Policyholder Services

Am I covered for the off-label use of Conductive Keratoplasty (CK) for the treatment of keratoconus?

Although OMIC’s policy would extend coverage to insured surgeons who perform CK (with or without Intacs) for the treatment of keratoconus, we caution our insureds against its performance for several reasons.

First, OMIC is not aware of any published, peer-reviewed evidence that supports the use of CK for keratoconus. To the contrary, available literature regarding CK for keratoconus, including work performed in California and Washington (state), appears to demonstrate that the use of CK with keratoconus patients is ineffective as a long-term treatment and that the use of CK combined with Intacs is no more effective than Intacs alone. It is likely that the change in the elasticity of the keratoconus cornea precludes the effectiveness of CK for more than a short period. The cornea often regresses to its original shape. In addition, there is considerable debate regarding the ideal area of placement for the spots; none of the placements appear to work well. Another concern is that induced astigmatism from CK, whether performed with or without Intacs, can be significant and is unpredictable. Furthermore, when coupled with keratoconus, CK causes a substantial loss of endothelium. When the cornea is thin, a normal penetrating effect of the CK for 350-400 microns directly affects the endothelium.

If an insured determines after careful deliberation that CK is the best treatment option for a keratoconus patient, the rationale for selecting this as the procedure of choice should be carefully documented in the patient’s medical record. In addition, the informed consent form must address the off-label status of the procedure as well as risks specific to treatment of keratoconus, including the risks of endothelial loss, induced astigmatism, potential loss of vision, potential loss of the ability to fit a contact lens, and possible short-term results.

Updated 12/8/2015