NUTS AND BOLTS OF IMPLEMENTINGCORNEAL CROSS-LINKING IN YOUR PRACTICESPONSORED BY

Avedro gathered leading refractive surgeons and eye care professionals for a roundtable discussion during the 2018 annual meetingof the American Society of Cataract and Refractive Surgery in Washington, DC. The discussion centered around current issues
experienced by ophthalmologists who perform corneal cross-linking in their practices.
BRANDON D. AYRES, MDnS urgeon on the Cornea
Service, Wills Eye Hospital,PhiladelphianF inancial disclosure:Consultant (Avedro)

KATHRYN M. HATCH, MDnD irector, Refractive Surgery
Service, Massachusetts
Eye and Ear; Site Director,
Massachusetts Eye and Ear,Waltham, Massachusetts;
Assistant Professor ofOphthalmology, Harvard
Medical School, BostonnF inancial disclosure:
Consultant (Avedro)

RICHARD L. LINDSTROM, MDnF
 ounder and Attending
Surgeon, Minnesota Eye
Consultants, Minneapolis,Minnesota
nF inancial disclosure:
Consultant (Avedro)

RAJESH K. RAJPAL, MDnF
 ounder, See Clearly Vision
Group, Tysons Corner, VirginianF inancial disclosure: Chief
Medical Officer, Avedro
SARA B. RAPUANO, MBA, CPC,COE, OCS
nO
 phthalmology PracticeManagement Consultant,PhiladelphianF inancial disclosure:
Consultant (Avedro)

Photrexa and KXL are registered trademarks of Avedro.
MA-01198ACXL APPROVAL IN THE US
Richard L. Lindstrom, MD: We now
have an FDA-approved product for corneal cross-linking (CXL) in the UnitedStates. Dr. Ayres, what was involved in
obtaining this approval, and what are
the approved indications?
Brandon D. Ayres, MD: It took a longtime for CXL to be approved in the US.
Reports on the procedure were published as early as 2003, but it was not
until 2016 when CXL was FDA approved,
proving that CXL was effective for treating progressive keratoconus and corneal
ectasia following refractive surgery. The
FDA approval encompassed Avedro’s
Photrexa Viscous, Photrexa, and theKXL system, using an epithelium-off
procedure modeled after the Dresden
protocol.1

INCORPORATING CXL IN YOUR PRACTICE
Dr. Lindstrom: What does it take toincorporate CXL in your practice?
Dr. Ayres: First, you need to let thecommunity know that you treat keratoconus. Incorporating CXL into ourpractice was a natural transition. We had
been treating keratoconus, and we havebuilt great relationships with diagnosing
providers, both optometrists and general
ophthalmologists.
You also need to determine how you
will implement the office-based procedure, particularly when it comes toscheduling and defining staff roles.
Dr. Lindstrom: As Dr. Ayres mentions,CXL is an office-based procedure at Wills
Eye Hospital. Dr. Hatch, is that also thecase at Massachusetts Eye and Ear?

Kathryn M. Hatch, MD: Yes, it is.
We are currently performing CXL at
the Massachusetts Eye and Ear satellite
location in Waltham. I typically perform
CXL during clinic, so I can efficiently see
patients and perform treatments.
Our process begins with the initial
evaluation. We have one person who
is our designated "CXL champion." He/she is our go-to administrative expert
and is responsible for scheduling theprocedures. It is critical to have one staff
member who can talk to patients preoperatively and explain what to expect.
Additionally, we have two technicians
who are quite comfortable with the procedure. They are extremely helpful withreassuring patients and guiding themthrough the process.
Dr. Lindstrom: As the entire procedure takes about 90 minutes, it can be
stressful for patients, so they will need tobe counseled.
I also perform CXL during clinic andbelieve other ophthalmologists choose
to perform the procedure on designated days.
Dr. Ayres: Initially, I tried to designatea specific day to treat my CXL patients,
but that turned out to be inefficient.
Now, with carefully trained staff, I canperform the procedure efficiently during an office day. Like Dr. Hatch, wehave two gifted staff members. Onestaffer is a good scheduler, sympathetic
with patients, and is great on the phonewith insurance companies making sure
we have the necessary approvals. The
second person is our bubbliest, friendliest technician who is good at talking toour patients.

