exv10w67




Exhibit 10.67


CORPORATE INTEGRITY AGREEMENT

between the 

Office of Inspector General

of the

Department of Health and Human Services

and

 Boston Scientific Corporation




I. Preamble




     Boston Scientific Corporation hereby enters into this Corporate Integrity Agreement
(CIA) with the Office of Inspector General (OIG) of the United States Department of Health and
Human Services (HHS) to promote compliance with the statutes, regulations, and written directives
of Medicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. §
1320a-7b(f)) (Federal health care program requirements). Notwithstanding the fact that Boston
Scientific Corporation (“Boston Scientific”) is the party to this CIA and responsible for ensuring
its implementation, the undertakings in this CIA relate only to its Cardiac Rhythm Management
business activities and the following related corporate entities: Guidant Corporation, Cardiac
Pacemakers, Inc. and Guidant Sales Corporation (collectively, “Guidant/CRM”) and those persons who
meet the definition of Covered Persons set forth below in Section II. Contemporaneously with this
CIA, Boston Scientific is entering into a Settlement Agreement with the United States. This CIA
shall apply only to the U.S. operations of Guidant/CRM that are subject to U.S. Federal health care
program requirements.



     Boston Scientific is the parent corporation of each of the corporate entities that comprise
Guidant/CRM. Prior to the effective date of this CIA Boston Scientific established a voluntary
compliance program (known as the “Global Compliance Program”), which includes a Chief Compliance
Officer, Global Compliance Program staff, a Global Compliance Steering Committee, a Code of
Conduct, written policies and procedures, a compliance education and training program, review and
disciplinary procedures, a confidential disclosure program, an ineligible persons screening
program, and internal audit and review procedures. The Global Compliance Program is fully
applicable to Guidant/CRM. Boston Scientific shall continue to apply the Global Compliance Program
to Guidant/CRM operations throughout the term of the CIA and shall do so in accordance with the
terms set forth below. The Global Compliance Program may be modified, as deemed appropriate by
Boston Scientific, but at a



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minimum, Boston Scientific shall ensure that during the term of this CIA, it shall comply
with the obligations as set forth herein.




II. Term and Scope of the CIA




     A. The period of the compliance obligations assumed by Boston Scientific under this CIA
shall be 5 reporting periods as defined below. The effective date of this CIA shall be the date on
which the final signatory of this CIA executes this CIA (Effective Date). The first Reporting
Period shall be from the Effective Date through December 31, 2010. The second and subsequent
Reporting Periods shall be from January 1 through December 31 for each of the subsequent four
calendar years. Each period, beginning with the period following the Effective Date, shall be
referred to as a “Reporting Period.”



     B. Sections VII, IX, X, and XI shall expire no later than 120 days after OIG’s receipt of: (1)
Boston Scientific’s final Annual Report; or (2) any additional materials submitted by Boston
Scientific pursuant to OIG’s request, whichever is later.



     C. The scope of this CIA shall be governed by the following definitions:




1. “Arrangements” shall mean every arrangement or transaction entered into by or on
behalf of Guidant/CRM that involves, directly or indirectly, the offer, payment,
solicitation, or receipt of anything of value; and is between Guidant/CRM and any
actual or potential source of U.S. health care business or referrals to Guidant/CRM
or any actual or potential recipient of U.S. health care business or referrals from
Guidant/CRM. The term “source” shall mean any U.S. Health Care Provider (HCP),
Health Care Institution (HCI), physician, contractor, vendor, or agent and the term
“health care business or referrals” shall be read to include referring,
recommending, arranging for, ordering, leasing, or purchasing of any good, facility,
item, or service for which payment may be made in whole or in part by a Federal
health care program.




a. “Contractual Arrangements” shall mean every Arrangement that is
contractual in nature and shall include all Arrangements related to
provision of services to Guidant/CRM, including, but not limited to,
training, education, speaking, consulting, research, clinical studies, focus
groups, and physician advisory boards; and intellectual property.



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b. “Non-Contractual Arrangements” shall mean all Arrangements that
are not Contractual Arrangements.




2. “Covered Persons” includes:




a. all owners of Boston Scientific who are natural persons (other than
shareholders who: (1) have an ownership interest of less than 5%; and (2)
acquired the ownership interest through public trading);




b. all directors of Boston Scientific;




c. all officers and employees of Guidant/CRM who are based in the United
States or have job responsibilities in the United States with respect to
Guidant/CRM; and all officers and employees of Boston Scientific who have
line or management responsibility with respect to the sales or marketing of
Guidant/CRM products, except as carved out below in this Section II.C.2; and




d. all contractors, subcontractors, agents, and other persons who are not
Third Party Personnel who perform sales or marketing of Government
Reimbursed Products that would otherwise be performed by Guidant/CRM
employees on behalf of Guidant/CRM. This definition does not include HCP
and/or HCIs who enter into Arrangements as defined above with Guidant/CRM.




Notwithstanding the above, the term “Covered Persons” does not include: (1)
part-time or per diem employees, contractors, subcontractors, agents, and other
persons who are not reasonably expected to work more than 160 hours per year, except
that any such individuals shall become “Covered Persons” at the point when they work
more than 160 hours during the calendar year; or (2) employees, contractors,
subcontractors, agents, and other persons of Boston Scientific and/or Guidant/CRM
who perform only (i) product building, movement or inspection functions, including
product builders, inspectors, material handlers and manufacturing or warehouse
functions; (ii) customer service, technical support services and telephone
operators; and (iii) physical plant maintenance and janitorial duties,
cafeteria-related duties, and/or similar non-core Guidant/CRM business related
duties.



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3. “Arrangements Covered Persons” includes each Covered Person involved with
the development, approval, management, or review of Guidant/CRM’s Arrangements, as
such term is defined in Section II.C.1.




4. “Government Reimbursed Products” refers to all Guidant/CRM medical devices
manufactured, promoted or sold by Guidant/CRM in the U.S. that are reimbursed by
Federal health care programs.




5. The term “Third Party Educational Activity” shall mean any continuing medical
education (CME), disease awareness, or other scientific, educational, or
professional program, meeting, or event conducted by a Third Party and financially
supported by Boston Scientific, including but not limited to, sponsorship of
third-party symposia at medical conferences.




6. “Third Party Personnel” shall mean personnel of the entities with whom Boston
Scientific has or may in the future (during the term of this CIA) enter into
agreements to co-sell or market a Government Reimbursed Product in the United States
or to engage in joint sales and marketing activities in the United States relating
to such a product. Boston Scientific has represented that: (a) Third Party Personnel
are employed by entities independent of Boston Scientific; (b) Boston Scientific
does not control the Third Party Personnel; and (c) it would be commercially
impracticable to compel the compliance of Third Party Personnel with the
requirements set forth in this CIA. Boston Scientific agrees to promote compliance
by Third Party Personnel with Federal health care programs by complying with the
provisions set forth below in Sections III.B.2, III.C.7, V.A.3 and 6.c.



III. Corporate Integrity Obligations




     Boston Scientific shall continue to maintain and apply the Global Compliance
Program to the operations of Guidant/CRM and ensure that it includes the following elements:



     A. Chief Compliance Officer, Committee, and Board Responsibilities.



          1. Chief Compliance Officer. Boston Scientific has appointed, and shall maintain during the
term of the CIA, an individual to serve as its Chief Compliance




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Officer. To the extent necessary, within 120 days after the Effective Date, Boston
Scientific shall modify the position description, scope of responsibility, and authority of the
Chief Compliance Officer such that the following requirements are satisfied. The Chief Compliance
Officer shall be primarily responsible for developing and implementing policies, procedures, and
practices designed to ensure compliance with the requirements set forth in this CIA and with
Federal health care program requirements. The Chief Compliance Officer shall be a member of senior
management of Boston Scientific, shall make periodic (at least quarterly) reports regarding
compliance matters directly to the Board of Directors of Boston Scientific (or designated
committee), and shall be authorized to report on such matters to the Board of Directors (or
designated committee) at any time. The Chief Compliance Officer shall not be, or be subordinate to,
the General Counsel or Chief Financial Officer. The Chief Compliance Officer shall be responsible
for monitoring the day-to-day compliance activities engaged in by Boston Scientific as applied to
Guidant/CRM as well as for any reporting obligations created under this CIA.




          Boston Scientific shall report to OIG, in writing, any changes in the identity or the position
description of the Chief Compliance Officer, or any actions or changes that would affect the Chief
Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA,
within 15 days after such a change.




          2. Compliance Committee. Prior to the Effective Date, Boston Scientific established a Global
Compliance Steering Committee, and Boston Scientific shall maintain a Global Compliance Steering
Committee during the term of this CIA. To the extent necessary, within 120 days after the Effective
Date, Boston Scientific shall amend the duties, responsibilities, and authorities of the Global
Compliance Steering Committee to meet the requirements set forth below. The Global Compliance
Steering Committee shall, at a minimum, include the Chief Compliance Officer and other members of
senior management of Boston Scientific and/or Guidant/CRM necessary to meet the requirements of
this CIA (e.g., senior executives of relevant departments, such as Human Resources, Corporate
Analysis and Control (internal audit), Legal, Clinical Affairs, and Sales and Marketing). The
Compliance Officer shall chair the Global Compliance Steering Committee and the Global Compliance
Steering Committee shall support the Chief Compliance Officer in fulfilling his/her
responsibilities including with regard to the CIA (e.g., shall assist in the analysis of the
organization’s risk areas and shall oversee monitoring of internal and external audits and
investigations).




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     Boston Scientific shall report to OIG, in writing, any changes in the functions or
management levels of individuals that make up the composition of the Global Compliance Steering
Committee, or any actions or changes that would affect the Global Compliance Steering Committee’s
ability to perform the duties necessary to meet the obligations in this CIA, within 15 days after
such a change.



