21st Century Cures Act
by Kristin Easterling
Monday, February 6, 2017

The 21st Century Cures Act provides funding for the National Institutes of Health (NIH) to the tune of $4.8 billion. The Act also provides key provisions for other areas of health research.

NIH Initiatives

  • 10 years of funding for the cancer “moonshot,” the BRAIN initiative and the Precision Medicine Initiative

Help for HME

  • Delays competitive bid derived pricing for complex rehab technology (CRT) accessories used with Group 3 power wheelchairs until July 1, 2017
  • Extends the transition period for the second part of the bidding-derived cuts from June 30, 2016 to December 31, 2016, paving the way for HME suppliers to recoup reductions for items with dates of service from July 1 to the end of 2016. The second phase of the cuts that had originally gone into effect on July 1, 2016 would again go into effect on January 1, 2017
  • Instructs the Department of Health & Human Services (HHS) to conduct a study on the impact of the bidding program on the overall number of HME providers and availability of HME products over the course of 2016

FDA Regulations

  • $500 million in funding to expand staffing and speed up processing
  • Directs FDA to include real-world evidence in considering new indications for approved drugs (e.g. a seizure drug used as a migraine preventative)
  • Fast-tracks drug approval process in most cases
  • The bill also includes provisions and funding to improve mental health care and suicide prevention, as well as $1 billion in grants to the states to fight the opioid epidemic

Next

The Act passed both houses of Congress with overwhelming bipartisan support (though not without controversy). President Obama signed the Act into law on December 13, 2016. Find a summary and full text of the Act at www.congress.gov/bill/114th-congress/house-bill/6