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, payors, and medical specialty societies. The ultimate aim is 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. The Section, chaired by Mark Carol, MD, CEO of SonaCare Medical, meets monthly by teleconference and semi-annually in person. To date, the Section has conducted numerous activities to raise the profile of focused ultrasound among key stakeholders and promote legislative and regulatory changes to address the challenges and barriers that exist for focused ultrasound and other innovative medical devices.
“By bringing the focused ultrasound industry together, MITA is able to engage with key policy makers in the legislative and regulatory processes to better promote the value of this innovative technology,” said MITA Executive Director Patrick Hope. “And by being at the table, manufacturers are able to control the future success of the industry.”
“This partnership has helped create a culture of collaboration between many key stakeholders – patients, physicians, industry, and the Focused Ultrasound Foundation – to present a unified front to decision makers in Washington and beyond,” said Dr. Carol. “Our work over the past year has helped create a foundation upon which we can build toward achieving our goal of establishing therapeutic ultrasound as a standard of care.”
Some key highlights from the first year of the partnership include:
The first Focused Ultrasound Capitol Hill Fly-In
In February 2019, patients and physicians from seven states joined manufacturers to meet with 17 Congressional offices during the Focused Ultrasound Capitol Hill Fly-In. Attendees educated lawmakers and staff about focused ultrasound as well as the coverage and reimbursement challenges the industry faces.
Health Care Innovation Caucus Showcase
Thanks to MITA, SonaCare Medical was selected out of more than 100 applicants to host a booth at the Health Care Innovation Caucus Showcase. The event allowed SonaCare to exhibit focused ultrasound technology to attendees, including nine Members of Congress and more than 200 congressional staff and health industry stakeholders.
MITA and Foundation staff conducted more than 30 meetings with Capitol Hill offices representing states with either a focused ultrasound footprint or those with leadership positions in relevant Congressional caucuses.
HHS Clinical Innovation Initiative Hearing
The partnership submitted comments ahead of the US Department of Health and Human Services (HHS) Clinical Innovation Initiative Hearing. During the hearing, Dr. Carol presented improvement proposals on behalf of the Section aimed at addressing the lag time between FDA approval and CMS reimbursement.
Draft Proposal Feedback
The Section submitted letters to HHS, the Office of Management and Budget, and Centers for Medicare & Medicaid Services (CMS) to comment on draft proposals relevant to focused ultrasound and other innovative technologies.
Foundation Chief Scientific Officer, Jessica Foley, PhD, and Dr. Carol co-authored an op-ed entitled, “Better treatment options exist – why don’t we use them?” The piece was published in The Hill.
MITA’s Right Scan Right Time blog also featured many focused ultrasound patient stories.
Building Momentum in Year Two
In the next year, the Section will continue outreach to policymakers and other stakeholders who can help us address the barriers and challenges in our industry. Some specific goals outlined by the group include:
- Holding a Capitol Hill briefing for focused ultrasound indication-related Congressional caucuses (Health Care Innovation, Parkinson’s, Men’s Health, etc.)
- Conducting a second annual focused ultrasound Capitol Hill Fly-In
- Drafting legislative proposals that break down the barriers that exist to wider establishment of focused ultrasound and other innovative devices as standards of care (e.g., CMS trial coverage for innovative devices)
- Facilitating Senator/Representative site visits to focused ultrasound manufacturing or research facilities
- Publishing blog posts for relevant indication disease awareness months, including patient spotlights
- Authoring and placing op-eds tied to the Section’s legislative and regulatory efforts
“In its first year, the MITA Focused Ultrasound Section was able to lay groundwork establishing focused ultrasound as a valuable, innovative technology with enormous potential,” said Dr. Foley. “Looking ahead, we want to cultivate and leverage the relationships we’ve made among policy makers to help advance our mission to reduce the barriers for focused ultrasound commercialization and widespread clinical adoption.”
Interested in Getting Involved?
We welcome the interest of focused ultrasound companies who would like to join these efforts as members of the MITA Focused Ultrasound Section. Please contact Dr. Foley, who leads the Foundation’s government relations and advocacy activities to learn more and to join this exciting partnership.