EyeWorld Asia-Pacific June 2016 Issue

June 2016 EWAP FEATURE 13 Why I don’t use the femtosecond laser for cataract surgery by David F. Chang, MD F emtosecond laser- assisted cataract surgery (FLACS) is one of the most polarizing topics currently in ophthalmology. Why is this, when we would all agree that the technology is amazing and that it works very well? As with any operation, shouldn’t cataract surgeons be free to individualize their techniques and instrumentation according to their own skill set and preferences? The problem of course is how to justify and to cover the high cost of FLACS for our most common and successful ophthalmic operation, at a time when aging population demographics are increasing the societal economic burden of providing it. Pro-FLACS or anti-FLACS? Like most of us, I welcome new technologies that may improve patient care. I am not “anti-FLACS” and I have nothing against the technology or anyone who wants to use it. As one of their first clinical consultants, I started working with the LensAR team in 2008 on developing their femtosecond laser cataract system. I was one of the first Americans to perform FLACS (Mexico City, 2009), and at one point served as the LensAR medical monitor. At the outset, we all embraced the concept of automating certain critical steps of cataract surgery whose perfect execution would be independent of an individual surgeon’s skill and experience. Of course the proverbial elephant in the room was how much would this cost, and who would pay for it? I could envision several different business models for FLACS. One would be a single, initial capital acquisition cost, along with paying for software upgrades and annual maintenance contracts. This emulates how we purchase phaco machines and operating microscopes, allowing the surgery center to amortize costs over the lifespan of the technology. Patients would not be charged, and surgeons could freely elect when to use FLACS because the per-case disposable costs would be relatively small. A second business model could have been that used by Wavetec (and later Alcon) with their ORA intraoperative wavefront aberrometry technology. Following the upfront capital acquisition cost, a recurring monthly fee would cover unlimited use. Surgery centers performing higher FLACS volumes would pay much less on a per case basis. Of course the economic model actually adopted industry-wide incorporated all of these components— initial acquisition cost, annual maintenance contract, per-case disposable costs, and click fees. This model is predicated on charging patients a premium. Impact of the Patient Pay Economic Model This requirement for patient payment has created the tangle of regulatory, clinical, and ethical issues that cataract surgeons must navigate in order to use this technology. Convincing patients to pay for FLACS requires some implication of superiority and greater safety. Conveniently, it is easy to market “laser” surgery to patients as a major advance but public advertising for FLACS has unjustifiably left many non- femto cataract patients feeling short-changed. Globally, adoption of FLACS mirrors the degree of economic freedom given to patients by their healthcare system. Some countries allow patients to pay out-of-pocket for FLACS without any restriction; other countries require patients to opt entirely out of their insurance system to pay privately for a cataract procedure utilizing FLACS. In the United States, we are not allowed to charge Medicare patients extra fees for any technology or instrumentation used to perform the cataract surgical steps. When using the laser, we are only allowed to charge patients for the refractive benefits of either astigmatic keratotomy or performing the OCT imaging for a premium refractive IOL. Our government healthcare system (Medicare) could have adopted two very different regulatory approaches. They could have prohibited any patient billing for the femtosecond laser aside from astigmatic keratotomy. That would probably have forced companies to abandon click fees both in the U.S. and worldwide. Alternatively, they could have ruled that “robotic” technology, such as FLACS, is not medically necessary, and therefore allowed patients the freedom to pay extra for this technology if they desired it for any reason. This would have been the best approach, and would have created a new market for dozens of other robotic technologies being developed across all surgical specialties. Why is this important? The innovation cycle often starts with a new technology that because of high development costs is so expensive that only a small minority can afford it. Having continued on page 14 David F. Chang, MD