Sanofi Sues HHS, HRSA for Contract Details Between Covered Entities, Pharmacies

Drug manufacturer Sanofi has sued the federal government for information about contracts between covered entities and contract pharmacies.
French drugmaker Sanofi recently filed suit against federal agencies seeking details from contracts between 340B covered entities and outside pharmacies. [...]

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Supreme Court to Review Case that Could Result in More Hospitals Qualifying for 340B Program

Supreme Court Justices announced in a June 10 order that they’d review the U.S. Court of Appeals for the D.C. Circuit’s September 2023 decision in Advocate Christ Medical Center v. Becerra.
The U.S. Supreme Court this week agreed to take on a case that potentially could expand the number of hospitals [...]

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Five Manufacturers Announce Refunds to 340B Providers

Five drug manufacturers will refund 340B covered entities for certain drug overcharges.
Five drugmakers have issued recent refund notices to 340B covered entities for drug overcharges. In letters posted on the website [...]

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OPA to Hold June 11 Webinar on Final ADR Rule

HRSA headquarters
The Health Resources and Services Administration announced that the Office of Pharmacy Affairs will hold a June 11 webinar on the ADR final rule.
The federal office tasked with overseeing the 340B program will brief covered entities and manufacturers next week on the administrative [...]

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CMS Drops ‘Stacking’ Proposal Which Could Have Boosted 340B Savings

CMS said it was no longer considering a "stacking" proposal for Medicaid drug pricing calculations, which could have increased 340B savings.
Federal regulators said they were dropping from consideration a proposal for “stacking” discounts as part of an update to Medicaid [...]

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Novo Nordisk To Provide Refunds on Ozempic and Three Other Drugs to 340B Entities

Drugmaker Novo Nordisk is providing refunds to 340B covered entities on its blockbuster diabetes/weight loss drug Ozempic and three other products.
Drugmaker Novo Nordisk announced it is providing 340B covered entities 12-months-worth of refunds on four drug products including two of [...]

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2024 Provider Audits Begin with No Adverse Findings

Federal auditors recently reported no adverse findings in their first fiscal year 2024 340B audit of a pharmaceutical manufacturer.
The first fiscal year 2024 340B provider audit reports included no adverse findings for 19 organizations. The May 8 audit [...]

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IRA Draft Guidance Leaves 340B Details Unclear

The latest CMS guidance on implementing the Inflation Reduction Act's Medicare price caps left unresolved key 340B pricing details.
Recently released draft guidance for implementing Medicare price caps would allow voluntary provider use of 340B codes on claims, while [...]

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NC Treasurer Report Suggests 340B Hospitals Overcharged State Health Plan, Hospitals Pan the Findings

A report from N.C. Treasurer Dale Folwell found some hospitals are using 340B “to enrich themselves rather than to serve vulnerable communities.”
North Carolina hospitals that participate in the 340B program routinely overcharged cancer patients, taxpayers and state employees for oncology drugs, [...]

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340B Hospital Groups Ask MedPAC to Oppose Part B Rate Cut

Jonathan Jaffery, chief health care officer for AAMC, said reduced Medicare reimbursement to 340B hospitals would “devastate an already fragile health care safety net.”
Groups representing hospitals that rely on the 340B program recently urged congressional advisers against recommending reduced Medicare reimbursement to 340B [...]

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