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The Centers For Medicare & Medicaid Services (CMS) Draft Decision Could Limit Patient Access To New Technology That May Help In Diagnosing Dementia
Date:7/25/2013

BERLIN, BOSTON and MUMBAI, India, July 25, 2013 /PRNewswire/ -- On Wednesday, July 3, 2013, the Centers for Medicare & Medicaid Services (CMS) released its proposed decision memorandum regarding the use of beta-amyloid imaging in dementia and neurodegenerative disease.1

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 Dr. 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.2
  • 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.

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SOURCE Piramal Imaging SA
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