While Patient Support Programs continue to grow and expand, the same cannot be said about the accompanying regulatory guidance from the Department of Justice (DOJ) or Office of Inspector General (OIG) that Compliance leaders rely on to design proper controls. An emerging pharmaceutical company preparing for FDA approval of its first product for chronic illness patients wanted to ensure its Patient Assistance Program was operational and available as an option for its patients upon product launch without exposing the company to significant risks.

• Reviewed and assessed proposed Patient Assistance Program structure and workflow including program eligibility, patient consent, and benefits offered.

• Performed analysis of OIG Advisory Opinions and recent enforcement activity to assist in the development of internal controls for addressing high-risk program areas.

• Conducted research and compiled industry benchmarking data to compare the proposed Patient Assistance Program’s benefits and eligibility criteria with those of competitors in related specialties.

• Collaborated with third-party vendors, including the company’s Patient Services HUB provider, to identify best practices for Patient Assistance Program data reporting and data stewardship and further mitigate program risk.

Working closely with program leaders and key stakeholders, HELIO was able to assist the company in making risk-based determinations for the final structure and benefits of its Patient Assistance Program. Once defined, HELIO developed policies, procedures, and monitoring protocols that enabled the execution and continuous oversight of the Patient Assistance Program upon program launch and thereafter.