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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Maine Issues Draft Rule for 340B Hospital Reporting Requirements with New Data, Enforcement Provisions

After Maine passed one of the nation's first 340B provider reporting laws last year, a state health agency has proposed a rule for implementation.
The state agency tasked with implementing Maine’s state 340B hospital reporting requirement has proposed a rule with additional data and [...]

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Novartis to Refund Covered Entities After Adjusting 340B Ceiling Prices for 100-Plus Products

Drugmaker Novartis filed suit to block Maryland's recently signed 340B contract pharmacy statute.
Thousands of covered entities that purchased more than one hundred Novartis products between late 2019 and early 2023 will be [...]

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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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Virginia Senate Democrats Narrowly Reject Governor’s Amendment to 340B Contract Pharmacy Access Bill; Bill is Back in Youngkin’s Court

Democrats in the Virginia Senate voted to reject a 340B amendment from Gov. Glenn Youngkin (R) and send the original bill back to the governor.
Virginia Senate Democrats yesterday narrowly voted to reject Gov. Glenn Youngkin’s (R) proposed amendment to a 340B contract pharmacy access [...]

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340B Contract Pharmacy Access Bill Clears Missouri House but Faces Tougher Path in Senate

Missouri Rep. Tara Peters (R), who introduced a 340B contract pharmacy access bill that passed the state house, said she hopes the state senate can "put politics aside" and approve the bill.
The Missouri House overwhelmingly passed a bill this week to bar drugmaker 340B contract pharmacy restrictions, but it could face [...]

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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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