OBJECTIVES: Outcome-based risk sharing agreements (OBRSAs) and related value-based purchasing are evolving in the complex context of regulations, policies, and operational factors in the U.S. This forward-facing analysis identified, categorized, and yielded opportunities to reform or otherwise act on these regulations, policies, and operations.

METHODS: Across 18 months during 2017-18, we reviewed health policy literature, examined stakeholder group communications, and conducted semi-structured interviews with representatives of 12 diverse stakeholder organizations. Across these, and incorporating real-time contextual changes, we identified priorities for enabling and improving OBRSAs.

RESULTS: Regulatory and policy priorities most often cited by manufacturers were: Medicaid Best Price rule, Medicare Part B Average Sales Pricing, FDA restrictions on communications, and the Anti-Kickback Statute. While recognizing these, health plans were more concerned about operational barriers, particularly associated with data collection and analysis, selection of outcomes that are feasible to assess, bandwidth for managing OBRSAs, and implementation costs relative to Return on Investment (ROI). Most recognized limitations on access to personal health information, target population turnover, and insufficient information sharing of OBRSA experiences. Noteworthy were asymmetries of administrative burden and cost management: individual manufacturers may pursue OBRSAs for one or a few products per year, while health plans are approached by multiple manufacturers about OBRSAs for their respective products; manufacturers focus on drugs, while health plans must manage broader costs of care.

CONCLUSIONS: While all stakeholders express interest in OBRSAs, health plans tend to consider them as a narrower priority than manufacturers. Solving operational barriers is essential for aligning efforts to advance OBRSAs. Doing so depends on collaboration to improve decisions about when and how to pursue OBRSAs, with attention to data management, modeling and piloting OBRSAs, and information sharing. These findings pertain to companies operating in the U.S. and some likely extend to certain value-based arrangements in other countries.