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Cover Focus | May/June '18

CXL From the Ground Up

From the time of my first ophthalmology rotation as a medical student, I had heard about the various methods of managing keratoconus: mask the astigmatism with a rigid gas-permeable lens, cover the irregular surface with a vaulted scleral lens, or stretch the central cornea flat over intrastromal corneal ring segments; hope that the patient doesn’t progress to the point of losing significant visual acuity; and finally, if all else fails, resort to a corneal transplant.

I don’t remember when I first heard about corneal crosslinking (CXL), but the idea is a novel one. What if we could strengthen the corneal tissue to alter the disease course? What if we could actually intervene—do something? After all, for all of our efforts, none of those vision-correcting measures I had learned about had any bearing on the disease course.

By the time Avedro received FDA approval (April 2016 for progressive keratoconus and July 2016 for corneal ectasia) for its proprietary »KXL UV light source, riboflavin drop formulation (Photrexa and Photrexa Viscous), and an epithelium-off crosslinking protocol modeled after the Dresden Protocol, the safety and efficacy of CXL had been established by our colleagues around the world.1-4 Tens of thousands of patients had already undergone the procedure.

From my perspective, as a young cornea specialist starting out in private practice, I saw a great opportunity. Here was a procedure that was clearly effective, not technically demanding—and, therefore, easily reproducible—and yet it was not being widely performed in my area. Best of all, with FDA approval for the drug and procedure, obtaining insurance coverage for qualified patients even seemed like an eventual possibility. I saw that introducing CXL into my practice could be a way to “declare” myself a cornea provider in my geographic area.

A Point of Advice

"My biggest tip is one I learned from Bill Trattler, MD: Use a scleral contact lens, not a rigid gas-permeable lens. A rigid gas-permeable lens rocks on the cone and acts as a slight rub on the eye with each blink. A scleral contact lens vaults over the cornea and protects it.

Additionally, you can’t overemphasize to patients the importance of stopping any eye rubbing. And have a plan for their vision during the postoperative period, including what you are going to do with their contacts"

John P. Berdahl, MD

BECOMING AN EXPERT

The first step toward implementing this novel treatment modality was to “become an expert.” I think this idea applies to any young surgeon wanting to adopt a new technique. I read as many articles on CXL as I could find, including some of the landmark studies referenced above. I attended the annual ASCRS meeting and sought out lectures on implementing CXL. I contacted my local Avedro representative to learn about the company’s FDA-approved system and the Avedro Reimbursement Customer Hub (ARCH) program, an insurance claims support network that was about to be launched. I asked my colleagues and mentors around the country about their experiences with CXL. This process served not only as clinical education for me but also as due diligence to find out if CXL would be feasible in my office.

In order to make CXL a success for my practice, I quickly saw that I would need to develop a referral network; I simply had to find enough patients who were candidates to make it worthwhile. For my young colleagues, whether implementing a new technique or just trying to build a successful practice, I cannot overstate the importance of marketing oneself and building relationships with other providers in one’s community. I started by looking for the ophthalmologists who were doing the most LASIK and the optometrists who were doing the most specialty contact lens fittings in my area. I scheduled meetings with some of these providers to gauge their level of interest, and the feedback I received was extremely positive.

As I had suspected, there seemed to be an unmet need for this procedure in my community. Some providers were extremely excited to hear that I would soon be performing CXL, stating that they had patients who had been waiting for this technology to become available. Subsequently, I have begun to speak at dinner meetings to groups of local providers to provide education on early diagnosis of keratoconus and ectasia, indications for CXL, and the effectiveness of the procedure. Avedro has helped to host several of these events, including a lecture at the monthly meeting for the local optometric society. In this way, my CXL project has helped me build relationships with other area providers.

In my first year of performing CXL, the biggest challenge has been guiding patients through the complex landscape of insurance coverage for this new procedure. I explain the benefits of the treatment to each patient in detail and communicate the fact that insurance coverage may not be granted. All patients undergoing CXL in my practice sign an ABN agreement and pay an up-front fee toward an insurance deductible. This fee is enough to cover our procedure costs, and the agreement states that we will refund this payment or an appropriate portion of this payment if insurance coverage is granted. We request preauthorization and submit formal claims for every procedure, and, with the help of Avedro’s ARCH program, we have submitted numerous denial appeals. All told, I have performed 31 CXL procedures since starting this project. Five of these have ultimately been covered by medical insurance, and we have several appeals still pending.

IN HINDSIGHT

Looking back on a year of successful procedures, the entire process of learning about CXL, building a referral network, and fighting to get insurance coverage has been both challenging and rewarding. A lot has changed since the medical school days of just hoping to avoid progression and vision loss, and I am happy to be a part of it.

 

1. Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003;135(5):620-627.

2. Raiskup-Wolf F, Hoyer A, Spoerl E, Pillunat LE. Collagen crosslinking with riboflavin and ultraviolet-A light in keratoconus: long-term results. J Cataract Refract Surg. 2008;34(5):796-801.
3. Caporossi A, Mazzotta C, Baiocchi S, Caporossi T. Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study. Am J Ophthalmol. 2010 Apr;149(4):585-593.

4. Raiskup-Wolf F, Thuering A, Pillunat LE , Spoerl E. Collagen crosslinking with riboflavin and ultraviolet-A light in keratoconus: ten-year results. J Cataract Refract Surg. 2015;41:41-46.

author
Geoffrey M. Hill, MD

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