Association Urges HRSA to Stop Sanofi 340B Rebate Scheme

December 3, 2024
Evan Schweikert

America’s Essential Hospitals this week called on the Health Resources and Services Administration (HRSA) “to take immediate action” to stop a plan by Sanofi to provide rebates rather than upfront discounts for 340B Drug Pricing Program drugs.

In the Dec. 2 letter to HRSA Administrator Carole Johnson, the association urged the agency to act against Sanofi and “other calculated moves by drug companies to put roadblocks between hospitals and the statutorily required 340B discounts that support lifesaving care.”

In a Nov. 22 notice to covered entities, Sanofi declared its intent to unilaterally impose a rebate model for 25 of its products on certain covered entities, beginning Jan. 6. Sanofi’s proposal would require multiple covered entity types — Critical Access Hospitals, Disproportionate Share Hospitals, Rural Referral Centers, Sole Community Hospitals, and Consolidated Health Centers — to submit 340B claims through a third-party platform, Beacon.

In its letter, America’s Essential Hospitals said Sanofi intends to impose its rebate model without required prior approval from HRSA and pointed out that Sanofi’s plan goes beyond the unlawful provisions of other rebate models, such as one Johnson & Johnson proposed in August, which the association also wrote to HRSA about. In the Dec. 2 letter, the association thanked HRSA for its strong actions to date to defend the 340B program against manufacturers’ rebate schemes.

Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.

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