1.0 Policy
By law, TRICARE can only cost-share
medically necessary supplies and services. TRICARE regulations and
program policies restrict benefits to those drugs, devices, treatments,
or procedures for which the safety and efficacy have been proven
to be comparable or superior to conventional therapies. Any drug,
device, medical treatment, or procedure whose safety and efficacy
has not been established is unproven and is excluded from coverage.
2.0 A drug, device, medical treatment,
or procedure is unproven:
2.1 If the
drug or device cannot be lawfully marketed without the approval
or clearance of the United States (US) 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.
2.2 If a medical device with an
Investigational Device Exemption (IDE) approved by the FDA is categorized
by the FDA as experimental/investigational (FDA Category A).
2.3 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.
2.4 If the reliable evidence shows
that the consensus among experts regarding the medical treatment
or procedure is that further studies or clinical trials are necessary
to determine its maximum tolerated dose, its toxicity, its safety,
or its effectiveness as compared with the standard means of treatment
or diagnosis.
3.0 This exclusion includes all
services directly related to the unproven drug, device, medical
treatment or procedure.
4.0 Cost-sharing may be allowed
for services or supplies when there is no logical or causal relationship between
the unproven drug, device, 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 cost-sharing
is authorized in the following circumstances:
4.1 Treatment
that is not related to the unproven drug, device, treatment, or
procedure; e.g., medically necessary treatment the beneficiary would
have received in the absence of the unproven drug, device, treatment, or
procedure.
4.2 Treatment which is a necessary
follow-up to the unproven drug, device, treatment, or procedure
but which might have been necessary in the absence of the unproven
treatment.
5.0 In
making a determination that a drug, device, medical treatment, or
procedure has moved from the status of unproven to the position
of nationally accepted medical practice, TRICARE uses the following
hierarchy of reliable evidence (see
32
CFR 199.2):
5.1 Well
controlled studies of clinically meaningful endpoints, published
in refereed medical literature.
5.2 Published
formal technology assessments.
5.3 The published
reports of national professional medical associations.
5.4 Published national medical
policy organization positions.
5.5 The
published reports of national expert opinion organizations.
6.0 The hierarchy of reliable evidence
of proven medical effectiveness, established by
paragraph 5.1 through
5.5,
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, medical treatment, or procedure as their personal
treatment or procedure of choice or standard of practice.
7.0 TRICARE policy and benefit
structure is never based solely on that of other Government medical
programs, including Medicare, because each operates under its own
statutes and regulations. Furthermore, while TRICARE may examine
the policies of private third party payers, TRICARE coverage may
only be based on governing statutes and regulations.
8.0 The contractor shall routinely
review the hierarchy of reliable evidence, as defined in
32
CFR 199.2, and provide a report to the Defense Health
Agency (DHA) when the contractor identifies drugs, devices, medical treatments,
or procedures that they believe have moved from unproven to proven.
DHA will apply the standards and procedures in TRICARE regulation
and policy and if determined by DHA to have moved to proven, will
notify all contractors that the drug, device, medical treatment,
or procedure is proven and a part of the TRICARE benefit.
9.0 For drugs, devices, medical
treatments, and procedures that TRICARE has determined have moved
from the status of unproven to the status of proven in accordance
with the procedure established in
paragraph 5.0, the effective date (or the
date on which the particular drug, device, medical treatment, or
procedure may be cost-shared) is the date published reliable evidence
(as described in
32 CFR 199.2)
shows proven medical effectiveness. For example, the effective date
may be established as the date of publication of a well-controlled
study of clinically meaningful endpoints published in refereed medical
literature, or the publication date of a formal technology assessment.
Note: See
Chapter 8, Section 5.1 for policy on medical
devices, including coverage of off-label uses of medical devices,
Humanitarian Use Devices and a FDA-approved IDE categorized by the
FDA as non-experimental/investigational (FDA Category B).