Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Degenerative disc disease

Treatment: outpatient procedure (64628 x 1), Intracept Intraosseous Nerve Ablation System

The insurer denied coverage for outpatient procedure (64628 x 1), Intracept Intraosseous Nerve Ablation System

The denial is upheld

This patient is a female. She was seen with complaints of low back pain and bilateral knee pain. She has no radiculopathy and there is no spinal stenosis. She has multifidus muscle dysfunction and degenerative changes. An exam demonstrates lumbar tenderness to palpation (TTP) and multifidus muscle weakness. Positive instability tests are noted, and neurological examination is normal. There are modic type one and two changes at L (lumbar) 5-S (sacral) 1.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. There is insufficient evidence to support this requested procedure. The procedure is approved by regulatory bodies.     

Traditional Treatments for 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 nonsequential, 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." (Lorio et al., 2020).

"Of the 725 publications screened, seven publications with 321 participants were ultimately included. The reported 3-month success rate for 50% pain reduction ranged
from 45% to 63%. Rates of functional improvement (10-point Oswestry Disability Index improvement threshold) ranged from 75% to 93%. For comparison to sham treatment, the relative risk of treatment success defined by 50% pain reduction and 10-point Oswestry Disability Index improvement was 1.25 (95% confidence interval [CI]: .88-1.77) and 1.38 (95% CI: 1.10-1.73), respectively. For comparison to continued standard care treatment the relative risk of treatment success defined by 50% pain reduction and 10-point Oswestry Disability Index improvement was 4.16 (95% CI: 2.12-8.14) and 2.32 (95% CI: 1.52-3.55), respectively.

Conclusions: There is moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with chronic low back pain who are selected based on type 1 or 2 Modic changes, among other inclusion and exclusion criteria used in the published literature to date. Success of the procedure appears to be dependent on effective targeting of the BVN (basivertebral nerve). Non-industry funded high-quality, large prospective studies are needed to confirm these findings." (Conger et al., 2021).   

The requested procedure is not likely to be more beneficial than any other standard service.                                                 

The carrier's denial of outpatient procedure (64628 x 1), Intracept Intraosseous Nerve Ablation System should be upheld.