Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic low back pain. 
Treatment: Pain management (64628 x 1). 

The insurer denied coverage for pain management (64628 x 1). 

The denial is upheld. 

The patient has a history of low back pain. The magnetic resonance imaging (MRI) showed Modic changes. The patient's treating provider is requesting plan approval for pain management (64628 x 1), which is under review. 

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

At this time, Intracept remains an experimental/investigational 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 (cLBP). 

In the multi-center, randomized, double-blind, sham-controlled SMART trial, Fischgrund, J. S., 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." 

"Intraosseous ablation of the BVN is a relatively new minimally invasive treatment for the relief of cLBP that is diagnosed using well-established clinical and MRI findings. The procedure is supported by level 1 evidence including 2 RCTs demonstrating a statistically significant decrease in pain and an improvement in function with outcomes sustained to at least 24 months in a limited number of studies. These results were seen in a patient population that is one of the most expensive and difficult to provide care for, and in this era of rising health care costs and increasing need for therapies to reduce the use of opioids, BVN ablation may provide a treatment option to fill the gap in the treatment paradigm for patients that fail nonsurgical treatment. 

LIMITATIONS 

(1) Industry funding is a potential source of study bias for the available data reviewed. 
(2) Limited number of studies. 
(3) Short-term follow up for the majority of studied patients. 
(4) Unknown effect on the primary degenerative process" (Lorio, M. et al. 2020). 

This patient is not a good candidate for pain management (64628 x1). 

Pain management (64628 x 1), for the is not the best available treatment for this patient at this time. 

Intracept remains without established efficacy. 

In summary, the denial of pain management (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.