Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Complex Regional Pain Syndrome (CRPS).

Treatment: Procedure code 64555 - Percutaneous implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve) (Sprint Peripheral Nerve Stimulation [PNS]).

The insurer denied coverage for procedure code 64555 - Percutaneous implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve) (Sprint Peripheral Nerve Stimulation).  The denial is upheld.

This patient has Complex Regional Pain Syndrome (CRPS) effecting his left leg. He has tried physical therapy (PT) and a home exercise program. The request is for placement of the Sprint PNS [peripheral nerve stimulation] at two separate nerves.

Nationally accepted guidelines from the Centers for Medicaid and Medicare Services (CMS) states that coverage of PNS trials requires that patients have all of the following:  1) Documented chronic and severe pain for at least 3 months, 2) Documented failure of less invasive treatment modalities and medications, 3) Lack of surgical contraindications including infections and medical risks, 4) Appropriate proper patient education, discussion and disclosure of risks and benefits, 5) No active substance abuse issues, 6) Formal psychological screening by a mental health professional, and 7) Successful stimulation trial with greater than or equal to 50% [percent] reduction in pain intensity before permanent implantation.

Based on the provided HPI [history of present illness] information it appears that less invasive therapies (i.e., ketamine infusions) have had "excellent" results as well as DRG [dorsal root ganglion] implant that helps with pain and is scheduled for reprogramming/lead assessment per the Plan in the medical record. Also confounding the request is a diagnosis of CRPS type 1 of both lower extremities. This bilateral leg pain is noted in the Chief Complaint. Based on a lack of failure of these less invasive treatment modalities and medications, along with insufficient clinical evidence in the literature, this patient is not a good candidate for unilateral percutaneous peripheral nerve stimulators (PPNS).

According to the National Institute of Neurological Disorders and Stroke, rehabilitation and physical therapy is the single most important treatment for CRPS as well as occupational therapy. Additional treatment options for this patient may include:

1) Psychotherapy - People with severe CRPS often develop secondary psychological problems including depression, situational anxiety, and sometimes post-traumatic stress disorder. These heighten pain perception, further reduce activity and brain function, and make it hard for patients to seek medical care and engage in rehabilitation and recovery. Psychological treatment helps people with CRPS to feel better and better recover from CRPS.

2) Graded motor imagery - Individuals are taught mental exercises including how to identify left and right painful body parts while looking into a mirror and visualizing moving those painful body parts without actually moving them. This is thought to provide non-painful sensory signals to the brain that helps reverse brain changes that are prolonging CRPS.

3) Non-narcotic Medications - those medications proven effective for other neuropathic pain conditions, such as nortriptyline, gabapentin, pregabalin, and duloxetine.

Given lack of sufficient clinical trials, adverse risks for implanted pPNS devices are not well defined. Nerve injury, implanted lead fracture and infection are all possible. 

Based on the lack of sufficient clinical evidence as illustrated above, a trial or permanent placement of an implantable peripheral nerve stimulator for the management of chronic pain of peripheral nerve origin is unsupported for all indications. There is no current clinical evidence that PNS is likely to be more beneficial than standard non-invasive treatments without increase risks over standard services.

The insurer's denial of coverage for procedure code 64555 - Percutaneous implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve) (Sprint Peripheral Nerve Stimulation) is upheld.