Industry News
PETNET Solutions poised to increase NaF production during shortages
PETNET Solutions has increased production and availability of 18F Sodium Fluoride (NaF) to replace Technetium MDP bone scans, in light of recent shortages of molybdenum. This shortage can result in limited availability of 99mTc-labeled radiopharmaceuticals.
Most recently, the global supply of medical isotopes was threatened with the temporary closure of the NRU reactor at Chalk River in Ontario. It was closed after a heavy water leak was discovered, following a power outage in the area. The 52-year-old reactor, which supplies about half of the world's medical isotope needs, is expected to be closed for a minimum of three months. Its operator, Atomic Energy of Canada, Ltd., is currently considering several supply options. The facility shutdown could further disrupt the supply of 99mTc which is used in bone scans to rule out a variety of conditions, from fractures to cancer metastases. By utilizing NaF for the bone scans, facilities can ration their 99mTc agents to perform scans for coronary artery disease or to image the brain, the liver and the lungs.
NaF PET has been shown to be both more accurate and more sensitive than planar imaging with 99mTc-MDP for localizing and characterizing both malignant and benign bone lesions, according to a study published in the January 2008 issue of The Journal of Nuclear Medicine.
To learn more, please click on the Ask a Pharmacist link on MILN or email us at knvAskaPharmacist@petnetsolutions.com.
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Reimbursement News
CMS Opens Reconsideration of FDG PET NCD for Cervical Cancer
On May 8, 2009, CMS opened the reconsideration of the National Coverage Determination (NCD) on Positron Emission Tomography (FDG). The requestors have asked CMS to reconsider the NCD and broaden national coverage of FDG PET (without CED restrictions) for the staging of cervical cancer (i.e. in those women who have been diagnosed with cervical cancer, but who do not otherwise meet the coverage criteria). The requestors also ask that the use of FDG PET should not be covered for the initial diagnosis of cervical cancer.
The initial 30-day public comment period begins 5/08/2009, and ends 6/08/2009. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the technology under review.
Read complete story on SNM website
NCA Tracking Sheet for FDG PET for Cervical Cancer (CAG-00181R2)
Submit comments
Instructions on submitting comments
NCD for PET Scans (220.6)
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Regulatory Update
Joint Commission Revises Radiopharmacy Policy
The Joint Commission has revised its 2009 hospital accreditation requirements to no longer require an appropriately-trained registered pharmacist or doctor of medicine or osteopathy to be present in a laboratory when radiopharmaceuticals are prepared.
View the revised policy
Read the full article and related stories on auntminnie.com
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Accreditation
ICANL Announces No More Quarterly Deadlines
Beginning on April 1, 2009, laboratories may now submit applications to the ICANL at any time via the Online Accreditation application. In the past, laboratories were required to adhere to quarterly submission deadlines. Submitted applications will undergo the same thorough review and site visit/audit process. However, the ICANL Board of Directors will now meet monthly, as opposed to quarterly, to review application findings and render accreditation decisions. As an added benefit, this new process reduces turnaround time. Participating nuclear cardiology, nuclear medicine and PET laboratories now receive their accreditation decisions from the ICANL within 12 - 16 weeks, allowing for faster compliance with insurance companies’ payment policy requirements.
For more details visit ICANL web page
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News in Molecular Imaging
PET/CT Bone Imaging Trial Enrolls First Ten Patients
The Academy of Molecular Imaging (AMI) announced on May 9, 2009 that its randomized, multi-center trial, investigating the use of 18F sodium fluoride PET•CT (18F NaF) to detect bony metastases, has enrolled its first 10 patients. This important study compares conventional planar 99mTc MDP bone imaging with 18F NaF PET•CT in patients with breast, prostate and non-small cell lung cancers. The protocol was developed in conjunction with the FDA and CMS, and calls for data on more than five hundred patients. The University of California-Los Angeles Medical Center, the VA Greater Los Angeles Healthcare Systems, and Scottsdale Medical Imaging have all started to image patients.
PETNET Solutions, a subsidiary of Siemens Medical Solutions USA in Malvern, PA, furnished the initial F-18 NaF doses. GE Healthcare of Chalfont St. Giles, U.K., and IBA Molecular, North America, a division of radiopharmaceutical firm Ion Beam Applications(IBA) of Louvain-la-Neuve, Belgium, also will provide doses in the future.
Read the full article and related stories on auntminnie.com
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What's New
AMIC Creates RightScanRightTime.org
The Access to Medical Imaging Coalition (AMIC) announced it has launched RightScanRightTime.org, a Web platform that promotes the initiative to ensure patients have access to diagnostic imaging services. A primary goal of the site is to foster an ongoing dialogue with policymakers about the personal value of imaging. Hoping to foster a more intimate exchange between patients, physicians, and policymakers, the Web platform encourages sharing of personal imaging stories.
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Patient Advocacy
National Cancer Survivors Day®
National Cancer Survivors Day is held annually in hundreds of communities throughout the world on the first Sunday in June. It is a symbolic event to demonstrate that life after a cancer diagnosis can be a reality.
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