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Form of Corporate Integrity Agreement

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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. a7 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 aBoston Scientific Corp.
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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.Boston Scientific Corp.
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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; andd. 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.Boston Scientific Corp.
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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 ComplianceBoston Scientific Corp.
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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).Boston Scientific Corp.
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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.Boston Scientific Corp.
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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 ScientificBoston Scientific Corp.
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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; ande. 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 CoveredBoston Scientific Corp.
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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 approvalBoston Scientific Corp.
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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. a7 1320a-7b), and the False Claims Act (codified at 31 U.S.C. a7a7 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' sBoston Scientific Corp.
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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,Boston Scientific Corp.
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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; andb. 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;Boston Scientific Corp.
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d. the legal sanctions under the Anti-Kickback Statute; ande. 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
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