[Federal Register Volume 61, Number 245 (Thursday, December 19, 1996)]
[Notices]
[Pages 67041-67047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32194]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[BPD-849-FN]
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: Final notice.
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SUMMARY: This notice grants deemed status to two organizations, the
Joint Commission on the Accreditation of Healthcare Organizations
(JCAHO) and the Accreditation Association for Ambulatory Health Care
(AAAHC), for their accredited ambulatory surgical centers (ASCs) that
request Medicare certification. We believe that accreditation of ASCs
by either organization demonstrates that all Medicare ASC conditions
are met or exceeded, and, thus, we grant deemed status to each
organization.
EFFECTIVE DATE: The provisions of this notice are effective beginning
on December 19, 1996 through December 19, 2002.
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Government Printing Office. Free public access is available on
[[Page 67042]]
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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. 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. 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.
In making our finding as to whether the accreditation body
demonstrates 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.
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
accreditation 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 that we grant deemed status for ASCs.
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 body, then ASCs must be accredited by that body to
receive Medicare certification. accreditation by an 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 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
accreditation organizations provide reasonable assurance that entities
accredited by them would meet Medicare conditions 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 (e.g., ASCs) under the provider entities that we may consider
for deemed status. We are required to publish an initial 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 we are required to publish a
notice of our findings within 210 days after we receive an
organization's deeming application.
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. We view this letter as triggering the schedule set forth in
the new law, and we published the initial notice within 60 days of the
May 23, 1996 letter from AAAHC. 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.
C. Ambulatory Surgical Center Conditions for Coverage and Requirements
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 us under section 1833(I)(1) of the Act.
II. Provisions of the Proposed Notice
The initial notice proposed to recognize the accreditation programs
of JCAHO and AAAHC, two national accrediting organizations, but only to
the extent that they accredited ASCs.
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 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
[[Page 67043]]
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.)
We met separately with representatives from each organization. In
evaluating the accreditation standards and survey processes of JCAHO
and AAAHC to determine if they demonstrated that their 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 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.
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. In seven areas, JCAHO has made the following revisions:
Exclusivity requirement--JCAHO has included a statement on
ASC surgical exclusivity as an integral part of its application
package.
Use of Medicare approved laboratory and radiological
facilities--An accredited 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
a certification under part 493 (``Laboratory Requirements''). The 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 Joint Commission determination that the ASC
qualifies for deemed status recognition.
Separate recovery and waiting areas--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 accredited ASCs seeking Medicare
certification based on their accreditation.
Emergency Equipment--In its 1996 manual revision, JCAHO
has amended its environmental care standard scoring guideline (EC.4.2)
and enumerated the emergency equipment required by 42 CFR
Sec. 416.44(c).
Patient care responsibilities for all nursing services
personnel--JCAHO has included, in 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 based on their
accreditation.
Administration of drugs, drug prescriptions, and the
administration of blood products--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.
Unannounced surveys and frequency of surveys--JCAHO has
agreed that it will conduct unannounced surveys of ASCs requesting to
use their JCAHO accreditation for Medicare certification purposes.
JCAHO resurveys its ASC every 3 years. Our original requirement was
to survey ASCs every year. In practice, our resurveys has been
averaging almost 3 years. Therefore, we accept JCAHO's 3-year resurvey
cycle as comparable to ours.
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. In nine areas, AAAHC has made the
following changes:
Exclusivity requirement--AAAHC has supplemented its
surgical services standard to include the Medicare exclusivity
requirement for its accredited ASCs that want to apply AAAHC
accreditation for Medicare certification purposes.
Separate recordkeeping and staffing requirement--AAAHC 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).
Separate recovery and waiting areas--AAAHC has included
this requirement in its supplement to Chapter 8, ``Facilities and
Environment,'' separate recovery and waiting areas for ASCs interested
in Medicare certification based on AAAHC accreditation.
Life Safety Code of the National Fire Protection
Association--AAAHC supplementary standard to Chapter 8, ``Facilities
and Environment,'' requires an ASC requesting Medicare certification,
based on accreditation, 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.
Requirements relating to pharmaceutical services--AAAHC
states in its supplement to Chapter 15, ``Pharmaceutical Services,''
that adverse
[[Page 67044]]
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.
Requirement relating to laboratory services--AAAHC did not
have this requirement but has included it in the supplement to Chapter
16, ``Pathology and Medical Laboratory Services.'' Specifically, as 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.
