News & Analysis as of

Medicare Supreme Court of the United States Drug Pricing

Holland & Knight LLP

Holland & Knight Health Dose: July 8, 2025

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With the reconciliation package signed into law, the U.S. House of Representatives is in recess and will return on July 14, 2025. In the interim, the U.S. Senate will focus on the appropriations bills for fiscal year (FY)...more

Stevens & Lee

A New Arena for Future Challenges to CMS Regulations – the Overturn of Chevron

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On June 28, 2024, the Supreme Court overruled Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., and consequently invalidated the “Chevron Deference” — a cornerstone of administrative law since 1984. In the 6-3 decision...more

Paul Hastings LLP

SuperValu and Executive Health Resources: What to Know About the FCA Following the 2023 Term

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As we take stock of the Supreme Court’s 2023 term, two landmark decisions shift our understanding of scienter and government intervention as it relates to the False Claims Act (“FCA”), 31 U.S.C. § 3729. First, on June 1,...more

Epstein Becker & Green

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

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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

Dickinson Wright

False Claims Act “Knowledge” Is a Subjective Standard

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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

BCLP

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

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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

Jackson Lewis P.C.

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

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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

Ballard Spahr LLP

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

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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

Warner Norcross + Judd

Supreme Court Removes Some Defenses to False Claims Act Liability for Government Contractors and Health Care Providers

Government contractors, health care providers and many other parties who submit claims for payment to the federal government are subject to liability under the False Claims Act (FCA). This month, the U.S. Supreme Court issued...more

ArentFox Schiff

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

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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

Patterson Belknap Webb & Tyler LLP

Supreme Court Rejects Objective Standard for Scienter for False Claims Act

On June 1, 2023, the United States Supreme Court decided two consolidated cases, United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway, 589 U.S. ___ (2023), holding that a defendant’s...more

Venable LLP

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

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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

Davis Wright Tremaine LLP

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

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

Morrison & Foerster LLP

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

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

Goodwin

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

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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

Clark Hill PLC

The U.S. Supreme Court Hands Down Decision That May Cool Pharmacy or Provider Discount, Coupon, or Financial Assistance Patient...

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Pharmacies and Healthcare Providers May Be Impacted - A June 1st U.S. Supreme Court (SCOTUS) decision on two whistleblower cases may have far reaching consequences for pharmacies or healthcare providers that charge a discount...more

Morgan Lewis

In Key FCA Scienter Opinion, US Supreme Court Turns Focus on Subjective Intent

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The United States Supreme Court held on June 1 that the False Claims Act’s (FCA) scienter element requires analysis of the defendant’s subjective intent at the time of the alleged false claim, and that a defendant can be...more

WilmerHale

Supreme Court Holds That False Claims Act Requires Subjective Inquiry

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On June 1, 2023, the Supreme Court decided a pair of closely watched False Claims Act (FCA) cases, U.S. ex rel. Schutte v. SuperValu Inc., No. 21-1326, and U.S. ex rel. Proctor v. Safeway, Inc., No. 22-111....more

Faegre Drinker Biddle & Reath LLP

Supreme Court Decides United States et al. ex rel. Schutte et al. v. SuperValu Inc. et al.

On June 1, 2023, the U.S. Supreme Court decided U.S. ex rel. Schutte v. SuperValu, No. 21-1326, together with U.S. ex rel. Proctor v. Safeway, Inc, No. 22-111, vacating and remanding the decisions below and holding that the...more

Bass, Berry & Sims PLC

CMS Reverses 340B Payment Cuts for 2023 but Does Not Address Remedy for Prior Years

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On November 3, the Centers for Medicare & Medicaid Services (CMS) issued an update to its Medicare Part B drug payment policy for hospitals participating in the 340B drug pricing program and reversed payment cuts in place...more

Robinson+Cole Health Law Diagnosis

340B Update: District Court Rejects 2022 Payment Methodology for 340B Hospitals Following Supreme Court Win

We follow up on our previous blog post concerning the U.S. Supreme Court’s unanimous ruling in favor of 340B hospitals. The Supreme Court previously held that “absent a survey of hospitals’ acquisition costs, HHS may not vary...more

King & Spalding

Supreme Court Overturns Medicare Outpatient Drug Rate Cut for 340B Hospitals

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On June 15, 2022, the Supreme Court issued a unanimous ruling in American Hospital Assn. v. Becerra declaring that CMS’s 2018 and 2019 reimbursement outpatient drug rate cut to 340B hospitals was “contrary to the statute and...more

Quarles & Brady LLP

Supreme Court Decision Maintains Status Quo for Disproportionate Share Percentage Calculation: What Does It Mean for the 340B...

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Last week, the Supreme Court released a decision relating to how the Department of Health and Human Services (HHS) requires hospitals to calculate its disproportionate share percentage. While this percentage is primarily used...more

Akin Gump Strauss Hauer & Feld LLP

Supreme Court Upends Medicare 340B Drug Payment Policy

Key Points - The Supreme Court invalidated 2018 and 2019 cuts to Medicare reimbursement rates for hospital outpatient drugs acquired through the 340B Drug Pricing Program, effectively reinstating the default rate of ASP...more

Verrill

Hospitals Win 340B Medicare Rate Cut Suit, But When, How, and How Much They Will Recoup Remains Unclear

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In a recent unanimous decision, the Supreme Court found that the Centers for Medicare and Medicaid Services (“CMS”), part of the federal Department of Health and Human Services (“HHS”), erred when it significantly reduced...more

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