Wednesday, November 6, 2019

Horizon Watch: The FDA's Payer Communications Page (Includes CMS Parallel Review)

I noticed that the FDA has updated its consolidated Payor Communications webpage, with multiple sections and links, as of September 2019.
  • See the FDA Payor Communications Page here.
  • See the FDA Drug & Device Payor Communications Guidance, here.
    • 26 pages, PDF, June 2018.
  • See Gottlieb statement about the value of FDA-Payor interactions, here.
  • See an archived commercial webinar on FDA's package of  payor communications at Icon, here.
Sections on the FDA Payor Communications Page include:

  • An overview and background section; 
  • A voluntary Commercial Payor section
    • Includes Aetna, Kaiser, Cigna, Humana, etc., and evidence groups like ECRI; 
  • Instructions and contact information for the "CMS-FDA Parallel Review" process.  
Note that the CMS Parallel Review process is very rare, used in full only twice in a decade. 

At the bottom of the webpage are a number of links to various Commissioner statements, Federal Register publications, etc.    For example, FDA last held a "Payor Summit for Medical Devices" three years ago, in 2016.

You can also request an FDA speaker to come talk about these policies at an event or conference (instructions on the webpage).