false claims act
Recently, pharmaceutical companies are gaining increased notoriety for violations of the False Claims Act, the Anti-Kickback Statute, and general fraudulent practices directed toward physicians and medical care providers with the intent to increase profits. In 2019, Avanir Pharmaceuticals settled with the Department of Justice to pay more than $108 million of criminal penalties and civil damages for engaging in kickbacks with physicians, and misleading marketing of their drug Nudexta for unapproved purposes. Then, in May of 2021, Incyte Corp., a Delaware-based pharmaceutical manufacturer agreed to pay $12.6 million for unspecified damages arising under a violation of the Federal False Claims Act for improperly using an independent foundation to cover copays of individuals consuming Incyte’s cancer drug, Jakafi. Despite widespread prosecutions against pharmaceutical drug manufacturers, and the fraud deterrent provisions of the False Claims Act, the risk of fraud and remuneration still runs high in relationships between healthcare professionals and pharmaceutical companies.
The False Claims Act (“FCA”) is one of the United States Government’s most powerful tools for fighting fraud. In fact, the Department of Justice recovered nearly $1.8 billion under the FCA for health care fraud and $1.6 billion in FCA qui tam relator cases in the 2020 fiscal year. Keeping the enforcement of fraud in mind, underlying all FCA qui tam suits is successfully pleading with particularity under Federal Rule of Civil Procedure 9(b). This requirement has led many U.S. District Courts to dismiss qui tam cases at the pleading stage and U.S. Courts of Appeals to affirm those decisions. The upshot is that amid changes to the Stark Law and Anti-Kickback law, the continuation of COVID-19 related fraud, and the continuing splits in the Federal Circuit regarding pleading standards, the ground may begin to shift for compliance officers, attorneys, and general counsels in health care organizations.
Finance Director for UnitedHealth Group brought qui tam suit against UnitedHealth Group, Inc. alleging that the organization upcoded risk adjustment data resulting in increased payments (more than $1.14 billion) to UnitedHealth Group. The Department of Justice (DOJ) intervened in the case, yet UnitedHealth Group was successful in getting the primary False Claims Act Claims dismissed by arguing that the Centers for Medicare & Medicaid Services (CMS) would not have refused to make the adjustment payments had they known of the errors in the risk adjustment. The Escobar materiality standard helps clarify threshold level of risk to Managed Care Providers in attesting to their risk adjustment payments; the falsities must have had an impact on the respective payment.
This summer I had the opportunity to intern with the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) in Washington, DC. I thoroughly enjoyed my time with OIG, and I learned a great deal about health care fraud, waste, and abuse. In spending my summer with OIG, I had a glimpse into the powerful regulatory bodies that protect the health care market from abuse. As I move forward with my career in regulatory work, I will take with me the invaluable experiences and skills from my internship.
The United States Department of Justice (“DOJ”) recently intervened in a qui tam action against UnitedHealth Group (“United”) and its subsidiary, UnitedHealthcare Medicare & Retirement, the nation’s largest provider of Medicare Advantage (“MA”) Plans. The suit alleges that United engaged in an “up-coding” scheme to receive higher payments than they should have under MA’s risk adjustment program. Assuming these allegations of United’s false claims are true, then United billed and received hundreds of millions of dollars in improper payments from Medicare.
Kaitlin Lavin Executive Editor Loyola University Chicago School of Law, JD 2017 In January, Baxter Healthcare Corporation (“Baxter”) agreed to pay $18,158 million after the Department of Justice (DOJ) brought suit for violating the Food, Drug, and Cosmetic Act (FCDA) and the False Claims Act (FCA). The Baxter case is unique because it was …