On December 7, 2016, the U.S. Senate voted 94-5 to pass H.R. 34, the 21st Century Cures Act, legislation that not only invests in biomedical research and innovation, but incorporates policies to further modernize the drug approval process and get cures and treatments to patients faster. ASA-supported provisions of the bill include dedicated funds to benefit the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), grants to states for fighting the opioid epidemic, and processes to encourage interoperability among electronic health record (EHR) technologies. The U.S. House of Representatives recently passed the bill, which is now expected to be signed into law by the President.
As part of a continuing effort to secure Congressional support for research into the effects of anesthesia on vulnerable populations, ASA is pleased the legislation includes funding for the NIH and creates an Innovation Fund, which provides over $4.8 billion over 10 years dedicated to funding biomedical research through the NIH and $500 million to the FDA over 10 years to implement programs that get drugs and medical devices to patients quicker.
In addition, to strong bipartisan and bicameral support in Congress, the bill also received strong support from the White House. President Obama expressed enthusiastic endorsement of the Cures Act, stating:
“It dedicates more than $6 billion to implement key priorities such as the President's proposal to combat the heroin and prescription opioid epidemic; the Vice President's Cancer Moonshot; and the President's signature biomedical research initiatives, the Precision Medicine and Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiatives. It also takes important steps to improve mental health, including provisions that build on the work of the President's Mental Health and Substance Use Disorder Parity Task Force, and includes policies to further modernize the drug approval process.”
ASA is also pleased that the Cures Act invests $1 billion over two years to combat the opioid epidemic. The funding will be granted to states to supplement opioid abuse prevention and treatment activities, such as improving prescription drug monitoring programs, implementing prevention activities, training for health care providers, and expanding access to opioid treatment programs. Beginning in early 2017, $500 million will already available for this grant program.
The legislation includes provisions designed to enable and facilitate the exchange of clinical outcomes data between EHR technologies and clinician-led clinical data registries, including provisions to promote interoperability of clinical data and prevent EHR vendors from blocking the transmission of such data to third parties. ASA joined with other physician organization members of the Physician Clinical Registry Coalition, in support of the provisions. Specifically, Cures requires that EHR technologies, as a condition of certification by the Office of National Coordinator, be capable of sharing data with clinician-led clinical data registries. The legislation also gives the HHS Inspector General the power to investigate and take enforcement action against improper information blocking by EHR technologies, giving real teeth to these prohibitions. These provisions will help ensure registries can collect the data they need to improve quality care for patients.
ASA commends the efforts of Congress to pass this monumental legislation and looks forward to working with Congress and relevant federal agencies on the opportunities created by 21st Century Cures Act.
• Learn more about 21st Century Cures
• ASA’s letters to Congress advocating for NIH funding prioritizing pediatric anesthesia research and more pediatric clinical trials
• Registry Coalition Letters to the House and Senate