Eyeworld

EW FEATURE 39 blurred and crossed." The surgeon either needs to ab- sorb that cost or pass it on to the pa- tient. It is with some of the options for bypassing the problem that the real ethical dilemmas are arising. "Companies are saying that you can up-charge your premium IOL pa- tients because that's something that is outside of Medicare," Dr. Hoffman said. The question, however, be- comes: Is that ethical? "They're showing that there might be a slight improvement in effective lens posi- tion consistency if you have a per- fect capsulorhexis," Dr. Hoffman said. But even if this is enough justi- fication to use the femtosecond, the financial pool is limited. "Right now, the premium IOL channel only cov- ers 7-10% of Medicare patients or patients that we're doing in gen- eral," Dr. Hoffman said. There's also the possibility of using the femtosecond laser to per- form peripheral corneal relaxing in- cisions (PCRIs) because this is not a Medicare-covered benefit. "Again, you have to ask the question that has not been answered yet: Is per- forming PCRIs with a femtosecond laser that much more accurate than doing it manually?" Dr. Hoffman said. "Can you justify passing those significant charges on to your pa- tient to have a femtosecond laser [peripheral corneal] relaxing incision rather than a manual one done with a diamond knife?" Dr. Hoffman worries that some surgeons may begin blurring the lines of who really needs PCRIs to offset financial woes. "Some sur- geons may, under financial stress, be pushing the envelope of who gets a limbal relaxing incision," he said. "Ordinarily we might not do a PCRI on someone who has a diopter or less of astigmatism, but if you're under stress to pay for this laser, you might start offering that to patients who you might not ordinarily offer it to if you were not 100% ethical, in my mind." Kevin M. Miller M.D., Kolokotrones Professor of Clinical Ophthalmology, Jules Stein Eye In- stitute, David Geffen School of Med- icine, University of California, Los Angeles, pointed out the importance of being up front with patients about charges. While practitioners can't legally charge more to remove a cataract using a laser, any refrac- tive work done, such as a PCRI, is fair game. "It should be disclosed to patients who have a femtosecond laser-based cataract operation that they're getting the cataract portion basically for free, but being charged for the refractive portion," Dr. Miller said. "None of the companies have 510(k) approval to perform astig- matic keratotomy at this time, but several have approval to make pe- ripheral corneal incisions. So compa- nies can say, 'PCRIs are an off-label use of the laser.'" Ophthalmologists can tell their patients that off-label use is common in clinical practice. Dr. Miller is also concerned that practitioners may overstep on what they tell patients about femtosecond cataract surgery. "I worry that practi- tioners might say to their patients they will get a better result with a laser and, if they want the better re- sult, they will have to pay for it," he said. "But there won't be any data to support that it produces better out- comes other than it makes a rounder CC, which probably doesn't mean anything." He stressed that practitioners may find themselves in hot water when it comes to Medicare fraud if they tread over that ethical line. "What you hear at the meetings right now, especially from some of the frontrunners, is, 'Patients will pay more for laser-based cataract sur- gery when you tell them the benefits —it's a win-win,'" he said. "It's a win except that it's illegal—it's Medicare fraud if you participate in the Medicare program." Questionable marketing From a marketing perspective, Dr. Banja likewise stressed that it's im- portant not to overstate what the data has shown. "You must resist the hype," he said. "Hype is a very real temptation because obviously the manufacturer has a financial inter- est, and possibly the researchers who developed this technology have a fi- nancial interest and may also have a self-esteem issue—this is their baby and it's easy for them to become so enamored with what they have pro- duced." When marketing this new ap- proach, Dr. Hoffman urged practi- tioners to stick to the facts. "I think the way that physicians can remain safe about this is to market it as laser cataract surgery," he said. "I think that if surgeons advertise that they have this technology, once in the room, they can explain to a patient, 'This has some potential benefits, al- though in your case there may not be much of a difference.'" Advertising that you have a technology that's superior, however, is pushing the ethical boundary, Dr. Hoffman thinks. Some practitioners may consider taking the gamble. "What's pushing a lot of this tech- nology right now is fear—there's fear from surgeons that the guy down the street is going to get one of these and is going to start advertising, and they're going to lose all of their cataract patients," Dr. Hoffman said. Going forward, Dr. Miller would like to see the situation evolve akin to what happened with premium lenses with Medicare offering a spe- cial exemption. "But we'll have to prove that there's a tangible benefit with improved clinical outcomes," he said. "Right now we don't have that data." Dr. Miller hopes that early adap- tors follow an ethical standard be- yond reproach. "I hope early adopters do everything above board and ethically so that the whole house of cards doesn't come down," he said. This happened to one province in Canada with premium lenses when it became apparent that fees were all over the map. After an investigation, the government stepped in and set a rate. "The same could happen here in a heartbeat," Dr. Miller said. "The government could decide if you want to use a laser you can charge an additional $169—and that will put the whole thing out of business." EW Editors' note: Drs. Banja and Hoffman have no financial interests related to their comments. Dr. Miller has finan- cial interests with Alcon (Fort Worth, Texas). Contact information Banja: 404-712-4804, jbanja@emory.edu Hoffman: 541-687-2110, rshoffman@finemd.com Miller: 310-206-9951, kmiller@ucla.edu February 2011 July 2011 Laser-assisted cataract surgery AT A GLANCE • Femtosecond technology for cataract surgery poses several ethical problems for practitioners • Practitioners must weigh whether increased cost translates into increased benefit for patients when urging femtosecond use for cataract removal • The ethics of up-charging for pre- mium IOLs or PCRIs to offset cost may in some cases be questionable • When marketing femtosecond cataract surgery, it's important that practitioners resist the hype and not overstate the data Dicing up a rock-hard cataract—such as the one pictured above—with the fem- tosecond laser may seem like an ethical no-brainer, but with softer cataracts weighing the cost, the advantages of the technology become more blurred Source: Richard S. Hoffman, M.D.

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