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Dispute Resolution HRSA Prescription Drugs

Mintz - Health Care Viewpoints

Will Sustained Pressure on the 340B Program Finally Lead to Much Needed Reform?

As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s...more

ArentFox Schiff

New ADR Rule to Govern Disputes Between 340B Covered Entities and Drug Manufacturers

ArentFox Schiff on

Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...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

McDermott Will & Emery on

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

Hogan Lovells

340B Program: HRSA Proposes to Modify Administrative Dispute Resolution Process

Hogan Lovells on

On November 30, 2022, the Health Resources and Services Administration (HRSA) published a proposed rule (Proposed Rule) in the Federal Register that proposes to introduce several changes to the current administrative dispute...more

Foley Hoag LLP

HRSA ADR Panel Dismisses NACHC's 340B Complaint Against Two Drug Manufacturers

Foley Hoag LLP on

The 340B program requires drug manufacturers to offer outpatient pharmaceuticals to statutorily defined covered entities (including certain hospitals and certain federal grantees, such as federally qualified health centers)...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

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

McDermott Will & Emery

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

McDermott Will & Emery on

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

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