Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Intracept procedure. Findings:  The physician reviewer found that the records provided for review support the diagnosis of chronic low back pain given the patients pain without meaningful radiculopathy for five years. The patient has attempted numerous therapies to improve his pain and his provider has recommended the Intracept procedure. The Intracept procedure, or radiofrequency ablation of the basivertebral nerve, is minimally invasive. The procedure is U.S. Food and Drug Administration (FDA) approved for patients with chronic low back pain of greater than six months duration who have failed to respond to other nonsurgical treatments for six months and have magnetic resonance imaging (MRI)-demonstrated Modic changes in at least one vertebral endplate at one or more levels from L3 to S1. Khalil and colleagues conducted an open-label randomized controlled trial of the Intracept procedure versus conservative therapy. The study was terminated early because ablation resulted in significant improvements in all outcome measures versus standard therapy. Outcomes were evaluated to three months. In summary, there are limited, but higher quality data that support the use of the Intracept procedure in a specific subset of patients. This patients records do not demonstrate that he is an ideal candidate for the Intracept procedure. The patients initial MRI in 2016 did not document Modic changes. The 2019 MRI noted these changes as well as at two other levels that are not included in the treatment plan, which focuses on L3-4. In addition, one of the exclusion criteria for selecting patients for the Intracept procedure, is predominant facet joint pain. The MRI reports from 2016 and 2019 document the presence of facet arthropathy at multiple levels. The provider reported that the patient experienced excellent relief of about 80% for at least five months after facet injections in 2020. This result demonstrates that the patient experienced a meaningful component of facet-mediated pain, which warrants additional management of this pain generator. Given these findings, the requested Intracept procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Findings:  Two of the three physician reviewers found the requested Intracept procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested services are not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in neurological surgery and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.