[Federal Register Volume 60, Number 96 (Thursday, May 18, 1995)]
[Proposed Rules]
[Pages 26705-26709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12031]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[DoD 6010.8-R]
RIN 0720-AA29
Civilian Health and Medical Program of the Uniformed Services
(CHAMPUS); Clarification of the CHAMPUS Definition of Experimental
AGENCY: Office of the Secretary, DoD.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This rule proposes to clarify the CHAMPUS definition of
``experimental'' and describes the process that the Office of CHAMPUS
follows in determining when an experimental procedure has moved from
the status of experimental to the position of nationally accepted
medical practice. This clarification is necessary to ensure the CHAMPUS
beneficiary and provider population understand the process the Office
of CHAMPUS (OCHAMPUS) follows prior to endorsement by CHAMPUS of a new
emerging medical technology, drug, or device for which the safety and
efficacy have been proven to be comparable or superior to conventional
therapies.
DATES: Written public comments must be received on or before July 17,
1995.
ADDRESSES: Forward comments to the Office of the Civilian Health and
Medical Program of the Uniformed Services (OCHAMPUS), Program
Development Branch, Aurora, CO 80045-6900.
FOR FURTHER INFORMATION CONTACT:
Ruth Smith, Program Development Branch, OCHAMPUS, telephone (303) 361-
1181.
SUPPLEMENTARY INFORMATION:
A. Discussion of CHAMPUS Policy
Under statutes governing CHAMPUS including 10 U.S.C. 1079, CHAMPUS
payments are prohibited for health care services that are ``not
medically or psychologically necessary.'' The purpose of this
provision, common in health care payment programs, is to prevent
CHAMPUS beneficiaries from being exposed to less than fully developed
and tested medical procedures and to avoid the associated risk of
unnecessary unproven treatment. CHAMPUS regulations and program
policies restrict benefits to those procedures for which the safety and
efficacy have been proven to be comparable or superior to conventional
therapies. In general, the CHAMPUS regulations and program policies
exclude cost-sharing of procedures which are experimental or
investigational. The evolution of any medical technology or procedure
from experimental status to one of national acceptance is often
controversial, with those members of the medical community who are
using and promoting the procedure arguing that the procedure has
national acceptance. In determining whether a procedure is
investigational, CHAMPUS uses the following hierarchy of assessment
sources: [[Page 26706]]
1. Outcome-based, Phase III trials published in refereed medical
literature.
2. Formal technology assessments from nationally recognized
technology assessment groups, such as the:
--Agency for Health Care Policy and Research (AHCPR); the
--Emergency Care Research Institute (ECRI); and the
--Food and Drug Administration (FDA).
3. National medical policy organization positions such as the:
--Medical Advisory Panel of the National Blue Cross/Blue Shield
Association.
4. National professional medical associations such as those
promulgated by the:
--American College of Obstetricians and Gynecologists.
5. National expert opinion organizations such as the
--Diagnostic and Therapeutic Technology Assessment (DATTA) group of the
American Medical Association;
--Health Care Financing Administration Technical Advisory Committee;
and the
--Office of CHAMPUS Physician Advisory Panel (representing the
Uniformed Services Surgeons General). OCHAMPUS has chosen Phase III
clinical trials as the test for measuring the safety and efficacy of
evolving medical technology procedures. Clinical trials are organized
into three phases according to the extent to which a therapy,
procedure, drug or device, has progressed in testing. The phase number
affixed to a study does not necessarily correspond to the disease stage
of patients enrolled in it. For example, in:
Phase I clinical trials, the therapies, procedures, drugs or
devices used in this stage of testing have been extensively studied in
laboratory and animal tests and are usually now being given to humans
for the first time. The aim is to find out how to give a drug or use a
procedure, and to make sure that it does not have harmful side effects.
Because the side effects in humans are unknown, only a relatively small
number of people are allowed to participate.
Therapies, procedures, drugs or devices, that successfully complete
Phase I trials then proceed to Phase II clinical trials. Since the
therapies, procedures, drugs, or devices were extensively studied in
Phase I clinical trials, side effects of each are generally known and
more people are included at this phase. Many of the people involved in
Phase II clinical trials still have other treatment options available
to them if the trial therapy, procedure, drug, or device is not
effective for them.
