In October 2021, Second Sight, the owner of 340B ESP, updated the Terms of Use (TOU) that covered entities must agree to when registering for the 340B ESP platform.  There were two notable changes.  First, the TOU now specifies that claims data will be used to identify duplicate discounts involving Medicaid, commercial payers, Medicare Part D, and TRICARE.  The previous version did not include a reference to Medicare or TRICARE (although FAQs issued by Second Sight noted that claims data would be used to identify Medicare Part D claims).  The 340B statute protects a manufacturer from providing both a Medicaid rebate to a state Medicaid agency and a 340B discount to a 340B covered entity.  However, the 340B statute does not protect manufacturers from paying duplicate discounts on Medicare Part D drugs, TRICARE, or private commercial plans.  By requiring covered entities to submit contract pharmacy claims data to 340B ESP, manufacturer clients of Second Sight had already sought protection from duplicate discounts beyond the scope of manufacturer protections afforded under the 340B statute.  By clarifying that 340B ESP will also be used to protect against duplicate discounts on Medicare Part D and TRICARE claims, Second Sight appears to give manufacturers additional protections in excess of the statute. 

The TOU was also updated to clarify that, in the event Second Sight updates the TOU in the future, a covered entity’s continued use of the 340B ESP platform constitutes acceptance of the updated TOU.  Second Sight is not required to notify the covered entity if the TOU is updated.  Covered entities that do not agree to the TOU may stop using 340B ESP and request to deactivate its 340B ESP User ID.  However, under the new language added by Second Sight, the company may continue to use claims data for the purposes outlined in the version of the TOU that was in effect at the time the covered entity terminates its User ID.  Purposes outlined in future iterations of the TOU will not be applied to the previously submitted data.