Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Back pain.
Treatment: Intracept Procedure (C9752, C9753, 22899).
The insurer denied the Intracept Procedure (C9752, C9753, 22899).
The denial is overturned.

The patient is a female with history of chronic low back pain of more than two decades. The pain has affected her ADLs (activities of daily living) and functionality.

The treating physician concluded that the pain is vertebrogenic and that she will benefit from intracept intraosseous nerve ablation for the ablation of basivertebral nerves at L4 (fourth lumbar spine vertebra), L5 (fifth lumbar spine vertebra) and S1 (first sacral vertebra).

MRI (magnetic resonance imaging) lumbar spine showed Modic types 1 and 2 signal changes at L4/L5 (fourth lumbar spine vertebra/fifth lumbar spine vertebra) and L5/S1 (fifth lumbar spine vertebra/first sacral vertebra).

The patient has failed conservative measures including Physical therapy, activity modifications, spinal injections, Lumbar facet blocks, Lumbar facet RFA (radiofrequency ablation), Lumbar epidural injections, naproxen, etc.

Yes, the health plan should cover the Intracept procedure.
The Intracept procedure is medically appropriate for this patient based on general standard of care for vertebrogenic pain. It also meets the following recommended requirements by RELIEVANT, the Intracept Medical device manufacturer, 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]."

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 [radiofrequency] 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]."

The patient presents with a history of chronic low back pain of more than 20 years.  She has tried and failed conservative measures including Physical therapy, activity modifications, spinal injections, Lumbar facet blocks, Lumbar facet RFA (radiofrequency ablation), Lumbar epidural injections, naproxen, etc., all treatments exceeding 12 months. The pain has affected her ADLs (activities of daily living) and functionality. The magnetic resonance imaging (MRI) of the lumbar spine showed Modic types 1 and 2 signal changes at L4/L5 (fourth lumbar spine vertebra/fifth lumbar spine vertebra) and L5/S1 (fifth lumbar spine vertebra/first sacral vertebra).

Therefore, based on the submitted information, current peer-reviewed literature and the current standards of care, the requested Intracept Procedure for this patient 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.