In his latest column for Omnicell, 340B Report Publisher and CEO Ted Slafsky ponders four burning questions as we approach the first anniversary of drug manufacturers stopping or placing restrictions on 340B drug discounts in the contract pharmacy setting.
1. If the drug manufacturers prevail, will the 340B law need to be opened up? Slafsky notes that a federal judge recently held in AstraZeneca’s lawsuit against the U.S. Health and Human Services Department (HHS) that the 340B statute is silent about contract pharmacy, and said it is up to Congress to clarify the law.
2. If the government prevails, what is the refund mechanism? “The mechanism for making covered entities whole” for manufacturer overcharges on drugs shipped to contract pharmacies “remains unclear,” Slafsky points out.
3. What’s next for the long-awaited administrative dispute resolution (ADR) process? “HHS is moving forward with the ADR even though a federal district judge in Indianapolis has barred the government from implementing or enforcing 340B ADR regulations against Eli Lilly,” Slafsky observes. “In issuing her temporary injunction, U.S. District Judge Sarah Evans Barker said Lilly would likely prevail in court on its claim that HHS violated administrative procedures in finalizing the ADR rule.”
4. Is there still a possibility for changes to the ADR rule? “Some leading 340B thought leaders have speculated that perhaps it would be a positive development for the ADR regulation to be re-opened to address what is perceived as an inherent bias among some of the panelists,” Slafsky says. “Some 340B advocates are worried that the CMS [Centers for Medicare & Medicaid Services] panelists will have difficulty serving in a neutral role,” he says.
“It will be very interesting to see how this all plays out in the coming months,” Slafsky concludes. Click here to see his full column.