Exhibit 10.2
SETTLEMENT AGREEMENT AND
RELEASE
I. PARTIES
This Settlement Agreement
(“Agreement”) is entered into by the United States of
America, acting through the United States Attorney’s Office
for the District of Massachusetts, and the Office of Inspector
General (“OIG-HHS”) of the United States Department of
Health and Human Services (“HHS”); and
NeuroMetrix, Inc. (“NeuroMetrix”), a Delaware
corporation with a principal place of business in Waltham,
Massachusetts, through their authorized representatives.
Collectively, all of the above shall be referred to as “the
Parties.”
II. PREAMBLE
A.
WHEREAS, at all relevant times,
NeuroMetrix developed, designed, distributed, marketed, and sold a
medical device known as the NC-stat System (the “medical
device”) to physicians nationwide for the purpose of
conducting nerve conduction studies on-site to assist in the
diagnosis of neuropathies in the peripheral nerves and spine
frequently caused by or associated with carpal tunnel syndrome, leg
pain, diabetes, and other clinical disorders;
B.
WHEREAS, NeuroMetrix has agreed to
enter into a deferred prosecution agreement with the United States
Attorney for the District of Massachusetts (the “Deferred
Prosecution Agreement”), under which NeuroMetrix will
acknowledge that it is guilty of a violation of 42 U.S.C.
§1320a-7b(b)(2) by offering and paying illegal
remuneration to physicians to induce them to refer and recommend
the use of the NC-stat System to other physicans, as set forth in
an Information attached to the Deferred Prosecution
Agreement;
C.
WHEREAS, the United States alleges
that NeuroMetrix caused to be submitted claims for payment for the
technical and professional component of use of the medical device
to the Medicare Program, established pursuant to Title XVIII of the
Social Security Act, § 1395-1395hhh, which is administered by
HHS;
D.
WHEREAS, the United States contends
that it has certain civil claims against NeuroMetrix as specified
in Paragraph 2 below for engaging in the following
conduct:
(i)
The United States contends that,
from August 2004 through October 2006, NeuroMetrix
knowingly and willfully offered and paid illegal remuneration to
induce physicians to refer and recommend purchase of the NC-stat
System, in violation of 42 U.S.C. §1320a-7b(b)(2) through
marketing programs known as the “Referral Rewards
Program” and “Customer Referral Program.”
As a result, NeuroMetrix knowingly caused the submission of false
or fraudulent claims to the Medicare Programs for nerve conduction
studies performed with the NC-stat System for which no payments
should have been made.
(ii)
The United States contends that,
from January 2003 through April 2006, NeuroMetrix
knowingly caused the submission of false or fraudulent claims for
payment to Medicare by providing coding reports to physicans that
falsely indicated the nerve conduction studies performed with the
NC-stat System should be billed under CPT Codes 95903 when no
F-wave had been obtained, and which services should have been
billed under CPT Code 95900 instead, a specific code for nerve
conduction studies where no F-wave was obtained. As a result,
NeuroMetrix knowingly caused the submission of false or fraudulent
claims to Medicare that resulted in excess payments from Medicare
to which the physicians were not entitled.
E.
NeuroMetrix’s conduct as
described in the Information attached to the Deferred Prosecution
Agreement and Preamble Paragraph D is hereafter referred to as the
“Covered Conduct.”
F.
WHEREAS, HHS-OIG contends that it
has certain administrative claims against NeuroMetrix, as specified
in Paragraph 4 below, for engaging in the Covered
Conduct.
G.
WHEREAS, this Agreement is neither
an admission of facts or liability by NeuroMetrix nor a concession
by the United States that its claims are not well-founded, and
NeuroMetrix denies that it engaged in any conduct giving rise to
criminal or civil liability with the sole exception of such
admissions as NeuroMetrix makes in connection with the
Deferred Prosecution Agreement referenced in Paragraph B
above.
2
H.
WHEREAS, to avoid the delay,
expense, inconvenience, and uncertainty of protracted litigation of
these claims, the Parties mutually desire to reach a full and final
settlement as set forth below.
III. TERMS AND CONDITIONS
NOW, THEREFORE, in reliance on the
representations contained herein and in consideration of the mutual
promises, covenants, and obligations set forth below in this
Agreement, and for good and valuable consideration as stated
herein, the Parties agree as follows:
1.
