For the fourth time this year, drug manufacturer Lilly has announced refunds for overcharges on 340B-purchased drugs during 2019.
The U.S. Health Resources and Services Administration (HRSA) posted the notice, dated May 27, on the Office of Pharmacy Affairs website last week. Lilly said the 340B ceiling price adjustments for Q4 2019 are due to changes in Medicaid average manufacturer and best price “to account for lagged transactional data.”
Lilly recently began adding to these notices lists of drugs whose 340B ceiling prices it adjusted upward for the quarter, followed by the statement that the company “has elected not to seek recoupment of these underpayments from covered entities.” 340B provider groups argue that manufacturers do not have the right to collect undercharges.
HRSA posted a Lilly notice of refunds for 340B overcharges during Q3 2019 in April, and two others for overcharges in Q2 2019 and Q1 2019 in February. All included the same “elected not to recoup” underpayments language.
In its 340B ceiling price and manufacturer civil monetary penalties final rule, which took effect on Jan. 1, 2019, HRSA said the 340B statute “is specific in addressing when a manufacturer overcharges a covered entity and it does not address refunds by covered entities if the manufacturer provides a price below the 340B ceiling price.” The final rule also said manufacturers must offer entities refunds or credits within 120 days of determining that an 340B ceiling price overcharge occurred.
Lilly’s newest notice of 340B pricing changes for Q4 2019 lists nine NDCs for which it is offering refunds and seven NDCs for which it says entities should have paid it more.
Lilly was the first manufacturer of the 18 to date that have imposed restrictions on 340B pricing involving the contract pharmacy program.
