Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic low back pain

Treatment: Pre-service authorization of outpatient surgery services Intracept Procedure, codes 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral

The insurer denied coverage for pre-service authorization of outpatient surgery services Intracept Procedure, codes 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral

The denial is upheld. 

This is a patient with chronic low back pain (CLBP). As per the clinical note, the patient has a diagnosis of lumbar (L) radiculopathy with brief improvement after injection at L3-4. Patient noted radiation down both legs worse in the thighs. The patient has had Physical Therapy (PT) and Epidural Steroid Injections.  The patient's medication trials have included Aspirin, Flexeril, Gabapentin, Mobic, and Tylenol.  A magnetic resonance imaging (MRI) states there is left lateral disc protrusion at L3-4 and mild disc bulges at L4-5 and L5- sacral (S)1. It does not mention Modic changes. There is a separate impression apparently generated that notes discogenic disease at  L5-S1. The request is for radiofrequency ablation (RFA) of the Basivertebral nerves at L5 and S1.

In 2018, Fischgrund and colleagues (1) published a double-blind, sham controlled randomized controlled trial (RCT) evaluating the Intracept system and radiofrequency (RF) ablation of the Basivertebral nerve (BVN) for the treatment of chronic low back pain. A total of 225 participants with chronic (>=  [greater than or equal to] 6 months) isolated lumbar pain who had not responded to at least 6 months of non-operative management were randomized to either a sham (n [number] = [equal] 78) or treatment (n=147) intervention. In the active treatment group, the RF probe was activated and the temperature at the tip was maintained at 85Celcius (C) for 15 minutes. The duration of the session in the sham group was the same but the RF treatment was only simulated. Study participants had a minimum Oswestry Disability Index (ODI) of 30 points (on 100-point scale) and a minimum visual analog scale (VAS) of 4 centimeters (cm) (10 cm scale). 

Additional data from the intervention group have been published; 24-month data in 2019 and five-year data in 2020. Data beyond 12 months on pain and function outcomes in the sham-treated group were not available as unblinding occurred at that time and most individuals crossed over to treatment with the Intracept system. Thus, long-term comparative outcomes are not known.

In sum, the publications to date have been company sponsored and had methodology flaws.  There is no published data on long term complication rates.  There are other evidence- based interventions available to this patient.  This procedure is unlikely to be more beneficial than the standard approaches.

Similarly, a clinical practice guideline (4) while favorable pointed out the limitations of the current literature:

1) Industry funding is a potential source of study bias for the available data reviewed.
2) Limited number of studies.
3) Short-term follow up for the majority of studied patients.
4) Unknown effect on the primary degenerative process.

Furthermore, radicular pain was an exclusion for the Intracept studies (Fischgrund et al., 2018).

In sum, this procedure is NOT likely to be more beneficial than the standard of care.
Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for pre-service authorization of outpatient surgery services Intracept Procedure, codes 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral is not substantiated.