The U.S. Department of Health and Human Services is seeking feedback from stakeholders on a potential rebate-based model change under the 340B Drug Pricing Program.
Earlier this month, following unfavorable court rulings, the agency halted a pilot program that would have changed the way in which rebates are applied. Although discounted prices traditionally have been provided upfront, the pilot program would have required hospitals to provide data to drug manufacturers after certain drugs were dispensed. The Trump administration said this would address drugmaker concerns about abuse and fraud as the number of 340B purchases increases.
The American Hospital Association and several leading hospitals countered that the proposed program would cost vulnerable safety-net hospitals hundreds of millions of dollars and reduce their ability to provide care. They filed a lawsuit in December, alleging that the administration was implementing changes without following the proper notice-and-comment rulemaking process.
Days before the pilot was set to take effect, a federal judge paused its implementation Although the administration appealed this decision, the First Circuit Court of Appeals upheld the lower court's ruling. It said the federal government had failed to convince the judges it would succeed on the merits of its case.
HHS is asking 340B stakeholders to provide answers to multiple questions so the Health Resources and Services Administration can evaluate whether it should implement a 340B rebate model pilot program and how such a program might be designed. The HRSA encourages commenters to "include supporting facts, research and evidence."
Aimee Kuhlman, the hospital association's vice president of advocacy and grassroots, welcomed the announcement.
"The AHA welcomes HRSA's attempt to gather detailed information about the impact of a rebate model," she said in a statement. "We look forward to working with the agency to answer the many specific questions it has posed to 340B hospitals and other stakeholders. We hope that after careful consideration of comments from 340B hospitals and other stakeholders, HRSA will recognize that imposing hundreds of millions of dollars in costs on hospitals serving rural and underserved communities is not a sound policy."
Comments will be accepted through March 19. Any new rebate program would require a delayed effective date of at least 90 days after announcing any manufacturer approvals.
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