     3. Board of Directors Committee Resolution. The Audit or Quality Compliance committee
of the Board of Directors of Boston Scientific (Board Committee) shall be responsible for the
review and oversight of matters related to compliance with Federal health care program requirements
and the obligations of this CIA. The Board Committee shall, at a minimum, be responsible for the
following:



          a. meeting in person or via tele- or video-conference at least quarterly to review and oversee
Boston Scientific’s Compliance Program, as applied to Guidant/CRM, including but not limited to the
performance of the Chief Compliance Officer and other Global Compliance Program personnel.




          b. for each Reporting Period of the CIA, adopting a resolution summarizing its review and
oversight of Boston Scientific’s compliance with Federal health care program requirements and the
obligations of this CIA by Boston Scientific and/or Guidant/CRM, as applicable. Each individual
member of the Board Committee shall sign a statement indicating that he or she agrees with the
resolution.




     At minimum, the resolution shall include the following language:



     “The [Name of the Board Committee] has made a reasonable inquiry into the operations of
Boston Scientific’s Compliance Program as applied to Guidant/CRM, including the performance of the
Chief Compliance Officer and the Global Compliance Program personnel. Based on its inquiry, [Name
of the Board Committee] has concluded that, to the best of its knowledge, Boston Scientific has
implemented an effective Global Compliance Program, as applied to Guidant/CRM, to meet the Federal
health care program requirements and the obligations of the CIA.”



     If the Board Committee is unable to provide such a conclusion in the resolution, the Board
Committee shall include in the resolution a written explanation of the reasons why it is unable to
provide the conclusion and the steps it is taking to implement an effective Global Compliance
Program at Boston Scientific, as applied to Guidant/CRM.



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     Boston Scientific shall report to OIG, in writing, any changes in the composition of
the Board Committee, or any actions or changes that would affect the Board Committee’s ability to
perform the duties necessary to meet the obligations in this CIA, within 15 days after such a
change.



     4. Management Accountability and Certifications: Within 120 days after the Effective
Date, Boston Scientific represents that for each Covered Person who is an employee compliance shall
be a component of his or her performance objective. In addition to the responsibilities set forth
in this CIA for all Covered Persons, certain Boston Scientific employees (“Certifying Employees”)
are specifically expected to monitor and oversee activities within their areas of authority and
shall annually certify, in writing or electronically, that the applicable Boston Scientific
Corporation component is compliant with Federal health care program requirements and the
obligations of this CIA. These Certifying Employees shall include, at a minimum, the following
individuals from Guidant/CRM: President and all vice presidents of Sales and Marketing as well as
the Vice President and General Manager of electrophysiology and the head of Clinical Affairs.



     For each Reporting Period, each Certifying Employee shall sign a certification that states:


“I have been trained on and understand the applicable Federal health care program compliance
requirements and obligations of the CIA and responsibilities as they relate to [department or
functional area], an area under my supervision. My job responsibilities include ensuring compliance
with regard to the [insert name of the department or functional area.] To the best of my knowledge,
except as otherwise described herein, the
                    [insert name of department or functional area] of Guidant/CRM is in compliance
with all applicable Federal health care program requirements and the obligations of the CIA.”




     B. Written Standards.



          1. Code of Conduct. Prior to the Effective Date, Boston Scientific developed, implemented and
distributed or otherwise made available a written Code of Conduct to its employees, officers, and
directors, including those of its subsidiaries, including Guidant/CRM. Boston Scientific currently
requires all newly employed Covered Persons to certify in writing or electronically, that they have
received, read, understood, and shall abide by Boston Scientific’s Code of Conduct. Boston
Scientific




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shall make the promotion of, and adherence to, the Code of Conduct an element in
evaluating the performance of all employees who are Covered Persons for all performance
review cycles that begin after the Effective Date.




          The Code of Conduct sets forth and shall continue to set forth, at a minimum, the
following elements:





a. the commitment to full compliance with all Federal health care program
requirements;




b. the requirement that all Covered Persons shall be expected to comply with
all Federal health care program requirements and with Boston Scientific’s
and/or Guidant/CRM’s own Policies and Procedures as implemented pursuant to
Section III.B (including the requirements of this CIA);




c. the requirement that all Covered Persons shall be expected to report to
the Chief Compliance Officer, or other appropriate individual designated by
Boston Scientific, suspected violations of any Federal health care program
requirements or of Boston Scientific’s and/or Guidant/CRM’s own Policies and
Procedures;




d. the possible consequences to both Boston Scientific and Covered Persons
of failure to comply with Federal health care program requirements and with
Boston Scientific’s and/or Guidant/CRM’s own Policies and Procedures and the
failure to report such noncompliance; and




e. the right of all individuals to use the Disclosure Program described in
Section III.F, and the commitment to nonretaliation and to maintain, as
appropriate, confidentiality and anonymity with respect to such disclosures.



     To the extent not already accomplished, within 120 days after the Effective Date, the Code of
Conduct shall be distributed to each Covered Person. By May 31, 2010, each Covered Person shall
certify, in writing or electronically, that he or she has received, read, understood, and shall
abide by Boston Scientific’s Code of Conduct. New Covered Persons shall receive the Code of Conduct
within 30 days after becoming a Covered



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Person or within 120 days after the Effective Date, whichever is later and shall complete
the required certification within 30 days after becoming a Covered Person or by May 31, 2010,
whichever is later.




     Boston Scientific shall periodically review the Code of Conduct to determine if revisions are
appropriate and shall make any necessary revisions based on such review. Any revised Code of
Conduct shall be distributed or made available (electronically or in hard-copy form) within 30 days
after any revisions are finalized by Global Compliance Program staff. Each Covered Person shall
certify, in writing or electronically, that he or she has received, read, understood, and shall
abide by the revised Code of Conduct within 30 days after the distribution of the revised Code of
Conduct.



     2. Third Party Personnel. Within 120 days after the Effective Date, and annually
thereafter by the anniversary of the Effective Date, Boston Scientific shall send a letter to each
entity employing Third Party Personnel. The letter shall outline Boston Scientific’s obligations
under the CIA and its commitment to full compliance with all Federal health care program
requirements. The letter shall include a description of Boston Scientific’s Global Compliance
Program, include a link to Boston Scientific’s Code of Conduct and request the entity employing
Third Party Personnel to either: (a) make a copy of the Global Compliance Program available to its
employees, contractors and agents; or (b) represent to Boston Scientific that it has and enforces a
substantially comparable code of conduct and compliance program for its employees, contractors and
agents.



          3. Policies and Procedures. Prior to the Effective Date, Boston Scientific implemented written
Policies and Procedures regarding the operation of the Global Compliance Program and compliance
with Federal health care program requirements. To the extent not already accomplished, within 120
days after the Effective Date, Boston Scientific shall implement written Policies and Procedures
regarding the operation of its Global Compliance Program and Guidant/CRM’s compliance with Federal
health care program requirements. At a minimum, the Policies and Procedures shall address:





	 	a.	 	the subjects relating to the Code of Conduct
identified in Section III.B.1;
	 
	 	b.	 	the requirements set forth in Section III.D
(Compliance with the Anti-Kickback Statute), including but not limited
to the Arrangements Database, the internal review and approval





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	 	 	 	process, and the tracking of remuneration to and from sources of
health care business or referrals;
	 
	 	c.	 	compensation (including salaries and bonuses)
for Arrangements Covered Persons. These Policies and Procedures shall
be designed to ensure that financial incentives do not inappropriately
motivate such individuals to engage in improper promotion, sales,
marketing, pricing, or contracting for Boston Scientific’s products;
	 
	 	d.	 	disciplinary policies and procedures for
violations of Boston Scientific’s Policies and Procedures, including
policies relating to Federal health care program requirements;
	 
	 	e.	 	appropriate ways to conduct sales and marketing
of Government Reimbursed Products in compliance with all applicable
Federal health care program requirements, including, but not limited to
the Federal anti-kickback statute (codified at 42 U.S.C. § 1320a-7b),
and the False Claims Act (codified at 31 U.S.C. §§ 3729-3733);
	 
	 	f.	 	consultant or other fee-for-service
arrangements entered into with HCPs or HCIs (including, but not limited
to, speaker programs, speaker training programs, advisory boards,
proctorships, preceptorships, or any other financial relationship with
an HCP or HCI) and all events and expenses relating to such engagements
or arrangements. These Policies and Procedures shall be designed to
ensure that the engagements, arrangements, and related events are used
for legitimate and lawful purposes in accordance with applicable
Federal health care program requirements. The policies shall include
requirements about the uses, content, and circumstances of such
engagements, arrangements, and events; and
	 
	 	g.	 	sponsorship or funding of grants (including
educational grants) or charitable contributions to HCPs and/or HCIs.
These Policies and Procedures shall be designed to ensure that
Guidant/CRM’s





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	 	 	 	sponsorship or funding complies with all applicable Federal
health care program requirements;
	 
	 	h.	 	funding of, or participation in, any Third
Party Educational Activity as defined in Section II.C.5 above. These
Policies and Procedures shall be designed to ensure that Guidant/CRM’s
sponsorship or funding of, or participation in, such programs satisfies
all applicable Federal health care program requirements related to the
sponsorship of any Third Party Educational Activity;
	 
	 	i.	 	sponsorship or funding of research or related
activities (including clinical trials and market research, or
authorship of articles or other publications) by Guidant/CRM in a
manner that is designed to ensure that Guidant/CRM’s funding or
sponsorship of, or participation in, such activities complies with all
applicable Federal health care program requirements. In addition, such
Policies and Procedures shall ensure that sales and marketing
activities are separate from research activities (i.e. enrollment in
post-market studies or clinical trials).





     To the extent not already accomplished, within 120 days after the Effective Date, the relevant
portions of the Policies and Procedures shall be distributed and/or made available (electronically
or in hard-copy form) to all Covered Persons to the extent that their job functions relate to those
Policies and Procedures. Appropriate and knowledgeable staff shall be available to explain the
Policies and Procedures.