Radiologic services--AAAHC states in its supplement to
Chapter 17, ``Diagnostic Imaging Services,'' that ASCs desiring
Medicare certification based on their accreditation must have
arrangements with a Medicare approved providers/suppliers of radiology
services to meet the needs of patients.
Hospitalization--AAAHC has included the Medicare
requirement in its supplement to Chapter 10, ``Surgical Services,'' for
ASCs seeking Medicare certification based on AAAHC accreditation to
transfer to a hospital a patient requiring emergency medical care
beyond the ASC's capabilities. If further requires that the hospital be
a local, Medicare-participating hospital, or a local, nonparticipating
hospital that meets the requirements for payment for emergency services
under Federal regulations.
Unannounced surveys and resurvey frequency--AAAHC handbook
section, ``Accreditation Policies and Procedures,'' has stated that it
will conduct unannounced surveys for ASCs seeking Medicare
certification based on AAAHC accreditation.
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. Therefore AAAHC's 3-year resurvey cycle meets Medicare
requirements.
C. Proposed Stipulations Relating to Accreditation by the Joint
Commission on the Accreditation of Health Care 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 grant 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 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(d):
We 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 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(d), JCAHO or AAAHC standards or accreditation policies would
not demonstrate that the revised Medicare ASC conditions are met.
We reserve the right to withdraw deemed status from all
JCAHO or AAAHC accredited ASCs if a validation review or a public
complaint review or a public complaint 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 cease to
demonstrate that they meet Medicare conditions.
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 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. The provisions of this notice are
effective beginning on December 19, 1996 through December 19, 2002.
D. Analysis and Responses to Public Comments
We receive 86 comments to our July 23, 1996 notice. Of these, 63
were from ASCs or medical centers, 11 from M.D.s, 1 from a dentist, 10
from professional medical associations an 1 from a State government.
Seventy-eight (78) commenters favored deeming for JCAHO and AAAHC, 6
approved deeming with reservations and 1 opposed it. A summary of these
comments and our responses are discussed as follows:
Comment: Seventy-eight (78) commenters, most of whom are
ASCs, expressed strong support for our approval of the JCAHO's and
AAAHC's applications for deemed status. Commenters stated that the two
organizations are leaders in the development of outpatient oriented
health care delivery and have developed standards of care and survey
process that accrue the highest possible quality health care in the
ambulatory setting.
Response: We acknowledge the support shown and have
developed an approval notice consistent with the provisions contained
in our initial notice.
Comment: One commenter suggested that since AAAHC's
application for deeming was filed prior to the enactment of the new
deeming legislation (Public Law 104-134), AAAHC's application should be
considered filed the date Public Law 104-134 was enacted (April 26,
1996).
Response: As we stated in the initial notice, we do not believe the
timeframe set forth in the new deeming legislation is applicable to
deeming applications filed prior to its enactment. We viewed the letter
that AAAHC wrote to us on May 23, 1996, requesting that we process its
application under the new timeframes, as triggering the new timeframes.
In order to comply with the requirements 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 the request, we placed our initial
notice on public display July 19, 1996, and it appeared in the July 23,
1996 issue of the Federal Register. Likewise, in order to comply with
the requirement that we publish an approval notice of our findings
within 210 days after we received an approved notice by December 19,
1996.
Comment: One commenter stated that AAAHC's ASC ``accreditees'' are
not ``members'' of AAAHC.
Response: We accept this comment and will refrain from referring to
AAAHC accredited ASCs as members of AAAHC.
Comment: Five commenters stated that if a national accreditation
organization has its deeming authority
[[Page 67045]]
withdrawn by HCFA, this change should not affect ASCs already granted
deemed status based on the organization's accreditation. In the same
vein, three other commenters expressed concern about possible
consequences to an ASC if the ASC's accreditation organization lost its
deeming authority. One commenter argued that HCFA would not revoke
Medicare certification of an ASC certified by a State surveyor if HCFA
changed the conditions for coverage, or if the State surveying agency
changed its survey procedures. The commenter stated that HCFA should
conduct a facility by facility review to determine which facilities
continue to satisfy Medicare conditions.
Response: Our procedures have been well established in regulations
and we must follow them in this notice. In accordance with 42 CFR 488.8
(f)(7), should we rescind an accreditation organization's deeming
authority, we will publish a notice in the Federal Register detailing
the reasons for such action. Accreditation organizations are required
to notify all accredited ASCs within 10 days of our withdrawal of their
deeming authority.
