Exempt FQHCs from 340B Rebate Pilot

"Under the 340B Rebate Model Pilot Program, covered entities must continue to make purchases through their 340B wholesaler account and must ensure they are only requesting rebates on the above drugs after a purchase is made. These purchases must be made for eligible 340B patients in accordance with the 340B statute. Manufacturers should work with their distributor partners to ensure the WAC price is loaded in the 340B wholesaler account where purchases will be made by covered entities to then obtain a rebate.   Manufacturers should subsequently work with their distributors to obtain necessary data from the 340B wholesaler account to monitor purchases in that account. Covered entities and manufacturers should maintain auditable records for purchases made subject to the 340B Rebate Model Pilot Program. HRSA will continue to audit both covered entities and manufacturers to ensure compliance with statutory requirements. All approved manufacturer plans will issue rebates based at the unit level."