Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: Pain Management Services/Radiofrequency Ablation 01 Unit

The insurer denied coverage for Pain Management Services/Radiofrequency Ablation 01 Unit

The denial is upheld 

Reviewer #3:

The patient has a chronic history of low back pain that began over two years ago. Providers were seen to diagnose, treat low back pain and to address the pain. The patient has had the following treatments: acupuncture, injections, medication management, physical therapy and sacroiliac joint injections. The pain has had a significant impact upon activities of daily living (ADLs) and nothing has provided significant sustainable relief. The letter also stated that the patient had a magnetic resonance imaging (MRI) performed and it demonstrated Modic changes L (lumbar) 5-S (sacral) 1, lumbarization of S1, and facet arthropathy.

The peer-reviewed literature does not support a result of improvement in health outcome. At this time Intracept remains a procedure without established efficacy. While results may appear promising, additional studies are necessary to determine efficacy as compared to other conventional therapies. Medicare does not have a national coverage determination (NCD) specifically for the use of the Intracept procedure in the treatment of chronic low back pain. 

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. 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.

An industry-sponsored study by Becker et al. (2017) assessed the efficacy of intraosseous BVN ablation, with the Intracept system, in 17 patients with chronic low back pain. Sixteen patients were treated successfully. Self-reported outcome measures were collected prospectively at each follow-up interval. There was a significant decrease in the average ODI at 3 months postoperatively, which was maintained at 12 months. Significant improvement in the VAS scores and quality of life were also reported at the 3-month follow-up. This study is limited by small sample size, lack of randomization and control and short-term follow-up.
      
Pain Management Services/Radiofrequency Ablation 01 Unit does not have final approval from the appropriate regulatory bodies for this diagnosis.     

This patient is not a good candidate for Pain Management Services/Radiofrequency Ablation 01 Unit. 

Pain Management Services/Radiofrequency Ablation 01 Unit is not the best available treatment for this patient at this time.     

The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.                                                    

In summary, the denial of Pain Management Services/Radiofrequency Ablation 01 Unit 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 not substantially increased over standard treatments.