HR7391-119

What This Bill Does

The Community Health Center Drug Pricing Protection Act amends section 340B so HHS may not enter a covered outpatient drug agreement that lets a manufacturer charge a federally qualified health center more than the applicable 340B ceiling price at the point of purchase. It also says the amendment does not permit rebate, reimbursement, or later-payment arrangements where the FQHC pays above the ceiling price first and is reconciled later. The rule takes effect on enactment and applies to drugs purchased on or after that date, including manufacturer agreements evaluated after enactment.

Who Benefits and How

Federally qualified health centers benefit from upfront 340B discounts, better cash flow, and less need to wait for manufacturer rebates or reconciliation payments. Patients served by FQHCs benefit if clinics can preserve 340B savings for services, medication access, or care coordination. HRSA gains a clearer enforcement standard for manufacturer agreements.

Who Bears the Burden and How

Drug manufacturers must structure 340B agreements so FQHCs pay no more than the ceiling price at purchase and cannot rely on rebate-style reconciliation for those entities. HHS and HRSA must evaluate manufacturer agreements under the upfront-pricing rule immediately. Manufacturers may lose float or leverage from charging above-ceiling prices before later reconciliation.

Key Provisions

• Bars HHS from entering 340B manufacturer agreements that require FQHCs to pay more than the ceiling price at the point of purchase.
• Prohibits rebate, reimbursement, or later-payment arrangements that make FQHCs pay above the ceiling price first.
• Applies immediately to drugs purchased on or after enactment and to manufacturer-agreement compliance determinations.