4.1 External
Infusion Pump (EIP)
4.1.1 Claims may be reimbursed for medically necessary
U.S. Food and Drug Administration (FDA)-approved EIPs when used
according to label specifications in delivering continuous or intermittent
drug therapy on an inpatient or outpatient basis.
4.1.2 Supplies
for the effective use of the EIP must be FDA approved. Such supplies
include those drugs and biologicals prescribed for usage directly
into the EIP in order to achieve the therapeutic benefit of the
EIP, or to assure the proper functioning of the equipment.
4.1.3 EIPs and
otherwise covered medical supplies required in the administration
of the drug therapy performed in the home are covered.
4.1.4 Other medical
conditions requiring the use of an infusion of medicine from a FDA-approved
EIP may be cost shared when medical review determines the treatment
to be medically necessary and generally accepted medical practice.
Examples of covered medical conditions requiring the use of FDA-approved
EIPs.
4.1.4.1 Cancer chemotherapy agents.
4.1.4.2 Morphine
when used in the treatment of intractable pain.
4.1.4.3 Desferoxamine.
4.1.4.4 Insulin:
When the patient has one of the following indications (list is all-inclusive):
• When
the diagnosis is insulin dependent Type 1 diabetes mellitus and
there is documentation by the physician of poor diabetic control;
OR
• For
Cystic Fibrosis-Related Diabetes (CFRD) under the rare disease policy
as described in
Chapter 1, Section 3.1; OR
• For Type 2 diabetes
mellitus when there is documentation by the physician of poor diabetic
control AND the patient has failed to achieve glycemic control after
six months of Multiple Daily Injection (MDI) therapy.
4.1.4.5 Antibiotic
therapy.
4.1.4.6 Heparin therapy in treatment of thromboemobolic
disease.
4.1.5 EIPs, to include disposable
EIPs that are medical supplies, are cost-shared as Durable Medical
Equipment (DME). (See the TRICARE Reimbursement Manual (TRM),
Chapter 2, Addendum A, paragraph 3.0 for cost-sharing
and copayment amounts; see TRM,
Chapter 1, Section 11 for more information
on reimbursement of DME.)
4.2 Transdermal Insulin Delivery
System
The Valeritas V-Go™ Insulin Delivery
Device (V-Go) is FDA approved as a Class II, EIIP for the continuous
subcutaneous delivery of insulin in preset basal rates with on-demand
bolus dosing for adult patients requiring insulin. The V-Go is a
fully mechanical device using a compressed spring and does not require
electronics, batteries, or software. It is a patient fillable, single-use,
completely disposable insulin infusion device with an integrated
stainless steel subcutaneous needle. The device is used for the
subcutaneous delivery of 24 hours of U-100 fast-acting insulin (i.e.,
Humalog® [insulin lispro] and Novolog® [insulin aspart]). Documentation
of the following must be provided in order for TRICARE to consider
a claim for payment:
4.2.1 The patient has Type 2 diabetes mellitus; and
4.2.2 The patient does not need
more than 40 units of basal insulin daily and the patient does not
need more than 36 units of bolus insulin daily; and
4.2.3 The patient does not need
less than two unit increments of bolus dosing; and
4.2.4 The patient has been maintained
on stable basal insulin for at least three months (at dosages of
20U, 30U, or 40U); and
4.2.5 The patient has been using prandial insulin
for at least three months.
4.3 Implantable Infusion Pump
(IIP)
Claims may be reimbursed for services
and supplies related to the use of medically necessary, U.S. Food
and Drug Administration (FDA) approved IIPs when used according
to pump label specifications. This may include but is not limited
to implantation, refilling, servicing, maintenance, and removal
of the pump and/or accessories. Uses may include but are not limited
to the following (please note “EXCLUSIONS” and “EFFECTIVE DATES”
listed below):
4.3.1 Treatment of primary liver cancer or metastatic
colorectal liver cancer where the metastases are limited to the
liver with continuous hepatic artery infusions of chemotherapeutic agents
(e.g., floxuridine, doxorubicin hydrochloride, cisplatin, methotrexate,
with bacteriostatic water or physiologic saline and/or heparin);
4.3.2 Treatment
of osteomyelitis with administration of antibiotics (e.g., clindamycin);
4.3.3 Treatment
of chronic intractable pain of malignant or nonmalignant origin
by administration of opioid drugs (e.g., morphine) intrathecally
or epidurally in patients who have a life expectancy of at least
three months and who have not responded to less invasive medical
therapy. Documentation of the following must be provided in order
for TRICARE to consider a claim for payment:
4.3.3.1 Inadequate
response to noninvasive methods of pain management such as systemic opioids,
including attempts to eliminate physical and behavioral abnormalities
which may cause an exaggerated reaction to pain, and
4.3.3.2 A preliminary
trial of intraspinal opioid with a temporary intrathecal/epidural
catheter to evaluate pain relief, side effects, and patient acceptance.
4.3.4 Treatment
of chronic intractable spasticity with administration of anti-spasmodic
drugs (e.g., baclofen) in patients who have proven unresponsive
to less invasive medical therapy. The following must be provided
in order to consider a claim for payment:
4.3.4.1 Documentation
of inadequate control of spasticity or intolerable side effects
resulting from at least a six week trial of noninvasive methods
of spasm control with drugs such as oral antispasmodics alone or
combined with anticonvulsants (depending on the disease progression
and the patient’s symptoms), and
4.3.4.2 Documentation
of a favorable response to a trial intrathecal dose of the antispasmodic drug
prior to pump implantation;
4.3.5 Second level review is required
for all other IIP uses. Reimbursement may be considered for other
uses of IIPs (not specifically excluded in
paragraph 6.0) with documentation
of the following:
4.3.5.1 The medical necessity of the drug;
4.3.5.2 The medical
necessity and appropriateness of an IIP to deliver the drug; and
4.3.5.3 The IIP
use adheres to the FDA approved labeling for the pump and the drug.
4.4 Off-Label
Uses For EIPs And IIPs
Effective July 27,
2012, when provided in accordance with
Section 5.1,
EIPs and IIPs, including related services and supplies, provided
for off-label uses may be cost-shared unless such use is specifically
excluded by TRICARE statute, regulation, or policy.