340B Ceiling Price Unavailable / Incorrect Notification for HRSA

Use this tool to report the following types of issues for covered outpatient drugs, to the Health Resources and Services Administration (HRSA):

• • Unavailable at a 340B ceiling price and/or
  • Incorrect 340B ceiling price (overcharge)

Before Submitting the Tool:

1. Contact the wholesaler and manufacturer directly to determine:

• • The reason for 340B price unavailability, or
  • The reason for incorrect 340B pricing

Maintain records of communication with other stakeholders to support a report of 340B price availability or accuracy issues to HRSA.

2. Confirm Drug Eligibility

• • Verify the product is a covered outpatient drug under the Medicaid Drug Rebate Program (MDRP).
  • Confirm:
    • MDRP participation
    • Labeler code is active in 340B OPAIS

For Rural Referral Centers, Sole Community Hospitals, Critical Access Hospitals, and Free-Standing Cancer Hospitals, orphan drugs are excluded from the definition of covered outpatient drug.

3. Validate Pricing (if applicable)

If the issue involves incorrect pricing:

• • Verify the drug should have a 340B ceiling price in OPAIS.
  • Compare:
    • The OPAIS ceiling price (unit level)
    • The invoice purchase price
  • Multiply the unit price by the total package size (mL, tablets, capsules, grams, etc.) as needed.
  • Adjust for wholesaler distribution fees or markups.

Prime Vendor participants can also verify the selling price using the Prime Vendor Program catalog.

4. Confirm Unavailability (if applicable)

• • Confirm product unavailability through the wholesaler and/or manufacturer.
  • Document confirmation of supply or pricing issues.

Tool Instructions:

1. Submit Documentation

• • Complete the required fields and upload your report using the 340B Ceiling Price Unavailable/Incorrect Submission Template.
  • Map all required fields correctly.
  • Do not include Protected Health Information (PHI) in any documentation submitted to HRSA.
  • Include only one (1) manufacturer per form. Multiple NDCs from the same manufacturer may be included on the same form.
  • If the 340B ceiling price is unavailable and/or incorrect from multiple manufacturers, please submit a separate form for each manufacturer.

If needed, upload additional supporting documentation (e.g., wholesaler catalog screenshots, third-party vendor replenishment reports, correspondence with wholesaler and/or manufacturer—no PHI).

2. After Submission

• • A copy of the report will be emailed to the address provided.
  • HRSA may contact the submitter for additional information.
  • HRSA investigates allegations of non-compliance and may extend follow-up timelines if more information is needed.