February 2008: Mayo Clinic Interview and more...

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Newsletter Vol 10
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Dear Subscriber,

"Good ideas are not adopted automatically. They must be driven into practice with courageous patience." - Admiral Hyman George Rickover

US Navy Admiral Hyman Rickover is rightly known as the "Father of the Nuclear Navy," as he almost single-handedly drove the development of nuclear propulsion for naval uses in remarkably little time. Although he demanded top performance of himself and others ? and was often disappointed when others failed to match his high expectations ? he never lost sight of his goal. "Patience" for him did not mean passively waiting for events to happen, but constantly pushing ? from many directions -- against the limitations that prevented him from realizing his objectives.

The incredible potential of MR-guided focused ultrasound surgery continues to amaze even those of us who work with it every day, and continues to drive the Focused Ultrasound Surgery (FUS) Foundation's mission to help pioneer research which will minimize the time between technology development and widespread patient treatment. However we know, as Rickover says, that good ideas are not adopted automatically. We have to bring our own "courageous patience" to bear on pushing this promising technology into regular clinical practice.

To that end, the Foundation works hard to ensure that all the elements necessary are being addressed, helping both clinicians and scientists to work entrepreneurially towards further innovation. In this newsletter ? and in future installments ? you will find information about your colleagues and their research interests and progress using FUS, our efforts to pursue new promising avenues, a new patient support organization, and other facets of our work. All of these undertakings are woven together in a concerted effort to ensure that this astounding technology is "driven into practice" sooner rather than later.

The work of the Foundation goes far beyond what we can describe in a single newsletter: for a fuller picture, you should visit our website http://www.fusfoundation.org. We also welcome questions, suggestions, and - above all - additional colleagues who see clearly the transformative potential of this work and want to join us in driving it into practice.


  • Mayo Clinic Expert Describes Importance of Reimbursement Support, Experience
Five years ago, Dr. Gina Hesley was one of the first physicians in the world to use Magnetic Resonance guided Focused Ultrasound (MRgFUS) to treat uterine fibroids. As a physician at the Mayo Clinic, Rochester, Minnesota, Dr. Hesley was involved in the first clinical trials in July 2002. The FDA approved the procedure in October 2004. In a telephone interview with the FUS Foundation, Dr. Hesley described her 5-year experience with MRgFUS and discussed how clinicians can increase access for patients who could benefit from focused ultrasound treatment. Dr. Gina Hesley

Helping patients to appeal reimbursement policy is key
Because MRgFUS is a relatively new procedure, many insurance companies do not automatically provide coverage. Mayo Clinic helps patients through the insurance process. "Whatever their insurance company needs, information-wise, we provide what we can to help them get the procedure covered by their insurance," said Dr. Hesley. "Oftentimes, if patients need it, we'll participate in phone conferences with the insurance companies to help in their reimbursement," she explained. The information provided varies with the insurance companies, and is tailored to the individual patient. "Even though it may be the same insurance carrier, if it's in a different state they may handle the cases quite differently," noted Dr. Hesley.

Sometimes patients request copies of peer-reviewed articles, or companies want a letter describing the treatment and why this patient is, or isn't, a good candidate. Insurance companies frequently want to know how many patients have been treated, what the success rate is, and how to evaluate what's out in the peer-reviewed literature.

The study coordinator at Mayo often sends information to an insurance company. "If they're going to have a meeting to review the patient's case and want our input, then it's either a gynecologist or myself that participates in the conference, depending on what the insurance company requests."
"...we feel like it's important to provide the information and help educate insurers. MRgFUS is a good treatment option and because it is relatively new requires some extra work to educate everyone"
"They are time-consuming for everyone to participate in, but we feel like it's important to provide the information and help educate insurers," said Dr. Hesley."It's a good treatment option and, because it is relatively new, requires some extra work to educate everyone."

"If patients are interested, we always encourage them to go through the process," Dr. Hesley emphasized. "I think the more times we talk with the insurers and have that dialogue, and show them the information, and the more patients that are interested, the more likely they are to cover the procedure. And the more likely they will be, in time at least, to consider covering it outright versus having the individual appeals process."

