Category: Regulatory

Lilly Posts 340B Refund Notice for Insulin Product Humulin

June 21, 2024 Bella Czajkowski, National Correspondent Views

Eli Lilly and Amgen announced refunds for 340B covered entities that purchased certain drugs in 2021.

Drug manufacturer Eli Lilly announced a new round of refunds for Humulin, a brand-name insulin, following a 340B ceiling price [...]

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It’s Official: Long-Awaited Final 340B ADR Rule Takes Effect, But Findings Still Distant

June 21, 2024 William Newton, Associate Editor/Senior Writer Views

The U.S. Department of Health and Human Services' final 340B Administrative Dispute Resolution rule formally took effect on June 18.

Fourteen years after the Congressional deadline, the long-anticipated revision to the 340B Administrative Dispute Resolution (ADR) process officially took effect [...]

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GAO Reissues Recommendations to Improve 340B Compliance, Medicare Financial Stability

June 21, 2024 Shannon Young, Associate Editor/Senior Writer Views

The Government Accountability Office this month recommended that HHS and Congress take long-proposed actions to better ensure 340B program compliance and Medicare’s financial stability.

HHS and Congress should each take long-proposed actions—including a contentious action to curb certain Part B prescribing incentives—to better ensure [...]

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

June 13, 2024 Rich Daly, Editor in Chief Views

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

June 13, 2024 Shannon Young, Associate Editor/Senior Writer Views

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

June 11, 2024 Rich Daly, Editor in Chief Views

Apotex Corp. announced in a July 2 notice to 340B providers that it will issue refunds to 340B covered entities that purchased any of nearly 400 products.

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

June 4, 2024 Shannon Young, Associate Editor/Senior Writer Views

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

May 23, 2024 Rich Daly, Editor in Chief Views

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

May 21, 2024 Rich Daly, Editor in Chief Views

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

May 14, 2024 Rich Daly, Editor in Chief Views

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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