Appeal type: Surgery
Decision: Unfavorable

 We decided that the Plan does not have to pre-approve the Intracept procedure.  You asked the Plan to pre-approve the Intracept procedure. You say that the requested Intracept procedure is medically necessary. The Plan denied your request. The Plan says the requested Intracept procedure is not medically necessary.  The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically necessary are not covered.   We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to determine if the Plan was correct in denying the request to pre-approve the Intracept procedure. Our reviewer says that the requested Intracept procedure is not medically necessary. Our physician reviewer found the enrollee was being treated for low back pain, degenerative disc disease, and vertebrogenic low back pain. He presented with persistent low back pain since 1994 with having undergone several treatments over the years, including medications, physical therapy, and injections. He was recommended for fusion and he declined. The pain has progressively worsened. He presented with predominantly low back pain that is described as dully, achy, cramping, and pain with numbness which occurs constantly. He denies radiation of the low back pain. The pain is typically always the same. The pain is exacerbated with sitting, driving. Pain is improved with medication and exercises. Pain is rated at 7-8 on a 0-10 numerical pain rating scale. Height is 180.34 cm, weight 87.54 kg, and body mass index 26.92 kg/m2. Exam reveals tenderness of the lumbar paraspinal musculature overlying the facet joint line from L3 to the lumbosacral junction. Facet loading is negative bilaterally. There is decreased range of motion. Sitting straight leg raise is negative bilaterally. Midline tenderness is noted. Strength is 5/5 in all muscle groups and normal reflexes are noted at the patella. MRI demonstrated Modic type I changes at L3-4, Modic type I and II changes at L4-5, and Modic type II changes at L5-S1.  However, the Magnetic resonance imaging (MRI) also demonstrated additional pathology of the lumbar spine. On the October 21, 2021, exam, the treatment plan included a request for a lumbar intralaminar epidural steroid injection at L4-L5 in 1-2 weeks. No updated documentation was provided to corroborate that this injection was provided and if any benefit was obtained. Moreover, this establishes that there are multiple other plausible pain generators in the lumbar/lumbosacral spine. There is also limited published, large-scale, long-term peer-reviewed literature that shows the requested Intracept to be an effective and/or safe treatment without ruling out all other plausible causes of low back pain. This is not evident in this case. There is no compelling rationale presented or extenuating circumstances noted to support the medical necessity of this request as an exception. Therefore, the request for Intracept procedure at L3-S1 is not medically reasonable or necessary.  We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that Medicare rules for coverage of the Intracept procedure have not been met. Therefore, we decided that the Plan does not have to pre-approve the Intracept procedure.