Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); Clarification of the CHAMPUS Exclusion of Unproven Drugs, Devices and Medical Treatments and Procedures

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