HHS is weighing whether to redesign its 340B rebate model pilot program after two federal court rulings blocked its implementation and the agency formally agreed to abandon the initiative.
On Feb. 13, the Health Resources and Services Administration issued a request for information to gather input from stakeholders on a potential rebate-based model under the 340B Drug Pricing Program. Comments are open through March 19.
Aimee Kuhlman, vice president of advocacy and grassroots at the American Hospital Association, said the group “welcomes HRSA’s attempt to gather detailed information about the impact of a rebate model.” She said HHS should reconsider policies that shift costs to hospitals serving vulnerable communities.
The original pilot program, announced in August, would have shifted 340B hospitals from upfront drug discounts to a rebate model requiring them to pay full market prices and seek reimbursement later. The American Hospital Association and other plaintiffs sued, arguing the change would impose hundreds of millions of dollars in added costs and jeopardize care for rural and underserved communities.
The U.S. District Court for the District of Maine issued a preliminary injunction Dec. 29. The 1st U.S. Circuit Court of Appeals denied the government’s request for a stay Jan. 7. In a Feb. 5 filing, HHS said further litigation would not be “fruitful” and asked the court to remand the issue to HRSA. On Feb. 10, the district court vacated and remanded the program and related approvals back to HHS.
Any new rebate program would require public notice, a comment period and a delayed effective date of at least 90 days after announcing any manufacturer approvals.
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