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.