     At least annually (and more frequently, if appropriate), Boston Scientific shall assess and
update, as necessary, the Policies and Procedures. Within 30 days after the effective date of any
revisions, the relevant portions of any such revised Policies and Procedures shall be distributed
and/or made available (electronically or in hard-copy form) to all individuals whose job functions
relate to those Policies and Procedures.



     C. Training and Education.



     Boston Scientific represents that it and/or Guidant/CRM provides training to Guidant/CRM
employees on a regular basis concerning a variety of topics. The training covered by this CIA need
not be separate and distinct from the regular training provided,



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but instead may be integrated fully into such regular training so long as the training
covers the areas specified below.




          1. General Training, Within 120 days after the Effective Date, Boston Scientific shall provide
at least one hour of General Training to each Covered Person. This training, at a minimum, shall
explain:





a. CIA requirements; and




b. The Global Compliance Program and its applicability to Guidant/CRM
(including the Code of Conduct and the Policies and Procedures as they
pertain to general compliance issues).



     New Covered Persons shall be required to complete the General Training described above within
30 days after becoming a Covered Person or within 120 days after the Effective Date, whichever is
later. After receiving the initial General Training described above, each Covered Person shall be
required to complete at least one hour of General Training in each subsequent Reporting Period.



          2. Arrangements Training. Within 120 days after the Effective Date, each Arrangements Covered
Person shall be required to complete at least three hours of Arrangements Training, in addition to
the General Training required above. The Arrangements Training shall include a discussion of:





a. Arrangements that potentially implicate the Anti-Kickback Statute, as
well as related regulations and other guidance documents related to this
statute;




b. all Boston Scientific policies, procedures, and other requirements
relating to Arrangements, including but not limited to the Arrangements
Database, the internal review and approval process, and the tracking of
remuneration to and from sources of health care business or referrals
required by Section III.D of the CIA;




c. the personal obligation of each individual involved in the development,
approval, management, or review of Guidant/CRM’s Arrangements to know the
applicable legal requirements and Boston Scientific’s policies and
procedures;



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d. the legal sanctions under the Anti-Kickback Statute; and




e. examples of violations of the Anti-Kickback Statute.



     New Arrangements Covered Persons shall be required to complete this training within 30 days
after the beginning of their employment or becoming Arrangements Covered Persons, or within 120
days after the Effective Date, whichever is later. A Guidant/CRM employee who has completed the
Arrangements Training shall review a new Arrangements Covered Person’s Arrangements-related work
until such time as the new Arrangements Covered Person completes his or her Arrangements Training.



     After receiving the initial Arrangements Training described in this Section, each Arrangements
Covered Person shall receive at least two hours of Arrangements Training in each subsequent
Reporting Period.



          3. Certification. Each individual who is required to complete training shall certify, in
writing, or electronically, that he or she has completed the required training. The certification
shall specify the type of training completed and the date received. The Chief Compliance Officer
(or designee) shall retain the certifications, along with all course materials. These shall be made
available to OIG, upon request.




          4. Qualifications of Trainer. Persons providing the training shall be knowledgeable about the
subject area, including applicable Federal health care program requirements.




          5. Update of Training. Boston Scientific shall review the training annually, and, where
appropriate, update the training to reflect changes in Federal health care program requirements,
any related issues discovered during internal audits or any IRO Review, and any other relevant
information.




          6. Computer-based Training. Boston Scientific may provide the training required under this CIA
through appropriate computer-based training approaches. If Boston Scientific chooses to provide
computer-based training, it shall make available appropriately qualified and knowledgeable staff or
trainers to answer questions or provide additional information to the individuals receiving such
training. If Boston Scientific chooses to provide computer-based training, all applicable
references to “hours” in this Section III.C shall mean “normative hours”, meaning the number of
hours usually




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required to complete the requirements of a training course through computer-based
modules. Normative hours may vary from actual hours of training.




     7. Third Party Personnel. Boston Scientific shall use its best efforts to encourage Third
Party Personnel’s attendance and participation in General and Arrangements Training, as applicable.
The Chief Compliance Officer shall maintain records of the names and percentage of all such Third
Party Personnel who do and do not attend General and/or Arrangements Training, and shall include
such percentages in the Implementation Report and each Annual Report to the OIG. Such records shall
also be available for inspection by the OIG.



     D. Compliance with the Anti-Kickback Statute.



          1. Arrangements Procedures. Within 120 days after the Effective Date, Boston Scientific and/or
Guidant/CRM, as appropriate, shall create procedures reasonably designed to ensure that each
existing Arrangement under which a transfer of value will occur during the term of this CIA and new
or renewed Arrangement does not violate the Anti-Kickback Statute or the regulations, directives,
and guidance related to the Anti-Kickback statute (Arrangements Procedures). These procedures shall
include the following:





a. creating and maintaining a database of all existing Arrangements under
which a transfer of value will occur during the term of this CIA and new or
renewed Contractual Arrangements that shall contain the information
specified in Appendix B (Arrangements Database);




b. tracking remuneration to and from all parties to the Contractual
Arrangements;




c. tracking service and activity logs to ensure that parties to the
Contractual Arrangement are performing the services required under the
applicable Contractual Arrangement(s) (if applicable);




d. establishing and implementing a written review and prior approval process
for all Contractual Arrangements, including but not limited to a legal
review by counsel with expertise in the Anti- Kickback Statute and
appropriate documentation of all internal



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controls, the purpose of which is to help ensure that all new or
renewed Contractual Arrangements under which a transfer of value will occur
during the term of this CIA do not violate the Anti-Kickback Statute;




e. establishing and implementing a written process for monitoring
Non-Contractual Arrangements, including but not limited to an annual legal
review by counsel with expertise in the Anti-Kickback Statute and
appropriate documentation of all internal controls, the purpose of which is
to help ensure that all Non-Contractual Arrangements do not violate the
Anti-Kickback Statute;




f. requiring the Chief Compliance Officer to review the Arrangements
Database, internal review and approval process, and other Arrangements
Procedures on at least a quarterly basis and to provide a report on the
results of such review to the Global Compliance Steering Committee; and




g. implementing effective responses when suspected violations of the
Anti-Kickback Statute are discovered, including disclosing Reportable Events
pursuant to Section III.I (Reporting) when appropriate.



          2. New or Renewed Contractual Arrangements. Prior to entering into new Contractual
Arrangements or renewing existing Contractual Arrangements, in addition to complying with the
Arrangements Procedures set forth above, Boston Scientific and/or Guidant/CRM, as appropriate,
shall comply with the following requirements (Arrangements Requirements):





a. Ensure that each Contractual Arrangement is set forth in writing and
signed by Boston Scientific and/or Guidant/CRM, as appropriate, and the
other parties to the Contractual Arrangement;




b. Include in the written agreement a requirement that all individuals who
meet the definition of Covered Persons shall comply with the Global
Compliance Program, including the training related to the Anti-Kickback
Statute. Additionally, Guidant/CRM shall include a description of the Global
Compliance Program, a link to the Boston



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Scientific Code of Conduct and an outline of Boston Scientific’s and
Guidant/CRM’s obligations under the CIA and its commitment to full
compliance with all Federal health care program requirements.




c. Include in the written agreement a certification or a representation and
warranty by the parties to the Contractual Arrangement that the parties
shall not violate the Anti-Kickback Statute with respect to the performance
of the Contractual Arrangement.



          3. Records Retention and Access. Boston Scientific shall retain and make available to OIG,
upon request, the Arrangements Database and all supporting documentation of the Arrangements
subject to this Section and, to the extent available, all non-privileged communications related to
the Arrangements and the actual performance of the duties under the Arrangements.




     E. Review Procedures.



          1. General Description,





a. Engagement of Independent Review Organization. Within 120 days
after the Effective Date, Boston Scientific shall engage an individual
and/or entity (or entities), such as an accounting, auditing, law or
consulting firm (hereinafter “Independent Review Organization” or “IRO”), to
perform reviews required by this CIA to assist Boston Scientific in
assessing compliance with the obligations under Section III.D of this CIA
(Arrangements Review) The applicable requirements relating to the IRO(s)
are outlined in Appendix A to this CIA, which is incorporated by reference.




Each IRO engaged by Boston Scientific shall have expertise in applicable
Federal health care programs as may be appropriate to the Review for which
the IRO is retained. Each IRO shall assess, along with Boston Scientific,
whether it can perform the engagement in a professionally independent and
objective fashion, as appropriate to the nature of the review, taking into
account any other business relationships or other engagements that may
exist.



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b. Frequency of Arrangements Reviews. The Arrangements Review shall
be performed annually and shall cover each of the Reporting Periods. If
there are no material changes in Guidant/CRM’s systems, processes, policies,
and procedures relating to Post-Approval Studies, the Studies Systems Review
shall be performed for the first and fourth Reporting Period. If Guidant/CRM
materially changes its systems, processes, policies, and procedures relating
to Post- Approval Studies, the IRO shall perform a Studies Systems Review
for the Reporting Period(s) in which such changes were made in addition to
conducting the Review of the first and fourth Reporting periods. The
additional Systems Review(s) shall consist of: (l) an identification of the
material changes; (2) an assessment of whether other systems, processes,
policies, and procedures previously reported did not materially change; and
(3) a review of the systems, processes, policies, and procedures that
materially changes. The IRO(s) shall perform all components of each Annual
Arrangements Review.




c. Retention of Records. The IRO and Boston Scientific shall retain and make
available to OIG, upon request, all work papers, supporting documentation,
correspondence, and draft reports (those exchanged between the IRO and
Boston Scientific) related to the reviews.



