[Federal Register: May 21, 2004 (Volume 69, Number 99)]
[Rules and Regulations]
[Page 29226-29230]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my04-14]
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DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
RIN 0720-AA76
TRICARE Program; Inclusion of Anesthesiologist Assistants as
Authorized Providers; Coverage of Cardiac Rehabilitation in
Freestanding Cardiac Rehabilitation Facilities
AGENCY: Office of the Secretary, DoD.
ACTION: Final rule.
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SUMMARY: This final rule establishes a new category of provider as an
authorized TRICARE provider and it increases the settings where cardiac
rehabilitation can be covered as a TRICARE benefit. It recognizes
anesthesiologist assistants (AAs) as authorized providers under certain
circumstances. It also authorizes cardiac rehabilitation services,
which are already a covered TRICARE benefit when provided by hospitals,
to be provided in freestanding cardiac rehabilitation facilities.
DATES: This rule is effective May 21, 2004. Comments on the addition of
Sec. 199.6 (c)(3)(iii)(J) will be accepted until June 21, 2004. The
chart below identifies start Healthcare Delivery dates of this rule in
various areas.
[[Page 29227]]
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T-NEX region/contractor States Start healthcare delivery
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North (Health Net Federal Illinois, Indiana, Kentucky, Michigan, Ohio, July 1, 2004.
Services, Inc.). Wisconsin, West Virginia, Virginia (except
the Northern Virginia/National Capital
Area), North Carolina, Eastern Iowa, Rock
Island, IL, Fort Campbell catchment area of
Tennessee.
Connecticut, Delaware, District of Columbia, September 1, 2004.
Maine, Maryland, Massachusetts, New
Hampshire, New Jersey, New York,
Pennsylvania, Rhode Island, Vermont,
Northern Virginia, West Virginia (portion).
South (Humana Military Oklahoma, Arkansas and major portions of November 1, 2004.
Healthcare Services). Texas and Louisiana.
Alabama, Florida, Georgia, Mississippi, August 1, 2004.
Eastern Louisiana, South Carolina,
Tennessee, small area of Arkansas, New
Orleans area.
West (TriWest Healthcare Washington, Oregon, Northern Idaho.......... June 1, 2004.
Alliance Corp.).
California, Hawaii, Alaska.................. July 1, 2004.
Arizona, Colorado, Idaho, Iowa, Kansas, October 1, 2004.
Minnesota, Missouri, Montana, Nebraska,
Nevada, New Mexico, North Dakota, South
Dakota, western portion of Texas, Wyoming.
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ADDRESSES: TRICARE Management Activity (TMA), Medical Benefits and
Reimbursement Systems, 16401 East Centretech Parkway, Aurora, CO 80011-
9043.
FOR FURTHER INFORMATION CONTACT: Stan Regensberg, Medical Benefits and
Reimbursement Systems, TMA, (303) 676-3742.
SUPPLEMENTARY INFORMATION:
I. Summary of Final Rule Provisions
A. Inclusion of Anesthesiologist Assistants as Authorized Providers
At present only two types of anesthesia providers may provide
services to TRICARE beneficiaries--anesthesiologists and certified
registered nurse anesthetists (CRNAs). In some areas of the country,
anesthesiologist assistants, after completing the specified training,
being accredited, and, where required, being licensed by the state also
provide anesthesia services. The Centers for Medicare and Medicaid
Services (CMS) already recognizes anesthesiologist assistants as
authorized providers (42 CFR 410.69). This final rule establishes
anesthesiologist assistants as authorized providers under the same
conditions applied by CMS.
The reader should refer to the proposed rule that was published on
April 3, 2003, (68 FR 16247) for detailed information regarding this
action.
B. Coverage of Cardiac Rehabilitation in Freestanding Cardiac
Rehabilitation Centers
Currently TRICARE provides coverage/payment for inpatient or
outpatient services and/or supplies provided in connection with a
cardiac rehabilitation program when provided by a TRICARE authorized
hospital. Since hospital based cardiac rehabilitation is already an
established benefit under TRICARE, this final rule simply applies that
benefit and reimbursement structure to freestanding cardiac
rehabilitation programs.
