Positron Emission Tomography (FDG) for Solid Tumors

The national coverage determination (NCD) for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R) was issued on April 3, 2009.  The NCD establishes specific clinical indications under which CMS will cover FDG Positron Emission Tomography (FDG PET).  This NCD supersedes the NCD on FDG PET for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers.  The NCD replaces the four-part framework of diagnosis, staging, restaging and monitoring response to treatment categories with a two-part framework of initial antitumor treatment strategy and subsequent antitumor treatment strategy.  The NCD concluded that certain FDG 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, FDG PET imaging for certain indications must lead to:

• A change in the likelihood of appropriate referrals for palliative 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.

Peer-reviewed, published literature related to this NCD allowed CMS to discontinue CED for the majority of FDG PET studies.  These studies no longer require data collection at the time of service.  This NCD continues to require data collection under CED for certain other FDG PET indications.

Decision memorandum: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=218

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.  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:

Study Title:  The National Oncologic PET Registry (NOPR)

Information about this study may be found at:

http://www.clinicaltrials.gov/ct2/show/NCT00868582?term=PET+Academy+of+Molecular+Imaging&rank=2

See Positron Emission Tomography (FDG) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers (CAG-00181N)