Payment may be made for surgical implantation of an infusion pump for the following FDA-approved usages and when the administered medications are FDA-approved for the route of administration and the medical condition:

Anti -Spasmodic  Drugs
An implantable infusion pump  is considered medically necessary when used to intrathecally administer 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:

1. A failed six-week trial of non-invasive 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. A favorable response to a trial intrathecal dosage of the anti-spasmodic drug prior to pump implantation.

Intrathecal baclofen (Lioresal) is considered medically necessary for the treatment of intractable spasticity caused by spinal cord disease, spinal cord injury, or multiple sclerosis. Baclofen is considered medically necessary for persons who require spasticity to sustain upright posture, balance in locomotion, or increased function.

Documentation in the medical record should indicate that the spasticity was unresponsive to other treatment methods and that the oral form of baclofen was ineffective in controlling spasticity or that the member could not tolerate the oral form of the drug. A trial of oral baclofen is not a required prerequisite to intrathecal baclofen therapy in children ages 12 years old or less due to the increased risk of adverse effects from oral baclofen in this group.

The medical record should document that there was a favorable response to the trial dosage of the baclofen before subsequent dosages are considered medically necessary.

Opioids drugs for the treatment of severe chronic intractable pain
An implantable infusion pump is considered medically necessary when used to administer opioid drugs (e.g., morphine) intrathecally, intravenously, 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:

1. For the treatment of non-malignant pain (e.g., pain not associated with cancer), the medical record must indicate the failure of six (6) months of other conservative treatment modalities (pharmacologic, surgical, psychologic, or physical), if appropriate and not contraindicated;
2. For the treatment of malignant pain (e.g., pain associated with cancer), strong opioids, or other analgesics in adequate doses, with a fixed dosing schedule (not PRN), have failed to relieve pain or intolerable side effects to systemic opioids or other analgesics have developed;
3. A preliminary trial of intraspinal opioid drug administration must be undertaken with a temporary intrathecal/epidural catheter to substantiate adequately acceptable pain relief (defined as at least a 50% reduction in pain), the degree of side effects (including effects on the activities of daily living), and acceptance.

Intra-arterial  injection of chemotherapeutic agents
Implantable infusion pumps are considered medically necessary for administration of intrahepatic/intra-arterial chemotherapy for patients with unresectable primary liver cancer, colorectal cancer with metastases limited to the liver, and head/neck cancers.

Contraindications to implantable infusion pumps
Implantable infusion pumps are considered not medically necessary for persons with the following contraindications:

1. An active infection that may increase the risk of the implantable infusion pump; or
2. Body size is insufficient to support the weight and bulk of the device; or
3. Known allergy or hypersensitivity to the drug being used (e.g., oral baclofen, morphine, etc.); or
4. Other implanted programmable devices where the crosstalk between devices may inadvertently change the prescription.

Implantable infusion pumps are considered experimental/investigational and therefore, non-covered, for all other uses (e.g., heparin for thromboembolic disease, insulin for diabetes, antibiotics for osteomyelitis). High quality studies do not provide support for possible additional uses of implantable infusion pumps. A participating, preferred, or network provider can bill the member for the non-covered service.

Generally, the pump has been approved for implantation in the thoracic or abdominal area for infusion into the nervous and vascular systems. However, drug delivery directly into the neural tissue or ventricle spaces of the brain via the implantable infusion pump is experimental/investigational and therefore, non-covered. Any method of delivery/conditions not listed above, are not FDA-approved and should be denied as experimental/investigational and therefore, non-covered. All services performed in connection with an experimental/investigational usage should also be denied. When eligible, separate charges for the implantable pump itself are payable.

Infusion of saline solution and bacteriostatic water used as diluting agents or to keep the catheter patent are considered pump maintenance. Coverage for chemotherapy administration (96416, 96425) in addition to code 96522 is determined according to individual or group customer benefits. Payment can be made for the pump filling and maintenance (95990, 95991, 96522) when provided in conjunction with covered FDA approved pump usages.

See Medical Policy Bulletin E-17 for information on the portable infusion pump and Medical Policy Bulletin I-76 for guidelines on Ziconotide (Prialt®).

Place of Service: Inpatient/Outpatient

The implantation of an infusion pump is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, intra-hepatic/intra-arterial chemotherapy pump implantation, the need to titrate medication to achieve control of symptomatology and the need for on-going monitoring for potential complications related to the specific medication being administered or the implantation of the pump.

Description

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.

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.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

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