AHF advocates hold a demonstration in support of 340B drug pricing in Washington D.C., 2015.

2023 State of Play for the 340B Drug Pricing Program

In Eblast by Brian Shepherd

Despite calls for reform by opponents, 340B enjoys broad bipartisan support. On the legislative front, lawmakers have introduced legislation that, if enacted, would alter program operations. Multiple court cases regarding contract pharmacy use are working through the judicial system. In the current environment, AIDS Healthcare Foundation navigates these complex political and legal challenges to ensure 340B functions as a health and wellness multiplier for our 100,000+ patients.

Multiple 340B-specific bills find themselves in different stages of the legislative process. By far, the bill with the most action in the U.S. House of Representatives comes from longtime 340B opponent, U.S. Representative Larry Buschon. In May, the unnamed H.R. 3290 advanced from the House Energy and Commerce Committee on a party-line vote, 29-22. The legislation adds new reporting requirements for 340B covered entities. If enacted, providers must report the number and percentage of patients who receive 340B priced drugs and how they use 340B savings.

Action in the U.S. Senate centers around a request for information authored by a bipartisan cadre of six senators; among other questions, the RFI asks 340B stakeholders for specific policy proposals that could improve program oversight, a frequent ask from drug companies, and policy specifics to establish certainty in contract pharmacy arrangements, a common refrain by covered entities. Legislation sponsored by the bipartisan group could have legs, as these longtime 340B supporters have credibility when it comes to how 340B functions.

The rapid onslaught of contract pharmacy restrictions handcuffs many 340B providers. To date, over two dozen drug companies have limited access to prescriptions available at 340B prices. Drug makers filed multiple lawsuits, resulting in legal ambiguity that ties the hands of federal regulators. On January 30, 2023, the U.S. Third Circuit Court of Appeals ruled in favor of drug manufacturers in Sanofi Aventis U.S. LLC v United States Department of Health and Human Services.  The court said drug makers have no obligation to provide drugs at 340B prices to an unlimited number of contract pharmacies. Providers await decisions in the D.C. Circuit and Seventh Circuit. If the appellate courts produce a split decision, the matter could head to the Supreme Court.

Here is the good news – 340B legislation appears stalled in both chambers.  Yet, opponents remain determined to dismantle the program.

To help protect 340B, please visit https://www.let340b.org/take-action/.

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