The ethical challenges of presbyopia correction

These ethical considerations will shape the future of presbyopia correction.

William F. Maloney

Recently, Dick Lindstrom, Chief Medical Editor of Ocular Surgery News, asked me to give a presentation on the ethical issues surrounding presbyopia correction at the OSN symposium in Las Vegas. Initially, I declined. I am no evangelist, and I certainly cannot claim to hold the ethical high ground on any of these matters.

But the topic got hold of me and wouldn’t let go. I reconsidered when I came to see how important these ethical issues are to our profession, especially right now. That presentation clearly struck a chord with the audience members, many of whom privately expressed their sentiment to me afterward. That presentation served as the outline for this column.

The new normal

Pseudophakic presbyopia correction is poised to become the “new normal” for cataract surgery. Once again, we are faced with the learning curve inherent in such a major transition. We have been here before, successfully meeting the surgical challenges of the IOL, phacoemulsification, foldable implants, astigmatic correction and the myriad other refractive refinements progressively linked to cataract extraction. Clinically, then, presbyopia correction is just the next chapter in the remarkable success story of refractive cataract surgery.

Presbyopia correction is not business as usual

There is an important sense in which this transition will be different. Yes, it is the latest refractive addition to cataract extraction. But it also marks a major shift in the course of this narrative, for pseudophakic presbyopia correction also brings the long overdue separation of the cataract surgeon’s fees into the covered medical and noncovered refractive components. The insidious “refractive bracket creep” to which I referred with some urgency in 2004 has been halted, at least for now (Cataract surgeons recalibrate to treat presbyopia as vital issues loom,” Nov. 15, 2004).

This alone makes the transition to pseudophakic presbyopia correction anything but business as usual. After this unexpected about-face, the financial trajectory of refractive cataract surgery now heads in a new and potentially positive direction. It is nevertheless probably wise to temper our enthusiasm, understandable as it is, while we carefully assess the challenges accompanying this new opportunity. A collective downshift is in order, to a slower, less frenzied pace than we saw with LASIK. The future of presbyopia correction must not be jeopardized, and it surely would be fortified by a renewed commitment to the particulars of our profession’s ethical standards.

Ethics: Something old, something new

“If it is not right do not do it; if it is not true do not say it.” — Marcus Aurelius

This fundamental dictum always holds true. It certainly applies here; indeed it lies at the core of this discussion. Without this, no other guidelines will matter. By itself, however, it is not enough.

We need to get this transition right on all counts, but in the end it will be our response to the ethical challenges that will determine the long-term viability of pseudophakic presbyopia correction. I can think of no prior moment when doing the right thing was more vital to the long-term interest of our profession.

But we are already seeing that there can be many wrong ways for us to try to do the right thing in this situation. The ethical considerations surrounding pseudophakic presbyopia correction — especially when it comes to the noncovered, private-pay charges — lead us to a convoluted world of overlapping legal determinations and legislative regulations. Much is confusing, even contradictory, and completely sorting out all of the correct procedures will be a work in progress for some time.

Guidelines to the noncovered patient charges

Recently, I experienced the maze of legal and regulatory challenges we face while working with coauthors Alan Reider, JD, and Allison Weber Shuren, MSN, JD, and billing expert Kevin Corcoran, COE, CPC, on the previous column (Presbyopia correction: Handling the new patient charges,” July 15, 2006). I heartily recommend that you read this document and then pass it on. While providing much-needed updates to several specific guidelines, it also calls for a measure of caution, and rightly so, in my view.

Consider this one segment. “If a physician does not perform any additional work, then there are no legitimate noncovered services …” This is clear enough as far as it takes us, but what legitimately constitutes the surgeon’s “additional work” in pseudophakic presbyopia correction? Many such services were more clearly delineated in this document.

Others that have emerged are still quite murky. Does the additional “chair time” required to explain presbyopia correction qualify? Does the planning of an individual’s limbal astigmatic keratotomy procedure — the “cognitive component” — warrant an additional fee over and above the charge for the procedure itself? These are critical issues in need of more guidance and clarity, which will come but only with more time.

Until then, our own best interests call for a conservative course. The May 2005 CMS ruling represents a major, potentially precedent-setting policy shift that will undoubtedly receive careful ongoing government scrutiny. We cannot allow the enormous long-term potential of pseudophakic presbyopia correction to be jeopardized by careless impatience or injudicious overreaching.

Defining cataract

The definition of a visually significant cataract has changed over the past 20 years. This changing definition creates a potentially slippery slope when pseudophakic presbyopia correction is performed in tandem with cataract extraction. We each must now be in the strongest position to justify the decision for the cataract component of this new hybrid procedure.