Next, the therapies, procedures, drugs or devices used in Phase II
clinical trials move to Phase III clinical trials if each is continuing
to demonstrate safety and effectiveness. In this phase the therapy,
procedure, drug or device being tested is compared directly with the
nationally accepted standard therapy to determine if one is superior to
the other, or if one is more effective for specific types or stages of
disease. Since reasonable safety and effectiveness have been shown
through Phase I and Phase II, many more patients are used in a Phase
III clinical trial. Additionally, the patients participating in a Phase
III clinical trial usually have not undergone standard treatment. The
patients participating in Phase III clinical trials are started on
either standard or experimental therapy so the results can be compared.
Additionally, instead of focusing on a single agent, some clinical
trials study a new drug used in combination with one or more other
compounds or other treatments such as surgery or radiation. These
clinical trials usually enroll large numbers of people, and often they
produce the most dramatic results.
CHAMPUS policy and benefit structure are never based solely on
coverage offered by other third party payers, including Medicare, since
each operates under different rules and requirements.
B. Need for the Regulation
This proposed rule does not present new agency policy. Rather, it
proposes to reaffirm and clarify existing CHAMPUS policy in the body of
the CHAMPUS regulation. We propose this primarily in response to a
series of U.S. district court decisions concerning one particular
experimental treatment, high dose chemotherapy (HDC) with stem cell
rescue (SCR) as a treatment for breast cancer (discussed more below),
in which the courts held that the CHAMPUS determination regarding this
treatment was not sufficiently established to be accepted by the
courts. For example, in Hawkins v. Mail Handlers Benefit Plan and
CHAMPUS, Civil No. 1:94CV6, W.D.N.C. (Jan. 28, 1994), the court ruled
on a motion for a preliminary injunction filed by a beneficiary of both
the Mail Handlers Benefit Plan and CHAMPUS, seeking a court order
overruling the exclusion in both plans of coverage for HDC/SCR as a
treatment for breast cancer. The court ruled in favor of the Mail
Handlers Benefit Plan, but against CHAMPUS based on judgment that the
determination that this procedure was experimental was not clearly
established by CHAMPUS and was not supported by the beneficiary's
evidence.
Similarly, in Wheeler v. Dynamic Engineering Inc., and CHAMPUS, No.
4.94CV16, E.D.Va. (April 4, 1994), another case of a beneficiary
covered by both an employer plan and CHAMPUS who sought a judgment that
both should cover HDC/SCR for breast cancer treatment, the court made a
distinction between a new company plan that specifically excluded the
procedure and the former company plan and CHAMPUS, both of which did
not expressly do so. After determining that the former plan was
applicable (based on the date the treatment began), the court ruled
that neither the plan nor CHAMPUS could properly exclude coverage of
the procedure.
OCHAMPUS has carefully reviewed the evidence on HDC/SCR as a
treatment for breast cancer. It is our conclusion that it is
experimental treatment because on Phase III trials have proven the
safety and efficacy of HDC/SCR to be comparable or superior to
conventional therapies for breast cancer (and certain other cancers as
well), and because formal technology assessment studies have concluded
similarly. The CHAMPUS policy regarding the investigational nature of
HDC/SCR for breast cancer is based upon four primary sources:
1. The 1988 study entitled ``Public Health Service Reassessment:
Autologous Bone Marrow Transplantation'' prepared by the Office of
Health Technology Assessment, Agency for Health Care Policy and
Research (OHTA/AHCPR) of the Public Health Service, and authored by
Harry Handelsman, D.O.; and
2. The American Medical Association Diagnostic and Therapeutic
Technology Assessment (AMA DATTA) evaluation of January 1990 entitled
`'Autologous Bone Marrow Transplantation 0 Reassessment'' by Elizabeth
Brown, M.D.; and
3. The June 1993 study entitled ``Autologous Bone Marrow Transplant
and Peripheral Blood Stem Cell Rescue for the Treatment of Breast
Cancer'' copyright by ECRI, 5200 Butler Pike, Plymouth Meeting, PA
19462; and
4. The most recent ECRI assessment of ``Autologous Bone Marrow
Transplant and Peripheral Blood Stem Cell Rescue for the Treatment of
Breast Cancer.'' Summary information on this assessment was published
in Health Technology Trends in June 1994. OCHAMPUS received a copy of
essentially the same material in press [[Page 26707]] release form
directly from ECRI on June 7, 1994. Based upon the information
contained in these press releases, OCHAMPUS has requested the purchase
of the completed Health Technology Assessment Report from ECRI, a draft
which has already been received.
