CHA News Article

OIG Releases Supplemental Special Advisory Bulletin on Independent Charity Patient Assistance Programs

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services today released a Supplemental Special Advisory Bulletin on patient assistance programs (PAPs) run by independent charities.  PAPs have long provided important safety net assistance to patients with chronic illnesses and high drug costs who cannot afford their cost-sharing obligations for prescription drugs. The supplemental bulletin — a follow-up to the 2005 Special Advisory Bulletin on PAPs for Medicare Part D enrollees — provides additional guidance regarding PAPs operated by independent charities that provide cost-sharing assistance for prescription drugs. To address some of the specific risks that have come to the OIG’s attention in recent years, the supplemental bulletin discusses problematic features of PAPs with respect to the federal anti-kickback statute and the provision of the Civil Monetary Penalties Law prohibiting inducements to Medicare and Medicaid beneficiaries. Other potential risk areas, including potential liability under the False Claims Act or other federal or state law, are not addressed in the supplemental bulletin.

The supplemental bulletin is based on experience the OIG has gained in the intervening years; it is not intended to replace the 2005 Special Advisory Bulletin, nor does it replace other relevant guidance, such as the 2002 OIG Special Advisory Bulletin on Offering Gifts and Other Inducements to Beneficiaries.