Category: Regulatory

340B Providers Take Issue with CMS Draft Guidance on IRA Implementation Calling It “Problematic, Unworkable and Inconsistent”

July 9, 2024 Shannon Young, Associate Editor/Senior Writer Views

340B provider groups strongly criticized the Centers for Medicare & Medicaid Services’ draft guidance for Medicare drug price negotiations.

Editor’s Note: In today’s issue, we look at the 340B provider community’s comments to CMS. In a future issue, we [...]

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Astellas Suspends its Contract Pharmacy Restrictions in More States; BMS and Sanofi Also Announce State Exemptions

July 9, 2024 Shannon Young, Associate Editor/Senior Writer Views

Astellas Pharma announced the suspension of its contract pharmacy policy in Maryland and Mississippi.

A Japanese drug manufacturer has ended its 340B contract pharmacy restrictions in Maryland and Mississippi in conjunction with new contract [...]

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340B Coalition Conference Keynote: Program Faces ‘Progress Amid Challenges’

July 8, 2024 William Newton, Associate Editor/Senior Writer Views

Maureen Testoni, president and CEO of 340B Health, gave a keynote "state of 340B" address July 8 at the 340B Coalition summer conference.

The 340B program faces unprecedented challenges despite a series of states enacting 340B contract pharmacy access laws, the leader of [...]

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Supreme Court ‘Chevron’ Ruling Increases Pressure on Congress to Act on 340B But Unlikely to Immediately Impact Program Oversight

July 2, 2024 William Newton, Associate Editor/Senior Writer Views

Hospital groups are urging the Supreme Court to correct what they called HHS' misinterpretation of DSH percentage calculations.

A landmark Supreme Court decision to limit the broad regulatory authority of federal agencies will increase pressure for Congress to [...]

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Hospitals in Texas and Other States Sue HHS Over DSH Calculation Changes That Impact 340B Eligibility

July 2, 2024 Shannon Young, Associate Editor/Senior Writer Views

Dozens of hospitals in Texas and other states have filed suit against HHS to block a rule that they say lowers their disproportionate share hospital adjustment percentage and could result in a loss of 340B discounts.

Dozens of hospitals in Texas and other states have filed suits against Department of Health and Human Services (HHS) Secretary [...]

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New York Times Sues HRSA To Release 340B Data, Communications Between Office of Pharmacy Affairs and Apexus Leaders; Information Could Be Released Soon

June 27, 2024 Shannon Young, Associate Editor/Senior Writer Views

A federal court sided with a group of Texas hospitals’ efforts to block an HHS rule.

The New York Times has sued the federal agency tasked with overseeing the 340B program to force the release of [...]

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IRA Could ‘Crush the 340B Margin,’ Force Transparency into Program, Says Adam Fein of Drug Channels

June 25, 2024 William Newton, Associate Editor/Senior Writer Views

Adam Fein, Ph.D., president of Drug Channels Institute, hosted a June 21 webinar that discussed the IRA's interaction with the 340B program.

The Inflation Reduction Act (IRA) may reduce 340B margins for certain high-cost drugs and drive more transparency into the program, an influential pharmaceutical supply chain analyst who has been a frequent 340B critic told an audience of stakeholders late last

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Lilly Adds Significant New Restrictions on 340B Contract Pharmacy Access; Alleges Lack of Oversight by HRSA, Pharmacies and TPAs

June 21, 2024 Bella Czajkowski and Ted Slafsky, National Correspondent Views

Pharmaceutical giant Eli Lilly has significantly escalated its restrictions on access to 340B pricing in the contract pharmacy setting, the company announced June 19 on the drug industry vendor site 340B ESP.

Pharmaceutical giant Eli Lilly has significantly escalated its restrictions on access to 340B pricing in the contract pharmacy setting, the [...]

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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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