Purpose: This tool is used to report the following types of issues for covered outpatient drugs subject to the Rebate Model Pilot Program, to the Health Resources and Services Administration (HRSA):
- 340B rebate denial and/or
- Incorrect 340B rebate amount
Instructions: Enter your information and upload the denied/incorrect rebate information below. Before submission, the covered entity should ensure that the following facts apply to their scenario for a denied 340B rebate and/or incorrect 340B rebate amount:
- Full data have been submitted to the rebate model IT platform and in alignment with approved 340B rebate model plan set forth by the manufacturer.
- Claim has been submitted to rebate model IT platform for 340B rebate within 45 calendar days from date of dispense or administration (unless extenuating circumstance).
- At least 10 calendar days have passed since the submission of rebate claim to rebate model IT platform with the rebate not paid.
- Covered entity has contacted both manufacturer and rebate model IT platform first to report concerns and attempted to resolve the issue in good faith.
- Only denials that are not related to MFP deduplication or a 340B rebate to another covered entity are submitted.
- The rebate amount paid is less than the wholesale acquisition cost (WAC) — 340B ceiling price as validated in OPAIS.
- Calculated Rebate at unit level
Note: do not include PHI in documentation submitted to HRSA. HRSA may reach out to the person submitting this notification for additional information.
All information submitted in this form will be sent directly to HRSA. If you have any questions, contact Apexus Answers.
