Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain
Treatment: intraosseous basivertebral nerve ablation, current procedural terminology (CPT) codes 64628 and 64629
The insurer denied coverage for intraosseous basivertebral nerve ablation, current procedural terminology (CPT) codes 64628 and 64629
The denial is upheld. 

In assessing whether intraosseous basivertebral nerve (BVN) ablation using the Intracept device is considered more beneficial for this patient than standard treatments or procedures, it is important to know that the publications in peer-reviewed literature to date have been mostly company sponsored, have had methodologic flaws, and were at risk for confirmation bias. UpToDate does not support the use of radiofrequency ablation for low back pain. Furthermore, despite Food and Drug Administration (FDA) approval, there are many exclusion criteria.

The INTRACEPT trial (sponsored by Relievant Medsystems, Inc.) was an open-label RCT conducted at 20 United States sites (Khalil et al 2019). A total of 140 patients with lower back pain of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between Lumbar (L)3 and Sacral (S)1 were randomized to undergo radiofrequency ablation of the BVN or continue standard care. Patients with previous lumbar spine surgery were excluded from the trial. Treatment of up to 4 vertebrae in nonconsecutive levels from L3 to S1 was allowed. The primary study endpoint was change in Oswestry disability index (ODI) at 3 months. The study was halted, and the individuals were allowed to cross over to the treatment arm. Study limitations include short term follow-up, lack of a sham group and allowance of crossover at 3 months.

BVN ablation using the Intracept procedure is FDA approved in a very select group of patients who have a history of chronic low back pain (cLBP) of at least 6 months duration; and failed to respond to at least 6 months of non-surgical management; and Magnetic Resonance Imaging (MRI) demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from L3 to S1; and activities of daily living that are limited by persistent low back pain; and all other reasonable sources of pain have been ruled out.

The Centers for Medicare and Medicaid Services (CMS) coverage guidance is currently not available for thermal destruction of the intraosseous basivertebral nerve for vertebrogenic lower back pain. A proposed Local Coverage Determination (LCD) is currently in progress (DL39420). The CMS proposed LCD indicates that thermal destruction of the intraosseous BVN will be considered medically reasonable and necessary for the treatment of cLBP in patients who meet all of an extensive inclusion criteria.

CMS also states in the proposed LCD that BVN ablation will not be considered reasonable and necessary and cannot be covered by Medicare if any of the following findings or situations are present: skeletally immature patients (less than or equal to 18 years old); severe cardiac or pulmonary compromise; active systemic infection or local infection at the intended treatment level; bleeding diathesis; pregnancy; active implantable pulse generators (pacemakers, defibrillators); radicular pain into the lower extremities (defined as nerve pain following a dermatomal distribution and that correlates with nerve compression on imaging); previous lumbar/lumbosacral spine surgery at the intended treatment level (with the exception of discectomy/laminectomy if performed greater than 6 months prior to BVN nerve ablation and radicular pain resolved); These limitations were considered exclusion criteria in the INTRACEPT study by Khalil et al.

In summary, the denial of intraosseous basivertebral nerve ablation, current procedural terminology (CPT) codes 64628 and 64629 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.