Under 42 CFR 488.8(f)(8) an affected ASC retains its deemed status
for 60 days after notification and it can be extended an additional 60
days if we determine that the ASC submitted an application within the
initial 60-days timeframe to another approved accreditation
organization or to us so that compliance with Medicare conditions can
be determined. An ASC's failure to do so will jeopardize its
participation in the Medicare program.
Comment: One commenter requested that HCFA address the issue of an
ASC applying to a deemed accreditation organization for Medicare
certification based on its accreditation when the ASC is exempted by
its State from licensure requirements. The commenter gave the example
of an entity qualifying as a physician's office which is exempt from
licensure under State law. In this case, the commenter concluded the
accreditation organization would request that the ASC procedure either
a license or evidence of exemption from licensure.
Response: Section 416.26(a)(2) requires that facilities seeking
Medicare certification as ASCs based on their accreditation by either
JCAHO or AAAHC comply with State licensure requirements where
applicable. Therefore, in the example cited, the commenter is correct
in stating that the accreditation organization would request a license
or evidence of exemption if the State permits a physician's office to
operate as an ASC.
Comment: One commenter questioned if deemed status will apply to
physicians' offices that meet the standards set by AAAHC for ASCs but
do not otherwise qualify as ASCs as defined by State laws.
Response: As previously stated, if State law requires a license for
a facility to operate in that State as an ASC, such requirement must be
met before an entity such as a physician's office accredited by the
JCAHO or AAAHC under its ASC accreditation program can be granted
deemed status for Medicare certification as an ASC.
Comment: Two commenters asked how deemed status affects ASCs that
were Medicare certified through State survey and accredited by either
JCAHO or AAAHC prior to HCFA's approval of deemed status for these
accreditation organizations. One of the commenters also asked if there
is a deadline by which a currently certified ASC should notify HCFA
that it is accredited by a deemed organization.
Response: After this approval notice is published in the Federal
Register, ASCs accredited by either JCAHO or AAAHC, and already
Medicare certified, are considered deemed for Medicare certification.
When this status change is executed 42 CFR 488.7(a) discharges the
State agencies from ongoing responsibility for conducting periodic
surveys in deemed ASCs unless the ASC is selected for a sample
validation survey or there is a substantial allegation of
noncompliance. If the ASC is selected for a sample validation survey,
the ASC will be notified by the State agency before the survey is
conducted. In accordance with 42 CFR 488.7, State surveyors will
determine if the ASC is out of compliance with a condition of coverage.
If the ASC is found to be out of compliance, the ASC will no longer be
deemed to meet the Medicare conditions and will be subject to full
review by the State agency. Likewise, if there is a substantial
allegation of noncompliance and the State agency conducts a compliance
survey and finds a condition for coverage out of compliance, the ASC
will be subject to full review by the State agency.
Comment: Another commenter asked that we explain the procedure that
new ASCs would follow to become Medicare certified after we grant deem
status to JCAHO and AAAHC.
Response: First, Medicare certification based on accreditation is
strictly voluntary. ASCs seeking Medicare certification, have the
option of determining whether they would prefer certification based on
(1) a State agency survey or (2) accreditation by one of the deemed
organizations. If the ASC chooses the first option, it would apply
directly to the State survey agency in its area with which we have a
survey agreement. After the survey is completed the State agency would
forward its recommendation for Medicare certification to the
appropriate regional office for processing. Our regional office would
notify both the ASC and the State agency of the ASC's eligibility to
participate in the Medicare program.
If the ASC elects the second option, the accreditation organization
would send a notice to our applicable regional office indicating the
ASC's accreditation status and whether the ASC is deemed or not deemed
for Medicare certification. The accrediting organization should also
send a courtesy copy of such notification to the appropriate State
agency. One receipt of such notification, the regional office will
advise both the ASC and appropriate State agency of the ASC's Medicare
certification status.
Comment: One commenter believed it should remain the sole entity
within the State responsible for determining facilities' Medicare
certification for outpatient surgery since it believed surgical
procedures could eventually be attempted in settings inappropriate for
surgery. The commenter stated that all such facilities should be
licensed by the State department of public health.
Response: We have no reason to believe that granting deeming
authority to either JCAHO or AAAHC will result in outpatient surgery
being performed in inappropriate settings. Based on our review of each
accreditation organization's standards and survey policies and
procedures, we have determined that they both demonstrate the ASCs
accredited by them would meet or exceed HCFA conditions. Furthermore,
in this notice we reserve the right to revoke deemed status for all
JCAHO-accredited or AAAHC-accredited ASCs should either organization
revise its standards or accreditation policies and procedures in a
manner which fails to demonstrate that its ASCs continue to meet
Medicare conditions; or if a validation review or a public complaint
review reveals widespread, systematic, and unresolved problems with
either organization's accreditation process for ASCs; or if we
determine that either organization has failed to sufficiently revise
its standards to the extend necessary to demonstrate that revised
Medicare conditions are met and enforced. Moreover, each State has the
option to establish more stringent licensure requirements or
[[Page 67046]]
monitoring procedures to safeguard the quality of surgery performed in
an ASC.
