Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Cervical disc displacement .
Treatment: procedure code 64555, 2 units, implantable peripheral nerve stimulation device.
The insurer denied coverage for procedure code 64555, 2 units, implantable peripheral nerve stimulation device.
The denial is upheld.

There is insufficient scientific evidence in peer-reviewed literature to support the use of peripheral nervous system (PNS) for the treatment of pain. While some studies have compared the effectiveness of PNS to placebo, the overall quality of the evidence is weak and limited due to small sample size, short follow-up, and retrospective reviews. To date there were no published systematic reviews and no published guidelines or position statements specifically addressing Sprint PNS for chronic pain.

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% reduction in pain intensity before permanent implantation.

Due to lack of scientific evidence and insufficient documentation specific to this patient's shoulder pain she is not a good candidate for procedure code 64555. Based on the provided history of present illness (HPI) there is insufficient documentation of the patient's severity of shoulder pain with lack of pain score documentation. In addition, there is lack of documentation of failure of less invasive treatment modalities and lack of documentation of formal psychological screening by a mental health professional. Finally, there is no documentation of a formal diagnosis for her shoulder pain, the only diagnoses listed are: M25.562 Pain in left knee; C83.90 Non-follicular (diffuse) lymphoma, unspecified, unspecified site; M54.5 Low Back Pain; M50.222 Other cervical disc displacement at C5-C6 level; M79.605 Pain in left leg; Z96.611 Presence of right artificial should joint. 

There are several non-invasive therapies available to this patient, including non-narcotic medications such as gabapentin/pregabalin, nortriptyline, and duloxetine, all of which have proven effective for neuropathic pain. Additional proven therapies for neuropathic pain include psychotherapy and graded motor imagery. Furthermore, adverse risks for implanted PNS devices are not well defined. Infection, nerve injury, and implanted lead fracture are all possible with invasive regional nerve procedures. Furthermore, this patient's lymphoma diagnosis and treatment is not well documented in the HPI, which may lead to increased risk of infection.  

Based on the lack of sufficient clinical evidence as previously noted above, and insufficient scientific evidence in peer-reviewed literature, there is no reason to believe that the implantation of a PNS device will be more beneficial than standard non-invasive and evidence-based treatments for this patient. 

The carrier's denial of procedure code 64555, 2 units, implantable peripheral nerve stimulation device should be upheld.