[Federal Register Volume 62, Number 3 (Monday, January 6, 1997)]
[Rules and Regulations]
[Pages 625-631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-101]


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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 Exclusion of Unproven Drugs, 
Devices and Medical Treatments and Procedures

AGENCY: Office of the Secretary, DoD.

ACTION: Final rule.

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SUMMARY: This final rule clarifies the CHAMPUS exclusion of unproven 
drugs, devices and medical treatments and procedures and describes the 
process that the Office of CHAMPUS follows in determining when such 
drugs, devices, treatments and procedures have moved from the status of 
unproven to the position of proven medical effectiveness. 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.

DATES: This final rule is effective February 5, 1996.

ADDRESSES: Office of the Civilian Health and Medical Program of the 
Uniformed Services (OCHAMPUS), Program Development Branch, Aurora, CO 
80045-6900.

FOR FURTHER INFORMATION CONTACT:
Rene Morrell, Program Development Branch, OCHAMPUS, telephone (303) 
361-1218.

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 or 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

[[Page 626]]

regulations and program policies exclude cost-sharing of procedures 
which are unproven, including those that remain in a developmental 
status. The evolution of any medical technology or procedure from 
unproven 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 has proven medical effectiveness, 
CHAMPUS uses the following hierarchy of assessment sources:
    1. Well-controlled studies of clinically meaningful endpoints, 
published in refereed medical literature.
    2. Formal technology assessments from nationally recognized 
technology assessment groups, such as the:

--Food and Drug Administration (FDA);
--Agency for Health Care Policy and Research (AHCPR);
--Emergency Care Research Institute (ECRI).
3. National medical policy organization positions such as the:
--Medical Advisory Panel of the National Blue Cross/Blue Shield 
Association.
4. National professional medical association positions 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.

    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 final rule does not present new agency policy. Rather, it 
reaffirms and clarifies existing CHAMPUS policy in the body of the 
CHAMPUS regulation. We revise the regulation primarily in response to a 
series of U.S. district court decisions concerning one particular 
unproven 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 evidence submitted to the court.
    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.
    Two Circuit Courts of Appeals have recently addressed this issue, 
and reached conflicting results. In Smith v. OCHAMPUS, No. 94-3744, 7th 
Cir., Sept. 26, 1995, the Seventh Circuit Court of Appeals ruled that 
the CHAMPUS exclusion for HDC/SCR for breast cancer was justified, but 
the opposite answer was reached by the Fourth Circuit Court of Appeals 
in Wilson v. OCHAMPUS, No. 95-1016, 4th Cir., Sept. 15, 1995. The 
Seventh Circuit recently granted a motion for rehearing in the Smith 
case.
    OCHAMPUS has carefully reviewed the evidence on HDC/SCR as a 
treatment for breast cancer. It is our conclusion that it continues to 
be an unproven treatment because the chemotherapy regimen is not 
approved by FDA, no well-controlled clinical trials have proven the 
effectiveness of HDC/SCR for breast cancer (and certain other cancers 
as well), and because formal technology assessment studies have 
concluded similarly. The CHAMPUS policy regarding the unproven nature 
of HDC/SCR for breast cancer is based upon a series of reports from 
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.;
    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.;
    3. The June 1993 study entitled ``Autologous Bone Marrow Transplant 
and Peripheral Blood Stem Cell Rescue for the Treatment of Breast 
Cancer'' copyright by the Emergency Care Research Institute (ECRI) 5200 
Butler Pike, Plymouth Meeting, Pa 19462; and
    4. The February 1995 ECRI assessment of ``Autologous Bone Marrow 
Transplant and Peripheral Blood Stem Cell Rescue for the Treatment of 
Breast Cancer.''
    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 
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 continually monitored development of the literature and 
the status of ongoing well-controlled clinical trials regarding the 
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 provided independent 
reconfirmation of the CHAMPUS position. This independent reconfirmation 
has been substantially bolstered by the 1995 ECRI studies which 
indicated 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 new studies and literature, the earlier 
conclusions of previous

[[Page 627]]

technology assessments that HDC/SCR has not been proven to be effective 
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 for the 
treatment of breast carcinoma. The CHAMPUS position is further 
supported by the Consensus Conference on Intensive Chemotherapy Plus 
Hematopietic Stem Cell Transplantation in Malignancies [(Journal of 
Clinical 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 (Hematopietic Stem Cell) 
transplantation outside the setting of clinical trial for any stage 
of breast cancer, there is amply scientific background for vigorous 
clinical investigation in this important area * * *

