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

This guideline lists specific HCPCS-coded devices (A4540, A4593, A4594, A4596, E0732, E0736, E0738, E0739, etc.) — e.g., distal transcutaneous and cranial electrical stimulators, PoNS® translingual systems, tibial nerve stimulators and interactive rehab systems — as experimental, investigational, or unproven and therefore not accepted as established covered DME. Coverage would require credible peer‑reviewed evidence (well‑conducted RCTs or adequately powered cohort studies) and collective specialty support; CES devices must be prescribed by a licensed practitioner per FDA, Nerivio™ (A4540) fails Medicare DME rental durability criteria, and the guideline specifies no additional documentation requirements.

"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..."