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.