Hospitals subject to the 340B Drug Pricing Program (340B Program) Group Purchasing Organization (GPO) prohibition now have an additional four months, until August 7, 2013, to comply with 340B Program guidance issued February 7, 2013, regarding GPO use and inventory replenishment models. Following many requests from members of Congress, industry groups and 340B-participating entities, the Health Resources and Services Administration Office of Pharmacy Affairs (OPA) announced that it will extend the original compliance deadline from April 7, 2013, to August 7, 2013, to allow additional time for hospitals to implement necessary pharmacy inventory systems changes.
OPA has advised that hospitals must continue to work toward meeting the requirements of the February Program Notice and must comply as soon as they are able prior to August 7, 2013. Hospitals must maintain documentation regarding their “best efforts” to come into compliance and be able to demonstrate legitimate reasons for any delays. According to the OPA website, covered entities that intentionally postpone compliance with the GPO prohibition face removal from the 340B Program. In addition, any covered entity that is unable to meet the GPO exclusion compliance standards by August 7 must notify the OPA and “will be terminated from the [340B] program.” The covered entity may then reapply once it is fully compliant during the applicable quarterly registration period.
View the official announcement regarding the deadline extension.
View “340B Drug Pricing Program Notices on Group Purchasing Organizations and Medicaid Exclusion File” for further details regarding the 340B Program GPO prohibition and the OPA Program Notice.