Beginning in July 2020, the manufacturers began taking specific actions that limited covered entity’s access to discounted drugs available for purchase under the 340B Program. Some manufacturers stopped providing the 340B ceiling price on their drug products sold to covered entities and dispensed through contract pharmacies, while others limited sales by requiring specific data submissions or selling drug products only after a covered entity demonstrated 340B compliance. HRSA conducted a review of these actions and an analysis of complaints received from covered entities, resulting in the letters sent by HRSA.
The 340B Program Ceiling Price and Civil Monetary Penalties final rule states that any manufacturer participating in the 340B Program that knowingly and intentionally charges a covered entity more than the ceiling price for a covered outpatient drug may be subject to a Civil Monetary Penalty (CMP) not to exceed $5,000 for each instance of overcharging. Assessed CMPs would be in addition to repayment for an instance of overcharging.The full text of the letters can be found on the HRSA Program Integrity page.