On Oct. 20, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued unfavorable Advisory Opinion 23-08 (AO 23-08).
On Oct. 20, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued unfavorable Advisory Opinion 23-08 (AO 23-08), continuing its long-held.
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Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers.
Please see full Article below for more information.
Health Care Counselarentfox.com2021 Stark & Anti-Kickback Statute Final RulesSmart InYour WorldContentsOur TeamDiscount Safe Harbor Final Rule Released: OIG Seeks to Adopt Major ChangesNew Stark Law and Anti-Kickback Reforms Aimed at Value-Based CareChanges to Stark Law Definitions Impact Innovative Relationships and “Commercially Reasonable” ConsiderationsRevisions to Stark Law Rules Covering Physician Profit Sharing and BonusesSearching for Safe Harbors? CMS-Sponsored Model Participants Receive Anti-Kickback Statute ProtectionChanges to the Stark Law’s Special Rules on Compensation Create Flexibility and Reduce Confusion for Physicians and Other Health Care Providers05 060813161821Stark Law Fair Market Value Comp
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On November 30, 2020, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a final rule (“Final Rule”) that removes safe harbor protection under the discount safe harbor to the federal Anti-Kickback Statute (“AKS”) for certain pharmaceutical rebates and creates two new safe harbors governing certain pharmaceutical manufacturer price reductions at the point of sale (“POS”) and certain pharmacy benefit manager (“PBM”) service fees.[1] While the new safe harbors become effective January 29, 2021, the removal of the discount safe harbor has a delayed effective date of January 1, 2022.[2] The Final Rule, if fully implemented, will have a significant impact on drug supply chain stakeholders operating under Medicare Part D, including health plans, PBMs, pharmaceutical manufacturers, drug wholesalers, and pharmacies.