Thursday, June 25, 2020

Legislators DeGette and Upton Release "CONCEPT PAPER" for 21st Century Cures 2.0

The 21st Century Cures Act of 2016 made a range of changes to FDA drug and device development, and also includes some sections relevant to CMS (mostly related to LCD processes).  See its Wikipedia page here.

The original legislators, Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) released in May 2020 a 12 page "concept paper" for a potential new version of 21st Century Cures (Cures 2.0).
  • Congressional page here.
  • 12 page cloud concept paper here.
    • Extra cloud copy here.
  • Coverage at:
Topics include pandemic response support, COVID & rare diseases, pandemic preparedness, antimicrobials commercialization support, vaccine support, etc.  FDA sections aim to improve FDA & digital health, FDA & clinical trials, FDA & real world evidence, etc

CMS sections include coverage modernization (see also a Trump executive order last fall on this point*), reduce CMS barriers to gene therapies, CMS barriers to small patient population services, CMS barriers to genomic sequencing services, and interaction between "breakthrough status" at FDA and CMS coverage.


* Re: Trump executive order on CMS coverage, see entry point here (look for Kadakia article paragraph).