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.