[Federal Register Volume 61, Number 142 (Tuesday, July 23, 1996)]
[Notices]
[Pages 38207-38212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18709]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[BPD-849-PN]
Medicare Program; Recognition of the Ambulatory Surgical Center
Standards of the Joint Commission on the Accreditation of Healthcare
Organizations and the Accreditation Association for Ambulatory Health
Care
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Proposed notice.
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SUMMARY: This notice proposes to grant deeming authority to two
organizations, the Joint Commission on the Accreditation of Healthcare
Organizations (JCAHO) and the Accreditation Association for Ambulatory
Health Care (AAAHC), for their member ambulatory surgical centers
(ASCs) that request Medicare certification. We believe that
accreditation of ASCs by both organizations would demonstrate that all
Medicare ASC conditions are met or exceeded, and, thus, we would grant
deeming authority to each organization.
DATES: Comments will be considered if we receive them at the
appropriate address, as provided below, no later than 5 p.m. on August
22, 1996.
ADDRESSES: Mail written comments (1 original and 3 copies) to the
following address: Health Care Financing Administration, Department of
Health and Human Services, Attention: BPD-849-PN, P.O. Box 7519,
Baltimore, MD 21207-0519.
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, D.C.
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 BPD-849-PN. 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,
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FOR FURTHER INFORMATION CONTACT: Bob Cereghino, (410) 786-4645.
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 regular 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 for coverage. (Under
our regulations at 42 CFR 416.40 (``Condition for coverage--Compliance
with State licensure law''), an ASC must still meet the State's
licensure requirements, however.) Specifically, section 1865(b) of the
Act provides that if we find that accreditation of a provider entity by
a national accreditation 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 making our finding as to whether the accreditation body makes
this demonstration, we consider factors such as the accrediting 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. If we find that the accreditation of an
ASC by the national accreditation body demonstrates that the Medicare
conditions imposed on ASCs are met, we would treat the accredited ASCs
as meeting those conditions. ASCs as suppliers are included by
definition of provider entity in section 1865(b)(4) of the Act. Thus,
if we were to recognize an ASC
[[Page 38208]]
accrediting organization's program as demonstrating that all the
Medicare ASC conditions are met, the ASCs it accredits would be
considered, or ``deemed,'' to meet the same conditions for which the
accreditation standards have been recognized. The Joint Commission on
the Accreditation of Healthcare Organizations (JCAHO) and the
Accreditation Association for Ambulatory Health Care (AAAHC) are the
first two organizations to which we have considered granting deemed
status.
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 accrediting organizations that wish to be recognized as
providing reasonable assurance that Medicare conditions are met
(Sec. 488.4, ``Application and reapplication procedures for
accreditation organizations''). A national 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 Downpayment Toward a Balanced Budget and for Other Purposes
(Public Law 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 requirement that accrediting organizations provide
reasonable assurance that entities accredited by them would meet
Medicare conditions or requirements. It now, in revised section
1865(b)(1) of the Act, requires organizations to demonstrate that their
accredited entities would meet or exceed all of the applicable Medicare
conditions. The legislation now also defines, in section 1865(b)(4) of
the Act, the provider entities that we may consider for deemed status
to include ASCs as suppliers. We are now required to publish an initial
notice in the Federal Register 60 days after the receipt of a written
request for a finding that accreditation by a national accreditation
body demonstrates that the Medicare conditions or requirements are met.
This particular notice, however, is unique in that an expanded
proposed draft had been developed along the lines of our requirements
in the statute and regulations that were in effect before the enactment
of section 516 of Public Law 104-134. We had received and accepted
applications from JCAHO and AAAHC, two national accrediting bodies,
long before the enactment of section 516 of Public Law 104-134.
Therefore, this initial notice, unlike future deeming notices, contains
material beyond the scope of the new legislative deeming requirements.
