For services on or after July 6, 2009, see policy N-122.

The implantable infusion pump is a drug delivery system that provides continuous infusion of an agent (e.g., morphine, heparin) at a constant and precise flow rate. It is frequently used to deliver chemotherapy directly to the hepatic artery or superior vena cava.

Infusion of saline solution and bacteriostatic water used as diluting agents or to keep the catheter patents are considered as pump maintenance. Pump filling and maintenance (95990, 95991, 96522) for covered pump usages may be covered.

1. Chemotherapy for Liver Cancer – The implantable infusion pump is covered forintra-arterialinfusion of 5-FU or 5-FUdR, for the treatment of liver cancer for patients with primary hepato-cellular carcinoma or Duke’s Class D colorectal cancer, in whom the metastases are limited to the liver, and where (1) the disease is unresectable or (2) where the patient refuses surgical excision of the tumor.
   
   
2. Anti-Spasmodic Drugs for Severe Spasticity – An implantable infusion pump is covered when used to administer anti-spasmodic drugs intrathecally (62361-62362, 62350-62351)(e.g., baclofen) to treat chronic intractable spasticity in patients who have proven unresponsive to less invasive medical therapy as determined by the following criteria:
   • As indicated by at least a 6-week trial, the patient cannot be maintained on noninvasive methods of spasm control, such as oral anti-spasmodic drugs, either because these methods fail to control adequately the spasticity or produce intolerable side effects, and
   • Prior to pump implantation, the patient must have responded favorably to a trial intrathecal dose of the anti-spasmodic drug.
   
   
3. Opioid Drugs for Treatment of Chronic Intractable Pain – An implantable infusion pump is covered when used to administer opioid drugs (e.g., morphine) intrathecally or epidurally (62361-62362, 62350-62351) for treatment of severe chronic intractable pain of malignant or nonmalignant origin in patients who have a life expectancy of at least 3 months and who have proven unresponsive to less invasive medical therapy as determined by the following criteria:
   • The patient’s history must indicate that he/she would not respond adequately to non-invasive 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 and degree of side effects (including effects on the activities of daily living) and patient acceptance.
   
   
4. Coverage of Other Uses of Implanted Infusion Pumps – Determinations may be made on coverage of other uses of implanted infusion pumps if the carrier’s medical staff verifies that:
   • The drug is reasonable and necessary for the treatment of the individual patient;
   • It is medically necessary that the drug be administered by an implanted infusion pump; and
   • The FDA approved labeling for the pump must specify that the drug being administered and the purpose for which it is administered is an indicated use for the pump.

   The removal of the intravenous pump (36590) is rarely covered. However, when billed with supportive documentation, the claim should be referred for medical review.

The insertion or revision of the intravenous pump (36563, 36575, 36576, 36578, 36581, 36582, 36584, 36585) is noncovered.

Supplies, equipment, and devices (i.e., DME, prosthetics, and orthotics) furnished to hospital inpatients are not reimbursable.

Pump filling and maintenance billed by a supplier, pharmacy, ect., should be denied.

Implanted infusion pumps for the infusion of insulin to treat diabetes is not covered and should be denied as experimental. The data do not demonstrate that the pump provides effective administration of insulin.

Documentation must be submitted with these claims to support the medical necessity criteria.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

The insertion, revision, or removal of the implantable intra-arterial pump should be processed under procedure codes 36260-36262.

When the insertion of the pump is eligible, the pump should be processed under procedure code E0782, E0783, E0785, or E0786, as appropriate.

When using procedure code 61215 to report the insertion of a pump for connection to a ventricular catheter, the word "pump" should be noted in the narrative field on electronic claims, or block 19 on the claim form. Determination for payment is based on item #4 above.

Refill kits billed by a physician are considered a supply used incident to the physician’s professional service. Payment is included as part of the refilling and maintenance (95990, 96522).

Refill kits billed by a supplier should be reported under code A4220.

Code 96522 should not be used to report port flushing. See Medicare Advantage Medical Policy Bulletin S-54 for additional information on post flushing.

Title XVIII of the Social Security Act, Section 1862 (a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862 (a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

CMS Online Manual Pub. 100-3, Chapter 1, Section 40.2

CMS Online Manual Pub. 100-3, Chapter 1, Section 280.14

CMS Online Manual Pub. 100-2, Chapter 1, Section 120

CMS Online Manual Pub. 100-2, Chapter 16, Section 180

See the "Indications and Limitations of Coverage" section of this policy.