Eyeworld

EW GLAUCOMA 58 December 2017 by Stefanie Petrou Binder, MD, EyeWorld Contributing Writer MIGS, not least because of a notion that glaucoma surgery is something belonging to glaucoma specialists. "I think many comprehensive ophthal- mologists and cataract surgeons see surgical glaucoma as something that is best left for the glaucoma special- ists to do," he said. "They've tradi- tionally sent out the classic glauco- ma surgeries, and many doctors are likely still doing that, despite the fact that these procedures could be managed by the comprehensive cat- aract surgeon. A second issue may be that some of the busier surgeons are comfortable doing what they're do- ing and don't want to be humbled by learning angle surgery. They may have tried certain MIGS procedures and experienced some early learning curve issues and abandoned the pro- cedure. Finally, I think economics play a role for those of us working in private practice. Especially for the MIGS procedures that involve a stent of some kind, some companies are asking doctors to pay for mul- tiple stents up front, which can be several thousand dollars. Given all the headaches these days with the payers, revenue cycle management is a full-time gig, and waiting months to get reimbursed for a product you paid for up front could be unat- tractive for surgeons who own their own practice." Dr. Williamson chooses MIGS devices in all patients in his practice MIGS has taken the "complicated" out of glaucoma surgery, but not all eye doctors are on board. Why not? M IGS treatments are being delivered to only a fraction of patients who are candidates. Given the remarkable safety profile and high potential of these treatments lowering pressure, what is holding surgeons back? In an interview with EyeWorld, refractive cataract surgeons Blake Williamson, MD, Williamson Eye Center, Baton Rouge, Louisiana, and Randy Craven, MD, associate professor, Johns Hopkins University, Baltimore, discussed why some sur- geons have not yet adopted MIGS. Why are some holding back? Are glaucoma procedures better left to glaucoma specialists? Not anymore. MIGS allows eye doctors to effectively reduce IOP in their glaucoma patients quickly and easi- ly. However, some ophthalmologists are cautious about the burdens of learning and mastering a new pro- cedure and the cost that comes with it. According to Dr. Williamson, there may be several reasons why some doctors have not yet adopted MIGS: The why and why not of using it O ne of the surprising impediments to adoption of MIGS has been the resistance of insur- ers to cover these new procedures. Every aspect of coverage has been difficult. Locally we have finally achieved coverage for the iStent (Glaukos), but the CyPass (Alcon) and Xen (Allergan) are generally not covered by most insurers. There is no hope for coverage of the iStent or CyPass as standalone procedures without a specific FDA study—and even with a successful FDA study, coverage probably would be resisted. Despite insurance problems, the adoption rate for MIGS has been remarkably high. But there remain many comprehensive cataract surgeons who have not started using the iStent or the CyPass. The barriers to beginning to use these MIGS devices include the learning curve, breaking outside one's comfort zone, and reimbursement concerns. The insurance issues are particularly troubling. When our patient's insurance company denies coverage for the MIGS procedure we want to perform because it is "investigational" or "experimental," it is very discouraging. It is also very hard to understand the justification. The iStent and CyPass were approved by the FDA only after their efficacy and safety were proven by arduous and costly randomized controlled clinical trials (RCTs). These are the most rigorous of all studies. I have worked on many RCTs for MIGS devices and have been the lead investigator for several. There is no question that these studies are the ultimate in determining whether a device or procedure is safe and effective. For example, the CyPass pivotal study included 505 patients followed for 2 full years after the CyPass was implanted. There will never be a study performed outside of FDA oversight that comes close to the size and duration of this inves- tigation. If insurance companies don't accept the outcome of this enormous and long-term FDA-monitored study, it is hard to know what studies they would accept. Although there will certainly be fine points in the use of these devices that come out with more widespread utilization, it is hard to believe that we will discover something that will in- validate the findings of the FDA study. Therefore, the denial of coverage seems more a benefit to the insurance provider than a protection of the patient. But coverage will eventually yield to efficacy and patient need. In the meantime, surgeons can operate where insurance coverage is available and use ABNs where it is not. Surgeons are grateful to have these new devices that offer patients an opportunity to reduce their medication burden and bend the curve of glaucoma damage to a safer trajectory. Reay Brown, MD, Glaucoma editor CyPass Micro-Stent 1 month postop Source: Randy Craven, MD Glaucoma editor's corner of the world

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