Lawyers representing ASHP, five national hospital associations, and three hospitals participating in the 340B Drug Pricing Program sent letters to Eli Lilly, AstraZeneca, Sanofi, Novartis, United Therapeutics, and Novo Nordisk demanding the companies cease 340B pricing practices that are in violation of federal law. The letters follow the Dec. 30 advisory opinion from the Department of Health and Human Services (HHS) General Counsel stating that “a drug manufacturer in the 340B Program is obligated to deliver its covered outpatient drugs to those contract pharmacies and to charge the covered entity no more than the 340B ceiling price for those drugs.”
Several manufacturers have maintained pricing practices in violation of the 340B statute, despite HHS’ advisory opinion. “HHS has very clearly stated that manufacturers cannot make up their own rules regarding pricing provided to 340B-covered entities,” said Tom Kraus, ASHP vice president of government relations. “This flagrant violation of the law threatens patient access to services, and — during a public health emergency — is unconscionable.”
ASHP and its partner associations and hospitals have filed a lawsuit asking the court to order that HHS direct the manufacturers to provide 340B discounts for drugs dispensed through community pharmacies and reimburse affected hospitals, and that HHS refer the issue to the Office of the Inspector General for assessment of penalties. A hearing on the federal lawsuit against HHS on this issue is scheduled next month.