News & Analysis as of

Hospitals Section 340B HRSA

McDermott Will & Emery

This Week in 340B: June 10 – 16, 2025

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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

McDermott Will & Emery

This Week in 340B: June 3 – 9, 2025

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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

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

McDermott Will & Emery

This Week in 340B: May 27 – June 2, 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 & Emery

This Week in 340B: April 22 – 28, 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 & Emery

This Week in 340B: April 15 – 21, 2025

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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

McDermott Will & Emery

This Week in 340B: April 8 – 14, 2025

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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

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

Cornerstone Research

5 Questions with Sayeh Nikpay: The 340B Drug Pricing Program

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A periodic feature by Cornerstone Research, in which our affiliated experts, senior advisors, and professionals, talk about their research and findings. We interview Professor Sayeh Nikpay of the School of Public Health,...more

Holland & Knight LLP

The 340B Drug Pricing Paradox

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The 340B Drug Pricing Program has been making headlines. Two recent developments are difficult to square with one another. First, the Health Resources and Services Administration (HRSA), the federal agency that administers...more

King & Spalding

HRSA Ends PHE Waivers, Requiring Hospitals to Register Off-Site Outpatient Facilities for 340B Program

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On October 27, 2023, the Health Resources and Services Administration of HHS (HRSA) issued a Federal Register Notice (the Notice) requiring hospitals to register their off-site outpatient facilities to continue participating...more

Quarles & Brady LLP

HRSA Notice Provides Clarity on 340B Child Site Registration Requirements

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After months of relative uncertainty, the Health Resources and Services Administration (HRSA) published a Notice confirming the end to a COVID-19 pandemic-era flexibility that allowed unregistered child sites to utilize 340B...more

McDermott Will & Emery

HRSA Issues Notice Confirming 340B Registration Requirement

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On October 26, the Health Resources and Services Administration (HRSA) published a Federal Register notice addressing the use of 340B drugs at off-campus hospital outpatient locations that have not yet appeared on a filed...more

Alston & Bird

Health Care Week in Review: New House Speaker Elected; HRSA Issued a Notice on 340B Drug Pricing Program Requirements

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Bass, Berry & Sims PLC

HRSA Clarifies Use of 340B Drugs in New Hospital Clinics, Ends COVID "Waiver"

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On October 26, the Health Resources and Services Administration (HRSA) issued a notice clarifying the registration requirements for offsite hospital outpatient facilities under the 340B drug pricing program. The Notice, which...more

Goodwin

340B Drug Pricing Program Reform Considerations

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The 340B Drug Pricing Program is a government program, administered by the Health Resources and Services Administration (HRSA), that allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy...more

Sheppard Mullin Richter & Hampton LLP

340B Drug Pricing Discount Program Update: HRSA Now Demands That Drug Manufacturers Provide 340B Discounts To Contract Pharmacies...

Now approaching a year-long battle, drug manufacturers and 340B covered entities, which include hospitals and community health centers, participating in the 340B Drug Pricing Discount Program (“340B Participants”) continue to...more

Sheppard Mullin Richter & Hampton LLP

Maneuvers on the 340B Drug Pricing Program Battlefield: Duplicate Discounts and Contract Pharmacies

In a December 12, 2017 Advisory Board article, “The 340B drug pricing controversy, explained,” Scott Orwig wrote, “the 340B Drug Pricing Program is one of the most contentious issues in health care: Its critics say it ‘hurts...more

Hinshaw & Culbertson - Health Care

OPA Program Update 2020 Highlights Changes to 340B Program Registration and Recertification Requirements

On July 20, 2020, the Health Resources and Services Administration's (HRSA) Office of Pharmacy Affairs (OPA) issued the OPA Program Update 2020. In addition to adopting new Covered Entity registration and recertification...more

K&L Gates LLP

K&L Gates Triage: Recent Developments in the 340B Drug Pricing Program

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In this episode, Richard Church, Andrew Ruskin, and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent actions by drug manufacturers to limit contract pharmacy access to 340B...more

Mintz - Health Care Viewpoints

Bipartisan Group of Senators Introduces Legislation to Waive 340B Eligibility Requirements Due to COVID-19

On July 2, a bipartisan group of six senators introduced legislation to waive 340B eligibility requirements for hospitals participating in the program during the COVID-19 pandemic. S. 4160 permits hospitals that are...more

Baker Donelson

HRSA Eliminates Delay in Use of 340B Drugs in New Hospital Clinic Locations

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The Health Resources and Services Administration (HRSA) has issued guidance eliminating a longstanding enforcement position that delayed the ability of hospitals participating in the 340B drug pricing program to use...more

Polsinelli

HRSA Poised to Allow 340B Child Sites to Participate Before Appearing on Cost Report

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There are initial indications that the Health Resources and Services Administration (HRSA), which administers the federal 340B drug pricing program, may allow hospitals to begin using 340B drugs at offsite locations (“Child...more

K&L Gates LLP

K&L Gates Triage: 340B Update - Hospitals Request Eligibility Flexibilities Amid COVID-19 Pandemic

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In this episode, Richard Church and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent COVID-19 guidance by the Health Resources and Services Administration and hospital requests...more

Baker Donelson

A Flurry of Recent Activity Highlights Continued Interest in 340B Program Oversight

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Four separate government releases coming over a three-week period have once again highlighted the intense interest in the 340B drug pricing program, with a federal agency and two government watchdog groups issuing guidance...more

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