Eyeworld

3 EW ASCRS NEWS by Ellen Stodola EyeWorld Senior Staff Writer procedure using HCPCS code J3490 (unclassified drugs), with a notation in Box 19 indicating the medication name. AAO also notes that although using a CPT code does not guarantee coverage under Medicare or com- mercial payers, many payers across the country cover crosslinking. Reza Zadno, PhD, CEO of Avedro, noted, "The challenges we are facing are not unique to crosslinking but in launching any new technology—especially when transitioning from non-covered to covered service and when indepen- dent of the price." The price should reflect the treatment's true value to the patient. "The current drug price is still well below the cost of a corneal transplant," he said. He added that crosslinking is an orphan indication, with about 10,000 done in the U.S. last year, as compared to millions of cataract surgeries. He noted the importance of working together in the reimburse- ment process. "The practices have to submit claims because we cannot define what the fee for the practice should be," he said. "Payment policy will only get established once there are enough claims so that the carri- ers can establish a payment policy. A good example of this is with Blue Cross Blue Shield of Massachusetts where we collaborated with local providers to help establish their pay- ment policy," Dr. Zadno said. Avedro has also set up its Avedro Reimbursement Customer Hub (ARCH) Program as a resource in this transition. The program includes patient assistance to help provide the procedure to financially eligible, uninsured patients, and a prescrip- tion assistance program to minimize drug costs in cases of commercial insurance coverage denials. Currently crosslinking is not covered under Medicaid, but Dr. Zadno said Avedro provides the drug for free for charitable cases. In terms of the J-code, Dr. Zadno said that after an initial lack of approval last year, Avedro has re- submitted another application with CMS. Today, he added, about 17 carriers have accepted the J-code and have paid separately the drug from the procedure. Rajesh Rajpal, MD, See Clear- ly Vision, McLean, Virginia, and Avedro chief medical officer, said that it's been a learning process both Experts comment on discussions surrounding the state of crosslinking reimbursement in the U.S. C rosslinking received U.S. FDA approval in April 2016, however, questions regarding reimbursement remain, as it will not be covered by all private payers and is often determined on a case-by-case basis. With recent cost increases of the riboflavin used in the procedure from $595 to $2,850, there is more discussion regarding the uncertainty of reimbursement. EyeWorld spoke with several experts on this topic. Background To report the procedure, Category III CPT code 0402T should be used. This includes the crosslinking and pachymetry, specifically an epithe- lium-off procedure. Code 0402T should not be reported in combina- tion with CPT codes 65435, 69990, or 76514. It is important, however, to note that Category III CPT codes are temporary codes that describe new or emerging technologies with the possibility of a permanent code in the future. With this Category III code, payment is not guaranteed, and the individual payers decide whether to cover the procedure. At present, a growing list of third party payers do cover crosslinking. An important question sur- rounding crosslinking reimburse- ment is whether to separately bill for Photrexa (riboflavin), in addition to crosslinking, using an HCPCS J-code. In 2017, Avedro (Waltham, Massachusetts) applied to HCPCS for a unique J-code for riboflavin. The question is whether riboflavin should be reported separately, or if it's integral to the crosslinking procedure and therefore already implicitly included in the reporting of the 0402T code. Perspectives According to recent recommenda- tions from the American Academy of Ophthalmology (AAO) on its website, the Category III code to re- port crosslinking is 0402T. AAO sug- gests that it's appropriate to report and bill the drug in addition to the Most patients wait until there is a response, he added, and if it's not covered, they can choose to have it as a self-pay procedure. from the practice perspective and the education process of the carriers. In his practice, they typically do a preauthorization or predeter- mination with the insurance carrier. April 2018 Crosslinking reimbursement CyPass ® Micro-Stent IMPORTANT PRODUCT INFORMATION CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. INDICATION: The CyPass ® Micro-Stent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG). CONTRAINDICATIONS: Use of the CyPass Micro-Stent is contraindicated in the following circumstances or conditions: (1) in eyes with angle-closure glaucoma; and (2) in eyes with traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle. MRI INFORMATION: The CyPass Micro-Stent is magnetic resonance (MR) Safe: the implant is constructed of polyimide material, a non-conducting, non-metallic, non-magnetic polymer that poses no known hazards in all magnetic resonance imaging environments. WARNINGS: Gonioscopy should be performed prior to surgery to exclude peripheral anterior synechiae (PAS), rubeosis, and other angle abnormalities or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard. PRECAUTIONS: The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The safety and effectiveness of the CyPass Micro- Stent has not been established as an alternative to the primary treatment of glaucoma with medications, in patients 21 years or younger, in eyes with significant prior trauma, chronic inflammation, eyes with an abnormal anterior segment, eyes with chronic inflammation, eyes with glaucoma associated with vascular disorders, pseudophakic eyes with glaucoma, eyes with uveitic glaucoma, eyes with pseudoexfoliative or pigmentary glaucoma, eyes with other secondary open-angle glaucomas, eyes that have undergone prior incisional glaucoma surgery or cilioablative procedures, eyes with laser trabeculoplasty performed ≤ 3 months prior to the surgical screening visit, eyes with unmedicated IOP less than 21 mmHg or greater than 33 mmHg, eyes with medicated IOP greater than 25 mmHg, in the setting of complicated cataract surgery with iatrogenic injury to the anterior or posterior segment, and when implantation is without concomitant cataract surgery with IOL implantation for visually significant cataract. The safety and effectiveness of use of more than a single CyPass Micro-Stent has not been established. ADVERSE EVENTS: In a randomized, multicenter clinical trial comparing cataract surgery with the CyPass Micro-Stent to cataract surgery alone, the most common postoperative adverse events included: BCVA loss of 10 or more letters at 3 months after surgery (8.8% for the CyPass Micro-Stent vs. 15.3% for cataract surgery only); anterior chamber cell and flare requiring steroid treatment 30 or more days after surgery (8.6% vs. 3.8%); worsening of visual field mean deviation by 2.5 or more decibels (6.7% vs. 9.9%); IOP increase of 10 or more mmHg 30 or more days after surgery (4.3% vs. 2.3%); and corneal edema 30 or more days after surgery, or severe in nature (3.5% vs. 1.5%). AT TENTION: PLEASE REFER TO THE INSTRUCTIONS FOR A COMPLETE LIST OF CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND ADVERSE EVENTS. © 2017 Novartis 9/17 US-CYP-17-E-2272 continued on page 10

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