David F. Chang, MD and Bryan S. Lee, MD, JD
The availability of presbyopia-correcting intraocular lenses (IOL) and the Centers for Medicare and Medicaid Services ruling allowing patients to pay for them out of pocket as noncovered refractive services have dramatically altered the practice of every cataract and refractive surgeon. Ready or not, the availability of these options has made every cataract patient a potential refractive patient. Furthermore, presbyopic patients who believed laser vision correction to be the only refractive procedure available now have entirely different surgical alternatives to consider. These myriad new options and the premium remuneration that they command create a number of ethical issues for ophthalmologists. In a profession in which the IOL industry spends a great deal of money to market products to us, we have the challenge and the important responsibility of educating patients as objectively as possible.
Offering and explaining the option of reduced spectacle dependence would be far easier if we had an IOL technology that consistently eliminated the need for eyeglasses in every patient. The benefit would be easy to understand, and qualified candidates would decide what they wanted based upon the affordability of this option. Lacking such an elegant solution, we and our patients must analyze and understand the potential benefits and tradeoffs of current refractive IOLs, knowing that the results will vary from one individual to the next.
Patients consulting a plastic surgeon already understand that their interest in elective cosmetic surgery is not because of a health need or recommendation. This concept may not be clear, however, to patients hearing about refractive IOLs for the first time prior to scheduling cataract surgery. Already somewhat confused about cataracts and IOLs, many patients won’t understand the distinction between what is the refractive treatment and what is the cataract treatment. They may not understand that the financial decision they are being asked to make concerns lifestyle benefits, such as convenience, rather than what is “best” for their eyes.
The nature of medical ethics is such that reasonable minds may have differing opinions and philosophies about a particular issue. However, we probably all agree that the essence of ethical practice means treating our patients in the same way that we and our families would want to be treated in an identical situation. With that in mind, what are some common ethical issues that cataract and refractive surgeons now face with respect to refractive IOLs?
SHOULD EVERY PATIENT UNDERGOING CATARACT SURGERY BE INFORMED OF THESE OPTIONS?
We believe that most patients want to hear about all of their options prior to cataract surgery. Even if they are not a good multifocal IOL candidate, they would prefer to have the surgeon explain why rather than to learn about this option later from a boastful friend. The question “Why wasn’t I told about this option?” may arise long after the patient was discharged from the surgeon’s care. If left unanswered, this doubt may be a nagging source of confusion or disappointment. What if the surgeon does not offer these IOLs? If you are worried about the drawbacks of these implants, you can share your concerns with your patients. However, you should then be willing to refer that patient if, after your discussion, you determine that he or she is an excellent candidate who wants a presbyopia-correcting or other refractive IOL.
Another issue might be one that we call financial profiling. Based upon their attire or their home address, it is tempting to assume that certain individuals would not be able to afford a premium IOL. Such assumptions are often but not always accurate. We believe that patients would be disappointed to learn that certain options were not explained to them because it was assumed that they could not afford them. Instead, we should still explain the choices, but in a way that is sensitive to their needs and means.
WHAT ABOUT NEW TECHNOLOGY IN THE PIPELINE?
This is an important question, as we have all read about improved IOL technologies being developed for the future. For instance, one practice consultant in the early 1990s recommended that with the anticipated approval of the excimer laser and the ensuing competitive free-for-all, now was the time to establish one’s reputation as a refractive surgeon by learning to perform radial keratotomy. But how would a patient feel seeing all of the ads touting the new laser’s advantages less than 1 year after having had bilateral radial keratotomy?
For cataract patients, the decision is often simple. Unless a better technology is imminently available, we would want our own family member to enjoy the benefits of cataract surgery now rather than later. Some of our current refractive IOLs took 10 or more years following initial human implantation to gain Food and Drug Administration approval. Even after it was finally approved, it took widespread clinical use of the Array IOL (Abbott Medical Optics) to truly understand its capabilities and limitations. Meanwhile, postponing cataract surgery that is otherwise functionally indicated may increase the risk of falls or traffic accidents.
