Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back pain
Treatment: intraosseous basivertebral nerve ablation (procedure code 64628)
The insurer denied coverage for intraosseous basivertebral nerve ablation (procedure code 64628)
The denial is upheld

This is an adult with chronic low back pain. The patient has taken Nucynta, Zanaflex, Flexeril, Baclofen, and Robaxin, and has had epidural steroid injections and radiofrequency ablation (RFA) without relief. The patient received physical therapy in the past and has had relief with trigger point injections. Magnetic resonance imaging (MRI) shows lumbar 4 - lumbar 5 (L4-L5) disc herniation, and disc bulges at L3-L4 and at L5- sacral (S) 1. There is no documentation of a surgical consultation. The treating provider wants to perform RFA of the basivertebral nerves.

In 2018, Fischgrund and colleagues (1) published a double-blind, sham-controlled randomized controlled trial (RCT) evaluating the Intracept system and RFA of the basivertebral nerve (BVN) for the treatment of chronic low back pain. Study participants had a minimum Oswestry disability index (ODI) of 30 points (on 100 point scale) and a minimum visual analog scale (VAS) of 4 centimeters (cm) on a 10 cm scale. The primary efficacy endpoint was the comparative change in ODI from baseline to 3 months. Both intention-to-treat (ITT) and per protocol (PP) analysis were pre-planned. 

Additional data from the intervention group have been published; 24-month data in 2019 and five-year data in 2020. Data beyond 12 months on pain and function outcomes in the sham-treated group were not available as unblinding occurred at that time and most individuals crossed over to treatment with the Intracept system. Thus, long-term comparative outcomes are not known.

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 BVN. Non-industry funded high-quality, large prospective studies are needed to confirm these findings."

Urits et al (5) also commented on the need for more research on this promising technique: "reproducible large 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 RFA in the management of chronic low back pain (CLBP) and improve the quality of life of CLBP patients in the near future."

Although intraosseous basivertebral nerve ablation procedure does have final approval from the appropriate regulatory bodies for this diagnosis, it is unclear if the scientific evidence in peer-reviewed literature supports a result of improvement in health outcome. The publications to date have been company-sponsored and had methodology flaws. There is no published data on long-term complication rates. It is unclear if the adverse risks are increased over standard treatment/services.

It is unclear if this patient a good candidate for intraosseous basivertebral nerve ablation, as there is no documentation of the patient having had a surgical consultation. 

Intraosseous basivertebral nerve ablation is therefore not the best available treatment for this patient at this time and the long-term risks are unknown.

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

The carrier's denial of intraosseous basivertebral nerve ablation (procedure code 64628) should be upheld.