On Tuesday, Dec. 13, President Obama signed into law the 21st Century Cures Act, which had easily passed the Senate last week by a vote of 94-5. The week before, the House also approved the legislation by a bipartisan vote of 392-26. The legislation is the culmination of months of negotiations between House and Senate leaders.
The Cures Act authorizes $6.3 billion in funding over the next decade for cancer research, the epidemic of opioid abuse, and mental health treatment; helps the Food and Drug Administration (FDA) speed up drug approvals; and pushes for better use of technology in medicine. It also allocates $4.8 billion for the NIH over the next 10 years to help fund biomedical research, including:
- $1.4 billion for All of Us Research Program, formerly known as the precision medicine initiative;
- $1.6 billion for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative; and
- $1.8 billion for the cancer “moonshot” initiative.
In a Dec. 13 perspective column published in the New England Journal of Medicine, NIH Deputy Director for Science, Outreach and Policy Kathy Hudson, PhD, and NIH Director Dr. Francis Collins describe the NIH view of the 21st Century Cures Act. They write that the law 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.”
The FDA will receive $500 million over the next 10 years to:
- Accelerate its review processes for breakthrough medical devices;
- Expedite the approval of regenerative advanced therapies, or stem cell therapies;
- Increase patient participation in the drug approval process; and
- Streamline the review process for products that are both a drug and a device.
The bill includes provisions intended to improve mental health efforts, such as creating new administrative positions at the Substance Abuse and Mental Health Services Administration to help coordinate mental health initiatives. Although the bill does not authorize new funding for mental health efforts, it does provide financial incentives for increasing the number of mental health professionals in the United States and better integrating mental health and primary care services. Further, the bill allows Medicare to cover short-term hospitalizations for patients with severe mental illnesses and bolsters oversight of mental health parity rules.
The legislation also includes several provisions related to Medicare, Medicaid, and health IT. For instance, the bill:
- Allows documentation by scribes to qualify under electronic health record (EHR) documentation requirements;
- Cracks down on Medicaid fraud by requiring HHS to create and maintain a centralized database of terminated Medicaid providers;
- Creates centralized enrollment standards for doctors to participate in Medicaid; and
- Seeks to improve interoperability of EHRs.
The Cures Act uses the Affordable Care Act’s (ACA) health care prevention fund, as well as money generated by the Strategic Petroleum Reserves, to offset the allocations. The funding allocated under the bill is not mandatory, despite objections from Democratic lawmakers, and instead will be subject to an appropriations process each year.
Updated Dec. 13, 2016