Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic low back pain.
Treatment: Outpatient procedure (64628 x 1) and coverage for the requested service/treatment.
The insurer denied coverage for outpatient procedure (64628 x 1) and coverage for the requested service/treatment.
The denial is upheld.

The patient is an adult with a small lumbar (L (lumbar)5) - sacral (S1) disc protrusion. The facet joints were normal. There was fatty marrow replacement at the L1 and L5 end plates. The patient reported back pain for six months and had pain with sitting and standing. The patient had chronic pain, fibromyalgia and depression. The patient had normal strength and sensation and reported radiating pain in the legs. 

The patient has predominantly myofascial pain. The patient also reports radicular pain which was an exclusion for the original study. 

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. 

The procedure has approval from the appropriate regulatory agencies. 

However, the patient is not a good candidate for the requested procedure. The patient has myofascial pain syndrome. 

The procedure is not the best available treatment for the patient at this time. The patient has significant chronic pain conditions. The pain is not just discogenic in nature as pain is reported with more than with just sitting and there are radicular symptoms.  

The adverse risks are increased over standard treatment/services. It is an interventional procedure requiring creation of a bone channel which is an increased risk over other standard procedures. 

The requested service may not be more likely to be more beneficial, as the studies provided are done during the trial for the product. 

"CLBP (chronic low back pain) may lead to a compromised quality of life, strained societal and familial relationships, and increased absenteeism or work-related disability claims. A lack of current validated diagnostic reference standards leads 85% of individuals to be diagnosed with nonspecific LBP (low back pain). This nonspecific diagnosis leads to nonspecific care that follows care pathways that are not scientifically validated. Individuals are advised to stay active, engage in core strengthening, lose weight, and avoid bed rest. They are put through non sequential, palliative injection treatments in the hope that these treatments will help the patient's function and that the pain will then regress. For refractory cases, surgical intervention may be recommended.
Procedure A unilateral transpedicular approach is used to advance a straight introducer under fluoroscopic guidance to the juncture of the pedicle and the vertebral body. A curved cannula assembly is used to penetrate the vertebral body and navigate toward the BVN (basivertebral nerve), which is located in the posterior half of the vertebral body. A straight channeling stylet is then used to extend the channel to the midline location of the BVN. A bipolar probe is inserted into the posterior half of the vertebral body, connected to the radiofrequency (RF) generator, and energy is applied for 15 minutes to destroy the BVN. Once ablated, these nerves no longer transmit pain signals. Data from the 2 level 1 randomized controlled trials (RCTs) would suggest that, in approximately 80% of patients, 2 vertebral bodies are treated, which constitute 1 vertebral motion segment. In the remaining patients, 1 or 2 additional vertebral bodies are treated for a total of 23 vertebral motion segments. Animal studies performed as a part of a Food and Drug Administration (FDA) submission also showed that the intraosseous BVN does not regenerate and that the vertebrae return to pretreatment strength after a period of normal healing." (Lorio, M., et al., 2020). 

In summary, the denial of outpatient procedure (64628 x 1) and coverage for the requested service/treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments.