Source: https://www.scribd.com/document/59886359/Addendum-to-Serono-Holdings-CIA
Timestamp: 2018-01-22 10:53:29
Document Index: 335132342

Matched Legal Cases: ['§ 1320', '§ 1320', '§ 3729', '§ 1320', '§ 3729', '§ 1128', '§ 1128', '§ 552', 'art 5', '§ 5']

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Description: Addendum to EMD Serono Holdings, Inc. CIA
Addendum to EMD Serono Holdings, Inc. CIA
ADDENDUM TO CORPORATE INTEGRITY AGREEMENT
BETWEEN THE OFFICE OF INSPECTOR OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES AND GENERAL
Effective October 14,2005, Serono Holding, Inc. entered into a Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) of the United States Department of Health and Human Services (HHS). In 2007, the following entities covered by the CIA changed their names as follows: (1) Serono Holding, Inc. changed its name to EMD Serono Holding, Inc.; and (2) Serono, Inc. changed its name to EMD Serono, Inc. The CIA applies to EMD Serono Holding, Inc., and all of its U.S. biopharmaceutical operating subsidiaries and affiliates that are subject to 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) and the statutes, regulations and written directives of the Food and Drug Administration (FDA requirements).
EMD Serono Holding, Inc. (EMD Serono Holding) hereby enters into this Addendum to the CIA (Addendum). This Addendum applies to EMD Serono Holding and all of its subsidiaries and affiliates, including but not limited.to EMD Serono, Inc., EMD Serono Research Institute, Inc., EMD Serono Research Center, Inc., and EMD Serono Biotech Center, Inc (collectively "EMD Serono"). For purposes of this Addendum, "affiliate" shall mean any entity that is owned or controlled, directly or indirectly, by EMD Serono Holding, ·Inc., and whose employees or contractors perform ''Promotional Functions" and "Product Related Functions," as defined below in Sections n.C.4andS.
Serono Laboratories, Inc., EMD Serono, Inc., Ares Trading S.A., and Merck Serono S.A. (formerly mown as Serono S.A.) will be entering into a Settlement Agreement with the United States (Settlement Agreement). Serono Laboratories, Inc., EMD Serono, Inc., Ares Trading S.A., and Merck Serono S.A. are hereafter referred to as the "Sereno Settlement Agreement Parties." The Serono Settlement Agreement Parties
EMD Serono Holding, Inc. - Addendum to Corporate Integrity Agreement
'also will enter intosettlement agreements with various States; and HMD Sereno Holding's agreement to this Addendum is a condition precedent to those agreements.
TERM AND SCOPE OF THE CIA AND ADDENDUM A. Continuation of CIA and Tenn of Addendum.
All of the obligations set forth in the CIA shall continue for the period set forth in the CIA, and ENID Serono shall comply with the CIA obligations for the remainder of the term of the CIA. In addition, unless otherwise specifically revised by this Addendum or excepted, all of the provisions of the CIA shall be and hereby are incorporated into this Addendum. and shall remain in full force and effect during the period covered by this Addendum. EMD Serono shall comply with all obligations of the CIA that are incorporated into this Addendum, all CIA obligations that are modified in this . Addendum, and all new obligations set forth in this Addendum. Where a term is defined differently in this Addendum than in the CIA, as of the Effective Date of the Addendum, EMD Serono shall comply with the term as defined in this Addendum. The term of compliance obligations assumed by EMD Serono under the Addendum shall be three years from the Effective Date of the Addendum, unless otherwise specified. The Effective Date of this Addendum shall be the Effective Date of the Settlement Agreement, Each one-year period, beginning with the one-year period following the Effective Date of this Addendum, shall be referred to as a "Reporting Period." B. Section U.B. of the CIA. Section II.B of the CIA remains in effect through the term of the CIA and this Addendum. EMD Serono's final Annual Report shall mean the final Annual Report due under this Addendum.
C. Definitions. The definitions set forth at Section II.C of the CIA shall apply unmodified to the CIA through end of its term. As of the Effective Date of this Addendum, the definitions set forth at Section II.C of the CIA shall be replaced with the following definitions, which shall apply throughout the term of this Addendum: 1. "Covered Persons" includes: a. all owners who are natural persons (other than shareholders who: (1) have an ownership interest ofless than 5% and (2) acquired the ownership interest through public trading), officers, directors, and employees ofEMD Serono Holding, Inc. and its subsidiaries and affiliates, including but not limited to EMD Serono, Inc., EMD Serono Research Institute, Inc., EMD Serono Research Center, Inc., and EMD Serono Biotech Center, Inc; and b. all contractors, subcontractors, agents, and other persons who perform Promotional Functions or Product Related Functions on behalf of EMD Serono; Notwithstanding the above, the term "Covered Persons" does not include: 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. 2. "Relevant Covered Persons" includes all Covered Persons whose job responsibilities relate to Promotional Functions or Product Related Functions. 3. "Government Reimbursed Products" refers to all EMD Serono human pharmaceutical products promoted or sold by EMD Serono in the United States that are reimbursed by Federal health care programs or pursuant to contracts with the United States.
4. The teim "PromotionalFunctions" includes: (a) the selling, detailing, marketing, advertising, promoting, or branding of Government Reimbursed Products; and (b) the preparation or dissemination of promotional materials or information about, or the provision of promotional services relating to, Government Reimbursed Products, including those functions relating to any applicable review committees.
5. The term "Product Related Functions" includes: (a) the preparation or
dissemination or non-promotional materials about Government Reimbursed Products, including those functions relating to any applicable review committees and to EMD Serono' s Medical Information Department (Medical Information); (b) contracting with healthcare professionals (RCPs) in the United States to conduct postmarketing clinical trials and other post-marketing studies relating to Government.Reimbursed Products; and (c) authorship, publication, and disclosure of articles or study results relating to Government Reimbursed Products.
6. The term. "Third Party Personnel" shall mean personnel of other entities with whom EMD Serono has or may, in the future, have joint venture
agreements and/or agreements to co-market its products. EMD Serono has represented that: 1) it has entered or may, in the future, enter into joint venture agreements and/or agreements to co-market its products with other entities; 2) the Third Party Personnel are employed by other pharmaceutical manufacturers; 3) EMD Serono does not control the Third Party Personnel; and 4) it would be commercially impracticable' to compel Third Party Personnel compliance with the requirements set forth in this CIA Addendum. However, EMD Serono agrees to use its best efforts to promote compliance by the Third Party Personnel with Federal health care program and FDA requirements. In order to fulfill this obligation,EMD Serono agrees to the following: a. Within 90 days after the Effective Date of this Addendum, and annually thereafter by the anniversary of the Effective Date of this Addenduin, EMD Serono shall send a letter to all entities with which it has entered into joint venture andlor co-market agreements to market Government Reimbursed Products. The
letter shall outline EMD Serono'sobligations under the CIA and its commitment to full compliance with all Federal health care program requirements. The letter shall include a description of EMD Serono's compliance program. EMD Serono shall attach a copy of its Code of Conduct to the letter and shall ask that the other entity either: (i) make a copy of EMD Serono' s Code of Conduct and the description of EM!> Serono's compliance program available to all relevant personnel within its organization; or (ii) represent to EMD Serono that it has and enforces a substantially comparable Code of Conduct and compliance program. for relevant persons within its organization. b. EMD Serono shall submit: (i) a copy of each such letter (including all attachments); (ii) a list of all EMD Serono existing joint venture and/or co-marketing agreements; and (iii) a description of the entities' responses to EMD Serono's letter to the OIG with the Implementation Report and each Annual Report. Provided that EMD Serono fulfills the requirements set forth in this Section II.C.6, EMD Serono shall not be required to fulfill the other CIA obligations that would otherwise apply to Third Party Personnel who meet the definition of Covered Persons. 7. 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 supported by EMD Serono, including but not limited to, sponsorship of medical education programs at medical conferences. 8. The term "Educational Sponsorship Arrangement' shall mean every arrangement or transaction that: involves, directly or indirectly, EMD Serono's provision of economic support (e.g., through a grant or other funding mechanism) or other prograD? support (e.g., through the provision of materials, speakers, logistical support) to a provider of an Third Party Educational Activity. This includes support that EMD Serono provides to an individual or entity that itself directly performs or
sponsors the Third party Educational Activity and support that EMD Serono provides to an individual or entity that makes arrangements for another individual or entity to perform. or sponsor the Third Party Educational Activity.
CIA AND ADDENDUM
Section lILA of the CIA shall remain in effect through the term of the CIA. As of the Effective Date of this Addendum, Section III.A of the CIA shall be replaced with the following Section III.A, which shall apply to this Addendum. Throughout the term of this Addendum, EMD Serono shall maintain a Compliance Program that includes the following elements: A. Compliance Officer and Committee; and Board and Management Accountability. 1. Section In.A.I of the CIA shall apply to this Addendum, as modified hereafter. In addition to the other requirements of Section III.A.l of the CIA, the Compliance Officer shall: (a) be a member of senior management ofEMD Serono, Inc.; (b) make periodic (at least semi-annual) reports regarding compliance matters directly to the Boards of Directors of EMD Serono Holding, Inc. and EMD Serono, Inc.; (c) be authorized to report on such matters to the Boards of Directors of EMD Serono Holding, Inc. and EMD Serono, Inc. at any time; and (d) report to the Chief Executive Officer of EMD Serono, Inc.
2. Compliance Committee. Section IILA.2 of the CIA shall remain In effect, and EMD Serono shall continue its obligations under Section III.A.2 through the term of the CIA and this Addendum. 3. Board of Directors. The Board of Directors ofEMD Serono, Inc. and the Board of Directors ofEMD Serono Holding, Inc. (the "Boards") shall retain responsibility for the review and oversight of matters related to EMD Serono's compliance with Federal health care program and FDA requirements and the obligations of the CIA and this Addendum. The Boards shall, at a minimum, be responsible for the following:
a. Oversight: The Boards shall meet at least quarterly to review and overseeEMD Serono's Compliance Program, including but not limited to, evaluating its effectiveness, and the performance of the Compliance Officer, the Corporate Compliance Department, and the Compliance Committee. b. Board Resolutions: For each Reporting Period, each of the Boards shall adopt a resolution, signed.by each individual member of the Boards summarizing the Boards' review and oversight of ElvID Serono' s compliance with Federal health care program and FDA.requirements, and the obligations set forth in this Addendum, including the CIA obligations incorporated into this Addendum and the CIA obligations modified by this Addendum. At a minimum, the resolution shall include the following language: "The Board of Directors of[EMD Serono, Inc.IEMD Serono Holding, Inc. (whichever applies)] (the "Board") has made a reasonable and due inquiry into the operations and effectiveness of the Compliance Program required by the CIA Addendum between the U.S. Department of Health and Human Services and EMD Serono Holding, Inc. (hereinafter the "EMD Serono Compliance Program") for the period [insert description of the time period], including but not limited to evaluating its effectiveness and the performance of the Compliance Officer, the Compliance Committee, and the Compliance Department. Based on its inquiry, the Board has concluded that, to the best of its knowledge, EMD Serono has implemented an effective compliance program to meet the applicable Federal health care program and FDA requirements and the obligations set forth in the CIA and this Addendum." If the Boards are (or either of them is) unable to provide such a conclusion in their respective resolutions, the respective Board shall include in its 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 compliance program at EMD Serono. Within 30 days after the Effective Date of this Addendum, EMD Serono shall report to the DIG, in writing, the names of the members of the Boards. EMD Serono shall also report to the OIG, in writing, any changes in the composition of the Boards or any actions or changes that would affect the Boards' ability to perform the duties necessary to meet the obligations of this Addendum within 15 days after such change.
The Boards' resolutions shall be provided to the OIG with each Annual Report, as set forth in Section V.B.2 below. 4. Management Accountability and Certifications. EMD Serono represents that EMD Serono makes the promotion of, and adherence to, EMD Serono's compliance program a component of employee performance. In addition to the responsibilities set forth in the CIA and this Addendum for all Covered Persons, certain EMD Serono 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 area of authority, to the best of their know ledge, is compliant with applicable Federal health care program and FDA requirements, and the obligations of the CIA and this Addendum. The Certifying Employees include, at a minimum, all EMD Serono: presidents, chairpersons, chief executive, financial, commercial, and medical officers; executive and senior vice presidents of EMD Serono business units that perform pricing, sales, marketing, contracting, promotion, or medical information functions; and, to the extent that an EMD Serono business unit performs pricing, sales, marketing, contracting, promotion, or medical information functions and is not covered by the certification of one of the above-listed individuals, such other appropriate EMD Serono business unit heads as would be necessary to ensure that there is a certifying officer or employee covering each such business unit. For each Reporting Period, each Certifying Employee shall certify in writing or electronically that: "I am the [title] of department or functional area] of [entity]. I have been trained on and understand the compliance requirements and responsibilities as they relate to [department or functional area], which is 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 the department or functional area] ofEMD Serono is in compliance with all applicable Federal health care program requirements, FDA requirements, and the obligations of the CIA and Addendum. I understand that this certification is being provided to and relied upon by the United States." If any Certifying Employee is unable to provide such a conclusion ill the certification, the Certifying Employee shall include in the certification a written
explanation of the reasons why he or she is unable to provide the conclusion and the steps being taking to address the issue(s) identified in the certification. B. Written Standards. 1. Code of Conduct. Section III.B.I of the CIA shall remain in effect, and EMD Serono shall continue the obligations set forth therein through the term of the CIA and this Addendwn. 2. Policies and Procedures. Section III.B.2 of the CIA shall remain in effect through its term, except that as of the Effective Date of this Addendum, Section III.B.2 of the CIA shall be replaced with the following language, which shall apply to this Addendum: To the extent not already accomplished, within 120 days after the Effective Date of this Addendum, EMD Serono shall implement written Policies and Procedures regarding the operation ofEMD Sereno's compliance program and its compliance with Federal health care program and FDA requirements, as well as the requirements of the CIA and this Addendum. At a minimum, the Policies and Procedures shall address: a. the subject relating to the Code of Conduct identified in Section III.B.I of the CIA; b. appropriate ways to conduct Promotional Functions in compliance with all Federal health care program requirements, including but not limited to the Federal anti-kickback statute (codified at 42 U.S.C. § 1320a-7b(b» and the False Claims Act (codified at 42 U.S.C. §§ 3729-3733); c. appropriate ways to conduct Product Related Functions in compliance with all Federal health care program requirements, including but not limited to the Federal anti-kickback statute (codified at 42 U.S.C. § 1320a-7b(b» and the False Claims Act (codified at 42 U.S.C. §§ 3729-3733);
d. appropriate ways to conduct Promotional Functions and Product Related Functions in compliance with all applicable FDA requirements;
e. the materials and information that may be distributed by EMD Serono sales representatives about Government Reimbursed Products and the manner in which EMD Serono sales representatives respond to requests for information about non-FDA approved (or "off-label") uses of Government Reimbursed Products. These Policies and Procedures shall require that sales representatives refer all requests for irifonnation about non-FDA approved ("off-label") uses of Government Reimbursed Products to Medical Information. These Policies and Procedures shall also require that distribution of any reprints of medical journal articles must be consistent with applicable FDA guidance and other relevant requirements; f. the manner in which Medical Information receives and responds to requests for information about off-label uses ofEMD Serono's products; the form and content of information disseminated by Medical Information in response to such requests; and the internal review process for the information disseminated; g. the manner and circumstances under which medical personnel from Medical Information interact with or participate in meetings or events with RCPs or healthcare institutions (HCrs) (either alone or with sales representatives or account executives) and the role of the medical personnel at such meetings or . events, as well as how they handle responses to unsolicited requests about off-label indications of Government Reimbursed Products; h. consultant or other fee-for-services arrangements entered into with HCPs or HCIs (including, but not limited to speaker programs, speaker training programs, presentations, consultant task force meetings, advisory boards, and ad hoc advisory activities, and any other financial engagement or arrangement with an HCP or He!) and all events and expenses relating to such engagements or arrangements. These Policies and Procedures shall be designed to ensure that the arrangements and related events are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements. The Policies and Procedures shall include requirements about the content and circumstances of such arrangements and events; i. programs to educate sales representatives, including but not limited to presentations by HCPs at sales meetings, preceptorships, tutorials, and experiencebased learning activities. These Policies and Procedures shall be designed to
EMD Sereno Holding, Inc. - Addendum to Corporate Integrity Agreement
ensure that the programs are used. for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements. The Policies shall include requirements about the content and circumstances of such arrangements and events;
j. sponsorship or funding of grants (including educational grants) or
charitable contributions These Policies and Procedures shall be designed to ensure that EMD Serono's funding and/or sponsorship complies with all Federal health care program and FDA requirements; of, or participation in, any Third Party Educational Activity, as defined in Section II.C.7 above. These Policies and Procedures shall be designed to ensure that EMD Serono' s funding and/or sponsorship of such programs satisfies all applicable Federal health care program and FDA requirements. These Policies and Procedures shall require that: (1) EMD Serono disclose its financial support of the Third Party Educational Activity and, to the extent feasible, consistent with subsection III.B.3.k.4 below; any financial relationships with faculty, speakers, or organizers at such Activity; (2) as a condition offunding, the third party shall agree to disclose the company's financial support of the Third Party Educational Activity and to require faculty, speakers, or organizers at such Activity to disclose any financial relationship with EMD Serono; (3) the Third Party Educational Activity have an educational focus; (4) the content, organization, and operation of Third Party Educational Activities conducted by third parties be independent ofEMD Serono's control; (5) EMD Serono support only Third Party Educational Activity that is non-promotional in tone/nature; and (6) EMD Sereno' s support of an Third Party Educational Activity be contingent on the provider's commitment to provide information at the Third Party Educational Activity that is fair, balanced, accurate and not misleading;
k, funding
1. sponsorship, funding of, and disclosures relating to Product Related Functions. These Policies and Procedures shall be designed to ensure that E:MD Serono's funding, sponsorship, and disclosures comply with all applicable Federal health care program and FDA requirements;
m. compensation (including through salaries, bonuses, and contests) for Relevant Covered Persons who are sales representatives. These Policies and Procedures shall be designed to ensure that fmancial incentives do not
inappropriately motivate such individuals to engage in improper promotion, sales, and marketing ofEMD Serono's Government Reimbursed Products; n. sponsorship, funding of, and disclosures relating to research and development-related activities (including clinical trials, market research, and authorship of articles or other publications). These policies and procedures shall be designed to ensure that EMD Serono funding andlor sponsorship complies with all applicable Federal health care program and FDA requirements; and Policies and Procedures for violations of EMD Serono' s Policies and Procedures, including policies relating to Federal health care program and FDA requirements. To the extent not already accomplished, within 120 days after the Effective Date of the Addendum, the relevant portions of the Policies and Procedures shall be distributed to all Covered Persons whose job functions relate to those Policies and Procedures. Appropriate knowledgeable staff shall be available to explain the Policies and Procedures. At least annually (and more frequently, if appropriate), EMD Serono 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 to all Covered Persons whose job functions relate to those Policies and Procedures. C. Training and Education.
1. Section lIl.C of the CIA shall remain in effect through the term of the CIA.
0: disciplinary
2. Section III.C of the CIA shall remain in effect through the term of this Addendum, except as of the Effective Date of this Addendum, the references in Sections III.C.l and IILC.2 to "150 days," shall be replaced with "120 days," and the term "Relevant Promotional and Product Services Covered Persons" shall be replaced with the term "Relevant Covered Persons."
D. Compliance with Requirements Applicable to Third Party Educational Activities. 1. Section IIT.Dof the CIA shall remain in effect through the term of the CIA. 2. Except as modified herein, Section HI.D of the CIA shall remain in effect, and EMD Serono shall continue the obligations under Section Ill.D, as modified herein, through the term of this Addendum, provided that the term "Educational Activity" shall be replaced with the term "Third Party Educational Activity," the term "Arrangements Procedures" shall be replaced with the term "Educational Sponsorship Arrangements Procedures," and the term "Arrangements Requirements" shall be replaced with the term "Educational Sponsorship Arrangements Requirements." E. Electronic Records. Section m.E of the CIA shall remain in effect through the term of the CIA, and EMD Serono shall continue its obligations under Section III.E through the term of this Addendum. F. Review Procedures. Section III.F of the CIA shall remain in effect through the term of the CIA. As of the Effective Date of this Addendum, Section HI.F shall be replaced with the following provisions, which shall apply through the term of this Addendum:
1. General Description. a. Engagement of Independent Review Organization. Within 90 days after the Effective Date of the Addendum, EMD Serono shall engage an entity (or entities), such as an accounting, auditing, or consulting firm (hereinafter "Independent Review Organization" or "IRO"), to perform the reviews required by this Addendum to assist EMD Serono in assessing and evaluating its Promotional Functions and its Products Related Functions. The applicable requirements relating to the IRO are outlined in Appendix A to this Addendum, which is incorporated by reference.
Each IRO engaged by EMD Serono shall have expertise in applicable Federal health care program and FDA requirements as may be appropriate to the Review for which the IRO is retained. Each IRO shall assess along with EMD Serono, 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 The IRO shall conduct two types of reviews to assess EMD Serono' s systems, processes, policies, procedures, and practices relating to Promotional Functions and to Product Related Functions (collectively, "IRQ Reviews"). b. Frequency and Description of Reviews. As set forth more fully in Appendix. B, the IRO Reviews shall consist of two components - a Systems Review and a Transactions Review. The Systems Review shall assess EMD Serono' s systems, processes, policies, and procedures relating to Promotional Functions and Product Related Functions. If there are no material changes in EMD Serono's relevant systems, processes, policies, and procedures, the IRQ Systems Review shall be performed for the second Reporting Period. If EMD Serono materially changes its relevant systems, processes, policies, and procedures in the first andlor third Reporting Periods, the IRQ shall perform. a Systems Review for the first and/or third Reporting Periods as well, as set forth more fully in Appendix B. The Transactions Review shall be performed annually and shall . cover each of the three Reporting Periods. The IRO shall perform all components of each annual Transactions Review. As set forth more fully in Appendix B, the Transactions Review shall include several components.