Comment: One commenter believes that both JCAHO's and AAAHC's
anesthesia requirements are not equivalent to Medicare's anesthesia
conditions since neither organization currently requires physician
supervision of non-physician administration of anesthesia and since
JCAHO's standards contain no provision as to the identity or
supervision of the actual anesthesia provider.
Response: We believe that the commenter may be referring to these
organizations' anesthesia standards as stated prior to each
organization's most recent handbook editions. JCAHO's 1996
Comprehensive Accreditation Manual for Ambulatory Care Section 2
Leadership (LD), standard LD 1.9-2.6 and AAAHC's 1996-1997
Accreditation Handbook for Ambulatory Health Care (Chapter 9)
supplement their previous requirements in order to meet Medicare's
anesthesia conditions. We have examined both organizations'
supplemental anesthesia standards and are satisfied that both
organizations demonstrate they meet our requirements for physician
supervision of non-physician administration of anesthesia and
identification of the anesthesia provider under 42 CFR 416.42(b)
Standard: Administration of Anesthesia.
Comment: One commenter advocated eliminating HCFA's requirement
that physicians supervise certified registered nurse anesthetists. The
commenter stated that HCFA seemed receptive to this recommendation when
considering revisions of its hospital conditions of participation.
Response: We cannot accept this comment. The issue raised is not
the subject of this notice, which is limited to the approval of ASC
deeming authority for JCAHO and AAAHC.
Comment: One commenter expressed concern about the dominating
presence of physicians on each of the governing bodies for JCAHO and
AAAHC. The commenter believed that these organizations should have
representatives on their governing bodies that reflect broad community
interest.
Response: Revised section 1865(b)(1) of the Act requires us to
determine whether accreditation by a national accreditation
organization demonstrates that Medicare conditions are met. We have
determined that accreditation by JCAHO and AAAHC demonstrate that
Medicare conditions for ASCs are met. Because there are no statutory or
regulatory requirements for broad community representation on the
governing or advisory boards or committees of private accreditation
organizations, we are not in a position to require either JCAHO or
AAAHC to include any specific groups on its boards or committees. Our
primary concern is the content and application of the accreditation
standards and procedures.
Comment: One commenter stated that HCFA should be aware that the
private creation of patient care standards is fraught with peril by
virtue of the thrust of the federal antitrust laws. The comment read:
``Simply stated, it cannot be routinely expected that private standard-
setting bodies will make legitimate patient safety considerations
paramount when confronted with the threat of antitrust legislation, a
threat which HCFA does not face.''
Response: HCFA, in its process of granting deemed authority, is not
fostering the creation of private patient care standards. We have our
own conditions for coverage and the organizations requesting deemed
authority must have their standards meet these conditions. Therefore,
since outside groups are not acting together to create private care
standards, we do not anticipate antitrust implications.
Comment: One commenter proposes that we modify our regulations to
allow AAAHC to perform ``unannounced inspections'' rather than
``unannounced surveys'' to assess an ASC's compliance with Medicare
conditions. The commenter suggests that unannounced inspections for
compliance be conducted in conjunction with regularly scheduled tri-
annual full surveys. The commenter contends that ``the time and cost
(disruption) associated with a full survey is quite high.'' The
commenter argues that inspections would be less disruptive and require
fewer staff resources.
Response: We believe the commenter has assumed that mandated use of
unannounced surveys for ASCs seeking Medicare certification based on
their AAAHC accreditation would necessitate two separate survey
processes for such ASCs, i.e., an announced survey to accredit an ASC
plus an unannounced survey to determine if the ASC meets our Medicare
conditions. We have no intention of imposing such survey requirements
on either AAAHC or ASCs. Instead, the required use of unannounced
surveys simply means that AAAHC would conduct full triennial surveys on
ASCS seeking deemed status without advising them in advance that such a
survey is forthcoming on a specific date.
Comment: One commenter asked for a definition of an ``unannounced''
survey. Specifically, the commenter wanted to know if JCAHO would still
send a notice of intent to survey prior to conducting the survey.
