Get caught up with the latest updates on 340B program drug manufacturers.
In August of 2020, Merck was one of the first drug manufacturers to request additional obligations from Covered Entities in order for the Covered Entity to continue to receive 340B Pricing for outpatient drugs through Contract Pharmacy arrangements. At that time, Merck requested Covered Entities to submit contract pharmacy transactions for its drugs through the Second Sight Solutions, 340B ESPTM platform.
Merck stated they were implementing this new program request “in order to monitor operations and help ensure compliance with the 340B Program requirements.” Beginning September 1st, 2021, Merck changed the requirements from voluntary submission of data to a required submission of data to receive 340B Pricing through a contract pharmacy arrangement.
Effective August 1st, 2021, Boehringer Ingelheim (BI) was the eighth drug manufacturer to impose 340B Pricing restrictions. BI stopped honoring shipment of 340B Priced drugs for Covered Entities to their contracted commercial pharmacies. Covered Entities can still select one contract pharmacy arrangement through 340B ESPTM if they do not have an in-house pharmacy capable of dispensing to its patients.
Currently, six drug manufacturers have filed lawsuits against HHS to prevent any legal enforcement by HHS resulting from drug manufacturers discontinuing 340B Pricing through all contract pharmacy arrangements. The lawsuits are all in different phases with no current indication on how the various federal courts will rule.
Recently, a federal judge presiding over a highly anticipated AstraZeneca suit moved the hearing date of the case from September 14th to October 18th.
We know it can be hard to keep track of regulations and guidance and make your hospital 340B compliant. If you’re tired of feeling overwhelmed and confused, our 340B auditing team is here to help. Schedule a call with our team today!