Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Head and neck pain
Treatment: Procedure codes 64590, 64575, 76000, 95972, 64555
(Electrical nerve treatment [occipital nerve stimulation])
The insurer denied the Procedure codes 64590, 64575, 76000, 95972, 64555
(Electrical nerve treatment [occipital nerve stimulation])
The denial is upheld.

The patient is a female with neck pain and headaches. She has history of anterior cervical discectomy and fusion (ACDF) from C3-C7 and posterior fusion at C6-7. She also had right occipital nerve decompression. She continues to have headaches. The treating neurosurgeon requests occipital nerve stimulation.

No, the health plan should not cover the proposed treatment, electrical nerve treatment, occipital nerve stimulation.

The literature to date consists of small case series, with only one randomized feasibility study and a small cross-over study identified. Randomized controlled trials (to account for potential placebo effect) with greater numbers of patients and longer follow-up are needed. The available evidence is insufficient to permit conclusions concerning the impact of occipital nerve stimulation on net health outcome. In addition, no implanted occipital nerve stimulators have received U.S. Food and Drug Administration (FDA) approval.

As of 01/2011, the U.S. Food and Drug Administration (FDA) had not cleared any occipital nerve stimulation device for treatment of headache. The Synergy IPG implanted stimulator device from Medtronic received marketing clearance in 1999 for management of chronic, intractable pain of the trunk or limbs, and off-label use for headache is described in the literature. Medtronic and Boston Scientific Neuromodulation Systems are currently conducting clinical trials of devices.

No, the requested health service is not likely to be more beneficial than any standard treatment(s) for the insured's condition or disease..

Choi et al. in 2016 found surgical treatment of occipital neuralgia can be considered when a patient does not respond adequately to medical therapies, such as repeated injections, or minimally invasive procedures, such as PRF treatment. Neurolysis of the occipital nerve (with or without sectioning of the inferior oblique muscle), C2 gangliotomy, C2 ganglionectomy, C2 to C3 rhizotomy, C2 to C3 root decompression, and neurectomy were historically introduced for medically refractory patients (5,50-57). However, the results were variable. Recently, there have been a few positive reports on peripheral nerve stimulation, a less invasive surgery, of the GON or LON. Of these approaches, both occipital neurolysis and occipital nerve stimulation (ONS) have been used commonly in the clinical field, recently. In selective cases, these methods have shown good outcomes, but a well-designed randomization study with a long-term observation is not yet available. Clinicians should bear in mind the risk that destructive procedures carry, which include the possibility of the development of painful neuroma or causalgia, conditions that may be even harder to control than the original complaint.

Slavin et al. in 2019 found although the first publications on clinical use of peripheral nerve stimulation for the treatment of chronic pain came out in the mid-1960s, it took ten years before this approach was used to stimulate the occipital nerves. 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 US Food and Drug Administration.