On Dec. 13, 2016, President Obama signed the 21st Century Cures Act (H.R. 34) into law. The legislation, which is focused on increasing research dollars for the National Institutes of Health (NIH) and streamlining aspects of regulation at the U.S. Food and Drug Administration (FDA), got a last-minute boost from provisions addressing mental health and opioid funding. Before arriving at the president's desk, the bill passed the U.S. House of Representatives by a vote of 392-26 and the Senate by a vote of 94-5. The American Association of Orthopaedic Surgeons (AAOS) congratulated members of Congress for passing this bipartisan legislation to accelerate innovation, boost research, and modernize physician practices, all of which will advance patient care exponentially.
"AAOS commends the focus on improving electronic health records and interoperability, enhancing the flow of patient information by preventing interference in information exchange, and encouraging important research and device approval efforts," stated Thomas C. Barber, MD, chair of the AAOS Council on Advocacy.
"These provisions will help support coordinated care and improve the quality, safety, and efficiency of healthcare delivery. AAOS thanks members of Congress for this important investment in our nation's health," he added.
The legislation has been in the works since the House Energy and Commerce Committee initiated a number of hearings and roundtables in 2014. Legislators engaged in conversations with patients, researchers, and healthcare providers about steps that could be taken to expedite the discovery, development, and delivery of new treatments and cures. The House passed an earlier version of the legislation in 2015 (see "House Passes 21st Century Cures Bill," AAOS Now, September 2015), but when the Senate began a parallel and somewhat different approach, legislators were forced to refocus their efforts.
The most recent version passed by Congress represents a House bill that incorporates select measures from the Senate process and resolves a funding dispute by making the provisions subject to the appropriations process (also known as discretionary funding). In total, the bill authorizes $4.8 billion over 10 years to the NIH for the Precision Medicine Initiative, the BRAIN Initiative, cancer research, and more. The bill also grants the FDA $500 million to implement the agency's drug and device provisions.
In addition to the funding, authors of the 21st Century Cures Act hope the legislation will be an "innovation game-changer" by reducing the administrative burden for researchers, increasing data sharing, improving opportunities for new researchers, and modernizing clinical trials (by, for example, requiring the NIH to better incorporate minority groups and update guidelines for the inclusion of women in clinical research studies).
The legislation also hopes to advance new therapies for patients through a number of FDA-focused provisions, including establishing a breakthrough device pathway, increasing the humanitarian device exemption, and improving the regulation of combination products.
As explained by the Energy and Commerce Committee, the development of new drugs and devices "is meaningless unless they are delivered to the right patients at the right time." To that end, the 21st Century Cures Act also implements a number of provisions related to health information technology. For example, the legislation will seek to do the following:
- reduce the regulatory burden faced by physicians relating to the use of electronic health records (EHRs)
- expedite interoperability among EHRs
- address information blocking
- encourage the exchange of health information between registries and EHR systems
"After three years, our legislative work is finally complete," stated Energy and Commerce Committee Chairman Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.), sponsors of the 21st Century Cures Act. "A new day for medical research is on the horizon. Today's vote is for patients and their loved ones. We all have more reason for hope."
Elizabeth Fassbender is communications manager in the AAOS Office of Government Relations. She can be reached at email@example.com