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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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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Humana Seeks Dismissal of Medicare Advantage 340B Underpayment Suit by Health System

Humana has asked a federal district judge to dismiss a health system's lawsuit alleging the company's MA plans underpaid for 340B drugs.
Humana asked a federal judge to dismiss Baptist Health of Alabama’s lawsuit against the company’s Medicare Advantage (MA) plans for [...]

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White House Completes Review of Final Rule for 340B Dispute Process, Release Expected Soon

The Department of Health and Human Services is expected to soon release its final 340B administrative dispute resolution rule after the White House completed its final review this week.
After missing its self-imposed deadline of the end of 2023, the White House this week completed its review to implement [...]

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AbbVie Replies to Louisiana’s Request for Court to Expedite Decision on Contract Pharmacy Law

Drug manufacturer AbbVie is challenging Louisiana's state 340B contract pharmacy access law in a federal district court.
Drug manufacturer AbbVie recently replied to Louisiana’s request for summary judgement and defended its own such request in its ongoing [...]

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Manufacturer Refunds to 340B Providers Have Steadily Increased Since 2019, Says Analysis

An analysis from the law firm Spencer Fane found that 340B refunds have been concentrated among certain manufacturers and drugs.
A recent analysis of the increasing annual total number of drug manufacturer refunds to 340B covered entities notes they are [...]

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Hospitals Raise Concerns on Biden Drug Shortage Proposal

HHS recently released a proposal to address drug shortages with measures focused on both hospitals and drug manufacturers.
While the Biden administration’s proposal to address drug shortages does not exempt certain drug products from 340B pricing like the [...]

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Hospitals Say HRSA Violated Federal Rulemaking in 340B Child Site Waiver Reversal

More than 40 health systems told a federal district court that a HRSA hospital offsite clinic registration policy reversal violated federal rulemaking requirements.
The dozens of health systems suing the federal government over the reversal of a pandemic-era 340B child site registration waiver [...]

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Genentech Officially Issues Contract Pharmacy Restrictions

Pharmaceutical manufacturer Genentech has formally implemented 340B contract pharmacy restrictions for hospitals.
Drugmaker Genentech has formally issued contract pharmacy restrictions after it gave some 340B hospitals advance notice last month of its [...]

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