What do you need to know about the 21st Century Cures Act?
- It will add new tools to the life science toolbox.
More patients may begin to receive more medical products than before, due to the fact that the Act includes numerous provisions meant to speed up the approval process for new drugs and devices.
- It supports evolution of the FDA approval process.
“The bill allows for more patient input in the drug development and approval process with the aim of increasing much needed innovation,” says Jake Caines, Director of Commercial Strategy and Performance at Curant Health. However, “shorter time periods for trials and smaller sample sizes raise concerns for some regarding diminished safeguards to protect our patients from adverse events.”
- It provides new opportunities to leverage data.
With a section of the Act focusing on real-world evidence, there may be an increase in incentives to capture patient data or more information drug performance.
- It’s not just about life science companies.
At almost 1,000 pages, providers will have to pay very close attention to the numerous provisions in the Act that place a spotlight on items like health IT, Medicare and Medicaid payments, new training grants and more. Advance awareness of these provisions can help providers identify business opportunities or threats.
For more information on what to know about the 21st Century Cures Act, read the full article at Managed Healthcare Executive.