340B Drug Pricing Program Legal Resources

Judge orders HHS to immediately halt unlawful reimbursement cuts for remainder of 2022 re: 340B.

The U.S. District Court for the District of Columbia should reject the Department of Health and Human Services’ request to devise on its own timeline a remedy for its 2018 and 2019 underpayments to 340B hospitals, with no limitations and no oversight by the court, AHA told the D.C. court today. 

AHA files reply brief as district court considers 340B payment remedy for the remainder of 2022.

The AHA, 340B Health, America’s Essential Hospitals, Association of American Medical Colleges, and Children’s Hospital Association yesterday filed a friend-of-the-court brief urging the U.S. Courts of Appeals for the 3rd Circuit to require drug companies to fulfill their legal obligations to provide 340B discounted drugs to eligible hospitals and health systems, regardless of whether the drugs are dispensed on site or through contract pharmacies.

The AHA, 340B Health, America’s Essential Hospitals, Association of American Medical Colleges, and Children’s Hospital Association yesterday urged the U.S. Courts of Appeals for the 3rd and District of Columbia Circuits to require drug companies to fulfill their legal obligations to provide 340B discounted drugs to eligible hospitals and health systems, regardless of whether the drugs are dispensed on site or through contract pharmacies.

The AHA, 340B Health, America’s Essential Hospitals, Association of American Medical Colleges, and Children’s Hospital Association yesterday urged the U.S. Courts of Appeals for the 3rd and District of Columbia Circuits to require drug companies to fulfill their legal obligations to provide 340B discounted drugs to eligible hospitals and health systems, regardless of whether the drugs are dispensed on site or through contract pharmacies.

The government does not dispute that the agency singled out Section 340B hospitals as a group and set their reimbursement based on acquisition cost rather than price, without conducting the cost study that the statute requires. The agency’s action was therefore contrary to law.

November 5, 2021 UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY

ORDERED that the plaintiffs' Motions for Summary Judgment, Dkt. 19 (Novartis), Dkt. 14 (United Therapeutics) are GRANTED IN PART and DENIED IN PART.

This case concerns conditions that plaintiffs Novartis Pharmaceuticals Corporation and United Therapeutics Corporation have imposed on discounted drug purchases by certain safetynet health care providers.

Court Order in the Lilly Challenge October 29, 2021

Court Decision on the Lilly Challenge October 29, 2021

Government responds to Hospital 340B Payment Reduction Challenge (Oct. 20, 2021).

Amici curiae are 37 non-profit state and regional hospital associations. They represent thousands of hospitals and health systems across the United States. Amici and their members are committed to improving the health of the communities they serve through the delivery of high-quality, efficient, and accessible health care. The 340B Program is essential to achieving this goal.

In 1990, Congress enacted the Medicaid Rebate Program, as part of the Omnibus Reconciliation Act of 1990 (Pub. L. No. 101-508).20. This law requires drug companies that choose to participate in Medicaid to give states, which administer Medicaid, discounts comparable to those given to other payers.

The AHA urged The Supreme Court of the United States to reverse the 2020 federal appeals court decision that upheld the authority of the Department of Health and Human Services to significantly cut payments to certain hospitals that participate in the 340B Drug Pricing Program.

Amicus Brief Eli Lilly v Cochran Re 340B Contract Pharmacy – Intervention filed June 23, 2021.

Amicus Brief NOVO NORDISK v Cochran Re 340B Contract Pharmacy – Intervention

The 340B program, established by section 340B of the Public Health Service Act, 42 U.S.C. § 256b, requires as a condition of participating in Medicaid and Medicare Part B that pharmaceutical manufacturers sell outpatient drugs at a discounted price to certain public and not-for-profit hospitals, community health centers, and other providers that serve patients with low incomes (340B providers or covered entities).

IN THE Supreme Court of the United States THE AMERICAN HOSPITAL ASSOCIATION, et al., Petitioners, v.