Risk Management in Cataract Surgery

Informed Consent

A claim of failure to obtain informed consent is common in malpractice cases and sometimes avoids an expert witness requirement, making it cheaper and easier to file a lawsuit. States following the “professional disclosure” standard do require expert testimony to establish what a typical member of the profession’s informed consent would contain, but those following a “reasonable person” standard take the patient’s lay perspective.

It is important to make sure that the informed consent conversation addresses all aspects of the planned cataract surgery, including issues that could complicate that particular individual’s surgery or affect visual potential. For example, one plaintiff who suffered vitreous loss argued that his informed consent was inadequate because he was on tamsulosin. Although that plaintiff lost, the court’s reasoning suggests that the outcome might be different now, when tamsulosin’s role in intraoperative floppy iris syndrome is better established than in 2005. Relatedly, risk for iris damage should be disclosed, as OMIC has reported lawsuits over iris injury during cataract surgery.

A signed informed consent is an important document to have, but mere paperwork is not a sufficient defense against an informed consent claim, especially if the patient has poor vision, is illiterate, or does not speak English. Surgeons should also obtain informed consent with documentation when patients opt for refractive services that are not medically necessary. Consent obtained before the day of surgery is preferable, and it is necessary to obtain consent before administration of any anesthetic medication.

Malpractice insurers may provide sample informed consent forms for practices. These examples provide useful guidance and also highlight the key points that ophthalmologists may want to raise during their time counseling patients. In Florida, the Boards of Medicine approved a cataract informed consent form endorsed by the Florida Society of Ophthalmology.

Advertising

Appropriate informed consent is essential for all patients, but establishing expectations for refractive cataract surgery is particularly important. For example, physician advertisements have been used to allege inadequate informed consent or violations of consumer protection laws. Physician advertising is governed by the Food and Drug Administration, Federal Trade Commission, and the states. In addition to drawing regulatory scrutiny, advertising that focuses on devices’ benefits without disclosing risks could be seen as undercutting informed consent.

With the amount of new technology available for cataract surgery, physicians should remember that they are only allowed to promote within a device’s labeling and must discuss relevant risk information. For instance, the Food and Drug Administration sent warning letters to four practices warning that their websites did not disclose laser assisted in-situ keratomileusis risks completely. Some malpractice insurers will review proposed advertising for potential compliance issues.

Surgeons must explain the risks and benefits of the technologies offered to patients. In particular, patients may be particularly inclined to believe in the advantages of using a laser to perform cataract surgery. Therefore physicians offering femtosecond laser-assisted cataract surgery need to be careful not to claim superiority of laser-assisted cataract surgery in light of multiple large studies that to date show only noninferiority to manual cataract surgery.

Similarly, discussion of glasses-free outcomes must be balanced with the downsides of presbyopia-correcting IOLs plus the possibility that patients will not be as glasses-free as desired afterward. Plaintiff attorneys often include claims alleging inadequate informed consent or fraud to enable them to ask for punitive damages, which may be much larger in amount and not be covered by malpractice insurance. Using plain language may help patients understand their choices more easily.

OMIC says it is “advisable” to inform patients about IOL options that surgeons may not offer, although it of course remains up to each ophthalmologist to decide which specific IOLs to implant.

Fraud and Abuse

The False Claims Act prohibits knowing presentation of a claim for payment to the government that is false or fraudulent and carries a civil monetary penalty for each false claim. The Department of Health and Human Services Office of Inspector General identified the entire specialty of ophthalmology as an auditing target for 2014, an unusual step. Its 2015 report discussed cataract surgery, noting variability between surgeons in percentage of cataracts billed as complex cases.

Multiple reviews have estimated that only about 2% of the cataract surgeries performed in the U.S. are not medically justified. However, lawsuits are often filed alleging fraudulent cataract surgery, so surgeons must document the exam, patient’s complaints, and desire for cataract surgery. Using a patient visual functioning questionnaire such as the VF-8R, which some insurers endorse, can help document necessity and patient desire for surgery.

Comanagement and Antikickback Statute

The antikickback statute creates criminal and civil penalties for offering anything of value to receive referrals for services paid by a federal healthcare program outside of its safe harbors. There is no safe harbor for cataract comanagement; it may be permissible, including for premium IOLs, but the details of the arrangement are important because the Office of Inspector General will take a case-by-case approach. It is better not to formalize a comanagement financial arrangement between surgeon and referrer in writing because any agreement to send a patient back to the referring provider must be based on patient choice.

The patient should agree in writing to comanagement, and the two providers should have an agreed-upon postoperative care protocol with defined situations in which the referrer will consult the surgeon or send the patient back to handle problems. Otherwise, a plaintiff could argue that the surgeon is vicariously liable if, for instance, an optometrist failed to recognize endophthalmitis. The transfer of care can occur only after the operating ophthalmologist deems the patient stable and ready for transfer, and a trained ophthalmologist must be available if medically necessary. The transfer of care should be documented. Also, the patient should write two checks rather than have the surgeon collect the entire fee and split it.