Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for percutaneous laminotomy/laminectomy (interlaminar approach) (mild procedure) (CPT 0275T). Findings:  The physician reviewer found that In a randomized control trial evaluating the minimally invasive lumbar decompression (MILD) procedure for the treatment of lumbar stenosis, Staats and colleagues reported, All outcome measures demonstrated clinically meaningful and statistically significant improvement from baseline through six-month, one-year, and two-year follow-ups. At two years, Oswestry Disability Index (ODI) improved by 22.7 points, Numeric Pain Rating Scale (NPRS) improved by 3.6 points, and Zurich Claudication Questionnaire (ZCQ) symptom severity and physical function domains improved by 1.0 and 0.8 points, respectively. There were no serious device or procedure-related adverse events, and 1.3% experienced a device or procedure-related adverse event. The authors further concluded, MILD showed excellent long-term durability, and there was no evidence of spinal instability through two-year follow-up. Reoperation and spinal fracture rates are lower, and safety is higher for MILD versus other lumbar spine interventions, including interspinous spacers, surgical decompression, and spinal fusion. In a randomized trial of 302 patients, Benyamin and colleagues compared treatment with the MILD procedure to standard conservative therapy and found, At one-year follow-up, ODI, NPRS, and all three ZCQ domains (symptom severity, physical function and patient satisfaction) demonstrated statistically significant superiority of MILD versus the active control. For primary efficacy, the 58.0% ODI responder rate in the MILD group was higher than the 27.1% responder rate in the epidural steroid group. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and epidural steroid injections (ESIs). The authors concluded, One-year results of this randomized controlled clinical trial demonstrate that MILD is statistically superior to ESIs in the treatment of lumbar spinal stenosis patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. Primary and secondary efficacy outcome measures achieved statistical superiority in the MILD group compared to the control group. In this case, visit notes reported a diagnosis of spinal stenosis of the lumbar region with neurogenic claudication. The patient had tried conservative measures including physical therapy and ESI. In this clinical setting, current medical literature supports the use of the MILD procedure as superior to conservative care without an increased risks of side effects, with durable benefits up to two years. Therefore, percutaneous laminotomy/laminectomy (interlaminar approach) (mild procedure) (CPT 0275T) is likely to be more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Two of the three physician reviewers found the requested percutaneous laminotomy/laminectomy (interlaminar approach) (mild procedure) (CPT 0275T) is 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 service is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in anesthesiology with sub-specialty certification in pain medicine 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.