The only FDA-approved products for cross-linking are from Avedro, and performed epi-off. Many insurance policies have detail about the fact that the epi-off procedure is the only FDA approved treatment for progressive keratoconus that is being covered, while epi-on is not. See the examples below from Aetna, Cigna, and other insurance coverage policies.

“Aetna considers epithelium-off photochemical collagen cross-linkage using riboflavin and ultraviolet A medically necessary for keratoconus and keratectasia.

Aetna considers epithelium-on (transepithelial) collagen cross-linkage experimental and investigational for keratoconus, keratectasia, and all other indications.”

“Conventional, epithelium-off, corneal collagen crosslinking (C-CXL) using an FDA approved drug/device system (e.g., Photrexa® Viscous or Photrexa® with the KXL® System) is considered medically necessary for the treatment of progressive keratoconus and corneal ectasia following refractive surgery.”

“Currently, the only CXL treatment approved by the Food and Drug Administration (FDA) is the epithelium-off method. There are no FDA-approved CXL treatments using the epithelium-on method.”

“Moda Health considers corneal collagen cross-linking (CXL) medically necessary if the requested procedure is for epithelium-off photochemical collagen cross-linkage using riboflavin (Avedro’s Photrexa) and ultraviolet A.”

“SelectHealth covers epithelium-off corneal cross-linking once per lifetime if the following criteria are met: The medicine used is Photrexa Viscous/Photrexa with the KXL device.”