MRgFUS then and now
The Mayo Clinic has accumulated plenty of experience, with increased understanding of how the technology works and how to use it to better advantage. "We treat differently now than we used to treat," observed Dr. Hesley. Compared with the first treatments performed, higher percentages of the fibroid volume and larger volumes of fibroid tissue are now being treated. This should provide greater symptom relief and longer lasting symptom relief. The increase in treatment volumes is due to a better understanding of how the treatments work, fewer regulatory restrictions, and improvements in technology. The treatment safety profile has remained excellent, with continual improvements in thermal monitoring and additional monitoring features.

With greater experience, clinicians are willing to tackle more complex cases. "We still learn on every case we do. Some patients have unique anatomy or scars in unique locations to get around," observed Dr. Hesley. Treatment of fibroids differs with their size and their signal intensity on MRI. Typically, the darker they are on T2 images, the less energy is required to treat them. Fibroids that appear brighter are known to take more energy to treat.

As word of MRgFUS spreads, the interest increases: Compared to last year, the number of procedures at Mayo is up about 20 to 25 percent. "January of this year...will be approximately double our volume last year," Dr. Hesley reported.

  • "Fibroid Relief:" An Advocacy Initiative
The Focused Ultrasound Surgery Foundation is pleased to announce "Fibroid Relief", an advocacy organization for uterine fibroid patients seeking a non-invasive alternative to hysterectomy, myomectomy and UAE.

With as many as 600,000 hysterectomies taking place in the USA each year, and at least one in three of these being due to fibroids, there are literally thousands of patients who could benefit from the improved outcome and rapid recovery offered by focused ultrasound treatment.

Informed choices for patients
With the internet as the most important channel through which patients learn about their conditions and treatment options, "Fibroid Relief" will have a robust website targeted at fibroid sufferers who want to learn more. Since thousands of women have been relieved to find an alternative to traditional surgery, "Fibroid Relief" will to ensure that patients are fully informed about the MRgFUS option in addition to providing educational information about fibroids.

Help with reimbursement
Increasing awareness of the MRgFUS option is only half of the battle. As a relatively new treatment, insurance companies are reluctant to approve its use and will initially refuse to reimburse. Therefore, "Fibroid Relief" will work tirelessly with patients and treatment sites to navigate reimbursement processes by providing step-by-step support materials and assistance.

Call to action
Fibroid Relief is looking forward to collaborating with clinicians, providers and patients and welcomes suggestions and offers of assistance as we move forward to launching our website by April. Fibroid Relief will build alliances with other relevant patient organizations, treatment providers, and suppliers of MRgFUS equipment and will be reaching out to these partners in the coming months.

Fibroid Relief contacts:
Elizabeth Cundari: Interim Director ? Fibroid Relief, ecundari@fusfoundation.org
Rolf Taylor: Communications Director ? FUS Foundation, rtaylor@fusfoundation.org


  • International MRgFUS Symposium
"The State of the Art and Future Applications of MR guided Focused Ultrasound Surgery" The 1st International MRgFUS Symposium to be organized and sponsored by the Focused Ultrasound Surgery Foundation will take place in Washington DC, October 6 ? 7, 2008.

Clinicians, scientists, administrators, payors, investors, manufacturers and foundations interested in the rapidly developing field of Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) are invited to attend this meeting which is dedicated to current and future applications.
FUS Treatment

The 2 day program will include:
  • Presentation of latest scientific data for MRgFUS research areas (including tumor ablation, metastatic bone-pain palliation, sonothrombolysis for ischemic and hemorrhagic stroke)
  • MRgFUS for targeted drug delivery
  • Uterine fibroid treatment updates and workshops
  • Updates on Focused Ultrasound Surgery technology
  • Future trends in MR imaging technology for FUS
  • Socioeconomic, regulatory and reimbursement aspects
  • Research funding awards and other FUSF initiatives
  • MRgFUS demonstrations / simulations
Please submit abstracts for presentations and poster display. Email abstracts@fusfoundation.org for submission details and to make program suggestions.

Organizations wishing to sponsor and exhibit at the meeting please email sponsors@fusfoundation.org for further information.

Online registration will commence in February 2008. For more information please email registrations@fusfoundation.org and you will receive registration details once available.



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