The American Society of Health-System Pharmacies is speaking out against Johnson & Johnson's plan to drop upfront discounts for some 340B drugs.
The drugmaker notified disproportionate share hospitals Aug. 23 of a new rebate system for its blood thinner Xarelto and anti-inflammatory drug Stelara. The change, set to take effect Oct. 15, would require hospitals to buy the drugs at commercial prices and then submit data via Beacon's claims portal to qualify for a rebate.
ASHP said the rebate framework "violates the basic operation" of the 340B program, which is built around prospective discounts. The group expressed concerns that J&J's rebate model will serve as a test case for other manufacturers to adopt similar policies if the program goes unchallenged.
ASHP has joined the hospital advocacy group 340B Health in requesting that the Health Resources and Services Administration intervene with J&J's plan.
"Manufacturer efforts to undercut the 340B program by skirting, or in this case, violating, program requirements harm patients and the healthcare providers they rely on," Tom Kraus, ASHP's vice president of government relations, said in an Aug. 23 release. "Manufacturers must be held to the same expectations of compliance as the covered entities who rely on 340B savings to care for their patients, particularly for vulnerable and underserved populations."
HRSA has confirmed that J&J's rebate plan does not align with the 340B statute and said it would take appropriate action as necessary.
Johnson & Johnson has stood behind the program, saying it is "fully consistent with the 340B statute, which specifically references rebates as a payment mechanism," in a statement to The Advisory Board.
"J&J's use of reasonable, standard and time sensitive business practices will help the 340B program meet its original intent, and better ensure discounts are more directly benefiting vulnerable patients," the company said.