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Hospitals Manufacturers Pharmaceutical Industry

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

ArentFox Schiff

Medicare 2026 Proposed Rules, Major Drug Pricing Updates, and What Stakeholders Need to Know

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Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These...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

Dinsmore & Shohl LLP on

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 & 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

McDermott Will & Schulte

New EO Targets Prescription Drug Costs – and Drug Manufacturers, Hospitals, and Health Centers

On April 15, 2025, President Trump signed an executive order (EO) aimed at addressing the cost of prescription drugs. This EO, titled “Lowering Drug Prices by Once Again Putting Americans First,” outlines specific directives...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

Baker Donelson on

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

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q1 2023

On February 7, the Department of Justice (DOJ) issued a press release indicating that settlements and judgments under the False Claims Act (FCA) exceeded $2.2 billion in the fiscal year ending September 30, 2022. Of this...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | January 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more

Baker Donelson

OIG Issues Favorable Opinion for Pharmaceutical Manufacturer's Free Drug Program

Baker Donelson on

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services has issued Advisory Opinion 2022-22, stating that it would not impose sanctions related to a proposed arrangement where a...more

Bass, Berry & Sims PLC

The California Insurance Frauds Prevention Act: What to Know About California’s Powerful Commercial Health Insurance Fraud Statute

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Although this blog focuses mainly on the federal False Claims Act (FCA), other antifraud statutes feature in the qui tam relator and government enforcement toolkit. Key among them: the California Insurance Frauds Prevention...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

Smart & Biggar

Special Access Program and Emergency Drug Release Program amendments in force

Smart & Biggar on

On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice,...more

King & Spalding

OIG Issues Advisory Opinion Permitting Drug Manufacturer to Provide Travel, Lodging, and Expenses to Patients in Limited...

King & Spalding on

On January 15, 2020, OIG issued Advisory Opinion No. 20-02 analyzing an arrangement between a pharmaceutical manufacturer and certain drug recipients whereby the manufacturer provides certain drug recipients with financial...more

K&L Gates LLP

K&L Gates Triage: Recent Developments Impacting Drug Pricing and the 340B Program: Part 1

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In Part One of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments that may affect drug pricing and pharmacy...more

Sheppard Mullin Richter & Hampton LLP

Is Prescription Drug Pricing The Cure For Partisanship?

In a rare act of bipartisanship, Senate Finance Committee Chairman Chuck Grassley, R-Iowa, and Ranking Member Ron Wyden, D-Ore., introduced on July 23rd a chairman’s mark, the Prescription Drug Pricing Reduction Act (PDPRA)...more

Verrill

No More Waiting: 340B Drug Pricing Program Pharma Oversight and Enforcement Rule To Be Effective January 1, 2019

Verrill on

The U.S. Department of Health and Human Services (“HHS”) recently published a final rule on the 340B Drug Pricing Program (“340B Program”), moving the effective date for changes to the program up to January 1, 2019. Making...more

Robinson+Cole Health Law Diagnosis

OIG Advisory Opinion Approves Surgical Device Warranty Program Intended to Reduce Readmissions

On September 17, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion allowing a manufacturer of surgical devices and wound care products to offer a...more

Butler Snow LLP

Pro Te: Solutio Vol. 11 No. 1 – A Reflection on the First Ten Years

Butler Snow LLP on

It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more

Holland & Knight LLP

340B Drug Pricing Program Final Rule Delayed … Again

Holland & Knight LLP on

In a notice published on June 5, 2018, the Health Resources and Services Administration (HRSA) announced that the January 2017 340B Drug Pricing Program final rule (the “Final Rule”) will again be delayed. The Final Rule,...more

Holland & Knight LLP

Healthcare Law Update: May 2018

Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Sheppard Mullin Richter & Hampton LLP

VA Streamlines MSPV-NG Acquisition through Distribution and Supply Agreements

The Department of Veterans Affairs issued a Justification and Approval (J&A) for Other than Full and Open Competition on April 12, 2018, to allow prime vendors currently performing “distribution” contracts under the...more

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