WebNov 25, 2024 · On November 20, 2024, the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a final rule (scheduled to be published in the Federal Register on November 30 th) that amends the Anti-Kickback Statute (AKS) discount safe harbor, removing protection for manufacturer rebates on … WebNov 24, 2024 · OIG emphasizes that the discount safe harbor will "continue to protect discounts on prescription pharmaceutical products offered to other entities, including, but not limited to, wholesalers, hospitals, physicians, pharmacies, and third-party payors in other Federal health care programs."
42 CFR § 1001.952 - Exceptions. Electronic Code of …
WebSep 7, 2015 · The discount safe harbor exempts from the definition of remuneration those discounts on items or services for which the federal government may pay, either fully or … WebDec 20, 2024 · Discounts. Domestic Safe Harbor and Related Arrangements. Domestically, the discount and rebate safe harbor to the AKS encourages life sciences … magmasoft 5.5 crack
DEPARTMENT OF HEALTH AND HUMAN SERVICES …
WebJan 15, 2024 · While the new safe harbors become effective January 29, 2024, the removal of the discount safe harbor has a delayed effective date of January 1, 2024. [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 ... WebJan 30, 2024 · — In response to litigation brought by the Pharmaceutical Care Management Association (PCMA) challenging the Medicare Part D rebate rule, the Biden Administration agreed to postpone the effective date of the provisions of the rule relating to the elimination of the regulatory discount safe harbor for retrospective rebates, from January 1, 2024, … WebAug 27, 2024 · [9] The safe harbor defines the term discount as “a reduction in the amount a buyer (who buys either directly or through a wholesaler or a group purchasing organization) is charged for an item or service based on an arms-length transaction.” nystrom renaissance worksheets