Scientific evidence is key driver for gaining reimbursement for MR-guided focused ultrasound

Medical researchers have a critical role to play in gaining optimal health insurance reimbursement for MR-guided focused ultrasound. As Susan Klees, Director of Patient Access for the Focused Ultrasound Surgery Foundation, reports, "Scientific evidence is the key driver for reimbursement, and it all begins with the way studies are designed. Today, research priorities must be grounded in sound science as well as the realities of the marketplace."

An interview with Klees appeared in the June 2011 of the Foundation's online newsletter, which featured several stories related to health insurance reimbursement.

According to Klees, designing studies that address marketplace realities requires an understanding of what is valued by different groups. "We know that physicians are seeking cutting-edge treatment modalities to solve medical challenges, patients want to avoid complex surgery and lengthy recovery times and medical payers expect enhanced outcomes and efficiencies in treatment," she explains.

Klees says that skyrocketing healthcare costs have prompted insurers to demand better results all around - increased value, improved quality outcomes, enhanced patient satisfaction and efficient care. In fact, many experts believe that today more proof is required to qualify for reimbursement than to receive regulatory approval for new medical devices.

Although there has been reimbursement success in Germany and elsewhere, Klees says private payers in the U.S. are not yet consistently covering focused ultrasound treatments for uterine fibroids. In fact, some have adopted 'negative' policies that actively seek to deny coverage.

"This is happening even though focused ultrasound is approved by the Food and Drug Administration as a treatment for uterine fibroids and has demonstrated important advantages over competing therapies," she notes. "These advantages include being an outpatient procedure, offering quick recovery and preserving the potential for future fertility."

Unconvinced by the current body of evidence, many American health insurers are asking for randomized comparative trials and long-term outcomes before reconsidering their stance on MR-guided focused ultrasound therapy.

To avoid such impasses in the future, the Focused Ultrasound Surgery Foundation is encouraging researchers, industry and other stakeholders to collaborate in setting priorities for investigating new focused ultrasound applications. Examples include essential tremor and Parkinson's disease. "We're pushing for studies that target the most commercially viable focused ultrasound applications, address safety and efficacy, and generate data that demonstrates the technology's comparative superiority in long-term benefits, quality of life and cost-effectiveness," Klees explains.