CMS opens comment period for 18F-NaF PET bone scan coverage

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The Centers for Medicare & Medicaid Services (CMS) has opened a reconsideration of the national coverage determination (NCD) on PET to review evidence on the use of 18F sodium fluoride (18F-NaF) to identify bone metastases.

18F-NaF is a radioisotope that can be used in PET imaging to detect bone metastases. Currently, 18F-FDG is the only nationally covered radioisotope for use in PET cancer imaging.

The initial 30-day public comment period began on June 4, and is scheduled to end on July 4, according to the agency. CMS said it will consider all public comments, and is "particularly interested in clinical studies and other scientific information relevant to the technology under review."

Instructions on submitting comments can be found at:

CMS may be reconsidering this coverage because of a recentĀ  medical isotope shortage due to the unscheduled closure of the National Research Universal reactor in Chalk River, Ontario, which has lead to a sparse molybdenum-99 (Mo-99) supply. Mo-99 is needed for conventional planar 99mTc-MDP bone imaging, which is currently covered by CMS.

The decision by the agency also comes on the heels of a recently initiated multicenter, multinational trial investigating the use of 18F-NaF PET/CT to detect bony metastases. The protocol, which compares conventional SPECT bone imaging with 18F-NaF PET/CT in patients with breast, prostate and non-small cell lung cancers, was developed in conjunction with the FDA and CMS and calls for data on more than 500 patients.

The agency said that its proposed decision memo date is Dec. 4, and the expected national coverage analysis completion date is set for March 4, 2010.