The reader should refer to the proposed rule that was published on
April 3, 2003, (68 FR 16247) for detailed information regarding this
benefit and reimbursement for it.
C. Clarification Regarding the Status of Certified Registered Nurse
Anesthetists
TRICARE is issuing a provision for certified registered nurse
anesthetists (CRNAs). It provides a separate designation for CRNAs by
clarifying their existing status in the TRICARE program as an
independent provider operating under their state licensure and meeting
the requirements for a certified registered nurse anesthetist.
II. Public Comments
We received no comments regarding the coverage of cardiac
rehabilitation services in freestanding cardiac rehabilitation
facilities.
We received a large number of comments, both in support of and
opposed to, our proposal to authorize AAs as TRICARE providers. The
comments were from individuals as well as national organizations
representing groups of providers. The following comments were in
support of our proposal.
Comment: A number of anesthesiologists commented that they employ
AAs and are very satisfied with their services.
Comment: A number of commenters noted that AAs are recognized by
many commercial insurances and managed care plans.
Comment: Many commenters, both individuals and national provider
organizations, described the extensive training that AAs receive. They
noted that the training lasts for 24-27 months and includes master's
level coursework after a bachelor's degree that must include pre-
medical courses such as biology, chemistry, physics, and calculus. The
training also includes 2,500 hours of direct patient contact of
clinical rotations in every area of anesthesia (i.e., trauma, cardiac,
thoracic, obstetrical, pediatric, etc.). They also noted that the AA
training programs are nationally accredited by the Commission on
Accreditation of Allied Health Education Programs (CAAHEP) which
accredits training programs for 2,100 other allied health educational
programs at 1,300 institutions. Presently, there are two AA training
programs (Case Western Medical School and Emory University Medical
School) with another to begin shortly (South University Medical
School). Graduates of the programs must pass a national certification
examination administered by the National Board of Medical Examiners for
the National Commission for Certification of Anesthesiologist
Assistants. This examination is administered the first Saturday in June
and has a six hour duration. The exam may occur prior to graduation;
however, all course work and instruction has been completed by the date
of the exam. Additional clinical experience finishes out the time from
exam to graduation. Upon graduation, the AA will be told whether he or
she has passed the exam. The AA can not practice without official
notification that he or she has passed the exam.
Comment: Many commenters noted that in order to practice their
profession, AAs must pass a national certification examination
administered by the National Board of Medical Examiners for the
National Commission for Certification of Anesthesiologist Assistants.
In addition, AAs must have 40 hours of continuing medical education
every two years and complete a recertification every six years.
[[Page 29228]]
As stated above, we also received a number of comments that were
opposed to our proposal to authorize AAs as TRICARE providers. Since
these comments disagree with our final decision, we provide a response
to each comment to explain why we have elected to authorize AAs as
TRICARE providers.
Comment: A number of commenters stated that only five states
license AAs and questioned why TRICARE should recognize AAs ``if most
of the country does not recognize the AA practice''.
Response: As stated in the proposed rule, we will require that AAs
comply with all applicable requirements of state law and be licensed,
where applicable, by the state in which they practice. As described in
Sec. 199.6(c)(2) of this part describing conditions of authorization
for individual providers, in jurisdictions that do not license a
specific category of individual professional, certification by a
Qualified Accreditation Organization is required. As described in Sec.
199.6(c)(3) of this part, in jurisdictions that do not provide for
licensure or certification, the provider must be certified by or
eligible for full clinical membership in the appropriate national
professional association that sets standards for the specific
profession. The fact that AAs are required to be licensed in six states
and not all is not pertinent. Many other states recognize them, but do
not require them to be licensed and we believe that their
qualifications justify TRICARE recognition.
Comment: A national provider organization noted that AAs have been
recognized by Medicare since 1983, and that CMS considers AAs and CRNAs
to be equivalent providers and uses the term ``anesthetist'' for both
professions.
