News & Analysis as of

Generic Drugs Patient Assistance Programs

Holland & Knight LLP

OIG Advisory Opinion Highlights Further Concerns for Patient Assistance Programs

Holland & Knight LLP on

Patient assistance programs (PAPs) that seek to subsidize patient co-payments for drugs covered by Medicare may involve compliance challenges. A recent U.S. Department of Health and Human Services (HHS) Office of Inspector...more

Bass, Berry & Sims PLC

OIG Closes the Door on Coalition-Model Patient Assistance Programs in its Latest Advisory Opinion

Bass, Berry & Sims PLC on

On October 5, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion No. 22-19, finding that a proposal by an entity funded entirely by manufacturers of oncology...more

The Volkov Law Group

Drug Companies and Charitable Patient Foundations

The Volkov Law Group on

Charitable organizations can easily become enmeshed in Justice Department enforcement issues. We have seen charities used in FCPA cases as a means to funnel bribes to government officials, spouses or family members....more

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