Reston, Va.—On June 4, the U.S. Centers for Medicare & Medicaid Services (CMS) announced that it is considering a pathway for coverage of 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 in patient imaging studies for many medical problems, including oncologic, cardiac and neurologic conditions.
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 (NCD) to evaluate the effectiveness of the radiotracer Sodium Fluoride (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.
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.
"The medical community is in crisis right now," said Robert W. Atcher, Ph.D., M.B.A., 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."
While F-18 as fluorodeoxyglucose (FDG) has been approved by the U.S. Food and Drug Administration (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," added 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."
"This is very good news," said Barry Siegel, M.D., chief of nuclear medicine at the Mallinckrodt Institute of Radiology, St. Louis, Mo., and co-chair 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."
SNM is actively working with CMS and members of the imaging community to submit data and ensure that CMS has the necessary information to cover F-18 fluoride for PET bone imaging procedures.
About SNM—Advancing Molecular Imaging and Therapy
SNM is an international scientific and medical organization dedicated to raising public awareness about what molecular imaging is and how it can help provide patients with the best health care possible. SNM members specialize in molecular imaging, a vital element of today's medical practice that adds an additional dimension to diagnosis, changing the way common and devastating diseases are understood and treated.
SNM's more than 17,000 members set the standard for molecular imaging and nuclear medicine practice by creating guidelines, sharing information through journals and meetings and leading advocacy on key issues that affect molecular imaging and therapy research and practice. For more information, visit www.snm.org.