On January 31, 2019, the Department of Health and Human Services (HHS) released a notice of proposed rulemaking (the Proposed Rule) as part of ongoing administration drug pricing reform efforts. The Proposed Rule would modify a regulatory provision that had previously protected certain pharmaceutical manufacturer rebates from criminal prosecution and financial penalties under the federal

On December 7, 2016, the Office of Inspector General of the US Department of Health and Human Services published a final rule containing revisions to both the federal Anti-Kickback Statute safe harbors and the beneficiary inducement prohibition in the civil monetary penalty rules. Effective January 6, 2017, the Final Rule modifies certain existing safe harbors

The Department of Health and Human Services Office of Inspector General (OIG) issued an update to its Work Plan on May 28 that included several new Medicare-related topics for OIG audit or inspection.  These additions expand OIG’s work in areas that OIG has previously identified as priorities, such as hospital-based services, lab testing and Part