          2. Arrangements Review. The IRO shall perform a review to assess whether Boston Scientific
and/or Guidant/CRM, as appropriate, is complying with the Arrangements Procedures and Arrangements
Requirements required by Section III.D.1 and III.D.2 of this CIA. The IRO shall randomly select a
sample of 40 Contractual Arrangements for which payments were made during the applicable Reporting
Period. The IRO shall assess whether Boston Scientific and/or Guidant/CRM, as appropriate, has
implemented the Arrangements Procedures and, for each selected Arrangement, the IRO shall assess
whether Boston Scientific and/or Guidant/CRM, as appropriate, has complied with the Arrangements
Procedures and Arrangements Requirements specifically with respect to that Arrangement. The IRO’s
assessment shall include, but is not limited to: (a) verifying that the Contractual Arrangement is
listed in the Arrangements Database; (b) verifying that the Contractual Arrangement was subject to
the internal review and approval process (including both a legal/compliance and business review)
and obtained the necessary approvals and that such review and approval is




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appropriately documented; (c) verifying (using a representative sample of Contractual
Arrangements) that the remuneration related to the Contractual Arrangement is properly tracked;
(d) verifying that the service and activity logs (if applicable) and/or other documented proof of
performance is provided to and reviewed by Boston Scientific and/or Guidant/CRM, as appropriate;
(e) verifying that the Chief Compliance Officer is reviewing the Arrangements Database, internal
review and approval process, and other Arrangements Procedures on a quarterly basis and reporting
the results of such review to the Global Compliance Steering Committee; (f) verifying that
effective responses are being implemented when violations of the Anti-Kickback Statute are
discovered; and (g) verifying that Boston Scientific and/or Guidant/CRM, as appropriate, has met
the requirements of Section III.D.2.




          3. Systems Review for Post-Approval Studies. The IRO shall have sufficient expertise in
clinical research and applicable federal laws and regulations to perform a review of each of
Guidant/CRM’s extant post-approval studies. The IRO shall assess whether the study is designed to
achieve its stated purpose, including whether the study is designed to obtain clinical information
or whether it is designed to market the product. The IRO shall summarize each study by providing a
description of the purpose, protocol, and timeframe. In assessing the study, the IRO shall
consider, at a minimum, the following questions: i) the purpose of the research; ii) whether the
research has been approved by an institutional review board; iii) whether participation in the
study will require subjects to make extra visits to HCPs and if so, who will pay for the visits and
how much will be paid; iv) how long the study will continue; v) whether a patient may be part of a
control group that will receive no treatment or a placebo; vi) what the participants will be told
after the study ends; vii) whether participants are informed that the issue of whether the device
is the best treatment remains a research question; viii) whether every piece of data collected has
been verified; and ix) the name(s) and credential(s) of each person who designed the study and any
underlying protocol. Where applicable, the IRO shall review protocols provided to the FDA, as well
as any correspondence with the FDA, concerning the study under review. The IRO shall maintain
copies of this information in its files.




          For purposes of this subsection Post-Approval Studies shall mean research studies wherein
Guidant/CRM is compensating HCPs or HCIs for collecting procedure and/or device performance
information on the use of commercially available Guidant/CRM devices. Studies in which either the
HCPs/HCIs or Guidant/CRM are blinded to the respective party’s identity shall be excluded from this
definition (studies that are blinded in either direction). Studies in which Guidant/CRM




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has provided an unrestricted research grant to a third party to conduct a study that does
not involve Guidant/CRM product development or marketing shall also be excluded from this
definition.




          4. IRO Review Reports. The IRO(s) shall prepare a report (or reports) based upon the
Arrangements Review performed. The Arrangements Review Report shall include the IRO’s findings with
respect to: (a) whether Boston Scientific and/or Guidant/CRM, as appropriate, has generally
implemented the Arrangements Procedures described in
Section III.D.1; and (b) specific findings as
to whether Boston Scientific and/or Guidant/CRM, as appropriate, has complied with the Arrangements
Procedures and Arrangements Requirements with respect to each of the randomly selected Arrangements
reviewed by the IRO. In addition, the Arrangements Review Report shall include any observations,
findings, and recommendations on possible improvements to Boston Scientific’s and/or Guidant/CRM’s
policies, procedures, and systems in place to ensure that all Arrangements do not violate the
Anti-Kickback Statute.




          5. Validation Review. In the event OIG has reason to believe that: (a) any IRO Review fails to
conform to the requirements of this CIA; or (b) the IRO’s findings or Review results are
inaccurate, OIG may, at its sole discretion, conduct its own review to determine whether the
applicable IRO Review complied with the requirements of the CIA and/or the findings or Review
results are inaccurate (Validation Review). Boston Scientific shall pay for the reasonable cost of
any such review performed by OIG or any of its designated agents. Any Validation Review of Reports
submitted as part of Boston Scientific’s final Annual Report shall be initiated no later than one
year after Boston Scientific’s final submission (as described in Section II) is received by OIG.




     Prior to initiating a Validation Review, OIG shall notify Boston Scientific of its intent to
do so and provide a written explanation of why OIG believes such a review is necessary. To resolve
any concerns raised by OIG, Boston Scientific may request a meeting with OIG to: (a) discuss the
results of any Review submissions or findings; (b) present any additional information to clarify
the results of the applicable Review or to correct the inaccuracy of the Review; and/or (c) propose
alternatives to the proposed Validation Review. Boston Scientific agrees to provide any additional
information as may be requested by OIG under this Section III.E.3 in an expedited manner. OIG will
attempt in good faith to resolve any Review issues with Boston Scientific prior to conducting a
Validation Review. However, the final determination as to whether or not to proceed with a
Validation Review shall be made at the sole discretion of OIG.



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          6. Independence and Objectivity Certification. The IRO shall include in its report(s)
to Boston Scientific a certification or sworn affidavit that it has evaluated its professional
independence and objectivity, as appropriate to the nature of the engagement, with regard to the
IRO Review and that it has concluded that it is, in fact, independent and objective.




     F. Disclosure Program.



     Boston Scientific currently has a disclosure program that Boston Scientific represents is
designed to facilitate communications relating to compliance with Federal health care program
requirements and Boston Scientific’s policies (the “Disclosure Program”). During the term of this
CIA, Boston Scientific shall continue to maintain a Disclosure Program that includes a mechanism
(e.g., a toll-free compliance telephone line and/or online electronic reporting) to enable
individuals to disclose, to the Chief Compliance Officer or some other person who is not in the
disclosing individual’s chain of command, any identified issues or questions associated with
Guidant/CRM’s policies, conduct, practices, or procedures with respect to a Federal health care
program believed by the individual to be a potential violation of criminal, civil, or
administrative law. Boston Scientific shall appropriately publicize the existence of the disclosure
mechanism (e.g., via periodic e-mails to employees or by posting the information in prominent
common areas).



     The Disclosure Program shall emphasize a nonretribution, nonretaliation policy, and shall
include a reporting mechanism for anonymous communications for which appropriate confidentiality
shall be maintained. Upon receipt of a disclosure, the Chief Compliance Officer (or designee) shall
gather all relevant information from the disclosing individual. The Chief Compliance Officer (or
designee) shall make a preliminary, good faith inquiry into the allegations set forth in every
disclosure to ensure that he or she has obtained all of the information necessary to determine
whether a further review should be conducted. For any disclosure that is sufficiently specific so
that it reasonably: (1) permits a determination of the appropriateness of the alleged improper
practice; and (2) provides an opportunity for taking corrective action, Boston Scientific shall
conduct an internal review of the allegations set forth in the disclosure and ensure that proper
follow-up is conducted.



     The Chief Compliance Officer (or designee) shall maintain a confidential disclosure log
pertaining to Guidant/CRM, which shall include a record and summary of each disclosure received
that is related to Guidant/CRM (whether anonymous or not), the



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status of the respective internal reviews, and any corrective action taken in response to
the internal reviews. The confidential disclosure log as to allegations involving Guidant/CRM shall
be made available to OIG upon request.




     G. Ineligible Persons.



          1. Definitions. For purposes of this CIA:





a. an “Ineligible Person” shall include an individual or entity who:




i. is currently excluded, debarred, suspended, or otherwise
ineligible to participate in the Federal health care programs or in
Federal procurement or nonprocurement programs; or




ii. has been convicted of a criminal offense that falls within the
scope of 42 U.S.C. § 1320a-7(a), but has not yet been excluded,
debarred, suspended, or otherwise declared ineligible.




b, “Exclusion Lists” include:




i. the HHS/OIG List of Excluded Individuals/Entities (available
through the Internet at http://www.oig.hhs.gov); and




ii. the General Services Administration’s List of Parties
Excluded from Federal Programs (available through the
Internet at http://www.epls.gov).



          2. Screening Requirements. Boston Scientific shall ensure that all prospective and current
Covered Persons are not Ineligible Persons, by implementing the following screening requirements.





a. Boston Scientific shall screen all prospective and current Covered
Persons against the Exclusion Lists prior to engaging their services and, as
part of the hiring or contracting process, shall require such Covered
Persons to disclose whether they are Ineligible Persons.



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b. Boston Scientific shall screen all Covered Persons against the
Exclusion Lists within 120 days after the Effective Date and on an annual
basis thereafter.




c. Boston Scientific shall implement a policy requiring all Covered Persons
to disclose immediately any debarment, exclusion, suspension, or other event
that makes that person an Ineligible Person.



          Nothing in this Section affects the responsibility of (or liability for) Boston Scientific to
(if applicable) refrain from billing Federal health care programs for items or services furnished,
ordered, or prescribed by an Ineligible Person. Boston Scientific understands that items or
services furnished by excluded persons are not payable by Federal health care programs and that
Boston Scientific may be liable for criminal, civil, and administrative sanctions for employing or
contracting with an excluded person regardless of whether Boston Scientific meets the requirements
of Section III.G.




          3. Removal Requirement. If Boston Scientific has actual notice that a Covered Person has
become an Ineligible Person, Boston Scientific shall remove such Covered Person from responsibility
for, or involvement with, Boston Scientific’s business operations related to the Federal health
care programs and shall remove such Covered Person from any position for which the Covered Person’s
compensation or the items or services furnished, ordered, or prescribed by the Covered Person are
paid in whole or part, directly or indirectly, by Federal health care programs or otherwise with
Federal funds at least until such time as the Covered Person is reinstated into participation in
the Federal health care programs.