NeuroMetrix agrees to pay to the
United States the sum of two million four hundred ninety eight
thousand three hundred thirty seven dollars ($2,498,337), plus
interest in an amount of 2.75% per annum on the Settlement Amount
as further set forth below ($188.23 per day) from January 1,
2009 and continuing until and including the day before complete
payment is made (the “Settlement Amount”). This
sum shall constitute a debt immediately due and owing to the United
States on the Effective Date of this Agreement. The
Settlement Amount shall be electronically transferred pursuant to
instructions provided by the United States Attorney’s Office
for the District of Massachusetts no later than the second business
day following the date on which this Agreement is fully executed by
the parties.
2.
Subject to the exceptions in
Paragraphs 3 and 4 below, and in consideration of the obligations
of NeuroMetrix set forth in this Agreement, conditioned upon
NeuroMetrix’s payment in full of the Settlement Amount,
subject to Paragraph 12 below (concerning bankruptcy proceedings
commenced within 91 days of the Effective Date of this Agreement or
any payment under this Agreement), and subject to the simultaneous
execution of the Deferred Prosecution Agreement described in
Preamble Paragraph B, the United States, on behalf of itself, and
its officers, agents, agencies, and departments, agrees to release
NeuroMetrix, its predecessors, and its current and former parents,
affiliates, divisions, subsidiaries, successors and assigns, and
their current and former directors, officers , and employees, from
any civil or administrative monetary claim that the United States
has or may have under the False Claims
3
Act, 31 U.S.C. §§ 3729-33; the Program
Fraud Civil Remedies Act, 31 U.S.C. §§ 3801-12; the
Civil Monetary Penalties Law, 42 U.S.C. § 1320a-7a; any
statutory provision applicable to the federal funded program in
this Agreement for which the Civil Division, United States
Department of Justice has actual and present authority to assert
and compromise pursuant to 28 C.F.R. Part O, Subpart I,
Section 0.45(d); and common law claims for fraud, unjust
enrichment, payment by mistake, or disgorgement for the Covered
Conduct.
3.
Notwithstanding any term of this
Agreement, the United States specifically does not release any
person or entity from any of the following claims or
liabilities: (a) any criminal, civil, or administrative
claims arising under Title 26, U.S. Code (Internal Revenue Code);
(b) any criminal liability except as set forth in the Deferred
Prosecution Agreement; (c) any liability to the United
States (or any agencies thereof) for any conduct other than the
Covered Conduct; (d) any claims based upon obligations created
by this Agreement; (e) except as explicitly stated in this
Agreement, any administrative liability, including mandatory
exclusion from Federal health care programs; (f) any express
or implied warranty claims or other claims for defective or
deficient products and services provided by NeuroMetrix;
(g) any claims for personal injury or property damage or for
other consequential damages arising from the Covered Conduct;
(h) any claim based on a failure to deliver items or services
due; or (i) any civil or administrative claims against
individuals, including current and former directors, officers, and
employees of NeuroMetrix, its predecessors, subsidiaries, and
affiliates, who receive written notification that they are the
target of a criminal investigation, are criminally indicted or
charged, or are convicted, or who enter into a criminal plea
agreement.
4.
In consideration of the obligations
of NeuroMetrix set forth in this Agreement, and the Corporate
Integrity Agreement (“CIA”) entered into between
OIG-HHS and NeuroMetrix, conditioned on NeuroMetrix’s payment
in full of the Settlement Amount, and subject to Paragraph 12 below
(concerning bankruptcy proceedings commenced within 91 days of the
effective date of this Agreement or any payment under this
Agreement), OIG-HHS agrees to release and refrain from instituting,
directing, or maintaining any administrative action
seeking
4
exclusion from the Medicare, Medicaid, or other
Federal health care programs (as defined in 42 U.S.C. §
1320a-7b(f)) against NeuroMetrix, its predecessors, and its current
or former parents, affiliates, divisions, subsidiaries, successors,
and assigns, under 42 U.S.C. § 1320a-7a (Civil Monetary
Penalties Law), or 42 U.S.C. § 1320a-7(b)(7) (permissive
exclusion for fraud, kickbacks or other prohibited activities), for
the Covered Conduct, except as reserved in Paragraph 3 above, and
as reserved in this Paragraph. The OIG-H