December 2014

The issue of duplicate discounts in the 340B Program is one that touches all stakeholders in the program, and requires unilateral cooperation to achieve compliance.  In order to ensure that manufacturers do not pay a Medicaid rebate in addition to providing a 340B discount, covered entities and states must work closely together.  Since the inception of the Program, HRSA has met its statutory requirement to provide a mechanism to assist this process by regularly posting a Medicaid Exclusion File, which lists all of the covered entities that choose to use 340B drugs for their Medicaid patients.

This issue has grown more complicated in recent years with the advent of Medicaid rebates for drugs paid through Medicaid Managed Care Organizations. While HRSA and the Centers for Medicare and Medicaid Services (CMS) continue to work closely together to develop policy in this area, HRSA has issued a clarification to its current policy pertaining to Medicaid Fee for Service, Clarification on Use of the Medicaid Exclusion File (PDF - 71 KB). We encourage covered entities and states to continue to communicate with HRSA and CMS to share best practices and inform the policy development process.