21st Century Cures: Deregulation and reinvestment will modernize healthcare in the U.S.
Following three years of bipartisan compromise, President Obama has signed landmark legislation, the 21st Century Cures Act, into law. In contrast with the legislative process that brought Americans the Affordable Care Act (ACA), the Cures Act is an example of how Congress and the White House should work together to modernize public programs that will result in new medical innovations to improve the lives of millions. The new law includes $6.3 billion in new funding for the U.S. Department of Health and Human Services (HHS) and will streamline the clinical trial process to accelerate the approval of new prescription drugs and medical devices through regulatory reforms at the Food and Drug Administration (FDA). In addition, the new law will authorize $1 billion in new grant funding to assist states in their response to the opioid addiction and overdose epidemic, improve mental healthcare services, and will significantly increase the investment in research for new therapies for cancer and Alzheimer’s disease.
To supplement state response efforts to the opioid abuse and overdose epidemic, states can apply to new block grant funding to improve their prescription drug monitoring programs, increased training for healthcare providers and expanding access to opioid treatment programs. Oversight of these initiatives will be led by Substance Use at the Substance Abuse and Mental Health Services Administration (SAMHSA) at HHS, who will ensure evidence-based practices and outcome measures are tied to the grant funding for treatment and prevention substance abuse disorders.
Increased oversight from SAMHSA will be instrumental in increasing coordination between federal, state and local officials to maximize efficiency, effectiveness and quality of care for both substance abuse and mental health disorders, as well as modify the current structure of healthcare delivery to better integrate with primary and mental healthcare services.
The National Institutes of Health (NIH) will receive $4.8 billion in funding, of which $1.8 billion is increased investment in cancer research related to Vice President Joe Biden’s ‘moonshot’ initiative. The remaining funds will be driven to research that could lead to a new generation of breakthrough therapies as we capitalize discoveries related to mapping the human genome and the rise of the use of ‘precision medicine’, which focuses on the impact genetic, lifestyle and environmental variations have on disease.
While the Cures Act passed with overwhelming majorities in both the House and Senate, critics of the bill remain skeptical. A recent piece in the New York Times referenced the great disparity in support for the Cures versus President Obama’s landmark legislation, the Affordable Care Act (ACA) widely known as Obamacare. This is not surprising. The Cures Act is the culmination of three years of white papers, roundtable discussions and outreach for feedback from stakeholders under the leadership of House Energy and Commerce Chairman Fred Upton (R-MI) and Representative Diana DeGette (D-CO). That level of bipartisan collaboration was absent from the passage of the Obamacare, which was the result of a party-line process, in which the ACA garnered not a single Republican vote.
By streamlining clinical trials and doubling down on investment to discover new innovative therapies, the Cures Act will speed the discovery of breakthrough treatments by the NIH, academic research institutions and the U.S. biopharmaceutical industry. These new policies will also provide states the critical resources they need to fully integrate treatment and prevention efforts in response to the opioid addiction and mental health epidemic we are experiencing, giving us the capacity to both improve and redefine the future of healthcare in the U.S.