Innovate and Pay for Value: Goals of New Anti-Kickback and Civil Monetary Penalty Rules

Lexology October 9, 2019
Frost Brown Todd LLC

The 386-page notice of proposed rulemaking seeks comment on revisions of the safe harbors to the Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b); “AKS”) and the Federal Civil Monetary Penalty (42 U.S.C. § 1320a-7a(a)(5); “CMP”) rules regarding beneficiary inducements. It also demonstrates a focus on permitting innovative arrangements and a shift to value-based care.^[1] Generally, the proposed rule seeks to add the following:

1. new safe harbor protections to the AKS for certain coordinated care and associated value-based arrangements between or among clinicians, providers, suppliers, and others; and
2. new protections under the AKS and CMP law that prohibit inducements offered to patients for certain patient engagement and that support arrangements to improve quality of care, health outcomes, and efficiency of...

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