News & Analysis as of

Manufacturers Section 340B Pharmaceutical Industry

Robinson+Cole Health Law Diagnosis

HRSA Publishes 340B Rebate Pilot Program FAQs

As previously discussed in our prior blog post, on August 1, 2025, the Department of Health and Human Services (HHS) issued a Notice announcing a much-anticipated 340B Rebate Model Pilot Program (Pilot Program). Subsequently,...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - August 2025 #2

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Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

McDermott Will & Schulte

This Week in 340B: August 12 – 18, 2025

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

Jones Day

HHS Pilot Program to Evaluate 340B Drug Pricing Program Rebate Models

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The Health Resources and Services Administration ("HRSA") plans to implement a limited pilot program that will allow approved manufacturers to issue post-purchase rebates for 340B covered outpatient drugs rather than upfront...more

Sheppard Mullin Richter & Hampton LLP

HRSA Launches and Seeks Comments on 340B Rebate Model Pilot Program

On August 1, 2025, the Health Resources and Services Administration (“HRSA”) issued a Notice announcing the launch of the 340B Rebate Model Pilot Program (“Pilot Program”), that would dramatically change the way in which...more

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

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On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

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The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

Shipman & Goodwin LLP

340B Drug Pricing Program Is on a Slippery Slope

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On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more

ArentFox Schiff

HHS Announces 340B Rebate Model Pilot Program

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On July 31, the US Department of Health and Human Services’ (HHS) Health Resources and Services Administration (HRSA) announced the availability of a new pilot program altering how pharmaceutical manufacturers can honor the...more

Goodwin

340B Rebate Pilot Program Proposed by HRSA

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On July 31, 2025, the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) issued a 340B Drug Pricing Program notice (the “Notice”) announcing the launch of a voluntary 340B rebate model pilot...more

Ropes & Gray LLP

HRSA Announces 340B Rebate Model Pilot Program

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On July 31, 2025, the Health Resources and Services Administration (“HRSA”) announced the availability of a voluntary 340B Rebate Model Pilot Program (the “340B Rebate Pilot” or the “Pilot”) that would test, for a limited...more

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more

McDermott Will & Schulte

This Week in 340B: July 15 – 21, 2025

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

McDermott Will & Schulte

This Week in 340B: July 8 – 14, 2025

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

McDermott Will & Schulte

This Week in 340B: July 1 – 7, 2025

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

McDermott Will & Schulte

This Week in 340B: June 10 – 16, 2025

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

McDermott Will & Schulte

This Week in 340B: June 3 – 9, 2025

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

Dinsmore & Shohl LLP

D.C. District Court Declines Manufacturers’ Unilateral Efforts to Move Forward with Proposed 340B Rebate Models

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Last month, the United States District Court for the District of Columbia (the “District Court”) evaluated Motions for Summary Judgment concerning drug manufacturers’ efforts to unilaterally pay 340B Program discounts in the...more

Goodwin

Federal Court Affirms HRSA Authority to Preapprove 340B Rebate Models but Urges HRSA to Reconsider Rejection of Rebate Model

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In a May 15, 2025, opinion, Judge Dabney Friedrich of the US District Court for the District of Columbia denied drugmakers’ motions for summary judgment against the US Department of Health and Human Services and the Health...more

McDermott Will & Schulte

This Week in 340B: May 13 – 19, 2025

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

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - May 2025 #2

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Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

Baker Donelson

HHS Previews Guidance Addressing Implementation of 340B Rebate System

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In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more

McDermott Will & Schulte

This Week in 340B: April 8 – 14, 2025

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

Baker Donelson

HHS and HRSA Defend 340B Discount Model Against Pharma Rebate Plan

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Summary of Changes - In the fall of 2024, several pharmaceutical companies – specifically, Eli Lilly and Company, Sanofi-Aventis U.S. LLC, Bristol Myers Squibb Company, and Novartis Pharmaceuticals Corporation – reacted to...more

Mintz

Mintz IRA Update — Duplicate Discounts Between the 340B Program & Medicare Drug Price Negotiation Program

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The 340B Drug Pricing Program (340B Program) is no stranger to controversy. We have previously covered the ongoing contract pharmacy legal battles and the new alternative dispute resolution process. And now, a new 340B hurdle...more

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