Actelion Corporate Integrity Agreement
Similar comparisons have not yet been made. For example, Irish-based jazz pharmaceuticals and Danish pharmaceutical company Lundbeck said they had in principle entered into agreements for non-profit foundations to help patients. In its stock release, Jazz said it set aside $57 million, while Lundbeck said he expected to pay $52.6 million. Other pharmaceutical companies that have received subpoenas include Astellas Pharma, Biogen, Celgene, Gilead Sciences, Johnson-Johnson and Valeant Pharmaceuticals. “Today`s comparison against Actelion is a victory for the public and underscores the FBI`s commitment to protecting the financial integrity of the Medicare program,” said Harold H. Shaw, special representative of the Federal Bureau of Investigation, Boston Field Division. “Simply put, the goal of the FBI`s health fraud program is to ensure that patients receive appropriate treatments and therapies based on their medical needs, without corrupt or lucrative influence from drug manufacturers.” “Kickback systems can undermine our health care system, compromise medical decisions and waste taxpayers` money,” said Phillip Coyne, Special Agent in charge, Office of the Inspector General of the Department of Health and Human Service`s Boston Regional Office. “We will continue to accuse pharmaceutical companies of inseminating the donation process to circumvent safeguards to protect the integrity of the Medicare program.” “Today`s agreement resolves the government`s investigation into donations of acts to a patient support foundation in 2014 and 2015,” the spokeswoman added. “Before the company is back in 2017.” AmerisourceBergen`s five-year Enterprise Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (OIG) provides compliance officials with a roadmap of best practices, including: implementing surveillance and audit controls. The Compliance Department should oversee donations to independent charitable PAPs each year by adopting both a risk-based approach to targeting and a random approach to sampling.
The documentation to be reviewed includes budget documents; Documents relating to the donation decision-making process; and all written agreements, as well as any communication and interaction between the company and the independent charity PAP. On June 16, 2017, Johnson and Johnson acquired Actelion, based on the moderate conduct of today`s transaction agreement. The claims resolved by the transaction are merely assertions; no establishing of responsibility. The CIA of AmerisourceBergen also requires that each board member receive at least two hours of long-term training to deal with the unique duties of members of the Public Health Commission, including risks, surveillance areas and strategic approaches to monitoring a health organization. “This training can be provided by an external compliance expert, who has been recruited by the board of directors,” the CIA said.