On August 26, Second Sight Solutions, the owner of the 340B ESP™ platform, hosted the second in a series of webinars on 340B ESP™. The webinar, entitled Data Security, Privacy, and HIPAA Compliance, addressed topics such as which data elements would be collected and how data elements will be used, how information submitted to 340B ESP™ will be de-identified, and the technical specifications of the 340B ESP™ web application. The webinar, moderated by 340B ESP™ business development lead Aaron Vandervelde, is now posted on the 340B ESP™ website.
Second Sight had previously stated that it would not enter into a Business Associate Agreement (BAA) with covered entities because Second Sight did not intend to collect protected health information (PHI) through the 340B ESP™ platform. However, after numerous stakeholders, including RWC-340B, expressed concern over submitting data without a BAA, Vandervelde announced that covered entities will now have the option to enter into a BAA with Second Sight. According to a set of FAQs that were distributed after the webinar (see attached), the BAA will be made available on the 340B ESP™ platform on September 11 for those covered entities that register. It is unclear whether covered entities will have a chance to review the BAA before they register for 340B ESP™ or whether Second Sight will accept any revisions from the covered entity if the BAA contains any unfavorable terms.
The webinar also addressed the recent letters that covered entities received from Wellpartner and Optum Specialty & Diplomat alerting covered entities to the vendor’s concerns about participation in 340B ESP™. Vandervelde stated that covered entities should not submit data to 340B ESP™ if doing so would violate any contract with a third-party administrator (TPA) or contract pharmacy. It is worth noting that prior to this webinar, Sanofi and Novartis told covered entities that they will not recognize 340B chargebacks for contract pharmacy claims from covered entities that do not submit contract pharmacy claims data to the 340B ESP™ platform. While Vandervelde acknowledged that this penalty would put covered entities in a “tough situation”, the only solution that Vandervelde offered was for covered entities to work with their TPAs or contract pharmacies to modify the terms of the contract. If an agreement is not reached, covered entities may be unable to participate in the 340B ESP™ platform because doing so might cause them to violate these contracts.
The next webinar in this series, Use of 340B ESP™ Data by Manufacturers and the Economics of Duplicate Discounts from a Manufacturer’s Perspective, will take place on Tuesday, September 1 at 1:00pm.