Tag Archives: PAP

Enforcement Trend: Patient Assistance Programs

binoculars-clipart-as1859Multiple pharmaceutical companies have disclosed the receipt of subpoenas from various U.S. Attorney’s offices, including Massachusetts and the Southern District of New York, related to the companies’ patient assistance programs. Patient assistance programs also have been the subject of recent Congressional inquiries related generally to the increasing price of certain prescription drugs.

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Filed under Corporate Compliance, Government Enforcement

Cooley Client Alert: HHS OIG Issues Supplemental Special Advisory Bulletin on Patient Assistance Programs

The following Cooley Client Alert was released today.  The PDF version is available here.   

On May 21, 2014, the United States Department of Health & Human Services Office of Inspector General (“HHS OIG”) issued a fifteen page Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs (“Supplemental Bulletin”) to expand on guidance provided in the 2005 Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees (“2005 Bulletin”) regarding industry support provided to patient assistance programs (“PAPs”).

The Supplemental Bulletin provides a number of significant clarifications related to independent charity PAPs that provide cost-sharing assistance for prescription drugs. Incorporating information learned from Advisory Opinion1 requests submitted to the OIG by PAPs and pharmaceutical manufacturers that provide financial support to PAPs, the Supplemental Bulletin expands on the guidance provided in the 2005 Bulletin by focusing on three specific areas: (1) disease funds; (2) eligible recipients; and (3) the conduct of donors.

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Filed under Cooley Alerts, DHHS OIG