Working with Stakeholders
Through engagement with the key stakeholders in our community – researchers, clinicians, patients, and industry – we identify and address the most critical challenges that are currently limiting successful commercialization and widespread patient access to focused ultrasound therapies.
In recent years the field of focused ultrasound has begun to shift from a mostly research-oriented enterprise toward 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 include lack of awareness by patients, providers, funding agencies, and policymakers. Regulatory and reimbursement hurdles also hinder the advancement of research, 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 United States and include the following high-level goals:
1. Address key reimbursement challenges:
- The lag between US Food & Drug Administration (FDA) approval and Centers for Medicare and Medicaid (CMS) coverage
- Coverage, coding, and payment issues
- Coverage for specific patient populations, such as veterans.
2. Secure more federal and state (Virginia) research funding for focused ultrasound
3. Increase awareness of focused ultrasound among key stakeholders:
- the US Department of Health & Human Services (National Institutes of Health, FDA, CMS)
- the White House
- the Veteran’s Administration
- the US Department of Defense
4. Engage in critical policy discussions, such as proposed legislation and administration priorities
Since 2018, the Foundation has established partnerships with the primary trade associations for the medical device industry: the Medical Imaging & Technology Alliance (MITA), the Advanced Medical Technology Association (AdvaMed), and the Medical Device Manufacturers Association (MDMA). These partners are on the front lines engaging with key stakeholders in support of policies and practices to address the unique challenges facing the medical device industry and that will ultimately better serve patients.
We have also engaged consultants G2G Consulting and McGuireWoods Consulting to help with federal government affairs and Virginia state government affairs efforts, respectively.
With these partners, the Foundation has been able to raise the profile of focused ultrasound among key stakeholders and advocate for additional government funding for focused ultrasound research, as well as critical legislative and regulatory changes. Our work has included numerous Capitol Hill meetings, blog posts, op-eds, public comments on draft federal policies, and active public relations and social media campaigns.
The Foundation and MITA have partnered to host two fly-in events on Capitol Hill (with another virtual fly-in planned for March 2022). 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 CMS reimbursement 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. The rule has since been rescinded, but we will continue our advocacy to support legislative efforts that would provide a similar pathway.
The Foundation and G2G Consulting hosted a virtual briefing in February 2022 aimed towards education of Congressional leaders and their staff. The briefing topics centered on established benefits of focused ultrasound, its potential in additional areas of healthcare, and the value of increasing research investment to advance this field of medicine. Watch a recording of this briefing on YouTube.
In 2022 and beyond, there are many key legislative and administration priorities that align well with our efforts. We will call on all of you – our focused ultrasound community – to support these efforts when the time is right, so please stay tuned.
For more information or to join in our efforts, contact Jessica Foley, PhD, Managing Director, Government Affairs.
Advocacy and Government Affairs Program
Regulatory and Reimbursement
Jessica Foley, PhD, is the Chief Scientific Officer and the Managing Director of the Cancer Immunotherapy Program and Government Affairs at the Focused Ultrasound Foundation.