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Piramal Imaging Provides Comments in Response to the Centers for Medicare and Medicaid Services (CMS) Proposed Coverage Decision for Beta-Amyloid Positron Emission Tomography (PET)
Date:8/19/2013

ditiously answer one or several of the three proposed research questions without onerous restrictions. Furthermore, CMS should ensure that it approves a sufficient range of clinical trials, allowing for a variety of practical clinical trial designs, providing they address relevant endpoints and help answer all or at least one of CMS' research questions.

3.  CMS should state in its final decision memo that once a clinical trial meets endpoints as agreed upon by CMS, they will expand Medicare coverage in a corresponding manner without any undue delay. 

The decision to expand coverage based on the results of a successful clinical trial should not unnecessarily delay the National Coverage Determination process. Medicare beneficiaries should not lose access to diagnostic technologies that have demonstrated clinical benefits in patient outcomes.

4.  CMS should not require a postmortem autopsy as an endpoint for any CMS-approved clinical trial.

Several pivotal autopsy studies demonstrate amyloid imaging agents bind to beta-amyloid in the brain; therefore, further biomarker studies are redundant. According to the Agency for Healthcare Research and Quality (AHRQ) Clinical Research Standard no. 3, "the research study does not unjustifiably duplicate existing studies."

Therefore, additional post-mortem autopsy studies would not fulfill the above AHRQ standard. In addition, many Medicare beneficiaries may understandably be very uncomfortable or unwilling to agree to such a requirement to undergo a diagnostic imaging scan.

About Piramal Imaging SA
Piramal Imaging SA, a division of Piramal Enterprises, Ltd., was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. By developing novel PET tracers for molecular imaging, Piramal Imaging is focusing on a key field of modern medicine. Piramal Imaging strives to be a leader in the Molecular Imaging fi
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