Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Spinal Stenosis with Hypertrophy

Treatment: outpatient procedure code 0275T x (times) 1, automated percutaneous or endoscopic discectomy

The insurer denied coverage for outpatient procedure code 0275T x 1, automated percutaneous or endoscopic discectomy

The denial is upheld.

This gentleman has chronic low back pain. His magnetic resonance imaging (MRI) shows spinal stenosis with hypertrophy of the ligamentum flavum.  He has had Epidural steroid injections, heat, home exercise program and a trial Topomax and Lidocaine patches.  His past medical history is also notable for Hodgkin's Lymphoma and prostate cancer.  The request is for the MILD [minimally invasive lumbar decompression] procedure.

Messiah et al. (1) reviewed the evidence supporting the MILD procedure and concluded: "there is not enough high-quality evidence to make a recommendation regarding the use of MILD versus interspinous spacers for neurogenic claudication. There remains a need for high-quality evidence regarding the efficacy of different conservative treatments, interventional procedures, and surgical outcomes in patients with neurogenic claudication in LSS [lumbar spine stenosis]."

Similarly, Jain et al (2) reviewed the literature and noted two ongoing studies: one is the Motion Study (NCT03610737), which is a multicenter RCT [randomized controlled trial] comparing the MILD procedure together with conventional medical management to conventional medical management alone in the treatment of LSS in a cohort of 150 patients. The primary outcome measure of the study is the Oswestry Disability Index, along with secondary outcome measures including the Numeric Pain Rating Scale, the Zurich Claudication Questionnaire, walking distance, and walking time to symptoms. Main inclusion criteria of the study are LSS with neurogenic claudication with evidence of LFH [ligamentum flavum hypertrophy] greater than or equal to ( >=) 2.5 mm on imaging. Main exclusion criteria of the study are an Oswestry Disability Index Score less than (<) 31, Numeric Pain Rating Scale <5 and prior surgery/interspinous spacer/mild procedure/vertebral augmentation/intradiscal procedure at the same treatment level...Another ongoing study is the MILD Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study (NCT03072927). This is a prospective longitudinal study comparing outcomes of Medicare beneficiaries treated with mild versus those treated with interspinous process decompression at the 24-month follow-up. Primary outcome measures will include the rate of surgery or minimally invasive intervention in the patient post index procedure and the rate of participants with harms associated with the index procedure.

In sum, this is a promising therapy, but it is still the subject of on-going clinical trials and its place in the therapy of lumbar spinal stenosis is still uncertain. The health plan acted reasonably with sound medical judgment in the best interest of the patient.

Based on the above, the medical necessity for the outpatient procedure code 0275T x 1, automated percutaneous or endoscopic discectomy is not substantiated. The insurer's denial is upheld.