Advertising Premium IOLs

Kimberly Wynkoop, OMIC Legal Counsel

Digest, Summer 2011

Ophthalmologists have both a legal and ethical obligation to truthfully advertise their services. This article will address issues to be aware of in advertising premium IOLs and the implications for coverage when improper advertising occurs. Much of this information was adapted from the American Academy of Ophthalmology 2008 Policy Statement: Guidelines for Refractive Surgery Advertising.

Both the Federal Trade Commission Act and the Federal Food, Drug, and Cosmetic Act prohibit false and deceptive or misleading advertising. The FTC has primary jurisdiction over the advertising of health care services, over- the-counter drugs, and devices. The FDA has jurisdiction over product labeling for prescription drugs and medical devices, and advertising of prescription drugs and medical devices that a licensed practitioner must authorize for sale, distribution, or use. Note that patient information brochures, seminars, and videos may be considered advertising.

State licensing authorities also regulate physician advertising and can impose disciplinary action against physicians who engage in false and deceptive advertising. In addition, every state has general laws and rules against false and misleading commercial claims. The American Academy of Ophthalmology has ethics rules which apply to advertising issues as well, most directly, Rule 13. Communications to the Public.

Under FDA regulations, advertising FDA-approved devices by brand name and model is permissible as long as a brief statement of the device’s intended uses and all relevant warnings, precautions, contraindications, and side effects are provided in the advertisement. Ads do not need to incorporate all informed consent disclosures, but they must not contradict them. If the device’s FDA premarket approval orders include requirements that promotional materials contain specific risk information, those must be adhered to.

There are additional precautions to take when advertising FDA- approved premium IOLs that the ophthalmologist may use off-label. While it is legal under the “practice of medicine” exception for physicians to use FDA-approved devices off-label, advertising this use is prohibited.

The FTC requires that advertisers have a “reasonable basis” for advertising claims at the time they are made. This will usually require “competent and reliable” scientific evidence that may include the physician’s own outcomes alone or in combination with other clinical studies, preferably those that have been peer reviewed or replicated in other studies.

If using a testimonial, the particular patient’s experience must be typical or representative of the experiences generally achieved by the physician’s patients, or else a clear and conspicuous disclosure of the results generally achieved by the users of the product or device must be included. Note that some states prohibit the use of patient testimonials.

As with LASIK advertisements, ophthalmologists should avoid ads that begin: “Throw Away Your Glasses” or have images with the same message. Even if the ad text states that the premium IOL “may correct your presbyopia and nearsightedness and may eliminate your need for glasses or contacts,” consumers are still likely to infer from the dramatic opening statement or image that if they select cataract or refractive surgery with use of a premium IOL, they will achieve perfect vision and be free of any need for glasses. Since the surgeon cannot guarantee this outcome, the claim is subject to legal challenge.

Another advertising pitfall is the use of statements such as, “We use premium IOLs so you get the best results.” This implies that premium IOLs produce better results than standard IOLs (or other procedures). Such a statement should be avoided unless the physician has competent and reliable scientific evidence to support it.

A statement that you can legally make is: “The Food and Drug Administration has determined that the premium IOLs we use are safe and effective for cataract surgery.” The Federal Food, Drug and Cosmetic Act was amended to allow references to the FDA-approved status of medical devices in advertisements.

Aside from action by the FDA, FTC, state agency, or the ophthalmologist’s professional society(ies), false or misleading advertising could lead to lawsuits against the physician by patients alleging lack of informed consent or fraud. In turn, this could result in uninsured risk as a result of the denial of the claim or termination of coverage by the ophthalmologist’s malpractice insurer.

Patients may prevail in a claim of lack of informed consent where aggressive advertising has occurred. The patient may allege that the overstated benefits misled him or her into agreeing to undergo the surgery without fully understanding or appreciating the consequences and alternatives. In this way, the advertisement destroys the validity of an otherwise properly executed consent form.

OMIC’s underwriting requirements for refractive surgery (which includes the use of premium IOLs for refractive lens exchange) state that advertisements must not be misleading, and must not make statements that guarantee results or cause unrealistic expectations. Violation of these underwriting requirements may cause termination of the policy or denial of coverage of a claim based on the violation. In addition, Exclusion III.B.1 of the policy provides that OMIC will defend insureds against allegations of medical malpractice that include false, misleading, or deceptive advertising or other fraudulent acts, but not if the claim is based solely on the advertising or fraud claim. Even then, the policy will not cover damages or supplementary payments for such claims.

