Tuesday, November 16, 2021

21st Century Cures Version 2.0 Legislative Draft Released; Includes Reboot of "MCIT" Section 404

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
    • Duke Margolis Center had an 11 page review of the draft MCIT inside 21CC-2, here.  They also submitted a comment letter to CMS on the original MCIT here.  

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
401, GAO reports on changes needed to improve coverage and reimbursement under Medicare for innovation.  improve interagency communication.

404, regarding BT coverage, it's complicated text and legalistic, inserting phrases here and there into existing laws (Bill, pp 87-109).  In October 2021, Duke Margolis reviewed the proposal in detail in its earlier draft from spring - Duke PDF here.  (I haven't redlined whether the final text in this legislation as #404 varies from what Duke reviewed.)  See also a trade article at HealthCare Dive here.

405, CMS to report on digital alternatives to treatment, including wearables and digital platforms.  Determine coverage processes for such technologies, including payment innovations.

407, CMS to issue guidance to health plans regarding coverage for genomic testing including WES/WGS and gene panels for pediatric patients, if for example there is a positive result from newborn screening or there are developmental anomalies or they have seizures or are referred to pediatric ICU. A pilot program is proposed, along with a report thereupon by the National Academy of Medicine, as well as a CMS report on genetic coverage in Medicaid in the 50 including WGS, WES, microarrays, FISH, etc.   

408 adds a benefit category for pharmacogenetic (PGx) consultations by a pharmacist, genetic counselor, or pathologist.