What Happens Next
As part of the agreement to vacate the challenged actions, HHS pledged that if it revisits a rebate model in the future, it will undertake a formal public comment period. The agency also committed that any new rebate program would not take effect until at least 90 days after public notice of drug approvals tied to the initiative.
Rick Pollack, president and CEO of the American Hospital Association, welcomed the retreat.
“The AHA hopes that through a new regulatory process and careful consideration of comments from 340B hospitals, HHS will recognize that imposing hundreds of millions of dollars in costs on hospitals serving rural and underserved communities is not a sound policy,” Pollack said in a statement.
HHS did not immediately respond to a request for additional comment.
The Legal Teams
HHS is represented by Jason K. Altabet, Michelle R. Bennett and Yaakov M. Roth of the U.S. Department of Justice’s Civil Division, Federal Programs Branch.
The hospitals are represented by Karen L. Dunn, L. Rush Atkinson, Lyle W. Gruby, Jenifer N. Hartley and Tyler T. Mikulis of Dunn Isaacson Rhee LLP, along with Melissa A. Hewey and Jennifer S. Riggle of Drummond Woodsum Attorneys at Law.
For now, the 340B program remains intact in its current form — a fragile equilibrium between hospitals and drugmakers that continues to shape access to medications for millions of low-income Americans.
