Federal healthcare officials told drug manufacturer UCB yesterday its restrictions on 340B pricing when covered entities use contract pharmacies are illegal and must stop or the company could face civil monetary penalties of up to $6,323.00 for each instance of overcharging.
UCB did immediately respond for a request for comment this morning.
It is the ninth drug manufacturer out of 17 with such a policy to get a 340B enforcement letter from the U.S. Health Resources and Services Administration. HRSA has referred seven of the nine to the U.S. Health and Human Services Department (HHS) Office of Inspector General (OIG) for possible imposition of CMPs. OIG has penalized none to date. Groups that represent 340B covered entities have been urging HHS to impose the fines and to weigh terminating Medicaid and Medicare Part B reimbursement for the companies’ drugs.
A bipartisan group of six U.S. House members is collecting signatures for a letter urging HHS Secretary Xavier Becerra, HHS Inspector General Christi Grimm, and HRSA Administrator Carole Johnson to impose CMPs against all drug manufacturers that unlawfully overcharge 340B entities.
In a May 2 letter, Senate Finance Committee ranking Republican Chuck Grassley (Iowa) asked Grimm if OIG “plans to take enforcement action against these drug manufacturers.”
HRSA Administrator Johnson signed yesterday’s letter to UCB.
Effective Dec. 13, 2021, the Belgian drug manufacturer stopped shipping 340B replenishment orders to hospital covered entity contract pharmacies. It lets hospitals lacking an in-house pharmacy designate one outside pharmacy for bill to / ship to orders. Grantee covered entities are exempt from the restrictions.
Merck was the last manufacturer that restricts the use of 340B contract pharmacies to get an enforcement letter from HRSA.