CBO Recommendation: Restrict 340B Access to Get Hospitals to Join ACOs

The Congressional Budget Office report recommended restricting 340B access to incentivize hospitals to join accountable care organizations.
As part of a report on incentivizing use of accountable care organizations (ACOs), Congress’ primary research arm recently recommended excluding [...]

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Takeda Issues Refunds to 340B Providers for 28 Drugs

Drugmaker Takeda is offering rebates to 340B providers on 28 of its drugs.
Japanese drugmaker Takeda recently announced refunds to 340B covered entities for 28 drugs, including one of its top-selling attention-deficit medications. [...]

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Attorneys Expect Many Filings under Newly Reconstituted 340B Dispute Resolution Process

Kyle Vasquez, an attorney for Polsinelli, said he expects a "wave of filings" under HRSA's latest ADR rule because it is more flexible than the prior process.
Attorneys for both covered entities and drug manufacturers say they expect a significant number of filings to the newly re-established [...]

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News Alert

Providers Generally Supportive, PhRMA Pans Final 340B Dispute Resolution Rule

After HHS released the long-awaited final rule for resolving 340B administrative disputes, provider groups generally supported and PhRMA denounced the updated process.
Provider advocates celebrated—with some reservations—the recently issued final rule reshaping the Administrative Dispute Resolution (ADR) process for 340B stakeholders. On [...]

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Key Senator Says 340B Overhaul May Clear Congress in End-of-Year Package

Sen. John Thune (R-S.D.) told hospital executives that 340B legislation could clear Congress as part of a broader healthcare package late this session.
Sen. John Thune (R-S.D.), who is spearheading a major bipartisan 340B reform package, told hospital executives Tuesday that 340B legislation [...]

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CMS Does Not Address Lump Sum Payments for 340B Hospitals in Latest Medicare Advantage Policies But Might in 2025

CMS put off a decision over whether to provide Medicare Advantage plans with funds to reimburse hospitals for past 340B payment cuts.
Federal regulators recently said any decision on whether to provide Medicare Advantage (MA) plans funds to reimburse hospitals for past [...]

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California Initiative Targeting Nation’s Largest HIV Provider Submits Enough Signatures to Qualify for Ballot

Protect Patients Now gained the signatures necessary to qualify for a California ballot initiative on Medicaid that appears focused on one 340B provider.
Supporters recently submitted enough signatures to qualify for the ballot a California ballot initiative that aims to codify the governor’s [...]

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Breaking News

HRSA Issues Final Regulations Revamping Process to Resolve Disputes Between 340B Providers and Manufacturers

Federal officials have released the long-awaited final rule for the 340B Administrative Dispute Resolution process.
The federal government issued the final rule early Thursday to implement a long-anticipated revision to the 340B Administrative Dispute Resolution [...]

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Appeals Court Judges Press Both AHF, Apexus When Considering Dismissal Appeal

AHF attorney David Gruen and Apexus attorney Karin Bohmholdt recently presented oral arguments before the U.S. 9th Circuit Court of Appeals.
A federal appeals court panel pressed both the AIDS Healthcare Foundation and (AHF) and Apexus, the 340B prime vendor, to [...]

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