Top 5 Myths About 340B Compliance — Busted

Misconceptions around 340B can create risk and missed opportunities. In 2025, as HRSA increases oversight and manufacturers tighten restrictions, it’s more important than ever for covered entities to separate fact from fiction. Believing these myths can cost millions in lost savings and expose providers to compliance risk.

Myth #1: TPAs Catch Everything
Reality: While TPAs are valuable partners, studies from the Government Accountability Office (GAO) show that TPAs can miss up to 20% of eligible claims due to limited data feeds and inconsistent eligibility rules. Platforms like Halo340Buse a Second Check Engine to recover those missed claims and provide transparency.

Myth #2: 340B Savings Are Guaranteed
Reality: 340B savings depend on accurate eligibility determinations and proper OPAIS registration. According to HRSA Program Integrity Updates, failure to maintain auditable records or update registrations can result in loss of eligibility — and significant financial penalties.

Myth #3: Audits Only Happen Rarely
Reality: HRSA has ramped up audits in recent years, conducting over 200 annually, according to HRSA. Audit findings frequently include duplicate discounts, ineligible prescriptions, and inadequate documentation. Being unprepared can jeopardize program participation.

Myth #4: Compliance Is Only About Avoiding Penalties
Reality: Compliance is directly tied to financial performance. The American Hospital Association (AHA) reports that hospitals spent over $115 billion on prescription drugs in 2023, making 340B savings essential for reinvestment in patient care. Noncompliance can mean both penalties and lost savings.

Myth #5: Manual Processes Are Good Enough
Reality: With today’s complexity, manual processes leave too much room for error. 340B Health emphasizes that advanced compliance software is now essential to manage eligibility, track savings, and stay audit-ready.