Category: Regulatory

Health Systems, HRSA Spar in Federal Court Over 340B Registration Policy Reversal

January 30, 2024 William Newton, Associate Editor/Senior Writer Views

A hospital association asked the U.S. District Court of the District of Columbia to side with more than 40 health systems that sued federal regulators over a hospital registration policy change.

Forty-four health systems have asked a federal district court to decide, without a full trial, on their lawsuit against federal [...]

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GSK, Vertex Offer Refunds to 340B Providers

January 30, 2024 Rich Daly, Editor in Chief Views

Senderra Rx will no longer dispense GlaxoSmithKline’s asthma drug, Nucala.

Drugmakers GlaxoSmithKline and Vertex Pharmaceuticals will offer refunds to 340B providers related to the purchases of several of their high-earning [...]

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HIV/AIDS Group Continues Legal Fight with Apexus Over 340B Prime Vendor Contract

January 25, 2024 William Newton, Associate Editor/Senior Writer Views

AHF has asked a federal appeals court to reverse an earlier court's decision to dismiss a case against Apexus over its provision of 340B sub-ceiling price discounts on drugs.

The AIDS Healthcare Foundation (AHF) recently urged a federal appeals court to reverse a lower court’s decision to dismiss its [...]

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New Medicaid Policy Change Could Reduce 340B Savings, Cause Drug Discontinuations, Warn Stakeholders

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

A Medicaid drug rebate policy change that recently took effect could lead to reduced 340B savings and drug discontinuations.

A Medicaid policy change that took effect at the start of 2024 could indirectly lead to lower 340B savings and [...]

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$7.8 Billion in Refunds from Underpayments to 340B Hospitals Begin to Roll In

January 19, 2024 Rich Daly, Editor in Chief Views

A map of Medicare administrative contractors' (MAC's) jurisdictions. MACs in more than half the states have begun to issue refunds to 340B hospitals for unlawful Medicare cuts from 2018-2022.

Medicare administrative contractors (MACs) covering more than half the states have initiated lump sum repayments to 340B hospitals, after getting [...]

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Drug Makers Issue Record Number of 340B Refunds in 2023, Merck First to Refund in 2024

January 17, 2024 Rich Daly, Editor in Chief Views

Drugmakers issued a record 41 refunds to 340B covered entities in 2023.

Drugmakers issued a record 41 refunds to 340B covered entities in 2023. And Merck is the first to announce it [...]

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HRSA Announces 340B Webinar for Grantees Before Upcoming Recertification Begins

January 17, 2024 Rich Daly, Editor in Chief Views

HRSA plans to host a webinar for federal grantees in the days leading up to the 2024 340B recertification period.

The Health Resources and Services Administration (HRSA) has announced plans to host a webinar for federal grantees just days prior [...]

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AHA Warns of ‘Adverse Impact’ from Lack of 340B Provisions in New MA Rule

January 11, 2024 Rich Daly, Editor in Chief Views

AHA's Ashley Thompson wrote that a proposed Medicare Advantage payment rule could have “double the adverse impact” on 340B hospitals.

The nation’s leading hospital group warned the decision by federal regulators not to address 340B policy in a new proposed [...]

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Lilly to Conduct HRSA-Approved Audit That Includes First-Time Look for Medicaid MCO Duplicate Discounts

December 19, 2023 Rich Daly, Editor in Chief Views

Eli Lilly is conducting government approved 340B provider audits that for the first time look for certain Medicaid health plan duplicate discounts.

Federal regulators have approved a first-time 340B provider audit by a drug manufacturer to examine processes to prevent duplicate discounts [...]

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CMS Defers Decision on Adding 340B Modifiers for Part D Drugs

December 19, 2023 Rich Daly, Editor in Chief Views

In response to the ongoing Change Healthcare cyberattack, CMS will direct contractors to provide some accelerated payments to hospitals.

Federal regulators recently deferred a decision on whether to add identifiers to 340B drugs purchased under Medicare Part D. The [...]

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