Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Complex regional pain syndrome 
Treatment: Revision of two separate nerve stimulators, occipital and thoracic
The insurer denied revision of two separate nerve stimulators, occipital and thoracic.
The determination is upheld.

This is a female patient with a history of an occipital nerve stimulator and thoracic spinal cord stimulator implantation. These devices have had multiple revisions. The patient has complex regional pain syndrome (CRPS) for the right side of her body. The patient is having increased pain. The devices have been interrogated and reprogrammed multiple times. The provider has recommended "pocket trial revisions of both simulator systems". At issue is the medical necessity of the revision of the two separate nerve stimulators.

The procedures are not medically necessary. Based on the current medical literature, while occipital nerve stimulation is a promising technology, the current literature relates that further studies are needed to show the efficacy of the procedure. Slavin et al cite "the future for occipital nerve stimulation is likely to bring new indications, devices, stimulation paradigms, and a decrease in invasiveness. As experience increases, one may expect that occipital nerve stimulation will eventually gain regulatory approval for more indications, most likely for occipital neuralgia, migraines and cluster headaches. This process may require additional studies, at least for approval from the United States (US) Food and Drug Administration". Leone et al cite "our data on long-term follow-up seem to temper earlier occipital nerve stimulation (ONS) results in chronic drug-resistant chronic headache (CH) but nevertheless show long-lasting benefit in two-thirds of patients. ONS is well tolerated and safe and has to be offered before proposing the more invasive hypothalamic stimulation". Chen et al cite "currently evidence on the effectiveness and safety of ONS is still limited in quantity and remains inconclusive given the challenges in trial methodology and patient selection. Further development of ONS and other similar techniques and validation of their efficacy require both continuous accumulation of clinical evidence (for which multicentre, prospective registries may have an important role to play) and further studies on the pathophysiology of migraine and its responses to various forms of neuromodulation. In the interim, the use of ONS may be best guided by individual patient preference, affordability, treatment response and contribution to the accumulation of the evidence base through randomized controlled trial (RCTs) or prospective registries". Rodrigo et al cite "we consider that the trigemino-cervical autonomous and cervical connection may explain why ONS might relieve chronic migraine pain, but this is just a theoretical explanation which should be demonstrated in future studies. The results achieved in this study suggest that ONS may provide long term benefits for patients with medically intractable chronic migraine". Lastly, in a prospective study, Miller et al cite "in this uncontrolled, open-label prospective observational study with long-term follow-up of efficacy, functional outcome and safety of ONS in highly intractable complex chronic migraine (CM) patients, over 40 percent (%) of patients reported sustained clinical benefit after a mean follow-up of 4 years. Sustained benefit was seen even in those with multiple headache types in addition to CM. Responders showed improvements in functional outcomes and headache related disability. Adverse event rates are low when implants are conducted in specialist centers. There appears to be a time delay of up to 6 months before clinical effect of ONS is seen which calls into question the practice of trial stimulation prior to implant. There are still concerns over the risk to benefit ratio and cost effectiveness of ONS despite positive open-label data and a well-designed double-blind controlled trial with long-term follow-up is needed to clarify the position of neuromodulation in chronic migraine".

Additionally, it should be noted that this patient has had multiple revisions of her devices due to increases in pain. A cortical stimulator was also trialed. There is no evidence documented that the devices are malfunctioning or that the implantable pulse generator (IPG) is at end of life, rather the patient is having pain and the provider is requesting "pocket trial revisions of both simulator systems".