In 2018, AdvaMed’s Public Affairs department implemented a multi-pronged media engagement strategy to bolster the industry’s reputation for providing innovative, safe and effective medical technologies that help save and improve patients’ lives. Designed to push back against biased and misleading depictions in the July Netflix film The Bleeding Edge and a lengthy series of stories by the International Consortium of Investigative Journalists (ICIJ) that began in November, our response included engaging with the producers before, during and after production to tell our story, and creation of extensive fact sheets and web-based materials to educate the critics and refute narratives questioning the safety of devices and the speed at which they are brought to market. This effort included extensive cross-departmental engagement of AdvaMed’s Technology & Regulation, Global Strategy & Analysis, Legal, Government and Public Affairs departments – as well as outreach and engagement with outside stakeholders including FDA, Capitol Hill and allied patient and industry groups – to effectively communicate that safety will always be the medtech industry’s top priority. These efforts – which succeeded in defusing or cancelling some ICIJ stories that were set to run – will continue into 2019 and beyond.
During the year, AdvaMed’s Government Affairs department marked significant progress in its state-level advocacy. In California we played a leadership role in negotiating an agreement lowering costs and allowing manufacturers flexibility to comply with sharps take-back requirements; we led efforts to exempt clinical trials and protected data from massive privacy legislation; and we worked to ensure new requirements for connected devices are harmonized with FDA standards. On third-party servicing, we also led industry efforts to block legislation or exempt devices in nearly 20 states to protect appropriate servicing channels. (For more details, see the State Affairs section of this report.)
Federal Legislative Wins
On the federal legislative front, in October Congress passed and the president signed important legislation to improve access to medical technology alternatives to treat and prevent opioid addiction. Key provisions AdvaMed fought for include those impacting Medicare reimbursement for non-opioid alternatives, adding coverage for pain management assessments and telehealth services to treat opioid and substance abuse, and providing clarification of FDA requirements for opioid-sparing claims.
AdvaMed advocacy also ensured that a February federal spending agreement included pro-industry provisions expanding telehealth services and facilitating appropriate reimbursement for diabetes testing supplies and radiation therapy. Meanwhile, the association marked significant progress on improvements to the Medicare local coverage decision process with House passage of legislation in September and CMS administrative changes in October that will increase transparency and accountability. In addition, our efforts helped ensure appropriate allowances for shipment of lithium ion batteries for medical devices under an FAA reauthorization bill passed by the House in October. The association also marked progress on legislation to address inefficiencies in the VA procurement process.
Device Tax Repeal
An expanded public affairs campaign for permanent repeal of the medical device tax – approved by AdvaMed’s Board of Directors in December 2017 and coupled with a continued robust lobbying campaign – helped secure a renewed, two-year suspension of the tax in January 2018 as well as House passage of a full repeal bill in July. AdvaMed advocacy efforts to achieve these votes – and advance progress toward Senate passage – were amplified through multiple Capitol Hill “fly-ins” with company CEOs and others, echoed by allies and partners in the patient and research communities, and supported by targeted print, digital and video ads.