Friday, February 2, 2018

Brief Blog: What Were EXCITE and PACER (accelerated device coverage) and What Happened To Them?

At the early January 2018 JP Morgan conference, there was a fireside chat between Jeff Shuren (FDA), Tamara Syrek Jensen (CMS), and the CEOs of Exact Sciences and Foundation Medicine about parallel review.    Shuren made a strong reference to a program in preparation that would provide accelerated device coverage at CMS which would be different from parallel review. 

In late January, Modern Healthcare and other sources reported that the rapid payment program, EXCITE, had been pulled from the regulatory process.   If you missed this news, here are some links.

According to Modern Healthcare, here, there had been an industry proposal presented to CMS in 2H2016 called PACER - Provisional Accelerated Coverage to Encourage Research.   Early in 2017, CMS pushed a similar idea forward in the regulatory pathway called EXCITE - Expedited Review of Innovation Technology.   Modern Healthcare quotes Elizabeth Halpern of Hogan Lovells that nobody outside the agency knows how close EXCITE was to the industry idea, PACER.    The EXCITE proposed regulation was canceled without being released by about January 20, 2018.

  • Modern Healthcare, January 22, here.
  • Mass Device, January 23, here.
  • Fierce Biotech, January 24, here.
  • For more on PACER, here and here.
Separately of interest, see a detailed overview of CMS FDA Parallel Review online at Modern Healthcare, here.   See also a RAND publication, "Medical Device Innovation in the Era of Affordable Care Act: The End of Sexy," 2016, by Mattke et al., here or here.

For a recent general National Academy of Sciences review of expedited innovation efforts, here.   In February 2018, Health Affairs features a special issues on diffusion of innovation and clinical translation, here.