Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic low back pain

Treatment: Intracept

The insurer denied coverage for Intracept

The denial is upheld 

This patient has chronic low back pain. The patient has had Epidural Steroid injection, facet injections and radiofrequency ablations (RFA). The patient has also tried acupuncture and physical therapy (PT). The patient medication trials have included nonsteroidal anti-inflammatory drugs (NSAIDs), muscle relaxants and Tramadol. The magnetic resonance imaging (MRI) shows Modic Type II changes at lumbar (L)4, L5 and sacral (S)1. Also notable is L3 - L4 disc herniation, L4 - L5 disc protrusion and at L5 - S1 disc protrusion. The request is for radiofrequency ablation (RFA) of the Basivertebral nerves at lumbar (L)4, L5 and sacral (S)1.

In sum, the publications to date have been company sponsored and had methodology flaws.  There is 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 clinical 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 low back pain (CLBP) and improve the quality of life of CLBP patients in the near future."

 This year, Nwosu et al (6) repeated the concern about NO non-industry funded studies in the literature:

"The review provided evidence showing that Basivertebral nerves (BVN) radiofrequency ablation RFA has clinically significant benefits in a reduction in pain and disability, opioid reduction, and improvement in quality of life and function in patients with vertebrogenic pain with distinct Modic type 1 and 2 changes. The review also showed that BVN RFA is a safe procedure with few transient adverse events. There were no device-related deaths or serious adverse events in reviewed studies. Additionally, nonindustry-funded large-scale, high-quality trials with generalizable study participants are needed to confirm the results of the current studies and further assess the adverse events (AEs) and complications. Basivertebral nerve ablation (BVNA) appears to be a safe and effective intervention for patients with vertebrogenic pain when proper patient selection and precise procedural techniques are employed."

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 Intracept procedure, codes 64628 and 64629 is not substantiated.