    Based on the evidence regarding this procedure, which demonstrates 
that it continues to be unproven, 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 unproven drugs, devices, and 
medical treatments and procedures and to specifically list a number of 
procedures we have determined are unproven.
    The Department shares public and scientific concern about 
disappointing cure rates under standard cancer therapies. In 
emphasizing refereed medical literature as the primary source of 
reliable evidence that a particular treatment or procedure has proven 
medical effectiveness, we also underscore our support for committed 
efforts to advance medical research. We have an interest and a 
responsibility to participate in the appropriate evaluation of improved 
therapeutic approaches for our patients. A number of military medical 
centers are engaged in such research protocols. In November 1994, under 
authority of 10 U.S.C. 1092, the Department of Defense undertook a 
demonstration project to authorize payment for breast cancer treatment 
under certain government approved clinical protocols. Initially, the 
demonstration project applied only to phase III clinical trials under 
approved National Cancer Institute protocols for high dose chemotherapy 
with stem cell rescue for breast cancer treatment. It was expanded in 
January of this year to include a broad range of National Cancer 
Institute sponsored Phase II and III clinical trials for other cancers. 
The Department has worked closely with the National Cancer Institute to 
establish a formal program for interagency cooperation which will 
provide an important contribution to the continued development of 
promising new cancer therapies.

C. Provisions of the Final Rule

    The final rule describes the criteria we use to identify the proven 
medical necessity of procedures, treatments, drugs, or devices, 
includes a partial list of unproven drugs, devices, treatments, and 
procedures, and makes provision for promptly treating a drug, device, 
treatment or procedure as no longer unproven when reliable scientific 
evidence supports that conclusion. Any changes to the partial list will 
be published periodically as a notice in the Federal Register.

D. Public Comments

    This final rule is based on a proposed rule published May 18, 1995 
(60 FR 26705-26709). We received seven public comments. Many of the 
comments were quite similar in wording and content. Some were very 
detailed and provided helpful insight and analysis. We thank those who 
provided input on this important issue. Significant items raised by 
commenters and our analysis of the comments are summarized below:
    1. Definitions of ``Experimental.'' We received a significant 
number of comments expressing concerns about terminology used in the 
proposed rule, particularly the use of the term ``experimental'' to 
describe treatments that had not yet established proven medical 
effectiveness.
    Response: We agree that use of this term causes more confusion than 
clarification, and have modified the final rule to delete the use of 
the term ``experimental.''
    2. Effect of CHAMPUS policy on other government agencies or other 
health care programs. We wish to underscore that this final rule 
relates to the CHAMPUS program. It does not directly affect Medicare, 
Medicaid or other payers. Each program has its own set of rules, 
requirements, and procedures. Thus, determinations by the Office of 
CHAMPUS concerning medical treatments that have established proven 
medical effectiveness and those that have not should be understood as 
representing the best judgment of the Department of Defense, but not 
necessarily reflecting the views of any other government agency or 
other health care program. In addition 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. In the interest of minimizing regulatory burden 
and confusion, CHAMPUS seeks to harmonize its coverage policy with 
other federal programs and the private sector to the extent 
appropriate.
    3. Discretionary waiver authority. One commenter suggested this 
rule provide discretionary waiver authority to the Director, OCHAMPUS, 
based on coordination at the professional level between the military 
medical services and OCHAMPUS, to ensure that individuals who might 
otherwise benefit, would not be unduly penalized by the inflexibility 
of the rule. Such a provision would be consistent with implementation 
of the managed care concept, current research protocols at military 
facilities, and the Department of Defense demonstration programs.
    Response: The CHAMPUS Regulation already allows for discretionary 
waiver authority for rare and unusual cases, consistent with applicable 
law. However, by law, CHAMPUS can only cost-share medically necessary 
supplies and services. Any drug, device or medical treatment or 
procedure whose safety and efficacy have not been established, is 
unproven and cannot be cost-shared by CHAMPUS.
    4. Definition of Reliable Evidence. We received several comments 
expressing concern about the use of the term ``reliable evidence'' in 
the proposed rule. Many of the types of evidence demanded by the 
proposed regulation do not exist for many surgical and other 
procedures. Also, simply stating that randomized controlled trials 
constitute a form of reliable evidence, does not address the question 
whether the trial demonstrates efficacy or lack thereof. The commenter 
believed that CHAMPUS needs to define more clearly how it will 
determine the boundaries of experimental, i.e., the ``gray zone'' 
between effective and ineffective treatment.
    Response: We agree that the use of this term was easily 
misunderstood and have modified the definition for clarity. The term 
``reliable evidence'' means well controlled studies of clinically 
meaningful endpoints, published in refereed medical literature; 
published formal technology assessments; published reports of national 
professional medical associations; published national medical policy 
organizations positions; and published reports of national expert 
opinion organizations. We have also included specific examples of 
resources not included in the meaning of reliable evidence. As stated 
previously, the