In this notice, we identify the national accreditation bodies
making the deeming request, describe the nature of the request, and
allow at least a 30-day public comment period. We received applications
from JCAHO and AAAHC before the April 26, 1996 enactment of Public Law
104-134. Therefore, the timeframes imposed by the new legislation are
not applicable to the processing of these two organizations'
applications. However, AAAHC wrote to us on May 23, 1996 requesting
that we process its application under the new timeframes. In order to
comply with the requirement in revised section 1865(b)(3)(A) of the Act
that we publish an initial notice identifying the national
accreditation body making the request not later than 60 days after the
date of receipt of that request, we must publish the notice by July 22,
1996. Likewise, in order to comply with the requirement that we publish
an approval notice of our findings within 210 days after we receive an
organization's deeming application, we must publish the approval notice
by December 19, 1996. Since both applications had been submitted and
considered before the enactment of Public Law 104-134, despite these
timeframes, we will make every effort to publish the approval notice by
November 22, 1996, which is 210 days after the date of the enactment of
the new legislation.
Under revised section 1865(b)(2) of the Act and our regulations at
Sec. 488.8 (``Federal review of accreditation organizations''), our
review and evaluation of a national accreditation organization is
conducted in accordance with, but is not necessarily limited to, the
following factors:
The equivalency of an accreditation organization's
requirements for an entity to our comparable requirements for the
entity.
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 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 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)(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 as we may require (including
corrective action plans).
C. Ambulatory Surgical Center Conditions of Coverage and Requirements
The regulations specifying the Medicare conditions of 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 us under section 1833(i)(1) of the Act.
II. Proposed Approval of the Ambulatory Surgical Center Accreditation
Standards of the Joint Commission of the Accreditation of Healthcare
Organizations and the Accreditation Association for Ambulatory Health
Care
The purpose of this notice is to propose that we recognize the
accreditation programs of JCAHO and AAAHC, two national accrediting
organizations, but only to the extent that they accredit ASCs. Based on
a thorough examination of the standards, accrediting programs, and
survey processes of both organizations, we believe that both JCAHO and
AAAHC demonstrate that ASCs accredited by them meet Medicare
conditions, and we, therefore, invite comments on our proposal to grant
ASC deeming
[[Page 38209]]
authority to these two national organizations.
Section 1865(b)(3)(A) of the Act, as amended by section 516 of
Public Law 104-134, states that a Federal Register approval notice
granting deeming to accreditation organizations will follow no later
than 210 days after the date of receipt of a written request or
documentation necessary to make a determination on the request for
deeming authority. We received applications from JCAHO and AAAHC before
the April 26, 1996 enactment of Public Law 104-134. Therefore, the
timeframes imposed by the new legislation are not applicable to the
processing of these two organizations' applications. However, AAAHC
wrote to us on May 23, 1996 requesting that we process its application
under the new timeframes. In order to comply with the requirement in
revised section 1865(b)(3)(A) of the Act that we publish an initial
notice identifying the national accreditation body making the request
not later than 60 days after the date of receipt of that request, we
must publish the notice by July 22, 1996. Likewise, in order to comply
with the requirement that we publish an approval notice of our findings
within 210 days after we receive an organization's deeming application,
we must publish the approval notice by December 19, 1996. Since both
applications had been submitted and considered before the enactment of
Public Law 104-134, despite these timeframes, we will make every effort
to publish the approval notice by November 22, 1996, which is 210 days
after the date of the enactment of the new legislation. The approval
notice will specify the effective date of the deeming authority and the
term of approval, which will not exceed 6 years.
Based on our initial review of each organization's standards and
survey procedures contained in their individual applications and after
our comparison of both organizations' standards to the Medicare ASC
conditions and survey procedures, we contacted both JCAHO and AAAHC to
discuss the differences between Medicare conditions and their
standards.
