PAGE: 1of 8 This Medical policy is not a guarantee of benefits or coverage, nor should it be deemed as medical advice. In the event of any conflict concerning benefit coverage, the employer/member summary plan document (SPD) supersedes this medical policy. DEFINITIONS: Infusion therapy involves the administration of medication through a needle or catheter. It is prescribed when a patient s condition is so severe that it cannot be treated effectively by oral medications. Typically, infusion therapy means that a drug is administered intravenously, but the term also may refer to situations where drugs are provided through other non-oral routes, such as intramuscular injections and epidural routes (into the membranes surrounding the spinal cord). INDICATIONS: Administration of drugs intravenously, or other non-oral routes, such as intramuscular injections and epidural routes for cancer and cancer-related pain, infections unresponsive to oral antibiotics, immune deficiencies, multiple sclerosis, rheumatoid arthritis, Crohn s disease, congestive heart failure, dehydration, gastrointestinal disease or disorders, and more per the National Home Infusion Association. POLICY: Administration of the drug must be medically necessary for the medical condition and it must be medically necessary that the drug be administered intravenously. The method of delivery. i.e., intravenously and/or implantable, must be FDA approved for the particular drug administration. The medical records and history regarding treatment request must be medically supportive. NOTE: When additional chemotherapy cycles or radiation treatments for the same illness previously approved by the medical director for that illness the utilization and case management nurse will facilitate when medical supportive documentation indicates there is no change in the regime. The nurse will review all clinical information from the provider s representative. Clinical information will include diagnosis and medical necessity for additional treatments, and any CT, MRI or PET/CT scan results to support continued treatment and document the patient s MHealth file. 1
PAGE: 2 of 8 Intravenous Iron Infusion Therapy Symptomatic iron deficiency (fatigue, irritability, decreased exercise tolerance, headaches) or microcytic iron deficiency anemia in the face of low stores that are unable to be replenished by oral iron therapy and/or the patient is intolerant of oral iron determined by the following criteria: Ferritin level <15 ng/ml (ferritin concentration > 100ng/ml effectively rules out iron deficiency). There are no absolute indicators of iron deficiency and the clinical state of the patient and other laboratory values must be taken into consideration. Iron levels are poor indicators of iron deficiency. Members who are unable to absorb iron orally as in Crohn s disease, celiac disease, gastric bypass, small bowel resection or other forms of malabsorption. Members who are on hemodialysis and receiving erythropoietic drugs such as erythyropoietin or darbepoetin. te: Intravenous iron infusion is NOT medically necessary for patients who are able to tolerate oral iron in the absence of renal insufficiency and/or administration of erythropoietic drugs. HCPCS CODES: J1750, J1756, J2916 Implantable Infusion Pumps Anti-spasmodic drugs to treat chronic intractable spasticity in persons who have proven unresponsive to less-invasive medical therapy as determined by the following criteria: Member has failed a six-week trial of noninvasive methods of spasticity control, such as oral anti-spasmodic drugs, either because these methods fail to adequately control the spasticity or produce intolerable side effects; and 2
PAGE: 3 of 8 Member has a favorable response to a trial intrathecal dosage of the antispasmodic drug prior to pump implantation. Opioid drugs for treatment of chronic intractable pain Implantable infusion pump is considered medically necessary when used to administer opioid drugs (e.g., morphine) and/or clonidine intrathecally or epidurally for treatment of severe chronic intractable pain in persons who have proven unresponsive to less-invasive medical therapy as determined by the following criteria: The member's history indicates that he or she has not responded adequately to noninvasive methods of pain control, such as systemic opioids (including attempts to eliminate physical and behavioral abnormalities which may cause an exaggerated reaction to pain); and A preliminary trial of intraspinal opioid drug administration must be undertaken with a temporary intrathecal/epidural catheter to substantiate adequately acceptable pain relief, the degree of side effects (including effects on the activities of daily living), and acceptance. Contraindications to implantable infusion pumps: Infusion pumps are considered not medically necessary for persons with the following contraindications to implantable infusion pumps: Member has active infection that may increase the risk of the implantable infusion pump Members body size is insufficient to support the weight and bulk of the device Members with known allergy or hypersensitivity to the drug being used (e.g., oral baclofen, morphine, etc.) Members with other implanted programmable devices where the frequency communications between both devices impact the accuracy of the initial device and alters the prescribed outcome Experimental and investigational uses of implanted infusion pumps are not a covered benefit. 3
