The 21st Century Cures Act—and Beyond

AAOS continues efforts to increase musculoskeletal research funding
As reported in the February 2017 issue of AAOS Now, one of the last legislative actions of 2016 was the passage of the 21st Century Cures Act (H.R. 34), which aims to provide “necessary resources to researchers to continue their efforts to uncover the next generation of cures and treatments.” In addition to streamlining some U.S. Food and Drug Administration (FDA) regulations, this important legislation increases research dollars for the National Institutes of Health (NIH) by $4.8 billion and implements a number of measures to encourage research and modernize clinical trials. The bill passed Congress with overwhelming support—the vote was 392-26 in the House and 94-5 in the Senate. The American Association of Orthopaedic Surgeons (AAOS) advocated for this bill because of its potential to advance patient care.

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In arguing for the legislation, stakeholders emphasized that for the aging American population, diseases will become more prevalent and cost taxpayers more money if researchers do not find cures. In fact, a New York Times op-ed focusing on the legislation pointed out that the federal government funds about one-third of all medical research in the United States, and because the government is on the hook for the costs of illness, it is “irresponsible and shortsighted, not prudent, to let financing for basic research dwindle.” More than one in four Americans has bone or joint health problems, making musculoskeletal conditions the leading cause of disability in the United States. Thus, these problems affect not only the patient's quality of life but the economy as a whole.

The 21st Century Cures Act addresses some of these issues through a number of research-related provisions. For example, the Act requires the NIH director—in consultation with the directors of national research institutes and centers—to develop a 6-year coordinated strategy to outline the direction of research investments made by the NIH, facilitate collaboration among the research institutes and centers, and advance biomedicine. The Act also requires the NIH to revise existing policies and reduce administrative burden. Other provisions are designed to help deliver cures to the right patients at the right time by improving interoperability among electronic health records (EHRs) and reduce unreasonable constraints externally imposed on the exchange of electronic health information, also known as “information blocking.” Finally, the $4.8 billion in added research dollars will benefit a number of NIH programs.

In a New England Journal of Medicine “Perspective” article, NIH Director Francis S. Collins, MD, PhD, and NIH Deputy Director Kathy L. Hudson, PhD, wrote: “Affecting everyone from researchers to research participants to patients suffering from numerous conditions, these measures will cut bureaucratic red tape that slows the progress of science, enhance data sharing and privacy protections for research volunteers, improve support for the next generation of biomedical researchers, exhort the NIH to extend its efforts to ensure inclusion of diverse populations, and provide the NIH with a bolus of additional funding over 10 years for key biomedical research initiatives.”

Continuing advocacy efforts
While the 21st Century Cures Act was an important step in advancing patient care, AAOS continues to advocate for other health-related legislation and research funding. For example, the annual AAOS Research Capitol Hill Days program works to raise awareness of the chronic, debilitating, and costly musculoskeletal diseases and disorders affecting our nation and to request continued support for musculoskeletal research. Specifically, the program advocates for increased research funding for the NIH's National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Physicians, researchers, and patients meet with members of Congress to share their stories and highlight the fact that funding for orthopaedic research does not match the burden of disease. Additionally, advocates in 2016 expressed support for legislation that was ultimately included in the 21st Century Cures bill—a provision to create a “Next Generation of Researchers Initiative” in the Office of the Director at the NIH to coordinate, develop, modify, and prioritize policies and programs to improve opportunities for new researchers.

Additionally, AAOS advocates for funding for the Peer Reviewed Orthopaedic Research Program (PRORP), which is a Congressionally Directed Medical Research Program (CDMRP) under the Department of Defense (DOD). PRORP is a competitive grant program that funds extremity trauma research. In fiscal year 2017, the AAOS has been successful in securing another $30 million worth of funding through the appropriations process, bringing the total funding to more than $300 million since the program's inception in 2009. The AAOS strongly believes in the value of this research and is proud of the way that extremity trauma research benefits American military members, veterans, retirees, military families, and civilians.

As Congress and the new administration discuss pending healthcare policy priorities, research funding should be a vital component of any conversation. The work done by NIH and DOD, as well as the specific need for additional musculoskeletal research funding, must continue to be emphasized.

“Congress has made it clear that these focused investments are not intended as a substitute or offset for supporting NIH research through the regular appropriations process,” wrote Drs. Collins and Hudson. “We remain optimistic that strong support for the NIH budget will be reflected in the ultimate decisions about the fiscal year 2017 budget and beyond. In the meantime, Congress has provided an enormous gift to science in the form of the Cures Act, a gift that reflects a deep confidence in the promise of biomedical research to make discoveries and develop cures in the 21st century.”   

Amy L. Ladd, MD, is secretary of the Board of Specialty Societies (BOS). Elizabeth Fassbender is the communications manager in the AAOS office of government relations.