On Wednesday, May 6, the Health Resources and Services Administration, Office of Pharmacy Affairs (“OPA”) forwarded a draft copy of its 340B Program Omnibus Guidelines (“Guidelines”) to the Office of Management and Budget for review.

What You Need to Know:

It is unclear whether the Guidelines represent OPA’s attempt to repackage and release the much anticipated Mega-Reg that was withdrawn back in November 2014. In any event, Polsinelli will continue to monitor the status of the Guidelines and will provide updates as they become available. A link to the OMB notification regarding the Guidelines can be found here.

In the meantime, watch for new legislation giving OPA 340B broader rulemaking authority beyond implementation of the 340B program.