February 1, 2023

Volume XIII, Number 32

340B ESP AND HIPAA Compliance

Many pharmaceutical manufacturers currently require 340B covered entities to provide de-identified pharmacy claims data for dispensed 340B drugs to a third party, 340B ESP, as a condition of receiving discounts under the 340B program. Although the claims data may be de-identified in the hands of 340B ESP, pharmaceutical manufacturers can link the data to identifiable rebate transactions to determine if pharmacy benefit managers (PBMs) have obtained rebates for previously discounted medications. This re-identification of the data, which manufacturers have been transparent about, has caused some 340B covered entities to question the permissibility of the 340B ESP data submission under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).