In the waning December days of the Obama administration, House and Senate passed "21st Century Cures," a set of FDA modernizations (and a few CMS updates) that garnered wide praise.
On June 22, 2021, see a press release and online documents that describe a wide-ranging "21st Century Cures 2.0."
There's more stuff. There is a concept document for a $6B translational research and innovation agency to be called ARPA - find that by Francis Collins et al. at Science.
A 120-page version of draft legislation is here.
A four-page highlights reel is here.
Please send feedback/comments to Cures2@mail.house.gov by July 16.
I've produced a separate nerdy blog, sort of a sidebar or text box, which some readers might find of interest, comparing prior breakthrough bill HR5333, the CMS MCIT regulation, and the new 21CC proposal. Find that sidebar here.
Return of the MCIT: Requires Close Reading, Though
Section 307 sort of recreates the MCIT (Medicare Coverage for Innovative Technologies) rule that was finalized by the Trump Administration and critiqued and put on hold by the Biden administration. However, Section 307 is quite long and takes a number of new twists not found in the MCIT rulemaking, so it will take a while to fully digest this. (For example, there's a section that deals with new FDA breakthrough devices that are not already in any existing Medicare benefit category - wow. And a section alludes to a breakthrough lab test being paid higher than the regular crosswalk amount, but it's vague what that higher amount would be. See some nerd notes in a side bar here.)
Do read this with the knowledge that the proposal is only draft legislation, for comment and suggestions.
The bill also incorporates, potentially, the PASTEUR legislation for novel antibiotics.
Below, I've done a direct copy of the sponsors' own bullet-point highlights of 21CC 2.0:
- Improve how Medicare covers innovative new health care technologies, making them more available to those who need them.
- Increase diversity in clinical trials to ensure new drugs and treatments are both safe and effective for a greater majority of patients throughout the country.
- Require FDA to expand the collection and use of Real World Evidence to aid in the development of new, patient-focused treatment approaches.
- Provide training and educational programs for caregivers – many of whom are often family members with no prior health care experience – to help improve the quality of care patients are provided at home, between clinical visits.
- Provide patients greater access to more health information to improve their understanding of the illness they face and make them a more integral part of the decision-making process when assessing which course of treatment is best for them.
- Increase access to telehealth services for patients covered under Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to make these services more accessible to more Americans.