After a year of discussion, and the circulation of draft versions, they've released a legislative draft of 21st Century Cures version 2.0.
- PASTEUR ACT, special funding for special antibiotics, is section 105. See a brand-new article on this policy issue here (Outterson, head of CARB-X, funded by BARDA).
- See another recent article on the antibiotic crisis by Andre Hudson here. See a law firm overview of 21CC-2, here.
- Something similar to the recently canceled Medicare Coverage for Innovative Technologies (MCIT), meaning Medicare coverage for Breakthrough Devices, is included at Section 404.
See a copy of the 173 page 21CC-2 bill here:
See a 5-page summary here:
See 2 pages of pre-boxed favorable quotes from groups like AMA and Friends of Cancer Research:
See coverage at ENDPOINTS (including proposals for real world evidence in FDA trials) here.
Title IV focuses on Medicare including:
- 401, GAO study
- 402, Access to telehealth in Medicaid
- 403, Medicare telehealth
- 404, Breakthrough device coverage.
- 405, HHS to report on its coverage for innovative technology
- 406, HHS to report on CMS computer systems
- 407, Precision Medicine for Kids
- 408, Medicare coverage for "consultations" (PGx)
- 409, Geographic tracking prohibitions
- 410, Electronic prescribing
- 411, Federal health plan claims data
- The next title, Section V, 501ff, creates a new "Advanced Research Projects Agency for Health," e.g. DARPA for Health, to focus on translational medicine and clinical trials