Advocacy and Government Affairs
The Foundation has a robust Advocacy and Government Affairs program that seeks to address challenges that are currently limiting successful commercialization and widespread patient access to focused ultrasound therapies.
The ultimate mission of the Focused Ultrasound Foundation is to catalyze the development and clinical adoption of focused ultrasound to facilitate widespread and equitable access to transformative therapies. In recent years the field of focused ultrasound has begun to shift from a mostly research-oriented enterprise towards clinical adoption and commercialization. We’ve also seen the creation of new and exciting fields of research that are capitalizing on the versatility of focused ultrasound to produce many different biological mechanisms of action including tissue destruction, anti-cancer immune response, neuromodulation, localized and targeted drug delivery, transient opening of the blood-brain barrier, and many others.
But despite this progress and focused ultrasound’s immense potential to transform treatments and improve patient outcomes, it is not widely accessible. Significant barriers including lack of awareness by patients, providers, funding agencies and policymakers, and regulatory and reimbursement hurdles, are hindering successful commercialization and patient access.
The Foundation has been fortunate to collaborate with leading advocacy organizations and consultants who have the expertise and relationships to help us address these challenges. Currently, our advocacy initiatives are focused primarily in the US.
Medical Imaging & Technology Alliance (MITA)
In April 2018, the Foundation and the Medical Imaging & Technology Alliance (MITA) formed a partnership with the goal of raising awareness of focused ultrasound technology among policymakers, payers, and medical specialty societies. The partnership has laid important groundwork to reduce barriers to commercialization and increase patient access to focused ultrasound therapies.
Under this partnership, MITA established a Focused Ultrasound Section that includes representatives from seven focused ultrasound companies and the Foundation. To date, the Section has conducted numerous activities to raise the profile of focused ultrasound among key stakeholders and advocate for critical legislative and regulatory changes, including Capitol Hill meetings, blog posts, op-eds, public comments on draft federal policies, and an active public relations and social media campaign.
The Foundation and MITA have partnered to host two “fly-in” events on Capitol Hill. In February 2019 and March 2020, passionate groups of focused ultrasound patients and physicians joined representatives from the Foundation, MITA, and industry in Washington, DC, to educate policymakers on the innovative technology. The goal of these events was twofold: (1) to clearly define a problem plaguing newly approved medical devices – that is, the lack of a clear and efficient path from FDA approval to reimbursement by the Centers for Medicare and Medicaid Services (CMS) for these treatments – and (2) to introduce a plan forward. Our group was thrilled to see our advocacy pay off with the release of a new rule from CMS that would establish a Medicare coverage pathway for innovative medical devices. If finalized, the Medicare Coverage of Innovative Technologies Pathway (MCIT) would pair FDA breakthrough and CMS coverage and grant immediate, four-year Medicare coverage for new, innovative devices. The rule has since been delayed but we will continue our advocacy to support its ultimate implementation.
Advanced Medical Technology Association
In the summer of 2019, the Foundation established a partnership with the Advanced Medical Technology Association (AdvaMed), which includes 11 focused ultrasound companies. The goal of the partnership is to address key issues that create roadblocks to commercialization and thus limit patient access to focused ultrasound therapies.
AdvaMed is a trade association that leads the effort to achieve healthier lives and healthier economies around the world through the advancement of medical technology. It includes more than 400 members in more than 80 countries and acts as the common voice for companies producing medical devices, diagnostic products, and health information systems.
On March 11, 2020, the Foundation and AdvaMed joined forces to host a summit on reimbursement strategies for focused ultrasound treatments. Stakeholders convened in Washington, DC, to discuss the state of US reimbursement for those focused ultrasound applications that have been approved by the FDA.