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Recent shortages of an isotope commonly used in bone scans have prompted several professional societies to urge CMS to offer cancer patients broad access to sodium fluoride-18 positron emission tomography to identify bone metastasis. In comments to CMS, the Academy of Molecular Imaging urges the Medicare agency to issue a final national coverage determination allowing unrestricted use of sodium fluoride-18 PET (18F-NaF PET) to diagnose bone cancer in patients already treated for another form of cancer. CMS plans to release a final decision by Feb. 28. AMI notes that Technetium-99m (99mTc) is the only bone imaging radiopharmaceutical agent currently covered by CMS for bone scintigraphy. In light of the "severity and expected long-term duration of the 99mTc shortage, we urge CMS to act quickly and expeditiously to reach a determination on 18F-NaF PET to mitigate further disruption in the availability of bone imaging to beneficiaries," AMI writes. The Dec. 30 comments were jointly submitted by AMI, the Institute for Molecular Technologies, the American College of Nuclear Medicine, the American College of Radiology and the Society of Nuclear Medicine. Stakeholders Debate Trials Versus Registries In its Nov. 30 national coverage proposal, CMS suggested it could cover 18F-NaF PET for bone metastasis only when the patient is enrolled in a prospective clinical trial gathering evidence on the technique (1 'The Gray Sheet' Dec. 7, 2009). AMI says evidence shows "18-F-NaF PET is equal or superior to the current covered technology in identifying bone metastasis of cancer," and asks CMS to offer coverage without the restriction of evidence gathering. As part of its coverage-with-evidence-development (CED) program, CMS has proposed research studies to help determine whether PET scans to diagnose bone metastases actually lead to changes in patient outcomes, such as patient referrals to palliative care, improved quality of life or survival. "Despite the fact that obtaining such data is clearly desirable, the practical challenges inherent in this effort are manifest," writes Bruce Hillner, chair of the National Oncologic PET Registry Working Group (NOPR). One challenge is finding a way to link research data with claims data in a way that would tell CMS whether "a bone scan conducted today led to a change in outcome at some later time," Hillner writes. He adds that breast and prostate cancers often require long observation periods before researchers can have any confidence in outcomes data. "Requiring that an intermediate imaging technique demonstrate a direct and quantifiable impact on either quality of life or survival in the absence of a randomized controlled clinical trial is, in most instances, neither reasonable nor feasible," Hillner argues. Even in the context of a clinical trial, however, the newer evidentiary standards proposed by CMS cannot be easily applied to cases "where the procedure in question constitutes only one element in a battery of intermediate clinical management decisions that a physician and patient make over the course of treatment," NOPR states. Hillner suggests that NOPR could work with CMS and the Agency for Healthcare Research and Quality to use NOPR's existing registry infrastructure to collect more data on the technology, and to provide broad patient access in the process. Results of previous NOPR data collections have helped lift some coverage restrictions on PET in diagnosing or staging certain cancers (2 'The Gray Sheet' April 13, 2009). AMI supports the broadest possible coverage of PET to diagnose bone metastasis. If CMS requires coverage with evidence development, however, AMI recommends using a patient registry to help collect evidence rather than requiring patients to be enrolled in a clinical trial. "This will afford Medicare cancer beneficiaries clinically necessary access to accurate bone imaging, even if they are distant from a trial center," AMI president Timothy McCarthy writes. America's Health Insurance Plans continues to caution against unrestricted Medicare coverage of PET to diagnose bone metastases and argues for strict evidence collection through clinical trials. In Dec. 30 comments, AHIP recommends that data collection focus on safety and effectiveness in specific patient populations and sub-populations, as well as different cancer types and stages. "CMS should request that CED data collection efforts provide data separately for each cancer type as PET NaF-18 may impact the management of one type of cancer differently than another," AHIP says. The insurer association acknowledges there is currently a worldwide shortage of 99mTc, "due to an unplanned shutdown of a North American nuclear reactor that supplies the material used to generate this radioisotope." The group asks CMS to "carefully review" available evidence on the effectiveness of NaF-18 "to help provide coverage through CED for this alternative test while the shortage is being addressed." AMI blames aging foreign reactors and resulting maintenance and repair shutdowns for the 99mTc shortage. "The unscheduled and continuing shutdown since May 2009 of the 52-year-old Chalk River facility in Ontario has forced thousands of hospitals throughout the United States to cancel or delay critical medical imaging procedures that depend on 99mTc," AMI notes. In contrast, AMI estimates that the 18F-NaF isotope is available to 99% of U.S. hospitals. More Provider Training Needed, Says AMI While 18F-NaF may be in ready supply, relatively few providers have experience in conducting PET bone imaging with the substance. AMI has created training materials, including FAQs and sample protocols, to help educate providers. It plans to host an educational webcast on the topic Jan. 19. - Monica Hogan ( 3
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