Allergan Corporate Integrity Agreement: What You Need to Know
Allergan, a leading pharmaceutical company, was recently the subject of a Corporate Integrity Agreement (CIA) with the U.S. Department of Health and Human Services and the Office of Inspector General. The CIA is a binding agreement between a company and the government to ensure compliance with federal healthcare laws and regulations.
The CIA stemmed from allegations that Allergan paid kickbacks to doctors to prescribe their medications. The company agreed to pay $15 million to settle the allegations and agreed to certain conditions to avoid further legal action.
So, what does this mean for Allergan and healthcare providers? Here’s what you need to know:
1. Allergan must implement a comprehensive compliance program.
As part of the CIA, Allergan is required to develop and implement a comprehensive compliance program, which includes policies and procedures for compliance with federal healthcare laws and regulations. The compliance program must also include regular training for employees and contractors on these policies and procedures.
2. Allergan must report any violations of federal healthcare laws.
Allergan is required to report any violations of federal healthcare laws to the government. This includes violations by its employees, contractors, and healthcare providers who prescribe or use Allergan’s products.
3. Healthcare providers must disclose any payments received from Allergan.
Under the CIA, healthcare providers who receive payments from Allergan must disclose these payments to the government. These payments can include consulting fees, travel expenses, and meals.
4. Allergan’s sales and marketing practices are under scrutiny.
The CIA requires Allergan to undergo regular monitoring and auditing of its sales and marketing practices. This is to ensure that Allergan is not engaging in any activities that violate federal healthcare laws and regulations.
5. Non-compliance can result in significant penalties.
If Allergan fails to comply with the CIA, the company could face significant penalties. This could include exclusion from federal healthcare programs, fines, and criminal prosecution.
In summary, the Allergan Corporate Integrity Agreement is a reminder that healthcare companies must comply with federal healthcare laws and regulations. Healthcare providers who prescribe or use Allergan’s products should be aware of the company’s compliance requirements and disclosure obligations. Failure to comply could result in serious consequences for everyone involved.