We met separately with representatives from both organizations. The
representatives responded to our concerns by proposing to change their
standards for their member ASCs seeking Medicare certification. We
subsequently received, from each organization, revised scoring
guidelines with amended standards for their member ASCs requesting
Medicare certification.
In evaluating the accreditation standards and survey processes of
JCAHO and AAAHC to determine if they demonstrated that their accredited
facilities meet 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. We outline below
the differences between the Medicare requirements and the standards of
the JCAHO and AAAHC and why we have concluded that they demonstrated
that our requirements are met by their respective accreditation
processes.
Before doing so, however, it is important to address the methods
accreditation organizations and Medicare use to determine compliance.
Information gathered during on-site surveys is the basis of an
organization's accreditation decision. A surveyor or team of surveyors
evaluates the ASC's level of compliance with applicable standards.
Surveyors assess compliance in a variety of ways, including interviews,
observations, and documentation reviews.
We refer frequently to the scoring guidelines that accompany each
organization's standards. The scoring guidelines express parameters or
common situations that the organizations' surveyors use to make
judgments and assign scores to key requirements. Although scoring
guidelines are not standards, they set forth the intent of the standard
and describe the organizations' expectations as to how a particular
standard must be met. These guidelines are consistently used by both
organizations' surveyors in determining the score that will be applied
to assess compliance with each standard.
When a surveyor evaluates a standard as having partial, minimal, or
noncompliance, that is, when the scoring guideline has not been met or
has been only partially met, a written recommendation results.
For example, an organization may use a 5-point scale to indicate an
ASC's level of compliance with a standard. An ASC score of 1 or 2 for a
particular accreditation standard corresponds to our determination of
substantial compliance. A score of 3, 4, or 5 corresponds to our
determination of noncompliance, which requires the ASC to submit an
acceptable plan of correction. The facility's improvement will be
monitored through a focused survey and/or written progress report. A
written progress report assigned to address these deficiencies is
normally due within either 1, 4, or 6 months from the date the
accreditation is final. The plan of correction is monitored by the
State Agency.
A. Differences Between the Joint Commission of the Accreditation of
Healthcare Organizations and Medicare Conditions and Survey
Requirements
We compared the standards contained in the JCAHO 1994 (and
subsequent 1996) Accreditation Manual for Ambulatory Health Care and
its survey procedures to the Medicare ASC conditions and survey
procedures. We note that JCAHO standards exceed our conditions for
coverage in some areas such as patient rights, education of patients
and family, and continuity of care. In the following seven areas,
however, Medicare conditions exceeded JCAHO standards as they existed
before our discussions with JCAHO. As explained below, however, JCAHO
now demonstrates that it meets our conditions in these areas.
Standards
Medicare ASC exclusivity requirement--Under our regulations at
Sec. 416.2 (``Definitions''), a Medicare ASC operates exclusively for
the purpose of furnishing surgical services to patients not requiring
hospitalization. JCAHO has no comparable surgical exclusivity
requirement; however, for its member ASCs seeking Medicare
certification, JCAHO has included a statement on ASC surgical
exclusivity as an integral part of its application package. This
statement by the ASC attests that the facility meets our requirements
as to exclusivity and JCAHO would verify this attestation. Thus, JCAHO
has taken adequate steps to match our exclusivity requirement.
Medicare requirement of ASC use of Medicare approved laboratory and
radiological facilities--Section 416.49 (``Condition for coverage--
Laboratory and radiologic services'') requires the use of Medicare-
approved laboratory and radiologic facilities for ASCs while JCAHO
requires only that laboratory and radiologic services be
``appropriate.'' JCAHO, however, has stated in its April 8, 1994
correspondence that an ASC seeking to use its accreditation for
Medicare certification will be required, as an integral part of its
application, to attest that, if it is not certified to perform its own
laboratory services, it will obtain the services from a laboratory with
certification under part 493 (``Laboratory Requirements''). The
applicant ASC must also attest that it has procedures for obtaining
radiologic services from a Medicare-approved facility to meet the needs
of its patients. The ASC agrees to undergo JCAHO verification of these
attestations before a
[[Page 38210]]
Joint Commission determination that the ASC qualifies for deemed status
recognition. With this standard also, JCAHO has raised its requirements
to an equivalency with our conditions.