PAGE: 4 of 8 External Infusion Pumps External infusion pumps are medically necessary DME for administration of any of the following medications: 1. Heparin to adequately anticoagulate women throughout pregnancy (warfarin compounds are not routinely used for this indication) 2. Insulin for persons with diabetes mellitus who meet the selection criteria for external insulin infusion pumps for diabetes set forth below 3. Morphine or other narcotic analgesics (except meperidine) for intractable pain caused by cancer 4. Heparin for the treatment of thromboembolic disease and/or pulmonary embolism (only external infusion pumps used in an institutional setting are considered medically necessary) 5. Other parenterally administered drugs where an infusion pump is necessary to safely administer the drug at home 6. Certain parenteral antifungal or antiviral drugs (e.g., acyclovir, foscarnet, amphotericin B, or ganciclovir) 7. Deferoxamine for the treatment of acute iron poisoning and iron overload (only external infusion pumps are considered medically necessary) 8. Parenteral epoprostenol or treprostinil for persons with pulmonary hypertension 9. Parenteral inotropic therapy with dobutamine, milrinone and/or dopamine MHealth considers external infusion pumps experimental and investigational for all other indications. Supplies and Drugs used with Implantable or External Infusion Pumps Supplies that are needed for the effective use of the DME are medically necessary. Such supplies include those drugs and biologicals that must be put directly into the equipment in order to achieve the therapeutic benefit of the DME or to assure the proper functioning of the equipment. 4
PAGE: 5 of 8 PROCESS: The member or provider must contact: 1. The Customer Service department to verify eligibility/benefits. 2. Medical Management to initiate a pre-authorization. 3. Provide clinical information which supports the medical necessity of the requested service. CPT, HCPC CODES: (te the codes below are not all-inclusive and MHealth does follow Medicare Guidelines): Selection criteria HCPCS codes considered (list not all-inclusive) and coverage is contingent on medical necessity and member s eligibility with no guarantees: A4300 Implantable access catheter, (e.g., A4301 Implantable access total catheter, venous, arterial, epidural subarachnoid, or port/reservoir (e.g., venous, arterial, peritoneal, etc.) external access epidural, subarachnoid, peritoneal, etc.) A4305 Disposable drug delivery system, flow rate of 50 ml or greater per hour [not covered for intralesional administration of narcotic analgesics and anesthetics] C1772 Infusion pump, programmable (implantable) C2626 Infusion pump, nonprogrammable, temporary (implantable) E0782 Infusion pump, implantable, nonprogrammable (includes all components, e.g., pump, catheter, connectors, etc.) E0785 Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement J0475 Injection baclofen, 10 mg A4306 Disposable drug delivery system, flow rate of less than 50 ml per hour [not covered for intralesional administration of narcotic analgesics and anesthetics] C1891 Infusion pump, nonprogrammable, permanent (implantable) C8957 Intravenous infusion for therapy/diagnosis; initiation of prolonged infusion (more than 8 ), requiring use of portable or implantable pump E0783 Infusion pump system, implantable, programmable (includes all components, e.g., pump, catheter, connectors, etc.) E0786 Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) J0476 Injection, baclofen, 50 mcg for intrathecal trial J0735 Injection, clonidine HCl, 1 mg J2270 Injection, morphine sulfate, up to 10 J2271 Injection, morphine sulfate, 100 mg mg J2275 Injection, morphine sulfate (preservative-free sterile solution), per 10 mg 5