In addition, each Transactions Review shall also include a review of up to three additional areas or practices of EMD Serono identified by the 010 in its discretion (hereafter "Additional Items"). For
purposes of identifying the Additional Items to be included in the Transactions review for the particular Reporting Period, the OIG will consult with EMD Serono and may consider internal audit work conducted by EMD Serono, the Government Reimbursed Product portfolio, the nature and scope ofEMD Serono's promotional practices and arrangements with RCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, EMD Serono may propose to the 010 that its internal audit(s) be partially substituted for one or more of the Additional Items that would otherwise be reviewed by the IRO as part of the Transactions Review. The OIG retains sole discretion over whether, and in what manner, to allow EMD Serono's internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The 010 shall notify EMD Serono of the nature and scope of the IRO-review for each of the Additional Items not later than 120 days prior to the end of each Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or EMD Serono shall submit an audit work plan to the OIG for approval and the IRO shall conduct the review of the Additional Items based on a work plan approved by the OIG. c. Retention of Records. The IRO and EMD Serono shall retain and make available to OIG, upon request, all work papers, supporting documentation, correspondence, and draft reports (those exchanged between the IRO and EMD Serono) related to the reviews.
2. IRO Review Reports. The IROCs) shall prepare a report (or reports)
based upon each Review performed (IRO Review Report). The information and content to be included in the IRO Review Report is described in Appendix B, which is incorporated by reference. 3. Validation Review. Section III.F.5 of the CIA shall remain in effect through the term of the CIA. As of the Effective Date of this Addendum, the term "Review" shall be replaced by the term "applicable IRO Review," and EMD Serono shall
EMD Sereno Holding, Inc. - Addendum to Corporate-Integrity Agreement
continue its obligations under Section Ill.F.5, as modified herein, throughthe term of this Addendum. 4. Independence and Objectivity Certification. Section III.F.6 of the CIA shall remain in effect through the term of the CIA, and EMD Serono shall continue its obligations under Section Ill.F.6 through the term of this Addendum. G. Disclosure Program. Section Ill.G of the CIA shall remain in effect through the term of the CIA, and EMD Serono shall continue its obligations under Section III.G through the term of this Addendum. H. Ineligible Persons. Section lII.H of the CIA shall remain in effect through the term of the CIA. As of the Effective Date of this Addendum, the following language shall be added to Section III.H, and EMD Serono shall continue its obligations under Section III.H of the CIA, as modified herein, through the term of this Addendum: The definition of the term "Screened Persons" shall be replaced such that "Screened Persons" shall mean "Covered Persons." EMD Serono understands that items or services furnished by excluded persons are not payable by Federa1 health care programs and that EMD Serono may be liable for overpayments (if applicable) and/or criminal, civil, and administrative sanctions for employing or contracting with an excluded person regardless of whether EMD Serono meets the requirements of Section llI.H. I. Notification of Government Investigation or Legal Proceedings. Section IILI of the CIA shall remain in effect throughout the term of the CIA. As of the Effective Date of this Addendum, Section III.! shall be replaced with the following language: Within 30 days after discovery by EMD Serono, EMD Serono shall notify OIG, in writing, of any ongoing investigation or legal proceeding conducted or brought by a U.S.based governmental entity or its agents involving an allegation that EMD Serono 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. EMD Serono 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. J. Reporting (of Reportable Events). Section III.J of the CIA shall remain in effect throughout the term of the CIA. As of the Effective Date of this Addendum., Section IIIJ shall be replaced with the following provisions :
1. Definition of Reportable Event. For purposes of this CIA, a "Reportable
Event" means anything that involves: a. a matter 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 or exclusion may be authorized; b. a matter that a reasonable person would consider a probable violation of criminal, civil, or administrative laws applicable to any FDA requirements relating to the promotion of Government Reimbursed Products (including an FDA Warning Letter issued to EMD Serono) or the sponsorship of any Third Party Educational Activity; or c. the filing of a bankruptcy petition by E:rvIDSerono. A Reportable Event may be the result of an isolated event or a series of occurrences.
2. Reporting of Reportable Events. IfEMD Serono determines (after a reasonable opportunity to conduct an appropriate review or investigation of the allegations) through any means that there is a Reportable Event, EMD Serono shall notify DIG, in writing, within 30 -days after making the determination that the Reportable Event exists. The report to OIG shall include the following information:
a. a complete description of the Reportable Event, including the
relevant facts, persons involved, and the legal and Federal health care program andlor FDA authorities implicated; and b. a description of EMD Serono' s actions taken to correct the Reportable Event and any further steps EMD Serono plans to take to address the Reportable Event and prevent it from recurring, including a description of any disciplinary action taken. c. 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 andlor FDA authorities implicated. K. Notification of Communications with FDA. Section III.K of the CIA shall remain in effect through the term of the CIA, and EMD Serono shall continue its obligations under Section m.K through the term of this Addendum. L. Review of Records Reflecting.the Content of Detailing Sessions. Section Ill.L of the CIA shall remain in effect through the term of the CIA, and EMD Serono shall not continue its obligations under Section III.L through the term of this Addendtun. M. Monitoring and Review of Requests for Off-Label Information. Section III.M of'the CIA shall remain in effect through the term of the CIA, and EMD Serono shall continue its obligations under Section IILM through the term of this Addendum. N. Field Force Monitoring and Review Efforts. To the extent not already accomplished, within 120 days after the Effective Date of this Addendum, EMD Serono shall establish a comprehensive Field Force Monitoring
Program (FFMP) to evaluate and monitor its sales representatives' interactions with RCPs and HCIs. The FFMP shall be a formalized process designed to directly and indirectly observe the appropriateness of sales representatives' interactions with HCPs and HCIs and to identify potential improper conduct. In addition to the monitoring identified above in Section III.M, the FFMP shall include: (1) a Speaker Monitoring Program; and (2) the monitoring and review of other records relating to sales representatives' interactions with HCPs and HCls. 1. Speaker Program Activities. Prior to the Effective Date of this Addendum, EMD Serono implemented processes to require all speakers to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements regarding annual caps on speaker fees, requirements that the speaker may only use EMD Serono approved materials, and the requirement that speakers may not directly or indirectly promote any product for off-label uses.) EMD Serono shall maintain such processes during the term of the Addendum. EMD Serono shall also maintain a centralized system through which all speaker programs are initiated, tracked, and administered. This system shall support EMD Serono's policies regarding eligibility and qualifications of speakers and venues for the programs and require that speakers are paid according to a centrally managed, pre-set rate structure determined based on a fair-market value analysis conducted by EMD Serono. EMD Serono shall ensure that speaker programs are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements. EMD Serono shall maintain a comprehensive list of speaker program attendees through its centralized system. In addition, EMD Serono shall use its centralized system to monitor all logistics and spending associated with speaker programs, including tracking and review of the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during the Reporting Period EMD Serono shall require certified evaluations by sales representatives or other EIVIDSerono personnel regarding whether a speaker program complied with EMD Serono requirements. In the event of non-compliance, EMD Serono shall require the identification of the policy violation and ensure appropriate follow-up activity to address the violation. Within 120 days of the Effective Date of this Addendum, EMD Serono shall establish a process to develop an annual speaker program budgeting plan and needs assessment that
identifies the business need for, and estimates the numbers of, various Speakerprogram engagements and activities to occur during the following year. The annual speaker program budgeting plan and needs assessment shall also identify the budgeted amounts to be spent on speaker program-related activities. EMD Sereno's compliance and/or legal personnel shall be involved in the review of such plans, including any subsequent modification of a reviewed plan. Within 120 days of the Effective Date of this Addendum, EMD Serono shall establish a Speaker Monitoring Program through which EMD Serono compliance or management personnel shall attend 50 speaker programs during each Reporting Period and conduct live audits of the programs (Speaker Program. Audits). The programs subject to Speaker Program Audits shall be selected both on a risk-based targeting approach and on a sampling approach. For each program reviewed, personnel conducting the Speaker Program Audits shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and EMD Serono representative activities during the program to assess whether the programs were conducted in a manner consistent with EMD Serono's Policies and Procedures. EMD Serono shall maintain the controls around speaker programs as described above, and shall conduct its Speaker Program Audits as described above throughout the term of this Addendum.
2. Records Reviews. As a component of the FFMP, EMD Serono shall also
review various types of records to assess sales representatives' interactions with HCPs and HeIs and to identify potential or actual compliance violations. For each Reporting Period, EMD Serono shall develop and implement a plan for conducting Records Reviews associated with at least two Government Reimbursed Products and a sampling of the representatives promoting those products in every separate region. The OIG shall have the discretion to identify the two Government Reimbursed Products to be reviewed for each Reporting Period. The OIG will select the products based on information about EMD Serono's products provided by Serono no later than 60 days prior to the beginning of the Reporting Period, and other information known to the OIG. If the OIG does not identify the Government Reimbursed Products to be reviewed within the first 30 days of the Reporting Period, EMD Serono shall select the two products to be reviewed. These Records Reviews shall include the monitoring and review of: (1) records and systems relating to sales representatives' interactions with Heps and HCls relating to promotional speaker program activities, samples, meals, and other events or items
. (including records from the electronic detailing system for the particular sales representative, sales communications from managers, and expense reports); (2) requests for medical information; (3) tutorials and preceptorships; (4) message recall studies or any other similar records in EMD Serono's possession purporting to reflect the details of sales representatives' interactions with HCPs and HCIs; (5) sales representative call notes; (6) sales representative e-mails and other electronic records; and (1) recorded results of any observations of sales representatives and applicable notes or information from the sales representatives' managers.
3. Reporting and Follow-up. Personnel conducting the Speaker Program Activities and Records Reviews shall have access to all relevant records and information
necessary to assess potential or actual compliance violations. Results from the FFMP reviews, including the identification of potential violations of policies and/or legal requirements, shall be compiled and reported to EMD Serono' s Compliance Officer for review and follow-up as appropriate. In the event that a potential violation ofEMD Serono's Policies and Procedures or of Federal health care program or FDA requirements, is identified during any aspect of the FFMP, EMD Serono shall investigate the incident consistent with established Policies and Procedures for the handling of investigations and shall take all necessary and appropriate responsive action (including disciplinary action) and corrective action, including the disclosure of Reportable Events pursuant to Section III.J above, if applicable. Any compliance issues, including but not limited to potential off-label promotion or potential violation ofEMD Serono's Policies and Procedures or of Federal health care program or FDA requirements, identified during the FFMP reviews and any corrective action shall be recorded in the files of the Compliance Department. EMD Serono shall include a summary of the FFMP and the results of the FFMP reviews as part of each Annual Report. EMD Serono shall make documents relevant to the FFMP reviews available to the OIG upon request. O. Monitoring of Non-Promotional Activities. To the extent not already accomplished, within 120 days after the Effective Date of this Addendum, EMD Serono shall develop and implement a monitoring program for the following types of activities: (1) consultant arrangement activities; (2) research-related activities; and (3) medical education and charitable grants. This program shall be referred to as the Non-Promotional Monitoring Program (NPMP).