Are Patients Who Chose Premium IOLs a Malpractice Risk?

By Anne M. Menke, RN, PhD

OMIC Risk Manager

Digest, Summer 2011

To view the tables referred to n this article, go to: http://www.omic.com/new/digest/Digest_2011Summer.pdf

Staff in OMIC ‘s Claims and Risk Management Departments field a significant number of calls from ophthalmologists about “premium” intraocular lenses (PIOLs), the name given to those IOLs for which patients are asked to pay extra. Questions range from whether physicians need to inform patients of the availability of PIOLs during the informed consent discussion to whether refunding the extra fees paid for them is an admission of liability. To determine if implantation of PIOLs has led to lawsuits, we conducted our first claims analysis of these lenses.

Thirty-four plaintiffs filed claims involving 47 PIOL implants against 40 OMIC-insured defendants. Thirty-five of these defendants were ophthalmologists, four were associated but separately-insured ophthalmology practices, and one was a separately-insured ambulatory surgery center. Forty-four of the PIOLs were implanted during cataract surgery and three during refractive lens exchange. We compared PIOL claims to cataract and refractive surgery claims; the former share the same procedure and the latter presumably have similar refractive goals and payment issues. Graph 1 on page 4 shows the number and type of PIOLs implanted, while Graph 2 gives the percentage of open, closed, and total claims for PIOL, cataract, and refractive claims. PIOL claims are still very infrequent and there are more open than closed claims, but it is too soon to predict whether claims from these relatively new devices will increase over time.

Many malpractice claims are dropped before a lawsuit is even filed and most close without any money being paid to the plaintiff. Table 1 on page 5 provides three more severity indicators: the median (middle), mean (average), and highest payments for PIOL, cataract, and refractive claims compared to all OMIC claim payments. Premium IOLs have the smallest percentage of claims that close with an indemnity payment, as well as the lowest median, mean, and high payments. In OMIC’s experience to date, PIOL claims are considered very low frequency/very low severity, while cataract claims are high frequency/moderate severity, and refractive surgery claims are low frequency/moderate severity. OMIC does not have data on the prevalence of use of PIOLs, so we cannot draw any conclusions about the relative risk of premium versus monofocal IOLs.

Premium IOL Causation Analysis

OMIC has developed a method of analyzing the primary driving force behind malpractice claims against ophthalmologists. In this analysis, which we call CPSP, we look at four factors: clinical, physician, system, and patient. Clinical issues are areas of controversy or of limits in knowledge or diagnostic/treatment modalities. They are identified during the investigation of a claim and derived in part from the opinions of physician expert witnesses. System issues cannot be attributed to a single individual; instead these are processes in which many individuals and entities are involved. Table 2 shows the primary and secondary causes of claims for premium IOLs in open and closed claims brought by 34 plaintiffs. System issues predominate; patient factors contribute about half as often, followed by clinical and physician ones. While physicians are the least likely contributor to claims against them, there is still much they can do to protect themselves starting with a review of the four contributing factors.

Candidacy issues emerged as the primary clinical issue: experts opined that the appropriateness of premium IOLs was not adequately evaluated for patients with multiple sclerosis, glaucoma, dry eye disease, posterior vitreous detachments, and monfocal IOLs in the fellow eye. Issues frequently seen in monofocal IOL cases were also found, such as when surgery is indicated, how long patients who wore contact lenses must be out of them before the IOL is chosen, and how to determine the dominant eye for monovision.

Experts pointed to faulty physician judgment as the most frequent way that ophthalmologists contribute to claims. An ophthalmologist was criticized by both plaintiff and defense experts for leaving an IOL whose haptic broke during surgery in the patient’s eye, since the defect could lead to the decentration issues the patient later encountered (this elderly patient did not pursue the claim). Plaintiff and some defense experts felt that repositioning a dislocated IOL five times caused the retinal detachment the patient developed (the case settled for $215,000, of which OMIC paid $122,500).

