Reps. DeGette and Bucshon Issue Cures 2.1 Issue Paper

Rep. Diana DeGette (D-Colo.) and former Rep. Larry Bucshon, MD (R-Ind.) on Dec. 24, 2024, published an issue paper outlining next steps and policy proposals for Cures 2.1 (PDF) and the 21st Century Cures initiative. The issue paper follows a June 2024 request for information, which garnered over 300 responses from invested parties, including feedback from the AAMC (PDF)[refer to Washington Highlights, Aug. 9, 2024].

The issue paper states that in a potential Cures 2.1 update the lawmakers aim to "create an environment that enables the rapid and appropriate deployment of innovative technologies to improve health outcomes; build a health care infrastructure that enables information sharing, continuous evidence gathering, and implementation of new knowledge; and foster innovations that improve public health, promote patient-centric care, reduce the burden of chronic disease, and conserve valuable resources."

Specific policy proposals in the paper address high-cost curative therapies, Medicare coverage of innovative products, local coverage determinations, modernizing Medicare's benefit categories, rapid adoption of preventative services, telehealth in Medicare accessing clinical trials, integrating research into practice, medical record maintenance and exchange, secondary clinical data use, adoption of certified electronic health record technology, reforming ClinicalTrials.gov, improving the Advanced Research Projects Agency for Health, Food and Drug Administration (FDA) approval pathways, and FDA regulation of software as a medical device.

In order for these proposals to gain the support of the Republican majority, DeGette, the incoming ranking member of the House Energy and Commerce Health Subcommittee, will need to identify a new Republican to co-lead potential Cures 2.1 legislation following Bucshon's retirement.