1. Consultant Arrangement Activities. To the extent-that EMD Serono engages HCPs orHCIs for services other than for speaker programs or research-related activities and those services relate to Promotional Functions or to Product Related Functions (e.g., a member of an advisory board or to attend consultant meetings), such HCPs or HCIs shall be referred to herein as Consultants. EMD Serono shall require all Consultants to enter written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the Consultants. EMD Serono shall establish and maintain a review and approval structure to ensure that Consultants shall be paid according to a centrally managed, pre-set rate structure that is determined based on a fair-market value analysis conducted by EMD Serono.
To the extent not already accomplished, within 120 days after the Effective Date of this Addendum., EMD Serono shall establish a process to develop annual budgeting plans that identify the business needs for, and the estimated numbers of, various Consultant engagements and activities to occur during the following year. The annual Consultant budgeting plans shall.also identify the budgeted amounts to be spent on Consultantrelated activities. ~MD Serono's legal or compliance personnel shall be involved in the review and approval of such budgeting plans, including any subsequent modification of an approved plan. The purpose of this review shall be to ensure that Consultant arrangements and related events are used for legitimate purposes in accordance with applicable EMD Serono Policies and Procedures. To the extent not already accomplished, within 120 days after the Effective Date of this Addendum, prior to the retention of Consultants, EMD Serono shall establish a process to ensure that a needs assessment has been completed to justify the retention of or payment to the Consultant. The needs assessment shall identify the business need for the retention of the Consultant and provide specific details about the consulting arrangement (e.g., information about the numbers and qualifications ofHCPs or HCIs to be engaged, the agenda for the proposed meeting (if one exists), and a description of the proposed work to be done and type of work product to be generated.) Any deviations from the Consultant budgeting plans shall be documented in the needs assessment and shall be subject to review and approval by EMD Serono legal or compliance personneL To the extent not already accomplished, within 120 days after the Effective Date of this Addendum, EMD Serono shall amend its policies to require the collection, assessment, and retention of work product generated by Consultants.
EMD Serono Holding, Inc .• Addendum. to Corporate Integrity Agreement
Within 120 days after the Effective Date oftbis Addendum, EMD Serono shall establish a Consultant Monitoring Program through which it shall conduct audits (Consultant Program Audits) of at least 40 consultant programs with HCPs during each Reporting Period. Of the Consultant Program Audits, at least 20 of the audits shall pertain to non-advisory board programs, and 20 shall pertain to advisory board programs. The Consultant Monitoring Program shall review Consultant arrangements both on a risk-based targeting approach and on a random sampling approach. Personnel conducting the Consultant Program Audits shall review needs assessments, consultant contracts, and materials relating to the program or work of the Consultant (including a verification that the work product resulting from any Consultant-related program or event or otherwise generated by the Consultant is consistent with the stated business need set forth on the needs assessment or elsewhere), and other information in order to assess whether the programs and arrangements were conducted in a manner consistent with EMD Serono's Policies and Procedures. Results from the Consultant Program Audits, including the identification of potential violations of policies, shall be compiled and reported to EMD Serono's Compliance Department for review, follow-up, and remediation as appropriate.
2. Research-Related Activities. To the extent that EMD Serono engages U.S.based RCPs or HCrs to conduct post-marketing research regarding Government Reimbursed Products, such HCPs· and HCrs shall be referred to collectively as . "Researchers". EMD Serono shall require all Researchers to enter written agreements describing the scope of the clinical research or other work to be performed, the fees to be paid, and compliance obligations for the Researchers. Researchers shall be paid according to a centrally managed, pre-set rate structure that is determined based on a fairmarket value analysis conducted by EMD Serono.
To the extent not already accomplished, within 120 days after the Effective Date of this Addendum, EMD Serono shall establish an annual budgeting plan for Researchers that identifies the business or scientific need for, and the estimated numbers of, the various Researcher engagements and activities to occur during the year. The annual Researcher budgeting plan shall also identify the budgeted amounts to be spent on Researcher-related activities and approval of such budgeting plans, including any subsequent modification of an approved plan. The purpose of this review shall be to ensure that Research arrangements and related events are used for legitimate purposes in accordance with EMD Serono Policies and Procedures.
To the extent not already accomplished, within 120 days after the Effective Date of this Addendum, EMD Serono shall establish a process to ensure that a needs assessment has been completed to justify the retention of the Researcher prior to the retention of the Researcher. The needs assessment shall identify the business or scientific need for the information to be provided by the Researcher and provide specific details about the research arrangement (including, for example, information about the numbers and qualifications of the Heps or HeIs to be engaged, a description of the proposedresearch to be done (including the research protocol) and type of work product to be generated). Any deviations from the Researcher budgeting plans shall be documented in the needs assessment fonn (or elsewhere, as appropriate) and shall be subject to review and approval by EMD Serono compliance personneL To the extent that EMD Serono provides fmancial or other support to Heps or HeIs for investigator sponsored studies regarding Government Reimbursed Products (ISSs), such Heps and HeIs shall be referred to as "Investigators," EMD Serono shall require all Investigators to enter into written agreements describing the scope of the work to be performed, the fees to be paid, and compliance obligations of the Investigators. To the extent not already accomplished, 'within 120 days of the Effective Date of this Addendum, EMD Serono shall, establish a review and approvalstructure to ensure that Investigators are paid fair market value. To the extent not already accomplished, within 120 days of the Effective Date of this Addendum, EMD Serono shall establish a process for review and approval of ISSs. The process shall require consideration of the business or scientific need for the research by the potential Investigators as well as review of specific details regarding the research arrangements (including, for example, information regarding the proposed research to be done and the type of work to be generated). EMD Serono represents that its has committees, each with legal representation, which review individual ISS requests to ensure that ISSs are used for legitimate purposes in accordance with EMD Serono policies and procedures. To the extent not already accomplished, within 120 days after the Effective Date of this Addendum, EMD Serono shall amend its Policies and Procedures in a manner designed to ensure that each Investigator and Researcher performed the work for which the Investigator or Researcher was engaged.
Within 120 days after the Effective Date of this Addendum, EMD Serono shall establish an Investigator and Researcher Monitoring. Program through which it shall conduct audits for each Reporting period (Investigator and Researcher Program Audits) of at least 20 Investigator and Researcher arrangements with HCPs or HCls. Of the Investigator and Researcher Program Audits, at least 15 shall pertain to ISSs and 5 shall pertain to post-marketing studies. The Investigator and Researcher Monitoring Program shall review Investigator and Researcher arrangements both on a risk-based targeting approach and on a sampling approach. EMD Serono compliance personnel conducting the Investigator and Researcher Program Audits shall review needs assessment documents, proposal and/or protocol documents, approval documents, contracts, and payments in order to assess whether the programs and arrangements were supported by EMD Serono and performed by the Investigators and Researchers in a manner consistent with EMD Serono's Policies and Procedures. Results from the Investigator and Researcher Program Audits, including but not limited to identification of potential violations of policies, shall be compiled and reported to the Compliance Department for review and follow-up as appropriate. EMD Serono represents that it has an online Grant Management System at www.grants.emdserono.com through which requestors may seek or be awarded grants for continuing medical education activities or healthcare-related charitable contributions. EMD Serono's Grant Committees review and determine whether to award such grants.
3. Medical Education and Charitable Grant Activities.
EMD Serono represents that its sales and marketing personnel do not have involvement in, or influence over, the review and approval of medical education grants. EMD Serono represents that its sales personnel do not have involvement in, or influence over, the review and approval of or healthcare related charitable contribution requests. Within 120 days of the Effective Date of this Addendum, EMD Serono shall revise its policies to provide that EMD Serono marketing personnel do not have involvement in, or influence over, the review and approval of healthcare related charitable contributions. Grant requests and the types of charitable contribution requests referenced in the preceding paragraph shall be submitted through an on-line process and requests shall be processed in accordance with standardized criteria developed by EMD Serono. On limited occasions, EMD Serono may process such charitable contributions outside of the on-line process, so long as such requests are otherwise reviewed, processed, and approved in accordance with the standardized criteria developed by EMD Serono in accordance with this paragraph. EMD Serono shall continue the medical education grant and
charitable contribution process described above (or an equivalent process) throughout the. term of the Addendum, and shall notify the OIG in writing at least 60 days prior to the implementation of any new system subsequent to the Effective Date of the Addendum. To the extent not already accomplished, within 120 days after the Effective Date of this Addendum, EMD Serono shall establish a Grant Monitoring Program through which it shall conduct audits for each Reporting Period of at least 50 medical education grant and healthcare related charitable contribution requests that have been processed through EMD Serono's online Grant Management System. The Grant Monitoring Program shall include audits of at least 15 medical education grant requests and at least 35 healthcare related charitable contribution requests. The Grant Monitoring Program shall select grants and healthcare related charitable contributions for review both on a risk... based targeting approach and on a random sampling approach. Personnel conducting the Grant Monitoring Program shall review grant and healthcare related charitable contribution requests, documents relating to the review and any approval of the requests, and contracts, documents, and materials relating to the grants, healthcare related charitable contributions and any events or activities funded through the grants or contributions in order to assess whether the activities were conducted in a manner consistent with EMD Serono's Policies and Procedures. Results from the Grant Monitoring Program shall be compiled and reported to EMD Serono headquarters for review and remediation as appropriate. Potential violations ofEMD Serono's Policies and Procedures shall be reported to the Compliance Department for appropriate follow-up activity.
