Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 3220 u S E C T O R S P O T L I G H T AdvaMed’s Wound Healing and Tissue Regeneration Sector is focused on ensuring patient access to innova- tive therapies for the treatment of chronic and complex wounds. In 2016, the Sector continued to advocate for effective use of wound technologies, as well as appropriate regulation, coverage and reimbursement policies. This was achieved in part through outreach and engagement with wound specialty groups on key topics, such as with the National Pressure Ulcer Advisory Panel on efforts to re-define wound terminology, and with the Association for the Advance- ment of Wound Care on their development of a white paper on appropriate clinical evidence. Through comments to CMS and FDA, the Sector also continued to advocate for appropriate reimbursement of skin substitute products and against the creation of additional regulatory barriers for wound dressings containing anti-microbial agents. During the year, the Sector collected additional funding for the American College of Wound Healing and Tissue Repair – a non-profit organization committed to advancing the field of wound care through education, research and advocacy – to support the organization’s 2017 projects. The Sector also partnered with the organization to host a joint meeting in conjunction with their annual conference, and contributed to planning for a payment policy panel at the event. WOUND HEALING & TISSUE REGENERATION OPHTHALMIC Members of AdvaMed’s Ophthalmic Devices Sector are focused on creating technologies that preserve, restore and improve healthy eyesight. The Sector meets quarterly to discuss key priorities and is committed to ensuring patient access to these vision-enhancing products. Ongoing activities in 2016 included working with FDA on use of patient-reported outcomes (PROs). The agency’s device center and its ophthalmic devices division are expecting PRO endpoints to be included in clinical trials to support regulatory approvals. There currently are no validated PROs in the ophthalmic space, although many companies have tried to develop these instruments without success. One option under consideration by the Sector would be to work with the agency to facilitate flexibility in the use of these endpoints and to develop a standardized guidance on developing and validating PROs. A number of payment-related issues that could impact ophthalmic device makers also are being closely monitored by the Sector, including: hospital and ambulatory surgical center payments, Physician Merit-Based Incentive Payment System development, potential use of physician offices as valid sites for cataract surgery, and possible CMS interest in guidance memos. SECTOR HEAD JOHN KILCOYNE President and Chief Executive Officer ReVision Optics, Inc. SECTOR HEAD FRANCOIS FOURNIER President U.S. Commercial Advanced Wound Management Smith & Nephew