TRICARE Policy Manual 6010.63-M, April 2021
Other Services
Chapter 8
Section 2.3
ExternalAnd Implantable Infusion Pumps
Issue Date:February 26, 1986
Authority:32 CFR 199.4(d)(1)
Copyright:CPT only © 2006 American MedicalAssociation (or such other date of publication of CPT).All Rights Reserved.
Revision:
1.0CPT CODES
36260 - 36262, 36530 - 36535,62350 - 62368, 96530
2.0HCPCS Codes
Level II Codes A9274, E0780,E0784, Q0081, Q0084 - Q0085
3.0DESCRIPTION
3.1An ExternalInfusion Pump (EIP) is a device designed to deliver measured amountsof a drug through injection over a period of time into a patientin a controlled manner.
3.2A Transdermal Insulin DeliverySystem is considered a subset of the broader category of ExternalInsulin Infusion Pumps (EIIPs). A patch filled with insulin is placedon the skin and penetration of the skin occurs by low-frequencyultrasound, use of an electrical charge (i.e., iontophoresis), oruse of a microneedle. Some devices deliver a continuous low doseof basal insulin through the skin and/or deliver bolus insulin upondemand. Other than the device worn on the skin, there are no additionalcomponents or separate control devices that manage or monitor theinsulin dosage. Additionally, these devices may be fully disposable.
3.3An Implantable Infusion Pump(IIP) system delivers therapeutic plasma levels of active drug toa target organ or body compartment for prolonged periods of time.The bulk flow of drug is generated either by fluorocarbon propellant(nonprogrammable IIP) or direct electromechanical action poweredby a battery (programmable IIP). The pump is surgically implantedin a subcutaneous pocket and connects to a dedicated catheter thathas been placed in the appropriate compartment. Constant or variable-rateinfusions are possible over long periods of time (several weeksto years) with minimal human intervention (refilling or reprogramming) whileretaining the capability for external control of rate and volumeof primary and supplemental drug delivery. In addition to the pumpitself, dependent on the type of pump used, the components of thesystem may include any of the following: reservoir, optional accessport, connectors, various size catheters, micropore filter, hand-held programmer,and a variety of accessories.
4.0POLICY
4.1ExternalInfusion Pump (EIP)
4.1.1Claims may be reimbursed formedically necessary United States (US) Food and Drug Administration (FDA)approved EIPs when used according to label specifications in deliveringcontinuous or intermittent drug therapy on an inpatient or outpatientbasis.
4.1.2Supplies for the effectiveuse of the EIP must be FDA approved. Such supplies include thosedrugs and biologicals prescribed for usage directly into the EIPin order to achieve the therapeutic benefit of the EIP, or to assurethe proper functioning of the equipment.
4.1.3EIPs andotherwise covered medical supplies required in the administrationof the drug therapy performed in the home are covered.
4.1.4Other medical conditions requiringthe use of an infusion of medicine from a FDA-approved EIP may be costshared when medical review determines the treatment to be medicallynecessary and generally accepted medical practice. Examples of coveredmedical conditions requiring the use of FDA-approved EIPs.
4.1.4.1Cancer chemotherapy agents.
4.1.4.2Morphine when used in the treatmentof intractable pain.
4.1.4.3Desferoxamine.
4.1.4.4Insulin: When the patient hasone of the following indications (list is all-inclusive):
•When the diagnosis is insulindependent Type 1 diabetes mellitus and there is documentation bythe physician of poor diabetic control; OR
•For Cystic Fibrosis-RelatedDiabetes (CFRD) under the rare disease policy as described in Chapter 1, Section 3.1; OR
•For Type 2 diabetes mellituswhen there is documentation by the physician of poor diabetic controlAND the patient has failed to achieve glycemic control after sixmonths of Multiple Daily Injection (MDI) therapy.
4.1.4.5Antibiotic therapy.
4.1.4.6Heparin therapy in treatmentof thromboemobolic disease.
4.1.5EIPs,to include disposable EIPs that are medical supplies, are cost-sharedas Durable Medical Equipment (DME). (See the TRICARE Reimbursem*ntManual (TRM), Chapter 2, Addendum A for cost-sharing and copaymentamounts; see TRM, Chapter 1, Section 11 for more informationon reimbursem*nt of DME.)
4.2TransdermalInsulin Delivery System
The ValeritasV-Go™ Insulin Delivery Device (V-Go) is FDA approved as a ClassII, EIIP for the continuous subcutaneous delivery of insulin inpreset basal rates with on-demand bolus dosing for adult patientsrequiring insulin. The V-Go is a fully mechanical device using acompressed spring and does not require electronics, batteries, orsoftware. It is a patient fillable, single-use, completely disposableinsulin infusion device with an integrated stainless steel subcutaneousneedle. The device is used for the subcutaneous delivery of 24 hoursof U-100 fast-acting insulin (i.e., Humalog® [insulin lispro] andNovolog® [insulin aspart]). Documentation of the following must beprovided in order for TRICARE to consider a claim for payment:
4.2.1The patienthas Type 2 diabetes mellitus; and
4.2.2The patientdoes not need more than 40 units of basal insulin daily and thepatient does not need more than 36 units of bolus insulin daily;and
4.2.3The patient does not need lessthan two unit increments of bolus dosing; and
4.2.4The patienthas been maintained on stable basal insulin for at least three months(at dosages of 20U, 30U, or 40U); and
4.2.5The patienthas been using prandial insulin for at least three months.
