Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) recently introduced new legislation intended to invest in research and deliver more cures to patients. The newly introduced 21st Century Cures 2.0 Act (Cures 2.0) is intended to build on the landmark 21st Century Cures Act, which was signed into law in late 2016 by former President Obama to improve and accelerate the pace of biomedical research in the United States.
The Association for Clinical Oncology (the Association) commends Representatives DeGette and Upton for introducing this bipartisan bill. If passed, it may increase diversity of clinical trials, expand patient access to telehealth, and provide a much-needed boost in funding to research institutions. The Association has endorsed and actively advocated for these provisions to be included in the bill and encourages Congress to move quickly to advance the legislation.
The bill is intended to accomplish the following goals:
Increase Diversity of Clinical Trials—Cures 2.0 includes several provisions designed to increase diversity in clinical trials—an issue that has long been a focus for the Association and its affiliate, the American Society of Clinical Oncology (the Society). The bill would authorize a study on barriers to clinical trial participation, require the U.S. Food and Drug Administration (FDA) to report on efforts to improve clinical trial diversity, and invest in initiatives to reach patients and increase awareness and understanding about clinical trials.
Authorize Funding for Advanced Research Projects Agency for Health (ARPA-H)—Cures 2.0 would authorize $6.5 billion to create a new ARPA-H within the National Institutes of Health (NIH). It would be designed to transform and improve medicine and health by funding bold, high-risk projects that could create new capabilities and that require large-scale, sustained coordination.
Extend Telehealth Flexibilities—In response to the COVID-19 public health emergency, the Department of Health and Human Services (HHS) issued a temporary waiver of strict geographic and originating-site restrictions for telehealth, allowing patients and providers around the country to utilize telehealth as an effective care delivery tool, regardless of where patients lived or where they participated in their telehealth visit. The Cures 2.0 bill would permanently remove these restrictions, providing access to telehealth services for all Medicare patients, regardless of where they live.
Increase Investment in Research—The bill would also authorize $25 billion in emergency, supplemental funding to ensure the U.S. biomedical research enterprise and clinical trials networks can recover from disruptions caused by COVID-19.
Promote Innovative Trial Design and Real-World Evidence—The bill requires the HHS to explore innovative ways to foster and incentivize the adoption of decentralized trials and maximize and expand the use of real-world evidence. Such steps may improve information about how all patients with cancer—not just those enrolled in trials—respond to cancer treatments.
Ensure Availability of Medicare Claims Data—The bill would improve research related to quality and value of care by providing clinician-led clinical data registries with access to Medicare claims information by linking claims with clinical data in registries.
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