Alternative Medical Isotope for Bone Imaging Reconsidered

A U.S.-governed medical insurance agency reported that it is considering a pathway for coverage of sodium fluoride (NaF-18) for positron emission tomography (PET) bone imaging as an alternative to technetium-99m imaging.

Currently, ^99mTc bone imaging is one of the more typically performed procedures using this radioisotope. Technetium-99m is in scarce 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, the U.S. Centers for Medicare & Medicaid Services (CMS; Baltimore, MD, USA) has opened the PET National Coverage Determination (NCD) to evaluate the effectiveness of the radiotracer 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, especially in pediatric patients.

Currently, approximately 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 in May 2009 at one of these reactors in Chalk River, Canada, has already left thousands of hospitals in the United States 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 the SNM (formerly called the Society of Nuclear Medicine; Reston, VA, USA) 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 is very good news,” said Barry Siegel, M.D., chief of nuclear medicine at the Mallinckrodt Institute of Radiology (St. Louis, MO, USA), and cochair of the U.S. National Oncologic PET Registry (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 ^99mTc 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.

Related Links:
U.S. Centers for Medicare & Medicaid Services
SNM