Appeal type: Experimental/Investigational
Decision: Upheld



Diagnosis: Low back pain

Treatment: Intracept procedure

The insurer denied coverage for Intracept procedure

The denial is upheld

The patient has a history of Lumbar spondylosis, Vertebrogenic pain, and Lumbar radiculopathy. The patient had a physician follow up visit, the note stated that the patient presented with chronic lower back pain. The chief complaint was constant pain in bilateral lower lumbar, described as constant aching and stiffness. The patient feels very stiff in the morning, aggravated by bending, twisting, extending movements, prolonged sitting, and sitting to standing. Pain continues to impede on function and activities of daily living (ADL's). The physician is requesting coverage for code 64628 and code 64629.

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

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 Owestry 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.

64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, Lumbar or sacral does not have final approval from the appropriate regulatory bodies for this diagnosis.         

This patient is not a good candidate for 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, Lumbar or sacral.     

64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, Lumbar or sacral 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 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, Lumbar or sacral and coverage for the requested service/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.