6 drugmakers in violation of 340B statute, HRSA says

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Six drugmakers are in violation of the 340B statute and must immediately begin offering their drugs at discounted prices to hospitals participating in the federal drug-pricing program, Diana Espinosa, acting administrator of the Health Resources and Service Administration, said. 

Ms. Espinosa sent letters to six drugmakers May 17 stating that HRSA determined their policies that place restrictions on the 340B drug pricing program for hospitals that dispense drugs through contract pharmacies have resulted in overcharges and are in direct violation of the 340B statute. 

The 340B program was created in 1992 and requires drugmakers to offer discounts on all outpatient drugs to hospitals and clinics that serve indigent populations. About 2,500 hospitals nationwide participate in the program. 

The letters were sent to AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi and United Therapeutics. 

Starting last July, the six drugmakers began putting policies in place that limited access to drug discounts for hospitals and other healthcare facilities covered under the 340B program. Some of the drugmakers stopped giving 340B discounts to hospitals that use contract pharmacies, and some limited sales by requiring specific data submissions from hospitals. For example, Novo Nordisk asked 340B hospitals to send them Medicare Part D and commercial health claims for patients before they'd offer the discounts. 

HRSA conducted a review of the drugmakers' actions and analyzed complaints from hospitals and other covered entities and found the policies violated the 340B statute and caused hospitals to be overcharged for the drugs covered under the program. 

Ms. Espinosa wrote in the letters that each drugmaker must immediately begin offering their covered drugs at the 340B ceiling price even if hospitals use contract pharmacies. They must also credit or refund all hospitals for overcharges that resulted from the limiting policies. If they don't, the drugmakers may face civil monetary penalties for each instance of overcharging. 

Read HRSA's full news release here.

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