Regulatory and Reimbursement
The Foundation uses its position as a trusted, independent, unbiased third party to form collaborations between industry and academia that facilitate achieving regulatory approval and reimbursement for new clinical applications of focused ultrasound.
A key aim of the Foundation’s Regulatory Affairs Program is to facilitate dialog with U.S. Food and Drug Administration officials—both scientific and clinical regulatory staff—and provide them with information to contribute to the advancement of focused ultrasound clinical studies and also to facilitate development of technical standards for focused ultrasound treatments. The Foundation also supports researchers in developing clinical study protocols that adhere to FDA standards and/or connecting them with regulatory experts for appropriate guidance.
The working relationship between the Foundation and FDA has helped to contribute to the advancement of focused ultrasound therapy. A major milestone was achieved in 2011 when the FDA for the first time officially recognized the field of focused ultrasound and its potential as “a leading-edge technology to perform surgery without incisions,” and as a way to “reduce the number of invasive surgeries that patients need."
Currently, there is not widespread reimbursement from private or government payers for focused ultrasound therapy. Until payers are willing to cover focused ultrasound therapy, patients will have limited access to this non-invasive treatment alternative.
To help make a case for coverage, the Foundation is establishing collaborations and developing methods to heighten the likelihood of new applications being considered commercially viable and reimbursable. As new clinical trials are designed, the Foundation is consulting with researchers to ensure that studies are designed from the start not only to demonstrate safety and efficacy, but also to meet insurers’ requirements for superior long-term benefits, quality of life, and cost-effectiveness.
We are also brokering partnerships with industry representatives to assess patient and clinician attitudes towards focused ultrasound, and designing and implementing patient registries to track long-term treatment results that insurance carriers can use to evaluate the efficacy of focused ultrasound treatments.