Medicare requirement of separate recovery and waiting areas--Our
regulations at paragraph (a)(2) of Sec. 416.44 (``Condition for
coverage--Environment'') require that Medicare ASCs have separate
recovery and waiting areas. JCAHO has no requirement comparable to this
Medicare condition for coverage. JCAHO in its revised 1996
Accreditation Manual for Ambulatory Health Care under the environmental
care standard scoring guideline (EC.4.2) has included the Medicare
requirement of separate recovery and waiting areas and will require
compliance from its member ASCs seeking Medicare certification.
Medicare requirement relating to emergency equipment--Paragraph (c)
of Sec. 416.44 (``Condition for coverage--Environment'') requires that
Medicare ASCs have specific equipment available to operating rooms.
This equipment must include at least the following: emergency call
systems, oxygen, mechanical ventilatory assistance equipment, cardiac
defibrillator, cardiac monitoring equipment, tracheostomy set,
laryngoscopes, endotracheal tubes, suction equipment, and emergency
medical equipment and supplies specified by the medical staff. In its
1996 manual revision, JCAHO has amended its environmental care standard
scoring guideline (EC.4.2) and enumerated the emergency equipment
required by Sec. 416.44(c). JCAHO's member ASCs requesting Medicare
certification will comply with this requirement.
Patient care responsibilities for all nursing services personnel--
Our regulations at Sec. 416.46 (``Condition for coverage--Nursing
services'') require that ASC nursing services be directed and staffed
to assure that the nursing needs of all patients are met. Patient care
responsibilities must be delineated for all nursing service personnel.
Nursing services must be furnished in accordance with recognized
standards of practice. Further, a registered nurse must be available
for emergency treatment whenever there is a patient in the ASC. There
was no comparable JCAHO requirement that patient care responsibilities
be delineated for all nursing personnel. However, JCAHO has included,
among its 1996 leadership standard scoring guidelines (LD.2.1 through
LD.2.6), patient care responsibilities for nursing service personnel
and requires compliance with this Medicare requirement for ASCs
requesting Medicare certification.
Administration of drugs, drug prescriptions, and the administration
of blood products--Our regulations at Sec. 416.48 (``Condition for
coverage--Pharmaceutical services'') are specific in their requirements
regarding the administration of drugs, written drug administration, and
follow-ups on oral prescriptions. JCAHO had no explicit standards
comparable to these Medicare requirements.
JCAHO has included in its ``Management of Information'' standard
scoring guidelines (IM.7 through IM.7.2) and ``Care of Patients''
standard scoring guideline (TX.5.3) revised procedures for obtaining
blood and blood components to satisfy Medicare requirements. For
example, in IM.7 through IM.7.2, orders given orally for drugs and
biologicals must be followed by a written order signed by the
prescribing physician and in TX.5.3, only physicians or registered
nurses may administer blood and blood products.
Procedural Issue
Medicare requirement of unannounced surveys and frequency of
surveys--JCAHO surveys of ASCs are announced, in contrast to the
Medicare practice of conducting unannounced surveys. We believe that
the findings on an announced survey are not comparable to those an
unannounced survey may find when the facility is in its normal routine.
JCAHO has agreed that it will conduct unannounced surveys of ASCs
requesting to use their JCAHO accreditation for Medicare certification
purposes.
JCAHO resurveys its ASCs every 3 years. Our original requirement
was to survey ASCs every year. In practice, our resurveys have been
averaging almost 3 years. Therefore, we accept JCAHO's 3-year resurvey
cycle as comparable to ours.