Response: However, TRICARE recognizes the increased training
required by certified registered nurse anesthetists compared to AAs,
and as a result, authorizes CRNAs to practice independent of physician
supervision in those states where the licensure permits. TRICARE is
publishing a provision in this rule to clarify CRNAs' authority to
practice independently.
Comment: Many commenters stated that AAs may not be the solution to
correct the current national anesthesia provider shortage, since they
must be supervised by an anesthesiologist.
Response: We did not propose authorizing AAs in order to alleviate
any provider shortage or to solve any other problem. Our proposal was
based on the fact that they are certified by a nationally recognized
organization, are a recognized provider in many states and by many
third-party payers, are licensed by several states, and are authorized
under Medicare.
Comment: One national provider organization questioned if
recognizing AAs will increase TRICARE costs.
Response: It will not. As we stated in the proposed rule, payment
for anesthesia services provided by an anesthesiologist and an AA under
the anesthesiologist's direct supervision will never exceed what would
have been paid if the services were provided only by the
anesthesiologist.
Comment: A number of commenters noted that the military system
requires healthcare providers who can be mobilized at a moment's notice
to provide quick response in military conflicts. It is not effective to
deploy AAs who would have to be accompanied by an anesthesiologist.
Response: We want to stress that this final rule affects only
services provided in civilian facilities and is wholly separate from
services provided within the military's direct care system. AAs will
not practice in MTFs; they will not be commissioned, nor will they
deploy to support our troops.
Comment: Many commenters suggested that TRICARE should conduct a
study on the safety record and cost effectiveness of AAs before
recognizing them.
Response: We believe the issue of cost effectiveness is moot, as
explained above. With regard to a study of the safety record of AAs, we
don't believe this is necessary for several reasons. First, CMS has
recognized AAs for 20 years and there have been no issues of safety.
Second, a national provider organization stated that the professional
liability insurance rates charged to AAs and nurse anesthetists are the
same, and there is no evidence to indicate there is any difference
between AAs and nurse anesthetists with respect to claims filed.
Perhaps most importantly, two national organizations representing
physicians have strongly endorsed our proposal, and the physician is
ultimately the person most responsible for patient safety. Third, AAs
will not be recognized as individual professional providers with the
ability to bill independently, but rather as extenders of the
anesthesiologist who is responsible for direct supervision of the AA or
AAs.
Comment: One commenter noted that when CMS proposed allowing CRNAs
to practice without physician supervision in 1997 this was opposed, and
the final rule called for a patient safety study to be conducted. The
commenter believes AAs should be included in this study.
Response: As stated above, we do not believe a study of the safety
of AAs is necessary. In addition, a study of whether an allied health
professional can safely practice without physician supervision is an
entirely different issue from what we have proposed, since we will
require AAs to be under the direct supervision of a physician. TRICARE
defines direct supervision of an AA by an anesthesiologist as follows:
The anesthesiologist performs a pre-anesthetic examination and
evaluation; the anesthesiologist prescribes the anesthesia plan; the
anesthesiologist personally participates in the most demanding aspects
of the anesthesia plan including, if applicable, induction and
emergence; the anesthesiologist ensures that any procedures in the
anesthesia plan that he or she does not perform are performed by a
qualified AA; the anesthesiologist monitors the course of anesthesia
administration at frequent intervals; the anesthesiologist remains
physically present and available for immediate personal diagnosis and
treatment of emergencies; the anesthesiologist provides indicated post-
anesthesia care; the anesthesiologist performs no other services while
he or she supervises no more than four anesthesiologist assistants
concurrently or a lesser number if so limited by the state in which the
procedure is performed. The Director, TMA, or a designee, shall issue
TRICARE policies, instructions, procedures, guidelines, standards, and
criteria as may be necessary to implement the intent of this section.