Since the time the 1988 and 1990 reports mentioned above were
initially prepared, OCHAMPUS has performed a continuous review of the
refereed medical literature on this topic, and has had numerous
confirming discussions with the Office of Health Technology Assessment
(OHTA) of the Public Health Service regarding their position. The
latest of these discussions confirmed the lack of refereed medical
literature that would support CHAMPUS coverage of this procedure for
the treatment of breast carcinoma. Therefore, although the initial
policy classifying HDC/SCR as investigational under CHAMPUS was based
upon literature and technical assessments dating from the 1988-1990
time-frame, OCHAMPUS has continually monitored the development of the
literature and the status of ongoing Phase III trials regarding the
safety and effectiveness of this form of treatment for breast carcinoma
and other carcinomas for which it is not currently authorized as a
CHAMPUS benefit. The June 1993 formal assessment by ECRI provides
independent reconfirmation of the CHAMPUS position. This independent
reconfirmation has been substantially bolstered by the most recent ECRI
studies which indicate that ``results from the experimental procedure
are not any better than published results for conventional therapy to
treat breast cancer,'' and that ``the impetus for this (treatment) is
more political than scientific * * * (It) is a treatment that's
becoming mandated by popular opinion.'' This most recent information
reconfirms, in even stronger terms and with newer studies and
literature, the earlier conclusions of previous technology assessments
that HDC/SCR is experimental in the treatment of breast cancer. To date
there has been no new evidence which would warrant a departure from the
original coverage determination to exclude CHAMPUS cost-sharing of this
procedure as investigational for the treatment of breast carcinoma. The
CHAMPUS position is further supported by the Consensus Conference on
Intensive Chemotherapy Plus Hematopoietic Stem Cell Transplantation in
Malignacies (Journal of Oncology, Volume 12, Number 1, (January 1994);
pages 226-231; (Attachment 5) which states in part:
* * * ``Although there is currently insufficient evidence to
justify the use of HDC/plus HSC (Hematopoietic Stem Cell)
transplantation outside the setting of clinical trial for any stage of
breast cancer, there is ample scientific background for vigorous
clinical investigation in this important area * * *''.
Based on the evidence regarding this procedure, which demonstrates
that it is experimental, and the series of recent court rulings
declining to follow an exclusion not clearly established in the
governing instruments of the program, we believe this rule is necessary
to reaffirm and clarify CHAMPUS policy on experimental procedures and
to specifically list a number of procedures we have determined are
experimental.
C. Provisions of the Proposed Rule
The proposed rule describes the criteria we use to identify the
experimental nature of procedures, drugs, devices, includes a partial
list, and makes provision for promptly treating a drug, device or
procedure as no longer experimental when the scientific evidence
supports that view and the resultant. Any change to the partial list
will be published as a notice in the Federal Register.
In emphasizing refereed medical literature as the primary source of
persuasive evidence that a particular procedure's safety and efficacy
have been proven to be comparable or superior to conventional therapies
for widespread use, we also underscore our support for committed
efforts to advance medical research. A number of military medical
centers are engaged in such research protocols. In addition, we are
beginning a new DoD demonstration project, under the authority of 10
U.S.C. 1092, to authorize payments for experimental treatments provided
to CHAMPUS beneficiaries under certain government approved phase III
clinical protocols. Initially, the demonstration project will apply to
clinical trials under approved National Cancer Institute protocols for
high dose chemotherapy with stem cell rescue for breast cancer
treatment.
D. Regulatory Procedures
Executive Order 12866 requires certain regulatory assessments for
any ``significant regulatory action,'' defined as one which would
result in an annual effect on the economy of $100 million or more, or
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 regulations which would
have significant impact on a substantial number of small entities.
This proposed rule is not a significant regulatory action under
Executive Order 12866. This proposed rule will not involve any
significant burden on the CHAMPUS beneficiary or provider population.
This proposed rule only clarifies the CHAMPUS definition of
experimental and describes the process that OCHAMPUS follows in
determining for purposes of benefit coverage when an experimental
procedure, drug, or device has moved from the status of experimental to
the position of nationally accepted medical practice. This proposed
rule does not impose information collection requirements on the public
under the Paperwork Reduction Act of 1980 (44 U.S.C. 3501-3511).
This is a proposed rule. Comments from all interested parties are
solicited.
List of Subjects in 32 CFR Part 199
Claims, Handicapped, Health insurance, Military personnel.
Accordingly, 32 CFR Part 199 is proposed to be amended as follows:
1. The authority citation for Part 199 continues to read as
follows:
Authority: 5 U.S.C. 301; 10 U.S.C. chapter 55.
