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Qui Tam Quarterly - Enforcement Trends in False Claims Act Liability for Patient Assistance Programs

Date: 18 November 2019
Enforcement Trends in False Claims Act Liability for Patient Assistance Programs
By: Leah D'Aurora Richardson, Matthew R. Hubbell, Laura A. Musselman, Richard P. Church

Patient assistance programs (PAPs) provide financial assistance to patients of limited financial means in a variety of forms, including free or discounted products, product coupons, cost-sharing assistance, and, in some cases, financial support to pay health insurance premiums, cost of living expenses, and travel reimbursement related to the receipt of medical care. Independent charitable organizations or foundations bolstered by donations from drug and medical device manufacturers generally administer these programs pursuant to the Health and Human Services Office of Inspector General’s guidance. However, in recent years, federal and state regulators have subjected PAPs to intense scrutiny and increased enforcement, particularly those programs that assist patients with drug costs.

In this edition of Qui Tam Quarterly, members of our Health Care Fraud and Abuse team provide a detailed analysis of the current legal landscape affecting administration of and contributions to PAPs, including:

  • Applicable law and government guidance
  • Recent DOJ enforcement and investigations, and
  • Key insights regarding government intervention, aggravating factors, and ongoing enforcement cases.

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About Qui Tam Quarterly
Qui Tam Quarterly is a quarterly publication authored by members of the K&L Gates Health Care Fraud & Abuse team highlighting emerging and pressing issues in health care fraud and abuse, including litigation and governmental investigations involving the False Claims Act, the Stark Law, the Anti-Kickback Statute, and other health care fraud related statutes.

Members of our team are regular contributors to Triage: Rapid Legal Lessons for Busy Health Care Professionals, a podcast created by K&L Gates to inform our clients and friends of the firm about the latest developments in health law. Subscribe to Triage through iTunes or Google Play.

Leah D'Aurora Richardson
Leah D'Aurora Richardson
Research Triangle Park

This publication/newsletter is for informational purposes and does not contain or convey legal advice. The information herein should not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer. Any views expressed herein are those of the author(s) and not necessarily those of the law firm's clients.

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