ACA / PPACA (Affordable Care Act)
Definition
The Patient Protection and Affordable Care Act (PPACA), commonly called the ACA, made several important changes to the 340B program when it was enacted in 2010. It expanded 340B eligibility to include critical access hospitals (CAH), sole community hospitals (SCH), rural referral centers (RRC), and free-standing cancer hospitals (CAN)—entity types that were not previously eligible.
The ACA also required HRSA to publish ceiling pricing and actual pricing data submitted by manufacturers, increased Medicaid rebate percentages, and created new integrity provisions for both manufacturers and covered entities. These included the ability to impose civil monetary penalties on manufacturers for violations and civil penalties for covered entities that knowingly violate the prohibition on diversion.
The ACA directed the Government Accountability Office (GAO) to prepare a 340B-related report to Congress, which contributed to ongoing legislative scrutiny of the program.
Frequently Asked Questions
Why ACA / PPACA (Affordable Care Act) Matters
The ACA's expansion of covered entity types significantly broadened the 340B program's reach. CAHs, SCHs, RRCs, and CANs added under the ACA now represent a substantial portion of covered entity participation. Understanding the ACA's impact helps covered entities in these categories understand their eligibility requirements and compliance obligations.
How Virtue 340B Uses It
Virtue 340B serves covered entities across all entity types, including those added under the ACA. We understand the specific eligibility requirements, GPO Prohibition obligations, and orphan drug exclusions that apply to hospital-type entities.