Because subjective visual symptoms have increasingly replaced Snellen acuity as the criteria, a new and different form of documentation is vital. Patients should state in their own writing, usually in a detailed questionnaire, the specific visual symptoms that they experience despite BCVA because these will constitute the rationale for cataract extraction.

When low contrast or illuminated glare testing is part of this justification, the patient’s written symptoms should correspond closely, and the original printout of the results should be part of the permanent medical record. These assessments should be repeated if and when the second eye becomes part of the surgical plan.

Even with our new understanding of functional visual impairments, early lens opacities do not always warrant removal. These patients should be advised that their options include waiting or refractive lens exchange.

Surgeons are the patient’s Consumer Reports

Presentations of various pseudophakic presbyopia correction options in our educational forums profoundly influence our evaluation of their relative merits. Patients assume that our assessment of these alternatives is comprehensive, accurate and objectively based on solid science, not salesmanship. Therefore, part of our due diligence must include a hard look at the objectivity of this information. Remember that our patients implicitly look to us as their Consumer Reports to pseudophakic presbyopia correction as we guide them.

Consumer Reports, J.D. Power & Associates and other such enterprises exist because of a broad consensus that objectivity is unlikely, if not impossible, without independence. These entities understand that products such as their annual “new auto rankings” would be rendered meaningless in the minds of consumers if there were any financial interests at hand.

They realize that, no matter how transparently a financial relationship is disclosed, the typical consumer would immediately assume that such an evaluation is de facto biased and therefore not a bona fide source of informed guidance. Without absolute autonomy, institutions such as these immediately lose their credibility along with their reason for being — and they know it.

It is at least a little curious, and not only to me, that our profession has a distinctly different take on this. For us, the disclosure of a financial interest somehow bestows the mantle of objectivity. Do we have a sound basis for seeing our approach to new product evaluation as objective where others automatically see just the opposite?

Is there an especially lofty level of professionalism at work here to support this sense of exceptionalism? Perhaps, but for many in our ranks, broad evidence for such acute ethical vigilance has been hard to come by in recent years, especially for those who have taken a clear-eyed look at the lessons of LASIK.

Our professional oath: First, do no harm

It is perhaps somewhat telling that the central tenet of the ancient oath of physicians is, today, something of a cliché. In fact, these words hold much to guide us as we transition to pseudophakic presbyopia correction.

Our oath reminds us that permission to perform this next step is contingent upon certain prerequisites. It requires that we be fully prepared with solid skills in all elements of state-of-the-art refractive cataract surgery — the foundation for presbyopia correction — and it expects us to first recalibrate so as to meet the new biometrics of accuracy. It requires that we come to know these patients more intimately than ever before so as to fully understand their particular reading goals and then craft a procedure to best deliver this result.

These words also delineate the only path for gradually gaining our first-hand experience with pseudophakic presbyopia correction. We are not permitted the layman’s reliance upon trial and error. We are committed to a higher standard that limits us to a series of carefully measured increments. Two steps forward and one step back may work when learning to replace a fuel pump, but for us physicians it is unethical.

This is why one aspect of the LASIK experience is such a worrisome precedent. In 1994, radial keratotomy was correcting up to 5 D to 6 D of myopia with generally good results. With the arrival of LASIK, we should have moved first to 7 D, then 8 D and so on. Instead, we took an unprecedented leap to 20 D and then spent the past decade backpedaling from unexpected complications, only to arrive at 7 D to 8 D today.

“First, do no harm” does not calculate some acceptable ratio of successes to failures. Rather, it focuses sharply on the unnecessary element of this unfortunate experience. In the end, LASIK was a small but qualitatively important step forward. However, in the process, we lost sight of our primary responsibility as physicians. How do we explain this collective ethical blind spot? Was this an isolated episode? We will soon see because we face much the same ethical challenge with presbyopia correction. If we can confront these questions without flinching, we may learn that we were not as exceptional as we thought, and that may be the best place for us to begin this next transition better aware of our responsibility as physicians.

In the September 1 issue

In the September 1 issue, we will focus on taking the true measure of monovision.

For more information:

• William F. Maloney, MD, is head of Maloney Eye Center of Vista, Calif., and a well-known teacher of cataract and lens-based refractive surgery techniques. He can be reached at 2023 West Vista Way, Suite A, Vista, CA 92083; e-mail: maloneyeye@yahoo.com. In the interest of objectivity, Dr. Maloney has no financial interest in any ophthalmic product and has no financial relationship with any ophthalmic company.

• Lens-based Refractive Surgery Column Mission Statement: To educate readers on all aspects of lens implant refractive surgery including presbyopia correction, refractive cataract surgery, refractive lens exchange and phakic IOLs.