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Showing 21 posts in Kickbacks.

The Anti-Kickback Statute and the False Claims Act: Working together to promote the responsible use of government funds

What is the Anti-Kickback Statute?

The Anti-Kickback Statute ("AKS")1 is a federal criminal law that prohibits the knowing exchange of valued items, services, or payments for referrals of goods or services reimbursable by federally funded healthcare programs. Any claim submitted in violation of the AKS is false, and therefore not reimbursable by federally funded healthcare programs. Accordingly, the AKS seeks to ensure patient health considerations drive medical decision-making, rather than monetary or other valuable incentives offered to providers. Combined with the False Claims Act ("FCA"),2 which allows individuals to sue parties who defraud the government, the two statutes provide a potent tool to combat health care fraud. More

Government Takes a Hard Line on Fraudulent Donations to Patient Assistance Programs

Last month, the Department of Justice ("DOJ") announced a settlement with two pharmaceutical companies – Astellas Pharma US, Inc. ("Astellas"), and Amgen Inc. ("Amgen") – resolving allegations that their "donations" to patient assistance programs violated the False Claims Act. The two companies agreed to pay a total of $124.75 million, and both entered into five-year corporate integrity agreements with the Office of Inspector General as part of their respective settlements. United States Attorney Andrew E. Lelling said that according to the allegations, the companies illegally subsidized the high costs of their own drugs at the expense of American taxpayers, and "[w]e will keep pursuing these cases until pharmaceutical companies stop engaging in this kind of behavior.” Multiple settlements related to similar investigations have already brought in hundreds of millions of dollars in only a few years' time. More

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Pharmaceutical Manufacturer US WorldMeds LLC Pays $17.5 Million to Settle False Claims Act Allegations

Pharmaceutical manufacturer US WorldMeds LLC (USWM), headquartered in Louisville, Kentucky, has agreed to pay $17.5 million to settle allegations that it violated the False Claims Act by paying kickbacks to both patients and physicians to induce prescriptions of its drugs Apokyn and Myobloc.  The Department of Justice (DOJ) announced the settlement on April 30, 2019. More

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Drug Maker Actelion Agrees to Pay $360 Million to Settle False Claims Act Investigation Into Kickbacks

The pharmaceutical company Actelion Pharmaceuticals US, Inc. ("Actelion"), based in South San Francisco, California, has agreed to pay $360 million to resolve claims that it illegally funneled kickbacks through a patient-assistance charity.  Federal prosecutors allege in a press release on December 6, 2018 that Actelion "illegally used a foundation as a conduit to pay the copays of thousands of Medicare patients taking Actelion's pulmonary arterial hypertension drugs." These actions are in violation of the False Claims Act.  More

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The Government Fights Back Against Ambulance Fraud: A Recent $21 Million Settlement and Other Related Cases

The U.S. Government has successfully combatted several instances of ambulance fraud this past year, by intervening in False Claims Act (FCA) qui tam suits and by pursuing a criminal health care fraud case against an ambulance company owner. These cases against AmeriCare, Hart to Heart, and the owner of Tonieann EMS and Rosenberg EMS, mainly involve allegations that these companies systematically billed government-provided insurance for medically unnecessary ambulance transports. However, a recently-resolved case against Paramedics Plus and several affiliates involved allegations of an illegal kickback scheme enacted to win and maintain exclusive ambulance contracts. More

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An Overview of Nursing Home Fraud: False Claims Act Cases from the Last Three Years

The last three years have seen several FCA cases related to nursing home fraud achieve success. Two cases of note—one against a skilled nursing facility chain and one against a rehabilitation therapy provider—settled for over $100 million, and a recent Third Circuit decision revived a dismissed case against a pharmaceutical company and narrowed the public disclosure bar. Still other cases involving similar allegations of inflating reimbursement levels and engaging in illegal kickback schemes have settled for millions or involved criminal prosecution of the individuals responsible. More

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Lincare Settles False Claims Act Allegations for $5.25 Million

Lincare, Inc., one of the nation's largest providers of durable medical equipment has paid $5.25 million to resolve allegations brought forth through a qui tam action filed by a Relator on behalf of the United States.  More

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False Claims Act and the Opioid Crisis: First-ever Civil Injunction Filed by Justice Department to Combat Opioid Over-Prescription

In August 2018, the U.S. Department of Justice announced allegations against an Ohio doctor for violating the False Claims Act (FCA) in addition to violating the Controlled Substances Act (CSA) for prescribing opioid prescriptions in excessive amounts or to those who are not in need of the medication. Although an FCA case is not the most traditional approach to these issues, it is clear that the Justice Department is making the opioid crisis a top priority and therefore potentially invoking the FCA more often in these cases. The government's focus on the opioid crisis has been consistently increasing and expanding from targeting manufacturers of opioids to targeting prescribers and healthcare providers that submit claims to federal health care programs or to the federal government. 


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Escobar decision continues to affect major FCA cases

In 2016, the Supreme Court decided the landmark FCA case Universal Health Servs., Inc. v. United States ex rel. Escobar, 136 S.Ct. 1989 (2016). Escobar resolved a circuit split over the implied false certification theory of liability under the FCA, upholding the theory as valid but tightly circumscribing its scope through a "rigorous" interpretation of the Act's materiality and scienter requirements—holding that "[a] misrepresentation about compliance with a statutory, regulatory, or contractual requirement must be material to the Government's payment decision in order to be actionable under the False Claims Act." Escobar, 136 S.Ct. at 1996. This holding continues to percolate through the federal courts, proving determinative in several recent cases of interest. More

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Four Houston-Area Hospitals Pay $8.6 Million to Settle Ambulance Swapping Allegations

Four Houston-area hospitals have paid $8.6 million collectively to settle allegations of "ambulance swapping"—that ambulance companies paid kickbacks to the hospitals in exchange for the hospitals' lucrative Medicare and Medicaid transport referrals. The hospitals—Bayshore Medical Center, Clear Lake Regional Medical Center, West Houston Medical Center, and East Houston Regional Medical Center—are all affiliates of the Nashville-based Hospital Corporation of America. More

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