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OPHTHALMOLOGY BUSINESS 74 August 2017 by Liz Hillman EyeWorld Staff Writer mittee creates Relative Value Units (RVUs), which allow payment for the approved code. When a Catego- ry III code is established, it is includ- ed in the CPT coding manual, but no RVUs are assigned for it, which means payment is not guaranteed. Ms. Rose said the purpose of Cate- gory III codes, which are considered investigational, is to allow Medicare and other payers to develop infor- mation on new technology with the possibility of eventual establishment of a permanent CPT code that could then be assigned RVUs. The initial strategy for crosslink- ing was to have patients be responsi- ble for payment with an established Category III CPT code. But that has changed slightly with Avedro applying to CMS for a J code for the riboflavin solution portion of the procedure. Reza Zadno, PhD, CEO of Avedro, said under the private-pay system, the company found a very large number of patients were un- able to afford the procedure, either because they didn't have the means or insurance wasn't covering it. "When we saw this, we realized that something had to be done to get reimbursement … so we took that on ourselves," he said. "The way this works is when physicians perform the procedure, they submit for the cost of the drug product, and they submit separately their own fee for the CPT code to the insurance company." Photrexa Viscous and Photrexa are coded as J3490. This code, it might be noted, describes it as "unclassified drug." The procedural portion of crosslinking is coded as 0402T, a Category III code, which classifies it as an investigational procedure. Reimbursement for the drug portion will be paid directly by insurance, without debate on how much to pay because the fee will be set by Avedro, Dr. Durrie said. As for the T code, this, according to the Medicare Physician Fee Schedule, is contractor priced. Currently, at least 14 insurers have policies that cover crosslinking. Some insurers have specifically said they will not cover crosslinking, while others have remained silent on the issue. any established codes, said Daniel Durrie, MD, Durrie Vision, Over- land Park, Kansas, "It's very rare to have a new pro- cedure with no coding, no past ex- perience. The best comparison that helps my colleagues think about it is that of retinal injections for macular degeneration. Ten years ago, those were new, insurance companies didn't know anything about them, so our colleagues had to educate them on that," Dr. Durrie said. The process of submitting a drug, technology, or procedure for inclusion in the American Medical Association's (AMA) CPT coding manual and the Centers for Medi- care and Medicaid Services (CMS) Medicare Physician Fee Schedule can take 15 months or more, said E. Ann Rose, principal and senior con- sultant, Rose & Associates Health- care Consultants, a division of BSM Consulting, Duncanville, Texas. And even then, insurance coverage and physician reimbursement are not guaranteed. The oversight body that devel- ops current procedural terminology (CPT) codes and reimbursement is called the CPT Editorial Panel, Ms. Rose explained. Changes and additions to CPT codes are reviewed quarterly and published in the next edition of the CPT book, with new codes going into effect on January 1 of the upcoming calendar year. When a Category I code, a per- manent CPT code, is established, the Relative Value Scale Update Com- What's going on with coding, coverage, and reimbursement? C orneal collagen crosslink- ing with the KXL System and Photrexa and Photrexa Viscous riboflavin solu- tions (Avedro, Waltham, Massachusetts) received approv- al from the U.S. Food and Drug Administration (FDA) more than a year ago for treatment of progres- sive keratoconus and corneal ectasia following refractive surgery, but questions and uncertainties about coding, insurance coverage, and reimbursement remain. From a patient perspective, it was "devastating" for them to learn after fighting for FDA approval that they would, in many cases, pay out of pocket for the procedure as "now we have to fight another battle to prove that [crosslinking] is the stan- dard of care" with insurance carri- ers, said Mary Prudden, executive program director, Gavin Herbert Eye Institute, which houses the National Keratoconus Foundation, Irvine, California. "FDA approval is never a guarantee of coverage," said David Glasser, MD, assistant professor of ophthalmology, Johns Hopkins School of Medicine, Baltimore. Part of the confusion with the current atmosphere of crosslinking coding and reimbursement is that this is a new procedure without Crosslinking paperwork: Clearing up confusion I n the June 2017 issue of EyeWorld, the "YES connect" column focused on pearls for young eye surgeons who are begin- ning to offer corneal crosslinking to their patients with keratoconus and post-refrac- tive surgery keratectasia. Many of us were surprised to learn that although crosslinking was approved in the U.S. in April 2016, many insurance carriers would not cover the procedure right away, and therefore patients are currently responsible for the cost of the procedure. Over the past few months, Avedro (Waltham, Massachusetts), manufacturer of the only FDA-approved crosslinking device (KXL System) and the only FDA-approved riboflavin solutions (Photrexa and Photrexa Viscous), announced increases in the pricing of its riboflavin solutions, in anticipation of crosslinking being covered by more insur- ance carriers. This has led to uncertainty about whether offering the procedure will be financially viable for surgeons in private practice and academic settings. Besides the learning curve of the procedure, there is perhaps an even steeper learning curve for understanding the financial considerations. This month, we do a deep dive into insurance and reimbursement issues related to corneal crosslinking. The same concepts can be applied to many new treatment ap- proaches in ophthalmology. We called upon Mary Prudden, David Glasser, MD, Daniel Durrie, MD, E. Ann Rose, and Reza Zadno, PhD, for their insights. Naveen Rao, MD, YES connect co-editor YES connect continued on page 76

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