Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Peripheral Neuropathy.
Treatment: Implantation of the percutaneous neurostimulator electrode.
The insurer denied implantation of the percutaneous neurostimulator electrode.
The determination is upheld.

This is a female patient who has complaints of right lower back pain. The physical examination notes motor strength testing is five out of five throughout; straight leg raise is negative. The suggested diagnosis is chronic pain from peripheral neuropathy. The patient is status post-implantation of a spinal cord stimulator. At issue is whether implantation of the percutaneous neurostimulator electrode is likely to be more beneficial than any standard treatment or treatment for the insured's life-threatening or disabling condition or disease.

According to guidelines, percutaneous electrical nerve stimulation (PENS) is not recommended as a primary therapeutic modality, although a trial may be considered as an adjunct during a program of evidence-based functional restoration, only after more conventional non-surgical treatments including exercise and transcutaneous electrical stimulation (TENS) have failed.
According to Amini J and Karimpour H, "The mechanism of TENS in pain relief is not well understood; however, gate control theory provides the most widely accepted explanation of the mechanism. Gate control theory postulates that the pain gate can be closed by the activity of large diameter alpha-beta (Ab) afferents, preventing the transmission of noxious information...Additional studies are recommended for the efficacy and comparison of these analgesic effects with current methods for future studies."
According to Hoffmeister M, et. al: "A total of 15 randomized controlled trials (RCTs) examining spinal cord stimulators (SCS), 7 RCTs examining peripheral nerve stimulation (PNS)/peripheral nerve field stimulation (PNFS), and 1 non-randomized trial examining supraorbital transcutaneous electrical nerve stimulation (TENS) were included. In nine SCS studies, neurostimulation had positive effects on pain. In three studies, neurostimulation did not significantly reduce pain. For PNS/PNFS, five studies found improvements in pain offered by neurostimulation; pain outcomes were not reported in two studies. In the TENS study, neurostimulation reduced headaches per month and medication consumption. Overall, 21 studies were of low or unclear risk of bias, 4 were high risk of bias, and the TENS study was not appropriate for assessment using the Cochrane Risk of Bias tool."
According to Johnson MI, "Trying to interpret research on TENS is at best challenging and at worst futile because synthesizing research findings is hindered by inconsistent terminology, variability in clinical technique, and poor study design."
According to the standards of medical care, percutaneous electrical nerve stimulation (PENS) is not recommended as a primary therapeutic modality. Validated studies and references have not shown its efficacy. 
As such, the proposed health service or treatment implantation of the percutaneous neurostimulator electrode is not likely to be more beneficial than any standard treatment or treatment for the insured's life-threatening or disabling condition or disease.