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Implantation and Control of Wireless, Battery-free Systems for Peripheral Nerve Interfacing
Published on: October 20, 2021
Peripheral Nerve Stimulation Is Medically Necessary and Clinically Validated and Can No Longer Be Deemed Experimental
Peter S Staats1, Timothy Deer2, Sean Li3
1National Spine and Pain Centers, Rockville, MD.
None:
Peripheral Nerve Stimulation (PNS) is a well-established neuromodulation therapy with decades of clinical use, a substantial body of clinically validated, peer-reviewed evidence, and endorsement in multiple evidence-based professional guidelines, including by the US Department of Defense. Despite this maturity, many commercial payers continue to deny coverage by categorizing PNS as "investigational" or "experimental," often conflating it with fundamentally different, indirect electrical stimulation modalities. This misclassification is increasingly misaligned with current science, clinical practice, and health-economic data, and has become a primary barrier to patient access to medically necessary care for refractory chronic pain. Given this extensive evidence base, it is no longer appropriate or ethical for payors to deny patients access to such an impactful treatment that clinicians and patients rely upon for managing refractory chronic pain.The present position statement - peripheral nerve stimulation is medically necessary and clinically validated, is developed by consensus of multidisciplinary experts with deep expertise in the field of neuromodulation, chronic pain, and peripheral nerve stimulation. This position statement provides background and rationale showing the justification for the statement supported by literature research and clinical evidence.

