Regulators and DOJ enforcement trends are increasingly focused on compliance gaps in patient support programs (PAPs), with scrutiny tied to program design, profit intent, and how federal dollars may indirectly subsidize sales. Panelists at the Access USA conference highlighted the Anti-Kickback Statute risk framework used by prosecutors. Speakers described how copay assistance can create red flags if federal dollars bear costs tied to price increases, and how internal communications and whistleblower accounts often determine whether a program is motivated by access or profit. They also warned that “access-only” framing does not automatically reduce legal exposure. The enforcement signals suggest biopharma compliance teams need to stress-test program structures and operational flows against enforcement objectives, particularly for chronic drug subsidies and tightly linked commercial arrangements.