(Lahey Clinic Foundation, Inc., Lahey Clinic Hospital, Inc., Lahey Clinic, Inc., Lahey Clinic Affiliated Services, Inc., and any other organizations whose governing boards are designated by the Board of Trustees of Lahey Clinic Foundation, Inc., are collectively referenced in this Policy as “Lahey” or “Lahey Clinic.”)
This Conflict of Interest Policy is intended to guide Lahey Health (“Lahey”) Colleagues in structuring appropriate relationships with care providers, payors, educational institutions, manufacturers and other vendors that affect or have the potential to affect patient safety or quality of care, treatment, research, and payment for services.
This policy should be read in conjunction with the following policies:
I. General Statement
All Lahey Colleagues must avoid any actual or perceived Conflicts of Interest to ensure that the Conflict of Interest does not affect, or appear to affect, patient safety, quality of care, research integrity, or interfere with Lahey’s responsibility to the community it serves. For example, any situation where a Lahey Colleague may benefit financially, whether directly or indirectly (e.g., through a family member) as a result of that Colleague’s position with Lahey is a potential Conflict of Interest.
A Conflict of Interest is not illegal per se. Rather, most Conflicts of Interest can be managed or cured with disclosure, consent or modification. However, depending on the circumstances, it is prudent to simply avoid certain Conflicts of Interest. Lahey Colleagues must disclose all potential Conflicts of Interest pursuant to this Conflict of Interest Policy for review and appropriate action.
The Lahey Health Senior Management Compliance Committee serves as Lahey Health’s principal conflict of interest committee and in such role, the Committee reports to the Audit and Compliance Committee of the Lahey Health Board of Trustees. As Lahey Health’s conflict of interest committee, the Senior Management Compliance Committee works to eliminate Conflicts of Interest, to prohibit or restrict Lahey Colleagues with Conflicts of Interest from being involved in activities related to their Conflicts of Interest, and to require additional disclosures related to Conflicts of Interest as appropriate.
"Agents" means all persons and entities that have contracted with Lahey to provide health care related services, equipment or other goods or services. Agents do not include Volunteers.
“Board Members” means members of the Boards of Trustees of Lahey.
"Colleagues" means all Lahey Health entity employees and temporary, per diem personnel, volunteers, students and others rendering paid or unpaid services to Lahey, including, but not limited to, Agents, Board Members, Medical Staff, and Officers.
“Conflict of Interest” means a situation in which financial, professional, or personal interests, including the interests of Immediate Family Members, may compromise one’s professional judgment or other obligations to Lahey. There is no minimum amount below which financial Conflicts of Interest do not need to be disclosed.
“Covered Person” means Board Members, Medical Staff, Nurse Practitioners, Physician Assistants, Officers, and all employees at the manager level or above.
“Disqualified Person” means any person who is in a position to exercise substantial influence over the affairs of Lahey (including Board Members, Officers, and others in positions of comparable authority), as well as Immediate Family Members of any such individuals.
“Entity” means any for-profit or not-for-profit organization, including, but not limited to, any corporation, trust, foundation, association, company, sole proprietorship, partnership, firm, venture, vendor, or other form of organization.
“Equity” means any investment having a value greater than ten thousand dollars ($10,000.00) or having an unknown value (such as stock options).
“Immediate Family Member” means a spouse/domestic partner, parent, child, sibling, stepparent, stepchild, stepbrother, stepsister, father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-law, sister-in-law, grandparent or grandchild, aunts, uncles, nephews, nieces and spouse of a grandparent or grandchild.
“Investigator” means the principal investigator and any other Colleague who is responsible for the design, conduct, or reporting of human subjects research.
“Medical Staff” means full-time and part-time members of the Senior, Scientific Associate, Consultant, Authorized Assistant, Affiliate, Adjunct, Visiting, Resident Staff and Clinical Fellows of Lahey Hospital & Medical Center and certain members of the medical staffs of Beverly Hospital, Addison Gilbert Hospital and BayRidge Hospital, as identified from time to time by the Senior Management Compliance Committee of their employment and/or positions of leadership.
“Officers” means corporate officers of Lahey Health and its entities.
“Research Compliance Committee” includes, but is not limited to, the Chairperson of the Institutional Review Board (IRB), the Director of the Office of Research Administration, and the Corporate Compliance Officer.
“Senior Management Compliance Committee” means the Lahey Health Senior Management Compliance Committee.
“Significant Financial Interest” means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). Significant Financial Interest does not include:
- Salary, royalties, or other remuneration from Lahey;
- Income from seminars, lectures, or teaching engagements sponsored by, or from service on advisory committees or review panels for, public or nonprofit entities;
- An equity interest that when aggregated for Colleague and the Colleague's spouse and dependent children, does not exceed $5,000 in value and does not represent more than a 5% ownership interest in any single entity; or
- Salary, royalties or other payments that when aggregated for the Colleague and the Colleague’s spouse and dependent children are not expected to exceed $5,000 over the next twelve months.
III. Individual Conflicts of Interest
All Colleagues are subject to this Conflict of Interest Policy and are required to be familiar with its content.
