Since the pandemic, COVID-19-related fraud has been a consistent target of the Department of Justice....more
9/3/2024
/ Anti-Fraud Provisions ,
Anti-Kickback Statute ,
CARES Act ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Economic Injury Disaster Loans ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Enforcement Guidance ,
Enforcement Priorities ,
Enforcement Statistics ,
False Claims Act (FCA) ,
Fraud ,
Healthcare Fraud ,
Paycheck Protection Program (PPP) ,
White Collar Crimes
The Food and Drug Omnibus Reform Act of 2022 (“FDORA” or the “Act”), signed into law on December 29, 2022, required, in part, drug and device manufacturers to submit Diversity Action Plans to the U.S. Food and Drug...more
In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers...more
On October 5, 2023, the U.S. Department of Health and Human Services (HHS), Office of the Secretary, Office of the Assistant Secretary for Health (OASH), Office of Research Integrity (ORI) issued a Notice of Proposed...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
8/23/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Health Insurance ,
Healthcare ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Scienter ,
SCOTUS ,
Subjective Standard ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
On 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...more
8/23/2023
/ False Billing ,
False Claims Act (FCA) ,
Healthcare ,
Medicaid ,
Medicare ,
Objective Unreasonableness Standard ,
Pharmacies ,
Prescription Drugs ,
Qui Tam ,
Reasonableness Factors ,
Scienter ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
On November 18, 2022, the Alliance Defending Freedom (“ADF”), a conservative legal group, filed a motion with the federal district court in the Northern District of Texas against the U.S. Food and Drug Administration...more
Given the volume of funds that were quickly dispersed during the COVID-19 pandemic, there were plenty of new areas for fraud and abuse. The Department of Justice (“DOJ”) initially set its sights on targeting the borrowers of...more
In September of this year, New York City Councilwoman Julie Menin announced her plan to introduce a series of bills that would create further price transparency requirements for hospitals, with noncompliance resulting in high...more
On April 20, 2022, the U.S. Department of Justice (“DOJ”) announced a nationwide coordinated law enforcement action to combat health care-related COVID-19 fraud. In line with the announcement, the federal government has...more
On November 19, 2021, the U.S. House of Representatives (“the House”) narrowly passed the Build Back Better Act (H.R. 5376, or “the Act”), a spending bill appropriating nearly $2 trillion for measures to expand the country’s...more
On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) released revisions to its Code on Interactions with Health Care Professionals (“Code”). The Code applies to pharmaceutical company...more
On July 19, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposal that would significantly increase the fines that would be imposed on hospitals for price transparency violations. This proposal,...more