Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for a Nalu Neurostimulation System. There are a number of treatment modalities available to treat challenging chronic pain syndromes. First line strategies generally involve pharmacotherapy, including nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, antiepileptics, and antipsychotic or antidepressant agents, followed by invasive procedures including injections with longer acting anesthetics and corticosteroids, depending on the location or anatomic target. When these techniques yield results, ablative procedures, which carry the risk of a permanent neurological deficit or deafferentation syndromes, may be pursued. If persistent structural problems, surgical intervention may be appropriate. While neuromodulation is often a strategy of last resort, the field has expanded tremendously over the last several decades, with current medical literature supporting the use of peripheral nerve stimulation (PNS). Sokal and colleagues note that PNS is a safe, minimally invasive, and convenient neuromodulative method for the treatment of peripheral neuropathic pain (PNP) and complex regional pain syndrome (CRPS). Banks and colleagues note that PNS, while not a first line therapy, has shown efficacy in treating a variety of neuropathic, musculoskeletal, and visceral refractory pain pathologies. In a prospective, multicenter, randomized, double-blind, partial crossover study of 94 patients to assess the safety and efficacy of peripheral nerve stimulation in the treatment of management of peripheral neuropathic pain, Deer and colleagues reported that the patients receiving active stimulation achieved a mean pain reduction of 27.2% from baseline at three months compared to those without treatment. The authors further reported that in addition to statistically significant improvement in pain relief, those receiving active stimulation reported significantly better improvement in quality of life and satisfaction. In a multicenter, double-blinded, randomized, placebo-controlled study on the safety and effectiveness of percutaneous PNS for chronic neuropathic pain following amputation, Gilmore and colleagues found that a significantly greater proportion of patients receiving PNS demonstrated 50% or greater pain control versus only 14% of patients in the placebo group. In a multisite case series with two-year follow-up, Wilson and colleagues demonstrated the safety and efficacy of a fully implantable axillary PNS system for patients with chronic hemiplegic shoulder pain. Dodick and colleagues concluded that results from a randomized, multicenter, double-blinded study supported the 12-month efficacy of PNS of the occipital nerves for headache pain and disability associated with chronic migraine. In this case, the provider reported that the patient had neuralgia and neuritis for the past seven months, reporting an average pain level of seven out of ten. She had tried and failed pharmacologic therapies including NSAIDs, opioids, muscle relaxers, and nerve medication, along with conservative treatment for greater than six months with physical therapy and chiropractic care. Visit notes reported diagnoses including CRPS, chronic pain, and sural nerve injury. The patient reported 100% relief for four to six hours following a left sural nerve block. Given that this patient has undergone repeated and exhaustive medical and surgical treatment strategies in an attempt to improve her chronic pain syndrome without relief, neuromodulation is one of the few remaining options that offers this patient an opportunity to avoid a permanent deficit from an ablative procedure with meaningful pain relief. Therefore, a Nalu Neurostimulation 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 Nalu Neurostimulation 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 equipment 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 neurological surgery and is actively practicing. Physician reviewers 2 and 3 are board certified in physical medicine and rehabilitation 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.