On October 24, 2016, the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) published a joint announcement of their plan to continue the Program for Parallel Review of Medical Devices.

The Program is a collaborative effort that is intended to reduce the time between FDA marketing approval and Medicare coverage decisions through the CMS National Coverage Determinations (NCD). The goal is to “ensure prompt and efficient patient access to safe and effective and appropriate medical devices for the Medicare population.”

The Program began in 2011 as a pilot project, and was extended in 2013. The Agencies have now decided to fully implement the Program and to extend it indefinitely. In determining which medical devices to include in the Program, the Agencies will prioritize devices:

  • that are innovative and will benefit from the efficiencies of the Parallel Review, and
  • that are expected to have the most impact on the Medicare population.

As they have in the past, the Agencies continued to caution manufacturers that, even with this collaborative process, FDA marketing approval does not guarantee a favorable coverage decision.  The notice outlines the eligibility requirements and the information medical device companies will need to submit to be eligible for the Program.