by Mitch Ibach, OD, FAAO
Nearly 4 years ago, the FDA approved corneal collagen cross-linking for progressive keratoconus, and a few months later there was a second approval for refractive surgery ectasia. Like many new surgical or pharmacological treatments in eye care — after rigorous clinical trials, subsequent FDA approval and commercialization — obtaining insurance payer coverage became the next hurdle. Both industry partners and practitioners have made admirable efforts to push the needle forward for our patients.
Today, more than 95% of commercially insured patients have access to corneal cross-linking. This means their insurance believes the procedure is medically necessary and has policies in place for reimbursement coverage. However, not everyone with these insurances has full coverage. Often insurances follow a similar path to FDA approval inclusion and exclusion criteria for which patients have coverage benefits. It is important to remember that patients younger than 14 years, patients with central corneal scars or corneal pathology that could delay healing, or pregnant/lactating patients were excluded from approval trial and may be flagged for noncoverage by insurance. (This does not signify that the previously listed patients could not safely have corneal cross-linking.)
A second major point preoperatively is to define progression for the basis of insurance coverage. If insurance mandates keratoconus or refractive surgery ectasia be progressive to meet medical necessity for cross-linking, four criteria were defined in the clinical trial for progression: an increase in steepest keratometry (Kmax) by 1 D, a 0.50 D myopia increase in subjective manifest refraction, a 1.0 D astigmatism increase on subjective refraction, and a decrease of 0.1 mm or more in the BOZR (back optical zone radius) in gas-permeable contact lens wearers. In our practice we prep charts to have the above four points as well as the criteria, failed conservative treatments, reviewed by the doctor before insurance submission.
Our patients are seeking and researching information on cross-linking. As patients continue to search for “cost of cross-linking,” an important consideration for insurance is to refer to a practice using FDA approved epithelium-off cross-linking. Most commonly, insurance does not provide benefits for non-FDA approved procedures. For patients who have no insurance, or patients with state low-income or disability health insurance benefits (Medicaid) there is a Patient Assistance Program through the ARCH program (Glaukos). In this program, underserved patients are able to work with participating surgical practices to have cross-linking at a drastically reduced fee or sometimes at no cost.