Eyeworld

OPHTHALMOLOGY BUSINESS 76 Moreover, a longer stabilizing effect of CXL increases cost effectiveness." 2 Separating the drug from the procedure In May 2017, Avedro announced its effort to help gain widespread insur- ance coverage and reimbursement for crosslinking. As part of this goal, the com- pany established the Avedro Reim- bursement Customer Hub (ARCH) Program. This program includes a hotline for questions to assist with commercial payer appeals and financial assistance for the riboflavin solutions. Dr. Zadno said if multiple appeals for drug coverage are denied by the patient's insurance company, Avedro will limit the out-of-pocket expense for the drug (he noted a plan to charge $2,850 overall for the drug) to the original $595. If the patient doesn't have insurance and can't afford the drug, Avedro will cover that cost. Dr. Zadno said reimbursement, in some cases, was happening "spontaneously, not rationally," which is why Avedro took up the charge to drive reimbursement. Pricing the procedure Dr. Durrie said if ophthalmologists are not adequately pricing the proce- dure and filing it, insurance compa- nies won't base their fees adequately. "Insurance bases their fees on what we bill. … Keratoconus costs the insurance companies a lot, especially corneal transplants, which cost $25,000 to $30,000," Dr. Durrie said. "In the long run, if we educate them well, they will come out better economically, even with the fairly high reimbursement for crosslinking. They say, 'It's just a light and riboflavin, it shouldn't cost very much to do that.' It costs more than $100 million to get something FDA approved, and the company is definitely going to try to get some reimbursement for that." From the procedural side of things, Dr. Durrie encouraged his crosslinking colleagues to consider the facility and machine fees, staff- ing, and time it takes for preopera- tive evaluations, the procedure itself, and postoperative care when setting a cost. Dr. Durrie said if physicians don't take all of this into account when filing their fees and insur- ance bases reimbursement on that, fewer physicians will perform this procedure. "If you look around the country, there are a lot of places where surgeons have the ability to do the procedure, but if they're not "The fact that crosslinking is not covered by some insurers does not surprise me. … Historically, most payers consider treatment of keratoconus to be refractive and non-covered under medical insur- ance," Ms. Rose said. She added that even if insurers did consider it medically necessary, they are less likely to reimburse given its current CPT Category III temporary code. CMS leaves payment of Category III codes up to the specific contractor to decide if it is covered or not. Both Dr. Zadno and Dr. Durrie said it takes time to educate insur- ance companies to obtain wide- spread coverage and reimbursement. In the case of keratoconus, Dr. Durrie said this starts with explain- ing that the disease is a billable diagnosis that already has some insurance-covered aspects. What's more, crosslinking, said to be a one- time procedure, could save com- panies money by avoiding costlier corneal transplants down the road, Dr. Durrie added. Data collected from Oslo Uni- versity Hospital, where all kerato- plasties for the regional population of 2.8 million are performed, from 2005 to 2006 (period 1) and 2013 to 2014 (period 2), found a reduced number of corneal transplants in period 2, which was well after crosslinking was introduced to the department in 2007. 1 "Although we performed more keratoplasty procedures in the last period compared with the first period (231 vs. 137), the frequency of keratoplasties in patients with keratoconus was more than halved (reduced from 55 to 26 cases)," Sandvik et al. wrote. "The large increase in the total number of kera- toplasty surgeries simply reflects the implementation of endothelial ker- atoplasty procedures in recent years. This also indicates that a reduction of keratoplasties in patients with keratoconus could not be explained by the lack of grafts or surgical capacity in period 2 compared with period 1. Because only 2 (7.7%) of the patients in period 2 had been treated with CXL before keratoplas- ty, and none of them had progres- sion before transplantation, this also indicates that CXL treatment may avoid the need for keratoplasty." A more recent study published in Ophthalmology described analy- sis that found crosslinking, from a healthcare system perspective, was "cost effective at a willingness-to-pay threshold of 3 times the current gross domestic product per capita. Crosslinking continued from page 74 getting appropriately reimbursed for their time, effort, and