TRICARE has modeled its definition of direct supervision on the current
Medicare definition of ``medically directed anesthesia services,'' with
three notable variations. First, Medicare uses the terminology
``medically directed anesthesia services;'' whereas, TRICARE uses
``direct supervision.'' For purposes of definition, such terminology is
interchangeable. Second, Medicare refers to a qualified individual who
performs anesthesia procedures not rendered by a physician as defined
in Medicare operating instructions. For TRICARE, a qualified individual
who performs anesthesia procedures under 32 CFR 199.6(I), established
by this final rule, is an AA. The final difference pertains to the
number of AAs an anesthesiologist may concurrently supervise. TRICARE
and MEDICARE both require that ``the anesthesiologist performs no other
services while he or she supervises no more than four anesthesiologist
assistants concurrently'' however TRICARE includes additional language
to indicate that in cases where state law further restricts the number
of AAs an
[[Page 29229]]
Anesthesiologist can concurrently supervise TRICARE will defer to state
law. The relevant phrase states ``or a lesser number if so limited by
the state in which the procedure is performed.''
Comment: One commenter noted that our proposed rule stated that AAs
will be authorized under the same conditions applied by CMS and
questioned if that means that all CMS rules relating to anesthesia
apply to AAs or just some. Also, will the CMS medical direction rules
apply, and what does direct supervision mean?
Response: We intend to apply all the CMS rules to AAs who provide
services to TRICARE beneficiaries. However, we are adding one
additional condition regarding the medical direction of AAs. CMS allows
physicians to provide concurrent medical direction of up to four AAs or
CRNAs. We will use that standard in general, but we will also require
that if a state has a more stringent requirement, the state's
requirement must be followed. Direct supervision means the same as
medical direction under CMS, and we have expanded the regulatory
section to include those requirements.
Comment: One commenter asked if AAs must be licensed or can they
practice under a form of delegated medicine?
Response: As stated in the proposed rule, AAs must comply with all
applicable requirements of state law and be licensed, where applicable.
Therefore, they must be licensed only where a state requires them to be
licensed. In other states, they may practice as unlicensed providers
under the delegated authority of a physician as permitted by state law.
Comment: One commenter noted that the proposed rule states that an
AA program must build on a premedical undergraduate science background
but stated that neither currently existing AA educational program
requires a premedical major. The commenter asked if this means the
programs will have to change their requirements.
Response: The AA programs will not have to change their
requirements. The proposed rule and the final rule require only that
the AA program must build on a premedical science background. It does
not require that the participant have a premedical science major. It is
important to note that both programs require extensive undergraduate
science coursework. In addition, the accreditation standard for AA
programs as required by the Commission on Accreditation of Allied
Health Education Programs requires undergraduate coursework that
includes ``studies in biology, chemistry, mathematics, and physics
which are usually required for graduate study or its equivalent in the
basic medical sciences.''
III. Changes in the Final Rule
We have made no changes to the provisions on coverage of cardiac
rehabilitation in freestanding cardiac rehabilitation centers. However,
based on comments we received on the proposed rule, we have made
several changes to the final rule language regarding the inclusion of
anesthesiologist assistants as authorized providers.
The profession's name is singular and not singular possessive as we
used it in the proposed rule. Accordingly, the final rule uses
``anesthesiologist assistant''.
It was suggested that we delete the term ``Master's level medical
school-based'' in describing the required AA programs in order to
reflect changes in CAAHEP accreditation standards that permit a shared
program between a medical school and a university program outside the
medical school. We reviewed the accreditation standards and, based on
that, we have changed the wording to require that the program be
established under the auspices of a medical school rather than be
``medical school-based''. However, we are retaining the language
regarding Master's level for clarity.
It was also suggested that when we refer to the Committee on Allied
Health Education and Accreditation we include the words ``or its
successor organization''. We have done this in the final rule.
As stated in our response to the public comments, we have added
language to the regulatory provisions to ensure clarity of what is
required for direct supervision.
Lastly, we have within this final rule included a provision to
provide a separate designation for certified registered nurse
anesthetists (CRNAs) by clarifying their existing status in the TRICARE
program as an independent provider operating under their state
licensure and meeting the requirements for a certified registered nurse
anesthetist.
IV. Regulatory Procedures
Executive Order (EO) 12866 requires that a comprehensive regulatory
impact analysis be performed on any economically significant regulatory
action, defined as one which would result in an annual effect of $100
million or more on the national economy or which would have other
substantial impacts.
