A Long-Standing Commitment to Compliance
We are proud of the manner in which our organization maintains safeguards to ensure that we operate our program, independently, free from donor influence, and in compliance with the guidance provided by the OIG in our opinion, # 04-15 issued to PAF in 2004 and modified in 2008 and 2015, as well as the Special Advisory Bulletins issued in 2005 and 2014, including a best in class organization wide compliance program.
PAF fosters an environment, both internally and externally, that is focused on our compliance with the applicable federal and state fraud and abuse laws including but not limited to, the anti-kickback statute and the civil monetary penalties law.
Compliance Program Leadership
For nearly two decades, PAF has engaged the services of Arent Fox, LLP, Washington, DC, as its regulatory counsel. Arent Fox are experts in regulatory affairs, specializing in compliance programs relative to patient assistance programs and lead the development, implementation and ongoing management of PAF’s organizational compliance program, as well as serves as its Compliance Counsel. The Compliance Program is based on the seven elements of an effective compliance program set forth in the Federal Sentencing Guidelines Manual and applicable Department of Health and Human Services Office of Inspector General (“OIG”) guidance and is designed to assist PAF in preventing, detecting, and responding to illegal, improper, and unethical conduct, serving as a procedural framework for enhancing and monitoring compliance with applicable law, regulation, the PAF Code of Conduct and PAF’s policies and procedures.
Stephanie Trunk, Esq.
Arent Fox, LLP
PAF Compliance Counsel