Today’s medical technology companies are developing exciting and innovative life changing products. While the industry is more innovative than ever before, it continues to run into barriers and other hurdles that hinder innovation. Regulatory and payment issues continue to lengthen the amount of time is takes to get a product into the hands of physicians and patients.
Mobilize for MedTech is AdvaMed’s grassroots campaign, working to ensure that patients have timely access to life-changing technologies.
Medical Device Tax
The medical device excise tax is a 2.3% excise tax on the sale of certain medical technology that was enacted as part of the Affordable Care Act. In January, Congress suspended the device tax until December 31, 2019 as part of legislation to continue funding government operations. This suspension is an important first step, but absent permanent repeal, the significance of this action for the industry is diminished.
On July 24, the House voted to permanently repeal the medical device excise tax with the passage of H.R. 184, the Protect Medical Innovation Act of 2017. 283 Members of Congress, including 57 Democrats, sent a strong signal of support for repeal.
Securing this significant House vote was very important. The large margin reemphasizes the level of support this issue has in Congress and distinguishes the need for repeal as an issue separate from other taxes included as part of the Affordable Care Act. Most importantly, this successful vote has well positioned this issue for further consideration in the Senate later this year.
Permanently repealing the device tax will provide medical technology innovators with the long-term certainty necessary to support future job growth and sustainable, cutting-edge R&D that will ultimately lead to the next generation of breakthroughs in patient care and treatment. With any other policy outcome, effective planning for a sustainable future becomes much more difficult.
We are grateful for the strong, bipartisan show of support for repeal from the House, and want to ensure that the members of Congress who supported repeal understand how appreciative we are. We asked these House members to take action to support our industry here in the United States, and they have done so.
We encourage you to send the following letter to your representative – if they voted in favor of the bill - to express our appreciation for their support of repeal of the device tax, for the medical technology industry, and for the patients and providers we serve. Our grassroots platform will be able to tell you if your local Member voted for the bill.
Urge Congress to Support U.S. MedTech Access to Global Markets
Recent trade actions proposed by the Administration and the US Trade Representative (USTR) have the ability to affect the medtech industry as a whole. In August, the Administration launched an investigation into China's trade practices under Section 301 of the Trade Act of 1974. USTR concluded that China was conducting unfair and harmful acquisition of U.S. technology. In response to this finding, the Administration directed USTR to propose 25 percent additional tariffs on imports that have benefited by China's trade practices, including about $3 billion in medtech.
Through collaboration with Congress and the Administration, we seek to maintain our status as a net exporting industry, and to improve patient access to medtech around the world. It is important that we take this time to contact our Members of Congress and urge them to weigh in as the Administration is currently considering tariffs that could impact our ability to compete abroad. Please use the link below to urge Congress to Support U.S. MedTech Access to Global Markets.
Medicare’s coverage and reimbursement process for new technologies lacks predictability and transparency, delaying patient access to innovative new technologies. AdvaMed is working with Congress on two approaches to reforming the CMS coverage and reimbursement process. First, improving coverage and reimbursement for breakthrough products while addressing current issues with the New Technology Add-on Payment program. Second, improving the LCD (local coverage determination) process through enhanced transparency, predictability, and accountability.
Having an efficient, predicatable, and transparent FDA is good for the medical device industry and for the patients we serve. One tool for ensuring the FDA is well-functioning is the medical device user fee program, or MDUFA. MDUFA gives FDA the authority to collect user fees from industry to support review activities. In exchange, FDA commits to meaningful performance goals to improve the agency’s review process. These goals and accompanying process improvements translate into more timely patient aaccess to life-changing medical technologies. AdvaMed is please that Congress took steps to pass a five-year reauthorization of the MDUFA program in August 2017, and will be working with FDA as it implements the terms of the agreement.
Ways to Get Involved
As an industry, it is important that we maintain visibility with Congressional members while they are back in their districts and states. Welcoming elected officials to visit your company and providing them with a tour of your facility, affords you the chance to highlight your company and the impact you make in their district. This also provides the opportunity to develop a relationship with your Member of Congress, opening channels of communication should you need to reach out to their office in the future. If you are interested in hosting a Member of Congress at your facility, please contact Angie Comte at firstname.lastname@example.org, and we will be happy to help facilitate that visit.
The AdvaMed Stateside program is aimed at getting local industry employees to engage with their Members of Congress by attending meetings at their Member’s district office. AdvaMed handles the meeting logistics, as well as provides background documents and talking points. We held more than 10 Stateside meetings in 2016, and are continuing the program this year. If your company would like to participate in the Stateside program moving forward, please let us know by contacting Angie Comte at email@example.com.