Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #1

Diagnosis: Lower back pain
Treatment: Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (64628)
The insurer denied coverage for thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (64628)
The denial is upheld

According to the documentation submitted, this is a patient with a history of lower back pain. The patient had a follow up with a physician for back and neck pain. The patient had an epidural steroid injection, and there was not much relief. The magnetic resonance imaging (MRI) of the lumbar (L) spine showed degenerative disc disease throughout the lumbar spine and Modic change at L4-5 and L5- sacral (S) 1. The physician recommended the Intracept procedure to treat the patient's lower back pain.

The publications to date have been company-sponsored and had methodology flaws. There are no published data on long term complication rates. There are other evidence-based interventions available to this patient. This procedure is unlikely to be more beneficial than the standard approaches.

Conger et al. (3) pointed out that all of the major studies while supportive, have been funded by the company:

"There is moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with chronic low back pain who are selected based on type 1 or 2 Modic changes, among other inclusion and exclusion criteria used in the published literature to date. Success of the procedure appears to be dependent on effective targeting of the basivertebral nerve (BVN). Non-industry funded high-quality, large prospective studies are needed to confirm these findings."

Similarly, a clinical practice guideline (4) while favorable, pointed out the limitations of the current literature:

	Industry funding is a potential source of study bias for the available data reviewed
	Limited number of studies
	Short-term follow up for the majority of studied patients
	Unknown effect on the primary degenerative process

Urits et al. (5) also commented on the need for more research on this promising technique: "reproducible large randomized controlled trials (RCTs) are still needed for clinicians to gain full confidence in utilizing this treatment in practice. Additionally, further research is needed on the anatomy of the vertebrae to optimize the method of treatment. These studies can help to elucidate the role of radiofrequency (RF) ablation in the management of chronic lower back pain (CLBP) and improve the quality of life of CLBP patients in the near future."

This is a patient with a history of chronic low back pain and deep vein thrombosis (DVT). Current medication is Tylenol. The patient takes anti-coagulants due to DVT, and so cannot take nonsteroidal anti-inflammatories (NSAIDs). The patient has had an epidural steroid injection without improvement. MRI shows disc protrusion at L1-L2, disc bulge at L4-L5 as well as spinal stenosis and facet arthropathy. There is no documentation submitted of diagnostic medial branch blocks, surgical consultation, physical therapy, or other conservative therapy.		

This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are possibly increased over standard treatments.

The carrier's denial of thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (64628) should be upheld.