February 340Buzz: Reverberations from the Genesis ruling

Greetings from the tail end of the 340B Coalition Winter Conference in San Diego, where much of the focus was on the landmark Genesis ruling from November over the definition of a 340B patient. The government let pass the Jan. 2 deadline to appeal the decision, which said a prescription does not necessarily need to originate from the covered entity to be deemed 340B eligible, leaving ambiguity to linger.

In a feisty press release, Tony Megna, CEO and general counsel of Genesis Healthcare, the winning plaintiff in that case, said “The court’s ruling is now a final declaratory judgment of a federal court and can be authoritatively used across the nation to help millions of Americans.”

Well, maybe.

While the 340B world continues to talk about this ruling — lawyers are having a field day dissecting the meaning — little appears to have changed on the ground. Remember that the judge cautioned, for what it’s worth, that his ruling applied only narrowly to Genesis, which is not exactly throwing the doors open for other entities to follow suit. And as we learned at 340B Winter, HRSA is reinforcing its standard 1996 patient definition, holding that the covered entity “maintains responsibility for care.” The wiggle room covered entities may find is the lack of language stating care that led to the prescription.

Megna also used his press release to say that “HRSA’s insistence on defining the word ‘patient’ in a manner Congress specifically rejected demonstrates federal agency rule-making authority is unmanageable as it now exists.” He also took swipes at the National Association of Health Centers (NACHC) over its alliance with Big Pharma in ASAP 340B (“Discussion to find common ground is good. Pharma’s financial support of the partnership is highly questionable,” he said), and the South Carolina Primary Health Care Association, saying that “a thorough investigation is ongoing” into what he describes as “serious allegations of misconduct regarding false allegations, the OPA audit, audit process and patient records” involving members of the group. Megna is a member of that organization’s board of directors. Oh, to be a fly on the wall in one of those meetings! Read more >