A. Regular Disclosures. All Colleagues must disclose potential Conflicts of Interest as follows:
- All Officers, Medical Staff, Nurse Practitioners, Physician Assistants, and manager level and above employees are required to disclose potential Conflicts of Interest by completing a Conflict of Interest Disclosure Form (“Form”) online via site Intranets upon hire or appointment and then annually.
- Board Members and Agents must complete and submit Forms to the Corporate Compliance Officer upon hire or appointment and then annually
- Employees who are below the manager level should disclose potential Conflicts of Interest to their immediate supervisors and must submit Forms upon request.
- Volunteers must complete and submit Forms to the Director of Volunteers when they begin providing services to Lahey and then annually.
B. Disclosing New Conflicts of Interest. If during the year any new potential Conflicts of Interest arise, Colleagues must report the potential Conflicts of Interest immediately (and prior to undertaking any activity that may raise a potential Conflict of Interest) as outlined above in III.A.
C. Confidentiality. Disclosure information will be confidentially maintained. It may be shared in a confidential manner with the person to whom the Colleague directly reports, the Legal Services Department, the Office of Research Administration, the Corporate Compliance Department and the Audit and Compliance Committee of the Lahey Health Board of Trustees. If research is disclosed, the Institutional Review Board and the Research Compliance Committee may also receive and review disclosure information.
D. Review of Individual Disclosure Forms and Resolution of Conflicts. Forms will be reviewed and conflicts resolved in the following manner:
- For Board Members and the Chief Executive Officer, the Corporate Compliance Officer will review the Form and make a recommendation to the Audit and Compliance Committee of the Lahey Health Board of Trustees. The Committee will review the Form and make a decision about any needed plan for curing or managing any disclosed conflict.
- For Volunteers, the Director of Volunteers will review the completed Form and send the Form and his/her written recommendation to the Corporate Compliance Officer. The Corporate Compliance Officer will review the recommendation of the Director of Volunteers and the completed Form and will take appropriate action.
- For all other Colleagues, the Corporate Compliance Officer will review the Forms. The Corporate Compliance Officer will review the Forms for Conflicts of Interest and may discuss with the Colleague any needed action to cure or manage the conflict
- For Members of the Lahey Health Board of Trustees and the Chief Executive Officer, any appeal will be made to the entire Lahey Health Board of Trustees. For employees who sit on the Lahey Health Senior Management Compliance Committee or who directly report to the Chief Executive Officer, appeals may be made to the Audit and Compliance Committee of the Board of Trustees. Appeals for all other Colleagues will be made to the Lahey Health Senior Management Compliance Committee.
- Review Factors. The Corporate Compliance Officer, the Director of Volunteers and the Senior Management Compliance Committee shall consider the following factors when reviewing completed Form:
• Whether the Colleague or an Immediate Family Member is a party to, or may directly or indirectly benefit from, a proposed agreement or transaction involving Lahey;
• Whether the Colleague’s desire for, or expectation of, direct or indirect external economic advantage could distort a Lahey decision or activity;
• Whether the Colleague or an Immediate Family Member is engaging in an activity, business, or transaction in which Lahey is likely to engage;
• Whether the Colleague’s outside activities may conflict with rights of, or the Colleague’s obligations to, Lahey or Lahey’s patients;
• Whether the Conflict of Interest can be cured or managed by recusal or other appropriate action; and
• Whether there is an appearance of a Conflict of Interest.
- Determination and Course of Action. If the Audit and Compliance Committee of the Lahey Health Board of Trustees, the Lahey Health Senior Management Compliance Committee, or the Corporate Compliance Officer determines that a Conflict of Interest exists, the Corporate Compliance Officer shall notify the applicable Colleague in writing of the determination and the recommended course of action. The Colleague shall respond in writing indicating how he/she complied with the determination.
- Discipline. Failure to comply with this Policy, as well as refusal to complete the Form, may result in disciplinary measures, up to and including removal from office or termination of employment.
- Records. Forms, in hard copy and electronic format, will be retained by all departments for six (6) years. The Corporate Compliance Officer will retain memoranda of all Audit and Compliance Committee and Corporate Compliance Committee decisions for six (6) years.
IV. Lahey Equity Interests
A. Clinical Research. If a Lahey entity plans to participate in clinical research sponsored or otherwise financed by a company in which either (a) Lahey holds Equity and the company has a market capitalization of less than $10 million; or (b) Lahey holds an Equity interest of at least 5% (regardless of the market capitalization of that company), then Lahey will give due consideration to Conflict of Interest and commitment concerns that may exist as a result of Lahey’s holdings in the company. Lahey will take appropriate action, including selling its Equity share in that company, in order to manage, reduce or eliminate conflicts of interests.
B. Inventors. Inventors may only hold Equity during the course of sponsored research as defined in and to the extent provided for in any applicable policies of Lahey. If for any reason the inventor desires to avoid Equity in order to obtain research funding from a company, the inventor may request that Lahey also avoid taking Equity through a license agreement so as to allow the sponsored research. Lahey normally will not accept Equity under such circumstances; provided, however, that Lahey will require in its license or other technology transfer agreement that the inventor will not obtain Equity at a later date without the consent of Lahey.
