Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #2:

Diagnosis: Low back pain

Treatment: procedure codes 64555 and C1778

The insurer denied coverage for procedure codes 64555 and C1778

The denial is upheld

This adult male injured his back and his magnetic resonance imaging (MRI) shows a board-based disc bulge at lumbar (L) 5- sacral (S) 1. He has done Physical therapy. He had epidural steroid injection (ESI) and medial branch blocks without significant relief. The request is for placement of peripheral nerve stimulation (PNS). 	 

The published peer-reviewed literature demonstrates insufficient evidence to support the safety and effectiveness of implanted PNS for low back pain. Studies primarily have small patient populations in the form of case reports, retrospective reviews, and case series.

An industry funded crossover study (1), described 94 patients with pain of peripheral origin that were implanted and then randomized to the treatment of 45 patients with peripheral nerve stimulation and 49 patients into the control group. The primary efficacy endpoint was response rate, defined as a 30 percent decrease in a numerical rating scale, with no upward titration in the patient's medication regimen, three months after randomization to treatment. The investigators reported that patients receiving active stimulation achieved a statistically significantly higher response rate of 38% versus the 10% rate found in the control group. Improvement in pain was statistically significant between the randomized groups, with the treatment group achieving a mean pain reduction of 27.2% from baseline to month 3 compared to a 2.3% reduction in the control group. During the partial crossover period, patients again demonstrated statistically significant improvement in pain relief with active stimulation compared to baseline. Further, the treatment group had significantly better improvement than the control group in secondary measures including but not limited to quality of life and satisfaction. Safety, assessed throughout the trial and with follow-up to one year, demonstrated no serious adverse events related to the device. The authors concluded, that all device-related adverse events were minor and self-limiting. They concluded that further studies confirming these benefits are needed.

Gilmore et al (2) reported on the 12 month outcomes from a cohort study. The authors concluded that percutaneous PNS delivered over a 60-day period may provide significant carry-over effects including pain relief, potentially avoiding the need for a permanently implanted system while enabling improved function in patients with chronic pain. With limitations of the study including the small number of subjects at 12 months and the loss of participants to follow-up, further robust studies are needed. 

In addition, a review by Hayes, Inc (3) has noted there is an insufficient quantity of published, peer-reviewed, human clinical data to evaluate the use of either the StimRouter System or the SPRINT PNS System for treatment of chronic pain in a health technology assessment (HTA). Finally, Xu et al in a systematic review noted that peripheral nerve stimulation for lower back pain noted that "Studies with a larger number of patients are required for demonstrating definitive validity of therapy. Additionally, studies must differentiate sources of back pain to stratify etiology and response to treatment." (4)

In summary, the denial of procedure codes 64555 and C1778 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 not substantially increased over standard treatments.