HHS can require approval for drugmakers to apply 340B rebate models, court rules

Judge: HHS has authority to preapprove implementation of 340B ‘rebate models’

A U.S. district court judge for the District of Columbia May 15 ruled the Department of Health and Human Services must preapprove the use of 340B “rebate models” before they can be implemented, which the department has not yet done for any of the models pursued by the plaintiff drug companies.  Judge Dabney Friedrich issued the ruling in a case brought by a number of drug companies, finding that when the statute says that in implementing price r…

HHS can require approval for drugmakers to apply 340B rebate models, court rules

The government “did not act contrary to the law” by requiring drugmakers to seek approval before implementing proposed new 340B rebate models, a federal judge ruled. The decision marks a key win for HHS and ...