[[Page 628]]

definition of ``experimental'' has been deleted from the rule.
    5. Benefit Limitations. We received several comments on the denial 
of payment for a procedure that uses FDA-approved products, and 
coverage of off-label uses of approved drugs in clinical trials. It was 
recommended that CHAMPUS cover the patient's care costs associated with 
any clinical trial (including all ``phases'' of evaluation) involving a 
life-threatening or other serious condition.
    Response: Some procedures, even though the procedure uses an FDA-
approved product, do not meet CHAMPUS' criteria for medically necessary 
treatment. The purpose of this provision 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 or unproven treatment. In addition, services or supplies 
for which the beneficiary or sponsor has no legal obligation to pay; or 
for which no charge would be made if the beneficiary or sponsor was not 
eligible under CHAMPUS, as may be the case in clinical trials, are not 
covered by CHAMPUS. One of the provisions of this rule allows coverage 
for a device with an FDA-approved IDE categorized by the FDA as non-
experimental/investigation (FDA Category B) for CHAMPUS beneficiaries 
participating in FDA-approved clinical trials.
    6. Off-Label Uses of Drugs. Several commenters were concerned that 
the proposed regulation does not give automatic coverage to many well-
recognized off-label uses. It was recommended that CHAMPUS adopt the 
approach that Congress utilized in the Medicaid program for all drugs 
and in the Medicare program for cancer chemotherapy. Under those 
statutes, off-label drug uses listed in the three major drug-use 
compendia--U.S. Pharmacopoeia Drug Information, the American Medical 
Association's Drug Evaluations, and the American Hospital Formulary 
Service--are automatically covered.
    Response: The above listed compendia do not meet the CHAMPUS 
criteria for ``reliable evidence.'' CHAMPUS can consider coverage of 
unlabeled or off-label uses of drugs that are otherwise approved by the 
FDA for use in humans. Approval for reimbursement of unlabeled or off-
label uses requires review for medical necessity, and also requires 
demonstrations from medical literature, national organizations, or 
technology assessment bodies that the unlabeled or off-label use of the 
drug is safe, effective and in accordance with nationally accepted 
standards of practice in the medical community.
    7. List of Excluded Procedures. We received several comments 
objecting to several of the items listed. Some comments state that the 
descriptions used in many of the items were too vague to define 
accurately which procedures are being excluded for payment and some are 
of procedures independent of the diseases or conditions that they may 
treat or mitigate. Several commenters submitted literature regarding 
intraoperative radiation therapy; single and dual photon 
absorptiomentry (DEXA); videofluroscopy, herniography, percutaneous 
balloon valvuloplasty (PBV); interoperative monitoring of sensory 
evoked potentials (SEP); radioimmunoguided surgery in the detection of 
cancer; quantitative computed tomography (QCT); percutaneous 
transluminal angioplasty (PBA); light therapy for seasonal depression; 
immunotherapy for malignant diseases; intracavity administration of 
cisplatin; palladium (103Pd) seed brachytherapy; cryosurgery for liver 
metastases; HLA-DNA typing; and home uterine activity monitoring. The 
greatest disagreement involved high-dose chemotherapy with stem-cell 
rescue for breast cancer, ovarian cancer, testicular cancer and 
multiple myeloma.
    Response: The issue of high-dose chemotherapy with stem-cell rescue 
(HSC/SCR) is addressed extensively in the preamble. The most recent 
information reconfirms, in even stronger terms and with new studies and 
literature, the earlier conclusions of previous technology assessments 
that HSC/SCR is unproven in the treatment of breast cancer. To date 
there has been no new evidence which would warrant a departure from the 
original coverage determination.
    Since the proposed rule was published, OCHAMPUS has removed 
herniography, HLA-DNA typing, cryosurgery for liver metastases, bone 
density studies [single and dual photon absorptiometry and quantitated 
computed tomography (QCT)], Contigen Bard collagen implant, 
transurethral laser incision of the prostate (TULIP) and 
intraventricular administration of narcotics from the list of unproven 
procedures. We will continually monitor the development of the 
literature and the status of ongoing well-controlled clinical trails 
regarding the effectiveness of the remaining procedures on the list. If 
and when the Director, OCHAMPUS determines that, based on reliable 
evidence, a procedure has proven medical effectiveness, the Director 
OCHAMPUS will initiate action to remove the procedure from the partial 
list of unproven drugs, devices or medical treatment or procedures.

