"The Omnibus Guidance is Dead!"
The proposed 340B Drug Pricing Program Omnibus Guidance that was issued in August 2015 and promised to turn the 340B world on its head was withdrawn on January 30, 2017.
Not that most covered entities are upset. The proposed 340B Drug Pricing Program Omnibus Guidance proposed a host of changes to the 340B Drug Pricing Program, a law that requires drug manufacturers to provide discounts on “covered outpatient drugs” to “covered entities,” when those “covered entities” provide the drug to “eligible patients.” As we’ve covered in multiple posts, these changes ran the gamut–and most of the time, to the detriment of covered entities. Probably the most significant proposed change was the overhaul of the patient definition, which, among other things, tightened the nexus between a patient, a prescriber, and the covered entity registered site.
If you are a long-time reader you are probably thinking–I’ve seen this title before. Yup, you absolutely have. This is not the first time the Health Resources and Services Administration (HRSA) and the Office of Pharmacy Affairs (OPA) have attempted to shake up the 340B world. On December 5, 2014, we told readers that a similar “Mega Rule” was dead. Funny, it was withdrawn as well.
Regardless of what happens, 340B guidance will continue to keep us on our toes.