On May 17, 2021, the Health Resources and Services Administration (HRSA) sent letters to six drug manufacturers stating that their policies placing restrictions on 340B Program pricing to covered entities that dispense medications through pharmacies under contract have resulted in overcharges and are in direct violation of the 340B statute. In it’s letter HRSA is requiring each manufacturer to:
- Immediately begin offering its covered outpatient drugs at the 340B ceiling price to covered entities through their contract pharmacy arrangements and
- Refund or credit all covered entities for overcharges that resulted from the manufacturers’ policies regarding drugs dispensed by contract pharmacies.
The 340B Program Ceiling Price and Civil Monetary Penalties (CMP) 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 not to exceed $5,000 for each instance of overcharging. Assessed CMPs would be in addition to repayment for overcharging.
HRSA stated that it had determined that these policies have resulted in 340B ceiling price overcharges and are in direct violation of the 340B statute. HRSA’s letter states: “[The drug manufacturer] must immediately begin offering its covered outpatient drugs at the 340B ceiling price to covered entities through their contract pharmacy arrangements, regardless of whether they purchase through an in-house pharmacy. [The drug manufacturer] must comply with its 340B statutory obligations and the 340B Program’s CMP final rule and credit or refund all covered entities for overcharges that have resulted from [this] policy. . . . Continued failure to provide the 340B price to covered entities utilizing contract pharmacies, and the resultant charges to covered entities of more than the 340B ceiling price, may result in CMPs as described in the CMP final rule.”
The full text of the letters can be found by visiting www.hrsa.gov/opa/index.html.