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Kaléo Inc. to Pay $12.7 Million to Resolve Allegations of False Claims for Anti-Overdose Drug
Kaléo Inc., a Virginia-based pharmaceutical manufacturer, has agreed to pay the United States $12.7 million to resolve allegations that kaléo caused the submission of false claims for the drug Evzio, an injectable form of naloxone hydrochloride indicated for use to reverse opioid overdose.
Evzio was the highest-priced version of naloxone on the market, and insurers frequently required the submission of prior authorization requests before they would approve coverage for Evzio.
The United States alleged that, between March 14, 2017, and April 30, 2020, kaléo directed prescribing doctors to send Evzio prescriptions to certain preferred pharmacies that in turn (1) submitted false prior authorization requests for Evzio that misrepresented to insurers that the prescribing physicians submitted the request when the pharmacies did so and/or contained false or misleading assertions about the patients’ medical histories, such as false statements that patients had previously tried and failed less costly alternatives to Evzio, and (2) dispensed Evzio without collecting or attempting to collect co-payment obligations from government beneficiaries.
The United States contends that kaléo knew of or deliberately ignored this pharmacy misconduct, but nevertheless kept directing business to these pharmacies. The United States also alleged that kaléo provided illegal remuneration to prescribing physicians and their office staff in violation of the Anti-Kickback Statute to induce and reward their prescribing of Evzio.
Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division stated, “Truthful and accurate documentation is essential to the integrity of federal health care programs. Today’s settlement demonstrates that the department will hold to account those who undermine these programs by causing false claims to be submitted to the government.”
Defendant: kaléo Inc.
Criminal Charges: Caused the submission of false claims for the drug Evzio
City and State: Virginia
Exact Date: Between March 14, 2017, and April 30, 2020
Sentence or Outcome: kaléo Inc. agreed to pay $12.7 million to resolve allegations
Dollar Amount: $12.7 million
Defendant Name: kaléo Inc.
Date of Crime: Between March 14, 2017, and April 30, 2020
Outcome: kaléo Inc. agreed to pay $12.7 million to resolve allegations
Key Facts
- State: Virginia
- Category: Fraud & Financial Crimes
- Source: DOJ Press Release â†â€â€
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