An implantable intrathecal drug delivery system (Pain pump or Baclofen pump) is a device used for the continuous infusion of a drug directly into the cerebrospinal fluid via a catheter placed in the intrathecal or epidural space. A pump is placed in the subcutaneous tissue of the abdomen and connected to the catheter. The pump reservoir holds the medication(s), and the pump is programmed to give a set dose of medication over time. For most individuals, it should be used as part of a program to facilitate restoration of function and return to activity, and not just for pain reduction.

The use of an implantable intrathecal or epidural drug delivery system may be considered medically necessary for ANY of the following indications when the associated criteria are met:

·         Nonmalignant, chronic intractable pain (e.g., failed back surgery syndrome with low back pain and/or radicular pain, complex regional pain syndrome [i.e., reflex sympathetic dystrophy], post-herpetic neuralgia); or

·         Severe, refractory spasticity or chronic intractable dystonia in individuals who are unresponsive to or cannot tolerate oral anti-spasticity agents (i.e., baclofen [Lioresal®]) (i.e., intrathecal injection of Baclofen); or

·         Cancer-related pain

A trial with a percutaneous intrathecal or epidural drug delivery system for nonmalignant chronic intractable pain may be considered medically necessary when ALL of the following criteria have been met:

·         There is a documented pathology (i.e., an objective basis for the pain complaint); and

·         Failure of a sufficient trial of at least six (6) months of all reasonable treatment options for pain management which could potentially provide benefit with a reasonable expectation that the treatment could possibly render the need for the intrathecal pain pump medically unnecessary; and

·         Participation in a reasonable trial of aggressive active rehabilitative exercises; and

·         Failure of a sufficient trial of strong opioids or other analgesics in adequate doses, with a fixed schedule (not on an as-needed basis) dosing; and

·         Further surgical intervention or other treatment is not indicated or likely to be effective; and

·         Statement from a primary care physician, neurologist, physiatrist, psychiatrist, psychologist, or other licensed behavioral and/or medical health care provider attesting to the absence of untreated, underlying mental health conditions/issues (e.g., depression, drug, alcohol abuse) as a major contributor to chronic pain.

A trial with a percutaneous intrathecal drug delivery system for severe, refractory spasticity or chronic intractable dystonia may be considered medically necessary when there is failure, contraindication or intolerance to at least a six-week trial of oral antispasmodic drugs and physical therapy.

A trial with a percutaneous intrathecal or epidural drug delivery system for cancer-related pain may be considered medically necessary when there is failure, intolerance, or contraindication to noninvasive methods of pain control, including systemic opioids.

A permanent implantable intrathecal or epidural drug delivery system for the above listed pain conditions may be considered medically necessary if the individual has met the above criteria for a preliminary trial and has experienced at least a 50% reduction in pain during an appropriate trial.

An intrathecal or epidural drug delivery system is experimental, investigational or unproven for ANY other indication, including the following:

·         Cancer-related pain, spastic/dystonic, or other pain conditions that do not meet the above criteria; or

·         Administration of insulin for diabetes; or

·         Administration of antibiotics for osteomyelitis; or

·         Administration of heparin for thromboembolic disease.