Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Back Pain
Treatment: Intracept Procedure (64628 and 64629)
The insurer denied: Intracept Procedure (64628 and 64629)
The denial is overturned.

This is an adult male with chronic low back pain due to degenerative disc disease resulting in development of vertebrogenic pain. The appeal letter notes that the pain started 15 years ago. The patient has failed conservative treatment with chiropractic care, home exercise program, and medications such as non-steroidal anti-inflammatory drugs (NSAIDs). The pain is interfering with activity. Despite treatment, pain has persisted.
Magnetic resonance imaging (MRI) of the lumbar spine without contrast revealed mixed Modic changes type 1 and 2 in the L3, L4, L5, and S1 vertebral bodies. This is confirmed on radiological read. There is also mild facet arthrosis. The provider requested Intracept procedure for L3, L4, L5, and S1 levels. This request was previously denied coverage by the health plan as not medically necessary due to insufficient evidence from large random controlled trials demonstrating net heath benefit and 
safety. This case is under review as external appeal for medical necessity. Four months ago, the patient seen for evaluation for low back pain, constant, current flare up persistent for over a month despite chiropractic care for six to eight weeks. The pain is axial, constant, aching, with occasional sharp stabbing across the lower back with no radiation into lower extremities. The pain is worse with standing, moving, and walking. Pain is rated 6.5/10. The pain does not interfere with sleep. Exam noted positive Ely's (bilateral production of mild increase of low back pain), lumbar flexion of 45 degrees and extension of 5 degrees without change in pain, Kemp's test (bilateral production of mild increase of low back pain), paraspinal muscles mildly increased tone with mild soreness on palpation of bilateral lumbar. Hamstrings, quads, and hip flexors had tightness. Negative bilateral straight leg raise. Impression was lower back pain of discogenic/vertebrogenic nature with multiple lumbar disc degeneration and Modic changes. Plan was for L3, L4, L5, S1 intraosseous basivertebral nerve radiofrequency ablation (Intracept). Progress note states the pain has been present for more than six months and the 
patient has failed conservative treatment.

The request health service is medically necessary.

The Intracept procedure is a relatively novel procedure used to treat vertebrogenic axial back pain. In properly selected patients with chronic low back pain, the SMART and SMART 24 randomized controlled trials (RCTs) demonstrated significant pain relief. In fact, close to 50% of the patients were able to cease opioid use for chronic low back pain. The procedure has been proven safe and effective and United States Food and Drug Administration (FDA) approved. Treatment should be considered when all conservative measures have tried and failed (as in this patient) and when the patient has clear Modic changes on magnetic resonance imaging (as in this patient). There is level 1 evidence for its safety and efficacy and, therefore, it should not be considered experimental/investigational. The cohorts used in the SMART and SMART 24 trials were large (more than 200 people) with statistically significant results. More recent 5-year data from the ongoing SMART study demonstrated that 66% of patients reported 50% reduction in pain, 47% reported a higher than 75% reduction in pain, and 34% had complete pain resolution. As mentioned by the provided appeal letter, clinical summary, and robust reference bibliography, several societies including the American Society of Pain and Neuroscience (ASPN) have given basivertebral nerve (BVN) ablation level A grade evidence with high certainty that the net benefit is substantial in appropriately selected pain patients. The current patient has had vertebrogenic pain for more than six months, he has failed conservative treatment including medications, injections, extensive home exercise program, and chiropractic care, and has significant functional decline and inability to complete activities of daily living due to his pain. Therefore, this procedure should be considered medically necessary and is regarded as standard of care in this well-selected patient.