Accelerating Innovation for Better Health

The federal government has made significant investments in a variety of domains to improve our nation’s healthcare ecosystem. These investments have ranged from health information technology and patient-centered outcomes research to expanded insurance coverage and a 10-year reauthorization of the National Institutes of Health (NIH) that reinforced Congress’ ongoing commitment that the U.S. continue to lead the world in funding ground-breaking biomedical research.

Thanks to such federal investments—and a robust commercial biomedical research and development sector—the United States has a strong foundation to rapidly advance health innovation in ways that benefit all people. President Biden has proposed in his Fiscal Year 2022 budget to create an Advanced Research Projects Agency for Health (ARPA-H), a proposed agency within the NIH that would accelerate biomedical breakthroughs with “the potential to transform important areas of medicine and health for the benefit of all patients and that cannot be readily accomplished through traditional research or commercial activity.”

This report describes the ecosystem improvements that will support ARPA-H’s success, and the role that ARPA-H could play in measuring innovation gaps, prioritizing societal needs, and attracting private capital alongside public funding. It outlines specific recommendations for the organization’s underlying legal authorities, governance, and coordination of its policies and activities with other federal agencies and nongovernmental sectors. In addition, this report details a Biomedical Innovation Framework, developed by MITRE, that proposes a system-level approach for accelerating biomedical innovation across the Department of Health and Human Services (HHS).

Our framework was envisioned to support an integrated, efficient, and equitable health innovation pipeline energized by the federal government—a vision that the emergence of ARPA-H may substantially fill and move in exciting directions. The perspectives offered throughout this paper are informed by MITRE’s decades-long experience supporting the Defense Advanced Projects Agency (DARPA’s) research and development, operating six federally funded research and development centers (FFRDCs), and investing in MITRE innovation for the public good.

Vision

ARPA-H is established with the appropriate funding, authorities, and cross-agency collaboration priorities to:

• Lead a national conversation about unmet health needs.
• Identify critical innovation gaps and accelerate major biomedical breakthroughs with the support of a Biomedical Innovation Framework.
• Apply federal authorities and resources—and create incentives to align private resources—to encourage the research and development required to generate biomedical breakthroughs that will improve health for all people across the nation.

Authorize Autonomy and Focus on Outcomes

To ensure that ARPA-H can realize this vision, focus the ARPA-H portfolio to consider health equitable outcomes, partnering with the Centers for Medicare and Medicaid Services (CMS) Innovation Center and a broad group of stakeholders to advance multi‑payer initiatives to give providers and patients the tools they need to manage care and costs. Authorize ARPA-H with autonomy to establish an independent research agenda, manage a portfolio of projects with milestones and performance measures, and use other transactions authorities to accelerate decision making and optimize use of public funds.

MITRE’s System-level Biomedical Innovation Framework

The MITRE Corporation has designed a framework with recommendations to accelerate health innovation to improve health outcomes for all people using an evidence-based, data-driven process fueled by interconnected electronic health information. These recommendations leverage a framework that describes the critical roles ARPA-H could play to measure innovation gaps, prioritize societal needs, and attract private capital alongside public funding. The recommendations consider the organization’s underlying legal authorities, governance, and coordination with other federal agencies and nongovernmental sectors.

1. Measure

Measure the health innovation ecosystem by developing and applying standardized measures for the health innovation ecosystem and creating an executive-level dashboard that permits ARPA-H decisionmakers to model the pipeline of health innovations, evaluate scenarios to inform regulatory and funding decisions, and project impact on health outcomes, value, and access.

2. Define

Define federal government priorities using a data-driven method to identify innovation gaps, communicate priorities transparently using Target Product Profiles, and use payment policy in federal programs such as Medicare and Medicaid to apply “pull” incentives to encourage innovators to fill other pressing gaps.

3. Align

Align policies, practices, priorities, and objectives with an executive-level Policy Committee; ARPA-H engagement across sectors, interests, and communities; and a “front door” path for innovators to foster partnerships.

4. Finance

Enable ARPA-H to attract private capital to federal government innovation priorities by constructing innovation investment funds, creating a secondary market for products with favorable outcomes that were deprioritized due to lower profit, and partnering with social impact investors.

5. Digitize

Position ARPA-H to benefit from a coordinated, digital ecosystem that supports increased access to, and ultimate use of, information for an equitable view of health that empowers individuals and communities.

To learn more, read the full paper or the executive summary.