4. Follow-Up Reviews and Reporting. In the event that a potential
violation ofEMD Serono's policies and procedures or applicable legal or compliance requirements is identified during any aspect of the NPMP, EMD Serono shall investigate the incident consistent with established Policies and Procedures for the handling of investigations. As part of the formal investigation procedures, findings shall be made and all necessary and appropriate responsive action (including disciplinary action) and corrective action shall be taken, including the disclosure of Reportable Events pursuant to Section III.! above, if applicable. Any compliance issues identified during any aspect of the NPMP referenced above and any corrective action shall be recorded in the files of the Compliance Department. EMD Serono shall include a summary of the results of the NPMP as part of each Annual Report. As part of each Annual Report, for any instance not previously reported as a Reportable Event under Section I1I.J of this CIA, EMD Serono also shall provide the
OIG with a detailed description of any instance 'identified through the NPMP activity in which it was determined that improper promotion of Government Reimbursed Products occurred or the activities violated EMD Serono's requirements or Policies. and Procedures, and a description of the action( s) that EMD Serono took as a result of such determinations. EMD Serono shall make the documents relating to NPMP available to the OIG upon request. P. Reporting of Physician Payments. On or before July 1,2011, EMD Serono shall post in a prominent position on its website an easily accessible and readily searchable listing of all physicians and Related Entities (as defined below) who or which received Payments (as defined below) directly or indirectly from EMD Serono during the first quarter of20ll. Beginning on September 1, 2011, and on or before the 60th day after the end of each calendar quarter, and continuing throughout the term of the Addendum, EMD Serono shall also post on its website a listing of all Payments made to physicians and Related Entities during the preceding calendar quarter(s) in the applicable calendar year and the cumulative value of the Payments in such calendar year. On or before February 1,2012, EMD Serono shall post in a prominent position on its website an easily accessible and readily searchable listing of all physicians and Related Entities (as defined below) who or which received Payments (as defined below) directly or indirectly from EMD Serono during 2011 and the cumulative value of the Payments. On or before February 1,2013, EMD Serono shall post in a prominent position on its website an easily accessible and readily searchable listing of all physicians and Related Entities (as defined below) who or which received Payments (as defined below) directly or indirectly from EMD Serono during 2012 and the cumulative value of the Payments. Each listing made pursuant to this Section HLP shall include a complete list of all individual physicians and/or Related Entities to whom or to which EMD Sereno directly or indirectly made Payments in the preceding calendar year or quarter (as applicable). Each listing shall be arranged alphabetically according to the physicians' last name or the name of the Related Entity. The Payment amounts in the lists shall be reported in $10,000 increments (e.g., $0 - $10,000; $10,001- $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 on the
listing. For each physician, the applicable listing shall include the following information: (i) physician's full name; (ii) name of any Related Entities (if applicable); (iii) city and state that the physician or Related Entity has provided to EMD Serono for contact purposes; and (iv) the aggregate value of the Payment(s) in the preceding quarter(s) or year (as applicable). If Payments for multiple physicians have been made to one Related Entity, the aggregate value of all Payments to the Related Entity will be the reported. amount. EMD Serono shall continue to make each annual listing and the most recent quarterly listing available on its website at least throughout the term. of this CIA. EMD Serono shall retain and make available to 010, upon request, all 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 IILP affects the responsibility of EMD Serono to comply with (or liability for noncompliance with) all applicable Federal health care program requirements and state laws as they relate to all applicable Payments made to physicians or Related Entities. For purposes of Section IILP., the term ''Payments'' is defined to include all "payments or transfers of value" as that term is defmed in 1128G(e)(1O) of the Social Security Act (SSA) (as added in Section 6002 of the Patient Protection and Affordable Care Act (Public Law 111-148) (ACA» and any regulations promulgated thereunder. The term includes: (i) all payments or transfers of value made to Related Entities on behalf, at the request of, for the benefit or use of, or under the name of a physician for whom EMD Serono would otherwise report a Payment if made directly to the physician; and (ii) any payments or transfers of value, made directly or indirectly, by EMD Serono under the auspices of a co-promotion arrangement or in connection with a joint venture. For purposes of its website posting of the quarterly and annual listings of Payments, and with regard only to payments made pursuant to product research or development agreements and clinical investigations as set forth in § 1128G(c)(E) of SSA, EMD Serono may delay the inclusion of such payments on its website listing consistent with § 1128G(c)(E) of SSA and any subsequent regulations promulgated thereunder. The term "Payments" does not include transfers of value or other items that are not included or are excluded from the definition of "payment" as set forth in 11280(e)(lO) of SSA and any regulations promulgated thereunder.
Forpurposes of this Section IILP, 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 EMD Serono or its subsidiaries. Q. Other TransparencylDisciosure Initiatives. EMD Serono provides funding to healthcare organizations that also provide continuing medical education, incidental to their healthcare mission. As described above in Section III.O, all requests for medical education grants shall be made through Serono's online Grant Management System. EMD Grant Committee Team reviews and determines whether to award grants for continuing medical education and reviews and awards certain charitable contributions to healthcare related charitable organizations, and, except for the limited exception referenced in Section III.O.3, these contributions shall be made through EMD Serono's online Grant Management System. Within 120 days of the Effective Date of this Addendum, EMD Serono shall condition the provision of CME grants and healthcare related charitable contributions on the recipients' consent to public disclosure of the grant or charitable contribution. By no later than July 1, 2011, EMD Serono shall, on a bi-annual basis, post on its company website: 1) the recipient organization's name: 2) a brief description of the program for which the grant or charitable contribution was requested; and 3) the amount of the grant or charitable contribution. EMD Serono shall continue to post (and provide quarterly updates to) the above-described information about continuing medical education grants and charitable contributions handled through EMD Serono's online Grant Management System on its website throughout the term of this CIA. EMD Serono shall notify the OIG in writing at least 60 days prior to any change in its policy regarding the funding of medical education grants and charitable contributions handled through EMD Serono's online Grant Management System or the posting of information. EMD Serono represents that it expects all Consultants to fully comply with all applicable disclosure obligations relating to their relationship with EMD Serono that may be externally imposed on the Consultants based on their affiliation with any HCI, medical committee (including formulary or P&T committees or committees associated with the development of treatment protocols or standards), or other medical or scientific organization. Within 120 days after the Effective Date of this Addendum, EMD Serono shall amend its policies relating to Consultants to explicitly state EMD Serono's expectation about full disclosure by Consultants consistent with the requirements of any
HCI, medical committee, or other medical or scientific organization with which the Consultants are affiliated. In addition, for any amendment to its contracts with Consultants and in any new contracts with Consultants entered into after 120 days following the Effective Date of this Addendum, EMD Serono shall include an explicit requirement that the Consultants fully comply with applicable disclosure requirements and disclose their relationship with EMD Serono as required pursuant to their affiliation with any HCr, medical committee, or other medical or scientific organization.
NEW BUSINESS UNITS OR LOCATIONS
Section IV .of the CIA shall remain in effect through the term of the CIA. A~ of the Effective Date of this Addendum, Section IV of the CIA shall be replaced with the following provisions, which shall apply through the term of this Addendum:
A. Change or Closure of Unit or Location. In the event that, after the Effective Date of this Addendum, EMD Serono changes locations or closes a business unit or location engaged in Promotional Functions or Product Related Functions, EMD Serono 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. Purchase or Establishment of New Unit or Location. In the event that, after the Effective Date of this Addendum, EMD Serono purchases or establishes a new business unit or location engaged in Promotional Functions or Product Related Functions, EMD Serono shall notify OIG no later than the date that the purchase or establishment is publicly disclosed by EMD Serono. This notification shall include the address of the new business unit or location, phone number, fax number, Federal health care program provider or supplier number (if applicable), 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 the CIA and its Addendum. C. Sale of Unit or Location. In the event that, after the Effective Date of this Addendum, EMD Serono proposes to sell any or all of its business units or locations that are subject to the CIA or this Addendum, EMD Serono shall notify OIG oftbe proposed sale no later than the date that the purchase or establishment is publicly disclosed by EMD Serono. 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. The CIA and this Addendum shall be binding on the purchaser of such business unit or location, unless otherwise determined and agreed to in writing by the DIG.
A. Implementation Report. Within 150 days after the Effective Date of this Addendum, EMD Serono 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:
1. the name, address, phone number, and position description of the Compliance Officer required by Section IILA.l, and a summary of other noncompliance job responsibilities the Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section Ill.A.2; 3. the names of the members of the Boards of Directors referenced in Section III.AJ; 4. the names and positions of the Certifying Employees referenced in Section III.A.4; 5. a copy of EMD Serono' s Code of Conduct required by Section III.B.l; 6. the number of individuals required to complete the Code of Conduct certification required by Section III.B.I, the percentage of individuals who have completed such certification, and an explanation of any exceptions (the documentation supporting this information shall be available to OIG, upon request); 7. (a) a copy of the letter (including all attachments) required by Section ll.C.6 of this Addendum sent to each party employing Third Party Personnel; (b) a list of all such existing co-promotion and other applicable agreements; and (c) a description of the entities' responses to EMD Serono's letter;
EM]) Serono Holding, Inc. - Addendum to Corporate Integrity Agreement
8. a summary of all Policies and Procedures required by Section UI.B.2 (a copy of such Policies and Procedures shall be made available to OIG upon request); 9. the following information regarding each type of training required by Section III.e: a. a description of such training, including a summary of the topics covered, the length of sessions, and a schedule of training sessions; and b. the number of individuals required to be trained, percentage of individuals actually trained, and an explanation. of any exceptions. A copy of all training materials and the documentation supporting this information shall be available to OIG, upon request. 10. a description of the records required to be collected, tracked, and maintained in accordance with Section III.D; Section HLD; 11. a description of the internal review and approval process required by
12. a description of the documentation, recordkeeping, and review procedures and other Educational Sponsorship Arrangements Procedures required by Section III.D; 13. 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 EMD Serono and the IRO; 14. a certification from the IRO regarding its professional independence and objectivity with respect to EMD Serono; 15. a description of the Disclosure Program required by Section IILG;
16. a description of the process by which EMD Serono fulfills the requirements of Section m.H regarding Ineligible Persons; 17. the name, title, and responsibilities of any person who is determined to be an Ineligible Person under section IILH; the actions taken in response to the screening and removal obligations set forth in section III.H; 18. a list of all ofEMD Serono's U.S. locations (including locations and mailing addresses); the corresponding name under which each location is doing business and the corresponding phone numbers and fax numbers; 19. a description ofEMD Serono's corporate structure, including identification of any parent and sister companies, subsidiaries, and their respective lines of business; and 20. the certifications required by Section V.C. 'B. Annual Reports. EMD Serono shall submit to OIG annually a report With respect to the status of, and findings regarding, EMD Serono's compliance activities for each of the three CIA Addendum Reporting Periods (Annual Report). Each Annual Report shall include, at a minimum: 1. an explanation of any change in the identity, position description, or other noncompliance job responsibilities of the Compliance Officer and any change in the membership of the Compliance Committee, the Boards of Directors, or the group of Certifying Employees described in Section IRA;
2. a copy of the resolution of each of the Boards required by Section
IILA.3; Procedures required by Section III.B and the reasons for such changes U change in contractor policy);
4. the number of individuals required to complete the Code of Conduct certification required by Section III.B.I, the percentage of individuals who have
3. a summary of any significant changes or amendments to the Policies and
