CMS Issues Preliminary Decision on Unique J Code for Avedro Photrexa® Drug Formulations
Jun. 12, 2018
WALTHAM, Mass.--(BUSINESS WIRE)--Jun 12, 2018--Avedro, Inc., an ophthalmic pharmaceutical and medical device company and world leader in corneal remodeling, today announced that the Centers for Medicare and Medicaid Services (CMS) has issued a preliminary decision to establish a product specific Healthcare Common Procedure Coding System (HCPCS) J code for Photrexa ® drug formulations. Claims submitted with a product specific J code are generally processed more efficiently than claims using a miscellaneous code (J3490), which requires manual review.
These Photrexa formulations are the only drugs approved by the U.S. Food and Drug Administration (FDA) for use in conjunction with the KXL ® System in corneal collagen cross-linking to treat progressive keratoconus and corneal ectasia following refractive surgery.
“We are pleased that CMS has recommended a unique J code for our Photrexa drugs,” said Reza Zadno, PhD, CEO of Avedro. “We would like to thank the ophthalmologists, the societies and the National Keratoconus Foundation for working with us in this collaborative effort. Finalization of this recommendation would be an important achievement for the company as we continue our efforts to make corneal cross-linking an accessible procedure for patients struggling with sight-threatening diseases.”
“If finalized, this J code will simplify billing for the FDA approved corneal cross-linking procedure,” said Eric Donnenfeld, MD, founding partner of Ophthalmic Consultants of Long Island and Connecticut. “A product specific J code will streamline the claims submission process for physician practices and better serve ectactic patients in need of treatment.”
CMS’ preliminary decision was announced at their public meeting held on Tuesday, May 15, 2018, and is expected to be finalized and announced in November of 2018, with new or revised codes becoming effective on January 1, 2019.
Avedro is a privately held pharmaceutical and medical device company and the world leader in corneal remodeling. Our patented cross-linking technology, consisting of drug formulations and medical devices, are approved for sale in numerous countries around the globe. We continue to develop proprietary corneal remodeling products for the treatment of keratoconus, corneal ectasia and for refractive correction as an alternative to contacts and eyeglasses. Keratoconus and corneal ectasia are rare and sight-threatening eye conditions in which the cornea progressively thins and weakens causing the development of a cone-like bulge and optical irregularity of the cornea which can result in significant visual impairment. At Avedro, our mission is to produce and deliver innovative, minimally invasive drugs and devices for corneal remodeling to eyecare professionals around the world to improve patients’ vision and quality of life.
IMPORTANT SAFETY INFORMATION
Photrexa ® 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.
In 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.
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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CONTACT: Avedro Contact:
David Iannetta, 781-768-3400
Gray Communications, LLC.
Michele Gray, 917-449-9250
KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS
INDUSTRY KEYWORD: SURGERY HEALTH BIOTECHNOLOGY MEDICAL DEVICES OPTICAL PHARMACEUTICAL MANAGED CARE
SOURCE: Avedro, Inc.
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PUB: 06/12/2018 08:00 AM/DISC: 06/12/2018 08:01 AM