Corporate Integrity Agreement Insys

  • Posted on: April 8, 2021
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The government`s approach to this regime, including the requirement that a company plead guilty to mail fraud and the hefty criminal and civil fines imposed on Insys, shows that increased penalties for wrongdoing by companies in the midst of the opioid crisis continue. The OIG`s recognition of the cooperation of companies in the pursuit of individuals as the basis for the non-persecution of exclusion continues to emphasize the individual responsibility of the government in the event of corporate misconduct and could indicate to other defendants the potential benefit of cooperation leading to individual convictions. Following the release of this transaction, Insys announced that it would present voluntary cases under Chapter 11 of the U.S. Bankruptcy Act. While much of the media coverage of this case in recent years has focused on the prosecution and high-level conviction of the company`s executives (including the founder of Insys) and other employees accused of paying bribes to prescribers in exchange for increased prescriptions and doses of Subsys, the solution of this case proved to be just as fascinating from the company`s point of view. Insys also entered into an agreement on corporate integrity and conditional exclusion authorization with the Office of Inspector General (OIG) of the U.S. Department of Health and Health Services, which gave the OIG the power to exclude Insys from DenS health programs such as Medicare, Medicaid and Tricare. The company integrity agreement forced Insys to sell Subsys, its flagship product, to a third party. Insys` press release after the declaration of insolvency states that it will “facilitate the sale of the bulk of all the company`s assets and address the company`s long-standing debts.” 4 The company intends to apply for authorization for a provision between itself and the government to correct the government`s unsecured debt of $243 million, capped at a recovery of $195 million.5 Without this ceiling, the United States has stated that it may have “claims against debtors for amounts in excess of $1 billion for covered behaviour.” 6 If the company survives this restructuring, it will always face challenges in compliance with the company`s integrity agreement, with the company having an order to ensure compliance. Insys entered into a five-year agreement with the Office of Inspector General described by the government as an “unprecedented” agreement on corporate integrity (CIA) and conditional exclusion authorization. Because of Insys` extensive collaboration in prosecuting the guilty persons and their consent to increase the CIA`s requirements, OIG decided not to follow Insys` exclusion at that time.

[2] See z.B. Novartis Corporation Corporate Integrity Agreement (June 30, 2020), oig.hhs.gov/fraud/cia/agreements/Novartis_Corporation_06302020.pdf. Over the past two years, much of the healthcare community has observed the government`s persecution of Insys Therapeutics because of its sales and marketing practices related to its Subsys spray. Subsys is a powerful and highly addictive fentanyl spray (administered under the tongue) approved by the FDA in 2012 for the treatment of persistent paroxysmal pain in adult cancer patients who have already received regular opioid treatment and are tolerant.