Category: Regulatory

NYT Investigation Highlights Federal Law’s Unintended Harm to 340B Providers

January 22, 2025 Bella Czajkowski, National Correspondent Views

A recent New York Times investigation found that part of a COVID-19 relief bill meant to lower drug prices actually increased costs for 340B providers and some of their most vulnerable patients.

A provision in a 2021 COVID-19 relief bill that sought to lower prescription drug prices has actually made some medications [...]

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Just Before Departing, Biden Admin Announces Next 15 Drugs for Medicare Negotiations Amid IRA Uncertainty and 340B Questions

January 22, 2025 Bella Czajkowski and William Newton, National Correspondent Views

The second group of high-cost prescription drugs chosen for Medicare price negotiations were announced last week just ahead of former President Joe Biden's departure from the White House.

The Department of Health and Human Services (HHS) announced the second group of high-cost prescription drugs chosen for Medicare price [...]

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Novartis is Fifth Drugmaker to Sue HRSA to Implement Controversial 340B Rebate Model

January 17, 2025 William Newton, Associate Editor/Senior Writer Views

Novartis is suing HRSA to impose a controversial 340B rebate model that the agency has not authorized.

Novartis this week became the fifth manufacturer to sue the Health Resources and Services Administration (HRSA) to implement a 340B [...]

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NYT Investigative Article Sparks Both Scrutiny and Support for 340B Prime Vendor Apexus

January 16, 2025 William Newton, Associate Editor/Senior Writer Views

The New York Times published a Jan. 15 investigative article about the 340B prime vendor.

Yesterday’s New York Times investigative article alleging that the 340B prime vendor, Apexus, profited by driving 340B program expansion has [...]

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HRSA Terminates 20 ‘Ineligible’ 340B Sites from STD Clinic; Clinic Rejects Allegations and Vows to Fight Back

January 14, 2025 William Newton, Associate Editor/Senior Writer Views

HRSA has terminated 20 Sagebrush Health sites from the 340B program for allegedly violating program eligibility requirements.

The Health Resources and Services Administration (HRSA) has terminated the 340B status of 20 sites affiliated with the Nevada-based STD [...]

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Heron, Dr. Reddy’s, Organon, CooperSurgical Issue NDC Changes

January 9, 2025 Bella Czajkowski, National Correspondent Views

Four drugmakers have notified 340B covered entities of changes to certain national drug codes (NDC) for their products over the past three weeks.

Four drugmakers have notified 340B covered entities of changes to certain national drug codes (NDC) for their products over the [...]

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Drugmaker Lawsuit Targets 340B Eligibility of In-Kind STD Clinics; STD Grantee Denies Allegations

January 7, 2025 William Newton, Associate Editor/Senior Writer Views

Three drugmakers sued HRSA in federal court over 340B eligibility for certain STD clinics, including Sagebrush Health.

Three large drugmakers are suing the federal government for allegedly allowing certain STD clinics to unlawfully participate in the 340B [...]

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AHA Urges CMS to Block Drugmaker 340B Rebate Models, Improve Medicare Transaction Facilitator

January 7, 2025 Bella Czajkowski, National Correspondent Views

The AHA raised concerns that October 2024 federal guidance on Medicare drug price negotiations may allow drugmakers to “wrongly justify fundamental changes to the 340B program.”

A major hospital advocacy group recently warned that October 2024 agency guidance on Medicare drug price negotiations may allow drugmakers [...]

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IRA Rollout, Regulatory Gaps May Drive Major 340B Reforms in 2025, Says Adam Fein of Drug Channels

December 17, 2024 William Newton, Associate Editor/Senior Writer Views

Adam Fein, Ph.D, president of Drug Channels Institute, predicted the IRA's implementation could drive major 340B changes during a Dec. 13 webinar.

Emerging regulatory conflicts between the Inflation Reduction Act (IRA) and the 340B program may soon force policymakers to enact major [...]

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Sanofi Pauses 340B Rebate Proposal, Sues HRSA to Impose Controversial Model

December 17, 2024 William Newton, Associate Editor/Senior Writer Views

Sanofi sued HRSA on Dec. 16 in a federal district court in an effort to implement its controversial 340B rebate model.

French pharmaceutical giant Sanofi late yesterday announced it would pause the implementation of its contested 340B rebate plan and become [...]

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Category: Regulatory

NYT Investigation Highlights Federal Law’s Unintended Harm to 340B Providers

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Just Before Departing, Biden Admin Announces Next 15 Drugs for Medicare Negotiations Amid IRA Uncertainty and 340B Questions

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Novartis is Fifth Drugmaker to Sue HRSA to Implement Controversial 340B Rebate Model

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NYT Investigative Article Sparks Both Scrutiny and Support for 340B Prime Vendor Apexus

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HRSA Terminates 20 ‘Ineligible’ 340B Sites from STD Clinic; Clinic Rejects Allegations and Vows to Fight Back

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Heron, Dr. Reddy’s, Organon, CooperSurgical Issue NDC Changes

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Drugmaker Lawsuit Targets 340B Eligibility of In-Kind STD Clinics; STD Grantee Denies Allegations

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AHA Urges CMS to Block Drugmaker 340B Rebate Models, Improve Medicare Transaction Facilitator

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IRA Rollout, Regulatory Gaps May Drive Major 340B Reforms in 2025, Says Adam Fein of Drug Channels

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Sanofi Pauses 340B Rebate Proposal, Sues HRSA to Impose Controversial Model

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