E. 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 rule will not involve any significant burden on the 
CHAMPUS beneficiary or provider population. This rule only clarifies 
the CHAMPUS exclusion of unproven drugs, devices, treatments and 
procedures and describes the process that the Office of CHAMPUS follows 
in determining for purposes of benefit coverage when a procedure, 
treatment, drug, or device has moved from the status of unproven to the 
position of nationally accepted medical practice. This rule does not 
impose information collection requirements on the public under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.)

List of Subjects in 32 CFR Part 199

    Claims, Handicapped, Health Insurance, and Military personnel.

    Accordingly, 32 CFR Part 199 is amended as follows:
    1. The authority citation for part 199 continues to read as 
follows:

    Authority: 5 U.S.C. 301; and 10 U.S.C. Chapter 55.

    2. Section 199.2 is amended in paragraph (b) by removing the 
definition of ``Experimental'' and adding the definitions for 
``Clinically Meaningful Endpoints'', ``Rare Diseases'', ``Reliable 
Evidence'', and ``Unlabeled or Off-Labeled Drugs'' and placing them in 
alphabetical order to read as follows:


Sec. 199.2   Definitions.

* * * * *
    (b) * * *
    Clinically Meaningful Endpoints. As used the definition of reliable 
evidence in this paragraph (b) and Sec. 199.4(g)(15), the term 
clinically meaningful endpoints means objectively measurable outcomes 
of clinical interventions or other medical procedures, expressed in

[[Page 629]]

terms of survival, severity of illness or condition, extent of adverse 
side effects, diagnostic capability, or other effect on bodily 
functions directly associated with such results.
* * * * *
    Rare Diseases. CHAMPUS defines a rare disease as one which affects 
fewer than one in 200,000 Americans.
* * * * *
    Reliable evidence. (1) As used in Sec. 199.4(g)(15), the term 
reliable evidence means only:
    (i) Well controlled studies of clinically meaningful endpoints, 
published in refereed medical literature.
    (ii) Published formal technology assessments.
    (iii) The published reports of national professional medical 
associations.
    (iv) Published national medical policy organization positions; and
    (v) The published reports of national expert opinion organizations.
    (2) The hierarchy of reliable evidence of proven medical 
effectiveness, established by (1) through (5) of this paragraph, is the 
order of the relative weight to be given to any particular source. With 
respect to clinical studies, only those reports and articles containing 
scientifically valid 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.
* * * * *
    Unlabeled or Off-Label Drugs. Food and Drug Administration (FDA) 
approved drugs that are used for indications or treatments not included 
in the approved labeling. 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) to read 
as follows:


Sec. 199.4  Basic program benefits.

* * * * *
    (g) Exclusions and limitations. * * *
    (15) Unproven drugs, devices, and medical treatments or procedures. 
By law, CHAMPUS can only cost-share medically necessary supplies and 
services. Any drug, device or medical treatment or procedure, the 
safety and efficacy of which have not been established, as described in 
this paragraph (g)(15), is unproven and cannot be cost-shared by 
CHAMPUS.
    (i) A drug, device, or medical treatment or procedure is unproven:
    (A) If the drug or device cannot be lawfully marketed without the 
approval or clearance of the United States Food and Drug Administration 
(FDA) and approval or clearance for marketing has not been given at the 
time the drug or device is furnished to the patient.

