March 25, 2013—Health care providers in the 340B program will notice changes in the contract pharmacy enrollment process the next time they use the 340B database to register a new pharmacy.
The Office of Pharmacy Affairs (OPA) described the changes, which take effect with the upcoming April 1-15 quarterly registration period, during a March 20 webinar.[ms-protect-content id=”2799″]
Among the changes:
- Certification of the existence of a 340B contract pharmacy services arrangement will now be done electronically. Previously, covered entities needed to print out, complete, and mail back to OPA a form certifying that a contract pharmacy arrangement was in effect between the parties. The paper form needed to be physically signed by representatives of both the covered entity and the pharmacy. Under the new system, the covered entity’s 340B authorizing official will check a box on an electronic form confirming that he/she is fully authorized to bind both the entity and the pharmacy.
- Language has been added to this certification statement that the authorizing official will now click to accept instead of printing out, signing, and mailing back to OPA. In addition to the attestations of program compliance that were on the old paper form, the authorizing official must now certify that the contract arrangement “will be performed in accordance with OPA requirements and guidelines including, but not limited to, that the covered entity obtains sufficient information from the contractor to ensure compliance with applicable policy and legal requirements, and the covered entity has utilized an appropriate methodology to ensure compliance (e.g., through an independent audit or other mechanism).” Further, the official must now certify that the covered entity “has, and continues to bear, full responsibility and accountability for compliance with all 340B requirements, including but not limited to any 340B violations by the contract pharmacy. The covered entity agrees to notify the Office of Pharmacy Affairs, in writing, of any material changes in the contract arrangement and/or material breach by the covered entity of any of the foregoing.”
- The Drug Enforcement Agency (DEA) pharmacy registration database and the OPA 340B contract pharmacy database have been integrated. Now, when a 340B covered entity begins registering a contract pharmacy online, it will be prompted to search by DEA number for the pharmacy it wants to register. If the entity does not know the pharmacy’s DEA number, or if the pharmacy does not have a DEA number, the entity can still search for the pharmacy by name, city, zip code, and/or state.
- If a covered entity wants or needs to terminate a contract pharmacy arrangement, there will now be a direct link on the OPA database home page allowing it to do so online. Previously, an entity could terminate a contract pharmacy arrangement either (1) by submitting a change request form or (2) while online as an option during the process of registering a different pharmacy.
- Fields in the online contract pharmacy registration form requesting identifying information for the pharmacy under contract will now be auto-filled if the information already exists in the OPA database.
The webinar slides and recording are available at https://hrsa.connectsolutions.com/p4j22g64vg3/.[/ms-protect-content]