340B ESP posted the new terms yesterday. Aaron Vandervelde, Second Sight’s business development lead, said yesterday that 340B ESP will notify covered entities about the changes either today or tomorrow.
The terms have been updated to reflect the following, 340B ESP said:
- further clarifying data use parameters for Second Sight Solutions and participating pharmaceutical manufacturers
- broadening the indemnification by Second Sight Solutions to include security incidents that result in an obligation to notify governmental authorities of the security incident or breach
- inclusion of a process for covered entities to terminate the agreement with Second Sight Solutions.
Covered entity groups have raised a number of concerns about 340B ESP’s terms. These include concerns about:
- liability in the event of release of protected health information
- how claims data submitted could be used by Second Sight or others for derivative works or for purposes beyond identifying ineligible rebates.
The federal government and 340B provider organizations also say drug manufacturers have no legal right to impose restrictions or conditions on access to 340B discounts in the contract pharmacy setting. Federal courts are reviewing the matter.
In the meantime, a growing number of hospitals have determined that they cannot afford to hold off on submitting the claims data considering the number of drug manufacturers that have imposed contract pharmacy restrictions. FQHCs and other federal grantees reportedly have been more hesistant.
Sixteen manufacturers have imposed restrictions on 340B pricing when entities use contract pharmacies. Most of the policies apply to hospital covered entities only.