Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Lower Back Pain
Treatment: Intracept Procedure (22899 and C9752)
The insurer denied the Intracept Procedure (22899 and C9752). 
The denial is overturned. 

The patient is a male with history of chronic low back pain s/p (status post) lumbar vertebrae 4-5 (L4/L5) and lumbar vertebrae 5 and sacral spine (L5/S1) microdiscectomy with persistent right sided low back pain and intermittently radiating to the right buttocks and thigh with no weakness, no numbness or tingling. The pain has affected his ADLs (activities of daily living) and functionality.

The patient has relevant medical history of OCD (obsessive compulsive disorder), anxiety, depression, etc. He has history of MVA (motor vehicle accident).

The treating physician concluded that the patient's pain is vertebrogenic and that the patient will benefit from Intracept intraosseous nerve ablation for the ablation of basivertebral nerves at  lumbar vertebrae 4 and 5 (L4, L5) and sacral spine 1 (S1).

MRI (magnetic resonance imaging) of the patient's lumbar spine showed Modic type-2 signal changes at lumbar vertebrae 4 and 5 (L4/L5) with moderate canal stenosis at lumbar vertebrae 2 and 3 (L2/L3), moderate-severe central canal stenosis at lumbar vertebrae 4, 5 (L4/L5) and right paracentral and lateral disc herniation at lumbar vertebrae 3 and 4 (L3/L4) and lumbar vertebrae 5 and sacral spine 1 (L5/S1) with associated foraminal stenoses.

The patient has failed conservative measures, including lumbar vertebrae 4 and 5 (L4/L5) and lumbar vertebrae 5 and sacral spine 1 (L5/S1) microdiscectomy, physical therapy, chiropractor, acupuncture, Flexeril, gabapentin, Percocet, naltrexone, Robaxin, several spinal injections, etc.

Yes, the health plan should cover the Intracept Procedure.

This decision is based on general standard of care for vertebrogenic pain. The patient also meets the following recommended requirements by RELIEVANT, the Intracept Medical device manufacturer (source: https://www.relievant.com/wp-content/uploads/2019/05/MKT_0066-RevD_-_Reimbursement_Guide.pdf).

Intracept is medically indicated in patients who have:
1) A history of low back pain of at least six months duration; and
2) Failed to respond to at least six months of non-surgical management; and - MRI [magnetic resonance imaging] demonstrated Modic Type-1 or Type-2 changes at one or more vertebrae from lumbar vertebrae 3 to sacral spine 1 (L3 to S1); and
3) Activities of daily living that are limited by persistent low back pain; and 
4) All other reasonable sources of pain have been ruled out.

The above recommended requirements have been met for the INTRACEPT procedure in this patient's case. The patient has history of chronic low back pain of more than six months, the MRI (magnetic resonance image) findings also pointed to evidence of Modic type 1-2 changes at lumbar 4 and 5 (L4 and L5) vertebrae. There is also documented evidence of limitation of ADLs (activities of daily living) by the patient, and all other reasonable sources of the chronic low back pain have been ruled out after failing spinal injections and discectomy.

Yes, the proposed Intracept Procedure is medically appropriate and likely to be more beneficial than any standard treatments for discogenic/vertebrogenic pain due to Modic changes.