Gaining regulatory approval for new medical devices easier than convincing insurers to provide coverage

What's easier: gaining regulatory approval for a new medical device, or convincing insurers to cover the treatments it provides? According to Susan Klees of the Focused Ultrasound Surgery Foundation, many experts say regulatory approval is the easier task.

An interview with Klees is one of the reimbursement-related articles featured in the June 2011 issue of the foundation's online newsletter. As Director of Patient Access, she is deeply engaged in the issues of health insurance reimbursement for MR-guided focused ultrasound in the U.S. In what may come as a surprise, she believes that medical researchers can play an important role in ensuring favorable reimbursement decisions.

Another interview features German radiologist Matthais Matzko, MD. He has not only created the most successful and busiest focused ultrasound center in Europe, but also convinced leading medical insurers to provide reimbursement for the uterine fibroid treatments he performs.

Rounding out coverage is a profile of Stephanie Small, the young and extremely gracious uterine fibroid patient featured recently on CBS Evening News. Denied coverage by her health insurer, she downloaded the Reimbursement Resource Toolkit from the Foundation's Fibroid Relief website. Ultimately, Small decided to participate in a clinical trial rather than appeal her insurance company's decision. Now fully recovered, she has become an advocate for MR-guided focused ultrasound and for patient empowerment, especially among young fibroid sufferers like herself.