News & Analysis as of September 23, 2024

Pharmaceutical Industry

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The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary with only a limited number of cases granted review each term. The Court is comprised of one chief justice and eight associate justices, who are nominated by the President and confirmed by the Senate to hold lifetime positions. less -

True Facts About False Claims: MoFo's FCA Newsletter - October 2023

Morrison & Foerster LLP on 10/11/2023

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...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

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

Supreme Court Rejects Objective Standard for Scienter for False Claims Act

Patterson Belknap Webb & Tyler LLP on 6/7/2023

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

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

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

Clark Hill PLC on 6/6/2023

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

Supreme Court Rules Knowledge and Subjective Belief Are Key for False Claims Act Liability

Stevens & Lee on 6/5/2023

In a unanimous decision Thrsday, the U.S. Supreme Court, in an opinion written by Justice Thomas, ruled that the False Claims Act’s (“FCA”) scienter element refers to a defendant’s knowledge and subjective beliefs — not to...more

The Government’s Ability to Combat Fraud is on the Line in False Claims Act Supreme Court Case

Kohn, Kohn & Colapinto LLP on 4/17/2023

Oral arguments are scheduled for April 18, 2023, in the Supreme Court case combining two Seventh Circuit Court of Appeals cases U.S. ex rel. Schutte v. SuperValu, Inc. (“SuperValu”) and U.S. ex rel. Thomas Proctor v. Safeway,...more

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

Robinson+Cole Health Law Diagnosis on 10/6/2022

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

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

Quarles & Brady LLP on 6/27/2022

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

Supreme Court Upends Medicare 340B Drug Payment Policy

Akin Gump Strauss Hauer & Feld LLP on 6/24/2022

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

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

Verrill on 6/24/2022

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

Enhanced Scrutiny of Opioid Prescriptions Poses Legal Risks for Medical Professionals

Fox Rothschild LLP on 5/31/2022

The U.S. Department of Justice recently charged multiple physicians and health care professionals for opioid-related crimes in a crackdown with a clear message to individuals in the industry: If you are involved with...more

Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act

Health Care Compliance Association (HCCA) on 9/9/2021

While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more

July Surprise - Supreme Court Agrees to Review Medicare Payment Cuts to 340B Drugs

McDermott Will & Emery on 7/7/2021

The US Supreme Court has announced that it will take up review of the decision by the US Court of Appeals for the District of Columbia Circuit upholding Medicare’s 2018 payment cuts to 340B drugs. The case will be closely...more

Three Pressing Challenges for Personalized Medicine

Foley & Lardner LLP on 11/4/2015

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

Also In The News - Health Headlines - July 2015

King & Spalding on 7/24/2015

CMS Reopens Attestation Period For First-Time Hospitals Until August – CMS recently announced that eligible hospitals participating in the Medicare Electronic Health Record Incentive Program for the first time in 2015 may...more

Supreme Court Declines to Opine on Circuit Split Over Rule 9(b) Pleading Requirements for FCA Claims

Epstein Becker & Green on 6/7/2014

On March 31, 2014, in U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, the Supreme Court of the United States declined to review a decision by the U.S. Court of Appeals for the Fourth Circuit upholding a district...more

Health Reform + Related Health Policy News Update - January 24, 2013

Polsinelli on 1/25/2013

In This Issue: - OMB Directs Department Heads to Prepare for Sequestration - HHS Finalizes Omnibus HIPAA Rule, Enhances Privacy Requirements - SCOTUS Says Equitable Tolling Not a Factor in DSH Case - Report...more

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