Exactech Corporate Integrity Agreement
July 25, 2023
Exactech, a medical device company specializing in orthopedic implants, entered into a Corporate Integrity Agreement (CIA) in 2018 with the Office of Inspector General (OIG) of the Department of Health and Human Services. The CIA was the result of a settlement with the OIG for alleged violations of the Anti-Kickback Statute and False Claims Act.
The Anti-Kickback Statute prohibits healthcare providers from offering, paying, soliciting, or receiving any form of remuneration in exchange for referrals. The False Claims Act prohibits individuals and entities from submitting false or fraudulent claims for payment to the government. In the case of Exactech, the allegations were related to improper payments to surgeons in exchange for using their products and submitting false claims to Medicare and Medicaid for reimbursement.
Under the CIA, Exactech agreed to establish and implement a compliance program that includes policies and procedures designed to prevent and detect violations of the Anti-Kickback Statute and False Claims Act. The company also agreed to provide training to all employees on the compliance program, including training on the Anti-Kickback Statute and False Claims Act.
In addition, Exactech is required to retain an independent review organization to conduct annual reviews of its compliance program and report any potential violations to the OIG. The company must also provide detailed quarterly reports to the OIG on its compliance activities and any known or suspected violations.
The CIA will remain in effect for five years and failure to comply with the terms could result in civil and criminal penalties. This agreement serves as a reminder to healthcare providers and medical device companies of the importance of complying with federal healthcare laws and regulations.
In conclusion, the Exactech Corporate Integrity Agreement is a significant step towards ensuring compliance with federal healthcare laws and regulations. The CIA demonstrates the OIG`s commitment to enforcing these laws and serves as a warning to healthcare providers and companies that violations will not be tolerated. As a professional, it is essential to include relevant keywords and phrases such as “Corporate Integrity Agreement,” “Exactech compliance program,” and “healthcare providers and companies.” By doing so, the article can be easily found by those searching for information on this topic.