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 3221 RADIATION THERAPY In 2016, AdvaMed’s Radiation Therapy Sector focused on developing a strategic plan, building relationships and educating all stakeholders to help address the unique policy challenges facing this dynamic and growing area of medtech innovation. The Sector cohosted a Capitol Hill briefing with the American Society for Radiation Oncology (ASTRO) to increase awareness of the value of radiotherapy and how legislative issues impact the industry. The Sector also began planning additional Hill briefings for 2017, and continues to develop collateral materials, including a primer on Radiation Therapy, to further its education goals. During the year, the Sector hosted two vendor days for FDA, giving member companies the opportunity to educate agency reviewers on their products and strengthen professional relationships. The Sector remains engaged on standards development with the Association for the Advancement of Medical Instrumentation, with one standard near completion and a second in development. The Sector also continues to work with ASTRO to address reimbursement-related challenges at CMS, alternative payment model and quality measure development, and implementation of the Medicare and CHIP Reauthorization Act (MACRA). In addition, the group continues to build relationships with potential global allies to help promote the benefits and value of radiation therapy for patients around the world. ORTHOPEDIC Orthopedic devices help patients by restoring mobility, relieving pain and improving quality of life. In 2016, AdvaMed’s Orthopedic Sector worked to advance key priorities, including ongoing support for the American Joint Replacement Registry and ensuring that each manufacturer has access to their own patient- level registry data. During the year, the Sector worked with the International Society of Arthroplasty Registries (ISAR) to support development of an international prosthesis library to eliminate the need for registry-by-registry data entry of hip and knee product information, and help make the process more efficient and less costly. The Sector also worked in conjunction with AdvaMed’s Global Strategy and Analysis department, and collaboratively with U.S. Customs and Border Protection, to defeat a proposal by Colombia before the World Customs Organization (WCO) to classify some orthopedic screws and lumbar fixation devices as hardware instead of medical devices. Colombia's proposal would have made the screws and fixation devices subject to import tariffs and potentially harm patient access. Finally, the Sector monitored implementation by the Centers for Medicare and Medicaid Services of the agency’s bundled payment programs for hip and knee replacement procedures, and their impact on short- and long-term patient care outcomes. SECTOR HEAD JUAN-JOSE GONZALEZ President DePuy Synthes, U.S. Johnson & Johnson SECTOR HEAD JOSHUA LEVINE President and Chief Executive Officer Accuray