Regulators increased focus on compliance gaps in patient support programs (PAPs), with DOJ and OIG scrutiny tied to program design intent and profit orientation. Coverage from Access USA highlighted that even “access-first” structures can still create Anti-Kickback Statute risk depending on how federal dollars effectively influence product sales. Speakers cited enforcement concepts centered on inducement—whether remuneration or something of value is offered to drive sales—and warned that copay assistance programs can raise red flags if they indirectly fund price increases for targeted drugs. The guidance emphasized that evaluations often rely on internal communications, whistleblower evidence, and operational specifics, not just stated access goals—raising the stakes for biopharma teams managing chronic-subsidy models and rare disease programs.