Corneal Collagen Cross-linking denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for corneal collagen cross-linking procedure, on the left eye and prospective authorization and coverage, procedure code 0402T, on the right eye. The Health Plan has denied this request indicating that the procedures at issue were and are considered investigational for treatment of the enrollee’s keratoconus.Findings: There is support in the medical literature for the efficacy of the corneal crosslinking in this patient’s case. Cross-linking is a U.S. Food and Drug Administration (FDA) approved procedure for keratoconus and post refractive ectasia. The FDA approved this procedure in 2016. The primary purpose of crosslinking is to halt the progression of corneal thinning that occurs with conditions such as keratoconus.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for corneal collagen cross-linking procedure for treatment of the enrollee’s bilateral keratoconus. Findings: The 3 physician reviewers found that there is support in the medical literature for the superior efficacy of the services at issue in this patient’s case. Based on the patient’s vision loss and previous treatment with glasses and contacts, the cross-linking was the most appropriate and effective treatment available. There is a large body of available literature in support of corneal collagen cross-linking for treatment of this patient. The evidence shows corneal collagen cross-linking as a safe and effective procedure for stabilizing corneal ectasia and potentially delaying or preventing the need for full thickness corneal transplant.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for corneal collagen crosslinking procedure. The records provided for review document that this patient has a diagnosis of keratoconus. Thus, corneal crosslinking may be beneficial for treatment of keratoconus. Per the recommendations in the medical literature, a patient should have documentation of progression along with corneal scans and corneal thickness measurements prior to undergoing corneal crosslinking. Although this patient may be a candidate for corneal crosslinking, there is a lack of report that the patient has undergone a thorough evaluation by a provider with expertise and subspecialty training in corneal diseases to document progression via measurement and scans and measure the corneal thickness.

A 23-year-old male enrollee has requested collagen cross-links (82523) for treatment of his keratoconus. Findings: Three physician reviewers found that corneal collagen cross-linking for keratoconus involves an application of riboflavin solution to the eye which is then activated with ultraviolet illumination for 30 minutes. The riboflavin causes new bonds to form across adjacent collagen strands in the corneal stroma which helps to preserve the cornea’s mechanical strength. The literature contains some articles concerning the merits of the procedure. Hafezi and colleagues cited 10 eyes treated with cross-linking for ectasia after Lasik with two years of follow-up and no progression of the ectasia. However, at this time, the long-term safety and efficacy of the requested services has not been established.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Corneal Collagen Cross-linking, then check the rights and deadlines that apply to your plan.