21st Century Cures Act includes ambitious health care spending

A once tiny bill is about to make a big impact on the health care industry.

After years of inactivity, the Senate passed the $6.3 billion 21st Century Cures Act by a 94-5 vote Tuesday, following House passage last week. President Barack Obama has pledged to sign the bill once it reaches his desk.

The bill will fund some of Obama’s top research priorities and includes the first major mental health legislation in nearly a decade. It includes $1.8 billion for the Cancer Moonshot Initiative, intended to speed up cancer research and is heralded by Vice President Joe Biden following the death of his son, Beau; $1.5 billion for Obama’s Precision Medicine Initiative designed to tailor treatments to people based on their genes and lifestyles; $1.5 billion for the BRAIN initiative to advance understanding of the brain to help find a cure for Alzheimer’s and $1 billion on anti-opioid efforts.

The bill also includes reforms to the Food and Drug Administration’s drug and medical device review process as well as clarifies the regulation of medical software. Five categories of medical software will not be regulated as a medical device because they are perceived to be low-risk to patients: administrative and operation, including appointment software; wellness, including exercise trackers; electronic health records; software for transferring, storing or displaying medical device data; and clinical decision support software.  

Topics: Executive Leadership , Regulatory Compliance