By letter dated June 30, 2021, drug manufacturer Boehringer Ingelheim Pharmaceuticals, Inc. notified covered entities that it will no longer honor all 340B contract pharmacy arrangements, effective August 1, 2021. Boehringer’s policy applies to all of its products except those distributed through specialty pharmacies (OFEV, Gilotrif, and Praxbind). The list of applicable NDCs can be found here. Boehringer will recognize the following exemptions from its new restrictive contract pharmacy policy:
- No In-House Pharmacy: Hospital covered entities that do not have an in-house pharmacy may designate a single contract pharmacy location to continue to receive and dispense Boehringer products purchased at 340B prices. Contract pharmacy designations must be made through 340B ESP at www.340besp.com/designations. Boehringer’s letter does not state that covered entities are required to register for an account with 340B ESP or submit claims data through the 340B ESP program in order to designate a single contract pharmacy location (this is similar to Sanofi’s policy).
Boehringer states that “a contract pharmacy must have a HIN assigned to it in order for a covered entity to designate it as its single contract pharmacy” (HIN stands for “Health Industry Number”). If a covered entity tries to designate a contract pharmacy in 340B ESP without an HIN, the system will notify the covered entity of this requirement and provide instructions for how to obtain an HIN. For any questions on obtaining an HIN, Boehringer instructs covered entities to contact email@example.com. In order to ensure that a contract pharmacy designation takes effect on August 1, covered entities must make their designation through the 340B ESP website by July 16. After July 16, covered entities must allow up to ten business days for the designation to take effect.
- Federal Grantees and Subgrantees: Federal grantees and subgrantees that are eligible to participate in the 340B program will remain eligible to place bill-to/ship-to replenishment orders for 340B drugs for multiple contract pharmacies. Federal grantees and subgrantees do not need to apply for or register for 340B ESP to qualify for this exemption.
- Wholly Owned Pharmacies: Contract pharmacies that are wholly owned by a 340B hospital, or are under common ownership with a 340B health system, will remain eligible to receive bill-to/ship-to replenishment orders for 340B drugs. The pharmacy must be registered with HRSA as a contract pharmacy for the 340B hospital. 340B hospitals that qualify for this exemption must apply for a “wholly owned contract pharmacy exemption” by contacting firstname.lastname@example.org.
Boehringer joins six other drug manufacturers that have taken similar actions to halt 340B pricing on drugs shipped to contract pharmacies, despite ongoing litigation challenging such actions and HHS issuing letters on May 17 condoning the manufacturers’ unlawful policies.