Six system issues were identified (followed by the number of resulting claims): communication among team members (2), the diagnostic process (2), documentation (5), equipment (3), informed consent (20), the litigation process (4), and sterilization (1). Issues are presented for open and closed claims, but specific case examples are only provided for closed claims.

Communication breakdowns are more likely to occur when many physicians are involved in care, and when there are frequent patient hand-offs from one provider to another or from one setting to another. “Wrong” IOL and “wrong” patient errors are the most common examples of these communication breakdowns in ophthalmology, and one case occurred in this series. The ophthalmologist had correctly chosen and ordered the PIOL, but no one on the team had noticed that it was not in the OR. When the physician asked for it, he indicated the correct power but not that it was a PIOL. With the patient’s permission, he immediately exchanged the IOL, and he and the ASC performed the exchange at no charge to the patient (the suit settled for $15,000 on behalf of the physician; the ASC refused to contribute and blamed the physician for the mishap).

The diagnostic process is one of the most complex tasks physicians perform. Certain scenarios frequently lead to allegations of delay in diagnosis, as is the case for some open claims in which multiple providers and specialties tried to find the cause of non-specific symptoms, such as headache or decreased visual acuity.

Documentation issues included omissions and additions. Experts criticized ophthalmologists’ failure to document the specifics of the informed consent discussion, the process of aligning toric IOLs during surgery, and to note complications that occurred during surgery in the operative report. They questioned the accuracy of the medical record when physicians relied heavily upon templates, when scribes documented too uniformly at each visit, and when electronic medical record systems did not individualize the content for each specific patient or visit.

Equipment problems were the primary factor in two PIOL claims. A defective plunger caused a capsular rupture and prevented the ophthalmologist from implanting a Crystalens. The surgeon documented the equipment problem, disclosed it to the patient, reported it to the hospital and the manufacturer, and offered subsequent care at no cost (the plaintiff dropped the suit). A registered nurse who had no prior experience with phacoemulsification equipment caused a corneal abrasion (the non-OMIC ASC settled the case; the physician was dismissed).

An allegation of lack of informed consent accompanies many malpractice claims but rarely turns out to be the pivotal factor. PIOL claims proved to be an exception to this trend, as informed consent issues were the primary factor in eleven cases, and a secondary factor in nine. We concluded that an inadequate informed consent process was the single most important driver of PIOL malpractice claims. See Hotline article for recommendations on how to improve the consent process.

The litigation process itself was the primary factor in three claims and a secondary factor in one. In some cases, expert witnesses appeared to act as an advocate for the attorney who hired them rather than as neutral experts who explain the medicine. One physician accepted a referral from the plaintiff attorney and agreed to examine and treat a patient who was not satisfied with the quality of her vision provided by her Crystalens implant. The plaintiff expert testified at trial that the defendant ophthalmologist had erroneously placed the IOL in the sulcus, despite documented exams by three prior ophthalmologists that the IOL was in the capsular bag (the jury returned a defense verdict). In another case, the plaintiff expert did not carefully review the medical records provided by the plaintiff attorney and certified that the care was substandard; when challenged by the defense attorney during his deposition, the plaintiff expert acknowledged that far from substantiating his criticisms, the medical record demonstrated that the ophthalmologist had met the standard of care (a motion for summary judgment was granted).

Defense expert witnesses can also surprise the attorneys who hire them. A patient in her forties with preoperative visual acuity of 20/40 was offered cataract surgery with a PIOL. The plaintiff expert felt a more careful preoperative exam would have noted a posterior vitreous detachment, which he believed led to an inferior retinal tear. The defense expert was initially supportive and noted that the tear did not impact the patient’s vision. Only during deposition did the defendant and defense attorney learn that their expert was critical of the failure to perform glare testing before recommending cataract surgery (the timing of this reversal of opinion led to a $45,000 settlement).

