The End of a Wild Year for 340B: HHS Issues Advisory Opinion and New GAO Report Sheds Light on HRSA’s Enforcement Pullback

2020 was a tumultuous year for virtually everyone and everything, and the 340B Program was no exception. As we outlined in previous articles, many drug manufacturers have decided that the Health Resources and Services Administration’s Office of Pharmacy Affairs (“HRSA OPA”) guidance on contract pharmacy[1] arrangements is no longer binding. Accordingly, many drug manufacturers have … Continue Reading

Notice to Covered Entities: Manufacturer Seeking 340B Claims Data

By Brenda Maloney Shafer and Richard Davis on July 10, 2020 Posted in Compliance, Covered Entities, Guidance, Manufacturers

While we addressed recent wins for 340B covered entities concerning manufacturer transparency in a previous article, Merck Sharpe & Dohme Corp. (“Merck” or “Manufacturer”) now appears to seek its own access to 340B covered entity data in a different fashion. Specifically, over the past few weeks, Merck has sent letters to numerous 340B covered entities … Continue Reading

Comparing 340B University and the 340B Coalition Conference

By Alyce Katayama and Elizabeth Gebarski on March 9, 2016 Posted in Audits, Contract Pharmacies, Covered Entities, Guidance, Manufacturers

Maybe it is just us, but we wanted to know whether we would get a different experience at 340B University versus the 340B Coalition Conference. In some ways, these conferences could not have been more different. But, at the heart of it all, each had the same underlying education of stakeholders so that covered entities … Continue Reading