[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