Patient factors played an important role in PIOL claims, second only to system issues. Accepting an unsatis- factory outcome requires more resiliency than some patients possess or can develop; mental health issues thus were a primary cause in three and a secondary cause in seven claims. One patient had bilateral Crystalens implants but was not satisfied with the quality of her distance vision, so she asked that her distance vision be improved with LASIK at the cost of near vision. Although she acknowledged the need for glasses before she had the refractive procedure, she nonetheless filed a claim and wrote to the medical board when she then had to wear the glasses (the claim was dismissed, and the medical board supported the care). The feeling that the ophthalmologist “must have been done something wrong” was strongest in patients who developed a cascade of complications requiring multiple office visits, medications, consultations, and procedures. A patient with a long eye and a history of prior LASIK surgery experienced a ruptured capsule during surgery to implant a ReSTOR lens; postoperatively, she had a hyperopic surprise and developed bullous keratopathy. Not surprisingly, she was unhappy when her final visual acuity after an IOL exchange and DSAEK was only 20/80 (there was strong defense support for the care and the statute of limitations had expired; the defense motion for summary judgment was granted and the case was dismissed).

As specialists who develop and incorporate new technology at a rapid pace, all ophthalmologists can learn from this early report on malpractice claims related to premium IOLs and implement measures to ensure that patients are carefully selected as candidates for the latest advances and are fully engaged in the decision and care process. The AAO recently published a Focal Points module on MFIOLs and AIOLs in which authors Steven I. Rosenfeld, MD, and Terrence P. O’Brien, MD, provide a systematic approach to determining the cause of the patient’s complaint and how to best address it.1

1. “The Dissatisfied Presbyopia-Correcting IOL Patient.” Focal Points: Clinical Modules for Ophthalmologists. American Academy of Ophthalmology, September 2011.

Coumadin and Ocular Anesthesia

By Paul Weber, JD

Digest, Spring 1998

Recently, I took an incident report from an insured who stopped a patient’s Coumadin five days prior to surgery. Two days after surgery, the patient suffered a devastating stroke. The specific risks of discontinuing Coumadin were not discussed with this patient prior to surgery. It was the first time an incident of this kind was reported to OMIC, although the question of whether to stop Coumadin prior to cataract (or intraocular) surgery has come up a number of times. Quite often, an important risk management issue such as this one will raise both clinical and legal issues. When this occurs, we are fortunate to be able to collaborate on the clinical issues with ophthalmologists from OMIC’s Board and Committees.

In this case, Risk Management Committee Chairman Dean C. Brick, MD, a cornea specialist in Tucson, addressed the prevalent clinical issues. We realize this is a controversial topic and would appreciate hearing from our readers on this one.

Q  Should I discontinue a patient’s Coumadin prior to cataract (or intraocular) surgery?
A  This is a difficult situation since Coumadin puts both patient and surgeon at increased risk. If you continue the patient on Coumadin, you risk being sued if the patient develops bleeding problems. If you discontinue the Coumadin and the patient suffers a stroke, you may be sued for not advising the patient of the risks involved in stopping the medication. Two critical decisions must be made in these patients.

The first is whether the patient needs to be maintained on full doses of Coumadin prior to and during surgery. In many cases, patients are on Coumadin for prophylactic reasons and may safely discontinue it for a few days prior to surgery to allow the INR to decrease but not to a normal level. This option should be discussed with the primary care physician monitoring the patient’s anticoagulant and the discussion and decision reviewed with the patient and documented in the chart. If the decision to stop Coumadin is made, routine technique and anesthesia (including retrobulbar anesthesia) are appropriate.

Q  What surgical technique or anesthesia should I use in patients whose anticoagulant cannot be discontinued or decreased such as those with artificial heart valves?
A  This leads to the second critical decision: Should you change your technique of surgery or anesthesia? If a patient’s INR remains significantly elevated prior to surgery, the patient faces the risk of retrobulbar hemorrhage following retrobulbar or peribulbar anesthesia as well as the possibility of a more severe suprachoroidal hemorrhage. It might seem that topical anesthesia would be the technique of choice in these cases; however, OMIC has had two cases of suprachoroidal hemorrhage associated with topical anesthesia in which the patients complained of pain during surgery. It was alleged that the patient’s pain and discomfort resulted in elevated blood pressure and hemorrhage. Even though there are still risks of complications, topical anesthesia is probably the technique of choice for such patients provided the physician and anesthetist are experienced with its application.

If not, the surgeon should refer the patient to a surgeon who is experienced with this technique or modify his or her technique to fit the circumstances.

