Lexology January 8, 2020
Cozen O'Connor

In an effort to modernize the federal fraud and abuse laws by “reduc[ing] regulatory barriers and accelerat[ing] the transformation of the healthcare system into one that better pays for value and promotes care coordination,”1 the OIG released a proposed rule2 (proposed rule) in the fourth quarter of 2019 that would amend the Anti-Kickback Statute safe harbors, as well as regulatory requirements under the Civil Monetary Penalty Law regarding beneficiary inducements. The CMS also simultaneously released a proposed rule that would amend and make clarifications to the Stark Law regulations. Below I highlight the standards for two of the OIG’s proposed rule’s new, proposed safe harbors that would be applicable to value-based arrangements with substantial downside financial risk and value-based arrangements...