The U.S. Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) posted a notice yesterday about changes to the covered entity registration and manufacturer pricing components of 340B OPAIS, the 340B program database.
Today is the first day of the 15-day third quarter 2020 period for registration of new covered entities and the addition of outpatient facilities to the 340B program.
The public notice says OPA made two changes to its database’s covered entity registration component.
Group Change Request Function. This new function will allow entities with the same Authorizing Official (AO), Medicare Provider Number (if hospital), or Entity Type (if non-hospital) to submit similar changes for multiple 340B IDs in one submission. Once approved, the changes will be applied to all 340B IDs in the submission.
Primary Contact Comment Function. This new function will allow a Primary Contact to make a comment on any 340B OPAIS submission (registration, change request, termination request, or recertification). The AO will have the ability to edit the comment before submission to OPA.
OPA made one change to 340B OPAIS’s pricing component.
New Drug Price Estimate Flag. A new designator will display in the flag column of the product search, when a manufacturer identifies a National Drug Code or NDC’s ceiling price as a new drug price estimate. **** will be displayed as this flag. New drug price estimates occur when a product’s average manufacturer price is not yet established and the 340B ceiling price is estimated as wholesale acquisition cost (WAC) less the appropriate rebate percentage.