Reporting of 340B Ceiling Prices

On November 30, HRSA announced that it is “notifying all stakeholders that the secure pricing component of the 340B Office of Pharmacy Affairs Information System (340B OPAIS) will be open for the submission of manufacturer pricing data in the first quarter of 2019.”

This means that manufacturers will be able to report 340B Ceiling Prices directly to HRSA in the OPAIS beginning Q1 2019. This appears why HRSA finalized its proposal moving up implementation of the final civil monetary penalty rule to January 1, 2019; as I noted in May, HRSA had previously proposed delaying implementation until July 1, 2019. If you have questions about how this may affect your reporting obligations, please contact Stephanie Trunk.