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FDA-approved version of CXL from Avedro. A patient whoseeks CXL from a provider not using FDA-approved products will be self-pay as insurance will not pay for a non-FDA
approved procedure.
Dr. Ayres: We also must consider liability. Many of us are
performing these procedures, and if you do a lot of anything, inrare instances something unusual happens. We need to ensure
we have insurance coverage if there is an issue.
An increasing number of commercial payers begin to recognize the medical necessity of CXL.
Coverage trend as of 9/21/18. For updated insurance information, visit www.avedro.com.

Dr. Hatch: An outgoing, positive technician can put patientsat ease. I also prescribe a small amount of a benzodiazepine,which patients bring to the office with them. We instruct themto take it after they check in, typically about 40 minutes prior
to the procedure. Additionally, patients may bring in theiriPods or stream internet radio, as music does wonders to create a relaxing atmosphere. I explain to patients that we have ateam approach to CXL in our office, and that multiple members of the team will be helping during the treatment.

BENEFITS OF USING AN FDA-APPROVED PROCEDURE
Dr. Lindstrom: Why is it important to use a product manufactured according to FDA guidelines?
Dr. Ayres: For a product to be FDA-approved, the manufacturer must adhere to current Good Manufacturing Practiceregulations. This requirement helps alleviate concerns about
the quality of a medication and the risk of potential contamination. This is particularly important to minimize the risk ofinfection when a procedure involves an epithelial defect.
Rajesh K. Rajpal, MD: Ms. Rapuano, as a practice administrator with experience in managing CXL, help us understand theimportance of using an FDA-approved product from an insurance perspective.

Ms. Rapuano: The Ophthalmic Mutual Insurance Company(OMIC) specifically requires that providers use the FDA-approved
version of a product or have authorization to study an investigational drug via an Investigational New Drug (IND) application.
Dr. Rajpal: Physicians, practices, and the community need tounderstand that an institutional review board (IRB) approval
is not enough to protect them from liability. Also, CXL clinicalstudies need to be performed under an IND.

THE ARCH PROGRAM
Dr. Rajpal: Moving to the Avedro Reimbursement Customer
Hub (ARCH) Program. This program has three components:
patient assistance, prescription assistance, and a hotline forpractices to call for help with the predetermination and appeals
process. The aim of the ARCH Program is to support patients
through the process, as we see progress in reimbursement frominsurance carriers.
Dr. Ayres: The ARCH program has helped streamline the CXL
process in our practice. For example, when a patient is ready forthe procedure, we send his or her information to ARCH, whichworks with the insurance company to obtain prior authorization,relieving our staff of this sometimes administratively burdensometask. The program has helped us to treat more patients who areinterested in having the procedure covered by their insurance. n1. Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J
Ophthalmol. 2003;135:620-627.

Sara B. Rapuano, MBA, CPC, COE, OCS: To bill insurancecompanies, a product needs FDA approval. When we look at
the coverage policies, insurers are specifically referencing theIMPORTANT SAFETY INFORMATION
INDICATIONSPHOTREXA® VISCOUS (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and Photrexa® (riboflavin 5’-phosphate ophthalmic solution) are indicated for use with the KXL System in corneal
collagen cross-linking (CXL) for the treatment of progressive keratoconus and corneal ectasia following refractive surgery.
LIMITATIONS OF USE
The safety and effectiveness of CXL has not been established in pregnant women, women who are breastfeeding, patients who are less than 14 years of age and patients 65 years of age or older.
Photrexa Viscous and Photrexa should be used with the KXL System only.
WARNINGS AND PRECAUTIONS
Ulcerative keratitis can occur. Patients should be monitored for resolution of epithelial defects.
ADVERSE REACTIONSIn progressive keratoconus patients, the most common ocular adverse reactions in any CXL treated eye were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain,
reduced visual acuity, and blurred vision. In corneal ectasia patients, the most common ocular adverse reactions were corneal opacity (haze), corneal epithelium defect, corneal striae, dry eye, eye pain,
punctate keratitis, photophobia, reduced visual acuity, and blurred vision.
These are not all of the side effects of Photrexa® Viscous, Photrexa® and the CXL treatment. For more information, see Prescribing Information (http://avedro.com/wp-content/uploads/ML-00043B.pdf).
You may report an adverse event to Avedro by calling 1-844-528-3376, Option 1 or you may contact the U.S. Food and Drug Administration (FDA) directly at 1-800-FDA-1088.

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