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 U.S. 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(s)
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).