Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: Procedure codes 64628; thermal destruction of intraosseous basivertebral nerve, including all imaging guidance, first 2 vertebral bodies, lumbar or sacral and 64629; thermal destruction or intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral

The insurer denied coverage for procedure codes 64628; thermal destruction of intraosseous basivertebral nerve, including all imaging guidance, first 2 vertebral bodies, lumbar or sacral and 64629; thermal destruction or intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral

The denial is upheld 



This is a patient who has a history of low back pain. The patient had a magnetic resonance imaging (MRI) that showed multilevel degenerative disc disease with disc bulges, disc space narrowing, and Modic changes. The treating provider is requesting treatment with an Intracept procedure [64628; thermal destruction of intraosseous basivertebral nerve, including all imaging guidance, first 2 vertebral bodies, lumbar or sacral and 64629; thermal destruction or intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral], which is under review.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome.

While results may appear promising, additional studies are necessary to determine efficacy as compared to other conventional therapies. Medicare does not have a National coverage determination (NCD) specifically for the use of the Intracept procedure in the treatment of chronic low back pain. 

In the multi-center, randomized, double-blind, sham-controlled SMART trial, Fischgrund et al. (2018) evaluated the safety and efficacy of radiofrequency ablation (RFA) of the basivertebral nerve (BVN) for the treatment of chronic low back pain. A total of 225 patients diagnosed with chronic low back pain were randomized to treatment with the Intracept procedure (n=147) or sham therapy (n=78). All patients had Type I or Type II Modic changes of the treated vertebral bodies. The primary endpoint was the comparative change in the Oswestry Disability Index (ODI) from baseline to 3 months. At 3 months, the average ODI in the treatment arm decreased 20.5 points, as compared to a 15.2-point decrease in the sham arm. A responder analysis based on ODI decrease 10 points showed that 75.6% of patients in the treatment arm as compared to 55.3% in the sham control arm exhibited a clinically meaningful improvement at 3 months. 

In summary, the denial of procedure codes 64628; thermal destruction of intraosseous basivertebral nerve, including all imaging guidance, first 2 vertebral bodies, lumbar or sacral and 64629; thermal destruction or intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral and coverage for the requested treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments.