CMS Implantable Infusion Pump Form

Summary Of Evidence

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Analysis of Evidence

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The implantable pump is a sealed, self-powered system, which is inserted under the skin by a physician. It provides a continuous controlled infusion of a drug to a select body site and can be refilled by percutaneous injection. Two separate ports are available: 1 for bolus injections and 1 for continuous infusion. Both may be utilized for blood or cerebrospinal fluid (CSF) withdrawals. An implantable infusion pump is utilized to administer many types of medications through the intra-arterial, intrathecal or epidural route.

Medicare will consider implantable infusion pumps, and associated services, medically reasonable and necessary for the conditions listed in the CMS Internet-Only Manual, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, §280.14 Infusion Pumps.

For the indication of opioid drugs used for the treatment of chronic intractable pain, it is useful to distinguish between pain caused by a malignancy from which the patient is not expected to recover from those non-malignant conditions that are longer term in nature. For terminal malignant conditions, the progression from a non-invasive pain control modality to a more invasive modality, such as use of an implanted pump, may occur more rapidly with less emphasis on behavioral approaches to pain control.

Ziconotide (Prialt®) intrathecal infusion documentation must meet the Food and Drug Administration (FDA)-approved indication that the patient is intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies or intrathecal therapy morphine in the treatment of severe, chronic pain.

Contraindication

The implantation of an infusion pump is contraindicated in the following patients:

• Those with a known allergy or hypersensitivity to the drug being used (e.g., oral baclofen and morphine)
• Those who have an infection
• Those whose body size is insufficient to support the weight and bulk of the device

In those patients with other implanted programmable devices, since crosstalk between devices may inadvertently change the prescription, it is recommended that all devices be checked for possible crosstalk at the time of implantation of the infusion pump, and that appropriate surveillance for such interactions be continued.