Welcome to this month's issue of the Focused Ultrasound Surgery Foundation newsletter, offering the latest developments in focused ultrasound as well as news of the Foundation and its programs.
The mission of the Foundation is to shorten the time from technology development to patient treatment, develop new applications and accelerate the worldwide adoption of magnetic resonance-guided focused ultrasound surgery (MRgFUS). In pursuit of these goals, the Foundation offers a fellowship program, a research award program and a collaborative network of focused ultrasound surgery sites. This month as well, the Foundation kicks off a new endeavor to initiate additional innovative research in the field of focused ultrasound surgery with its Research Program Planning Groups.
To keep up with the Foundation's activities and the latest news in the world of Focused Ultrasound Surgery, visit our website at http://www.fusfoundation.org.
CMS moves MRgFUS for Uterine Fibroids into higher paying code
In a significant step toward obtaining the appropriate payment codes for MRgFUS, the Center for Medicare and Medicaid (CMS) moved MRgFUS treatment of uterine fibroids into a higher paying category in the 2008 HOPPS Proposed Rule, which came out earlier this month.
Under the Proposed Rule, MRgFUS uterine fibroid treatments will be moved into the same Ambulatory Payment Classification as that occupied by several linear accelerator-based stereotactic radiosurgery treatments, as both these treatment approaches share similar clinical resources and both involve image guidance to ablate abnormal tissue.
This proposal would mean that MRgFUS uterine fibroid treatments would receive an APC median cost of $3869.96. Although this a major step forward, the proposed rule fails to take into account treatment planning time and expenses.
FUSF Call to Action The FUS Foundation and other interested parties are preparing a response to this proposed ruling in order to encourage the CMS to move MRgFUS treatment into a higher paying code. We encourage you too to send CMS a comment letter to urge them to move the technology into the appropirate code that covers all the costs of the treatment. In the next few weeks we will be preparing some draft letters, which will be posted on our website, for your use. The deadline for these responses is September 12th.
FUS Foundation Initiates Research Program Planning Groups
The Foundation is pursuing a new avenue by which to foster and accelerate the field of focused ultrasound research with its Research Program Planning Groups (RPPGs).
The RPPGs will allow the Foundation to initiate studies on its own, bringing together investigators, sites, and funding with the goal of developing new applications for treating patients with MRgFUS.
Current areas of interest for Foundation initiated research include:
Intracerebral and intraventricular hematomas
Acute ischemic stroke
Targeted drug delivery
Benign prostatic hypertrophy
The purpose of the RPPGs will be to create a roadmap for initiating and establishing research projects focused on the Foundation's areas of interests. The Foundation is currently establishing teams of thought leaders, including clinicians, scientists, engineers from academia and industry, and authorities on regulatory and reimbursement issues, for each research interest area.
More information about how the Foundation is spearheading research initiatives in MRgFUS will follow soon.
Researcher Highlight - Fiona Fennessy, MD, PhD
This month, we begin a new feature where we highlight the research of experts in the field of MRgFUS. Fiona Fennessy, MD, PhD (who is also our newsletter's medical reviewer) is this month's contributor. Dr. Fennessy is an Assistant Prof of Radiology, Harvard Medical School and staff radiologist at Brigham and Women's Hospital, and has been involved in MRgFUS research for the past 3 years.My current research concentrates on the evaluation of MRgFUS in the treatment of uterine fibroids, from both a clinical outcome point of view, and a technology assessment point of view. As the clinical trial treatment guidelines evolved and changed over time, with less restrictive guidelines in place subsequent to FDA device approval, patients with symptomatic fibroids who were consecutively enrolled and treated with either an original or a less restrictive modified protocol had symptomatic improvement 12 months post-treatment. Those treated under the less restrictive guidelines demonstrated greater clinical effectiveness and suffered fewer adverse events than those treated under the original protocol. But how does this outcome compare to other currently available forms of currently available non-invasive forms of treatment for uterine fibroids?
Taking the above outcomes into consideration, my current research focuses on decision modeling to perform a pre-emptive technology assessment of MRgFUS for treatment of uterine fibroids. Considering that (a) the time in the MR scanner is approximately 3 hours, (b) a very small percentage of women require pain medication post-procedure, and (c) patients are usually discharged home within 1 hour of finishing the procedure, this appears to be a well-tolerated procedure. As concerns about quality of life and cost containment have prompted the development of treatment alternatives to hysterectomy, the costs and effectiveness of a promising non-invasive treatment such as MRgFUS would best be compared to another minimally invasive radiological treatment, such as uterine artery embolization (UAE), which has already been shown to be a cost-effective alternative to hysterectomy. The aim of my analysis is to determine the necessary effectiveness MRgFUS has to attain to make it a cost-effective alternative to UAE.
This paper examines the anti-tumor effect that is exhibited when cancerous tissue is exposed to the thermal and mechanical effects of HIFU tissue ablation, suggesting that mechanical ablation can lead to greater anti-tumor response.
This study compares the results of 107 research studies conducted from 2000-2006 to treat uterine fibroids, with MRgFUS being one of the compared treatment options. The importance of performing side-by-side comparisons with other treatment methods is discussed.
We are always looking for new content of interest to the FUS community, so if you know of any relevant stories that we should be covering, please contact us at .
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