    Note: Although the use of drugs and medicines not approved by 
the FDA for commercial marketing, that is for use by humans, (even 
though permitted for testing on humans) is excluded from coverage as 
unproven, drugs grandfathered by the Federal Food, Drug and Cosmetic 
Act of 1938 may be covered by 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), are not covered 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.
    CHAMPUS can also consider coverage of unlabeled or off-label 
uses of drugs that are Food and Drug Administration (FDA) approved 
drugs that are used for indications or treatments not included in 
the approved labeling. Approval for reimbursement of unlabeled or 
off-label uses requires review for medical necessity, and also 
requires demonstrations from medical literature, national 
organizations, or technology assessment bodies that the unlabeled or 
off-label use of the drug is safe, effective and in accordance with 
nationally accepted standards of practice in the medical community.

    (B) If a medical device (as defined by 21 U.S.C. 321(h)) with an 
Investigational Device Exemption (IDE) approved by the Food and Drug 
Administration is categorized by the FDA as experimental/
investigational (FDA Category A).

    Note: CHAMPUS will consider for coverage a device with an FDA-
approved IDE categorized by the FDA as non-experimental/
investigational (FDA Category B) for CHAMPUS beneficiaries 
participating in FDA approved clinical trials. Coverage of any such 
Category B device is dependent on its meeting all other requirements 
of the laws and rules governing CHAMPUS and upon the beneficiary 
involved meeting the FDA-approved IDE study protocols.

    (C) Unless reliable evidence shows that any medical treatment or 
procedure has been the subject of well-controlled studies of clinically 
meaningful endpoints, which have determined its maximum tolerated dose, 
its toxicity, its safety, and its efficacy as compared with standard 
means of treatment or diagnosis. (See the definition of reliable 
evidence in Sec. 199.2 of this part for the procedures used in 
determining if a medical treatment or procedure is unproven.)
    (D) If the consensus among experts regarding the medical treatment 
or procedure is that further studies or clinical trials are necessary 
to determine its maximum tolerated doses, its toxicity, its safety, or 
its effectiveness as compared with the standard means of treatment or 
diagnosis. (See the definition of reliable evidence in Sec. 199.2 of 
this part for the procedures used in determining if a medical treatment 
or procedure is unproven.)
    (ii) CHAMPUS benefits for rare diseases are reviewed on a case-by-
case basis by the Director, Office of CHAMPUS, or a designee. In 
reviewing the case, the Director, or a designee, may consult with any 
or all of the following sources to determine if the proposed therapy is 
considered safe and effective:
    (A) Trials published in refereed medical literature.
    (B) Formal technology assessments.
    (C) National medical policy organization positions.
    (D) National professional associations.
    (E) National expert opinion organizations.
    (iii) Care excluded. This exclusion from benefits includes all 
services directly related to the unproven drug, device, or medical 
treatment or procedure. However, CHAMPUS may cover services or supplies 
when there is no logical or causal relationship between the unproven 
drug, device or medical treatment or 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 
coverage is authorized in the following circumstances:
    (A) Treatment that is not related to the unproven drug, device or 
medical treatment or procedure; e.g., medically necessary in the 
absence of the unproven treatment.
    (B) Treatment which is necessary follow-up to the unproven drug, 
device or medical treatment or procedure but which might have been 
necessary in the absence of the unproven treatment.
    (iv) Examples of unproven drugs, devices or medical treatments or

[[Page 630]]

