David E. Williams

Highlights From the 21st Century Cures Act

On Dec. 13, 2016, President Obama signed the 21st Century Cures Act, a sweeping legislative effort aimed to alter the health care landscape in the U.S. in significant ways. The Act provides funding for the National Institutes of Health (NIH), reforms regulatory functions of the Food and Drug Administration (FDA), and takes steps to address the nation’s opioid crisis by establishing frameworks for filling gaps in care for people struggling with mental illness. Here are some notable highlights from the law:

NIH Funding

The Act authorizes more than $4.8 billion in funding over 10 years for the several centers comprising the NIH. The authorization specifically targets the Precision Medicine Initiative, which aims to leverage the gains made by the Human Genome Project to develop treatments tailored to individuals, as opposed to one-size-fits-all therapies. Major funding is also authorized for the Brain Research Through Advancing Innovative Neurotechnologies Initiative (BRAIN), which aims to advance understanding of the human brain, the least well-understood organ in the body. Substantial outlays are authorized as well for cancer research, a particular concern of former Vice President Joe Biden, who lost his son Beau to brain cancer. Finally, funds are authorized for regenerative medicine using adult stem cells, a field that has had a difficult time obtaining funding in the past.

Regulatory Changes at the FDA

The act authorizes $500 million over 10 years to implement provisions in U.S. Code Title III that promise to afford faster access to drugs and medical devices while maintaining the same standard for safety and effectiveness.

Changes were made as well to the Humanitarian Device Exemption, authorizing the FDA to accelerate approval of devices used to treat diseases and conditions that affect up to 8,000 individuals in the U.S. Previously, the limit had been 4,000.

Jeffrey A. Singer, a general surgeon in Phoenix who writes on health care issues, characterizes the legislation as “a very slight improvement in the FDA drug and device approval process,” but an improvement nonetheless. Singer observed that in recent years, the FDA drifted away from its original mission of clearing drugs for safety, focusing increasingly on drug efficacy. He hopes the new legislation will help restore the FDA to its original mission.

Prescription Drugs

Regarding prescription drugs, the Act has stipulations that apply to individuals enrolled in Medicare Advantage plans. Beginning in 2019, prescription drug plans will be subject to open enrollment rules, meaning that in the first three months of any year, Medicare Advantage plan members may enroll in or update their prescription drug plans.

Combating the Opiate Crisis

The new legislation authorizes $1 billion over two years for state grants to supplement opioid abuse prevention and treatment activities. Funding targets include prescription drug monitoring programs and expanding access to opioid treatment programs.

This particular part of the Act dovetails with the Comprehensive Addiction and Recovery Act (CARA), signed in July 2016. Among other features of CARA is a provision enabling first responders to carry naloxone, the opioid reversal agent. According to Stanton Peele, author of The Meaning of Addiction, “Putting naloxone in the hands of first responders is essential.”

Funding for Mental Health

The Act reaffirmed the Obama administration’s commitment to providing parity for mental health services. The Act reauthorized many existing community-based mental health and addiction services that support individuals and families. In addition, it authorized funding for several new programs to assist states in addressing growing demands for mental health services.

Also included are alterations in sentencing laws to help those struggling with mental illness who run afoul of the law. According to USA Today, under provisions of the Act, the U.S. attorney general is asked to launch “mental health court” pilot programs, designed to divert people with mental illness or drug addiction into treatment programs, rather than jail for the commission of minor offenses.

Though the 21st Century Cures Act is broad and ambitious in its aims, it’s only an authorization. Congress must now vote to appropriate the Act’s several initiatives. In an era of tight budgets and political pressures, some portions of the Act may end up languishing in committee. However, given the bipartisan positive response so far, the future could be bright for the bill’s supporters.

David E. Williams is president of Health Business Group, a strategy consulting firm serving clients in technology-enabled health care services, pharmaceuticals, biotech, medical devices and software. He’s frequently quoted in the media on the business of health care and is the author of the Health Business Blog. David sits on the board of both private health care companies and nonprofits.