We propose to make approval of JCAHO's accreditation program
contingent on its continued agreement to implement the above seven
changes in its standards and survey requirements. We believe that these
changes bring JCAHO's accreditation program to a level at least
equivalent to ours. JCAHO has thus demonstrated to our satisfaction
that all of our applicable conditions or requirements are met or
exceeded.
B. Differences Between the Accreditation Association for Ambulatory
Health Care and Medicare Conditions and Survey Requirements
We compared the standards contained in the 1994 through 1995 (and
subsequent 1996 through 1997) AAAHC Accreditation Handbook for
Ambulatory Health Care and its survey procedures to the Medicare ASC
conditions and survey procedures. We note that AAAHC standards exceed
our conditions for coverage in some areas such as patient rights,
radiation oncology treatment services, and occupational health
services. In the following nine areas, however, Medicare conditions
exceeded AAAHC standards, as they existed before our discussions with
AAAHC. As explained below, however, AAAHC now demonstrates that it
meets our conditions in these areas.
Standards
Medicare exclusivity requirement--Our regulations at Sec. 416.2
(``Definitions'') define an ASC as a distinct entity operating
exclusively for the purpose of furnishing surgical services to patients
not requiring hospitalization. AAAHC had no comparable requirement.
AAAHC has supplemented its surgical services standard to include
the Medicare exclusivity requirement for its ASCs that want to apply
their AAAHC accreditation for Medicare certification purposes.
Medicare separate recordkeeping and staffing requirement--An ASC
must be a separately identifiable entity, physically, administratively,
and financially independent and distinct from other operations. Thus,
an ASC maintains separate staff and keeps exclusive records. AAAHC had
no comparable requirement but has supplemented its Chapter 10,
``Surgical Services'' section, to include requirements on exclusivity
(that is, separate space, the nonmixing of functions, and separate
recordkeeping and staffing).
Medicare requirement of separate recovery and waiting areas--
Paragraph (a)(2) of Sec. 416.44 (``Condition for coverage--
Environment'') requires that Medicare ASCs have separate recovery and
waiting areas. AAAHC does not require accredited facilities to have
separate recovery room and waiting areas. AAAHC has included this
requirement in its supplement to Chapter 8, ``Facilities and
Environment,'' for ASCs interested in Medicare certification.
Adherence to the Life Safety Code of the National Fire Protection
[[Page 38211]]
Association--Under our regulations at paragraph (b) of Sec. 416.44
(``Condition for coverage--Environment''), ASCs are generally required
to comply with the provisions of the 1985 edition of the Life Safety
Code of the National Fire Protection Association. While AAAHC standards
contain a number of provisions related to ensuring patient and facility
safety in the event of fire, AAAHC had not previously mandated
compliance with the provisions of the National Fire Protection
Association Life Safety Code but required compliance with applicable
local or State safety codes.
Nevertheless, in its supplementary standard to Chapter 8,
``Facilities and Environment,'' AAAHC requires an ASC requesting
Medicare certification to comply with the provisions of the National
Fire Protection Association Life Safety Code. More specifically, the
Life Safety Code is incorporated by reference into the AAAHC standard.
Specific Medicare requirements relating to pharmaceutical
services--Medicare has specific requirements regarding adverse patient
reaction to drugs, the administration of blood products and written/
oral orders for drugs and biologicals (Sec. 416.48, ``Condition for
coverage--Pharmaceutical services''). AAAHC requirements did not
address these concerns.
AAAHC has stated in its supplement to Chapter 15, ``Pharmaceutical
Services,'' that adverse drug reactions will be reported to the
responsible physician and will be documented in the written record.
Blood and blood products will only be administered by physicians and
registered nurses. Further, orders given orally for drugs and
biologicals will be followed by a written order, signed by the
prescribing physician. We believe AAAHC's adoption of these practices
ensures compliance with our requirement.
Medicare requirement relating to laboratory services--Medicare
requires that physicians and other suppliers performing laboratory
services meet the requirements of part 493 of our regulations
(``Laboratory Requirements'').
