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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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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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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MedPAC Analysis Estimates Medicare Part B Payments to 340B Hospitals are Significantly Higher than Ceiling Prices

A MedPAC analysis found that Medicare paid 340B hospitals significantly more than the ceiling price for dozens of medications in 2022.
Medicare paid hospitals substantially more—almost $4 billion in aggregate—than the 340B ceiling price costs for dozens of single-source drugs, biologics [...]

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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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HRSA Names Britton As New Leader of Office Overseeing 340B Program

The Health Resources and Services Administration (HRSA) on Monday announced Chantelle Britton as its next Office of Pharmacy Affairs (OPA) [...]

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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 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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Amgen, J&J to Issue Refunds on High-Selling Drugs to 340B Providers

Drugmakers Amgen and Johnson & Johnson have announced they will provide refunds to 340B providers on past purchases of multiple [...]

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