HRSA directs Sanofi to cease implementing unapproved 340B rebate proposal聽
The Health Resources and Services Administration last week directed Sanofi to cease implementation of its 340B rebate proposal immediately and to inform HRSA of its plans no later than Dec. 20 in order to provide adequate notice to covered entities.
鈥淏y way of this correspondence, HRSA provides warning that this unapproved credit proposal violates Sanofi鈥檚 obligations under the 340B statute, and HRSA expects Sanofi to cease implementation of it,鈥 HRSA Administrator Carole Johnson.
The letter says that the proposal, if implemented, would violate Sanofi鈥檚 obligations under the 340B statute and subject Sanofi to potential consequences, such as termination of Sanofi鈥檚 Pharmaceutical Pricing Agreement and civil monetary penalties.
In its to 340B covered entities, Sanofi said it would be effectuating 340B discounts via the new credit model as of Jan. 6, 2025, for disproportionate share hospitals, critical access hospitals, rural referral centers and sole community hospitals.