The 21st Century Cures Act was passed in December 2016 as a funding bill for the National Health Institute and includes significant funding and process changes related to mental health, medical research, and the FDA drug approval process.Last month, President Obama signed the 21st Century Cures Act, named because of the expressed purpose of accelerating the discovery, development, and delivery of 21st century cures. This legislation is a large and important health funding bill – $6.3B – with large support from both political parties and many healthcare industries – though some criticism from consumer protection groups.
The bill provided significant funding – for the National Institute of Health (NIH), an agency of the U.S Department of Health and Human Services – $4.8B. This money is allocated for precision medicine and biomedical research, including brain disease and cancer – specifically the Beau Biden Cancer Moonshot initiative.
The bill also directs significant changes to mental health reimbursements, informed consent, and the FDA drug approval process, as well as increased funding for the ongoing opioid epidemic.
Mental Health Reimbursements
The largest change to mental health reimbursements is that payers are not required to cover mental health treatments the same way as medical treatments. The bill also strengthens the nation’s mental health workforce and expands assisted outpatient treatments.
This part of the bill is a little more nuanced, but it essentially allows researchers to swap in new and experimental medical devices without patient consent, as long as the new device doesn’t’ impose any additional health risks than the normally used device. That’s a lot of explanation, but the example given is that a normal wound bandage may be replaced with a newer bandage that also tracks blood flow – in the past this would have required patient consent.
FDA Drug Approval Process
Perhaps the most debated part of the bill were changes to the FDA’s Drug Approval Process, which has simplified and expedited the process for new drugs and devices to be approved. This eases the requirements for drug companies and device manufacturers, which is intended to support innovation drive investment in new treatments. However, consumer protection groups warn that it may allow harmful drugs or devices to get to patients.
Other notable changes include privacy protections for grant research subjects; accessing sharing, and using health data for research projects; a rescinded $464M of ACA funding available to US territories; streamlined regulation for better clarity and consistency for health software and mobile medical apps; and additional funding for EHR interoperability.
You can find out more information about this bill at www.Congress.gov.