Covered entitles and 340B program stakeholders should prepare now for a disruption to the 340B Office of Pharmacy Affairs Information System (340B OPAIS) from August 15, 2017 to mid-September, 2017. During this time, the Office of Pharmacy Affairs (OPA) database will be offline and covered entities will be unable to make any changes. The information in the database as of August 15, including covered entity, contract pharmacy, and manufacturer listings, and the Medicaid Exclusion File, will be available for download in the form of static spreadsheets. OPA will use this time to transition to a new system that will include the long-awaited ability for covered entities to verify 340B ceiling prices. The new system will come online in mid-September 2017, according to OPA.
While the 340B OPAIS is unavailable, covered entities will not be able to submit change requests or terminations. More specifically, covered entities will not be able to terminate participation in the 340B program for itself, a child site, or a contract pharmacy. Additionally, covered entities will be unable to change their Medicaid Exclusion File designation or the contacts listed as their authorizing official or primary contact. Covered entities and other program stakeholders can also expect reduced search functionality, due to the limitations of the static spreadsheet reports. The reports, however, will allow stakeholders to verify covered entity participation in 340B, manufacturer participation, and contract pharmacy relationships as registered on August 15, 2017.
Feldesman Tucker Leifer Fidell LLP strongly encourages covered entities to request any needed changes by the end of the day on Monday, August 14. Covered entities should also document and develop their own archive of the information currently included on the 340B OPAIS, in case there are any issues with the migration of data to the new system. Covered entities should print their current database entries and/or save screenshots and retain the records until they can verify that the migration is complete and the new database accurately reflects the records.
If you have any questions or concerns regarding this topic, please contact Jason Reddish, Michael Glomb, Issie Karan or the Feldesman Tucker Leifer Fidell LLP attorney with whom you regularly work.