America’s Essential Hospitals on May 28 urged the Department of Health and Human Services (HHS) to reject rebate models in formal guidance for the 340B Drug Pricing Program.
In a letter to HHS Secretary Robert F. Kennedy Jr., the association argued that “rebate policies have the effect of letting the fox guard the hen house” and “impose unacceptable burdens on safety net providers, and cause significant harm to patients.” The letter urges HHS to make clear it has carefully and fully considered all relevant factors, while rejecting all rebate models.
The letter follows several lawsuits from drug manufacturers asking the court to immediately authorize 340B rebate models that the government has blocked. While the judge ultimately ruled that secretarial pre-approval is required for such changes to the 340B program, the court questioned the lack of clarity from the department under which circumstances rebates could be authorized. Before the court issued a decision, HHS alerted the court of its intent to issue guidance on rebate models within the 340B program.
The judge in that case ordered HHS to reconsider manufacturer Sanofi’s proposed rebate model. Separately, the courts are yet to rule on the case brought by Johnson & Johnson, also seeking rebate model authorization.
Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.
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