Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic low back pain

Treatment: 64628; thermal destruction of intraosseous basivertebral nerve (BVN), including all imaging guidance; first 2 vertebral bodies, lumbar (L) or sacral (S) and 64629; thermal destruction of intraosseous BVN, including all imaging guidance; each additional vertebral body, L or S

The insurer denied coverage for 64628; thermal destruction of intraosseous BVN, including all imaging guidance; first 2 vertebral bodies, L or S and 64629; thermal destruction of intraosseous BVN, including all imaging guidance; each additional vertebral body, L or S.

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 (RFA) 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 U.S. sites (Khalil 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 L (lumbar) 3 and S (sacral) 1 were randomized to undergo RFA of the BVN or continue standard care. Patients with radiographic evidence of lumbar/lumbosacral disc extrusion or protrusion > (greater than) 5 millimeters (mm) at levels L3-S1 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 changed in Oswestry Disability Index (ODI) at 3 months. A pre-planned interim analysis was undertaken when 60% (percent) of participants reached the 3-month follow-up (n=51 in the treatment group and n=53 in the standard care group) and reported statistically significant differences between groups on all patient-reported outcome measures, favoring the treatment group. 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. 

There are other medications and treatments available to this patient. This procedure is unlikely to be more beneficial than the standard approaches. Any invasive procedure has risk of bleeding, infection, nerve injury, or retained foreign body compared to non-invasive treatments.

In summary, the supporting publications 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 RFA for low back pain. Despite FDA approval, Centers for Medicare and Medicaid Services (CMS) guidelines limit the use of BVN ablation to a very select group of patients, including those who do not have evidence of lumbar disc extrusion/protrusion. The Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient.

In summary, the denial of 64628; thermal destruction of intraosseous BVN, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral and 64629; thermal destruction of intraosseous BVN, 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 risks are substantially increased over standard treatments.