          4. Pending Charges and Proposed Exclusions. If Boston Scientific has actual notice that a
Covered Person is charged with a criminal offense that falls within the scope of 42 U.S.C. §§
1320a-7(a), 1320a-7(b)(1)-(3), or is proposed for exclusion during the Covered Person’s employment
or contract term, Boston Scientific shall take all appropriate actions to ensure that the
responsibilities of that Covered Person have not and shall not adversely affect the accuracy of any
claims submitted to any Federal health care program.




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     H. Notification of Government Investigation or Legal Proceedings.



     Within 30 days after discovery by Boston Scientific, Boston Scientific shall notify OIG, in
writing, of any ongoing investigation or legal proceeding known to Boston Scientific’s senior
management conducted or brought by a U.S.-based governmental entity or its agents involving an
allegation that Guidant/CRM has committed a crime or has engaged in fraudulent activities. This
notification shall include a description of the allegation, the identity of the investigating or
prosecuting agency, and the status of such investigation or legal proceeding. Boston Scientific
shall also provide written notice to OIG within 30 days after the resolution of the matter, and
shall provide OIG with a description of the findings and/or results of the investigation or
proceedings, if any.



     I. Reporting.



          1. Reportable Events.





a. Definition of Reportable Event. For purposes of this CIA, a
“Reportable Event” means anything that involves:




i. a matter brought to the attention of Boston Scientific’s senior
management (i.e. a member of the corporate Operating Committee or
any successor committee/group) relating to conduct of Guidant/CRM
that a reasonable person would consider a probable violation of
criminal, civil, or administrative laws applicable to any Federal
health care program for which penalties and/or exclusion may be
authorized; or




ii. the filing of a bankruptcy petition by Boston Scientific.




A Reportable Event may be the result of an isolated event or a series of
occurrences.




b.
Reporting of Reportable Events. If Boston Scientific determines (after a
reasonable opportunity to conduct an appropriate review or investigation of
the allegations) through any means that there is a Reportable Event, Boston
Scientific shall notify OIG, in writing, within 30 days after making the
determination that the Reportable



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Event exists. The report to OIG shall include the
following information:




i.
a complete description of the Reportable Event, including the
relevant facts, persons involved, and legal and Federal health care
program authorities implicated;




ii. a description of Boston Scientific’s actions taken to correct
the Reportable Event; and




iii. any further steps Boston Scientific plans to take to address
the Reportable Event and prevent it from recurring.




iv. If the Reportable Event involves the filing of a bankruptcy
petition, the report to the OIG shall include documentation of the
filing and a description of any Federal health care program
authorities implicated.




v. Boston Scientific shall not be required to report as a
Reportable Event any matter previously disclosed under Section
III.H.



     J. Reporting of Physician Payments.



     1. Posting of Payment Information



     By June 30, 2011, Guidant/CRM shall post in a prominent position on its website an easily
accessible and readily searchable listing of all U.S.-based physicians and Related Entities (as
defined below in Section III.J.2) or Product Decision-Makers (as defined below in Section III.J.2)
who or which received Payments (as defined below in Section III.J.2) directly or indirectly from
Guidant/CRM during the first three months of 2011.



     After the initial posting, 90 days after the end of each subsequent calendar quarter,
Guidant/CRM shall also post on its website a listing of updated information about all Payments
provided during the preceding calendar quarter(s) in each calendar year. No later than March 31,
2012, and each March 31 of each of the three successive Reporting Period years, Guidant/CRM shall
also post on its website a report of the cumulative



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information about Payments made by Guidant/CRM during the preceding calendar year. The
quarterly and annual reports shall be easily accessible and readily searchable.




     Each listing made pursuant to this Section shall include a complete list of all individual
physicians, Related Entities and/or Product Decision-Makers to whom or to which Guidant/CRM
directly or indirectly made Payments in the preceding calendar quarter or year (as applicable).
Each listing shall be arranged alphabetically according to the physicians’ last name, the name of
the Related Entity, or the name of the Product Decision-Maker. The Payment amount for each
physician, Related Entity, or Product Decision Maker shall be reported in increments up to $10,000
(e.g., $0 – 100; $0 -$1,000, $0 – $5,000; $0 – $10,000; $0 – $20,000; etc.) or in the actual amount
paid, provided, however, that the Payment amounts shall be listed in the same way (incrementally or
in actual amounts) for all physicians and/or Related Entities, or Product Decision-Maker on the
listing. For each entry, the applicable listing shall include the following information: i) payee
information (physician’s, Product Decision-Maker’s, HCI’s full name); ii) if payment is to a
Related Entity for services of a specific physician or Product-Decision-Maker, the name of Related
Entity on whose behalf payment was made to the physician or Product Decision-Maker (if applicable);
iii) city and state that the physician or Related Entity has provided to Guidant/CRM for contact
purposes, or the Product Decision-Maker (as applicable); iii) the purpose of the Payment; and iv)
the aggregate value of the Payment(s) in the preceding quarter(s) or year (as applicable).



     2. Definitions and Miscellaneous Provisions.



     Boston Scientific shall continue to make each annual listing and the most recent
quarterly listing of Payment information available on its website at least throughout the term of
this CIA. Boston Scientific shall retain and make available to OIG, upon request, all existing work
papers, supporting documentation, correspondence, and records related to all applicable Payments
and to the annual and quarterly listings of Payments. Nothing in this Section III.J affects the
responsibility of Boston Scientific to comply with (or liability for noncornpliance with) all
applicable Federal health care program requirements and state laws as they relate to all applicable
Payments made to physicians, Related Entities, or Product Decision-Makers.



     If the proposed Physician Payments Sunshine Act of 2009 or similar legislation is enacted, the
OIG shall determine whether the purposes of this Section III.J are reasonably satisfied by Boston
Scientific’s compliance with such legislation. In such case, and in its



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sole discretion, the OIG may agree to modify or terminate provisions of Section III.J as
appropriate.




     For purposes of this Section III.J, the term “Payments” is defined to include all payments or
transfers of value (whether in cash or in kind) made to physicians, Related Entities, and/or
Product Decision-Makers. The term Payments includes, for example, payments or compensation for
services rendered, grants, fees, honoraria, and payments relating to research or education. The
term Payments also includes food, entertainment, gifts, trips or travel, product(s)/item(s)
provided for less than fair market value; or other economic benefit. The term Payments does not
include discounts, rebates, or other pricing terms.



     For purposes of this Section III.J, the term “Related Entity” is defined to be any entity by
or in which any physician receiving Payments is employed, has tenure, or has an ownership interest.
The term “physician” as used herein does not include bona fide employees of Boston Scientific or
its subsidiaries.



     For purposes of this Section III.J, the term “Product Decision-Maker” is defined to be any
individual or entity in a position to arrange for or recommend the purchasing, prescribing,
ordering, or furnishing of any Government Reimbursed Product.



          3. If Guidant/CRM does not make any Payments to physicians, Related Entities, or Product
Decision-Makers during a Reporting Period, Boston Scientific shall not be required to post Payment
information as set forth in Section III.K.1 for that Reporting Period. Instead, the Chief
Compliance Officer shall certify that Guidant/CRM made no such Payments during the applicable
Reporting Period. Boston Scientific shall include such certification(s) in the applicable Annual
Report(s).




IV. Changes to Business Units or Locations




     A. Change or Closure of Unit or Location. In the event that, after the
Effective Date, Guidant/CRM changes locations or closes a business unit or location engaged in
sales or marketing of Government Reimbursed Products, Boston Scientific shall notify OIG of this
fact as soon as possible, but no later than within 30 days after the date of change or closure of
the location.



     B. Transfers to Affiliates. Boston Scientific and/or Guidant/CRM may transfer the
capital stock, or substantially all of the assets of Guidant/CRM, or any of the legal



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entities that comprise Guidant/CRM to Boston Scientific or a direct or indirect wholly-owned
subsidiary of Boston Scientific, provided that Boston Scientific shall notify the OIG of such
transfer within 30 days thereafter, and the CIA shall be binding on such transferee with respect to
the Guidant/CRM business unit, functions, and/or products.




     C. Purchase or Establishment of New Unit or Location. In the event that, after the
Effective Date, Guidant/CRM purchases or establishes a new business unit or location engaged in
sales or marketing of Government Reimbursed Products for Guidant/CRM, Boston Scientific shall
notify OIG no later than the date the purchase or establishment is publicly disclosed or the
operation of the new business unit or location. This notification shall include the address of the
new business unit or location, phone number, fax number, Federal health care program provider
and/or supplier number, and the name and address of the contractor that issued each number (if
applicable). Each new business unit or location and all Covered Persons at each new business unit
or location shall be subject to the applicable requirements of this CIA.



     D. Sale of Unit or Location. In the event that, after the Effective Date, Guidant/CRM
proposes to sell any or all of its business units or locations that are subject to this CIA, Boston
Scientific shall notify OIG of the proposed sale no later than the date the sale is publicly
disclosed. This notification shall include a description of the business unit or location to be
sold, a brief description of the terms of the sale, and the name and contact information of the
prospective purchaser. This CIA shall be binding on the purchaser of such business unit or
location, unless otherwise determined and agreed to in writing by the OIG.



     E. For purposes of this section IV, “business unit or location” shall mean physical places of
business, where employees routinely carry out job responsibilities and does not include non-Boston
Scientific-owned or leased properties such as offices operated out of individuals’ residences.



