The White House Office of Management and Budget (OMB) is reviewing a long-awaited Trump Administration proposed rule to amend the safe harbors to the Anti-Kickback Statute (AKS) and exceptions to the beneficiary inducement provisions of the Civil Monetary Penalty (CMP) statute to better support coordinated care. The proposed rule presumably builds on the related request for information (RFI) on this topic issued by the Office of Inspector General (OIG) of the Department of Health Human Services (HHS) in August 2018. As discussed in a Reed Smith client alert, the RFI sought information on, among other things, changes needed in current safe harbors and beneficiary inducement CMPs to promote beneficial care coordination, patient engagement, and value-based arrangements.

The OIG sent the safe harbor proposed rule to OMB for review on June 5, 2019. The text of the rule is not yet available, and regulatory review can take anywhere from hours to months. The latest Trump Administration regulatory agenda projects that the proposed rule will be released in July 2019. While such projections are not always accurate, the notation on the agenda indicates that the wait for this highly-anticipated proposed rule may be coming to a close, and the beginning of the comment period may be on the horizon. We will be closely monitoring developments.