(NaF-18) Positron Emission Tomography to Identify Bone Metastasis of Cancer

This national coverage determination (NCD) was issued on February 26, 2010.  It establishes specific clinical indications under which CMS will cover NaF-18 Positron Emission Tomography (NaF-18 PET).  The NCD concluded that NaF-18 PET scans are reasonable and necessary under Section 1862(a)(1)(E) of the Social Security Act in the context of Coverage with Evidence Development (CED).

Prospectively under CED, NaF-18 PET imaging must lead to:

• A change in patient management to more appropriate palliative care; or
• A change in patient management to more appropriate curative care, or
• Improved quality of life; or
• Improved survival

The clinical research study also must adhere to certain standards of scientific integrity and relevance to the Medicare population.

Decision memorandum: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=233

On its website, CMS will maintain a list of all approved studies and facility locations.  There are approximately 2200 facilities participating in the clinical research study for NaF-18 PET.  A list of facility locations can be found here: http://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage\

The following study has been approved by CMS: The National Oncologic PET Registry (NOPR)

Information on the clinical study may be found at: http://www.clinicaltrials.gov/ct2/show/NCT00868582?term=PET+Academy+of+Molecular+Imaging&rank=2

The protocol for FDG PET for Solid Tumors was amended to include a second clinical research study to include this NCD.