HRSA orders Boehringer Ingelheim to comply with 340B drug pricing

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The Health Resources and Services Administration has sent a letter to Boehringer Ingelheim ordering the pharmaceutical company to comply with federal requirements under the 340B drug pricing program.

HRSA informed the company that its August 1 policy cutting off discounted pricing to hospitals on drugs dispensed at community-based pharmacies is unlawful. 

The agency directed Boehringer Ingelheim to produce a plan by October 18 for restoring the discounted pricing and said the company must issue credits or refunds to affected hospitals for all past overcharges.

WHY THIS MATTERS

Pharmaceutical companies have balked at mandates to give drug discounts to for-profit pharmacies.

In May, Eli Lilly filed a motion to prevent giving 340B drug discounts to contract pharmacies, but said it would continue to offer 100% of the discounts to covered entities such as hospitals.

On September 22, Eli Lilly was still refusing to give for-profit pharmacies the discounts, according to a letter from the Health Resources and Services Administration of the Department of Health and Human Services to Derek L. Asay, senior director of government strategy for Eli Lilly and Company.

Michelle Herzog, acting director of the Office of Pharmacy Affairs wrote, "By letter dated May 17, 2021, HRSA instructed Eli Lilly and Company (Lilly) to comply with its 340B statutory obligations and to immediately begin offering Lilly's covered outpatient drugs at the 340B ceiling price to covered entities that dispense the discounted medications through their contract pharmacy arrangements.

"HRSA informed Lilly that continued failure to provide the 340B price to covered entities utilizing contract pharmacies could result in civil monetary penalties. Given Lilly's continued refusal to comply, HRSA has referred this issue to the HHS Office of the Inspector General (OIG) in accordance with the 340B Program Ceiling Price and Civil Monetary Penalties Final Rule."

HRSA also sent letters to AstraZeneca, Novartis, Novo Nordisk, Sanofi and United Therapeutics, telling the drugmakers they were violating the 340B statute and ordering them to comply.

All six drugmakers face fines for continued violation of the statute.

THE LARGER TREND

In December 2020, five hospital groups and an organization of hospital pharmacists representing participants in the 340B drug pricing program, filed a federal lawsuit against the U.S. Department of Health and Human Services over what they called the department's failure to enforce program requirements that require drug companies to provide prescription drug discounts under the 340B program.

In February, a federal judge dismissed the lawsuit.

ON THE RECORD

340B Health president and CEO Maureen Testoni said, "We commend HRSA for taking quick enforcement action against Boehringer Ingelheim as we requested, and we call on the company's executives to heed the government's directive and restore statutory discounts for safety-net hospitals.

"BI's policy of withholding discounts for many of its outpatient drugs, including those used to treat patients with diabetes, is immensely harmful to 340B hospitals and the patients they serve. HRSA again makes crystal clear that the law requires drug companies to discount their prices when selling drugs to safety-net providers no matter where the drugs are dispensed."
 

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com