July 01, 2021

Congress Introduces Discussion Draft Creating ARPA-H; Advancing 21st Century Cures Act

U.S. Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.) released Cures 2.0, draft legislation, which sponsors hope will build upon the success of the 21st Century Cures Act. The Cures Act transformed how the United States researches and develops new cures and treatments for some of the world’s most difficult diseases, including cancer and Alzheimer’s.

Included in the bipartisan discussion draft is a provision that would create an Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health (NIH), and authorize the more than $6.5 billion the White House has requested for the agency.

The draft defines ARPA-H’s mission as speeding transformational innovation in health research and implementing health breakthroughs by funding projects that could:
• Tackle bold challenges requiring large scale, sustained coordination.
• Create new capabilities (e.g., technologies, data resources, disease models).
• Support high-risk exploration that could establish entirely new paradigms.
• Overcome market failures through critical solutions, including financial incentives.
• Complement NIH’s existing research portfolio and mission and the private sector’s research initiatives.

According to a White House fact sheet, ARPA-H would be a division within the National Institutes of Health. It would establish partnerships and collaborations with key stakeholders from industry, government, non-profits and academia to leverage critical skills and expertise in tackling systemic challenges the current systems were not designed to address. ARPA-H would focus on time-limited projects with goals, benchmarks and accountability. The ARPA-H director would be selected based on extraordinary technical and leadership skills, such as proven innovation and partnership-building track-records, and be responsible for setting the culture, including injecting the principles of risk-tolerance, urgency, equity and innovation into every decision. In addition, a diverse cohort of program managers would be recruited from industry, academia or other sectors based on demonstrated scientific vision, judgment and management skills, and have broad autonomy to drive transformational change.

Sponsors intend Cures 2.0 to increase diversity in clinical trials by requiring:
• An update on efforts to improve diversity in clinical trials from the U.S. Food and Drug Administration.
• A study of barriers to clinical trial participation conducted by Government Accountability Office.
• A publicity campaign to increase public awareness and understanding of clinical trials — particularly in minority communities — conducted by the U.S. Department of Health and Human Services (HHS).
• Establishment of a task force to make clinicaltrials.gov more user- and patient-friendly.

The discussion draft also would require the HHS Secretary to submit a report to Congress about efforts to ensure collaboration and alignment across the FDA related to the regulation of digital health technologies. These would include the validation and qualification of digital endpoints and digital biomarkers, the acceptance of decentralized trials, the use of digital health technologies in patient-focused development of products and the use and validation of digital health technology tools.

The measure would modify telehealth uses by incorporating the Telehealth Modernization Act, which would permanently remove Medicare's geographic and originating site restrictions that require a patient to live in a rural area and be physically in a doctor's office or clinic to use telehealth services. It also would allow the secretary of HHS to permanently expand the types of health care providers that can offer telehealth services and the types of services that can be reimbursed under Medicare.

The sponsors included the Ensuring Patient Access to Critical Breakthrough Products Act, codifying the current Medicare Coverage of Innovative Technology pathway at the Centers for Medicare and Medicaid Services. In addition, the HHS Secretary would submit a report on the feasibility of establishing alternative coverage pathways for innovative technologies.

$25 billion would be awarded to independent research institutions, public laboratories and universities throughout the country to continue their work on thousands of federally backed projects, of which $10 million would be allocated to NIH.

A copy of the full Cures 2.0 discussion draft is available here.

A section-by-section summary of Cures 2.0 is available online.

For more information, please contact Tina Getachew.