Posts Tagged ‘safe harbors’
HHS, CMS Announce Changes to Stark Law and Anti-Kickback Statute
The U.S. Department of Health and Human Services Office of Inspector General and Centers for Medicare & Medicaid Services recently published long-awaited final rules that significantly reform regulations interpreting the federal Stark Law and Anti-Kickback Statute. The agencies have stated that the changes “aim to reduce regulatory barriers to care coordination and accelerate the transformation…
Read MoreProposed Changes to Stark and Anti-Kickback Laws
HHS Proposes Changes to Drug Rebate Safe Harbors
The U.S. Department of Health & Human Services (HHS) has issued a proposed rule that would amend the safe harbor regulation for certain drug rebates that manufacturers pay to pharmacy benefit managers (PBMs) Medicare Part D, and Medicaid managed care organizations (MCOs). Published in the Federal Register on February 6, the proposal is designed to…
Read MoreOIG’s New Safe Harbors, Civil Monetary Penalty Exceptions Set to Take Effect
On January 6, new safe harbors to the federal anti-kickback statute and amendments to the civil monetary penalty rules will take effect. The expansion of existing safe harbors, along with the addition of new ones, were issued by the Department of Health and Human Services Office of the Inspector General on Dec. 7, and are…
Read MoreHHS proposes new safe harbors
The U.S. Department of Health and Human Services has proposed a rule that would amend the safe harbors to the anti-kickback statute and the civil monetary penalty rules under the authority of the Office of Inspector General. The 94-page proposed rule, if adopted would add new safe harbors and codify civil monetary provisions for gain…
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