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PMC Submits Comments to CMS Regarding CED Draft Guidance

The Personalized Medicine Coalition (PMC) today submitted comments to the Center for Medicare & Medicaid Services (CMS) in response to its Draft Guidance for the Public, Industry, and CMS Staff - Coverage with Evidence Development (“CED”) in the Context of Coverage Decisions.

PMC urged CMS to consider the following recommendations:

• CMS should adopt the principles included in the 2006 CED guidance document.
  
• CMS should ensure that review of evidence and decisions about evidence development are clearly explained and transparent.
  
• CMS should clarify the role of the Agency for Healthcare Research and Quality (“AHRQ”) in the application of CED.
  

Edward Abrahams, president of PMC, stated, "We will have continued support for CED provided that the new policy does not negatively affect the ability of clinicians to provide the optimal treatment to each patient based on the patient's individualized needs."

PMC's full comment letter may be accessed here.

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Contact:
Chris Wells
cwells@personalizedmedicinecoalition.org
Phone: 202-589-1770

About the Personalized Medicine Coalition:
The Personalized Medicine Coalition (PMC), representing innovators, scientists, patients, providers and payers, promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system. For more information about PMC, visit www.personalizedmedicinecoalition.org.