Risk Management

Coverage for Use of Premium IOLs

By Kimberly Wittchow

OMIC Legal Counsel

Digest, Winter 2009

While use of premium intraocular lens implants (IOLs) does not directly impact your policy coverage with OMIC, you should be aware of the policy provisions and underwriting requirements related to the use of IOLs and how they might vary for premium IOLs. There are two scenarios in which premium IOLs might be employed. The first is refractive lens exchange (RLE) surgery and the second is cataract surgery.

Refractive Lens Exchange

OMIC uses the term refractive lens exchange for refractive surgery in which IOLs (premium or otherwise) are used to replace a patient’s natural lens in order to improve vision when visually significant cataracts are not present. All refractive surgery is excluded under the policy unless specifically added back on by endorsement.

If you seek coverage for refractive lens exchange, you must fill out a supplemental questionnaire and submit it to the underwriting Department for review. In applying, you agree to abide by OMIC’s general refractive surgery and specific RLE requirements.

If approved, an endorsement will be placed on your policy, adding coverage back for this procedure at full policy limits. (No additional premium is required.) This endorsement specifies that RLE is covered, but only when performed within OMIC’s underwriting requirements or any exceptions to the requirements granted in writing by OMIC. If you seek an exception to the requirements, you may do so in writing to your underwriter by completing the Exception Request Form. OMIC discourages exceptions except in extenuating circumstances and only grants exceptions on a patient- specific basis. Do not schedule surgery until your exception is granted.

RLE Underwriting Requirements

To see all of the refractive surgery and RLE-specific underwriting requirements, see the Guide to Refractive Surgery Requirements. These requirements, along with the RLE supplemental application, address patient selection criteria, informed consent, operative procedures, postoperative care, and advertising.

One specific requirement to note is that RLE must take place in a hospital or outpatient surgical facility approved for cataract surgery and full sterile technique must be followed. RLE may not be performed in a physician’s office, laser refractive center, or other facility that does not meet the standard for sterile conditions required for accreditation.

Other requirements specific to RLE are: (1) there must be an interval of at least a week between primary procedures, (2) all patients must undergo a retinal exam pre- and postoperatively and be advised of the increased risk of retinal detachment, and (3) patient selection guidelines for myopia and hyperopia (treatment of emmetropic patients is not covered) must be followed (see box).

The use of premium versus standard IOLs in RLE procedures does not make a difference as far as coverage is concerned, as long as, in using them, no underwriting requirements are violated. You are, though, required to address the specific IOL to be used in the informed consent process and explain its indications, risks, benefits, alternatives, and complications, as well as its off-label use for RLE.

Cataract Surgery

If the patient has selected the use of premium IOLs in cataract treatment, no special underwriting is required. Remember that a procedure is considered refractive surgery if the lens is completely clear or there are visible cataract changes that aren’t visually significant and not associated with patient complaints about vision. Cataract surgery is automatically covered under the policy (under surgery class 3). As long as the use of premium IOLs is within OMIC’s general policy requirements, no endorsement is required.

You should also note that the policy excludes coverage of clinical research or trials that are not conducted under and in accordance with an American IRB-approved protocol. Make sure that any premium IOL clinical trials you are involved in meet these standards in order to ensure coverage under your OMIC policy.

RLE UNDERWRITING REQUIREMENTS

Myopia. Patients must be presbyopic, age 40 or older, and have at least 6 diopters and not more than 15 diopters of myopia.

Hyperopia. Axial length must be at least 20 mm, and uncorrected visual acuity must be 20/40 or worse. Patients age 40 and older must be presbyopic and have at least 1 diopter and not more than 15 diopters of hyperopia. Patients under age 40 must have at least 4 diopters and not more than 15 diopters of hyperopia.