Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Low back pain.

Treatment: Intracept procedure.

The insurer denied coverage for Intracept procedure.

The denial is upheld.

This patient has pain that radiates to the left lateral thigh, and anterior thigh. The patient reported having a lumbar epidural steroid injection that reduced pain by 50 percent (%) but only for a duration of 3 days. The patient describes the quality of pain as throbbing, with pain score of 7/10 and pain symptoms are worsening. The patient has had multiple treatments including: activity modification, chiropractic care, facet injections, home exercises, injections, lumbar epidural steroid injections, medial branch block injections, medication management, physical therapy, and radiofrequency (RF) ablations. Medications have included: Celebrex, Lidocaine patches, and Medrol Dose Pak. A magnetic resonance imaging (MRI) was performed, and impression shows disc degeneration at the lumbar (L) 4-L5 and L5- sacral (S) 1 levels with Modic type I and type II endplate changes. The request is for RF ablation of the basivertebral nerves (BVN) at L4, L5 and S1.

The publications to date have been company sponsored and had methodology flaws. There are no published data on long term complication rates. 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 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 RF ablation in the management of chronic low back pain (CLBP) and improve the quality of life of CLBP patients in the near future."

In sum, this procedure is not likely to be more beneficial than the standard of care.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Neurosurgery/Spine services (Intracept Procedure for intraosseous ablation of basivertebral nerve), codes 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral and 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral (List separately in addition to code for primary procedure) is not substantiated.