Continued concerns by drug manufacturers about the size of the 340B program are driving a surge in manufacturer good faith inquiries to 340B covered entities and 340B program audits by manufacturers. Knowing how to respond is essential to safeguard program integrity and continued participation—especially with the 340B rebate pilot model launching in 2026 and expanding manufacturer policies limiting purchasing of 340B drugs.
Join McDermott and Rx|X Advisory Services for a practical discussion for 340B covered entities on appropriately responding to and managing good faith inquiries and audit notices.

The program will explore:

• Why manufacturers are reaching out and what it means for your organization
• Office of Pharmacy Affairs’ (OPA’s) view on good faith outreach
• How good faith inquiries escalate into audits—and how to navigate both
• Risks of mismanaging the process
• 340B program operational elements that may increase the risk of a manufacturer good faith inquiry or audit

For inquiries contact Kajal Rohatgi.

Continuing legal education (CLE) credit is pending. McDermott Will & Schulte LLP is an approved provider and can provide credit in California, Illinois, and New York. McDermott Will & Schulte is a sponsor and will apply for credit in Delaware, Florida, Georgia, Tennessee, Texas, and Virginia when lawyers licensed in these jurisdictions are in attendance. We can issue reciprocal credit for lawyers licensed in Connecticut and New Jersey. For all other jurisdictions not listed, attendees will be provided with a Universal Certificate of Attendance that they may use to self-apply for CLE credit in their state of admission. Attendees should contact their state’s CLE board for current rules, regulations, and guidance.