Saturday, December 14, 2019

Very Brief Blog: Catching Up with 21st Century Cures Act 2.0; Comments Due December 16

In late 2016, Congress passed the 21st Century Cures Act, a series of actions aimed to improve the efficiency and effectiveness of the FDA and promote other improvements to biomedical research.  See Wikipedia here, FDA here

In November 2019, Congr. Degette and Upton opened a request for comments on topics that could be included in a new 21st Century Cures "2.0" bill in CY2020.

See press release here, see 2-page PDF request for comments here.

See trade press here, here, here.

Per the request for comments, Cures 2.0 would want to "modernize coverage and access to life-saving cures" and modernize the health delivery system.  One significant focus is digital health.  Another focus is improvements at both FDA and CMS.  For example, the request states, "As a key goal is to support access to life-savings cures, we would like to explore how reform of Medicare coding, coverage, and payment could better support patients’ access to innovative therapies."  Yup, that would be good.

Comments can be submitted to per the request for information and the deadline is listed as December 16, 2019.

The areas of interest called out in the request for comments are:
  1. Modernize coverage and access.
  2. Digital health and digital platforms including coverage and reimbursement.
  3. Reduce the delay from FDA to coverage (CMS), including coding and logistics.
  4. Real world data.
  5. Help families and caregivers support their loved ones with illness.