Eyeworld

EW FEATURE 38 by Maxine Lipner Senior EyeWorld Contributing Editor Balancing on the ethical edge with femtosecond cataract surgery How to take the moral high-ground with the technology I t has become an ethical quag- mire—what to do about the femtosecond laser for cataract surgery. While the femtosec- ond laser has wound its way into the cataract arena, a host of ethical issues abound, according to John D. Banja, Ph.D., professor in the Department of Rehabilitation Medicine and a medical ethicist, Center of Ethics, Emory University, Atlanta. Practitioners must of course abide by the Hippocratic Oath and "do no harm," but what ethical obli- gations do practitioners have when implementing a new technology such as the femtosecond laser for cataract surgery? "I think that the primary obligation is that one needs to act the way that a reasonable and prudent doctor is going to act with regard to this clinical situation," Dr. Banja said. One of the key ethical issues currently is the comparative benefit between the femtosecond laser ap- proach and traditional cataract sur- gery. "Clearly, if we find out that the outcomes with the femtosecond are much better than they are with ex- isting technologies, that's going to start to make a very strong case for implementing the femtosecond standard-of-care," Dr. Banja said. "The tricky part is determining how much better than the competition the femtosecond must be to per- suade physicians to adopt it as the standard-of-care and to persuade Medicare to cover it." Ethical dilemmas Richard S. Hoffman, M.D., clinical associate professor of ophthalmol- ogy, Oregon Health and Science University, Portland, sees several femtosecond-related ethical dilem- mas. "You've got a technology that's going to increase the cost of a proce- dure and you've got to look at whether the increased cost translates into an increased benefit," Dr. Hoffman said. "For instance, when we went from radial keratotomy [RK] to photorefractive keratectomy there was an increased cost, but the benefit of that new technology made it worthwhile—in fact it was almost negligent, unethical, to per- form RK when you had this other technology." Currently companies are trying to demonstrate a benefit for using the femtosecond technology for cataract surgery. However, it's also important to consider whether any increased benefit is worth substan- tial additional cost, Dr. Hoffman stressed. He sees the ethical weight here as unfortunately falling on the sur- geon's shoulders. "The companies are not really concerned about the ethical issues—they're concerned about the bottom line," Dr. Hoffman said. "I'd like to think that most sur- geons are concerned about the ethi- cal issues and the patient first, but when you've invested $500,000, all of a sudden you're under a lot of fi- nancial stress to pay for that thing and then the goal boundaries get February 2011 Laser-assisted cataract surgery July 2011 Rules continued from page 37 But can surgeons charge enough for astigmatic reduction, and do they have enough patients who desire such a refractive result, to offset the cost of the expensive technology? "That's up to the market and what you believe is fair and reason- able," Dr. Cionni said about pricing for astigmatic reduction with the laser. "You have to formulate a busi- ness plan, and you have to recoup your costs for using the laser. If you can't clear at least a few hundred dollars per case for that additional time, it's probably not worth doing from a business standpoint. "If you're just doing cataract surgery and nothing else, you've just bought yourself a $500,000 scalpel. Medicare will not allow you to charge any extra for what they've al- ready paid for—cataract surgery. This has to be viewed as providing an additional non-covered service for which Medicare already has sev- eral existing rules: 1) refractive ker- atoplasty, 2) astigmatism-correcting IOLs, and 3) presbyopia-correcting IOLs. "Prices vary from practice to practice for implants designed to re- duce spectacle dependence," he said. "Those who are using the laser for astigmatic reduction would need to set a higher price than those who are not using the laser. "A laser-assisted cataract surgery patient will need a battery of supple- mental tests to determine what addi- tional treatments are required in order to obtain the desired refractive goal," he said. "If we perform cataract surgery for a patient who re- quests a specific refractive outcome, we can bill for the additional non- covered testing, such as corneal to- pography to evaluate astigmatism," Dr. Cionni said. "We can also bill for the astigmatism correction proce- dure. There is follow-up beyond the 90-day cataract global period and the possibility of enhancement, which can be charged as well." But some experts say that there is enough of a gray area in billing to cause great concern. "I think it is dangerous to take the precedent of presbyopia-correct- ing surgery and extend it to this sit- uation without specific guidance, as the guidance from the administra- tion at that time was specific to the presbyopia-correcting lenses," said Michael X. Repka, M.D., professor of ophthalmology and pediatrics, Johns Hopkins University, Balti- more, and AAO medical director for governmental affairs. "Right now, if the cataract is sufficiently blurring vision to require a medically neces- sary removal, then calling the serv- ice a refractive cataract surgery does not exempt, in my opinion, the cov- ered aspect of the service. Those sur- geons may be billing the patient for a service that they can't actually ask the patient to pay a portion of." Stephen S. Lane, M.D., clinical professor of ophthalmology, Univer- sity of Minnesota, Minneapolis, agreed. "This isn't a contract you're making with a patient," he said. "You have to follow the Medicare laws. That's what I think people for- get. The boundaries are clear, but they are getting muddied." Dr. Rich said he fears that aber- rant coding advice out there now could threaten the entire premium IOL business. "The gray area is what you do with the premium patients and the wild coding advice that's out there now for regular cataracts," he said. "It could ruin everything for both the premium IOL market and the physicians who provide that official service." Both Ms. McCann and Dr. Rich expressed concern that advertising the laser's abilities may backfire, especially if the procedure is consid- ered quick and easy. Dr. Rich said, "The entire value of cataract surgery can come up for review, and it will. The vast majority of a cataract surgery is based on the doctor's work. The doctor's work is predicated on four factors—time (the time that the physician is actu- ally operating), mental effort and judgment, technical skill, and iatro- genic risk. The people who are going to make this value judgment read blogs. They read advertising by in- dustry and coding consultants. If they are saying this dramatically simplifies the procedure, cataract surgery itself could be cut precipi- tously." Ms. McCann concluded, "In our effort to respond to the myriad of questions being raised by our mem- bers, ASCRS is working collabora- tively with AAO to develop joint guidelines for ophthalmologists regarding the reimbursement issues associated with the use of the fem- tosecond laser for cataract surgery." EW Editors' note: Dr. Cionni has financial interests with Alcon (Fort Worth, Texas). Mr. Corcoran has financial in- terests with Corcoran Consulting Group. Dr. Donnenfeld has financial interests with Abbott Medical Optics (Santa Ana, Calif.) and Alcon. Dr. Lane has financial interests with Alcon. Ms. McCann has no financial disclo- sures to report. Drs. Repka and Rich have no financial interests to report in relation to this article. Contact information Cionni: rcionni@theeyeinstitute.com Corcoran: kcorcoran@corcoranccg.com Donnenfeld: eddoph@aol.com Lane: sslane@associatedeyecare.com Repka: mrepka@aaodc.org Rich: hyasxa@gmail.com continued on page 39

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