On June 15, 2022, in a win for hospitals, the Supreme Courtroom issued its opinion in American Hospital Affiliation et. al. v. Becerra (“Becerra”), overturning huge reimbursement reductions within the 340B drug pricing program (“340B Program”).
The 340B Program, wherein some 40% of U.S. hospitals take part, requires drug producers to supply outpatient medication to taking part suppliers at closely discounted charges. Taking part hospitals depend on income from the differential between the reimbursement they obtain for these medication and the discounted charges they pay to fund affected person care companies.
Becerra reversed a D.C. Circuit ruling that upheld the U.S. Division of Well being and Human Companies’ (“HHS”) $1.6 billion annual reduce to reimbursement within the 340B Program. Writing for a unanimous Courtroom, Justice Brett Kavanaugh famous that “all agree that HHS didn’t conduct a survey of hospitals’ acquisition prices” earlier than decreasing reimbursement within the 340B Program a number of years in the past. The Courtroom discovered that “beneath the textual content and construction of the statute, this case is due to this fact easy,” and concluded that HHS’ choice to differ reimbursement charges just for hospitals in 2018 and 2019 was illegal as a result of it didn’t conduct a survey of hospitals’ acquisition prices in these years.
HHS’ transfer to scale back 340B drug reimbursement originated in 2017, when it issued a remaining rule decreasing hospital reimbursement beneath the 340B Program for 2018 from 6% over every drug’s common gross sales worth to 22.5% beneath the typical gross sales worth, leading to a complete reimbursement discount of $1.6 billion. A number of hospital teams sued to problem this discount within the U.S. District Courtroom for the District of Columbia, claiming that the change was in violation of federal legislation and exceeded HHS’ statutory authority. The District Courtroom dominated in favor of the hospitals in December 2018, and ordered further briefing to find out an applicable treatment. However, on January 1, 2019, HHS effectuated its 2019 Outpatient Potential Fee System rule, which continued the 340B Program cuts first carried out within the prior yr, and expanded them to further hospital areas. In Might 2019, the District Courtroom additionally discovered the 2019 rule illegal, however didn’t vacate both rule, selecting as a substitute to remand the principles to HHS for the company to determine easy methods to “unscramble the egg,” given the complexities of Medicare reimbursement.
HHS didn’t revert to its prior fee methodology for 340B Program medication, nor did it make retroactive fee changes to suppliers. As an alternative, HHS appealed the District Courtroom selections to the U.S. Courtroom of Appeals for the District of Columbia Circuit. In July 2020, a three-judge panel of the Courtroom of Appeals reversed the District Courtroom, ruling in favor of HHS and cleared the best way for HHS to proceed and construct up their cuts to 340B Program drug reimbursement. In August 2020, HHS proposed additional cuts to 340B reimbursement, with medication to be reimbursed at common gross sales worth minus 34.7%, plus an add-on of 6% of the merchandise common gross sales worth, for a web fee fee of common gross sales worth minus 28.7%.
If HHS decides to maneuver ahead with its plan to slash funds beneath the 340B Program after Becerra, it’s going to take time to conduct surveys and future rulemaking. For now, hospitals can take a sigh of reduction as they’re now not dealing with a 10-figure discount in reimbursement from the 340B Program.