News & Analysis as of August 14, 2025

Prescription Drugs

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

TX AG Prescribes Legal Action Against Eli Lilly for Alleged Kickbacks

Cozen O'Connor on 8/14/2025

Texas AG Ken Paxton has sued pharmaceutical manufacturer Eli Lilly for allegedly bribing and illegally inducing medical providers to prescribe and continue prescribing several Lilly drugs—including GLP-1 medications Mounjaro...more

State AGs Join $202M Settlement Over HIV Drug Kickback

Troutman Pepper Locke on 8/4/2025

On July 16, 49 attorneys general (AGs) announced that they joined a $202 million settlement with Gilead Sciences, Inc. (Gilead). Previously announced by the Department of Justice in April, the settlement resolved allegations...more

AGs Inject Accountability into Pharma Practices via $202M Gilead Settlement

Cozen O'Connor on 7/18/2025

New York AG Letitia James, along with a bipartisan coalition of 48 other AGs and in coordination with the U.S. DOJ, announced a $202 million settlement in principle with Gilead Sciences, Inc. (“Gilead”), to resolve...more

Two False Claims Act Cases From SDNY Highlight Continuing Bite of Aggressive Healthcare Enforcement

Lowenstein Sandler LLP on 5/8/2025

The U.S. Attorney’s Office for the Southern District of New York last week announced the resolution of two significant False Claims Act (FCA) cases—one from a large settlement and the other the result of a jury verdict after...more

First Circuit Imposes Higher “But-for” Causation Standard for False Claims Act Liability Based on Alleged Anti-Kickback Statute...

Perkins Coie on 4/15/2025

On February 18, 2025, the U.S. Court of Appeals for the First Circuit added its voice to a growing chorus of appellate courts to elevate the standard of proof required to show a violation of the federal False Claims Act in...more

FCA Enforcement Risk Remains for Rare Disease Stakeholders

Morgan Lewis - As Prescribed on 2/12/2025

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

“It’s Okay, These Products Aren’t Paid for by Medicare” – Think Again

Quarles & Brady LLP on 1/31/2025

A recent Securities and Exchange Commission (“SEC”) settlement with DMK Pharmaceuticals Corporation (“DMK Pharmaceuticals”) and its Chief Financial Officer (“CFO”) serves as a good reminder that SEC-regulated entities...more

OIG Issues Favorable Opinion Regarding a Program to Provide Patients with Free Access to a Pharmaceutical Product

King & Spalding on 1/28/2025

On January 10, 2025, OIG posted a favorable advisory opinion approving a proposed program (Program) to provide patients who meet certain financial need criteria with free access to a pharmaceutical product that has limited...more

OIG Issues a Favorable Advisory Opinion to a Pharmaceutical Manufacturer Regarding Free Transportation, Lodging and Support for...

King & Spalding on 1/21/2025

On December 31, 2024, OIG posted Advisory Opinion No. 24-13, a favorable advisory opinion allowing a pharmaceutical manufacturer (the Requestor) to offer free transportation, lodging, and other support to eligible patients...more

OIG Advisory Opinion 24-03 Greenlights Travel and Lodging Assistance for Gene Therapy Patients

Bass, Berry & Sims PLC on 6/28/2024

On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...more

When a Gift Becomes a Kickback: Gifts from Florida Pharmacies to Long-Term Care Facilities

Akerman LLP - Health Law Rx on 5/23/2024

The Florida Board of Pharmacy permits pharmacies serving residents and patients at long-term care facilities (nursing homes, ALFs, homes for DD residents, etc.) as either Special Closed System Pharmacies or Community...more

Health Care Fraud and Abuse 2023 Year in Review

Polsinelli on 4/12/2024

Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement...more

A Pharmacist's Guide To Prescription Drug Fraud Investigations

Hendershot Cowart P.C. on 3/22/2024

Prescription drug fraud has long been a focus for government regulators, but it has taken on new significance in the wake of America’s opioid crisis. The U.S. Department of Justice (DOJ), Department of Health and Human...more

Doctors: Don’t Fall Victim To Telemedicine Fraud Schemes

Hendershot Cowart P.C. on 3/11/2024

Telemedicine companies are supposed to facilitate medically necessary services to beneficiaries over the telephone via licensed medical professionals. In reality, however, many of these “telemedicine companies” are...more

Healthcare Regulatory Check-Up Newsletter | January 2024 Recap

McDermott Will & Schulte on 2/26/2024

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...more

Fraud Week: CT Behavioral Health Providers Sentenced

Rivkin Radler LLP on 5/1/2023

We’ll wrap up this edition of Fraud Week with a look at two Connecticut behavioral health providers, one bad and one very, very bad. First, Alicia Thompkins, a social worker from Hartford, pleaded guilty on April 27 to...more

California Passes New Law Requiring Physicians and their Employers to Notify Patients about the Open Payments Database

Mintz - Health Care Viewpoints on 10/11/2022

A new California law (AB 1278) will require physicians and their employers to provide patients with several forms of notices about the Open Payments database, starting January 1, 2023. The law is intended to increase...more

OIG’s First Advisory Opinion of 2022 Allows for Expansion of Discount Programs

Arnall Golden Gregory LLP on 2/15/2022

On January 19, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) released a favorable advisory opinion, OIG Advisory Opinion No. 22-01 (the “Opinion”), analyzing a proposed expansion of...more

OIG Issues Favorable Advisory Opinion on Retailer’s Proposed Expansion of Discount Programs for Low-Income Individuals

King & Spalding on 1/26/2022

On January 19, 2022, OIG posted a favorable Advisory Opinion on a pharmacy-owning retailer’s proposal to expand its existing discount programs for low-income individuals by including enrollment in Medicaid as an additional...more

Healthcare Law Update: October 2021

Holland & Knight LLP on 10/18/2021

Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more

How The Truth Is False: Accurate Prescription Drug Event Data Can Trigger False Claims Act Liability

McCarter & English Blog: Government Contracts... on 5/12/2021

In United States ex rel. Silver v. Omnicare, Inc., et al. (D.N.J. No. 11-cv-01326), a whistleblower relator consistently alleged that certain pharmaceutical service providers have engaged in an illegal kickback arrangement...more

Healthcare Law Update: April 2021

Holland & Knight LLP on 4/28/2021

William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

Eleventh Hour Rulemaking: HHS Eliminates Safe Harbor Protections for PBM Drug Rebates and Creates Two New Safe Harbors for...

Sheppard Mullin Richter & Hampton LLP on 12/3/2020

On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute...more

Uncertainty on Drug Pricing Remains Following Trump Administration Executive Orders

White & Case LLP on 8/1/2020

On July 24 2020, President Trump signed three Executive Orders targeting prescription drug prices and proposed a fourth. The Orders represent the Trump Administration's latest effort to implement previously outlined...more

New Risks, New Rewards, New Exposure

King & Spalding on 6/24/2020

Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more

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