Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for a Boston Scientific stimulator trial. Occipital nerve stimulation (ONS) is a form of peripheral nerve neuromodulation that places stimulator electrodes along the regions of the greater, lesser, and or third occipital nerves to induce paresthesias in these regions to treat head pain or headache syndromes due to pathology of the occipital nerves. Sakharpe and Cascella report that there is limited available data from small and uncontrolled studies on the use of ONS, and few studies with long-term data. The authors concluded, ONS seems a valuable option for patients who have failed all conventional treatment, but further studies are needed to evaluate the safety and efficacy. While Raoul and colleagues described ONS as an effective treatment for intractable occipital headaches in a retrospective study of the outcomes in 60 patients at one year follow up, 20% of patients suffered adverse effects including lead fracture/migration or surgical site infections. The authors noted that the frequency of complications remains quite high and must be taken into account. In a comprehensive review on the treatment of occipital neuralgias, Urits and colleagues report that there is a lack of evidence based on randomized controlled trials supporting the use of ONS for occipital neuralgia and note that these procedures have a high rate of complications that warrants further study. Based on the available literature, the authors indicated that evidence supports the use of occipital nerve blocks as an effective treatment with minimal invasiveness and complications. While Sweet and colleagues report that the use of ONS is a treatment option for patients with medically refractory occipital neuralgia, this recommendation was based on only nine studies and on limited level 3 evidence. Overall, evidence supporting the use of ONS to treat occipital neuralgia is extremely limited. Despite being requested, the submitted documentation did not include records noting that the patient underwent occipital nerve blocks to aid in the diagnosis and potentially treat his condition, or other alternatives including ablative procedures conserved at least as effective and with lower rates of invasiveness than an invasive surgical procedure with the potential of complications. Therefore, a Boston Scientific stimulator trial is not likely to be more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Three of the three physician reviewers found the requested Boston Scientific stimulator trial is not 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 not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in neurological surgery 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.