By Surabhi Dangi-Garimella, Ph.D.
Advanced Research Projects Agency for Health (ARPA-H)—that’s the name of the new $6.5 billion agency being proposed as part of the next iteration of the 21st Century Cures Act (CURES 2.0). Along with an infusion of funding into the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS), the creation of ARPA-H (within the National Institutes of Health) is expected to accelerate innovation in health research.
Overseen by the Director, ARPA-H will be run by program managers who will have the independence to identify and support high-risk programs that will deliver high rewards, similar to a defense-focused agency that was created within the Pentagon in the 1950s, which yielded the internet, GPS, and even the mRNA vaccine by Moderna that is aiding our current battle against the SARS-CoV-2 virus. ARPA-H will be assigned the responsibility of finding new treatment options for some tough diseases, in addition to identifying ways to prevent cancer, by partnering with and providing grant support to diverse institutions—from universities to nonprofit organizations.
In coordination with other federal agencies, ARPA-H could invest in breakthrough technologies and widely applicable platforms, capabilities, and resources that can transform medicine and healthcare. The scientific portfolio will also focus on ensuring healthcare data are accessible, interoperable, integrated, and shareable while creatively leveraging artificial intelligence. For diseases with a high unmet need, ARPA-H will focus on de-risking commercialization and translation to create a path for promising treatments to reach patients sooner.
What Else is in CURES 2.0?
CURES 2.0 also includes the following provisions:
- Focus on long-COVID-19, including research in children, evaluation of disparities, and educational programs for both providers and the public
- Telehealth Modernization Act: Several policy changes that stakeholders were demanding of CMS have been included under Sec. 403 of CUREs 2.0. These include:
- Eliminating Medicare’s originating site restrictions to improve virtual access, including the home of the individual who is eligible for a telehealth service
- Expanding practitioners eligible to provide telehealth services
- Enhancing telehealth services for Federally Qualified Health Centers and rural health clinics
- Use telehealth services for dialysis and hospice care, as appropriate
- Ensuring Patient Access to Critical Breakthrough Products Act: Medicare has to cover devices approved under the FDA’s Breakthrough Devices Program for a four-year transitional period and CMS should then establish a process for continued coverage at the end of the transition period.
Surabhi Dangi-Garimella, Ph.D. is a biologist with academic research experience, who brings her skills and knowledge to the health care communications world. She provides writing and strategic support to non-profit groups via her consultancy, SDG AdvoHealth, LLC.