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
There are more than 2 million MedTech employees in the U.S. What if every one of them reached out to Congress to thank them for repealing the medical device excise tax? Talk about a powerful message!
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.