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).