The Biden administration’s embrace of the federal government’s traditional stance on the enforceability of program guidance—which the Trump administration rejected—may lead to stronger enforcement of 340B program guidance and possibly even the issuance of new 340B guidelines, 340B Report Publisher & CEO Ted Slafsky predicts in his latest column for Omnicell, a 340B report sponsor.
Slafsky observes that the 340B program has been administered largely under federal guidelines, which carry less weight than federal regulations. The U.S. Health Resources and Services Administration (HRSA), he says, “made it clear over the four years of the Trump administration that its hands were tied when it came to 340B enforcement, due to a Trump administration policy that had required federal departments and agencies to treat guidance documents as non-binding, both in law and in practice, except as incorporated into a contract.”
HRSA’s supposed lack of authority to enforce its 340B guidance is central to the recent debate over the contract pharmacy program, he continues. Drug manufacturers have refused to provide 340B pricing at contract pharmacies on the grounds that that HRSA’s 340B contract pharmacy guidance is not enforceable, he says. Slafsky looks further into this argument and why it may not hold sway under the new administration.
Also in his column, Slafsky provides an update on Community Voices for 340B (CV340B), the first grass tops / grassroots advocacy organization for the 340B program.