Current Report Filing (8-k)
March 08 2018 - 1:35PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
8-K
CURRENT REPORT
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
ABIOMED, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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04-2743260
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(State or other Jurisdiction
of Incorporation)
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(IRS Employer
Identification Number)
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001-09585
(Commission File Number)
22 Cherry Hill Drive
Danvers, MA 01923
(Address of Principal Executive Offices, including Zip Code)
(978)
646-1400
(Registrants Telephone Number, including Area Code)
Not Applicable
(Former
Name or Former Address, if Changed Since Last Report)
Check the appropriate box below
if the Form
8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17 CFR
240.14a-12)
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Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c)
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Indicate by check mark whether the registrant is an emerging growth company as defined
in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule
12b-2
of the Securities Exchange Act of 1934
(§240.12b-2
of this chapter).
Emerging growth company ☐
If an emerging growth
company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange
Act. ☐
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.
SIGNATURES
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.
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ABIOMED, Inc.
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By:
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/s/ Stephen C. McEvoy
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Stephen C. McEvoy
(Vice President and
General Counsel)
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Date: March 8, 2018
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