Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: chronic low back pain (CLBP)

Treatment: Intracept procedure (CPT (current procedural terminology) codes 64628/64629)

The insurer denied coverage for Intracept procedure (CPT codes 64628/64629)

The denial is upheld

This is an adult patient with a history of vertebrogenic lower back pain. A magnetic resonance imaging (MRI) was performed that showed Type l Modic endplate changes along the right aspect of lumbar (L) 4-L5. Per the progress note the doctor notes that the patient had Modic Type l, ll on lumbar MRI at the L4, L5, sacral (S) 1 levels. The patient had failed more than 6 months of conservative pain care. The physician recommended the Intracept procedure to treat lower back pain.

For individuals who have vertebrogenic low back pain who receive ablation of basivertebral nerves, the evidence includes two randomized controlled trials (RCTs): SMART (Surgical Multi-center Assessment of RF (radiofrequency) Ablation for the Treatment of Vertebrogenic Back Pain) and INTRACEPT trials, both sponsored by device manufacturer Relievant Medsystems, Inc. Relevant outcomes were symptoms, functional outcomes, quality of life and treatment-related morbidity. In one RCT, at 12 months, 73% (percent) of patients crossed over to the active treatment group and therefore, long-term comparative data is not available. Limitations to the other RCT include lack of a sham control and short duration of follow-up. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

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 L3 and S1 were randomized to undergo radiofrequency ablation of the BVN (basivertebral nerve) or continue standard care. Patients with Modic changes at levels other than L3 to 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 change in Owestry Disability Index (ODI) at 3 months. A pre-planned interim analysis was undertaken when 60% of participants reached the 3 month follow-up (n (number) =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.

Intracept is Food and Drug Administration (FDA)- approved in patients who have - A history of low back pain of at least 6 months duration; and - Failed to respond to at least 6 months of non-surgical management; and - 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 patient is not a good candidate for the requested procedures. There are other evidence-based medications and treatments available to this patient. 

The adverse risks are increased over standard treatment/services. Any invasive procedure has risk of bleeding, infection, nerve injury or retained foreign body compared to non-invasive treatments.

In summary, the denial of Intracept Procedure (CPT codes 64628/64629) and coverage for the requested treatment should be upheld. With a history multiple previous lumbar spine surgeries without evidence provided for change in the patient's baseline pain and lack of documentation of additional evidence-based nonpharmacologic treatment, the Intracept procedure is unlikely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are substantially increased over standard treatments.