equipment, they won't get involved in it, and we'll have people who are losing vision and going on for transplants for keratoconus who don't need to because crosslinking works so well," Dr. Durrie said, explaining that as a procedure that doesn't refer well, he hopes for widespread availability. Because insurance coverage of a Category III code might be unclear, Ms. Rose recommended physicians have patients sign an Advance Ben- eficiary Notice (ABN), which states that the procedure might not be covered by insurance and that they will bear that financial responsibil- ity. In this case, the physician col- lects payment from the patient, but if insurance pays after the service is billed, the physician refunds the pa- tient any overage. The ABN must be very specific as to why the physician feels the service may not be covered. For example, CXL may be consid- ered experimental as a Category III code and non-covered. "Even though the Category III code may not be paid, it is import- ant for physicians to understand they should report the code to Medi- care and other payers anyway. If the code is not billed enough to consid- er a permanent CPT code, then the code will be removed from CPT after 5 years," Ms. Rose said. Dr. Glasser pointed out that commercial carriers tend to base their payments on CMS valuation. Without that at this point, payers are on their own. Payers might use crosslinking's Category III CPT code status to deny coverage, he said. Even if crosslinking graduates to Category I status, Dr. Glasser added that insurance coverage is not guar- anteed. "Only Medicare routinely pays upon publication of a Category I code," Dr. Glasser said. Crosslink- ing as a Category III code means insurance carriers will be evaluating the published literature to inform their coverage decisions, as they would with other Category III code filings. "They look at safety, efficacy, and cost/benefit ratio. … Some of them may consider only studies per- formed in the U.S. with the device approved for use in the U.S. For all of these reasons, there is typically a lag between FDA approval of a new procedure and insurance coverage." A thread on EyeMail, the ASOA listserv, described a case where in- surance preauthorized the procedure but wouldn't disclose the allowable billable amount. Could the practice decline to file with the patient's insurance and have them pay out of pocket, having them file the claim on their own? Ms. Rose said in this case, perhaps, but it might depend on the contract with the payer. "The practice should check the contract for that payer first to make sure this would not be in violation of their contact," she said. "When there is a permanent CPT code or a temporary code, such as 0402T for crosslinking, the patient has the right to see if his or her insurance will pay for the service first. Even if the patient could file the claim, pay- ment would be the same regardless of whether the practice submitted the claim. Since the practice would receive notice of payment, the prac- tice is still responsible for refunding the patient for any monies collected over and above what was paid by Medicare or other payers." Comparing this process again to reimbursement of retinal injections, Dr. Durrie said he thinks physicians will be less confused and more comfortable with the reimbursement process in about 5 years. "It will take quite awhile, but the sooner we start, the sooner we get done," he said. "At the end of the day, this should work for all four parties, which starts with patients. We think that if this is reimbursed, more patients will have access to this procedure," Dr. Zadno said. "It has to make sense for the practice; it should be reimbursed adequately for their time and effort. It should make sense for insurance companies, and that's where cost-effectiveness of crosslinking becomes important. It should make sense to us because we want to continue to provide FDA-ap- proved crosslinking solutions and invest in future research to improve the procedure." EW References 1. Sandvik GF, et al. Does corneal collagen cross-linking reduce the need for keratoplas- ties in patients with keratoconus? Cornea. 2015;34:991–5. 2. Godefrooij DA, et al. Cost-effectiveness analysis of corneal collagen crosslinking for progressive keratoconus. Ophthalmology. 2017 May 19. Epub ahead of print. Editors' note: Drs. Durrie and Zadno have financial interests with Avedro. Dr. Glasser, Ms. Prudden, and Ms. Rose have no financial interests related to their comments. Contact information Durrie: ddurrie@durrievision.com Glasser: dbg@comcast.net Prudden: mprudden@uci.edu Rose: arose@bsmconsulting.com August 2017

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