Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 220: Healthcare Regulation Under the Trump Administration with Bob Coble of Maynard Nexsen
Podcast — Drug Pricing: How Might the Trump Administration Transform FDA Enforcement Activities?
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
12 Days of Regulatory Insights: Day 3 - State AG Oversight in the Health Care Industry — Regulatory Oversight Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
340B Drug Pricing Program Compliance
Inflation Reduction Act’s Drug Price Negotiation Provisions – What Now? – Diagnosing Health Care Podcast
Podcast: Inflation Reduction Act’s Drug Price Negotiation Provisions – What’s Next? - Diagnosing Health Care
Podcast: Chevron Deference: Is It Time for Change? - Diagnosing Health Care
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Podcast: IP(DC): Drug Prices, Political Pressures & Patents
Drug Pricing Initiatives During the Trump Presidency
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
Last week, the Supreme Court granted review to clarify the scienter requirement in False Claim Act (31 U.S.C. §§ 3729 et seq.) (FCA) cases. This significant decision will affect the scope of FCA liability by addressing what...more
With just a few short weeks left until August recess, there is no shortage of items on the congressional to-do list. The latest round of Supreme Court decisions has inspired new action within Congress to pass legislation...more
In a much-awaited Seventh Circuit decision, the court joined four other circuits in endorsing the “objective reasonableness” defense under the federal False Claims Act (FCA). In a 2-1 panel decision, the court not only upheld...more
Recently, my colleague Regina DeSantis told you about the ongoing saga involving disputes between 340B contract pharmacies and pharmaceutical manufacturers. We often write about the 340B program on our blog because of the...more
Supreme Court Upholds Affordable Care Act: On June 17, 2021, the Supreme Court ruled 7 to 2 to dismiss for lack of standing a challenge to the Affordable Care Act (ACA) brought by Texas and other states. The states had...more