July 7, 2017

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What’s Next In US Payor Communications: The Impact of FDA’s Proposed Guidance on Communication of Healthcare Economic Information

  • The 21st Century Cures Act (CURES), signed in to law in December 2016, outlines important new provisions of relevance to pharmaceutical/biotech and medical device industries.
  • CURES establishes significant guardrails to industry regarding the communication of Healthcare Economic Information (HCEI) to payors for approved drugs, as well as for investigational drugs and devices.
  • It is vital that those within health care industries responsible for developing and disseminating HCEI communications to payors fully understand the provisions of the CURES Act and the implications for how they interact with payors.