Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for StimQ Peripheral Nerve Stimulator System for the right knee (CPT codes: 64555 x2, L8680 x16, L8682 x1, L8683 x1). While it has been suggested that peripheral nerve stimulation may augment or be a monotherapy for pain treatment, there are still gaps in knowledge requiring further research. Data on these techniques has been limited to case reports, retrospective reviews, and small case series. In a prospective, multicenter, randomized, double-blind partial crossover study to assess the safety and efficacy of the novel neuromodulation system in the treatment of patients with chronic pain of peripheral nerve origin, Deer and colleagues identified statistically significant modest improvement in pain scores, activity, mood, walking, sleep, and enjoyment of life. However, the authors noted that the mean reduction in pain from baseline was 27.2%. Although statistically significant when compared with the control group, a reduction in pain that is less than 30% is extremely low for a permanent implanted device. Furthermore, the study did not separate out findings from lower extremity implantation compared with upper extremity implantation, did not demonstrate any statistically significant improvement in lower extremity peripheral stimulation itself, and improvements in pain and function work followed for only three months. Demonstrating improvement in lower extremity conditions with peripheral nerve stimulation has proved challenging to the point that some clinicians have abandoned peripheral nerve stimulation for lower extremities altogether in favor of spinal cord stimulation, the improvements from which may wear off over time. While Hasson and colleagues report that peripheral nerve stimulation is an effective treatment of a variety of chronic pain conditions, the authors conclusions were based on a single patient case. Likewise, Chitneni and colleagues conclusions on the use of peripheral nerve stimulation but reached conclusions were based on a single patient case. Thus, there is currently a lack of data in current medical literature supporting the use of peripheral nerve stimulation in the lower extremities. Therefore, StimQ Peripheral Nerve Stimulator System for the right knee (CPT codes: 64555 x2, L8680 x16, L8682 x1, L8683 x1) 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 StimQ Peripheral Nerve Stimulator System for the right knee (CPT codes: 64555 x2, L8680 x16, L8682 x1, L8683 x1) 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 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.