April 2016 - 340B Pricing System: Manufacturers 340B Database Verification and Other Updates

April 2016

340B Pricing System: Manufacturers 340B Database Verification and Other Updates

As part of the continuous efforts to improve program integrity with the 340B Drug Pricing Program, the Health Resources and Services Administration (HRSA) continues to develop the 340B Pricing System which is designed to calculate, verify, and display 340B ceiling prices.  This secure, web-based system will allow authorized users from covered entities the ability to view 340B ceiling prices for covered outpatient drugs.  Manufacturers participating in the 340B Program will be able to easily upload their quarterly pricing data for their portfolio of covered outpatient drugs and validate their prices with the HRSA-verified 340B ceiling price. This new system will strengthen HRSA’s commitment to transparency and our ability to ensure manufacturer compliance with 340B requirements. HRSA continues to make progress in its efforts to make the system available to manufacturers and covered entities and we will provide details on the timelines and instructions for testing and fully implementing the system as we move forward.

Manufacturers

In order to prepare for the rollout of the new 340B Pricing System, the Office of Pharmacy Affairs (OPA) is requesting that pharmaceutical manufacturers verify the accuracy and completeness of the information on file for each drug labeler code that is currently in the 340B Drug Pricing Program database. Information in the current database will be used by OPA to initiate communication with manufacturers in creation of appropriate users of the new 340B Pricing System.  Therefore, manufacturers should review the database record for each of their labeler codes and submit a manufacturer change request form to 340Bpricing@hrsa.gov if any updates are necessary. If considering a change to the authorizing official, please ensure that the new designee is a corporate officer or someone authorized to legally bind the company to the terms of the Pharmaceutical Pricing Agreement (e.g., Chief Executive Officer, Chief Financial Officer, Chief Operating Officer).

Covered Entities

Covered entities will be assigned log-in credentials for individuals within the organization to access the 340B Pricing System and view 340B ceiling prices.  HRSA will have mechanisms in place to validate the identity of individuals authorized to access the system.  The 340B Pricing System will serve as a mechanism for covered entities to verify that they are paying at or below the posted 340B ceiling price for a covered outpatient drug.

HRSA looks forward to working with all stakeholders as we roll-out the new 340B Pricing System to ensure it is meeting statutory requirements and the needs of the users.