Patient Assistance Programs, Compliance

Why Compliance Audits Are Non-Negotiable

Gardner Law on 3/26/2025

In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more

Court Upholds OIG Advisory Opinion Shooting Down a Patient Assistance Program

Holland & Knight LLP on 2/5/2024

Healthcare compliance risks exist even when a company takes steps to structure its business activities to follow the government's own statements. A recent decision by the U.S. District Court for the Eastern District of...more

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 3/30/2018

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

A Continued Examination of Charitable Patient Assistance Programs Part Eight in a Series: What Products Say About Charitable PAPs

Mintz - Health Care Viewpoints on 9/17/2013

In today’s challenging health care environment, Charitable Patient Assistance Programs (Charitable PAPs) have emerged to meet the needs of the nearly 30 million Americans that are underinsured and have difficulty paying...more

A Continued Examination of Charitable Patient Assistance Programs - Part Seven in a Series: Charitable PAPs: Donations and...

Mintz - Health Care Viewpoints on 8/29/2013