Risk Management

Eye on OMIC: LASIK, PRK Study Identifies Malpractice Predictors

OMIC Digest, Fall 2003

Higher surgical volume and a history of prior claims or lawsuits are the primary predictors of whether a refractive surgeon will be sued in the future. Additional medical-legal risk factors for surgeons who perform more than 100 LASIK or PRK procedures a year include advertising use, comanagement with optometrists, preoperative time spent with patient, and physician gender.

These are the findings of a retrospective cohort study presented by Richard L. Abbott, MD, professor of clinical ophthalmology, University of California San Francisco, at the American Academy of Ophthalmology Annual Meeting in Anaheim. Dr. Abbott, who is chairman of OMIC’s Underwriting Committee, compared physician characteristics of 100 consecutive OMIC LASIK and PRK claims and lawsuits to demographic and practice pattern data for all active refractive surgeons insured with OMIC between 1996 and 2002.

The study, which also looked at informed consent issues in LASIK and PRK, found that patients who sued were often presented with informed consent for the first time on the day of surgery and many had no consent note written by the surgeon in the patient record.

These findings, published in Ophthalmology (November 2003), will be useful in improving the quality of care for patients undergoing refractive surgery. In addition, OMIC will incorporate the data in its underwriting criteria and risk management protocols to help insureds who perform refractive surgery manage and reduce their risk of claims and lawsuits.

Coverage for Phakic Implants

In early October, the FDA’s Ophthalmic Devices Advisory Panel recommended approval with conditions for use of the Staar Implantable Contact Lens for the treatment of myopia. It is anticipated that many ophthalmologists, including those who may have never previously performed refractive surgery, may be interested in offering this procedure to their patients once the lenses have gained final FDA approval.

OMIC is in the process of developing a special questionnaire and underwriting guidelines, similar to other refractive surgery procedures, so that coverage may be offered to qualified ophthalmologists for their performance of phakic implants. The questionnaire and guidelines will address training, patient selection criteria, informed consent, operative procedures, postoperative care, and advertising. If approved, coverage for phakic implants will be endorsed to the policy at full policy limits. No additional premium will apply.

Please note that OMIC’s standard policy excludes coverage for all refractive surgery procedures unless specifically added by endorsement. Each type of refractive surgery procedure must be separately endorsed for coverage to apply. While the technique for phakic implants is very similar to that for intraocular lens implants, phakic implants are considered to be refractive surgery and, therefore, are not automatically covered by OMIC. No coverage will extend for any phakic implant procedures performed unless the physician has specifically applied and been approved for coverage and the policy has been amended accordingly.

Other procedures for which coverage is available by endorsement following review and approval of a supplemental questionnaire are radial and astigmatic keratotomy, PRK, LASIK (including LASIK variations such as epi-LASIK, LASEK, IntrLase, and Custom-Cap procedures), CK, LTK, Intacs, and clear lens extraction (refractive lensectomy).