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Dispute Resolution HRSA Drug Pricing

McDermott Will & Emery

HHS Issues 340B Administrative Dispute Resolution Final Rule

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On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...more

Polsinelli

HRSA Aims for Swift Dispute Resolution with new 340B ADR Final Rule

Polsinelli on

On April 18, 2024, HRSA released its 2024 340B Administrative Dispute Resolution (ADR) Final Rule (2024 ADR Final Rule) and it is largely favorable to covered entities (CEs) with pending ADR claims against drug manufacturers....more

McDermott Will & Emery

This Week in 340B: February 21 – 26, 2024

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Holland & Knight LLP

HHS Issues Proposed Rule to Overhaul 340B Administrative Dispute Resolution Process

Holland & Knight LLP on

Through its Health Resources and Services Administration (HRSA), the U.S. Department of Health and Human Services (HHS) issued a proposed rulemaking on Nov. 29, 2022, that would drastically overhaul the 340B Drug Pricing...more

Foley Hoag LLP

HRSA Proposes to Overhaul 340B Dispute Process

Foley Hoag LLP on

On November 29, 2022, the Health Resources and Services Administration (“HRSA”) published a notice of proposed rulemaking (“Proposed Rule”)[1] to implement an Administrative Dispute Resolution (“ADR”) process for resolving...more

ArentFox Schiff

Health Resources and Services Administration Enjoined from Implementing the 340B Dispute Resolution Rule

ArentFox Schiff on

US District Court for Southern District of Indiana granted plaintiffs Eli Lilly and Company and Lilly USA a preliminary injunction barring HRSA from implementing the final Administrative Dispute Resolution rule that was to...more

K&L Gates LLP

340B Update: HRSA Moves Forward with 340B ADR Rule as Covered Entities Challenge Contract Pharmacy Actions

K&L Gates LLP on

In this episode of Triage, Andrew Ruskin and Victoria Hamscho provide an update on recent developments in the 340B Program and, in particular, on two recent legal challenges covered entities brought in response to drug...more

ArentFox Schiff

340B Entities Sue HHS Over Lack of Dispute Resolution Process

ArentFox Schiff on

Three organizations serving primarily HIV and AIDS patients and who each are also considered “Covered Entities” under the 340B Drug Pricing Program (the Plaintiffs) filed a lawsuit against Department of Health and Human...more

Polsinelli

New 340B Dispute Resolution Process: Will It Level the Playing Field?

Polsinelli on

On August 12, HRSA published a formal proposed rule regarding a 340B Drug Pricing Program administrative dispute resolution (ADR) process. HRSA’s use of the administrative rulemaking process is a rare occasion given its...more

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