The Health Resources and Services Administration (HRSA) on April 1 launched a long-awaited website that outlines pharmaceutical manufacturers’ ceiling prices under the 340B Drug Pricing Program.
The website is part of the Office of Pharmacy Affairs Information System (OPAIS).
In December 2018, HRSA finalized a Jan 1, 2019, effective and implementation date for a rule providing guidance on the calculation of ceiling prices for drugs administered through the 340B program. The rule also imposes civil monetary penalties for manufacturers who knowingly and intentionally charge covered entities more than the ceiling price for covered outpatient drugs. The announcement came after America’s Essential Hospitals and other plaintiffs sued the agency to move up the implementation date, following several delays.
After HRSA moved up the effective date, the association released a statement praising the change and encouraging the Department of Health and Human Services (HHS) to launch a website providing price information to 340B participating hospitals as soon as possible.
Webinar: Overview of New Site
A recent HRSA webinar offered 340B covered entities a preview of the secure pricing component of the OPAIS.
Recommended for authorizing officials and primary contacts, the recorded webinar includes a review of the website’s quarterly workflow, including manufacturer data submission and publication of 340B ceiling prices. Covered entities also learned how they can view this data and report 340B pricing issues to the agency.
Contact Senior Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.