Coverage with Evidence Development
Amyloid PET
Approved study posted
http://www.cms.gov/Medicare/
Approved study posted
http://www.cms.gov/Medicare/
PET is a minimally-invasive diagnostic imaging procedure used to distinguish normal from diseased tissue in conditions such as cancer, ischemic heart disease, and some neurologic disorders. A radioactive tracer (also called a radioisotope or radionuclide) is coupled to a biologically active molecule, and the resulting radiopharmaceutical is injected into the patient. The tracer gives off subatomic particles (positrons) as it decays, which can be detected by a positron camera (tomograph). Tracer concentration is then mapped in a three-dimensional image of the patient’s body. One widely used, positron-emitting radiopharmaceutical is F-18-fluorodeoxyglucose (FDG). FDG PET is used clinically to help diagnose, exclude or stage multiple diseases, and to measure patient response to therapy. Amyloid PET uses a new class of radiopharmaceuticals that detect levels of amyloid in human brain. Measurements of cerebral amyloid may be clinically useful in the work up and management of patients with cognitive impairment who are being evaluated for possible Alzheimer's disease or other causes of cognitive decline.
CMS issued a Medicare National Coverage Determination (NCD) on September 27, 2013 which allows conditional coverage of amyloid PET under Coverage with Evidence Development (CED). The complete NCD is available on our website:
http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=265
Below is a list of Medicare-approved clinical trials we have reviewed and determined meet the requirements for coverage under CED.
Sponsor: University of California, Los Angeles
ClinicalTrials.gov Number: NCT02317250
CMS Approval Date: 03/17/2015
Study Title: Effect of Aerobic Exercise on Pathophysiology in Preclinical Alzheimer’s Disease
Sponsor: National Institute on Aging
ClinicalTrials.gov Number: NCT02000583
CMS Approval Date: 04/02/2014
CMS issued a Medicare National Coverage Determination (NCD) on September 27, 2013 which allows conditional coverage of amyloid PET under Coverage with Evidence Development (CED). The complete NCD is available on our website:
http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=265
Below is a list of Medicare-approved clinical trials we have reviewed and determined meet the requirements for coverage under CED.
Clinical Study Approvals
Study Title: Molecular Cerebral Imaging in Incipient Dementia (MCI-ID) IISponsor: University of California, Los Angeles
ClinicalTrials.gov Number: NCT02317250
CMS Approval Date: 03/17/2015
Study Title: Effect of Aerobic Exercise on Pathophysiology in Preclinical Alzheimer’s Disease
Sponsor: National Institute on Aging
ClinicalTrials.gov Number: NCT02000583
CMS Approval Date: 04/02/2014
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