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 32A D V A M E D 2 0 1 6 A N N U A L R E P O R T u A D V O C A C Y I N A C T I O N 21ST CENTURY CURES In December 2016, Congress passed and the president signed the 21st Century Cures Act, putting the final capstone on two years of AdvaMed advocacy in support of the legislation. Championed by former House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) and Committee Member Diana DeGette (D-Colo.), and Senate HELP Committee Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.), the new law aims to accelerate the discovery, development and delivery of 21st century cures for patients in need. AdvaMed played a prominent role – working in concert with many allied stakeholder groups – in proposing and advancing key provisions of the legislation that will help continue improvement of FDA regulatory processes and begin addressing significant reimbursement challenges at the Centers for Medicare and Medicaid Services (CMS). The legislation includes a number of important FDA regulatory reforms from AdvaMed’s Innovation Agenda, led by the breakthrough pathway provision that will improve use of the agency’s Expedited Access program. There are also provisions to: raise the humanitarian device exemption cap; establish a process for FDA recognition of international standards; improve selection of experts on FDA advisory panels; update the Class I/II exemption list; allow for the use of central institutional review boards (IRBs) for device trials; require FDA to update its CLIA-waiver guidance; reinforce FDA’s use of the “least burdensome” principle in conducting reviews; clarify FDA regulation of software and certain digital health technologies; and improve the regulation of combination products. The pack- age also provided $500 million in discretionary appropriations for FDA implementation of these and other provisions. Importantly, the Cures Act also includes key health care delivery system reforms. For example, language requiring greater transparency in local coverage decisions (LCDs) represents a positive step forward on AdvaMed’s work to improve the LCD process. The legislation also includes a retroactive delay in the application of competitive bidding rates to non-competitively bid areas for durable medical equipment (DME) through the end of 2016. The latter provision mirrored AdvaMed-supported legislation previously introduced by Rep. Tom Price (R-Ga.) and John Thune (R-S.D.). AdvaMed’s leadership in assisting development and advancement of this important legislation from the beginning included Board member participation in multiple congressional roundtables and hearings that informed the legislative process. Led by our regulatory and government affairs teams, AdvaMed staff worked through final passage to encourage the strongest possible provisions for medical technology innovators and the patients we serve. AdvaMed’s Capitol Hill R&D fly-in in September includes (from left to right) Steve LaPierre of Boston Scientific, John Mikszta of BD, Christian Eusemann of Siemens, Tim Girton of Boston Scientific, John Grimm of B. Braun, and Joe DuPay of CVRx. AdvaMed ran print and electronic ads in key Capitol Hill publications highlighting the need to repeal the medical device tax. www.lifechanginginnovation.org WELCOME 115TH CONGRESS: LET’S MAKE MEDICAL INNOVATION A PRIORITY. REPEAL THE DEVICE TAX. Congress, let’s make innovation, job creation and patient care a priority in 2017 by swiftly repealing the medical device tax for good. The temporary suspension is working: Companies are increasing investment in R&D, re-starting delayed projects, and adding much-needed jobs to the U.S. economy. But it’s not enough. Early action this year is necessary to continue sustained investment for life-changing medical technologies. AdvaMed welcomes the 115th Congress and asks that you permanently repeal the medical device tax. 6