Risk Management

Maintaining an Effective Informed Consent Process

Anne M. Menke, RN, PhD, OMIC Risk Manager

Digest, Summer 2011

In nearly all PIOL claims we reviewed, ophthalmologists had lengthy informed consent discussions with patients and asked them to sign detailed procedurespecific forms before surgery; yet, patients alleged lack of informed consent. What happened? Almost inevitably, a breakdown in physician-patient communication occurred after surgery when patients experienced side effects or complications, or did not quickly achieve spectacle independence or the quality of vision they wanted— and for which they paid thousands of dollars out of their own pockets.

Q  What information was missing from the initial informed consent discussion in the PIOL claims?

A  Ophthalmologists can do a better job of identifying, evaluating, disclosing, and documenting the presence of systemic or ocular comorbidities that could impact the quality of the visual outcome: “As you know, you are a glaucoma suspect. My review of the visual field and OCT results show no signs of active disease, so I feel you are an appropriate candidate for a PIOL. You may be at increased risk, however, for optic nerve damage and vision loss if your intraocular pressure rises during or after surgery, or if you develop swelling and need to be on steroid eye drops for a prolonged period of time. Are you willing to go forward knowing you could have this problem?

Eye surgeons can also educate patients about areas of clinical uncertainty: “Not all ophthalmologists agree that patients with a monofocal IOL in one eye are good candidates for a premium IOL in the other eye, so I want to talk to you about the drawbacks for you of implanting this type of IOL.

Q  Why do you recommend relating postoperative problems with the consent the patient signed before surgery?

Although patients hear and read information about potential complications, they tend to emphasize the benefits, minimize the risks, and assume that these problems will not happen to them. When they face disappointing outcomes, some patients may fear that something they did caused it. Others may decide the surgeon was at fault, probably in agreeing to implant the premium IOL rather than insisting on a monofocal one, or in not preventing or better managing the complication. Ophthalmologists can help patients by “normalizing” the outcome: far from being a surprise, perioperative complications are expected in a certain number of cases, despite the best efforts of patients and surgeons alike, and that is why they are discussed before every surgery. When physicians listen to patients’ concerns with empathy rather than defensiveness, they promote emotional healing and strengthen the physician/patient relationship.

Q  Should I discuss the extra charges as part of informed consent?

A  Unmet expectations and confusion over what services were covered by the extra charges led to dissatisfaction in a number of cases. One patient called her ophthalmologist when she received a bill for toric IOLs from the ASC. Trying to be helpful, a staff member at the practice explained that the ASC orders and provides the IOL. Convinced that the ophthalmologist had double-billed her, she filed a claim alleging fraud (it was dismissed). ASCs already receive $105 for the IOL as part of the surgical fee, so a recent AAO Coding Bulletin on PIOLs advises them to collect the extra fee for the PIOL, both to clarify the billing process for the patient and to avoid the appearance of splitting fees with the surgeon.[1] Ophthalmologists may prevent billing surprises by providing patients with an itemized account of the professional services they will provide and clearly indicating whether the fee covers any additional surgery needed to optimize the quality and precision of the visual outcome. ASCs would be well-advised to provide details about their fees as well as part of the admission process.

At what point should I consider refunding the extra amount the patient has paid for a PIOL?

A  Some patients may ask for a refund as soon as a problem arises, others may not bring it up at all. If you were not able to implant a PIOL, consider refunding the extra fee right away. If after doing everything you can to improve the refractive outcome and address any complications, the patient still is not satisfied, consider a refund then. Whether or not to offer a refund is a business decision and not an admission of liability. OMIC risk management staff are here to assist you. Call the confidential Hotline at (800) 562-6642, ext. 641.

1. Vicchrilli S. “Coding for Premium IOLs.” AAOE Coding Bulletin. American Association of Ophthalmic Executives, October 2011, www.aao.org.

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