1.0 DESCRIPTION
1.1 Section
201(h) of the Food, Drug and Cosmetic Act defines medical devices
as an instrument, apparatus, implement, machine, contrivance, implant,
in vitro reagent, or other similar or related article, including
a component part, or accessory which is:
1.1.1 Recognized
in the official National Formulary, or the United States Pharmacopoeia,
or any supplement to them;
1.1.2 Intended
for use in the diagnosis of disease or other conditions, or in the
cure, mitigation, treatment, or prevention of disease, in man or
other animals; or
1.1.3 Intended
to affect the structure of any function of the body of man or other
animals, and which does not achieve any of its primary intended
purposes through chemical action within or on the body of man or
other animals and which is not dependent upon being metabolized
for the achievement of any of its primary intended purposes.
1.2 Devices which meet this definition
are regulated by the U.S. Food and Drug Administration (FDA) and
are subject to premarketing and postmarketing regulatory controls.
(For further information see the FDA’s web site:
http://www.fda.gov.)
2.0 POLICY
2.1 Medical
devices may be covered when medically necessary, appropriate, the
standard of care, and not otherwise excluded.
2.2 Medical devices must be FDA
approved or of a type not requiring pre-market approval by the FDA.
Not all of these (either FDA approved or those not requiring pre-market
approval) are covered. Not all FDA approved devices are covered.
Coverage of a medical device is subject to all other requirements
of the law, rules, and policy governing TRICARE. If the device is
used for a noncovered or excluded indication, benefits may not be
allowed. For example, tinnitus masker is an FDA approved device;
however, TRICARE considers this device unproven and, therefore,
not a benefit.
2.3 Effective July 27, 2012, coverage
may be considered for off-label uses of devices.
2.3.1 Off-label
uses of devices must meet the definition of Off-Label Use of a Drug
or Device as described in
32 CFR 199.2:
Off-Label Use of a Drug or
Device. A use other than an intended use for which the prescription
drug, biologic or device is legally marketed under the Federal Food,
Drug, and Cosmetic Act or the Public Health Services Act. This includes
any use that is not included in the approved labeling for an approved drug,
licensed biologic, approved device or combination product; any use
that is not included in the cleared statement of intended use for
a device that has been determined by the Food and Drug Administration
(FDA) to be substantially equivalent to a legally marketed predicate
device and cleared for marketing; and any use of a device for which
a manufacturer or distributor would be required to seek pre-market
review by the FDA in order to legally include that use in the device’s
labeling.
2.3.2 Approval
for reimbursement of off-label uses of devices shall be provided
by the contractor. The contractor shall provide approval for the
reimbursement of off-label uses when the off-label use is medically
necessary and demonstrations from medical literature, national organizations,
or technology assessment bodies show that the off-label use of the
device is safe, effective and in accordance with nationally accepted
standards of practice in the medical community. If the device is
FDA approved and the off-label use is medically necessary, supported
by medical literature identified by the contractor, which indicates
the device is nationally accepted as standard practice, and is not
otherwise excluded, the contractor shall approve the cost-sharing
for the off-label medical device.
2.4 A humanitarian use device approved
for marketing through a Humanitarian Device Exemption application
may be covered. Coverage of any such device is subject to all other
requirements of the law, rules, and policy governing TRICARE.
2.5 TRICARE
will consider for coverage a device with an FDA approved Investigational
Device Exemption (IDE) categorized by the FDA as non-experimental/investigational
(FDA Category B) for beneficiaries participating in FDA approved
clinical trials. Coverage of any such Category B device is dependent
on its meeting all other requirements of the law, rules, and policy
governing TRICARE and upon the beneficiary involved meeting FDA
approved IDE study protocols.
2.6 Devices
with a FDA approved IDE categorized by the FDA as non-experimental/investigational (FDA
Category B), which was the subject of an FDA approved clinical trial(s),
may be considered for coverage once it receives FDA approval for
commercial marketing. Coverage is dependent on the device meeting
the FDA requirements/conditions of approval and all other requirements
governing TRICARE.
4.0 EFFECTIVE DATES
4.1 Device
used for an FDA approved application. Effective date is the date
of the FDA approval.
4.2 Category
B IDEs. Effective date is the date the device is classified as a
Category B device by the FDA.
4.3 Off-label
uses of medical devices. Effective date is July 27, 2012.