Medicaid, Drug Pricing, Pharmacies

The 340B ‘Saga’ Continues: As More States Pass 340B Contract Pharmacy Laws, More Lawsuits Follow

ArentFox Schiff on 9/4/2024

In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more

This Week in 340B: July 2 – 8, 2024

McDermott Will & Emery on 7/10/2024

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

340B Drug Pricing Program Compliance

Health Care Compliance Association (HCCA) on 5/9/2024

The 340B Drug Pricing Program was created to protect safety net hospitals from rising drug prices. It allows them to purchase outpatient drugs, and pharma companies to sell those drugs, at a discount. In this podcast, Jason...more

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

Epstein Becker & Green on 3/26/2024

Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

Government Continues to Explore Role of 340B Contract Pharmacies

Goodwin on 9/15/2023

The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...more

SuperValu’s Effect on the FCA Scienter Standard and Impact to Future Litigation

Epstein Becker & Green on 8/23/2023

n June 1, 2023, the U.S. Supreme Court unanimously settled a long-standing dispute over a subjective versus objective standard for scienter under the False Claims Act (FCA), holding that a defendant’s own subjective belief is...more

This Week in 340B: August 2023 #2

McDermott Will & Emery on 8/22/2023

This weekly series provides brief summaries 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

False Claims Act “Knowledge” Is a Subjective Standard

Dickinson Wright on 8/2/2023

The Federal False Claims Act (“FCA”) allows private parties to bring lawsuits in the name of the federal government against defendants who allegedly “knowingly” present a false claim to the government for payment. The...more

U.S. Supreme Court Explains Meaning of “knowingly” Under the False Claims Act

BCLP on 7/12/2023

In its recent unanimous and significant decision in the consolidated cases of United States ex rel. Schutte v. SuperValu, No. 21-1326 (6-1-23), and United States ex rel. Proctol v. Safeway, Inc., No. 22-111 (6-1-23), the...more

U.S. Supreme Court: False Claims Act Liability Depends on Defendant’s Subjective Beliefs

Jackson Lewis P.C. on 6/22/2023

Liability in False Claims Act (FCA) suits depends on whether a defendant subjectively believed its claims were false, not on whether it can offer an objectively reasonable basis for its claims, the U.S. Supreme Court has held...more

Supreme Court’s SuperValu Decision: a Game-Changer for Assessing FCA Violations

Ballard Spahr LLP on 6/20/2023

Summary - On June 1, 2023, the Supreme Court issued a landmark decision in False Claims Act cases. In United States ex rel. Schutte v. SuperValu Inc., it unanimously held that liability under the False Claims Act depends...more

CMS Releases Its List of 43 Part B Rebatable Drugs for Q3: Inflation Reduction Act Updates

Epstein Becker & Green on 6/12/2023

On June 9, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its next list of Part B drugs subject to the Medicare Prescription Drug Inflation Rebate Program’s adjusted coinsurance rates (“Rebatable Drugs”) from...more

Investigations Newsletter: Supreme Court Again Tightens FCA Intent, But Tricky Questions Linger

ArentFox Schiff on 6/8/2023

The US Supreme Court brushed aside novel assertions from two pharmacy retailers on June 1 and ruled unanimously that False Claims Act liability hinges on whether defendants subjectively believed their claims were “false.” In...more

SCOTUS Pro-employer Pendulum Swings When It's the Fed's Ox Getting Gored

Sherman & Howard L.L.C. on 6/8/2023

The False Claims Act ("FCA") imposes liability on anyone who "knowingly" makes a false claim to the Federal Government. This includes making false claims for reimbursement from the government under federal programs. As part...more

Yes, Contractors and Providers, What You Think Matters - U.S. Supreme Court Unanimously Holds That Defendants' Subjective Beliefs...

Venable LLP on 6/7/2023

On June 1, 2023, the U.S. Supreme Court issued a unanimous opinion in United States ex rel. Schutte v. SuperValu Inc. reversing a pair of False Claims Act (FCA) cases on review from the Seventh Circuit Court of Appeals. In...more

Part 2 of 2: U.S. Supreme Court Confirms False Claims Act’s Scienter Standard Accounts for Subjective Intent

Dechert LLP on 6/6/2023

On June 1, 2023, the U.S. Supreme Court released a unanimous decision in U.S. ex rel. Schutte v. SuperValu Inc., No. 21-1326; U.S. ex rel. Proctor v. Safeway, Inc., No. 22-111, clarifying the False Claims Act’s scienter...more

Supreme Court Clarifies FCA Scienter Standard – Overturns 7th Circuit Decision

Davis Wright Tremaine LLP on 6/6/2023

Ruling in case involving national retail pharmacies rejects the “objective reasonableness” standard for the False Claims Act - On June 1, 2023, the U.S. Supreme Court unanimously vacated the 7th Circuit's decision in U.S....more

United States Supreme Court: Look to Defendant’s Subjective Beliefs to Decide Whether It “Knowingly” Submitted False Claim

Morrison & Foerster LLP on 6/6/2023

On June 1, 2023, the Supreme Court issued a decision in United States ex rel. Schutte v. SuperValu, Inc., clarifying when a defendant “knowingly” submits a false claim for payment under the False Claims Act (FCA). The Court...more

The Supreme Court Holds that the False Claims Act’s Scienter Element Turns on Defendant’s Subjective Beliefs, Rejecting Seventh...

Goodwin on 6/6/2023

The Supreme Court recently issued a significant decision clarifying what it means to “knowingly” submit a false claim under the False Claims Act. At issue in United States ex rel. Schutte v. SuperValu Inc. were allegations...more

Medicaid › Drug Pricing › Pharmacies