Feds threaten Sanofi over proposed 340B changes

A U.S. government agency warned Sanofi that it faces sanctions over plans to change the way payments are made to most hospitals participating in a drug discount program, the third time in recent months that a major pharmaceutical company has been threatened with such a step.

In a Dec. 13 letter, the Health Resources & Services Administration said that if Sanofi proceeds with its plan, the company could be terminated from the 340B Drug Discount Program. The agency also wrote that the changes require approval by the U.S. Department of Health and Human Services, which oversees the agency. Consequently, HRSA instructed the drugmaker to immediately halt its plans.

The move came after Sanofi disclosed last month that, as of Jan. 6, certain hospitals covered by the 340B Drug Discount Program would receive credits for medicines ordered at full price from a wholesaler. However, the credit would only be issued after the hospital or clinic submits claims data, including the prescription order, a patient’s hospital visit, and dispensing information.