Proposed Changes to Stark and Anti-Kickback Laws

The U.S. Department of Health and Human Services Office of the Inspector General, in conjunction with the Centers for Medicare & Medicaid Services, has unveiled long-awaited proposals to revise safe harbor protections under the federal anti-kickback statute for certain coordinated care and associated value-based arrangements. The proposed new regulations also would add protections under the […]

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 […]

OIG’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 […]

HHS 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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