Refractive lens exchange (RLE) patients are a different story. We all acknowledge that current refractive IOL technology is imperfect, and this is why so many of us are reluctant to perform RLE for a presbyopic emmetrope. RLE is a legitimate option for hyperopes and myopes who are presbyopic. However, if we were myopic, we would want to be told about the uncertain but higher risk of retinal detachment in pseudophakes. We would also want to know if there were a better technology on the foreseeable horizon worth waiting for. This might not influence a frustrated high hyperope who has become contact lens–intolerant and increasingly presbyopic. On the other hand, consider a presbyopic myope who is reasonably happy with contact lenses but came in for a LASIK consultation only to learn that this won’t eliminate reading glasses. Although he or she may be a multifocal IOL-RLE candidate, this patient might prefer to wait for better IOL technology if this possibility were explained.
HOW AGGRESSIVELY SHOULD OUR PRACTICE PROMOTE THIS OPTION TO PATIENTS?
Compared to radial keratotomy, LASIK is a great procedure. In appropriate candidates, there are very few risks and downsides, the benefit is stable, and the satisfaction rate is extremely high. Marketing not only spreads the word about this exciting procedure but can help to justify the significant cost by defining the potential benefits. In our opinion, presbyopia-correcting IOLs are not yet on par with laser vision correction in terms of patient satisfaction. Costs aside, there are inherent optical drawbacks with multifocal IOLs that must be counterbalanced by that patient’s strong motivation to see without glasses. In a significant percentage of patients, the potential upside to multifocal IOLs outweighs the downside; in many other patients, it does not.
The manner by which patients are informed about these options is therefore very important. In most cataract practices, the majority of patients will still receive a monofocal IOL. Over-touting presbyopia-correcting IOLs through internal marketing may leave those who cannot have or afford them feeling shortchanged. It is also very easy for patients to misunderstand and think that the more expensive lens is better for their eyes. If they could afford to, most patients would pay extra for a technology that benefited their ocular health, particularly if they perceived that the doctor favored it. “My eyes are important to me,” we so often hear. Historically, this was the concern that the Centers for Medicare and Medicaid Services had with allowing surgeons to balance-bill patients for noncovered services. Would some surgeons take advantage of less sophisticated patients by selling them on costly upgrades that they didn’t need? It is important that patients who choose these premium technologies understand the real nature of the refractive benefits.
CAN I MAINTAIN OBJECTIVITY DESPITE STRONG FINANCIAL INCENTIVES?
The higher the reimbursement, the more important this question becomes. As physicians, we have enormous power to influence elective decisions that our patients make. This is only true because patients trust us to make treatment recommendations without regard to which choice is more profitable to us. The tradition of implicit patient trust in this fundamental responsibility has been forged throughout the long course of modern medical history. Putting ourselves in our patient’s shoes should guide each of us with respect to issues such as co-management, specialist referrals, and recommendations for testing and procedures.
In the end, being constantly mindful of this responsibility provides us with good guidance. Patients can accept that you tried your best on their behalf, even if they are disappointed with their postoperative vision. However, by virtue of the high out-of-pocket premium that they paid, unhappy refractive IOL patients may look back and view what they perceive to have been promotion or sales pressure with suspicion. Your unhappiest refractive IOL patients will be those who are dissatisfied and believe that someone in your practice talked them into choosing the more expensive IOL.
SHOULD SURGERY BE BILLED TO THE INSURANCE COMPANY?
For insurance purposes, if the decision to have lens replacement surgery is because of visually significant cataract symptoms, then it should be billed as cataract surgery. On the other hand, if the patient’s primary motivation for surgery is the correction of refractive error, then it should be billed as an RLE, which is not medically necessary. Insurance companies rely upon the surgeon to make this distinction. The reason why the operation is or is not covered by insurance should also be explained to the patient. This decision is similar to that involved in other elective surgeries, such as ptosis, in which the functional indications must be distinguished from the cosmetic motivation.
WHAT IS A FAIR PRICE FOR A NONCOVERED SERVICE?
