DME.GG.102.A - Experimental, Investigational, or Unproven Policy

This policy deems specific devices and HCPCS codes (A4540 [Nerivio], A4593/A4594 [PoNS], A4596/E0732 [cranial electrotherapy/CES], E0736 [transcutaneous tibial nerve stimulator], E0738/E0739 [upper‑extremity/interactive rehab systems]) experimental, investigational, or unproven and therefore not covered. Key requirements for coverage are robust supporting evidence (adequately powered RCTs/cohort studies or collective specialty support), compliance with Medicare DME durability rules (3‑year minimum rental — Nerivio’s 18‑month lifespan fails this), and FDA prescription/appropriate documentation for CES.

"Items currently considered to be experimental, investigational, or unproven in this guideline include but are not limited to the following: Distal Transcutaneous electrical nerve stimulator, stimul..."

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