Q  If after weighing the options, it is decided that injectable anesthesia is the technique to use on a patient, how can I minimize the risk of complications?
A  Use a Greenbaum cannula or blunted needle to administer the anesthetic. A prolonged massage following the injection will prevent the formation of a large hemorrhage, which would compromise circulation to the globe or optic nerve. Closely observe the patient for signs of hemorrhage prior to, during and after surgery. Provide instructions before the patient leaves the hospital on how to recognize the signs of hemorrhage and how to contact you if any of these symptoms occur. Always be prepared to respond to emergencies. There are health risks to the patient and concomitant liability risks to the surgeon with any decision in situations like this. Discuss all the options and risks with the patient and document the reasons for the final decision in the chart.

Anesthesia and Sedation Risks and Precautions

By Carol Poindexter, JD, and Kimberly Wittchow, JD

Ms. Poindexter is a partner with the international law firm of Shook, Hardy and Bacon LLP specializing in health law.

Ms. Wittchow is OMIC’s staff attorney.

Digest, Summer/Fall 2004

Use the Download option in the toolbar above view the chart  titled “Monitoring and Recovery Equipment for Office-Based Anesthesia” mentioned in this article.

Advances in science, technology, and training, combined with reimbursement pressures by third party payors, have had the effect of moving the vast majority of ophthalmic procedures from hospitals to freestanding ambulatory surgery centers (ASCs) and office-based facilities. While this change has generally benefited ophthalmologists and their patients, there are concerns about compromised patient safety and increased physician liability when sedation and anesthesia are administered outside the hospital setting. The first section of this article outlines several risk avoidance practices that can help ophthalmologists, especially those operating in office-based settings, maximize patient safety and minimize sedation and anesthesia-related liability risks.

In some cases, sedation or anesthesia may be administered by an anesthesiologist or other qualified anesthesia provider, such as a certified registered nurse anesthetist (CRNA). Federal and state guidelines often require that in hospital and ASC settings, the treating surgeon supervise the CRNA. The second section of this article addresses the surgeon’s supervisory role and how it affects liability risk.

While hospitals and ASCs are typically closely regulated by accrediting agencies, the office-based surgical setting is currently only regulated in a handful of states. If surgeons do not follow reasonable and published guidelines for office-based surgery and sedation, there is an increased risk that procedures may be performed in settings lacking the appropriately educated and trained clinical staff and/or sufficient equipment and emergency protocols to handle adverse reactions to sedation or anesthesia or other emergencies that may arise. Administering sedation and anesthesia without adequate experience or equipment can have devastating consequences.

Precautions for In-Office Procedures The decision to perform a procedure in an office-based setting should only be made after careful evaluation. The surgeon is responsible for conducting or reviewing an appropriate physical exam and formulating and prescribing a written patient-specific plan for sedation or anesthesia care that addresses fasting requirements and treatment locale. Because it is impossible to accurately predict how each patient will respond to sedation or anesthesia of any type, and given the fact that the physician and office staff may be called upon to rescue the patient if an adverse reaction occurs, all staff should be thoroughly trained in emergency treatment protocols. The surgeon and other clinical support staff should be certified in Basic Life Support (BLS); Advanced Cardiac Life Support (ACLS) or Pediatric Advanced Life Support (PALS) certification is ideal.

To address patient safety con- cerns, the physician must have an adequate number of competent, professional staff members available to monitor the patient during the sedation. The person responsible for monitoring the patient during the procedure cannot be the same one performing it. This person should be familiar with the medications used; know how to recognize airway obstruction and correct it; know how to monitor the required para- meters, recognize abnormalities in them, and intervene; and be able to manage ventilation with a self- inflating bag valve mask. Additionally, all staff members who will be involved in patient care duties must meet all licensure and certification requirements; have sufficient experience to perform their duties; and be supervised by the operating surgeon or other licensed physician throughout the peri, intra, and postoperative/anesthesia periods.

Upon completion of the surgical procedure, the ophthalmologist who administered or medically directed the sedation should evaluate the patient prior to transferring the care to a qualified licensed nurse. The nurse assuming care of the patient should be qualified to identify surgical and sedation or anesthetic complications that might occur during the postoperative period. The patient should be sent home only after discharge criteria are met and in the company of a competent adult. (For more information on office-based sedation, see Hotline article.)

Supervision of CRNAs at Hospitals and ASCs In ASC and hospital settings, ophthalmologists are often required to supervise nurse anesthetists and sign various anesthesia-related orders, evaluations, and reports. This has raised questions about the ophthalmologist’s exposure to claims based on the actions of the CRNA.

