The Centers for Medicare and Medicaid Services (CMS) released its proposed decision memorandum regarding the use of beta-amyloid imaging in dementia and neurodegenerative disease. 
Piramal Imaging is concerned about CMS' proposal, which appears to take an overly cautious approach to expanding Medicare coverage for positron emission tomography (PET) tracers to include beta-amyloid imaging agents. Limiting Medicare coverage only to patients enrolled in CMS-approved clinical trials imposes restrictions that reduce patient access to long-awaited diagnostic tools.
"We are concerned that the CMS draft coverage decision is too restrictive and, if finalized in its current form, will place an undue burden on physicians, patients and caregivers by delaying the definitive diagnosis of certain types of dementia and neurodegenerative disease, including Alzheimer's," said Ludger Dinkelborg, director of the board, Piramal Imaging SA.
In Piramal Imaging's view, the CMS decision needs to be reviewed for the following reasons:
- The draft decision does not reference the Appropriate Use Criteria (AUC) that was developed by the Society for Nuclear Medicine and Molecular Imaging (SNMMI) and the Alzheimer's Association. The taskforce was comprised of a cross-section of experts including radiologists, nuclear medicine specialists and neurologists. 
- It lacks clear guidance on clinical trial designs that should be practical and provide CMS with the requested evidence in a reasonable timeframe.
- There is general disagreement with the relevance of autopsy as an appropriate endpoint to demonstrate clinical utility in the intended population.
The use of new beta-amyloid imaging agents should help to reduce uncertainties in the diagnosis of Alzheimer's disease and related dementias, which is of importance for patients and their caregivers. Piramal Imaging is hopeful that CMS will moderate its position when it renders its final decision by finding less restrictive ways to gather the information it seeks regarding health outcomes.
CMS is accepting public comments on its proposed decision from all stakeholder groups and is accepting public comments now through Aug. 2, 2013. Comments can be posted at: http://www.cms.gov/medicare-coverage-database/indexes/nca-open-and-close....
"We urge anyone concerned with Alzheimer's disease — patients, caregivers, healthcare professionals, patient advocacy groups and the general public — to share opinions on the value of beta-amyloid PET imaging during the initial 30-day public comment period," said Dinkelborg. "Every letter will have an impact on CMS' final decision in September."
For more information: imaging.piramalenterprises.com
1 Centers for Medicare & Medicaid Services. Proposed decision memo for beta amyloid positron emission tomography in dementia and neurodegenerative disease (CAG-00431N). http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decis.... Published July 3, 2013. Accessed July 3, 2013.
2 Johnson KA, Minoshima S, Bohnen NI, et al. Appropriate use criteria for amyloid PET: a report of the Amyloid Imaging Task Force, the Society of Nuclear Medicine and Molecular Imaging, and the Alzheimer's Association [published online ahead of print January 28, 2013]. Alzheimer's Dement. doi:10.1016/j.jalz.2013.01.002.