2. Section 199.2 is amended in paragraph (b) by revising the
definition of ``Experimental'', removing the Note following the
definition of ``Experimental'' and adding the definitions for ``Rare
diseases'' and ``Unlabelled or off labeled drugs'' in alphabetical
order to read as follows:
Sec. 199.2 Definitions.
* * * * *
(b) * * *
Experimental. A drug, device, or medical treatment or procedure is
experimental or investigational;
(1) If the drug or device cannot be lawfully marketed without
approval of the Untied States Food and Drug Administration (FDA) and
approval for marketing has not been given at the time the drug or
device is furnished to the patient; or
(2) If reliable evidence shows that the drug, device, or medical
treatment or procedure is the subject of ongoing Phase I, II, or III
clinical trials or is under study to determine its maximum tolerated
dose, its toxicity, its safety, its efficacy as compared with the
standard means of treatment or diagnosis; or
(3) If reliable evidence shows that the consensus of opinion among
experts regarding the drug, device, or medical [[Page 26708]] treatment
or procedure is that further studies or clinical trials are necessary
to determine its maximum tolerated dose, its toxicity, its safety, or
its efficacy as compared with the standard means of treatment or
diagnosis. (See Exclusions and limitations, ``Not in accordance with
accepted standards, experimental or investigational'' in Sec. 199.4 for
procedures in determining experimental.)
* * * * *
Rare diseases. CHAMPUS defines a rare disease as one which affects
fewer than one in 200,000 Americans.
* * * * *
Unlabelled or off labeled drugs. Medications that are otherwise
Food and Drug Administration (FDA) approved for general use in humans.
The drug must be medically necessary for the treatment of the condition
for which it is administered, according to accepted standards of
medical practice.
* * * * *
3. Section 199.4 is amended by revising paragraph (g)(15) as
follows:
Sec. 199.4 Basic program benefits.
* * * * *
(g) Exclusions and limitations. * * *
* * * * *
(15) Not in accordance with accepted standards, experimental, or
investigational. Among the services excluded from CHAMPUS program
benefits on the grounds that they are not medically or psychologically
necessary are services and supplies not provided in accordance with
accepted professional medical standards, or related to essentially
experimental or investigational procedures or treatment regimens. (See
the definition of ``experimental'' in Sec. 199.2.)
(i) General. For the purpose of determining experimental:
(A) The term reliable evidence shall mean only:
(1) Outcome-based, Phase III trials published in refereed medical
literature.
(2) Published formal technology assessments.
(3) The published reports of national professional medical
associations.
(4) Published national medical policy organization positions.
(5) The published reports of national expert opinion organizations.
(B) The order given in the iteration of sources of evidence in
paragraph (g)(15)(i)(A) of this section is in the order of the relative
weight to be given to any particular source. Only those reports and
articles containing scientifically validated data and published in the
refereed medical and scientific literature shall be considered as
meeting the requirements of reliable evidence. Specifically not
included in the meaning of reliable evidence are reports, articles, or
statements by providers or groups of providers containing only
abstracts, anecdotal evidence or personal professional opinions. Also
not included in the meaning of reliable evidence is the fact that a
provider or a number of providers have elected to adopt a drug, device,
or medical treatment or procedure as their personal treatment or
procedure of choice or standard of practice.
(C)(1) Use of drugs and medicines and devices not approved by the
FDA for commercial marketing, that is, for general use by humans (even
though permitted for testing on human beings) is considered
experimental. Drugs grandfathered by the Federal Food, Drug and
Cosmetic Act of 1938 may be covered under CHAMPUS as if FDA approved.
Certain cancer drugs, designated as Group C drugs (approved and
distributed by the National Cancer Institute) and Treatment
Investigational New Drugs (INDs), cannot be cost-shared under CHAMPUS
because they are not approved for commercial marketing by the FDA.
However, medical care related to the use of Group C drugs and Treatment
INDs can be cost-shared under CHAMPUS when the patient's medical
condition warrants their administration and the care is provided in
accordance with generally accepted standards of medical practice. In
areas outside the United States, standards comparable to those of the
FDA are the CHAMPUS objective.
(2) CHAMPUS can consider cost-sharing ``unlabelled or off label''
uses of medications that are otherwise approved by the FDA for general
use in humans. Approval for cost-sharing of ``off label or unlabelled''
indications requires review for medical necessity, and also requires
demonstrations from medical literature, national organizations, and/or
technology assessment bodies that the ``off label or unlabelled'' usage
of the drug is safe, effective, and a nationally accepted standard of
practice in the medical community.
