Important 340B Program news alert (5/17/2021)
HRSA has weighed in on a significant issue that has plagued the 340B industry over the past several months by sending letters to six manufacturers expressing that not offering 340B pricing on products directly violates the 340B Program statute (read more here). HRSA made references to the 340B Program Ceiling Price and Civil Monetary Penalty final rule in their communication to the manufacturers. As a result, covered entities should be prepared to work with the manufacturers, wholesalers, and 340B software systems to discuss incorporating these items back into their 340B programs. Additionally, auditable records of any instance where the lack of 340B price prevented a discount from occurring should be collected in the event a historical settlement is available. As always, please let us know how we can help with your 340B program.