May 22, 2014

HHS-OIG Updates Guidance on Pharmaceutical Manufacturer Donations to Independent Charity Patient Assistance Funds

Arnold & Porter Advisory

On May 21, 2014, the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released a supplemental Special Advisory Bulletin (SAB) regarding independent charity patient assistance programs (PAPs). The SAB provides additional guidance and identifies areas of risk under the Anti-Kickback Statute and Beneficiary Inducement Statute, based on the OIG's experience since issuance of the 2005 SAB on PAPs for Medicare Part D Enrollees.

OIG cautions that charities that are not sufficiently independent from drug manufacturer donors may operate PAPs that harm patients and Federal health care programs and may, depending on the facts, violate fraud and abuse laws. Specifically, the SAB focuses on three areas of risk: disease funds, eligible recipients and the conduct of donors.


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