Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: Intracept/radiofrequency ablation, 2 units

The insurer denied coverage for Intracept/radiofrequency ablation, 2 units

The denial is upheld 

Reviewer #3:

This is a patient with a diagnosis of back pain greater than three (3) years. The patient has tried and failed non-operative management including: baclofen, Naprosyn, Neurontin, tizanidine, physical therapy, chiropractic care, acupuncture, epidural injections, home exercise programs, and facet ablations. A magnetic resonance imaging (MRI) of the spine showed the patient has moderate disc degeneration, shallow disc profusion, marginal osteophytosis to left at lumbar five (L5) to sacral one (S1), and disc bulging at lumbar four (L4) to L5. The treating provider is requesting approval for Intracept/radiofrequency ablation, two (2) units, which is under review.

The scientific evidence in peer-reviewed literature does not widely support a result of improvement in health outcome with an Intracept/radiofrequency ablation, two (2) units.

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 (CLBP). 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.

Intracept/radiofrequency ablation, 2 units does have final approval from the appropriate regulatory bodies for this diagnosis.

Although the U.S. Food and Drug Administration (FDA) gave 510(k) clearance for the INTRACEPT Intraosseous Nerve Ablation System, it has only limited studies for use with treatment-resistant chronic axial low back pain associated with advanced degenerative disease.

Medicare does not have a National coverage determinations (NCDs) specifically for the use of the Intracept procedure in the treatment of chronic low back pain. 

The patient is not a good candidate for Intracept/radiofrequency ablation, 2 units.

Although the U.S. Food and Drug Administration (FDA) gave 510(k) clearance for the INTRACEPT Intraosseous Nerve Ablation System, there is not widely supported literature for its safety and efficacy.

Since this procedure does not have established clinical efficacy, the patient is not a good candidate for Intracept/radiofrequency ablation, 2 units.     

Intracept/radiofrequency ablation, 2 units is not the best available treatment for this patient at this time.

There are adverse risks increased over standard treatment/services.

The requested Intracept/radiofrequency ablation, 2 units is not more likely to be more beneficial than any of the standard treatments/procedures for this patient.

In summary, the denial of Intracept/radiofrequency ablation, 2 units 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 risks are substantially increased over standard treatments.