The Regulatory Flexibility Act (RFA) requires that each Federal
agency prepare, and make available for public comment, a regulatory
flexibility analysis when the agency issues a regulation which would
have a significant impact on a substantial number of small entities.
This is not a significant regulatory action under EO 12866 and has
been reviewed by the Office of Management and Budget. In addition, we
certify that this final rule will not significantly affect a
substantial number of small entities.
Paperwork Reduction Act
This rule imposes no burden as defined by the Paperwork Reduction
Act of 1995.
List of Subjects in 32 CFR Part 199
Claims, Handicapped, Health Insurance, Military personnel.
0
Accordingly, 32 CFR part 199 is amended as follows:
PART 199--[AMENDED]
0
1. The authority citation for Part 199 continues to read as follows:
Authority: 5 U.S.C. 301; 10 U.S.C. Chapter 55.
0
2. Section 199.4 is amended by revising paragraph (e)(18)(iv) to read
as follows.
Sec. 199.4 Basic program benefits.
* * * * *
(e) * * *
(18) * * *
(iv) Providers. A provider of cardiac rehabilitation services must
be a TRICARE authorized hospital (see Sec. 199.6 (b)(4)(i)) or a
freestanding cardiac rehabilitation facility that meets the
requirements of Sec. 199.6 (f). All cardiac rehabilitation services
must be ordered by a physician.
* * * * *
0
3. Section 199.6 is amended by redesignating paragraph (c)(3)(iii)(I)
as paragraph (c)(3)(iii)(K) and adding new paragraphs (c)(3)(iii)(I)
and (c)(3)(iii)(J)) to read as follows:
Sec. 199.6 Authorized providers.
* * * * *
(c) * * *
(3) * * *
(iii) * * *
(I) Anesthesiologist Assistant. An anesthesiologist assistant may
provide covered anesthesia services, if the anesthesiologist assistant:
(1) Works under the direct supervision of an anesthesiologist who
bills for the services and for each patient;
[[Page 29230]]
(i) The anesthesiologist performs a pre-anesthetic examination and
evaluation;
(ii) The anesthesiologist prescribes the anesthesia plan;
(iii) The anesthesiologist personally participates in the most
demanding aspects of the anesthesia plan including, if applicable,
induction and emergence;
(iv) The anesthesiologist ensures that any procedures in the
anesthesia plan that he or she does not perform are performed by a
qualified anesthesiologist assistant;
(v) The anesthesiologist monitors the course of anesthesia
administration at frequent intervals;
(vi) The anesthesiologist remains physically present and available
for immediate personal diagnosis and treatment of emergencies;
(vii) The anesthesiologist provides indicated post-anesthesia care;
and
(viii) The anesthesiologist performs no other services while he or
she supervises no more than four anesthesiologist assistants
concurrently or a lesser number if so limited by the state in which the
procedure is performed.
(2) Is in compliance with all applicable requirements of state law,
including any licensure requirements the state imposes on nonphysician
anesthetists; and
(3) Is a graduate of a Master's level anesthesiologist assistant
educational program that is established under the auspices of an
accredited medical school and that:
(i) Is accredited by the Committee on Allied Health Education and
Accreditation, or its successor organization; and
(ii) Includes approximately two years of specialized basic science
and clinical education in anesthesia at a level that builds on a
premedical undergraduate science background.
(4) The Director, TMA, or a designee, shall issue TRICARE policies,
instructions, procedures, guidelines, standards, and criteria as may be
necessary to implement the intent of this section.
(J) Certified Registered Nurse Anesthetist (CRNA). A certified
registered nurse anesthetist may provide covered care independent of
physician referral and supervision as specified by state licensure. For
purposes of CHAMPUS, a certified registered nurse anesthetist is an
individual who:
(1) Is a licensed, registered nurse; and
(2) Is certified by the Council on Certification of Nurse
Anesthetists, or its successor organization.
* * * * *
Dated: May 17, 2004.
L.M. Bynum,
Alternate OSD Federal Register, Liaison Officer, Department of Defense.
[FR Doc. 04-11464 Filed 5-20-04; 8:45 am]
BILLING CODE 5001-06-P