Tag: Anti-Kickback Statute
Q4 Government Settlements Round-Up: Life Sciences
The U.S. Department of Justice (DOJ) and other government enforcers announced a number of key settlements in the life sciences industry in October – December 2019. These settlements include: LIFE SCIENCES INDIVIDUALS/ ENTITIES SETTLEMENT DATE RESOLUTION KEY AREAS OF ENFORCEMENT Pharmaceutical company Dec. 3, 2019 $3 million Deferred prosecution agreement […]
Q3 GOVERNMENT SETTLEMENTS ROUND-UP: LIFE SCIENCES
The U.S. Department of Justice (DOJ) and other government enforcers announced a number of key settlements in the life sciences industry in July – September 2019. These settlements include: LIFE SCIENCES INDIVIDUALS/ ENTITIES SETTLEMENT DATE RESOLUTION KEY AREAS OF ENFORCEMENT Pharmaceutical company Sept. 26, 2019 $108M Deferred prosecution agreement Forfeiture […]
White House Withdraws Rebate Rule
Earlier this morning, the White House announced that they were scrapping a proposed rule (the rebate rule) that, among other items, would have [would eliminate the current safe harbor protection under the Anti-Kickback Statute for pharmaceutical manufacturer rebates to Medicare Part D plans, Medicaid MCOs and the PBMs with which […]
HHS Proposed Rule Would Remove Safe Harbor Protection for Certain Discounts
On January 31, 2019, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a proposed rule designed to combat rising drug costs (“Proposed Rule”). The Proposed Rule seeks to eliminate rebates paid by pharmaceutical manufacturers to plan sponsors or their pharmacy benefit managers (“PBMs”) […]
OIG Advisory Opinion Permits Refunding Device Purchase Price Under Limited Conditions
On September 17, 2018, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 18-10 regarding a proposed arrangement in which a surgical device and wound care product manufacturer (“Manufacturer”) will offer its hospital customers (“Customer”) who purchase the following three products for use in a joint replacement surgery: (i) […]
OIG Seeks Comments to Anti-Kickback Statute and Beneficiary Inducements CMP Related to ‘Patient Centered Care’
The Health and Human Services (HHS) Office of Inspector General (OIG) published today a request for information (RFI) seeking ways in which it might modify or add new safe harbors to the federal Anti-Kickback Statute (AKS) and exceptions to the definition of “remuneration” in the beneficiary inducement provision of the Civil […]
