With all due credit to the Coroner from the Wizard of Oz, like the Wicked Witch of the East crushed by Dorothy’s house, the 340B Drug Discount Program mega-reg is “not only merely dead, it’s really most sincerely dead.” And to quote one of my favorite sports commentators, Tony Kornheiser, “I believe I had that.”
Let’s recap. In January 2014, HRSA announced that it would be “formalizing” existing guidance and issuing a regulation designed to cover “a number of aspects” of 340B program operations. Termed the “mega-reg,” it was intended to address such controversial issues as the definition of a “patient” eligible to receive a 340B drug, compliance requirements for 340B contract pharmacies, and mandatory criteria for hospital eligibility as a 340B covered entity. HRSA stated that the proposed mega-reg would be published and available for comment no later than June 2014. And indeed the draft rule was forwarded to OMB for review in April 2014. So what happened? Well, let’s just say that HRSA’s Orphan Drug Rule was the tornado which carried the house to Oz, causing it to land on the witch.