completed such certification, and an explanation of any exceptions (the documentation supporting this information shall be available to OIG, upon request); 5. a list of the parties with whom EMD Serono entered into or renewed Educational Sponsorship Arrangements during the Reporting Period; a description of the aggregate number of Educational Sponsorship Arrangements that EMD Serono entered into with each particular individual or entity during the Reporting Period; and a description of the aggregate amount of funding provided by EMD Serono to each individual or entity provider of Third Party Educational Activities during the Reporting Period. 6. (a) a copy of the letter (including all attachments) required by Section II.C.6 of this Addendum; (b) a list of all such existing co-promotion and other applicable agreements; and (c) a description of the entities' responses to HMO Serono's letter; 7. the following information regarding each type of training required by Section lILC: a. a description of the initial and annual training, including a summary of the topics covered, the length of sessions, and a schedule of training sessions; and b. the number of individuals required to complete the initial and annual training, the percentage of individuals who actually completed the initial and annual training, and an explanation of any exceptions. A copy of all training materials and the documentation supporting this information shall be available to OIG, upon request. 8. a description of any changes to the records collected, tracked and maintained pursuant to Section lILO; 9. a description of any changes to the internal review and approval process, and any changes to the documentation, recordkeeping, review and other procedures required by Section IlI.D;
10. a summary and description of any and all current and prior engagements and agreements between EMD Serono and the IRO (if different from what was submitted as part of the Implementation Report); 11. a certification from the IRO regarding its professional independence and objectivity with respect to EMD Serono; 12. a complete copy of all reports prepared pursuant to Section III.F; 13. EMD Serono's response and corrective action planes) related to any issues raised by the reports prepared pursuant to Section III.F; 14. a summary of the disclosures in the disclosure log required by Section III.G that relate to Federal health care program or FDA requirements; 15. any changes to the process by which EMD Serono fulfills the requirements of Section III.H regarding Ineligible Persons; 16. the name, title, and responsibilities of any person who is determined to be an Ineligible Person under Section III.H; the actions taken by EMD Serono in response to the screening and removal obligations set forth in Section III.H; 17. a summary describing any ongoing investigation or legal proceeding required to have been reported pursuant to Section III.I. 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; 18. a summary of Reportable Events (as defined in Section IILJ) identified during the Reporting Period and the status of any corrective and preventative action relating to all such Reportable Events; 19. a swnmary describirig any written communication with the FDA required to have been reported pursuant to Section IU.K. This summary shall include a description of the matter and the status of the matter; 20. a summary describing any Serostim Inquiry Report(s) as required by Section III.M of this Addendum indicating that an undue or unusual number of requests for off-label information has been generated in any particular sales territory or that
otherwise suggests that improper off-label promotion may have occurred, the Compliance Officer's review and inquiry into any such occurrence(s), and the results and resolution of the matter; 21. a list and description of all actively promoted EMD Serono products and, if available from third parties or other sources, information about the estimated relative usage (e.g., the percentage) of those products for off-label purposes; 22. a summary of the FFMP and the results of the FFMP reviews required by Section IILN.; . 23. a summary of the NPMP and the results of the program described in Section IILO., including detailed description of any identified instances in which it was determined that the activities violated EMD Serono's policies; 24. a certification from the Compliance Officer that, to the best of his/her knowledge, information regarding Payments has been posted as required by Section HI.P on EMD Serono's website as required by Section Ill.P 25. a description of all changes to the most recently provided list ofEMD Serono's locations (including addresses) as required by Section V.A.18; the corresponding name under which each location is doing business; and the corresponding phone and fax numbers; 26. a description ofEMD Serono's corporate structure, including identification of any parent and sister companies, subsidiaries, and their respective lines of business; and 27: the certifications required by Section V.C. The first Annual Report shall be received by OIG no later than 60 days after the end of the first Reporting Period. Subsequent Annual Reports shall be received by OIG no later than the anniversary date of the due date of the first Annual Report. C. Certifications. The Implementation Report and each Annual Report shall include the following certifications:
EMD Serono Holding, Inc. - Addendum
1. Certifying Employees. In each Annual Report, EMD Serono shall include the certifications of the Certifying Employees, as required by Section III.A.4 of this Addendum; 2. Compliance Officer. In the Implementation Report and Annual Reports, EMD Serono shall include the following individual certification by the Compliance Officer: a. 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; b. to the best of his or her knowledge, except as otherwise described in the applicable report, EMD Serono is in compliance with the Federal health care program and FDA requirements and the obligations of the CIA and this Addendum; c. to the best of his or her knowledge, except as otherwise described in the applicable report, EMD Serono's promotional materials containing claims or information about Government Reimbursed Products and other materials and information intended to be disseminated outside EMD Serono have been reviewed by competent regulatory, medical, andlor legal personnel in accordance with applicable Policies and Procedures to ensure that: (i) legal, medical, and regulatory concerns are properly addressed and are elevated when appropriate; and that (ii) the materials and information when finally approved are in compliance with all applicable Federal health care program and FDA requirements. If the applicable legal requirements have not changed, after the initial review of the materials listed above, only material changes to the documents must be reviewed by competent regulatory, medical, and/or legal personnel. The certification shall identify, for each piece of promotional material, approximately when the review was completed. The documentation supporting this review shall be available to OIG, upon request; and d. EMD Serono's: (1) Policies and Procedures as referenced in Section Ill.B.2 above; and (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 andlor legal personnel working at their direction and have been found to be in compliance with all applicable Federal health care program and FDA requirements. If the applicable legal requirements have not changed after the initial
EMD Serono Holding, Inc. - Addendum. to Corporate Integrity Agreement
review of the documents listed above, only material changes to the documents must be reviewed by competent legal counsel and/or legal personnel working at their direction. The certification shall include a description of the document(s) reviewed and approximately when the review was completed The documentation supporting this certification shall be available to OIG, upon request. D. Designation of Information. EMD Serono 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 ofInformation Act (FOIA), 5 U.S.C. § 552. EMD Serono shall refrain from identifying any information as exempt from disclosure if that information does not meet the criteria for exemption from disclosure under FOIA.
Unless otherwise stated in writing after the Effective Date of this Addendum, 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 Dan Moynihan Chief Compliance Officer EMD Serono, Inc. One Technology Place Rockland, MA 02370 Telephone: 781.681.2490 Facsimile: 781.681.2949
EMD Serono:
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, EMD Serono may be required to provide OIG with an electronic copy of each 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
Section VII of the CIA shall remain in effect through the term of the CIA, and EMD Serono shall continue its obligations under Section VII through the term of this Addendum. VIII.
Section VIII of the CIA shall remain in effect through the term of the CIA, and EMD Serono shall continue its obligations under Section VIII through the term of this Addendum. IX.
Consistent with HHS's FOIA procedures, set forth in 45 C.F.R. Part 5, OIG shall make a reasonable effort to notify EMD Serono prior to any release by OIG of information submitted by EMD Serono pursuant to its obligations under this CIA and identified upon submission by EMD Serono as trade secrets, or information that is commercial or financial and privileged or confidential, under the FOIA rules. With respect to such releases, EMD Serono shall have the rights set forth at 45 C.F.R. § 5.65(d). X.
Section X of the CIA shall remain in effect through the term of the CIA. As of the Effective Date of this Addendum, Section X shall be replaced with the following provisions, which shall apply through the term of the Addendum:
A. Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, EMD Serono and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA Addendum 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 EMD Serono fails to establish, implement, or accomplish any of the following obligations as described in Section III: a. a Compliance Officer; b. a Compliance Committee; c. the resolutions from the Boards; d. a written Code of Conduct; e. written Policies and Procedures; f. the training of Covered Persons and Relevant Covered Persons; g. the Educational Sponsorship Arrangements Procedures and/or the Educational Sponsorship Arrangements Requirements described in Section III.D.
j. notification of Government investigations or legal proceedings; k. the reporting of any Reportable Event, as required by Section III.J; .
I notification of written communications with FDA as required by Section llI.K;
EMD Serono Holding, Inc. - Addendwn to Corporate Integrity Agreement
m. monitoring and review of requests for off-label information, as required by Section HI.M; n. a FFMP, as required by Section III.N; o. a NPMP, as required by Section III.O; and p. posting of Payments, as required by Section III.P. 2. Sections X.A.2 through X.A.7 of the CIA shall remain in effect through the term of the CIA and through the term of this Addendum. B. SectionX.B of the CIA shall remain in effect through the term of the CIA and through the term of this Addendum. ~. Payment of Stipulated Penalties. 1. Section X.C of the CIA shall remain in effect through the term of the CIA and, as modified below, through the term of this Addendum. 2. On the Effective Date of this Addendum, Section X.C.3 of the CIA shall be replaced with the following language: "Payment of the Stipulated Penalties shall be made by electronic funds transfer to an account specified by 010 in the Demand Letter." D. Exclusion for Material Breach oftrus CIA. 1. Definition of Material Breach. Section X.D of the CIA shall remain in effect through the term of the CIA. As of the Effective Date of this Addendum, Section X.D shall be replaced with the following provisions, which shall apply through the term of the Addendum: A material breach of this CIA Addendum means: a. a failure by EMD Serono to report a Reportable Event and take corrective action as required in Section III.J; b. repeated or flagrant violation of the obligations under this CIA
EMD Serono Holding, Inc. - Addendum to Corporate Integrity Agreement ,
Addendum, 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.F and Appendices A-B; or e. a failure of either of the Boards to issue the resolutions in accordance with Section IILA.3. 2. Sections X.D.2 through X.D.4 of the CIA remain in effect through the term of the CIA and through the term of this Addendum.
Section X.E of the CIA remains in effect through the term of the CIA and through the term of this Addendum.
AND BINDING AGREEMENT
A. Section XI of the CIA remains in effect through the term of the CIA. As of the Effective Date of this Addendum, Section Xl is replaced with the following provisions, which shall apply through the term of this Addendum: B. EMD Serono and 01G agree as follows: 1. This CIA Addendum shall be binding on thesuccessors, assigns, and transferees of EMD Serono; 2. This CIA Addendum shall become final and binding on the date the final signature is obtained on the CIA Addendum; 3. This CIA Addendum constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA Addendum;
4. The undersigned EMD Serono signatories represent and warrant that they are authorized to execute this CIA Addendum. The undersigned OIG signatory represents that he is signing this CIA Addendum in his official capacity and that he is authorized to execute this CIA Addendum. 5. This CIA Addendum may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA Addendum. Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA Addendum.
ON AlUuur ott £MD SIRONO HOLDtNGS,IHC.
!Thomas Gunning! 1'homlIs Gunning, Esq. / Vice President and Oe~ Counsel EMD SeJono ~g. Inc._ /John T. Bentivoglio!
Skadden, A1'p$, Slate, Meagher & Flom LLP Counsel for EMD Serono
Jo1t6 T. Benuvoglio,
ON BEHALF OF THE OFFICE OF L'lSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES
/Gregory E. Demskel
Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services
APPENDIX INDEPENDENT REVIEW
As of the Effective Date of the CIA Addendum, Appendix A attached to the CIA shall be replaced with this Appendix A, which shall apply during the term of the CIA Addendum. This Appendix A contains the requirements relating to the Independent Review Organization (IRO) required by Section m.F of the CIA Addendum. A. IRO Engagement.
EMD Serono shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. TheIRO shall conduct the review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIa receives the information identified in Section V.A.13 and Section V.A.14 of the CIA Addendum, OIG will notify EMD Serono if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, EMD Serono may continue to engage the IRO. IfEMD Serono engages a new IRO during the term of the CIA Addendum, this IRO shall also meet the requirements of this Appendix. If a new IRO is engaged, EMD Serono shall submit the information identified in Section V.A.l3 and Section V.A.14 of the CIA Addendum to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information, OIa will notify EMD Serono if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, EMD Serono may continue to engage the IRO.
IRO Qualifications.
The IRO shall: 1. assign individuals to conduct the IRO Reviews who have expertise in all applicable Federal health care program and FDA requirements relating to Promotional Functions and Product Related Functions. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which EMD Serono products are reimbursed; 2. assign individuals to design and select the samples for the Transactions Reviews who are knowledgeable about the appropriate statistical sampling techniques; and
Appendix A EMD Sera no Holding, Inc. - Addendum to Corporate Integrity Agreement
3. have sufficient staff and resources to conduct the reviews required by the CIA and this Addendum on a timely basis.
IRO Responsibilities.
The IRQ shall: 1. perform each IRQ Review in accordance with the specific requirements of the CIA Addendum; 2. follow all applicable Federal health care program and FDA requirements in making assessments in each IRQ Review; 3. ifin doubt of the application of a particular Federal health care program or FDA requirement, policy, or regulation, request clarification from the appropriate authority (M, CMS or 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 Appendix B to the CIA Addendum. D. IRO Independence and Objectivity.
