Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic low back pain

Treatment: Outpatient services, 64628 x 1

The insurer denied coverage for outpatient services, 64628 x 1

The denial is upheld 

Reviewer #3:

This is a patient with back pain requesting authorization of the Intracept procedure.

Per records the patient has chronic low back pain (CLBP) due to degenerative disc disease that has resulted in the development of vertebrogenic pain identified by degenerative endplates changes (Modic) on magnetic resonance imaging (MRI). The patient has tried activity modification, home exercises, lumbar epidural steroid injections, physical therapy, and medications which have included, Acetaminophen, Duloxetine, Gabapentin, Ibuprofen, Lidocaine patches, Meloxicam, non-steroidal anti-inflammatory drugs (NSAIDs), and Oxycodone.

The peer-reviewed literature does not support a result of improvement in health outcome.

At this time Intracept remains 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. 

This study is limited by small sample size, lack of randomization and control and short-term follow-up.  

This procedure, outpatient services, 64628 x 1 does not have final approval from the appropriate regulatory bodies for this diagnosis. It only has 510k clearance as a neuroablative device.     

This patient is not a good candidate for outpatient services, 64628 x 1. 

Outpatient services, 64628 x 1 is not the best available treatment for this patient at this time. Intracept remains a procedure without established efficacy. 

There are adverse risks which are increased over standard treatment/services. 

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 outpatient services, 64628 x 1 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.