V. Implementation and Annual Reports




     A. Implementation Report. Within 150 days after the Effective Date,
Boston Scientific shall submit a written report to OIG summarizing the status of its
implementation of the requirements of this CIA (Implementation Report). The Implementation
Report shall, at a minimum, include:



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          1. the name, address, phone number, and position description of the Chief Compliance
Officer required by Section III.A, and a summary of other noncompliance job responsibilities the
Chief Compliance Officer may have;




          2. the names and positions of the members of the Global Compliance Steering Committee
required by Section III.A;




          3. a copy of Boston Scientific’s Code of Conduct required by Section III.B.I and a copy of the
letter (including all attachments) required by Sections III.B.2 sent to each party employing Third
Party Personnel; (b) a list of all such existing Third Party Personnel agreements; and (c) a
description of the Third Party Personnel entities’ response to Boston Scientific’s letter;




          4. a copy of all Policies and Procedures required by Section III.B.3;




          5. the number of Covered Persons required to complete the Code of Conduct certification
required by Section III.B.l, the percentage of Covered Persons who have completed such
certification, and an explanation of any exceptions (the documentation supporting this information
shall be available to OIG, upon request);




          6. the following information regarding each type of training required by Section III.C:





a. a description of such training, including a summary of the topics
covered, the length of sessions, and for in-person training, a schedule of
training sessions;




b. the number of Covered Persons required to be trained, percentage of
Covered Persons actually trained, and an explanation of any exceptions; and




c. the percentage of Third Party Personnel who do and do not attend General
and/or Arrangements Training (as referenced in Section III.C.)


A copy of all training materials and the documentation supporting this information shall be
available to OIG, upon request.




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          7. the following information regarding the IRO(s): (a) identity, address, and phone
number; (b) a copy of the engagement letter; and (c) a summary and description of any and all
current and prior engagements and agreements between Boston Scientific and the IRO;




          8. a certification from the 1RO regarding its professional independence and objectivity with
respect to Boston Scientific;




          9. a description of the Disclosure Program required by Section III.F;




          10. a description of the process by which Boston Scientific fulfills the requirements of
Section III.G regarding Ineligible Persons;




          11. the name, title, and responsibilities of any person who is determined to be an Ineligible
Person under Section III.G; the actions taken in response to the screening and removal obligations
set forth in Section III.G;




          12. a list of all of Guidant/CRM’s United States-based business units and locations (as that
term is defined in Section IV) (including locations and mailing addresses, but excluding non-Boston
Scientific-owned or leased properties such as offices operated out of individuals’ residences) at
which it performs sales and marketing of Government Reimbursed Products; the corresponding name
under which each location is doing business; the corresponding phone numbers and fax numbers; each
location’s Federal health care provider or supplier number(s) (if applicable), and the name and
address of each Federal health care program contractor to which Boston Scientific currently submits
claims (if applicable);




          13. a description of Guidant/CRM’s corporate structure, including identification of any parent
and sister companies, subsidiaries, and their respective lines of business; and




          14. the certifications required by Section V.C.




     B. Annual Reports. Boston Scientific shall submit to OIG annually a report with
respect to the status of, and findings regarding, Boston Scientific’s compliance activities for
each of the five Reporting Periods (Annual Report).



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Each Annual Report shall include, at a minimum:




          1. any change in the identity, position description, or other noncompliance job
responsibilities of the Chief Compliance Officer and any change in the membership of the Global
Compliance Steering Committee described in Section III.A;




          2. a summary of any significant changes or amendments to the Policies and Procedures required
by Section III.B and the reasons for such changes (e.g., change in applicable Federal health care
program requirements);




          3. the number of Covered Persons required to complete the Code of Conduct certification
required by Section III.B.1, the percentage of Covered Persons who have completed such
certification, and an explanation of any exceptions (the documentation supporting this information
shall be available to OIG, upon request);




          4. the following information regarding each type of training required by Section III.C:





a. a description of such training, including a summary of the topics
covered, the length of sessions, and, for any in-person training, a schedule
of training sessions; and




b. the number of Covered Persons required to be trained, percentage of
Covered Persons actually trained, and an explanation of any exceptions
(including the percentage of Third Party Personnel who do and do not attend
General and/or Arrangements Training.)


A copy of all training materials and the documentation supporting this information shall be
available to OIG, upon request.




          5. a complete copy of all reports prepared pursuant to Section III.E, along with a copy of the
IRO’s engagement letter (if applicable);




          6. Boston Scientific’s response and corrective action plan(s) related to any issues raised by
the reports prepared pursuant to Section III.E;




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          7. a summary and description of any and all current and prior engagements and
agreements between Boston Scientific and the IRO, if different from what was submitted as part of
the Implementation Report;




          8. a certification from the IRO regarding its professional independence and objectivity with
respect to Boston Scientific;




          9. a summary of the disclosures in the confidential Guidant/CRM disclosure log required
by Section III.F that relate to Federal health care programs;




          10. any changes to the process by which Boston Scientific fulfills the requirements of
Section III.G regarding Ineligible Persons;




          11. the name, title, and responsibilities of any person who is determined to be an Ineligible
Person under Section III.G; the actions taken by Boston Scientific in response to the screening and
removal obligations set forth in Section III.G;




          12. a summary describing any ongoing investigation or legal proceeding required to have been
reported pursuant to Section III.H. The summary shall include a description of the allegation, the
identity of the investigating or prosecuting agency, and the status of such investigation or legal
proceeding;




          13. a summary of Reportable Events (as defined in Section III.I) identified during the
Reporting Period and the status of any corrective and preventative action relating to all such
Reportable Events;




          14. a description of all changes to the most recently provided list of all business units or
locations (as that term is defined in Section IV) (including addresses) as required by Section
V.A.12; the corresponding name under which each location is doing business; and the corresponding
phone numbers and fax numbers; each location’s Federal health care program provider number or
supplier number(s) (if applicable); and the name and address of each Federal health care program
contractor to which Boston Scientific currently submits claims (if applicable); and




          15. the certifications required by Section V.C.




     The first Annual Report shall be received by OIG no later than 90 days after the end of the
first Reporting Period. Subsequent Annual Reports shall be received by OIG



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no later than the anniversary date of the due date of the first Annual Report.




     C. Certifications. The following certifications shall be included in the
Implementation and Annual Reports.



               1. Certifying Employees: In each Annual Report, Boston Scientific shall include the
certifications of Certifying Employees as required by Section III.A.4;



               2. Chief Compliance Officer: In the Implementation Report and
Annual Reports, Boston Scientific shall include the following individual certifications by the
Chief Compliance Officer that:



          a. to the best of his or her knowledge, except as otherwise described in the applicable
report, Boston Scientific is in compliance with all of the requirements of this CIA;




          b. to the best of his or her knowledge, Boston Scientific and/or
Guidant/CRM, as appropriate, has implemented procedures reasonably designed to ensure that all
Arrangements do not violate the Anti-Kickback Statute, including the Arrangements Procedures
required in Section III.D of the CIA.




          c. to the best of his or her knowledge Boston Scientific and/or Guidant/CRM, as
appropriate, has fulfilled the requirements for New and Renewed Contractual Arrangements
under Section III.D.2 of the CIA;




          d. to the best of his or her knowledge, Boston Scientific has complied with its obligations
under the Settlement Agreement.




          e. Boston Scientific’s: 1) Policies and Procedures as referenced in Section III.B.2 above; 2)
templates for standardized contracts and other similar documents; and 3) the training materials
used for purposes of Section III.C all have been reviewed by competent legal counsel and have been
found to be consistent with all applicable Federal health care program requirements. The
documentation supporting this certification shall be available to OIG, upon request; and




          f. he or she has reviewed the Report and has made reasonable inquiry regarding its
content and believes that the information in the Report is accurate and truthful.




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     D. Designation of Information. Boston Scientific shall clearly identify any
portions of its submissions that it believes are trade secrets, or information that is commercial
or financial and privileged or confidential, and therefore potentially exempt from disclosure under
the Freedom of Information Act (FOIA), 5 U.S.C. § 552. Boston Scientific shall refrain from
identifying any information as exempt from disclosure if that information does not meet the
criteria for exemption from disclosure under FOIA.



VI. Notifications and Submission of Reports




     Unless otherwise stated in writing after the Effective Date, all notifications and
reports required under this CIA shall be submitted to the following entities:



          OIG:



Administrative and Civil Remedies Branch

Office of Counsel to the Inspector General

Office of Inspector General

U.S. Department of Health and Human Services

Cohen Building, Room 5527

330 Independence Avenue, S.W.

Washington, DC 20201

Telephone: 202.619.2078

Facsimile: 202.205.0604




          Boston Scientific:



Jean Fitterer Lance

Chief Compliance Officer

One Scimed Place

Maple Grove, MN 55311

Telephone No: 763-494-2688

Facsimile No: 763-494-2616



Unless otherwise specified, all notifications and reports required by this CIA may be made by
certified mail, overnight mail, hand delivery, or other means, provided that there is proof that
such notification was received. For purposes of this requirement, internal facsimile confirmation
sheets do not constitute proof of receipt. Upon request by OIG, Boston Scientific may be required
to provide OIG with an electronic copy of each




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notification or report required by this CIA in searchable
portable document format (pdf),
either instead of or in addition to, a paper copy.



VII. OIG Inspection, Audit, and Review Rights




     In addition to any other rights OIG may have by statute, regulation, or contract, OIG or
its duly authorized representative(s) may examine or request copies of Boston Scientific’s books,
records, and other documents and supporting materials and/or conduct on-site reviews of any of
Boston Scientific’s locations for the purpose of verifying and evaluating: (a) Boston Scientific’s
compliance with the terms of this CIA; and (b) Guidant/CRM’s compliance with the requirements of
the Federal health care programs in which it participates. The documentation described above shall
be made available by Boston Scientific to OIG or its duly authorized representative(s) at all
reasonable times for inspection, audit, or reproduction. Furthermore, for purposes of this
provision, OIG or its duly authorized representative(s) may interview any of Boston Scientific’s
and/or Guidant/CRM’s, as appropriate, employees, contractors, or agents who consent to be
interviewed at the individual’s place of business during normal business hours or at such other
place and time as may be mutually agreed upon between the individual and OIG. Boston Scientific
shall assist OIG or its duly authorized representativc(s) in contacting and arranging interviews
with such individuals upon OIG’s request. Boston Scientific’s employees may elect to be interviewed
with or without a representative of Boston Scientific present.


