The novel coronavirus may be propelling Cures 2.0 efforts to the forefront.
A revamp of 2016’s bipartisan 21st Century Cures Act has been a topic of discussion for months. But as the COVID-19 outbreak has focused national attention on health care, the bill’s key messages are now taking shape in earnest, with a new focus on pandemic preparedness.
According to a concept paper from Rep. Dianna DeGette (D-CO) and Rep. Fred Upton (R-Mich.), authors of the original 21st Century Cures Act, the forthcoming bill will cover six basic issues.
- Public health. The bill will seek to improve the country’s preparedness for pandemics and increase education on vaccine and immunization.
- Caregiver integration. The bill will fund training programs for caregivers.
- Patient engagement. The bill will direct the Centers for Medicare and Medicaid Services to explore ways to improve health literacy.
- Clinical trials. The bill will require an FDA update on improving diversity in clinical trials and would require the Department of Health and Human Services to increase awareness and understanding of clinical trials.
- The Food and Drug Administration. The bill will ramp up efforts to modernize health care delivery, including the role of digital technology and digital health, as well as increase the use of real-world evidence.
- The Centers for Medicare & Medicaid Services. The bill’s authors seek more input on how to modernize coverage with a specific interest in genomic sequencing and gene therapies, along with treatments for small patient populations.
While the original 21st Century Cures Act encouraged innovation and research, this second iteration looks at modernization, from improving present-day pandemic preparedness to integrating digital technology into health care delivery. “As our world faces the worst public health crisis in more than a century, Cures 2.0 offers hope for today’s pandemic and tomorrow’s challenges,” Reps. DeGette and Upton said. “It’s more important than ever that we continue our efforts to modernize the way we treat the world’s most vexing diseases.”
The concept paper acknowledges testing strategy, data sharing and medical readiness as key components for getting the nation ready for a pandemic. It also highlights the role of innovation in allowing the United States to respond to a pandemic with antibiotics and vaccines.
Efforts to improve clinical trials also feature prominently. The original 21st Century Cures Act made strides in encouraging clinical research. Organizations such as the Coalition for Clinical Trials Awareness, however, point out that low awareness levels continue to hamper enrollment, hamstringing research efforts. The concept paper indicates that Cures 2.0 would aim to increase diversity in clinical trials as well as boosting clinical trials awareness and understanding.