procedures. This paragraph (g)(15)(iv) consists of a partial list of 
unproven drugs, devices or medical treatment or procedures. These are 
excluded from CHAMPUS program benefits. This list is not all inclusive. 
Other unproven drugs, devices or medical treatments or procedures, are 
similarly excluded, although they do not appear on this partial list. 
This partial list will be reviewed and updated periodically as new 
information becomes available. With respect to any procedure included 
on this partial list, if and when the Director, OCHAMPUS determines 
that based on reliable evidence (as defined in section 199.2) such 
procedure has proven medical effectiveness, the Director will initiate 
action to remove the procedure from this partial list of unproven 
drugs, devices or medical treatment or procedures. From the date 
established by the Director as the date the procedure has established 
proven medical effectiveness until the date the regulatory change is 
made to remove the procedures from the partial list of unproven drugs, 
devices or medical treatment or procedures the Director, OCHAMPUS will 
suspend treatment of the procedure as unproven drugs, devices, or 
medical treatments or procedures. Following is the non-inclusive, 
partial list of unproven drugs, devices or medical treatment or 
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 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, except when using drugs 
approved by the FDA for this purpose.
    (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) Dorsal root entry zone (DREZ) thermocoagulation or 
micorcoagulation neurosurgical procedure.
    (S) Brain electrical activity mapping (BEAM).
    (T) Topographic brain mapping (TBM) procedure.
    (U) Ambulatory blood pressure monitoring.
    (V) Bilateral carotoid body resection to relieve pulmonary system.
    (W) Intracavitary administration of cisplatin for malignant 
disease.
    (X) Cervicography.
    (Y) In-home uterine activity monitoring for the purpose of 
preventing preterm labor and/or delivery.
    (Z) Sperm evaluation, hamster penetration test.
    (AA) Transfer factor (TF).
    (BB) Continuous ambulatory esophageal pH monitoring (CAEpHM) is 
considered unproven for patients under age 12 for all indications, and 
for patients over age 12 for sleep apnea.
    (CC) Adrenal-to-brain transplantation for Parkinson's disease.
    (DD) Videofluoroscopy evaluation in speech pathology.
    (EE) Applied kinesiology.
    (FF) 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.
    (GG) Iridology (links flaws in eye coloration with disease 
elsewhere in the body).
    (HH) Small intestinal bypass (jejunoileal bypass) for treatment of 
morbid obesity.
    (II) Biliopancreatic bypass.
    (JJ) Gastric wrapping/gastric banding.
    (KK) 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.
    (LL) Percutaneous balloon valvuloplasty for mitral and tricuspid 
valve stenosis.
    (MM) Amniocentesis performed for ISO immunization to the ABO blood 
antigens.
    (NN) Balloon dilatation of the prostate.
    (OO) Helium in radiosurgery.
    (PP) Electrostimulation of salivary production in the treatment of 
xerostomia secondary to Sjogren's syndrome.
    (QQ) Intraoperative 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.
    (RR) Autolymphocyte therapy (ALT) (immunotherapy used for treating 
metastatic kidney cancer patients).
    (SS) Radioimmunoguided surgery in the detection of cancer.
    (TT) Gait analysis (also known as a walk study or electrodynogram)
    (UU) Use of cerebellar stimulators/pacemakers for the treatment of 
neurologic disorders.
    (VV) Signal-averaged ECG.
    (WW) Peri-urethal Teflon injections to manage urinary incontinence.
    (XX) Extraoperative electrocorticography for stimulation and 
recording
    (YY) Quantitative computed tomography (QCT) for the detection and 
monitoring of osteoporosis.
    (ZZ) [Reserved]
    (AAA) Percutaneous transluminal angioplasty in the treatment of 
obstructive lesions of the carotoid, vertebral and cerebral arteries.
    (BBB) Endoscopic third ventriculostomy.
    (CCC) 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.
    (DDD) In utero fetal surgery.
    (EEE) Light therapy for seasonal depression (also known as seasonal 
affective disorder (SAD)).
    (FFF) Dorsal column and deep brain electrical stimulation of 
treatment of motor function disorder.
    (GGG) Chelation therapy, except with products and for indications 
approved by the FDA.
    (HHH) All organ transplants except heart, heart-lung, lung, kidney, 
some bone marrow, liver, liver-kidney, corneal, heart-valve, and 
kidney-pancreas transplants for Type I diabetics with chronic renal 
failure who require kidney transplants.
    (III) Implantable infusion pumps, except for treatment of 
spasticity, chronic intractable pain, and hepatic artery perfusion 
chemotherapy for the treatment of primary liver cancer or metastic 
colorectal liver cancer.
    (JJJ) Services related to the candidiasis hypersensitivity 
syndrome, yeast syndrome, or gastrointestinal candidiasis (i.e., 
allergenic extracts of

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Candida albicans for immunotherapy and/or provocation/neutralization).
    (KKK) Treatment of chronic fatigue syndrome.
    (LLL) Extracorporeal immunoadsorption using protein A columns for 
conditions other than acute idopathic thrombocytopenia purpura.
    (MMM) Dynamic posturography (both static and computerized).
    (NNN) Laparoscopic myomectomy.
    (OOO) Growth factor, including platelet-derived growth factors, for 
treating non-healing wounds. This includes Procurene, a 
platelet-derived wound-healing formula.
    (PPP) High dose chemotherapy with stem cell rescue (HDC/SCR) for 
any of the following malignancies:
    (1) Breast cancer, except for metastic breast cancer that has 
relapsed after responding to a first line treatment.
    (2) Ovarian cancer.
    (3) Testicular cancer.


    Dated: December 30, 1996.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 97-101 Filed 1-6-97; 8:45 am]
BILLING CODE 5000-04-M