A recent Health Resources and Services Administration (HRSA) webinar gave covered entities in the 340B Drug Pricing Program an overview of the new secure pricing component of the Office of Pharmacy Affairs Information System (OPAIS), scheduled to launch April 1.
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.
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.
Contact Senior Director of Policy Erin O’Malley at firstname.lastname@example.org or 202.585.0127 with questions.