VIII. Document and Record Retention




     Boston Scientific shall maintain for inspection all documents and records relating to
reimbursement from the Federal health care programs, or to compliance with this CIA, for six years
(or longer if otherwise required by law) from the Effective Date.



IX. Disclosures




     Consistent with HHS’s FOIA procedures, set forth in 45 C.F.R. Part 5, OIG shall make a
reasonable effort to notify Boston Scientific prior to any release by OIG of information submitted
by Boston Scientific pursuant to its obligations under this CIA and identified upon submission by
Boston Scientific as trade secrets, or information that is commercial or financial and privileged
or confidential, under the FOIA rules. With respect to such releases, Boston Scientific shall have
the rights set forth at 45 C.F.R. § 5.65(d).



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X. Breach and Default Provisions




     Boston Scientific is expected to fully and timely comply with all of its CIA
obligations.



     A. Stipulated Penalties for Failure to Comply with Certain Obligations. As a
contractual remedy, Boston Scientific and OIG hereby agree that failure to comply with certain
obligations as set forth in this CIA may lead to the imposition of the following monetary penalties
(hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.



          1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day  after the date the
obligation became due) for each day Boston Scientific fails to establish and/or implement any of
the following obligations as described in Section III:





a. a Chief Compliance Officer;




b. a Global Compliance Steering Committee;




c. the Board Committee resolution;




d. a written Code of Conduct;




e. written Policies and Procedures;




f. the training of Covered Persons and Arrangements Covered Persons;




g. a Disclosure Program;




h. Ineligible Persons screening and removal requirements;




i. notification of Government investigations or legal proceedings; and




j. posting of Payment information as required by Section III.J.



          2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day




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after the date the obligation became due) for each day Boston Scientific fails to engage an
IRO, as required in Section III.E.




          3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the
obligation became due) for each day Boston Scientific fails to submit the Implementation Report or
any Annual Reports to OIG in accordance with the requirements of Section V by the deadlines for
submission.




          4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the
obligation became due) for each day Boston Scientific fails to submit the annual IRO Review
Report(s) in accordance with the requirements of Section III.E.




          5. A Stipulated Penalty of $1,500 for each day Boston Scientific fails to grant access as
required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Boston
Scientific fails to grant access.)




          6. A Stipulated Penalty of $5,000 for each false certification submitted by or on behalf of
Boston Scientific as part of its Implementation Report, Annual Report, additional documentation to
a report (as requested by the OIG), or otherwise required by this CIA.




          7. A Stipulated Penalty of $1,000 for each day Boston Scientific fails to comply fully and
adequately with any obligation of this CIA. OIG shall provide notice to Boston Scientific stating
the specific grounds for its determination that Boston Scientific has failed to comply fully and
adequately with the CIA obligation(s) at issue and steps Boston Scientific shall take to comply
with the CIA. (This Stipulated Penalty shall begin to accrue 10 days after Boston Scientific
receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this
Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty
under Subsections 1-6 of this Section.




     B. Timely Written Requests for Extensions. Boston Scientific may, in advance of the
due date, submit a timely written request for an extension of time to perform any act or file any
notification or report required by this CIA. Notwithstanding any other provision in this Section,
if OIG grants the timely written request with respect to an act, notification, or report,
Stipulated Penalties for failure to perform the act or file the notification or report shall not
begin to accrue until one day after Boston Scientific fails to meet the revised deadline set by
OIG. Notwithstanding any other provision in this



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Section, if OIG denies such a timely written request, Stipulated Penalties for failure to
perform the act or file the notification or report shall not begin to accrue until three business
days after Boston Scientific receives OIG’s written denial of such request or the original due
date, whichever is later. A “timely written request” is defined as a request in writing received by
OIG at least five business days prior to the date by which any act is due to be performed or any
notification or report is due to be filed.




     C. Payment of Stipulated Penalties.



          1. Demand Letter. Upon a finding that Boston Scientific has failed to comply with any of the
obligations described in Section X.A and after determining that Stipulated Penalties are
appropriate, OIG shall notify Boston Scientific of: (a) Boston Scientific’s failure to comply; and
(b) OIG’s exercise of its contractual right to demand payment of the Stipulated Penalties (this
notification is referred to as the “Demand Letter”).




          2. Response to Demand Letter. Within 10 days after the receipt of the Demand Letter, Boston
Scientific shall either: (a) cure the breach to OIG’s satisfaction and pay the applicable
Stipulated Penalties or (b) request a hearing before an HHS administrative law judge (ALJ) to
dispute OIG’s determination of noncompliance, pursuant to the agreed upon provisions set forth
below in Section X.E. In the event Boston Scientific elects to request an ALJ hearing, the
Stipulated Penalties shall continue to accrue until Boston Scientific cures, to OIG’s satisfaction,
the alleged breach in dispute. Failure to respond to the Demand Letter in one of these two manners
within the allowed time period shall be considered a material breach of this CIA and shall be
grounds for exclusion under Section X.D.




          3. Form of Payment. Payment of the Stipulated Penalties shall be made by electronic funds
transfer to an account specified by OIG in the Demand Letter.




          4. Independence from Material Breach Determination. Except as set forth in Section X.D.l.c,
these provisions for payment of Stipulated Penalties shall not affect or otherwise set a standard
for OIG’s decision that Boston Scientific has materially breached this CIA, which decision shall be
made at OIG’s discretion and shall be governed by the provisions in Section X.D, below.




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     D. Exclusion for Material Breach of this CIA.



          1. Definition of Material Breach. A material breach of this CIA means:





a. a failure by Boston Scientific to report a Rcportablc Event and take
corrective action as required in Section III.I;




b. a repeated or flagrant violation of the obligations under this CIA,
including, but not limited to, the obligations addressed in Section
X.A;




c. a failure to respond to a Demand Letter concerning the payment of
Stipulated Penalties in accordance with Section X.C;




d. a failure to engage and use an IRO in accordance with Section III.E; or




e. a failure of the Board Committee to issue a resolution in
accordance with Section III.A.3.



          2. Notice of Material Breach and Intent to Exclude. The parties agree that a material breach
of this CIA by Boston Scientific constitutes an independent basis for Boston Scientific’s exclusion
from participation in the Federal health care programs. Upon a determination by OIG that Boston
Scientific has materially breached this CIA and that exclusion is the appropriate remedy, OIG shall
notify Boston Scientific of: (a) Boston Scientific’s material breach; and (b) OIG’s intent to
exercise its contractual right to impose exclusion (this notification is hereinafter referred to as
the “Notice of Material Breach and Intent to Exclude”).




          3. Opportunity to Cure. Boston Scientific shall have 30 days from the date of receipt of the
Notice of Material Breach and Intent to Exclude to demonstrate to OIG’s satisfaction that:





a. Boston Scientific is in compliance with the obligations of the CIA cited
by OIG as being the basis for the material breach;




b. the alleged material breach has been cured; or



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c. the alleged material breach cannot be cured within the 30-day
period, but that: (i) Boston Scientific has begun to take action to cure the
material breach; (ii) Boston Scientific is pursuing such action with due
diligence; and (iii) Boston Scientific has provided to OIG a reasonable
timetable for curing the material breach.



          4. Exclusion Letter. If, at the conclusion of the 30-day period, Boston Scientific fails to
satisfy the requirements of Section X.D.3, OIG may exclude Boston Scientific from participation in
the Federal health care programs. OIG shall notify Boston Scientific in writing of its
determination to exclude Boston Scientific (this letter shall be referred to hereinafter as the
“Exclusion Letter”). Subject to the Dispute Resolution provisions in Section X.E, below, the
exclusion shall go into effect 30 days after the date of Boston Scientific’s receipt of the
Exclusion Letter. The exclusion shall have national effect and shall also apply to all other
Federal procurement and nonprocurement programs. Reinstatement to program participation is not
automatic. After the end of the period of exclusion, Boston Scientific may apply for reinstatement
by submitting a written request for reinstatement in accordance with the provisions at 42 C.F.R. §§
1001.3001-.3004.




          E. Dispute Resolution




          1. Review Rights. Upon OIG’s delivery to Boston Scientific of its Demand Letter or of its
Exclusion Letter, and as an agreed-upon contractual remedy for the resolution of disputes arising
under this CIA, Boston Scientific shall be afforded certain review rights comparable to the ones
that are provided in 42 U.S.C. § 1320a-7(f) and 42 C.F.R. Part 1005 as if they applied to the
Stipulated Penalties or exclusion sought pursuant to this CIA. Specifically, OIG’s determination to
demand payment of Stipulated Penalties or to seek exclusion shall be subject to review by an HHS
ALJ and, in the event of an appeal, the HHS Departmental Appeals Board (DAB), in a manner
consistent with the provisions in 42 C.F.R. § 1005.2-1005.21. Notwithstanding the language in 42
C.F.R. § 1005.2(c), the request for a hearing involving Stipulated Penalties shall be made within
10 days after receipt of the Demand Letter and the request for a hearing involving exclusion shall
be made within 25 days after receipt of the Exclusion Letter.




          2. Stipulated Penalties Review. Notwithstanding any provision of Title 42 of the United States
Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for Stipulated
Penalties under this CIA shall be: (a) whether Boston Scientific was in full and timely compliance
with the obligations of this CIA for which




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OIG demands payment; and (b) the period of noncompliance. Boston Scientific shall have the
burden of proving its full and timely compliance and the steps taken to cure the noncompliance, if
any. OIG shall not have the right to appeal to the DAB an adverse ALJ decision related to
Stipulated Penalties. If the ALJ agrees with OIG with regard to a finding of a breach of this CIA
and orders Boston Scientific to pay Stipulated Penalties, such Stipulated Penalties shall become
due and payable 20 days after the ALJ issues such a decision unless Boston Scientific requests
review of the ALJ decision by the DAB. If the ALJ decision is properly appealed to the DAB and the
DAB upholds the determination of OIG, the Stipulated Penalties shall become due and payable 20 days
after the DAB issues its decision.




