Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lower Back Pain

Treatment: Intracept Procedure 

The insurer denied the Intracept Procedure. The denial was upheld. 

Reviewer # 1:

This is a male patient who presented to his provider with complaints of lower back pain. He described the pain to be constant, aching, and throbbing discomfort. He reported that the pain worsens with physical activity that included bending, walking, and standing for prolonged periods of time. A magnetic resonance imaging (MRI) of the spine was preformed that revealed Modic changes in the vertebral end plates. It was reported that he had prior injection to help with his pain; temporary relief was noted. He reported getting mild relief with his pain by taking over the counter medication and resting. It was noted that the patient's pain was impacting his function and all areas of his activities of daily living (ADLs). A request was made for the Intracept Procedure.

Khalil et al (2019) performed a prospective randomized controlled trial to compare the effectiveness of interosseous radiofrequency (RF) ablation of the basivertebral nerve (BVN) to standard of nonoperative care for the treatment of chronic low back pain in a specific subgroup of patients suspected to have vertebrogenic related symptomatology. The study found that based on the changes in the patient-reported function on the Oswestry Disability Index (ODI), there was a statistically significant decrease in low back pain in the RF ablation treatment group than the standard of care group. However, follow-up was very limited in the standard care group in the final analysis because of limited results collected up to the point of cross-over or study exit. Further follow-up of the treatment arm patients for 5 years is underway as a single arm study, and control subjects that elect to crossover to treatment are being followed at 3 and 6 months post-procedure. Finally, another important limitation of this study is a lack of generalizability to the broader chronic low back pain population who do not meet the strict clinical and radiographic criteria of this study.

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. In this study, 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 greater than or equal to 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.  
The Intracept Procedure is not likely to be more beneficial than any of the standard treatments/procedure for this patient.

The carrier's denial of coverage for Intracept Procedure should be upheld.