AAAHC did not have this requirement but has included it in the
supplement to Chapter 16, ``Pathology and Medical Laboratory
Services.'' Specifically, an ASC that performs laboratory services must
meet the requirements of part 493 of our regulations; if an 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 of our regulations. AAAHC
further adds that this revised standard will be applicable to all
organizations surveyed by AAAHC regardless of Medicare ASC status.
Medicare requirement on radiologic services--Medicare ASCs are
required to obtain radiologic services from Medicare-approved
facilities as outlined in our regulations at Sec. 416.49 (``Condition
for coverage--Laboratory and radiologic services''). The ASC must have
procedures for obtaining radiologic services from a Medicare-approved
facility to meet the needs of patients. AAAHC states in its supplement
to Chapter 17, ``Diagnostic Imaging Services,'' that ASCs desiring
Medicare certification must have arrangements with providers/suppliers
of radiology services meeting Medicare conditions. This action, we
believe, ensures that AAAHC's member ASCs seeking Medicare
certification will comply with this requirement.
Hospitalization--Medicare requires ASCs to have procedures for
transfer to a hospital of patients requiring emergency medical care
beyond the ASC's capabilities. Medicare requires the hospital to be a
local, Medicare-participating hospital, or a local, nonparticipating
hospital that meets the requirements for payment for emergency services
under Federal regulations. AAAHC required procedures for transfer to a
nearby hospital but did not specify that it must be a Medicare
participating hospital or a nonparticipating hospital meeting Federal
emergency payment requirements. AAAHC has included this Medicare
requirement in its supplement to Chapter 10, ``Surgical Services,'' for
ASCs seeking Medicare certification.
Procedural Issue
Medicare requirement of unannounced surveys and resurvey
frequency--AAAHC surveys of ASCs are announced in contrast to the
Medicare practice of conducting unannounced surveys. In its handbook
section, ``Accreditation Policies and Procedures,'' AAAHC has altered
its original position and has stated that it will conduct unannounced
surveys for ASCs seeking Medicare certification. AAAHC resurveys ASCS
every 3 years. Our original requirement was to survey ASCs every year.
In practice, our resurveys have been averaging almost 3 years. We
therefore believe AAAHC's 3-year resurvey cycle meets Medicare
requirements.
We propose to make our approval of AAAHC's accreditation program
contingent on its continued agreement to implement the above nine
changes to its standards and requirements. We believe that these
changes bring AAAHC's accreditation program to a level at least
equivalent to ours. AAAHC has thus demonstrated to our satisfaction
that it meets or exceeds all Medicare applicable conditions or
requirements.
After we evaluate public comments on this initial notice, we will
issue an approval notice in accordance with section 516 of Public Law
104-134 and our regulations at Sec. 488.12 (``Effect of survey agency
certification''). Once this approval notice is approved and published
in the Federal Register, ASCs would inform their respective State
Agencies of their accreditation status with either the JCAHO or AAAHC.
The State Agencies in turn, would inform their respective HCFA Regional
Offices. The Regional Offices collect this information and put the
information into the HCFA Online Survey and Certification Automated
system.
C. Proposed Stipulations Relating to Accreditation by the Joint
Commission on the Accreditation of Healthcare Organizations and the
Accreditation Association for Ambulatory Health Care
According to our regulations at Sec. 488.8 (``Federal review of
accreditation organizations''), to ensure continuing comparability, an
accreditation organization granted deeming authority is subject to
continuing Federal oversight, which includes comparability reviews and
validation reviews. Section 488.8 lists reapplication procedures, which
may be no later than every 6 years. We propose to recognize as meeting
Medicare's ASC conditions those ASCs accredited under JCAHO's and
AAAHC's accreditation programs with the following restrictions included
in Sec. 488.8(e):
We would reserve the right to withdraw deemed status from
all JCAHO-accredited or AAAHC-accredited ASCs should either
organization revise its standards or accreditation policies and
procedures in a manner in which it fails to demonstrate that its ASCs
continue to meet Medicare conditions.