The IRQ must perform each IRQ Review 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 ENID Serono. E. IRO RemovallTennination.
1. EMD Serono termination ofIRO. IfEMD Serono terminates its IRO during the course of the engagement, EMD Serono must submit a notice explaining its reasons to OIG no later than 30 days after termination. EMD Serono must engage a new IRQ in accordance with Paragraph A of this Appendix. 2. OIG Removal ofIRO. In the event QIG 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 EMD Serono to engage a new IRQ in accordance with Paragraph A of this Appendix.
Appendix A EMD Serono Holding, Inc. - Addendum to Corporate Integrity Agreement
Prior-to requiring EMD Serono to engage a new IRO, OIG shall notify EMD Serono of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG~EMD Serono 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. EMD Serono 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 EMD Serono prior to requiring EMD Serono to terminate the IRO. However, the final determination as to whether or not to require EMD Serono to engage a new IRO shall be made at the sole discretion of DIG.
APPENDIXB Addendum to Corporate Integrity Agreement IRO Review of Promotional Functions and Product Related Functions I.
Promotional Functions and Product Related Functions Review, General Description
Appendix B to the CIA is hereby replaced with this Appendix B, which shall apply through the term of the Addendum. As specified more fully below, EMD Serono shall retain an Independent Review Organization (IRO) to perform reviews to assist EMD Serono in assessing and evaluating its systems, processes, policies, procedures, and practices related to EMD Serono's Promotional Functions and Product Related Functions (IRO Review). The IRO Review shall consist of two components - a systems review (the "Systems Review"), and a transactions review (the "Transactions Review") as described more fully below. EMD Serono may engage, at its discretion, a single IRO to perform both components of the Promotional Functions and Product Related Functions Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in EMD Serono's systems, processes, policies, and procedures relating to Promotional Functions and/or Product Related Functions, the IRO shall perform the Systems Review in the second Reporting Period. If EMD Serono materially changes its systems, processes, policies, and procedures relating to Promotional Functions and/or Product Related Functions in the first and/or third Reporting Period, the IRO shall perform a Systems Review for the first and/or third Reporting Period(s) as well. The additional Systems Review(s) shall consist of: 1) 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 changed. The IRO shall conduct the Transactions Review for each Reporting Period of the CIA Addendum.
Promotional Functions and Product Related Functions Review Description of Reviewed Policies and Procedures
The Systems Review shall be a review ofEMD Serono's systems, processes, policies, and procedures (including the controls on those systems, processes,
AppendixB 1 EMD Serono Holding, Inc. - Addendum to Corporate Integrity Agreement
policies, and procedures) relating to certain Promotional Functions and Product Related Functions. Where practical, EMD Serono personnel may compile documentation, 'schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by EMD Serono pursuant to the preceding sentence. Specifically, the IRO shall review EMD Serono's systems, processes, policies, and procedures associated with the following (hereafter "Reviewed Policies and Procedures"); 1) EMD Serono's systems, policies, processes, and procedures applicable to the manner in which EMD Serono representatives handle requests or inquiries relating to off-label uses ofEMD Serono products and the manner in which EMD Serono disseminates materials relating to off-label uses and other medical information about its products. This review includes: a) the manner in which sales personnel and Medical Information receive and respond to requests for information about off-label uses; b) the form and content of information disseminated by Medical Information; c) EMD Serono's internal review process for the information disseminated by Medical Information; d) EMD Serono's systems, processes, and procedures to track information requests and responses to those requests; e) the manner in which Medical Information collects and documents information in the Serostim Inquiry Database; f) the manner in which Medical Information provides Serostim Inquiry Reports to the Compliance Officer; and g) the internal review of Serostim Inquiry Reports and related processes, procedures, and resolution of any issues identified; 2) EMD Serono's policies and procedures applicable to the manner and circumstances under which medical affairs personnel (including medical science liaisons) participate in meetings or events with physicians, pharmacists, or other health care professionals (RCPs) (either alone or with members of the sales force) and the role of the medical affairs personnel at such meetings or events; 3) EMD Serono's systems, policies, processes, and procedures relating to the retention of HCPs as consultants (e.g., including as members of advisory boards, focus groups, or clinical research project teams) or speakers. This shall include a review of;
AppendixB 2 EMD Serono Holding. Inc. - Addendum to Corporate Integrity Agreement
a) the criteria used to determine whether, how many, and under what circumstances (including the venue for the performance of any services) EMD Serono will enter contracts for such arrangements; b) the processes and criteria used to identify and select HCPs with whom EMD Serono enters consultant, speaker, or other contractual arrangements, including the role played by sales representatives in the process. This includes a review of EMD Serono's internal review and approval process for such contracts, and the circumstances under which there may be exceptions to the process; c) EMD Serono' s tracking or monitoring of services provided or the work performed by the consultants or speakers (including the receipt of the consultants' work product, if any); d) the uses made of work product received from consultants or speakers, if any; e) EMD Serono's processes for establishing the amounts paid to HCPs and the reasons or justifications for any differentials in the amounts paid to different HCPs; f) the criteria used to determine under what circumstances entertainment, recreation, travel, lodging, meals and/or other items or reimbursements are provided to consultants or speakers, and EMD Serono's processes for establishing the amounts reimbursed or the type of entertainment or recreation provided; g) whether and in what manner EMD Serono tracks or monitors the prescribing habits or product use of individuals or entities with whom it enters consulting, speakers, or other contractual arrangements, if any; and h) the budget funding source within EMD Serono (e.g., department or division) for the consulting or contractual arrangement; 4) EMD Serono's systems, policies, processes, and procedures relating to healthcare related charitable contributions or sponsorships by EMD Serono. This review shall include a review of the following items: a) the processes and procedures used to approve healthcare related charitable contributions or sponsorships; b) the criteria used to determine whether and under what circumstances the healthcare related charitable contributions or sponsorshipswill be provided; c) the processes and criteria used to select and approve recipients of the healthcare related charitable contributions or sponsorships from EMD Serono, including the role played by sales representatives in
Appendix B 3 EMD Serono Holding, Inc. - Addendum to Corporate Integrity Agreement
the processes {if any), and the circumstances under which there may be exceptions to the processes; d) EMD Serono's policies and procedures related to circumstances, if any, under which the recipient or the recipient's agent is required to disclose EMD Serono's healthcare related charitable contribution or sponsorship and any fmancial relationship EMD Serono may have with the recipients; e) EMD Serono's policies or procedures for determining and memorializing the amounts paid to recipients of the healthcare related charitable contribution or sponsorship and the purpose or justifications for the amounts paid; f) EMD Serono' s policies and procedures relating to the independence of any programs funded through the healthcare related charitable contribution or sponsorship; g) EMD Serono's policies and procedures relating to the content and promotional nature of any programs sponsored through the healthcare related charitable contributions or sponsorships; h) whether and in what manner EMD Serono tracks or monitors the prescribing habits or product use of individuals or entities receiving the healthcare related charitable contribution or funding, if any; and i) the budget funding source within EMD Serono (e.g., department or division) from which the healthcare related charitable contributions or sponsorships are provided; 5) EMD Serono's systems, policies, processes, and procedures relating to "Research-Related Activities" (as defined in Section ill.O.2 of this Addendum) entered into or funded by EMD Serono. This review shall include a review of the following items: a) the processes and procedures used by EMD Serono to approve Research-Related Activities; b) the criteria used to determine whether, and under what circumstances, EMD Serono will fund or otherwise participate in the Research-Related Activities; c) the processes and criteria used to select and approve the funding or other participation by EMD Serono in Research-Related Activities, including the role played by sales representatives in the processes (if any), and the circumstances under which there may be exceptions to the processes; d) EMD Serono's policies and procedures for requiring the recipient of the funding for the Research-Related Activity to disclose EMD Serono's participation in or funding of Research-Related Activities
AppendixB 4 EMD Serono Holding, Inc. - Addendum to Corporate Integrity Agreement
and any fmancialrelationship EMD Serono may have with the recipient; e) EMD Serono's policies or procedures for determining and memorializing the amounts paid to participants in the ResearchRelated Activities and the purpose or justifications for the amounts paid; f) EMD Serono's policies and procedures relating to the independence of the programs funded through Research-Related Activities; g) EMD Serono's policies and procedures relating to the content and promotional nature of any programs sponsored through or associated with the Research-Related Activities; h) whether and in what manner EMD Serono tracks or monitors the prescribing habits or product use of individuals or entities receiving funding or otherwise participating in the Research-Related Activities, if any; and i) the budget funding source within EMD Serono (e.g., department or division) for Research-Related Activities; 6) El\tID Serono's systems, policies, processes, and procedures relating to the provision of any gifts, meals, receptions, travel, entertainment or other items of value (collectively "Expenses") to HCPs. This shall include a review of: a) the criteria used to determine whether, how many, and under what. circumstances (including the venue for the performance of any services) EMD Serono will reimburse for Expenses ofHCPs; b) the processes and criteria used to identify and select HCPs to whom EIvID Serono provides reimbursement of Expenses. This includes a review ofEl\tID Serono's internal review and approval process for such Expenses, the circumstances under which there may be exceptions to the processes, and the role played by sales representatives in the process; c) EMD Serono's tracking or monitoring of services provided, or the work performed by the HCPs in exchange for the Expenses, if any; d) the uses made of work product received from HCPs receiving Expenses from EMD Serono, if any; e) EMD Serono's processes for establishing the amounts paid to HCPs and the reasons or justifications for any differentials in the amounts paid to different HCPs; f) whether and in what manner EMD Serono tracks or monitors the prescribing habits or product use ofHCPs who receive Expenses from EMD Serono, if any; and
Appendix B 5 EMD Serono Holding. Inc. - Addendum to Corporate Integrity Agreement
g) the budgetfundingsource within EMD Serono (e.g., department or division) for the Expenses; 7) EMD Serono's systems, policies, processes, and procedures for tracking expenditures (individual and aggregate) associated with the Reviewed Policies and Practices; 8) EMD Serono's policies, processes, and procedures relating to the disciplinary actions that EMD Serono may impose in the event a Covered Person violates an EMD Serono policy or procedure; and 9) EMD Serono's systems, polices, processes and procedures for compensating (including with salaries and bonuses) non-Overtime Eligible employees, with regard to whether the systems, policies, processes, and procedures are designed to ensure that financial incentives do not inappropriately motivate sales and marketing personnel to engage in the improper promotion, sales, and marketing ofEMD Serono's products. This shall include a review of the bases upon which compensation is determined and the extent to which compensation is based on product performance. B. Promotional Functions and Product Related Functions Review Report The lRO shall prepare a report based upon each Systems Review. For each of the Reviewed Policies and Procedures identified in Section ILA above, the report shall include the following items: 1) a description of the documentation (including policies) reviewed and any personnel interviewed; 2) a detailed description ofEMD Serono's systems, policies, processes, and procedures relating to the items identified in Sections ll.A.1-9 above, including a general description of EMD Serono's control and accountability systems Cll, documentation and approval requirements, and tracking mechanisms) and written policies regarding the Reviewed Policies and Procedures; 3) a description ofthe manner in which the control and accountability systems and the written policies relating to the items identified in Sections ILA.1-9 above are made known or disseminated within EMD Serono;