4.3Implantable Infusion Pump (IIP)
Claims may be reimbursed forservices and supplies related to the use of medically necessary,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 mayinclude but are not limited to the following (please note “EXCLUSIONS”and “EFFECTIVE DATES” listed below):
4.3.1Treatmentof primary liver cancer or metastatic colorectal liver cancer wherethe metastases are limited to the liver with continuous hepaticartery infusions of chemotherapeutic agents (e.g., floxuridine,doxorubicin hydrochloride, cisplatin, methotrexate, with bacteriostaticwater or physiologic saline and/or heparin);
4.3.2Treatment of osteomyelitiswith administration of antibiotics (e.g., clindamycin);
4.3.3Treatment of chronic intractablepain of malignant or nonmalignant origin by administration of opioid drugs(e.g., morphine) intrathecally or epidurally in patients who havea life expectancy of at least three months and who have not respondedto less invasive medical therapy. Documentation of the followingmust be provided in order for TRICARE to consider a claim for payment:
4.3.3.1Inadequate response to noninvasivemethods of pain management such as systemic opioids, including attemptsto eliminate physical and behavioral abnormalities which may causean exaggerated reaction to pain, and
4.3.3.2A preliminary trial of intraspinalopioid with a temporary intrathecal/epidural catheter to evaluate painrelief, side effects, and patient acceptance.
4.3.4Treatment of chronic intractablespasticity with administration of anti-spasmodic drugs (e.g., baclofen) inpatients who have proven unresponsive to less invasive medical therapy.The following must be provided in order to consider a claim forpayment:
4.3.4.1Documentation of inadequatecontrol of spasticity or intolerable side effects resulting fromat least a six week trial of noninvasive methods of spasm controlwith drugs such as oral antispasmodics alone or combined with anticonvulsants(depending on the disease progression and the patient’s symptoms),and
4.3.4.2Documentation of a favorableresponse to a trial intrathecal dose of the antispasmodic drug priorto pump implantation;
4.3.5Secondlevel review is required for all other IIP uses. Reimbursem*nt maybe considered for other uses of IIPs (not specifically excludedin paragraph 6.0)with documentation of the following:
4.3.5.1The medical necessity of thedrug;
4.3.5.2The medical necessity and appropriatenessof an IIP to deliver the drug; and
4.3.5.3The IIP use adheres to theFDA approved labeling for the pump and the drug.
4.4Off-Label Uses For EIPs AndIIPs
Effective July 27, 2012, whenprovided in accordance with Section 5.1,EIPs and IIPs, including related services and supplies, providedfor off-label uses may be cost-shared unless such use is specificallyexcluded by TRICARE statute, regulation, or policy.
5.0POLICY CONSIDERATIONS
5.1FDA-approved IIPs are labeledfor specific drugs and routes of administration, e.g., intravenous fluorouracil(5-FU), intra-arterial floxuridine, epidural morphine sulfate, intrathecalmorphine sulfate, and intrathecal baclofen. Payments of claims maybe considered for IIPs used according to label specifications.
5.2Reimbursem*nt will follow theappropriate methodology for the place where the services are delivered, i.e.,services provided in a hospital will be reimbursed according tothe appropriate inpatient reimbursem*nt methodology; reimbursem*ntfor physician’s office services will follow appropriate outpatientreimbursem*nt procedures. When the implantation is performed onan inpatient basis, charges for the pump and the related equipment,supplies, and drugs will be included in the hospital charges. Ifservices performed in the physician’s office are primarily for maintenanceand refilling of the infusion system, reimbursem*nt is limited tothe charges for the maintenance and refilling services; no allowancemay be made for an office visit.
5.3In additionto IIPs, implanted access ports and pulsatile pumps forming a self-sealingpatent access portal for the administration of intravenous medications(e.g., Port-a cath, Medi-port and Infusiport systems) may be cost-shared.These systems are distinguished from IIPs by the method of controllingthe drug delivery rate. Access ports deliver drugs by passive diffusion.Pulsatile pumps deliver drugs when the patient manually compressesthe device. Drug delivery rates in IIPs are controlled by vaporpressure or by direct electromechanical action.
6.0EXCLUSIONS
6.1TRICARE currently classifiesthe use of implantable infusion pumps in the treatment of thromboembolic diseaseand diabetes as unproven. TRICARE may not, therefore, reimbursecharges for the use of IIPs for these indications.
6.2IIP labels include specificcontraindications. Claims for IIPs and related services and suppliesfor pumps not used in accordance with FDA approved label specificationsmay not be reimbursed.
7.0EFFECTIVE DATES
7.1Chemotherapyfor malignancies: March 14, 1988.
7.2Antibioticsfor osteomyelitis: February 2, 1989.
7.3Opioidsfor chronic intractable pain of malignant origin: July 25, 1991.
7.4Opioids for chronic intractablepain of nonmalignant origin: October 28, 1991.
7.5Antispasmodics for chronicintractable spasticity: August 12, 1992.
7.6Insulinfor Type 2 diabetes mellitus: August 1, 2010.
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