Policyholder Services

Coverage Considerations for Intraocular Refractive Surgery

The following is a modified version of a letter sent to OMIC insureds in June 2004.

Last updated 12/8/2015

OMIC’s Coverage of Intraocular Refractive Surgery

We would like to take this opportunity to remind physicians that OMIC’s standard policy excludes coverage for intraocular refractive surgery procedures unless specifically added by endorsement.  While the techniques for refractive lens exchange and phakic implants are very similar to those for cataract surgery with intraocular lens implantation, refractive lens exchange (RLE) and phakic implants are considered to be intraocular refractive surgery and, therefore, are not automatically covered by OMIC. A separate application/questionnaire for the particular procedure must be completed by the insured. If approved, coverage is endorsed to the policy at full policy limits.  No additional premium applies.

Refractive Lens Exchange

RLE Coverage

OMIC has developed a special questionnaire and implemented underwriting requirements so that we may offer coverage to qualified ophthalmologists for their performance of refractive lens exchange.  The questionnaire and requirements address patient selection criteria, informed consent, operative procedures, post-operative care, and advertising.  Please note that lens extraction performed on patients who have visually significant cataracts is considered “cataract surgery” for underwriting purposes and coverage automatically extends to insured surgeons.  Special application and endorsement for refractive lens exchange are required only if the surgeon performs the procedure on patients who have completely clear lenses or for patients with visible cataract changes that are not associated with visual complaints.

RLE Considerations

Although OMIC recognizes that refractive lens exchange may be the best alternative for select patients and, as a result, offers coverage for this procedure, we have numerous concerns regarding the potential liability exposure refractive lens exchange presents.  We are particularly concerned with the risk-benefit ratio, both from the patient’s point of view regarding high expectations of better vision balanced against the known risks of cataract surgery (such as endophthalmitis or other serious vision-threatening complications) and the company’s potential for future claims frequency or severity arising from these procedures.  Should the patient have an adverse outcome or serious complication, it may be difficult to defend the surgeon’s decision to proceed with refractive lens exchange when other proven, FDA-approved surgical options (such as LASIK) are available to treat many refractive errors.  Furthermore, the off-label status of  multi-focal intraocular lenses for use in patients without cataracts could have an adverse effect on the defensibility or ultimate resolution of any resulting claims.  Additionally, because refractive surgery patients tend to be younger than the typical cataract patient, there is a potential for larger awards for economic damages.

There is limited data currently available regarding the long-term safety and efficacy of refractive lens exchange for treatment of refractive errors and even less data available to aid OMIC in predicting the frequency, severity, or defensibility of claims arising from such cases.

As a result of these concerns, OMIC has chosen to take a conservative stance regarding coverage for refractive lens exchange.  Currently, coverage is generally available only for cases performed on patients who meet specific criteria regarding degree of myopia or hyperopia, age, and other factors.  Coverage is not currently available for the treatment of emmetropic patients (with or without presbyopia).

Additional Information

OMIC will continue to monitor this issue closely and will watch for both positive and negative trends in our claims experience and in the ophthalmic literature.  OMIC invites its insureds to share any statistical data, clinical trial results, or other information available regarding refractive lens exchange procedures.

Phakic Implants

Subject to underwriting review and approval of a supplemental questionnaire, OMIC extends coverage for phakic implant procedures performed with, and following the FDA-approved guidelines for, implants specifically approved by the FDA for phakic use. In addition, coverage is available for phakic implant procedures performed under, and in accordance with, an IRB-approved protocol.

Physicians interested in obtaining additional information or an application for coverage of phakic implants or refractive lens exchange should contact their underwriting representative at (800) 562-6642.  Physicians who would like to submit trial results, statistical data, or other information for review by the Underwriting Committee may send it to Betsy Kelley, Vice President, Product Management, at OMIC, 655 Beach Street, San Francisco CA 94109.

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