On October 9, 2019, the Trump administration released two proposed rules seeking to revamp current fraud and abuse regulations to support the transition to value-based payment. The first would amend regulations implementing the anti-kickback statute and civil monetary penalty law by revising and implementing additional safe harbor protections for certain coordinated care activity, value-based payment arrangements, and patient engagement tools, among others. The second rule seeks to modify the federal “Stark Law,” adding new exceptions for value-based arrangements and clarifying key definitions like “fair market value.” These proposed rules are part of the Administration’s “Regulatory Sprint to Coordinated Care,” which seeks to reduce regulatory burdens on physicians, promote more effective patient management, and enhance value-based delivery. Comments on the proposed rules are due on December 31.
