Drug Industry Takes Issue with IRA’s Drug Negotiation Guidance

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 

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340B Providers Take Issue with CMS Draft Guidance on IRA Implementation Calling It “Problematic, Unworkable and Inconsistent”

340B provider groups strongly criticized the Centers for Medicare & Medicaid Services’ draft guidance for Medicare drug price negotiations.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

Astellas building mounted sign
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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AbbVie, AstraZeneca Sue Minnesota Over Contract Pharmacy Access Law

AbbVie and AstraZeneca filed a pair of lawsuits to block Minnesota's law barring manufacturer 340B contract pharmacy restrictions.
Two major drug manufacturers are suing Minnesota to block a new 340B contract pharmacy access law, which took effect this [...]

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News Alert

AbbVie, AstraZeneca Challenge Kansas’ New Contract Pharmacy Access Law

AbbVie will no longer offer voluntary 340B pricing on any of its orphan-designated drugs to covered entities subject to such exclusions.
Two major drug manufacturers this week sued Kansas in an effort to block the state’s new contract pharmacy access law, [...]

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Hospital Groups Urge Federal Court to Uphold Maryland’s 340B Contract Pharmacy Access Law

American Hospital Association logo
AHA officials penned a Medical Economics op-ed on “the truth behind growth of the 340B prescription drug program.”
Groups representing Maryland providers along with national advocacy groups recently urged a federal judge to reject Novartis’ attempt to block [...]

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

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

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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Just Days Before New Laws Go Into Effect, GSK, Pfizer Exempt Additional States from Contract Pharmacy Restrictions

GlaxoSmithKline wordmark and GSK logo on a building
GlaxoSmithKline and Pfizer announced updates to their 340B contract pharmacy policies to comply with new state laws that will take effect in July.
Correction, Thursday, July 27, 2024, 7:00 p.m. EDT—The original version of this article mistakenly said Minnesota’s contract pharmacy access law [...]

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