Under federal law, it is a condition of participation in the Medicare and Medicaid programs for ASCs that a non-physician anesthetist be under the supervision of the operating physician. The requirement for hospitals varies slightly in that a CRNA must be under the supervision of the operating practitioner or an anesthesiologist who is immediately available if needed.

States may request that their ASCs and hospitals be exempted from this supervision requirement. According to the American Association of Nurse Anesthetists’ web site, however, the only states that had opted out of the federal supervision requirement as of November 2004 were Alaska, Idaho, Iowa, Kansas, Minnesota, Montana, Nebraska, New Hampshire, New Mexico, North Dakota, Oregon, and Washington. If your state is not on this list, there is likely a state law that either mirrors or expands upon the federal provision. See your state government, state medical society, or nurse anesthetists’ association web sites for more information.

Proving Supervision Has Occurred

The Centers for Medicare & Medicaid Services (CMS) do not define or specify how to prove supervision. Nevertheless, having the supervising physician sign certain anesthesia orders, evaluations, or records may be the simplest way for the ASC or hospital to confirm that supervision has occurred.

It is OMIC’s understanding that the role of the treating physician, in relation to the provision of anesthesia services, is to (1) determine whether a patient requires the surgery or diagnostic procedure, (2) request that anesthesia be administered, and (3) determine that the patient is an appropriate candidate for the procedure and anesthesia. Therefore, it is not uncommon for the treating physician to be asked to sign perioperative orders for anesthesia, sedation, and anxiolytic drugs and to co-sign the pre-anesthesia evaluation conducted by the nurse anesthetist in addition to signing the record of the operation prepared by the circulating nurse as well as the dictated operative report. It is less common, however, for the surgeon to sign the anesthesia record. If asked to do so, the ophthalmic surgeon may wish to clarify with the ASC or hospital the reason for this requirement, since proof of the surgeon’s presence and/or supervision during the procedure should be ample from the aforementioned signed orders, co-signed pre-op evaluation, and/or operative records.

Liability for the Actions of CRNAs

Depending on state law, you may be held vicariously liable under the doctrine of “respondeat superior” for the actions of nurse anesthetists who are your employees. Also termed the “master-servant rule,” this doctrine holds that an employer is liable for the employee’s wrongful (or negligent) acts committed within the scope of employment.

If you supervise nurse anesthetists who are not your employees, however, you are not necessarily liable for their actions. Courts generally focus on the amount of control the treating physician exercises over the anesthesia provider to determine whether the physician should be liable for the anesthetist’s actions (whether the anesthetist is a CRNA or an anesthesiologist). The fact that you sign certain anesthesia orders, evaluations, or records might be used by a plaintiff’s attorney to attempt to prove control, but without further evidence, it would doubtfully be sufficient.

Similarly, the fact that you are required to supervise nurse anesthetists’ provision of services during a procedure does not, by itself, create an employer-employee relationship, nor does it prevent you from maintaining independent contractor relationships with them (or no formal relationships at all, such as in a hospital setting). The substance of the relationship, not the label, governs the nurse anesthetist’s status as an employee or independent contractor. In order to determine whether a CRNA would be considered an employee, there are several factors to consider:

Do you have a right to direct and control how the nurse anesthetist does the task for which he or she was hired? An employee is generally subject to the employer’s instructions about when, where, and how to work.

Does he or she bill separately for his or her own services? Independent contractors are more likely than employees to have non- reimbursed expenses and to bill separately for their own services.

Is there a written contract describing the relationship of the parties? Do you provide the nurse anesthetist with benefits, such as insurance, a pension plan, vacation pay, or sick pay? Is his or her compensation subject to withholdings for income taxes, unemployment, or workers’ compensation? Whether under contract or not, an employee often will receive benefits and his or her compensation is subject to withholdings.

An ophthalmologist’s supervision of one portion of the nurse anesthetist’s provision of services is not determinative of the nurse anesthetist’s employment status. Rather, it is only one of many factors used to determine the nature of the relationship.

OMIC’s policy covers its insureds for liability arising from the supervision of nurse anesthetists (subject to all policy conditions and exclusions). It is your decision whether to seek less responsibility for CRNA supervision at ASCs or hospitals.