(D) CHAMPUS benefits for a rare disease are reviewed on a case-by-
case basis by the Director, OCHAMPUS, or designee. In reviewing the
case, the Director, OCHAMPUS, or designee may consult with any or all
of the following sources to determine if the proposed therapy is
considered safe and effective:
(1) Trials published in refereed medical literature.
(2) Formal technology assessments.
(3) National medical policy organization positions.
(4) National professional associations.
(5) Regional expert opinion organizations.
(6) Individual and small group expert opinion.
(ii) Care excluded. This exclusion includes all services directly
related to the experimental or investigational procedure. However,
CHAMPUS may cost-share services or supplies when there is no logical or
causal relationship between the experimental or investigational
procedure and the treatment at issue or where such a logical or causal
relationship cannot be established with a sufficient degree of
certainty. This CHAMPUS cost-sharing is authorized in the following
circumstances:
(A) Treatment that is not related to the investigational or
experimental procedure; e.g., medically necessary in the absence of the
experimental or investigational treatment.
(B) Treatment which is a necessary follow-on to the experimental or
investigational procedure but which might have been necessary in the
absence of the experimental or investigational treatment.
(iii) Examples of experimental procedures. This paragraph consists
of a partial list of experimental or investigational procedures. Such
procedures are excluded from CHAMPUS program benefits. This list is not
all inclusive. Other experimental procedures, as defined in Sec. 199.2,
are similarly excluded, although they do not appear on this partial
list. With respect to any procedure included on this partial list, if
and when the Director, OCHAMPUS determines that based on the standards
established in the definition of ``experimental'' in Sec. 199.2, such
procedure is no longer experimental or investigational, the Director
will initiate action to remove the procedure from this partial list of
experimental procedures. From the date established by the Director as
the date the procedure became no longer experimental until the date the
regulatory change is made to remove the procedures from the partial
list of experimental procedures, the Director, OCHAMPUS will suspend
treatment of the procedure as an experimental procedure. Following is
the non-inclusive, partial list of experimental procedures, all of
which are excluded from CHAMPUS benefits:
(A) Radial keratotomy (refractive keratoplasty).
(B) Cellular therapy.
(C) Histamine therapy.
(D) Stem cell assay, a laboratory procedure which allows a
determination to be made of the type and dose of [[Page 26709]] cancer
chemotherapy drugs to be used, based on in vitro analysis of their
effects on cancer cells taken from an individual.
(E) Topical application of oxygen.
(F) Immunotherapy for malignant disease.
(G) Prolotherapy, joint sclerotherapy, and ligamentous injections
with sclerosing agents.
(H) Transcervical block silicone plug.
(I) Whole body hyperthermia in the treatment of cancer.
(J) Portable nocturnal hypoglycemia detectors.
(K) Testosterone pellet implants in the treatment of females.
(L) Estradiol pellet implants.
(M) Epikeratophakia for treatment of aphakia and myopia.
(N) Bladder stimulators.
(O) Ligament replacement with absorbable copolymer carbon fiber
scaffold.
(P) Intraoperative radiation therapy.
(Q) Gastric bubble or balloon.
(R) Single and dual photon absorptiometry for the detection and
monitoring of osteoporosis.
(S) Dorsal root entry zone (DREZ) thermocoagulation or
microcoagulation neurosurgical procedure.
(T) Brain electrical activity mapping (BEAM).
(U) Topographic brain mapping (TBM) procedure.
(V) Ambulatory blood pressure monitoring.
(W) Bilateral carotid body resection to relieve pulmonary symptoms.
(X) Intracavitary administration of cisplatin for malignant
disease.
(Y) Cervicography.
(Z) Ambulatory home monitoring--uterine contractions.
(AA) Sperm evaluation, hamster penetration test.
(BB) Transfer factor (TF).
(CC) Continuous ambulatory esophageal pH monitoring (CAEpHM) is
considered investigational for patients under age 12 for all
indications, and for patients over age 12 for sleep apnea.
(DD) Adrenal-to-brain transplantation for Parkinson's disease.
(EE) Videofluoroscopy evaluation in speech pathology.
(FF) Herniography.
(GG) Applied kinesiology.
