Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain.
Treatment: 22899 - Unlisted procedure, spine (Intracept procedure).
The insurer denied the 22899 - Unlisted procedure, spine (Intracept procedure).
The denial is overturned. 

The patient is a female with history of chronic low back pain of more than five years. The pain has affected her activities of daily living (ADLs), functionality and quality of life.  The treating physician concluded that the pain is vertebrogenic and that the patient will benefit from Intracept intraosseous nerve ablation for the ablation of basivertebral nerves at L3 (third lumbar spine vertebra) and L4 (fourth lumbar spine vertebra).

The patient's magnetic resonance image (MRI) of the lumbar spine showed Modic Type I signal changes at L3/L4 (third and fourth lumbar spine vertebra) and therefore Modic changes affecting L3 (third lumbar spine vertebra) and L4 (fourth lumbar spine vertebra).  The patient has failed conservative measures including physical therapy, intra-thecal pump, sacroiliac joint injections, spinal injections, trigger point injections, Oxycodone, Zanaflex, etc for more than five years. Also, she has failed lumbar fusion.

Yes, the Intracept procedure should be covered by the health plan.

The proposed treatment is medically necessary based on general standard of care for vertebrogenic pain and also meeting 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)  as per the Food and Drug Administration (FDA) approved requirements and indication for which the device is approved.

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
3) Magnetic resonance image (MRI) demonstrated Modic Type 1 or Type 2 changes* at one or more vertebrae from L3 (third lumbar spine vertebra) to S1 (first sacral vertebra); and
4) Activities of daily living that are limited by persistent low back pain; and all other reasonable sources of pain have been ruled out.

Per Khalil J, Smuck M, Koreckij T, et al:
"The purpose of this RCT (randomized control trial) was to compare the effectiveness of intraosseous RF (radiofrequency) ablation of the BVN (basivertebral nerve) to standard care for the treatment of chronic LBP (low back pain) in a specific subgroup of patients suspected to have vertebrogenic related symptomatology."  Their conclusion states: "Minimally invasive RF (radiofrequency) ablation of the BVN (basivertebral nerve) led to significant improvement of pain and function at 3-months in patients with chronic vertebrogenic related LBP (low back pain)."

Per a study performed by Fischgrund JS, Rhyne A, Franke J, et al:
"The purpose of the present study is to report the 2-year clinical outcomes for chronic low back pain (CLBP) patients treated with radiofrequency (RF) ablation of the basivertebral nerve (BVN) in a randomized controlled trial that previously reported 1-year follow up." The conclusions of this study are cited as: "Patients treated with RF ablation of the BVN (basivertebral nerve) for CLBP(chronic low back pain) exhibited sustained clinical benefits in ODI (Oswestry Disability Index) and VAS (Visual Analogue Scale) and maintained high responder rates at 2 years following treatment. Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of CLBP (chronic low back pain)."

This patient presents with a history of chronic low back pain of more than 15 years.  She has tried and failed conservative measures as stated above, etc., all treatment exceeding five years. The pain has affected her functionality. The magnetic resonance imaging (MRI) of the lumbar spine showed Modic Type 1 changes at L3/L4 (third and fourth lumbar spine vertebra) vertebral body. Therefore based on the submitted information, current peer-reviewed literature and the current standards of care, the requested Intracept procedure would be considered medically necessary.

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