21st Century Cures Act: Moves Closer to Becoming Law

Update: December 7, 2016, the U.S. Senate voted 94 to 5 to pass the 21st Century Cures Act which now moves to President Obama who has indicated that he will sign it “as soon as it reaches my desk.”

In a show of bipartisanship and further support of precision medicine and health care innovation—including genomics and other diagnostic innovations, the House of Representatives passed the 21st Century Cures Act and sent it to the Senate, which voted 85-13 Dec. 5 to end debate on the legislation and proceed to a vote.

What’s at stake? Billions of dollars of funding will support precision medicine initiatives and other efforts to discover, develop and deliver treatments and cures for diseases such as cancer, Alzheimer’s and rare diseases. As the American Clinical Laboratory Association pointed out in a 2014 letter to the Energy and Commerce Committee supporting the 21st Century Cures legislation, diagnostics “are an essential component to providing the most effective and highest quality care” with laboratory testing innovations helping physicians by “providing more accurate diagnoses, quicker; allowing physicians and patients to choose the best treatment, first and sooner.”

There are four main parts to the legislation: Part I addresses discovery, innovation and opioid abuse; Part II addresses research and development, patient access to new products, protection for human research subjects, and data sharing; Part III addresses health care delivery, interoperability and telehealth; and Part IV addresses Medicare and Medicaid reforms. Here are some highlights of the legislation:

• $4.8 billion in funding for NIH; funds will in part support the Precision Medicine Initiative ($1.5 billion) and the Cancer Moonshot ($1.8 billion)

• $500 million for the FDA to modernize its regulatory efforts and secure the best talent

• Measures that promote electronic health records and interoperability so patient care is seamless

• $1 billion to states for opioid abuse prevention and treatment programs including improvement of drug monitoring programs