AbbVie is the 11th Manufacturer to Restrict Access to 340B Prices at Contract Pharmacies
By letter dated December 29, 2021, AbbVie announced that, effective February 1, 2022, it will implement a new “340B program integrity initiative” under which it will no longer honor bill-to/ship-to orders for contract pharmacy arrangements with hospitals unless the hospital submits 340B contract pharmacy claims through the 340B ESP platform or qualifies for an exception described below. AbbVie’s policy currently applies to the 24 products listed on the last page of the December 29 letter, although AbbVie notes that it intends to expand this list. AbbVie will recognize the following exemptions from its new restrictive contract pharmacy policy:
- Federal Grantees: As stated above, federal grantees in the 340B program will be able to order 340B drugs through their contract pharmacies. They do not have to take any further steps for this exemption to apply.
- No In-House Pharmacy: Hospitals that do not have an in-house outpatient pharmacy capable of dispensing 340B priced drugs to their patients may designate a single contract pharmacy location to dispense 340B drugs on the hospital’s behalf. Contract pharmacy designations must be made through 340B ESP at www.340besp.com/designations. Hospitals that request this exception are not required to register for an account with 340B ESP or submit claims data through the 340B ESP program. Unlike other manufacturers, AbbVie does not provide a date by which hospitals must designate a single contract pharmacy in order for the designation to take effect on February 1, 2022.
- Wholly Owned Pharmacies: Contract pharmacies that are wholly owned by a hospital, or under common ownership with a health system, will continue to receive bill-to/ship-to replenishment orders for 340B drugs. The wholly owned or commonly owned pharmacy must be registered in OPAIS as a contract pharmacy of the hospital. 340B hospitals that qualify for this exemption must apply for a wholly owned contract pharmacy exemption at www.340Besp.com/wholly_owned_application.
Lilly Recognizes Multiple Contract Pharmacies if the Covered Entity Submits Claims Data to 340B ESP
By letter dated December 16, 2021, Lilly announced that it will honor contract pharmacy replenishment purchases for drugs dispensed to eligible 340B patients on or after October 29, 2021 for those covered entities that provide claims data through the 340B ESP platform. Lilly’s willingness to extend 340B pricing to 340B ESP-enrolled covered entities applies to all of the entities’ contract pharmacy arrangements, regardless of how many contract pharmacies the covered entity has. 340B ESP enrollees will not receive 340B pricing on replenishment orders for prescriptions dispensed prior to October 29, 2021.
When Lilly implemented its “Limited Distribution Plan” with respect to contract pharmacy arrangements on September 1, 2020, the Plan included the following exemptions to allow covered entities to continue to receive 340B priced drugs through a retail pharmacy: (1) covered entities that lack an in-house retail pharmacy may designate a single contract pharmacy to receive 340B priced drugs; (2) contract pharmacies that are wholly owned by a hospital, or under common ownership with a health system, will continue to receive 340B priced drugs at those pharmacies; and (3) covered entities that agree to pass on the 340B discounted price to 340B eligible patients at the point of sale, and agree to other conditions, will receive 340B pricing on Lilly’s insulin products. Lilly will continue to recognize these exemptions for covered entities that choose not to register for 340B ESP.