PAGE: 6 of 8 CPT, HCPC CODES cont d: (te the codes below are not all-inclusive and MHealth does follow Medicare Guidelines): S0093 Injection, morphine sulphate, 500 mg (loading dose for infusion pump) S5036 Home infusion therapy, repair of infusion device (e.g., pump repair) S5502 Home infusion therapy, catheter care/maintenance, implanted access device S5518 Home infusion therapy, all supplies necessary for catheter repair S9326 Home infusion therapy, continuous (24 or more) pain management infusion S9328 Home infusion therapy, implanted pump pain management infusion supplies and equipment (drugs and nursing visits coded separately) A4221 Supplies for maintenance of drug infusion catheter, per week (list drugs separately) A4232 Syringe with needle for external insulin pump, sterile, 3 cc A4301 Implantable access total catheter, port/reservoir (e.g., venous, arterial, epidural, subarachnoid, peritoneal, etc.) A4306 Disposable drug delivery system, flow rate of less than 50 ml per hour C8957 Intravenous infusion for therapy/diagnosis; initiation of prolonged infusion (more than 8 ), requiring use of portable or implantable pump S5035 Home infusion therapy, routine service of infusion device (e.g., pump maintenance) S5497 Home infusion therapy, catheter care/maintenance S5517 Home infusion therapy, all supplies necessary for restoration of catheter patency or declotting S9325 Home infusion therapy, pain management infusion S9327 Home infusion therapy, intermittent (less than 24 ) pain management infusion S9363 Home infusion therapy, antispasmodic therapy nursing visits coded separately) A4222 Infusion supplies for external drug infusion pump, per cassette or bag (list drugs separately) A4300 Implantable access catheter, (e.g., venous, arterial, epidural subarachnoid or peritoneal, etc.) external access A4305 Disposable drug delivery system, flow rate of 50 ml or greater per A9274 External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories E0779 Ambulatory infusion pump, mechanical, reusable, for infusion 8 or greater 6
PAGE: 7 of 8 CPT, HCPC CODES cont d: (te the codes below are not all-inclusive and MHealth does follow Medicare Guidelines): E0780 Ambulatory infusion pump, mechanical, reusable, for infusion less than 8 E0784 External ambulatory infusion pump, insulin E1520 Heparin infusion pump for hemodialysis J0476 Injection baclofen, 50 mcg for intrathecal trial J1250 Injection, Dobutamine HCL, per 250 mg J1815 Injection insulin, per 5 units J2260 Injection, milrinone lactate, 5 mg Q0081 Infusion therapy, using other than chemotherapeutic drugs, per visit S9336 Home infusion therapy, continuous anticoagulant infusion therapy (e.g., Heparin) S9346 Home infusion therapy, alpha-1- proteinase inhibitor (e.g., Prolastin) S9348 Home infusion therapy, sympathomimetic/inotropic agent infusion therapy (e.g., Dobutamine) S9355 Home infusion therapy, chelation therapy S9359 Home infusion therapy, antitumor necrosis factor intravenous therapy; (e.g., Infliximab) S9373 Home infusion therapy, hydration therapy E0781 Ambulatory infusion pump, single or multiple channels, electric or battery operated, with administrative equipment, worn by patient J0475 Injection baclofen, 10 mg J0895 Injection, defoxamine mesylate [Desferal], 500 mg J1644 Injection, Heparin sodium, per 1,000 units J1817 Insulin for administration through DME (i.e., insulin pump) per 50 units K0601 - K0605 Replacement battery for external infusion pump owned by patient S9145 Insulin pump initiation, instruction in initial use of pump (pump not included) S9345 Home infusion therapy, antihemophilic agent infusion therapy (e.g., factor VIII) S9347 Home infusion therapy, uninterrupted, long-term, controlled rate intravenous or subcutaneous infusion therapy (e.g., epoprostenol) S9353 Home infusion therapy, continuous insulin infusion therapy S9357 Home infusion therapy, enzyme replacement intravenous therapy; (e.g., Imiglucerase) S9363 Home infusion therapy, antispasmodic therapy S9374 Home infusion therapy, hydration therapy 7
PAGE: 8 of 8 CPT, HCPC CODES cont d: (te the codes below are not all-inclusive and MHealth does follow Medicare Guidelines): S9375 Home infusion therapy, hydration therapy; more than 1 liter but no more than 2 liters per day S9377 Home infusion therapy, hydration therapy; more than 3 liters per day S9494 Home infusion therapy, antibiotic, antiviral, or antifungal therapy S9500 Home infusion therapy, antibiotic, antiviral, or antifungal therapy; once every 24 S9502 Home infusion therapy, antibiotic, antiviral, or antifungal therapy; once every 8 S9504 Home infusion therapy, antibiotic, antiviral, or antifungal therapy; once every 4 S9376 Home infusion therapy, hydration therapy; more than 2 liters but no more than 3 liters per day S9490 Home infusion therapy, corticosteroid infusion S9497 Home infusion therapy, antibiotic, antiviral, or antifungal therapy S9501 Home infusion therapy, antibiotic, antiviral, or antifungal therapy; once every 12 S9503 Home infusion therapy, antibiotic, antiviral, or antifungal therapy; once every 6 J1642 Injection, heparin sodium, (heparin lock flush), per 10 units 1. Copyright 2011 National Home Infusion Association 2. U.S. Department of Health and Human Services, Health Care Financing Administration (HCFA). Infusion pumps. Medicare Coverage Issues Manual 60-14. HCFA Pub. 6. Baltimore, MD: HCFA; 2000. 3. National Heritage Insurance Company (NHIC). External infusion pumps. Local Coverage Determination. L5044. Durable Medical Equipment Medicare Administrative Contractor (DME MAC) Jurisdiction A. Chico, CA: NHIC; revised March 1, 2008. 8