Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for STIMQ peripheral nerve stimulator (PNS) system. Findings:  The physician reviewer found that a systematic review of peripheral nerve stimulation for neuropathic pain, Xu and colleagues state, To summarize, there is only one high-quality study (Level II evidence) that demonstrated efficacy of PNS in patients with peripheral neuropathic pain secondary to trauma or surgery; others are case reports (Level IV evidence). PNS can be considered in this patient population when the pain is refractory to other more conservative treatments. In a systematic literature review of PNS for pain that included 14 randomized controlled trials (RCTs), Deer and colleagues found moderate to strong evidence supporting the use of PNS to treat pain. Helm and colleagues report, One high-quality RCT and two moderate-quality RCTs documented the efficacy of PNS in treating refractory peripheral nerve neuropathic pain. Therefore, there is level II evidence supporting PNS in the treatment of refractory peripheral nerve neuropathic pain. Four moderate-quality case series reports corroborate the findings of the RCTS and provide documentation of long-term, multiple-year relief. The authors further state, These nine studies provide level II evidence for neuropathic pain, including complex regional pain syndrome (CRPS), and level III evidence for tibial nerve stimulation for pelvic pain and sphenopalatine ganglion stimulation for cluster headaches. The level of evidence for neuropathic pain is supported by both RTCs and case series. RCTS provide high-quality evidence of efficacy, but by their nature are limited to relatively short-term results, up to one year. Case series, on the other hand, can provide evidence of efficacy extending out a decade or more. Combined, these two sources provide powerful evidence of the effectiveness of PNS. In this case, the patient has a diagnosis of mononeuropathy and has tried and failed standard medication management with opioids, muscle relaxers, antidepressants, and anticonvulsants with limited benefit. Notes reported that the patient developed chronic right foot and lower extremity pain following lumbar surgery. She had a diagnosis of CRPS. Other standard therapies that this patient has tried and failed included physical therapy, Ketamine infusions, and spinal cord stimulation. In this case, current medical literature supports the use of PNS for the treatment of this patients peripheral neuropathy and CRPS of the lower extremity as likely to be superior to standard treatment modalities which have already been attempted and have failed to provide clinically relevant pain relief and functional improvement. Therefore, STIMQ PNS system is likely to be more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Two of the three physician reviewers found the requested STIMQ PNS system is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested service is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewer 1 is board certified in physical medicine and rehabilitation with sub-specialty certification in pain medicine and is actively practicing. Physician reviewers 2 and 3 are board certified in anesthesiology with sub-specialty certification in pain medicine and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.