“These comparisons demonstrate the FBI`s commitment to protecting the Medicare program and ensuring that patients receive treatment solely based on their medical needs,” said Joseph R. Bonavolonta, Special Representative of the Federal Bureau of Investigation, Boston Area Division. “Not only have these companies undermined a program that has been put in place to help patients reduce the cost of their drugs, but they have also threatened the financial integrity of medicare, to which we all contribute and on which we all depend.” The government said Jazz and Lundbeck have both entered into five-year business integrity agreements as part of the transaction agreements. The agreements will require companies to implement measures, controls and oversight to promote the independence of all patient assistance programs for which they donate, the government said. In 2019, the total number of new insurance and integrity (IA) agreements remained unchanged, as in 2018, but was below the five-year average. We are proud of Alexion`s culture and leadership and look forward to a bright future that builds on our ongoing commitment to compliance and integrity, while fulfilling our mission to change the lives of people with rare and devastating diseases. In 2019, HHS-OIG welcomed 37 new CIA and IAs,3 that match the number of CIA in 2018. As of January 6, 2020, according to the HHS-OIG website, there were 234 CIA open. Of the 39 agreements in 2019, two were amended to an earlier CIA, 21 were new ICAs, 15 were AI and one was an agreement on compliance with public authorities. Jazz and Lundbeck have entered into five-year Enterprise Integration Agreements (CIA) with OIG as part of their respective comparisons. The CIA requires companies to implement measures, controls and controls to promote the independence of all programs to assist patients for whom they donate. In addition, companies have agreed to implement risk assessment programs and obtain compliance certifications from executives and board members. “These kickback programs are hurting Medicare and the public,” said Gregory E.
Demske, chief of the inspector general. “The CIA OIG, like Jazz and Lundbeck, aims to reduce future risks to patients and taxpayer-funded programs. OIG decided not to ask for a CIA with Alexion because after the bad behavior, it made significant and fundamental organizational changes. Changes included the recruitment of a new eight-member management team and the modification of half of the board members. In addition, 40% of Alexion`s employees are new and the company is moving its head office. “Kickback systems undermine the integrity of our country`s health care system, including health care managed by the U.S. Department of Veterans Affairs,” said Sean Smith, Special Representative of the VA Office of Inspector General, Northeast Field Office. “The VA`s Office of the Inspector General, along with our law enforcement partners, will continue to conduct this investigation aggressively and will do everything in its power to detect these systems.” In 2019, the Business Integrity Agreements (CiAs) have been an important instrument for the Office of Inspector General, and the Department of Health and Human Services (HHS-OIG). In particular, drug and device manufacturers recorded a significant increase in the total number of CIA, including new and generally improved provisions, tailored to the extent of alleged (and, in some cases, authorized) misconduct.