Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Low 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 female with chronic low back pain which has not improved significantly with therapeutic exercise (Pilates and a home exercise program), 12 weeks of physical therapy, medication management (Medrol Dose Pak, methocarbamol, NSAIDs [nonsteroidal anti-inflammatory drugs], Tramadol, and Nucynta), interventional procedures (medial branch blocks), and lumbar spine surgery (L4-S1 [fourth lumbar spine vertebra-first sacral vertebra] decompressive laminectomy). Her pain causes limitations with ADLs (activities of daily living). She is requesting pre-authorization for the Intracept procedure for treatment of her low back pain.

The patient was seen and evaluated by a Pain Medicine specialist. The provider reported the patient's pain level as being 8-9/10. On physical examination, the patient had decreased lumbar flexion and extension, and lateral bending, negative Straight Leg Raise test, tenderness to palpation of lumbar surgical site, and a normal neurologic examination.

An MRI (magnetic resonance imaging) of the Lumbar spine with and without contrast was done, and it showed the following: right foraminal disc herniation at the L3/L4 (third lumbar spine vertebra/fourth lumbar spine vertebra) level with mild compression of the right L3 (third lumbar spine vertebra) nerve root, Modic type I endplate changes from L2/L3 (second lumbar spine vertebra/third lumbar spine vertebra) through L5/S1 (fifth lumbar spine vertebra/first sacral vertebra).

The patient's provider has requested the Intracept procedure. This was denied coverage by the health plan as being experimental/investigational. The denial is the subject of this appeal.

Yes, the health plan should cover the Intracept procedure.

The patient is documented to have severe chronic low back pain, with MRI (magnetic resonance imaging) findings of Modic changes in the lumbar spine. Her pain is causing functional deficits and limitations with ADLs (activities of daily living). Her pain not significantly improved with conservative management (physical therapy and medication management) or surgery.

The Intracept procedure is based on 30 years of basic science knowledge on the innervation of the vertebral bodies and vertebral endplates. Multiple studies, including two level 1 randomized control trials (SMART and INTRACEPT studies) have shown the safety and efficacy of the Intracept procedure.

Yes, the requested Intracept procedure is more beneficial than any standard treatment for the insured's condition or disease.
The standard treatment algorithm, conservative management (physical therapy and medication management), interventional procedures, and surgery have been tried and have been ineffective in this patient.

Indications for Intracept procedure are chronic vertebrogenic low back pain (low back pain secondary to vertebral pathology) that has not improved with conservative management with MRI (magnetic resonance imaging) findings of Type 1 or Type 2 Modic changes of the treated vertebral bodies. Per Fischgrund, et al, "Patients treated with Intracept for chronic vertebrogenic low back pain exhibited sustained clinical benefits in ODI [Oswestry Disability Index] and VAS [Visual Analogue Scale] and maintained high responder rates at 24 months following treatment. Intracept is a durable, minimally invasive treatment for the relief of chronic vertebrogenic low back pain."

The patient had Modic changes on her MRI (magnetic resonance imaging) of the L-spine. Since the patient has chronic low back pain secondary to vertebrogenic source per the provider, confirmed by MRI (magnetic resonance imaging) findings (Modic changes), and has failed conservative management the Intracept procedure is indicated. There is adequate evidence based literature on the safety and efficacy of this procedure.