Are patients currently being overcharged? Unlike prescription medications and gasoline, refractive surgery and refractive IOLs are luxury items. As long as patients understand the optional and elective nature of this service, they can ultimately judge the value of the service and whether the cost is fair. We certainly don’t profess to know what the correct premium charge should be. However, we believe that additional surgical time is not the deciding factor. For instance, the charge for elective astigmatic keratotomy is based on the knowledge of when and how to correct astigmatism at the time of cataract surgery, not the additional operative time. Refractive IOL surgery undeniably raises the bar, both in terms of patient expectations and necessary surgical precision. Offering these IOLs requires an entirely different level of preoperative evaluation, counseling, and education. The necessary commitment to excellence is significant, and the value of the professional component of reducing spectacle dependence should not be calculated based on the additional surgical time or preoperative testing necessary to implant these IOLs. For a patient, it is what lies between the surgeon’s 2 ears that matters most: knowledge, experience, preparation, clinical judgment, compassion, and the ethical commitment to do what is best.
HOW SHOULD I HANDLE RESIDUAL POSTOPERATIVE REFRACTIVE ERROR?
Some physicians include the potential cost for laser vision enhancement to correct residual refractive error in their charge for a multifocal IOL. Others choose not to increase their price for the premium IOL, but they should be prepared for the need to discuss the cost of laser keratorefractive surgery after cataract surgery. Patients may understandably be upset to be asked to make an additional out-of-pocket payment postoperatively; surgeons taking the latter approach should therefore discuss this possibility before the cataract operation, especially in patients at higher risk of having residual refractive error.
Other alternatives to address refractive error include intraocular lens exchange and astigmatic keratotomy. Cataract surgeons who do not perform laser vision correction may utilize these procedures effectively but should be willing to refer patients elsewhere if surface ablation or LASIK is a superior option.
HOW DO I COMMUNICATE ABOUT SURGICAL COMPLICATIONS?
According to the Institute of Medicine, transparency is an essential characteristic of quality care. It is difficult to discuss any type of bad outcome or complication with a patient, and this may be even harder when that patient has paid extra to receive a refractive IOL or has been referred by another provider. However, this type of honest communication is necessary both before and after surgery.
The patient has the right to know what has occurred, what the prognosis is, and what the plan is for optimal outcome. Second, there is evidence that this type of discussion decreases the likelihood of a lawsuit. Third, disclosing physicians may experience less guilt and emotional distress. We are fortunate that cataract surgery has such a high success rate and is so beneficial to our patients, but the saying “The only surgeon without complications is one who doesn’t operate” is true. In these rare situations, we should be prepared to act ethically and compassionately and treat our patient as we would want our own family member treated in the same situation.
HOW SHOULD I DISCUSS THE FEMTOSECOND LASER WITH PATIENTS?
Advertising for femtosecond laser should adhere to the relevant legal and ethical restrictions. Broad claims that this is superior to conventional cataract surgery are not supported by the peer-reviewed literature at this time. As with presbyopia-correcting IOLs, strong promotion may cause patients not having this technology to feel shortchanged.
Preoperatively, surgeons who do use the femtosecond laser for cataract surgery should discuss the laser with patients honestly and using the best available scientific evidence. In the United States, this discussion should recognize the fact that Medicare patients are only permitted to pay out of pocket for the femtosecond laser technology’s refractive benefits. In situations and cases in which surgeons feel that the femtosecond laser would improve outcomes, this should be explained to the patient in a way that clarifies the elective and noncovered status of the laser. Large studies involving several thousands of patients do not currently support a general claim of increased safety. As with any new technology, the risk-benefit and cost-benefit analyses may evolve over time and with a patient’s or surgeon’s individual situation.
Medical decisions require balancing the benefits vs the risks. There are arguably stronger ethical considerations when presenting elective options requiring out-of-pocket payment. The added expense may pose a financial burden to many patients, who must rely on their surgeon’s advice regarding the importance or advisability of these options. Cataract surgeons should therefore avoid being overly promotional of any refractive IOL technology and should be especially careful regarding the femtosecond laser because the implications of using a laser are easily misunderstood by patients.
Most of us are reluctant to place a price on safety, but the value of refractive enhancement is very personal and subjective. Patients need our unbiased help to understand the difference between medical and refractive benefits when deciding whether they should spend the extra fees. They trust us to place our own financial conflicts of interest aside and to advise and act in their best interest. This is the essence of ethical practice.
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