(HH) Hair analysis to identify mineral deficiencies from the
chemical composition of the hair. Hair analysis testing may be
reimbursed when necessary to determine lead poisoning.
(II) Iridology (links flaws in eye coloration with diseases
elsewhere in the body).
(JJ) Small intestinal bypass (jejunoileal bypass) for treatment of
morbid obesity.
(KK) Biliopancreatic bypass.
(LL) Gastric wrapping/gastric banding.
(MM) Calcium EAP/calcium orotate and selenium (also known as Nieper
therapy)--Involves inpatient care and use of calcium compounds and
other non-FDA approved drugs and special diets. Used for cancer, heart
disease, diabetes, and multiple sclerosis.
(NN) Percutaneous balloon valvuloplasty for mitral and tricuspid
valve stenosis.
(OO) Amniocentesis performed for ISO immunization to the ABO blood
antigens.
(PP) Balloon dilatation of the prostate.
(QQ) Helium in radiosurgery.
(RR) Palladium 103Pd) seed brachytherapy.
(SS) Electrostimulation of salivary production in the treatment of
xerostomia secondary to Sjorgren's syndrome.
(TT) Interaoperative monitoring of sensory evoked potentials (SEP).
To include visually evoked potentials, brainstem auditory evoked
response, somatosensory evoked potentials during spinal and orthopedic
surgery, and sensory evoked potentials monitoring of the sciatic nerve
during total hip replacement. Recording SEPs in unconscious head
injured patients to assess the status of the somatosensory system. The
use of SEPs to define conceptional or gestational age in preterm
infants.
(UU) Autolymphocyte therapy (ALT) (immunotherapy used for treating
metastatic kidney cancer patients).
(VV) Radioimmunoguided surgery in the detection of cancer.
(WW) HLA-DNA typing.
(XX) Gait analysis (also known as a walk study or electrodynogram).
(YY) Cryosurgery for liver metastases.
(ZZ) Use of cerebellar stimulators/pacemakers for the treatment of
neurologic disorders.
(AAA) Signal-averaged ECG.
(BBB) Intraventricular administration of narcotics.
(CCC) Peri-urethral Teflon injections to manage urinary
incontinence.
(DDD) Extraoperative electrocorticography for stimulation and
recording in order to determine electrical thresholds of neurons as an
indicator of seizure focus.
(EEE) Quantitative computed tomography (QCT) for the detection and
monitoring of osteoporosis.
(FFF) Percutaneous transluminal angioplasty in the treatment of
obstructive lesions of the carotid, vertebral and cerebral arteries.
(GGG) Endoscopic third ventriculostomy.
(HHH) Holding therapy--Involves holding the patient in an attempt
to achieve interpersonal contact, and to improve the patient's ability
to concentrate on learning tasks.
(III) In utero fetal surgery.
(JJJ) Light therapy for seasonal depression (also known as seasonal
affective disorder (SAD)).
(KKK) Transurethral laser incision of the prostrate (TULIP).
(LLL) Contigen Bard collagen implant.
(MMM) Dorsal column and deep brain electrical stimulation of
treatment of motor function disorder.
(NNN) Chelation therapy, except under specific conditions.
(OOO) All organ transplants except heart, heart-lung, lung, kidney,
some bone marrow, liver, liver-kidney, corneal, and heart-valve.
(PPP) Implantable infusion pumps, except for hepatic artery
perfusion chemotherapy for the treatment of primary liver cancer or
metastatic colorectal liver cancer.
(QQQ) Services related to the candidiasis hypersensitivity
syndrome, yeast syndrome, or gastrointestinal candidiasis (i.e.,
allergenic extracts of Candida albicans for immunotherapy and/or
provocation/neutralization).
(RRR) Treatment of chronic fatigue syndrome.
(SSS) Extracorporeal immunoadsorption using protein A columns for
conditions other than acute idiopathic thrombocytopenia purpura.
(TTT) Dynamic posturography (both static and computerized).
(UUU) Laparoscopic myomectomy.
(VVV) Growth factor, including platelet-derived growth factors, for
treating non-healing wounds. This includes procuremen, a
platelet-derived wound-healing formula.
(WWW) High dose chemotherapy with stem cell rescue (HDC/SCR) for
any of the following malignancies:.
(1) Breast cancer.
(2) Ovarian cancer.
(3) Testicular cancer.
(4) Multiple myeloma.
* * * * *
Dated: May 11, 1995.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 95-12031 Filed 5-17-95; 8:45 am]
BILLING CODE 5000-04-M
