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 (US) 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 US Food and Drug Administration (FDA) and are subject
to premarketing and postmarketing regulatory controls. (For further
information see the FDA’s website:
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 The contractor shall provide
approval for the reimbursement of off-label uses of devices 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.