Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Spinal stenosis 
Treatment: 22869 - Insertion of lumbar interspinous process stabilization device without decompression or fusion 

The health plan should not cover the 22869 - Insertion of lumbar interspinous process stabilization device without decompression or fusion. 

This is a male with low back pain. Pain radiates to both lower extremities. The patient has intact motor and sensory function. MRI of lumbar spine showed severe stenosis at L4-5 with disc herniation to the left at L2-3, to the right at L3-4 and centrally at L5-S1. The AP recommended indirect decompression with interspinous process device insertion. MRI of lumbar spine showed severe central spinal stenosis secondary to broad central disc herniation with ligamentous hypertrophy and facet hypertrophy, left L1-2 disc herniation, right paracentral L3-4 disc herniation, central L5-S1 disc herniation. 
The AP recommended interspinous spacer placement at L4-5 with Vertiflex Superion. The patient had negative straight-leg raise test, intact sensation; lower extremity motor testing is intact and symmetrical. The AP noted severe stenosis at L4-5 with ligamentum and facet hypertrophy. The AP noted the patient having low back pain with pain radiating to buttocks and bilateral posterior lower extremities with standing, walking. 

The AP wrote a letter stating medical necessity of interspinous device insertion. He stated interspinous spacer insertion would provide quality of life benefits for his patient. 

The AP wrote a letter asking for reversal of denial of request for interspinous spacer. The AP insisted that a reviewer be an accredited and board-certified surgeon. The AP also stated that Medicare Administrative Contractors approved indications for use of interspinous process spacer. 

Appeals analyst wrote a letter denying appeal of denial request for interspinous spacer, because there is no proof or not enough proof it improves health. 

The AP appealed denial. The AP stated that there is a growing, substantial body of published literature supporting safety, effectiveness and cost-utility of interspinous spacers. 

Interspinous process device is not medically appropriate, because clinical studies show recurrence of symptoms two years after insertion of device and reoperation rate after insertion of interspinous device at 23%. 

The 22869 - Insertion of lumbar interspinous process stabilization device without decompression or fusion is not likely to be more beneficial. 

Pintauro et al. in 2017 found the long-term functionality of interspinous devices questionable, with radiologic changes and recurrence of symptoms often seen by two years following implantation. Next-generation devices do not appear to be subject to the same "bounce back" effect of symptom re-emergence after several years. 

Phan et al. in 2016 found interspinous spacers are used in selected patients for the treatment of lumbar spinal stenosis. The uses of interspinous devices are still debated, with reports of significantly higher reoperation rates and unfavorable cost-effectiveness compared to traditional decompression techniques. Current evidence indicates no superiority for mid- to long-term patient-reported outcomes for IPD compared with traditional bony decompression, with lesser surgical complications but at the risk of significantly higher reoperation rates and costs. 

Nunley et al. conducted a study in 2018. This study estimated the type, dosage, and duration of opioid medications through 5 years of follow-up after IPD with the Superion Indirect Decompression System (Vertiflex Inc., Carlsbad, CA USA). Data were obtained from the Superion-treatment arm of a randomized controlled noninferiority trial. The prevalence of subjects using opiates was determined at baseline through 60 months. Primary analysis included all 190 patients randomized to receive the Superion device. In a subgroup of 98 subjects, we determined opioid-medication prevalence among subjects with a history of opioid use. Note: Caporlingua found Nunley et al. actually reoperated on 23.2% of the Superion arm at 24 months. Patients should be informed of the high rate of possible reintervention.