C. Corporate or Scientific Board Seats. Without the prior consent of the Senior Management Corporate Compliance Committee, no Covered Person will accept a board seat of a company or a seat on a company’s scientific advisory board if either (a) Lahey holds Equity in the company and the company has a market capitalization of less than $10 million; or (b) Lahey holds an Equity interest of at least 5% in the company (regardless of the market capitalization of that company).
V. Colleague Consulting Agreements/Speaking Engagements
All Colleagues must file with the Corporate Compliance Officer a final copy of every agreement for “Consulting Services” (as defined in the Consulting Policy) to which he or she is a party, including speaking engagement invitations,(a) that is connected to work which he or she has done, is doing, or expects to do within the scope of his or her employment by, appointment or association with, or education at Lahey or (b) for which he or she has made, is making, or expects to make use of facilities, materials, equipment, staff, information, ideas, data or other resources furnished by or through Lahey.
VI. Transactions with Lahey
The following process must be followed (before a Lahey entity enters into any transaction with (a) a Disqualified Person, (b) an individual who was a Disqualified Person at any time during the five (5) years prior to the transaction, or (c) an Entity in which a Disqualified Person directly or indirectly holds at least a thirty-five percent (35%) interest:
A. The transaction must be approved by the Audit and Compliance Committee of the Board of Trustees. If any member of the Audit and Compliance Committee has any Conflict of Interest with respect to the proposed transaction (including any family, employment or financial relationships with the Disqualified Person who would engage in the transaction with Lahey), that member must recuse himself or herself from all proceedings pertaining to the proposed transaction.
B. The Audit and Compliance Committee must rely on objective data (such as independent appraisals, written offers, comparables and independent compensation surveys) in approving the transaction.
C. The Audit and Compliance Committee must adequately document the basis for its decision in minutes or other records that describe
- the terms of the transaction and date of approval,
- the individuals who were present during the discussion of and vote on the transaction,
- the source and substance of the data relied upon,
- the actions taken with respect to any conflicts of interest, and
- if the approved compensation or other payments are above or below the comparables, the reason for the discrepancy.
D. The minutes or other records containing this information must be prepared before and approved at the next meeting of the Audit and Compliance Committee.
VII. Research-Related Conflicts of Interest
A. Submission of Disclosure Forms. At the time of submission of each proposed research protocol, Investigators who plan to participate in the proposed research must report potential Conflicts of Interest related to the research by submitting a Form. These disclosure requirements are intended to supplement, not replace, the Conflict of Interest disclosure requirements set forth in Sections III and IV of this Conflict of Interest Policy.
B. Investigators’ Forms will be referred to the Research Compliance Committee.
C. Review and Action. The Research Compliance Committee will review Investigators’ Forms to determine if a Significant Financial Interest exists that could directly and significantly affect the design, conduct, or reporting of the research. If such a Significant Financial Interest exists, the Research Compliance Committee must determine what actions should be taken to manage, reduce, or eliminate the Significant Financial Interest. For example, the Research Compliance Committee may determine that one of the following conditions or restrictions is necessary to manage the Significant Financial Interest:
- Public disclosure of the Significant Financial Interest;
- Monitoring of the research by independent reviewers;
- Modification of the research plan;
- Disqualification of the Investigator from participation in all or a portion of the research;
- Divestiture of the salary, payments, or other monetary value creating the Significant Financial Interest; or
- Severance of the relationships that create the actual or potential Significant Financial Interests.
D. Appeal. Decisions of the Research Compliance Committee may be appealed to the Corporate Compliance Committee and then to the Audit and Compliance Committee of the Board of Trustees.
VIII. Institutional Conflicts of Interest
A. Reporting. Institutional conflicts of interest are conflicts involving Lahey or an institutional component thereof, rather than an individual. Anyone who becomes aware of a potential institutional conflict of interest should refer the potential conflict to the Corporate Compliance Officer who will review the potential conflict and either issue a decision or refer the matter to the Senior Management Compliance Committee and/or the Audit and Compliance Committee of the Board for a decision.
B. Regular Reviews. Lahey conducts regular conflicts of interest reviews of its relationships with other health care providers, educational institutions, payors, and pharmaceutical, device and equipment manufacturers to determine whether conflicts exist and whether these relationships comply with applicable laws.
IX. Conflicts of Interest Related to Immediate Patient Care
Potential conflicts of interest that effect direct care of particular patients may be referred to the Institutional Ethics Committee.
Contact: Corporate Compliance Officer
Applies to: Lahey Health System, Inc., each and all of its affiliated entities and each individual working therein.
- Anti-kickback Statute, 42 U.S.C. §1320A ff.
- The Joint Commission Standards LD. 02.02.01 and 04.02.01.
- Internal Revenue Code §4958 (Intermediate Sanctions)
Approved by: Lahey Health Senior Management Compliance Committee and Audit and Compliance Committee of the Lahey Health Board of Trustees