CMS Considers New Alternatives for Bone Imaging

On June 4, the U.S. Centers for Medicare & Medicaid Services (CMS) announced that it is considering a pathway for coverage of the radiotracer sodium fluoride (NaF-18) for PET bone imaging as an alternative to technetium-99m imaging. Currently, Tc-99m bone imaging is one of the more commonly performed procedures using this radioisotope. Technetium-99m is in scant supply because of ongoing production outages, resulting in serious delays of patient imaging studies for many medical problems, including oncologic, cardiac, and neurologic conditions.
 
"The medical community is in crisis right now," says Robert W. Atcher, PhD, MBA, president of SNM and chair of the society's isotope task force. "Physicians can't get access to essential isotopes for common nuclear medicine procedures. As a consequence, patients are being denied tests, or have to be diagnosed with procedures that involve more radiation dose, less accuracy, more cost, or more invasive techniques."
 
Because of the severity of the radioisotope supply crisis and the long-term duration of the anticipated outage, CMS has opened the PET National Coverage Determination to evaluate the effectiveness of NaF-18 for PET bone imaging. PET bone imaging is a nuclear medicine procedure that is sensitive for the detection of the spread of many common cancers—such as breast, lung, and prostate—to the bone. It also can be used to detect fractures when x-rays do not provide a definitive diagnosis, particularly in pediatric patients. While F-18 as fluorodeoxyglucose has been approved by the FDA, CMS does not currently reimburse for F-18 fluoride PET bone imaging procedures for the many Americans who would be eligible for coverage as Medicare recipients.
 
"This reopening paves the way for Medicare beneficiaries who need critical tests to get the coverage and support they deserve," adds Atcher. "We encourage CMS to consider the most efficient path forward to provide both themselves and the medical field with sufficient information to analyze and open access to patients across the nation."
 
Currently, about 80% of the world's nuclear medicine scans are performed using technetium-99m. However, the medical community depends on only six nuclear reactors in the world for over 30 million nuclear medicine tests performed annually with this critical isotope. A shutdown last month at one of these reactors, in Chalk River, Canada, has already left thousands of hospitals in the U.S. and Canada without access to this medical isotope.
 
"This is very good news," says Barry Siegel, MD, chief of nuclear medicine at the Mallinckrodt Institute of Radiology in St. Louis, Mo., and cochair of the NOPR working group. "With the potential for a coverage opening, physicians will be able to provide the evidence necessary to build the case that F-18 fluoride is a viable alternative to Tc-99m in this situation—a case the preliminary evidence suggests will be readily made."
 
— Source: Society of Nuclear Medicine