Response: As a matter of policy, we interpret unannounced surveys
to mean the accreditation organization will not send a notice of intent
to survey an ASC prior to conducting the survey for those ASCs that
want their accreditation to count for Medicare certification. We
understand that unannounced surveys may result in some minor survey
problems; therefore, under section 2700 (``The Survey Process'') of our
State Operations Manual, facilities may be given advanced notice (no
more than two working days) if the following two criteria are met:
The facility is inaccessible via conventional travel means
and making special or extraordinary travel arrangements are necessary;
and
There is a high probability that the staff essential to
the survey process will be absent or the facility will be closed unless
the survey is announced.
Both accrediting organizations have agreed to the unannounced
survey process for those ASCs that wish to be deemed to meet Medicare
conditions for coverage based on their accreditation. Hence, the ASCs
that are deemed to meet Medicare conditions for coverage based on
accreditation will not be sent a notice of intent to survey, unless
both of the above criteria are met.
Comment: One commenter said it is unclear from our initial notice
whether we have made an attempt to assess the ability of JCAHO and
AAAHC to monitor Life Safety Code application. The commenter was not
aware of any ongoing capability to survey and assess the compliance
with Life Safety Code requirements.
Response: In our initial notice, we discussed specific areas in
which our Medicare conditions for ASCs exceeded accreditation standards
for both JCAHO and AAAHC as they existed prior to discussions with both
organizations and before their submittal of amendments or supplements
to their standards, survey procedures are scoring guidelines were
submitted to comply with Medicare ASC conditions. On examination, we
found no disparity between our Life Safety Code condition and JCAHO's
standard. However, as stated in our initial notice, examination
revealed that AAHC had not previously mandated compliance with the
provisions of the National Fire Protection Association Life Safety Code
as we require for ASCs. Instead, AAAHC had heretofore required
compliance with applicable local or State safety codes to ensure
patient and facility safety in the event of fire. We advised in our
initial notice
[[Page 67047]]
that AAAHC had developed a supplementary standard to Chapter 8,
``Facilities and Environment'', that requires an ASC requesting
Medicare certification to comply with the provisions of the National
Fire Protection Association Life Safety Code. Furthermore, AAAHC has
incorporated the Life Safety Code by reference into the AAAHC standard.
Therefore, we have no reason to believe these two organizations lack
the ability to monitor Life Safety Code application.
Comment: One commenter asked how State agencies would monitor plans
of corrections for deficiencies or violations cited by JCAHO or AAAHC
as proposed on page 61 FR 38209 of our initial notice. The commenter
also asked how State agencies would obtain such violations in a timely
manner; how State surveys would be trained to survey against the deemed
organization's standards; and how this monitoring activity would be
funded.
Response: Thank you for indicating a discrepancy in our discussion
on page 61 FR 38209 about monitoring an ASC's plan of correction. The
discussion pertains to the use of an accreditation organization's
scoring guidelines to assess an ASC's level of compliance with its
standards. In that discussion, we incorrectly stated that the State
agency would monitor an ASC's plan of correction if the ASC received
from the organization a score of 3, 4, or 5, which corresponds to our
determination of noncompliance. We should have instead stated that in
such cases the accreditation organization, not the State agency, would
monitor the ASC's correction plan.
Comment: One commenter expressed concern about the ability of JCAHO
and AAAHC to investigate individual complaints about a specific
provider it accredits.
Response: Our evaluation of the accreditation programs for both
JCAHO and AAAHC did not detect any indications that either of these
organizations would be incapable of investigating individual complaints
about any ASC either organization accredits.
III. Paperwork Reduction Act
The public reporting and recordkeeping 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 HSQ-159-F 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 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.
In fiscal year 1996, there were 2,219 ASCs. This was an increase of 114
Medicare/Medicaid certified ASCs. We conducted 180 initial, 115
recertification (both at a cost of $848,125) and one complaint survey.
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 during
fiscal year 1996 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.
While the fiscal year 1997 appropriation for survey activities has
been substantially increased (by seven percent) for the first time in
four years, the increase is insufficient to meet the survey demand. The
numbers of participating providers and suppliers continue to increase.
As indicated above, there was a 25 percent increase in ASCs within 4
years (fiscal years 1993 through 1996). 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 approving deeming for 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 provision 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: December 6, 1996.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Dated: December 13, 1996.
Donna E. Shalala,
Secretary.
[FR Doc. 96-32194 Filed 12-18-96; 8:45 am]
BILLING CODE 4120-01-P
