Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: 0275T; percutaneous laminotomy/laminectomy (interlaminar approach) for decompression of neural elements, (with or without ligamentous resection, discectomy, facetectomy and/or foraminotomy), any method, under indirect image guidance (for example (e.g.) fluoroscopic, computed tomography [CT]), single or multiple levels, unilateral or bilateral; lumbar

The insurer denied coverage for 0275T; percutaneous laminotomy/laminectomy (interlaminar approach) for decompression of neural elements, (with or without ligamentous resection, discectomy, facetectomy and/or foraminotomy), any method, under indirect image guidance (e.g. fluoroscopic, computed tomography [CT]), single or multiple levels, unilateral or bilateral; lumbar

The denial is upheld 

Reviewer #2:

This patient has chronic low back pain due to spinal stenosis most pronounced at L (lumbar) 4-L5. The patient has tried rest, activity modification, non-steroidal inflammatory drugs (NSAIDs), opioids, anticonvulsants and muscle relaxants. The patient has had Epidural Steroid Injections (ESI) as well as sacroiliac (SI) joint injections. The patient has done aqua therapy and a home exercise program. The request is for the Minimally Invasive Lumbar Decompression (MILD) procedure.	

The Emergency Care Research Institute (ECRI) (1) performed a literature review of the Vertos MILD device kit. Evidence from studies synthesized in systematic reviews shows the MILD procedure is safe and relieves lumbar spinal stenosis (LSS) symptoms at up to one-year follow-up. Evidence from additional studies suggests the MILD procedure may be as effective but safer than laminectomy (three nonrandomized studies) and may be more effective than epidural steroid injections (one randomized controlled trial), but these findings need validation in additional randomized controlled trials (RCTs) to permit conclusions. Despite the large amount of available data, some evidence gaps remain. Additional RCTs are needed to verify findings and assess mild's effectiveness compared with other decompression procedures. Large, multicenter studies that assess the MILD procedure's long-term effectiveness (that is (i.e.), five years or longer) are also needed.

A Hayes (2) for the Vertos MILD procedure included 6 studies published in 11 publications that met the inclusion and exclusion criteria and evaluated the Vertos MILD device kit and associated procedure (referred to as the Vertos MILD procedure) for the treatment of LSS and ligamentum flavum hypertrophy. The authors concluded that the low-quality body of evidence suggested statistically significant reductions in pain intensity and function, but that long-term durability and safety of more than 2 years is needed for the Vertos MILD procedure. In addition, studies addressing appropriate patient selection criteria are needed to discern for whom the Vertos MILD procedure may be most effective. Trials comparing the Vertos MILD procedure with other minimally invasive procedures or open lumbar decompression are also needed. In addition, manufacturer support occurred in half of the studies. Limitations of the individual studies included limited follow-up, lack of blinding, high attrition, absence of power analyses, and missing data for some outcomes and endpoints (Hayes, 2019, updated May 2021).

In summary, the denial of 0275T; percutaneous laminotomy/laminectomy (interlaminar approach) for decompression of neural elements, (with or without ligamentous resection, discectomy, facetectomy and/or foraminotomy), any method, under indirect image guidance (e.g. fluoroscopic, computed tomography [CT]), single or multiple levels, unilateral or bilateral; lumbar and coverage for the requested 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.