Tips for Manufacturers: 340B Ceiling Price Reporting

Office of Pharmacy Affairs Update

Reporting Mechanism

The fourth submission window to the 340B Office of Pharmacy Affairs Information System (OPAIS) Pricing Component will open in November 2019. HRSA reminds manufacturers that both section 340B(a) of the Public Health Service Act and the Pharmaceutical Pricing Agreement (PPA) require a manufacturer to submit quarterly pricing information. The 340B OPAIS pricing component is the sole reporting mechanism for this information. Emailing price lists to HRSA does not meet this obligation and lists that are submitted via email or other means are not routinely reviewed. Manufacturers should notify any third party vendors that submit pricing information on their behalf, that email notification is not required.

Restatements

If a restatement of a manufacturer’s product(s) occurs, that price change will not be captured in the 340B OPAIS pricing component. The pricing component is a static system; therefore, once a 340B ceiling price is published in the 340B OPAIS pricing component, that published price will remain posted in OPAIS. HRSA receives a quarterly correction file from the Centers for Medicare & Medicaid Services (CMS) to use as a reference, should a dispute arise regarding a 340B ceiling price that may have changed since the original reporting to 340B OPAIS. 

New Drug Products Reporting

New drug products may not appear in the 340B OPAIS pricing component for the first reporting period after product launch. CMS’ quarterly Medicaid Drug Rebate Program (MDRP) drug product file feeds the 340B OPAIS pricing component the list of covered outpatient drugs that will receive pricing submissions. A new drug product may launch at any point in the quarter and the MDRP drug product file for that quarter may already be established. If there is a new drug product for a labeler that does not appear in 340B OPAIS, the manufacturer is still required to estimate and charge covered entities the new drug ceiling price as described in the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties final rule (82 FR 1210, January 5, 2017), even though no price will be published for the new drug product that quarter. Once the product appears on the MDRP drug product file, a manufacturer can submit pricing information:

  • AMP or URA, if available, or
  • WAC with the appropriate rebate percentage and an explanation in the notes field that it is a new drug price estimation.

Data Discrepancies

Whenever there is a discrepancy with the information submitted by a manufacturer and the information loaded in the 340B OPAIS pricing component, the manufacturer is required to provide a comment in the notes field. The notes field was recently upgraded to allow for 1000 characters to be entered. Please provide a detailed justification of the information submitted by the manufacturer. This will limit the number of requests from HRSA for additional information outside the 340B OPAIS pricing component.

For More Information

Please visit HRSA OPA’s 340B OPAIS Educational Resource page and the 340B Prime Vendor website HRSA Exit Disclaimer to view newly published FAQs and published tutorials. For technical assistance, or if you need further information, the 340B Prime Vendor Program is available at ApexusAnswers@340bpvp.com or by phone at 888-340-2787.

Date Last Reviewed:  October 2019