The 21st Century Cures Act, proposed by Representatives Fred Upton (R-MI) and Diana DeGette (D-DO), was signed into law by President Barack Obama in December of 2016. Broadly, the bill focuses on medical research and Food and Drug Administration (FDA) regulation, while seeking to advance medical product and drug research and development (R&D) and bring new and effective innovations to patients and providers.
The 21st Century Cures Act and The Final Rule
While increasing research, development, and accessibility, the bill established helpful programs, such as the Regenerative Medicine Advanced Therapy Designation (RMAT) and the Breakthrough Devices Program. The 21st Century Cures Act also aims to ease regulation related to electronic health record (EHR) systems and health information technology (IT) services. In order to prevent information blocking practices, The Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) produced The Final Rule, which was finalized by the U.S. Department of Health and Human Services (HHS) in March 2020.
Listed below are some of the areas that the 21st Century Cures Act aims to address:
- Ending opioid abuse,
- Advancing precision medicine, drug development and therapies,
- Supporting scientists and collaborative research,
- Enhancing mental health services, and
- Improving patient and vaccine access.
Cures 2.0 Proposal
On June 22, 2021, Representatives Upton and DeGette released a 21st Century Cures Act 2.0 Discussion Draft outlining critical updates and improvements to the current Cures law.
Cures 2.0 development began in late 2019 and focuses on key areas including medical research, public health, and clinical trials and therapy development. Some notable additions to the Cures Act include authorizing:
- An Advanced Research Projects Administration for Health (ARPA-H) to research cures for diseases,
- A long-term study of those impacted by the COVID-19 pandemic to understand the effects of the virus,
- Preparedness through national testing and response strategy for future pandemics,
- Funding for research grants, and
- Increased diversity of participants in clinical trials.
What to Expect Moving Forward
While the 21st Century Cures Act was signed into law in December of 2016, the Final Rule Information Blocking provision went into effect on April 5, 2021. By October 6, 2022, compliance around information blocking will include all Electronic Protected Health Information (ePHI) and by December 31, 2023, various requirements will extend for certified health IT vendors.
Looking at Cures 2.0, several propositions remain controversial. Predicting where this piece of legislation will go and how it will change is uncertain at this time, but it is clear that this proposal is still in its early stages.
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Contributions by Rachel Ruth