AppendixB 6 EMD Serono Holding, Inc. - Addendum to Corporate Integrity Agreement
4) a detailed description ·ofany system(s) used to track and respond to requests for information about EMD Serono's products that come to Medical Information; 5) a detailed description ofEMD Serono's systems, policies, processes, and procedures for tracking expenditures associated with the Reviewed Policies and Procedures or other promotional activities; 6) a general description of the disciplinary measures EMD Serono has established for failure to comply with its systems, processes, policies and procedures relating to the Reviewed Policies and Procedures. 7) a detailed description ofEMD Serono's compensation system (including salaries and bonuses) for sales representatives, including a description of the bases upon which compensation is determined and the extent to which compensation is based on product performance. To the extent that EMD Serono may establish compensation differently for individual products, the IRO shall report separately on each such type of compensation arrangement; and 8) findings and supporting rationale regarding any weaknesses, if any, inEMD Serono's Reviewed Policies and Procedures and systems. 9) recommendations to improve any of the systems, processes, policies, or procedures relating to the Reviewed systems, Policies and Procedures. III. Promotional Functions and Product Related Functions Transactions Review
As described more fully below, the Transactions Review shall include: (1) a review of records relating to a sample of the Payments that are reported by E.MD Serono pursuant to Section TILPof the CIA Addendum; and (2) a review of up to three additional items identified by the OIG in accordance with Section IILF.l.b of the CIA Addendum (hereafter "Additional Items".) The IRO shall report on all aspects of its reviews in the Transactions Review Reports. A. IRO Review of Physician Payment Listings 1) Information Contained in Physician Payment Listings
As set forth in Section III.P of the CIA Addendum, EMD Serono shall post quarterly and annual listings of physicians and Related Entities who received Payments, as defined in the CIA, directly or indirectly from EMD Serono. For purposes of the IRO review as set forth in this Section IILA, each annual listing
AppendixB 7 EMD Serono Holding, Inc. - Addendum to Corporate Integrity Agreement
shall be referred toasthet'PhysicianPayment Listing" or "Listing." For each physician and Related Entity, each Physician Payment Listing shall include the following information: (i) physician's full name; (ii) name of Related Entity (if applicable); (iii) city and state that the physician or the Related Entity has provided to E:MD Serono for contact purposes; and (iv) the aggregate value of the payment(s) in the preceding year. If payments for multiple physicians have been made to one Related Entity, the aggregate value of all payments to the Related Entity will be the reported amount. For purposes of this IRQ review, the term "Control Documents" shall include all documents or electronic records associated with each Payment reflected in the Physician Payments Listing for the sampled physician and/or Related Entity. For example, the term "Control Documents" includes, but is not limited to, documents relating to the nature, purpose, and amount of all Payments reflected in the Listing; contracts relating to the Payment(s) reflected in the Listing; documents relating to the occurrence ofPayment(s) reflected in the Listing; documents reflecting any work product generated in connection with the Payment(s); documents submitted by sales representatives or headquarters personnel to request approval for the Payment(s); and business rationale or justification forms relating to the Payment(s). 2) Selection of Sample for Review
For each Reporting Period, the QIG shall have the discretion to identify up to 50 physicians or Related Entities from the applicable Physician Payment Listing that will be subject to the IRQ review described below. If the QIG elects to exercise this discretion, it shall notify the IRQ of the physicians and/or Related Entities subject to the IRQ review by no later than 30 days prior to the end of the applicable Reporting Period. If the QIG elects not to exercise its discretion as described above, the IRQ shall randomly select 50 physicians and/or Related Entities to be included in the review. For each selected physician and/or Related Entity, the IRQ shall review the entry in the Physician Payment Listing and the Control Documents relating to Payments reflected in Listing identified by the IRQ as necessary and sufficient to validate the Payment information in the Listing. 3) IRQ Review of Control Documents for Selected Physicians and/or Related Entities
For each physician and/or Related Entity selected as part of the sample, the IRQ shall review the Control Documents identified by the IRQ as necessary and sufficient to validate each Payment reflected in the Listing to evaluate the following:
Appendix B 8 EMD Serono Holding. Inc. - Addendum to Corporate Integrity Agreement
Whether Control Documents are available relating to each Payment reflected in the Listing for the sampled physician andlor Related Entity; Whether the Control Documents were completed and archived in accordance with the requirements set forth in ENID Serono's policies; Whether the aggregate value of the Payment(s) as reflected in the Listing for the sampled physician or Related Entity is consistent with the value of the Payments(s) reflected in the Control Documents; and Whether the Control Documents reflect that ENID Serono's policies were followed in connection with Payment(s) reflected in the Listing ~ all required written approvals for the activity were obtained in accordance with EMD Serono's policies.)
Identification of Material Errors and Additional Review A Material Error is defmed as any of the following: a) A situation in which all required Control Documents relating to Payments reflected in the Listing for the sampled physician andlor Related Entity do not exist and: 1. no corrective action was initiated prior to the selection of the sampled physicians and/or Related Entities; or ii. the IRO cannot confirm that ENID Serono otherwise followed its policies and procedures relating to the entry in the Listing for the sampled physician or Related Entity, including its policies and procedures relating to any Payment(s) reflected in the Listing; or b) Information or data is omitted from key fields in the Control Documents that prevents the IRO from assessing compliance with ENID Serono's policies and procedures, and the IRO cannot obtain this information or data from reviewing other Control Documents.
AppendixB 9 EMD Serono Holding, Inc. - Addendum to Corporate Integrity Agreement
If a Control Document does not exist, but EMD Serono has initiated corrective action prior to the selection of the sampled physicians and/or Related Entities, or if a Control Document does not exist but the IRO can determine that EMD Serono otherwise followed its policies and procedures with regard to each entry in the Listing for a sampled physician or Related Entity, the IRO shall consider such a situation to be an exception (rather than a Material Error) and the IRO shall report the situation as such. The IRO shall note as exceptions any Control Documents for which non-material information or data is omitted. If the IRO identifies any Material Errors, the IRO shall conduct such Additional Review of the underlying Payment associated with the erroneous Control Documents as may be necessary to determine the root cause of the Material Errors. For example, the IRO may need to review additional documentation and/or conduct interviews with appropriate personnel to identify the root cause of the Material Error(s) discovered. B.
IRO Review of Additional Items
As set forth in Section III.F.1.b of the CIA, for each Reporting Period, the OIG at its discretion may identify up to three additional items for the IRO to review (hereafter "Additional Items".) No later than 120 days prior to the end of the applicable Reporting Period, the OIG shall notify EMD Serono of the nature and scope of the IRO review to be conducted for each of the Additional Items. Prior to undertaking the review of the Additional Items, the IRO and/or EMD Serono shall submit an audit work plan to the OIG for approval and the IRO shall conduct the review of the Additional Items based on a work plan approved by the . OIG. The IRO shall include information about its review of each Additional Item in the Transactions Review Report (including a description of the review conducted for each Additional Item; the IRO's findings based on its review for each Additional Item; and the IRO's recommendations for any changes in EMD Serono 's systems, processes, policies, and procedures based on its review of each Additional Item.) EMD Serono may propose to the OIG that its internal audit(s) andlor reviews conducted as part of the EMD Serono Compliance Monitoring Program be partially substituted for one or more of the Additional Items that would otherwise be reviewed by the IRO for the applicable Reporting Period. The orG retains sole discretion over whether, and in what manner, to allow E1ID Serono 's internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO.
Appendix B 10 EMD Serono Holding, Inc. - Addendum to Corporate Integrity Agreement
In making-its-decision, the OIG agrees to consider,amongotherfactors, the nature and scope ofEMD Sereno's planned internal audit work andlor reviews conducted under the EMD Serono Compliance Plan, the results of the Transactions Review(s) during prior Reporting Period(s), and EMD Serono 's demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies EMD Serono 's request to permit its internal audit work to be substituted for a portion of the IRO's review of Additional Items in a given Reporting Period, EMD Serono shall engage the IRO to perform the Review as outlined in this Section m. If the OIG agrees to permit certain ofEMD Serono 's internal audit work
for a given Reporting Period to be substituted for a portion of Additional Items review, such internal work would be subject to verification by the IRO (Verification Review). In such an instance, the OIG would provide additional details about the scope of the Verification Review to be conducted by the IRO. However, for purposes of any Verification Review, the IRO shall review of at least 20% of the sampling units reviewed by EMD Serono in its internal audits. C. Transactions Review Report
For each Reporting Period, the IRO shall prepare a report based on its Promotional Functions and Product Related Functions Transactions Review. The report shall include the following:
a) Review Objectives: A clear statement of the objectives intended to be achieved by each part of the review; Review Protocol: A detailed narrative description of the procedures performed and a description of the sampling unit and universe utilized in performing the procedures for each sample reviewed; and Sources of Data: A full description of documentation and other information, if applicable, relied upon by the IRO in performing the Transactions Review.
The following results shall be included in each Transaction Review Report:
Appendix B 11 EMD Sereno Holding. Inc. - Addendum to Corporate Integrity Agreement
(Relating to the Physician Payment Listings) a) a description of the entries in the Physician Payment Listing for each physician or Related Entity sampled and a description of Control Documents reviewed in connection with each selected physician or Related Entity; for each sampled physician or Related Entity, findings and supporting rationale as to whether: (i) all required Control Documents exist; (ii) each Control Document was completed in accordance with all of the requirements set forth in the applicable EMD Serono policy; (iii) the aggregate value of the Payment(s) as reflected in the Listing for the sampled physician or entity is consistent with the value of the Payment(s) reflected in the Control Documents; (iv) each Control Document reflects that EMD Serono 's policies were followed in connection with the underlying activity reflected in the document ~ all required approvals were obtained); and (v) any corrective action or disciplinary action was undertaken in those instances in which EMD Serono policies were not followed; for each sampled physician or Related Entity unit reviewed, an identification and description of all exceptions discovered. The report shall also describe those instances in which corrective action was initiated prior to the selection of the sampled physicians or Related Entities, including a description of the circumstances requiring corrective action and the nature of the corrective action; if any Material Errors are discovered in any sample unit reviewed, a description of the error, the Additional Review procedures performed and a statement of findings as to the root cause(s) of the Material Error;
(Relating to the Review of Additional Items) e) for each Additional Item reviewed, a description of the review conducted;
Appendix B 12 EMD Serono Holding, Inc. - Addendum to Corporate Integrity Agreement
for each Additional Item reviewed, the IRO's findings based on its review; for each Additional Item reviewed, the findings and supporting rationale regarding any weaknesses in EMD Serono's systems, processes, policies, procedures, and practices relating to the Additional Item, if any; and for each Additional Item reviewed, recommendations, if any, for changes in EMD Serono's systems, processes, policies, and procedures that would correct or address any weaknesses or deficiencies uncovered during the review.
Appendix B 13 EMD Serono Holding, Inc. - Addendum to Corporate Integrity Agreement
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