Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lumbosacral Degenerative Disc Disease
Treatment: Intracept Procedure
The health plan denied the Intracept Procedure
The determination is upheld.


The patient was diagnosed with lumbosacral degenerative disc disease and sacroiliac dysfunction. Magnetic resonance imaging (MRI) of the lumbar spine revealed lumbar (L) 4-L5, mild diffuse disc bulge with superimposed right central annular fissure/disc herniation. L5-sacral (S)1 diffuse disc bulge with superimposed shallow left central and subarticular disc protrusions/disc herniation, uterine leiomyomata, incompletely evaluated. The patient had complaints of pain in the low back and bilateral legs with tingling in the feet. It was noted that the date of onset was years ago without a precipitating event but more intense in the past six months. The patient has difficulty sleeping when leg symptoms are present. The patient performs a home exercise and stretching program. She is not on any medications currently. On physical examination, there was diminished lumbar range of motion and pain with extension. The treatment plan was to proceed with bilateral S1 transforaminal epidural steroid injections, the patient was started on a trial of Celebrex inflammatory pain relief, and it was noted that if treatments fail, the patient will undergo intraosseous basivertebral nerve radiofrequency ablation (Intracept) at L5 and S1. At issue is whether the Intracept procedure is likely to be more beneficial than any standard treatment(s) for the patient.
The proposed health service or treatment Intracept Procedure Intraosseous Basivertebral Nerve Ablation is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Although this procedure appears to be showing some promising results, current studies remain limited without long-term follow-up periods and current studies appear to be primarily sponsored by the industry and/or small studies with limited follow-up periods. Currently, this procedure is not considered standard of care in the general medical community due to limited evidence to suggest that this treatment would be considered as effective as other standard means of treatment for chronic back pain. The patient has a long-standing history of chronic back pain and with complaints of pain, numbness and tingling in the legs suggesting radiculopathy. On examination there was decreased motor strength and positive straight leg raise testing. There are also findings related to the sacroiliac (SI) joints on exam. There appear to be multiple pain generators in this case and it is not clear that other treatments have failed such as recent physical therapy, medications, or injection therapies such as epidural injections, SI joint injections, facet joint injections. Although the MRI does show degenerative type and plate changes typical for discogenic sclerosis at L5 - S1 level, there appear to be multiple pain generators present. The patient may potentially be a candidate for some form of surgery, however, the requested procedure, intraosseous basivertebral nerve radiofrequency ablation (Intracept), has not been proven to be safe or effective or result in improvement in overall net health outcomes over that of standard treatments.

The determination is upheld in whole.