The federal government is appealing a district court ruling from March 3, 2026 that struck down a Health Resources & Services Administration (HRSA) policy requiring registration for new off-site outpatient facilities (child sites) of 340B hospitals before those facilities could access 340B pricing.
In the ruling, the court found that HRSA lacked statutory authority to require child sites to be listed on a filed Medicare cost report and registered in its database as prerequisites to receive the drug discounts.
The decision overturned a policy that had postponed 340B savings for months or years for many hospitals. For now, the decision remains in effect, but the federal government may seek a stay to pause the ruling during the appeal. If a stay is granted, the prior requirements would be at least temporarily reinstated, meaning that before receiving 340B pricing, new child sites would have to:
- Appear on the hospital’s Medicare cost report
- Be registered in the Office of Pharmacy Affairs Information System (OPAIS) database
How Forvis Mazars Can Help
Our experienced professionals will continue to monitor this case and other 340B litigation and share updates as they become available. If you have questions about how the court ruling or the appeal may affect your organization, please reach out to our team today.