[Federal Register Volume 69, Number 99 (Friday, May 21, 2004)]
[Rules and Regulations]
[Pages 29226-29230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11464]


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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]]



----------------------------------------------------------------------------------------------------------------
     T-NEX region/contractor                         States                        Start healthcare  delivery
----------------------------------------------------------------------------------------------------------------
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