Category: Regulatory

Drug Industry Takes Issue with IRA’s Drug Negotiation Guidance

July 11, 2024 Views

PhRMA recently urged CMS to establish a neutral clearinghouse and require accurate use of 340B claim modifiers to address nonduplication in its final guidance for Medicare drug price negotiations under the IRA.

Editor’s Note: In Tuesday’s issue, we looked at comments from 340B provider stakeholders, today we look more closely at the [...]

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Apotex to Issue Refunds to 340B Covered Entities

July 11, 2024 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.

A Canadian drug manufacturer recently announced that it will refund covered entities for hundreds of different products purchased between 2021 [...]

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340B Providers Take Issue with CMS Draft Guidance on IRA Implementation Calling It “Problematic, Unworkable and Inconsistent”

July 9, 2024 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340B provider groups strongly criticized the Centers for Medicare & Medicaid Services’ draft guidance for Medicare drug price negotiations.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 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 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 Views

The Supreme Court further limited federal agencies' regulatory authority, but it is unlikely to significantly effect program oversight in the short-term.

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 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 Views

The New York Times has filed suit in the U.S. District Court for the Southern District of New York against the Health Resources and Services Administration to obtain an order requiring the production of 340B-related records requested in November 2023 under the Freedom of Information Act.

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 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 & 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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