Tag: Anti-Kickback Statute

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 Provides Strong Rebuke of Pharmaceutical Free Drug Program

On November 16, 2018, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion No. 18-14 regarding a proposed free drug program (“Proposed Arrangement”). Under the Proposed Arrangement, a pharmaceutical manufacturer (“Manufacturer”) will give free drug product (“Drug”) to hospitals for inpatient use to […]

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 […]

OIG Advisory Opinion Permits Limited Provision of Free Telemedicine Hardware and Services

On May 31, 2018, the Office of Inspector General (OIG) issued Advisory Opinion No. 18-03 regarding an arrangement in which a not-for-profit Federally qualified health center look-alike (Provider) would provide, at no charge, certain information technology-related equipment and services to a County Department of Health health clinic (County Clinic) for […]

OIG Advisory Opinion Approves Ostomy Supply Distributor to Provide Free Product Samples

On Monday, the Office of Inspector General (OIG) issued Advisory Opinion No. 18-02 regarding an arrangement in which the Requestor who distributes and sells, but does not manufacture, certain ostomy products (Products) provides a limited number of free Product samples to patients and contracts with a third party (Contractor) to […]