We also would reserve the right to withdraw deemed status
from all JCAHO-accredited or AAAHC-accredited ASCs if we should change
ASC conditions in a manner in which, after a time allowance specified
in Sec. 488.8(e), JCAHO or AAAHC standards or accreditation policies
would not demonstrate that the revised Medicare ASC conditions are met.
We would reserve the right to withdraw deemed status from
all JCAHO or AAAHC accredited ASCs if a validation review or a public
complaint
[[Page 38212]]
review reveals widespread, systematic, and unresolvable problems with
the JCAHO or AAAHC accreditation process with respect to these ASC
programs. These problems would provide evidence that JCAHO or AAAHC
ASCs cease to demonstrate that they meet Medicare conditions.
D. Conclusion
For the reasons stated above, we believe that the JCAHO and AAAHC
accreditation standards and survey processes, subject to the
stipulations described, demonstrate that Medicare conditions or
requirements have been met or exceeded. We therefore propose to deem
ASCs accredited by JCAHO and AAAHC to be in compliance with the
Medicare conditions for ASCs in accordance with the authority provided
in section 1865 of the Act.
III. Paperwork Reduction Act
The burden reflected in this notice is referenced in the currently
approved regulation entitled ``Granting and Withdrawal of Deeming
Authority to National Accreditation Organizations (HSQ-159-F).'' The
paperwork burden referenced in this regulation has been submitted to
the Office of Management and Budget for review and approval under HCFA
form number ``HCFA-R-191.'' Persons can reference the supporting
statement for this paperwork collection (HCFA-R-191) on the INTERNET at
http://www.hcfa.gov until the Office of Management and Budget's
approval has been obtained.
IV. Response to 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 comments we receive by the date and time specified in the DATES
section of this preamble, and, if we proceed with a subsequent
document, we will respond to the comments in the preamble to that
document.
V. Impact Regulatory Statement
In fiscal year 1993, there were 1,657 certified ASCs participating
in the Medicare/Medicaid programs. We conducted 141 initial, 549
recertification (both at a cost of $537,312), and 18 complaint surveys.
In fiscal year 1994, there were 1,855 certified ASCs. This was an
increase of 198 facilities. We conducted 213 initial, 492
recertification (both at a cost of $555,068), and 24 complaint surveys.
In fiscal year 1995, there were 2,105 ASCs. This was an increase of 250
Medicare/Medicaid certified ASCs. We conducted 211 initial, 288
recertification (both at a cost of $714,069), and 24 complaint surveys.
As the data above indicate, the number of ASCs and the cost for
conducting ASC surveys are increasing; however, the number of surveys
conducted is decreasing. We contacted several Regional Offices to
determine the number of pending ASC initial surveys, which number
approximately 200 to 300. These pending initial surveys are not
uniformly dispersed among the Regional Offices, so there would be a
significant impact on some Regional Offices.
For the current fiscal year, the appropriation for survey
activities has not increased over the levels granted for fiscal years
1994 and 1995. Yet, the numbers of participating providers and
suppliers continue to increase. As indicated above, there was a 22
percent increase in ASCs within 3 years (fiscal years 1993 through
1995). In an effort to guarantee the continued health, safety, and
services of beneficiaries in facilities already certified, as well as
provide relief in this time of tight fiscal restraints, we are
proposing to deem ASCs accredited by the JCAHO and AAAHC as meeting
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. 93.774,
Medicare--Supplementary Medical Insurance Program)
Dated: June 28, 1996.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Dated: July 18, 1996.
Donna E. Shalala,
Secretary.
[FR Doc. 96-18709 Filed 7-22-96; 8:45 am]
BILLING CODE 4120-01-P
