On Nov. 29, the Health Resources and Services Administration (HRSA) finalized a new Jan 1. 2019 effective and implementation date for a final rule providing guidance on the calculation of ceiling prices for drugs administered through the 340B Drug Pricing Program.
The rule will impose civil monetary penalties (CMPs) for manufacturers who knowingly and intentionally charge covered entities more than the ceiling price for covered outpatient drugs. Following several delays, the rule most recently was scheduled for implementation on July 1, 2019.
The Jan. 1 effective date represents a significant victory for essential hospitals. Earlier this year, America’s Essential Hospitals and three other national organizations representing hospitals and other stakeholders in the 340B Drug Pricing Program sued the federal government over the delay of these regulations.
The association released a statement praising the rule, which will benefit patients and essential hospitals that rely on 340B savings to make affordable drugs and health care services available to vulnerable people and underserved communities.
Contact Senior Director of Policy Erin O’Malley at firstname.lastname@example.org or 202.585.0127 with additional questions.