AAAASF
agrees to contract with a State agency or qualified subcontractor to
perform the inspections.
Inspector Training Program--AAAASF has submitted a revised
training program that provides for consistent, national training of all
inspectors in their processes and integrates instruction in the
Medicare requirements based on either the trainer's participation in
Medicare training or using Medicare survey experts as instructors.
We have agreed to accept language that requires compliance with the
1985 edition of the Life Safety Code with an encouragement by AAAASF
that facilities comply with the 1997 Code. These standards will apply
to all facilities regardless of size.
B. Analysis and Responses to Public Comments and Provisions of the
Final Notice
We received no comments on our proposed notice. The provisions of
the proposed notice are being made final in this notice.
III. Paperwork Reduction Act
The public reporting and record keeping burden reflected in this
notice is referenced in the currently approved regulation entitled
``Granting and Withdrawal of Deeming Authority to National
Accreditation Organizations (58 FR 61816).'' The paperwork burden
referenced in the above mentioned regulation is currently approved by
the Office of Management and Budget (OMB), under OMB approval number
0938-0690, with an expiration date of 8/31/99.
IV. Regulatory Impact Statement
In fiscal year 1995, there were 2,105 certified ASCs participating
in the Medicare/Medicaid programs. We conducted 211 initial surveys,
288 recertification surveys (both at a cost of $714,069), and 24
complaint surveys. In fiscal year 1996, there were 2,219 certified
ASCs. This was an increase of 114 facilities. We conducted 180 initial
surveys, 115 recertification surveys (both at a cost of $848,125), and
one complaint survey. In fiscal year 1997, there were 2,433 certified
ASCs. This was an increase of 214 facilities. We conducted 236 initial
surveys, 252 recertification surveys (both at a cost of $1,403,000),
and seven complaint surveys. As the data above indicate, the number of
ASCs and the cost for conducting ASC surveys by State Agencies are
increasing.
As indicated above, there was a 16 percent increase in ASCs within
3 years (fiscal years 1995 through 1997). The fiscal year 1998
appropriation for ASC survey activities to HCFA was decreased as the
priority of both initial surveys and resurveys remained in the bottom
10 percent of surveys performed, but without any adjustment for
inflation. This does not allow sufficient resources for some regions to
meet the survey demand. In an effort to guarantee the continued health,
safety, and services of beneficiaries in facilities already certified
as well as provide relief to State budgets in this time of tight fiscal
restraints, we are approving deeming for ASCs accredited by AAAASF as
meeting our Medicare requirements. Thus, we continue our focus on
assuring the health and safety of services by providers and suppliers
already certified for participation in a cost effective manner.
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: October 19, 1998.
Nancy-Ann DeParle,
Administrator, Health Care Financing Administration.
[FR Doc. 98-32102 Filed 12-1-98; 8:45 am]
BILLING CODE 4120-01-P