          3. Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or
Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on
a material breach of this CIA shall be:





a. whether Boston Scientific was in material breach of this CIA;




b. whether such breach was continuing on the date of the Exclusion Letter;
and




c. whether the alleged material breach could not have been cured within the
30-day period, but that: (i) Boston Scientific had begun to take action to
cure the material breach within that period; (ii) Boston Scientific has
pursued and is pursuing such action with due diligence; and (iii) Boston
Scientific provided to OIG within that period a reasonable timetable for
curing the material breach and Boston Scientific has followed the timetable.



          For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision
favorable to OIG, or, if the ALJ rules for Boston Scientific, only after a DAB decision in favor of
OIG. Boston Scientific’s election of its contractual right to appeal to the DAB shall not abrogate
OIG’s authority to exclude Boston Scientific upon the issuance of an ALJ’s decision in favor of
OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such
exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that
Boston Scientific may request review of the ALJ decision by the DAB. If the DAB finds in favor of
OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB
decision. Boston Scientific shall waive its right to any notice of such an exclusion if a




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decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of
Boston Scientific, Boston Scientific shall be reinstated effective on the date of the original
exclusion.




          4. Finality of Decision. The review by an ALJ or DAB provided for above shall not be
considered to be an appeal right arising under any statutes or regulations. Consequently, the
parties to this CIA agree that the DAB’s decision (or the ALJ’s decision if not appealed) shall be
considered final for all purposes under this CIA.




XI. Effective and Binding Agreement




     Boston Scientific and OIG agree as follows:



     A. This CIA shall be binding on the successors, assigns, and transferees of Boston Scientific;



     B. This CIA shall become final and binding on the date the final signature is obtained
on the CIA;



     C. This CIA constitutes the complete agreement between the parties and may not be amended
except by written consent of the parties to this CIA;



     D. The undersigned Boston Scientific signatories represent and warrant that they are
authorized to execute this CIA. The undersigned OIG signatory represents that he is signing this
CIA in his official capacity and that he is authorized to execute this CIA.



     E. This CIA may be executed in counterparts, each of which constitutes an original and all of
which constitute one and the same CIA. Facsimiles of signatures shall constitute acceptable,
binding signatures for purposes of this CIA.



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On Behalf of Boston Scientific Corporation




	 	 	 	 	 
	/s/ J. Raymond Elliott
	 	 	 	 
	 

	 	 	 	 
	J. RAYMOND ELLIOTT

	 	 	 	DATE
	President, Chief Executive Officer and
	 	 	 	 
	Chief Operating Officer
	 	 	 	 
	 
	 	 	 	 
	/s/ Robert D. Keefe
	 	 	 	12/22/09
	 

	 	 	 	 
	ROBERT D. KEEFE

	 	 	 	DATE
	WilmerHale
	 	 	 	 
	Counsel for Boston Scientific Corporation
	 	 	 	 
	 
	 	 	 	 
	/s/ Gary W. Thompson
	 		 	12/22/09
	 

	 		 	 
	GARY W. THOMPSON

	 	 	 	DATE
	Akin Gump Strauss Hauer & Feld
	 	 	 	 
	Counsel for Boston Scientific Corporation
	 	 	 	 






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on behalf of the office of inspector general of

the department of health and human services




	 	 	 	 	 
	/s/ Gregory E. Demske

	 	 	 	12/23/09
	 

	 	 	 	 
	GREGORY E. DEMSKE

	 	 	 	DATE
	Assistant Inspector General for Legal Affairs
	 	 	 	 
	Office of Inspector General
	 	 	 	 
	U. S. Department of Health and Human Services
	 	 	 	 






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APPENDIX A




INDEPENDENT REVIEW ORGANIZATION


This Appendix contains the requirements relating to the Independent Review Organization
(IRO) required by Section III.E of the CIA.



A. IRO Engagement.




     Boston Scientific shall engage an IRO that possesses the qualifications set forth in Paragraph
B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct its review
in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days
after OIG receives written notice of the identity of the selected IRO, OIG will notify Boston
Scientific if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable,
Boston Scientific may continue to engage the IRO.



     If Boston Scientific engages a new IRO during the term of the CIA, this IRO shall also meet
the requirements of this Appendix. If a new IRO is engaged, Boston Scientific shall submit the
information identified in Section V.A.7 of the CIA to OIG within 30 days of engagement of the IRO.
Within 30 days after OIG receives written notice of the identity of the selected IRO, OIG will
notify Boston Scientific if the IRO is unacceptable. Absent notification from OIG that the IRO is
unacceptable, Boston Scientific may continue to engage the IRO.



B. IRO Qualifications.




The IRO shall:




     1. assign individuals to conduct the IRO Review(s) who have expertise in all applicable
Federal health care program requirements related to the Reviews. The individuals shall also be
knowledgeable about the general requirements of the Federal health care program(s) under which
Boston Scientific products are reimbursed;



     2. assign individuals to design and select the Arrangements Review sample(s) who are
knowledgeable about the appropriate statistical sampling techniques; and



     3. have sufficient staff and resources to conduct the Reviews required by the CIA on a timely
basis.



Boston Scientific Corporation CIA

Appendix A




 









 





C. IRO Responsibilities. 




The IRO shall:




     1. perform each IRO Review in accordance with the specific requirements of the CIA;



     2. follow all applicable Federal health care program requirements in making assessments
in the IRO Reviews;



     3. if in doubt of the application of a particular Federal health care program requirement,
request clarification from the appropriate authority (e.g., CMS, the FDA);



     4. respond to all OIG inquires in a prompt, objective, and factual manner; and



     5. prepare timely, clear, well-written reports that include all the information required
by the CIA and Appendix B to the CIA.



D. IRO Independence and Objectivity.



The IRO must perform the IRO Reviews in a professionally independent and objective fashion, as
appropriate to the nature of the engagement, taking into account any other business relationships
or engagements that may exist between the IRO and Boston Scientific.



E. IRO Removal/Termination.




     1. Provider. If Boston Scientific terminates its IRO during the course of the engagement,
Boston Scientific must submit a notice explaining its reasons to OIG no later than 30 days after
termination. Boston Scientific must engage a new IRO in accordance with Paragraph A of this
Appendix.



     2. OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess
the qualifications described in Paragraph B, is not independent and/or objective as set forth in
Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may,
at its sole discretion, require Boston Scientific to engage a new IRO in accordance with Paragraph
A of this Appendix.



     Prior to requiring Boston Scientific to engage a new IRO, OIG shall notify Boston Scientific
of its intent to do so and provide a written explanation of why OIG believes



Boston Scientific Corporation CIA

Appendix A




 









 




such a step is necessary. To resolve any concerns raised by OIG, Boston Scientific may request a
meeting with OIG to discuss any aspect of the IRO’s qualifications, independence or performance of
its responsibilities and to present additional information regarding these matters. Boston
Scientific shall provide any additional information as may be requested by OIG under this Paragraph
in an expedited manner. OIG will attempt in good faith to resolve any differences regarding the IRO
with Boston Scientific prior to requiring Boston Scientific to terminate the IRO. However, the
final determination as to whether or not to require Boston Scientific to engage a new IRO shall be
made at the sole discretion of OIG.




Boston Scientific Corporation CIA

Appendix A




 









 





APPENDIX B




ARRANGEMENTS DATABASE


Boston Scientific Corporation shall create and maintain an Arrangements Database to track all
existing and new and renewed Arrangements, including Contractual and Non-Contractual Arrangements
in order to ensure that each Arrangement does not violate the Anti-Kickback Statute.



A. The Arrangements Database shall contain certain information to assist Boston Scientific
Corporation in evaluating whether each Contractual Arrangement violates the Anti-Kickback Statute,
including but not limited to the following:





1. Each non-Boston Scientific party involved in the Arrangement;




2. The type of Arrangement (e.g., consultant or other fee-for-service arrangements entered
into with HCPs or HCIs, including, but not limited to, post- market study, clinical trials,
continuing medical education, speaker programs, speaker training programs, advisory boards,
proctorships, preceptorships, fellowship grants, symposia, medical directorships, lease
agreements);




3. The term of the Arrangement, including the effective and expiration dates and any
automatic renewal provisions;




4. The amount of compensation to be paid pursuant to the Arrangement and the means by which
compensation is paid;




5. The methodology for determining the compensation under the Arrangements, including the
methodology used to determine the fair market value of such compensation;




6. Whether the amount of compensation to be paid pursuant to the Arrangement is determined
based on the volume or value of referrals between the parties;




7. Whether each party has fulfilled the requirements of Section III.D.2; and




8. Whether the Arrangement satisfies the requirements of an Anti-Kickback Statute safe
harbor.



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  Appendix B




 









 




B. Notwithstanding the timing requirements set forth in III.D.I, Boston Scientific
Corporation shall, consistent with the dates set forth for posting physician payment information
in Section III.J., create and maintain as part of its Arrangements Database certain information to
assist Boston Scientific Corporation in evaluating whether each Non-Contractual Arrangement
violates the Anti-Kickback Statute, including but not limited to the following:





1. Name of entity or individual receiving the Non-Contractual remuneration;




2. The type of Non-Contractual remuneration Arrangement (listing in the aggregate multiple
distributions of the same type of Non-Contractual remuneration to each individual or
entity);




3. The aggregate value of each type of Non-Contractual remuneration given to each entity or
individual during the Reporting Period;




4. Whether the Non-Contractual remuneration given pursuant to the Non- Contractual
Arrangement is determined based on the volume or value of referrals between the parties;




5. Whether the Non-Contractual Arrangement satisfies the requirements of an Anti-Kickback
Statute safe harbor.



Boston Scientific Corporation CIA

  Appendix B