Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Back pain; leg pain.
Treatment: Intracept procedure.
The insurer denied the Intracept procedure.
The denial is overturned.

The patient is a male with history of chronic low back pain. The pain has affected his ADLs (activities of daily living) and functionality.

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), L4 (fourth lumbar spine vertebra) and L5 (fifth lumbar spine vertebra).

MRI (magnetic resonance imaging) lumbar spine showed Modic types 1 signal changes at L3/L4 (third lumbar spine vertebra/fourth lumbar spine vertebra) and L4/L5 (fourth lumbar spine vertebra/fifth lumbar spine vertebra).

The patient has failed conservative measures including physical therapy, home exercise program, spinal injections, Tylenol, and muscle relaxants. He is unable to take NSAIDs (nonsteroidal anti-inflammatory drugs) because of history of GI (gastrointestinal) Bleed, etc.

Yes, the health plan should cover the Intracept procedure.
The Intracept procedure should be covered by the health plan, as it is medically appropriate in this patient's case.

The proposed Intracept procedure is medically appropriate based on general standard of care for vertebrogenic pain. It also meets the following recommended requirements by RELIEVANT the Intracept Medical device manufacturer (3), as per the FDA (United States Food and Drug Administration)-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 6 months duration; and
2) Failed to respond to at least 6 months of non-surgical management; and
3) MRI (magnetic resonance imaging) 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 controlled 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 [lower 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 [lower back pain]."

The patient presents with a history of chronic low back pain of more than 12 months. He has tried and failed conservative measures including physical therapy, home exercise program, spinal injections, Tylenol, and muscle relaxants. He is unable to take NSAIDs (nonsteroidal anti-inflammatory drugs) because of history of GI (gastrointestinal) bleed, etc. All treatments have exceeded 12 months. The pain has affected his functionality. The magnetic resonance imaging (MRI) of the lumbar spine showed Modic type 1 changes at L3/L4 (third lumbar spine vertebra/fourth lumbar spine vertebra) and L4/L5 (fourth lumbar spine vertebra/fifth lumbar spine vertebra) vertebral bodies.

Therefore based on the submitted information, current peer-reviewed literature and the current standards of care, the requested Intracept Procedure would be considered medically appropriate, as it is in accordance with Generally Accepted Standards of Medical Practice; Clinically appropriate, in terms of type, frequency, extent, service site and duration, and considered effective for the patient's Sickness, Injury, Mental Illness, substance-related and addictive disorders, disease or its symptoms; not mainly for the patient's convenience or that of the patient's doctor or other health care provider; not more intensive than an alternative drug, service(s), service site or supply that is at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the patient's Sickness, Injury, disease or symptoms.

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