SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 6, 2018
(Exact name of registrant as specified in its charter)
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22 Cherry Hill Drive
Danvers, MA 01923
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Item 8.01 Other Events.
ABIOMED, Inc. (the Company) has resolved its previously disclosed Department of Justice investigation. Specifically, on March 6, 2018, the Company entered into a Settlement Agreement (the Settlement Agreement) with the United States Attorney for the District of Massachusetts (the DOJ) and on behalf of the Office of Inspector General of the Department of Health and Human Services (OIG-HHS), and Max Bennett (the Relator) to resolve civil claims relating to the Companys reimbursement of employee expenses for meals with healthcare providers. Those claims are derived from a civil qui tam action captioned United States ex rel. Bennett v. Abiomed, 13-cv-12277 (IT), which was brought by a former Company employee who was terminated in 2012, after just 29 days of employment. The Department of Justices investigation spanned almost four years. During that period, the government inquired about thousands of business and educational engagements the company conducted with physicians. The investigation revealed that less than 2% of those meals exceeded Abiomeds internal guidelines.
After careful consideration, the Company determined that resolving this matter was in the best interests of its patients, customers, shareholders and employees. The Settlement Agreement contains no admission of liability on the part of the Company, and it does not require the Company to enter into a corporate integrity agreement. Under the terms of the Settlement Agreement, the Company will pay $3,100,000, plus approximately $30,000 of accrued interest, to the United States no later than 7 days after the effective date of the Settlement Agreement. The Company will also pay $150,000 to Relator in settlement of Relators claims for reasonable expenses, costs and attorneys fees. At no point did the investigation question the safety, effectiveness, medical necessity or life-saving function of the FDA-approved Impella® devices. The Company cooperated in the investigation from its inception in 2014, and believes that this Settlement Agreement avoids significant additional costs of litigation, and removes legal risks and uncertainty related to this issue.
The United States and the Relator have agreed to release the Company from any civil monetary liability arising from allegations that the Company caused third parties to submit false claims for payment to Medicare by providing inducements in the form of meals intended to cause healthcare professionals to purchase Impella heart pumps. The parties have agreed to file a joint stipulation of dismissal of the Civil Action with prejudice. In connection with this resolution, all alleged State Claims will be dismissed without prejudice. The Company intends to vigorously defend the Relators individual claims of employment retaliation, which are not encompassed in the Settlement Agreement.
Like many medical technology companies, the Company is a member of the Advanced Medical Technology Association (AdvaMed). AdvaMeds Code of Ethics, which the Company adopted in 2006, recognizes that company meetings held in conjunction with business meals can play an important role in educating physicians. As AdvaMed guides, the Company has instituted a Code of Conduct and Compliance Policy through which the Company has set internal expense limits for such business meals, and monitors and disciplines employees who exceed these limits.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|By:||/s/ Stephen C. McEvoy|
Stephen C. McEvoy
(Vice President and General Counsel)
Date: March 8, 2018