President Obama Signs 21st Century Cures Act into Law

Dec. 14, 2016
With President Barack Obama’s signature today, the 21st Century Cures Act, widely considered to be landmark healthcare legislation, was passed into law.

With President Barack Obama’s signature today, the 21st Century Cures Act, widely considered to be landmark healthcare legislation, was passed into law.

The bill, which was more than two years in the making, gained bipartisan support and was passed by both chambers of Congress during a lame duck session. The bill passed in the Senate last week with a vote of 95-4, and two weeks ago, the U.S. House of Representatives approved the bill by a vote of 392-26.

The sweeping legislation largely focuses on medical research and changing the approval process for new drugs and medical devices but also includes a number of health IT provisions aimed at improving interoperability and electronic health information exchange.

More broadly, the $6.3 billion package of medical innovation bills contained in the 21st Century Cures Act includes $4.8 billion to the National Institutes of Health (NIH). That NIH funding includes $1.4 billion for President Obama’s Precision Medicine Initiative; $1.8 billion for Vice President Biden’s Cancer Moonshot; and $1.6 billion for the BRAIN initiative.

The legislation also provides $1 billion to states to supplement opioid abuse prevention and treatment activities, such as improving prescription drug monitoring programs (PDMPs). Additionally, the bill includes $500 million in funding to the U.S. Food and Drug Administration (FDA) over 10 years with the aim of moving drugs and medical devices to patients more quickly. With regard to mental health, the bill aims to strengthen the enforcement of the mental health parity law, which requires insurers to cover mental illness as they would treatment for other diseases.

In his remarks before signing the bill, President Obama praised the bipartisan support behind the legislation and focused specifically on the funding for NIH research efforts, such as the Precision Medicine Initiative, the Cancer Moonshot and the BRAIN initiative. “This legislation is bringing to reality the possibility of new breakthroughs to some of the greatest health challenges of our time,” he said during the signing ceremony.

Regarding the Precision Medicine Initiative, President Obama said the legislation would help to support the efforts to “use data to modernize research and accelerate discovery so treatment and healthcare can be tailored to individual patients,” and also noted that this spring, the NIH will launch its groundbreaking research cohort.

President Obama also noted that NIH’s Cancer Moonshot initiatives in the legislation had been named in honor of Vice President Biden’s son, Beau, who died of brain cancer in 2015. “It is a bittersweet day. My mother was two and a half years younger than I am today when she died of cancer. Being able to honor those we’ve lost in this way, and to know we may be able to prevent other families from feeling that same loss, that makes it a good day and I’m confident that there will be better years and better lives for millions of Americans,” Obama said.

Vice President Joe Biden said that the bill “will fundamentally change the culture of our fight against cancer.”

As it relates to healthcare information technology, healthcare stakeholders have touted the health IT provisions of the bill, particularly regarding the Food and Drug Administration’s (FDA) oversight of the sector, as well as encouraging interoperability of electronic health records (EHRs) and patient access to health data, and discouraging information blocking. A number of health IT industry organizations have expressed strong support for the legislation, specifically the focus on EHR interoperability and efforts to improve patient records matching.

In an interview two weeks ago when the legislation was making its way through Congress, Jeffrey Smith, vice president of public policy at the American Medical Informatics Association (AMIA), said, “Essentially what this legislation does is give matching orders to both the public and the private sectors towards trying to improve the state of health IT and interoperability and usability.”

Smith continued, "One of the unknowns, heading into a new Administration and a new Congress, is the status of precision medicine, and the Cancer Moonshot, and the BRAIN initiative, in addition to the opioid and mental health legislation. I think that this legislation is incredibly important to try to assuage those who are concerned about the unknowns of the Trump administration, and the willingness of the 115th Congress, to fund what is really seen as a game of catch-up in terms of funding the NIH and research.”

In a statement, Russell Branzell, president and CEO of the College of Healthcare Information Management Executives (CHIME), praised the enactment of the 21st Century Cures Act for spurring interoperability.

“The 21st Century Cures Act will help pave the way to greater interoperability and improve electronic health information exchange. The law reflects the growing need to develop a standards-based information exchange infrastructure. CHIME has been at the forefront of advocating for greater attention to standards development and for improving interoperability,” Branzell said.

CHIME also lauded the bill’s provisions that address the issue of accurately identifying patients and matching them to their health records. CHIME is sponsoring a $1 million challenge, the National Patient ID Challenge, focused on finding a solution for accurate patient identification.

“While that $1 million-challenge continues, and we hope to identify a winner in 2017, we welcome the opportunities laid out in the 21st Century Cures Act that could allow us to collaborate with our federal partners on this important patient safety issue,” Branzell said.

Further, Branzell stated, “CHIME also supported language in the law that will create a more transparent process for certifying electronic health record systems; a process that will include real-world testing for interoperability. This will add a layer of confidence that health IT systems are capable of supporting the transition to a more integrated and value-based delivery system.”

On the CHIME website, the organization provides a summary of the health IT provisions and a timeline of actions directed by the legislation.

The law establishes authority for the U.S. Department of Health and Human Services (HHS) Office of the Inspector General to investigate claims of information blocking and assign penalties for practices found to be interfering with the lawful sharing of EHRs. Organizations that are found to have committed information blocking face civil monetary penalties up to $1 million. Additionally, the law instructs HHS to work with healthcare providers, payers and vendors to reduce regulatory and administrative burdens relating to the use of EHRs. 21st Century Cures also authorizes $15 million for ONC’s certification process to improve interoperability and fight information blocking by establishing a grant program to create an unbiased reporting system to engage stakeholders and gather information about EHR usability, interoperability, and security to help providers better choose EHR products.

Smith noted that while the 21st Century Cures Act authorized funding for NIH, it does not appropriate funds. "I think the funding is going to be an important piece to watch," Smith said in an interview two weeks ago.