Category: Regulatory

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

April 23, 2024 William Newton, Associate Editor/Senior Writer Views

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

April 23, 2024 Shannon Young, Associate Editor/Senior Writer Views

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

April 19, 2024 Rich Daly, Editor in Chief Views

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

April 18, 2024 Rich Daly, Editor in Chief Views

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

April 18, 2024 Rich Daly, Editor in Chief Views

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

April 16, 2024 Rich Daly, Editor in Chief Views

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

April 16, 2024 Shannon Young, Associate Editor/Senior Writer Views

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

April 11, 2024 Rich Daly, Editor in Chief Views

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

April 9, 2024 Shannon Young, Associate Editor/Senior Writer Views

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

April 9, 2024 Rich Daly, Editor in Chief Views

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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Category: Regulatory

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

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

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News Alert

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

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

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

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

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

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

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

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

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