OPA Director Touches on 340B Rebate Litigation and Other Key Matters at 340B Coalition Conference

Office of Pharmacy Affairs (OPA) Director Chantelle Britton addresses 340B stakeholders during remarks to open the 340B Coalition’s annual summer conference in National Harbor, Md. on Monday.
A key federal regulator highlighted the Health Resources and Services Administration’s (HRSA) legal fight against proposed drugmaker 340B rebate models [...]

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340B PATIENTS Act Reintroduction Expected Soon, Hospital Trade Group Challenges Drug Industry Criticisms

340B Health President and CEO Maureen Testoni speaks at the 340B Coalition's Summer Conference in National Harbor, Md. on Monday.
The leader of a major 340B hospital trade group heralded the forthcoming reintroduction of a federal bill that would codify [...]

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Safeguarding Your 340B Program

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Introduction: Navigating Political Headwinds

As the 2025 political season heats up, federally qualified health centers (FQHCs), hospitals, STD clinics, Ryan White grantees, and other covered entities must brace for another round of uncertainty. With renewed debates around entitlement spending,

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Federal Court Consolidates Drugmaker 340B Rebate Appeals, Denies Hospital Group’s Cross-Appeal Request

A federal appeals court in Washington, D.C. consolidated multiple drugmaker appeals in ongoing 340B rebate litigation.
A Washington, D.C. federal appellate court on Friday consolidated multiple drug industry appeals challenging the government’s authority to preapprove 340B [...]

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GSK Exempts New States from 340B Contract Pharmacy Restrictions, Teva Issues New Update on Restricted Drugs

GSK and Teva recently announced new changes to their 340B contract pharmacy restrictions.
Two major drugmakers announced new changes to their 340B contract pharmacy restrictions in notices posted to 340B ESP’s website late [...]

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Lilly, Indivior, Kedrion to Refund 340B Covered Entities for Overcharges, Others Announce NDC Changes

Three drugmakers recently announced refunds to 340B covered entities, while two others announced NDC changes.
Three drugmakers are offering refunds to 340B covered entities that purchased certain drugs between 2022 and 2025 following recalculations of [...]

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For the First Time, CMS Proposes Claims-Based Methods to Identify 340B Drugs Billed to Medicare Part D

CMS recently proposed two policies for identifying 340B claims billed to Medicare Part D.
In a first for the agency, the Centers for Medicare and Medicaid Services (CMS) is proposing to track 340B drugs [...]

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Advocates Warn New CMS Proposed Rule Could Hurt 340B Program, Be ‘First Step Towards Payment Cuts’

Hospital groups and other 340B backers condemned proposals, which CMS included in its 900-plus page draft hospital outpatient prospective payment system and ambulatory surgical center rule released this week.
340B hospital advocates are raising concerns that a new Trump administration proposal to accelerate hospital outpatient payment cuts to offset [...]

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Rethinking 340B: Where Compliance Ends and Strategy Begins

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Let’s be honest. 340B compliance is demanding. It takes time, coordination, and precision. After more than a decade working in 340B compliance and auditing, I’ve learned it always comes back to one thing: the data.

Where does the data come from? How accurate is it? How quickly

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California Senators Abruptly Pull 340B Bill from Hearing; Massachusetts Lawmakers Debate Drug Pricing Measures

California lawmakers cancelled a hearing on a 340B contract pharmacy bill on July 16, while Massachusetts lawmakers debated multiple 340B provisions on July 15.
California state senators yesterday abruptly pulled a 340B contract pharmacy access bill from a scheduled hearing just days before a [...]

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