Compliance program

Our long-standing commitment to compliance

Patient Advocate Foundation (PAF) is proud of its track record of full and complete compliance with all applicable laws and regulations throughout the entire history of the organization.

PAF is the recipient of the second opinion issued by the Office of Inspector General (OIG) to a charitable patient assistance program, and as such we have always understood our obligation to operate our program with the highest degree of ethical decision making, ensuring all policies, procedures and practices are designed and implemented in a manner that comports with both the spirit and intent of the OIG guidance received by the foundation over the past two decades.

Compliance program highlights

  • OIG Advisory Opinion #07-18
  • Program oversight by tenured executive leadership
  • Funds identified from first-hand patient need data
  • In-house operations model trusted by 20+ nonprofit partners
  • 45 years of combined charitable patient assistance operations

Board of Directors and leadership

Our commitment to compliance starts with our Board of Directors, and their oversight role is embedded at every level within our organization.

Office of Inspector General Advisory Opinion

Patient Advocate Foundation and its TotalAssist program will adhere to OIG Advisory Opinion #07-18 (as modified).

Advisory Opinion #07-18 documentation

Compliance Program

Patient Advocate Foundation’s best-in-class Compliance Program will continue to be the foundation of our work, overseen by the Board of Directors and led internally by Stephanie Trunk, Esq., Partner, ArentFox Schiff, LLP.

Since the inception of its program in 2004, PAF has engaged the services of ArentFox Schiff, LLP, Washington, DC, as its compliance counsel. ArentFox Schiff are experts in regulatory compliance, specializing in compliance programs related to patient assistance programs and lead the development, implementation, and ongoing management of PAF’s organizational compliance program, as well as serve as its Compliance Counsel.

The program is designed to prevent, detect, and respond to illegal, improper, and unethical conduct, serving as a procedural framework for enhancing and monitoring compliance with applicable laws, regulations, the PAF Code of Conduct, and PAF’s policies and procedures.

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Annual reports and financials

Visit the Patient Advocate Foundation website for audited financials, 990s, and annual impact reports.

Compliance counsel

Stephanie Trunk, Esq., Partner, ArentFox Schiff, LLP

Stephanie Trunk is a partner in the Health Law Group and also the co-leader of the Life Sciences industry group at ArentFox Schiff LLP in Washington, D.C. Ms. Trunk has significant experience structuring patient assistance programs for and providing ongoing counseling to both independent charitable foundations and pharmaceutical manufacturers to ensure compliance with applicable fraud and abuse laws, regulations and governing Office of Inspector General Advisory Opinions and guidance related to such patient assistance programs.

In her practice, Ms. Trunk routinely counsels clients on reimbursement, fraud and abuse and regulatory compliance related to pharmaceuticals and devices for manufacturers, entities in the supply chain and other stakeholders. She received a J.D. with Highest Honors from the George Washington University Law School in 2003, also holds has a graduate certificate in health management from the George Washington University School of Public Health (2003) and received a B.S. in Accounting Summa Cum Laude from the University of Maryland in 1997. Ms. Trunk serves in the formal role of Compliance Counsel for PAF.

Contact our compliance counsel or report a concern

Stephanie Trunk: (202)-857-6171

Confidential Compliance Hotline: (202)-480-2291

Submit a message to our compliance counsel

How compliance sets us apart

We are proud to lead a compliant and comprehensive charitable assistance program that puts patients at the center.

Driven by patient need

PAF is the only charity to use data derived from the delivery of in-depth case management services provided to patients living with hundreds of unique chronic, debilitating and/or life-threatening diseases to accurately identify and define the disease funds in our program, grounded in actual demonstrated patient need data collected first-hand.

Comprehensive oversight

A Compliance Program with oversight from our Board of Directors, led by one of the most tenured top executives in the sector.

Extensive combined experience

Nearly 45 years of combined experience operating charitable copay assistance programs, with Patient Advocate Foundation being among the first to receive an OIG Advisory Opinion in 2004.

Led by subject matter experts

The most tenured executive operational leader in the sector, Fran Castellow, MSEd., President, Operations, oversees all charitable copay assistance programs, including the TotalAssist program.

Operational excellence

All operations have been conducted in-house from day one, and more than twenty nonprofit partners trust us to operate their own programs, with compliance at the center.

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