(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 Colleagues (as defined below) 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 or quality of care, treatment, research, or payment for services 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 (except from normal compensation) is a potential Conflict of Interest and should be avoided. Lahey Colleagues must disclose all potential Conflicts of Interest pursuant to this Conflict of Interest Policy for review and appropriate action.
The Corporate Compliance Committee serves as Lahey’s conflict of interest committee and in such role, the Corporate Compliance Committee reports to the Audit/Compliance Committee of the Board of Trustees. As Lahey’s conflict of interest committee, the Corporate 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 provide additional disclosures of 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 Board of Trustees of Lahey.
"Colleagues" means all Lahey 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 professional or business obligations. There is no de minimus level below which financial Conflicts of Interest do not need to be reported. A Conflict of Interest is not illegal per se. Rather, most Conflicts of Interest can be cured with disclosure, consent or modification. However, depending on the circumstances, it is prudent to simply avoid certain Conflicts of Interest. Examples of Conflicts of Interest are set forth on the Conflict of Interest Disclosure Form.
“Covered Person” means Board Members, Medical Staff, Nurse Practitioners, Physician Assistants, Officers, and all employees at the manager level or above.
“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.
“Entity” means any for-profit or not-for-profit entity, including, but not limited to, any corporation, trust, foundation, association, company, sole proprietorship, partnership, firm, venture, vendor, or other 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).
“Investigator” means the principle 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.
“Officers” means corporate officers of Lahey Clinic.
“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 the Investigator and the Investigator'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 Investigator and the Investigator's spouse and dependent children are not expected to exceed $5,000 over the next twelve months.
- “Volunteers” means volunteers, students and others rendering unpaid services to Lahey.
III. Process for Handling Individual Conflicts of Interest
All Colleagues are subject to this Conflict of Interest Policy and are required to be familiar with its content.
Regular Disclosures. All Colleagues must disclose potential Conflicts of Interest as described below.
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 the MassNet Colleague Resources COI Web Kit (“MassNet”) upon hire or appointment and then annually during Mandatory Education. Forms completed via MassNet will be automatically sent to immediate supervisors and the Corporate Compliance Officer.
Board Members and Agents must complete and submit paper Forms to the Corporate Compliance Officer upon hire or appointment and then annually during Mandatory Education.
Employees that are below the manager level should disclose potential Conflicts of Interest to their immediate supervisors and submit Forms upon request.
Volunteers must complete and submit paper Forms to the Director of Volunteers when they begin providing unpaid services to Lahey and then annually during Mandatory Education.
Disclosing Interim 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).
Review of Disclosure Forms. Except for research-related Conflicts of Interest and institutional Conflicts of Interest (which are handled as set forth later in this Conflict of Interest Policy), Forms will be reviewed 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/Compliance Committee of the Board of Trustees. The Audit/Compliance Committee will review the Form and make a decision. Any appeal will be made to the Board of Trustees.
- 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 Colleague’s immediate supervisor and the Corporate Compliance Officer will review the Forms. The immediate supervisor will review the Forms for conflicts of commitment and other administrative concerns. The Corporate Compliance Officer will review the Forms for Conflicts of Interest and will take appropriate action. Appeals for employees who sit on the Corporate Compliance Committee or who directly report to the Chief Executive Officer will be made to the Audit/Compliance Committee of the Board of Trustees. Appeals for all other such Colleagues will be made to the Corporate Compliance Committee.
Review Factors. The Corporate Compliance Officer, the Director of Volunteers, and supervisors should consider the following factors when reviewing completed Forms:
- 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 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; and
- Whether there is an appearance of a Conflict of Interest.
Financial Interests in Manufacturers. Colleagues with financial interests in a manufacturer of pharmaceuticals, devices, or equipment or any provider of services should recuse themselves from involvement in purchasing decisions relevant to the Conflict of Interest.
Determination and Course of Action. If the Audit/Compliance Committee of the Board of Trustees, the Corporate 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 and sign 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/Compliance Committee and Corporate Compliance Committee decisions for six (6) years.
IV. Equity Interests
Purchases by Covered Persons. If a Covered Person orders or purchases items or services from a company in which Lahey has a financial interest, and if Lahey is in a position to profit financially from the order or purchase, then Lahey must either (1) refuse any profits that it would obtain from the order or purchase, or (2) donate any profits that it obtains from the order or purchase to Lahey’s charity care program or to a general local charity.
Clinical Research. If Lahey 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.
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.
Corporate or Scientific Board Seats. Without the prior consent of the 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. Consulting Agreements/Speaking Engagements
All Colleagues must file with the Corporate Compliance Committee 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 (Compliance with Intermediate Sanctions Rules)
Definition. “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.
Process. The following process must be followed (as recommended under regulations promulgated pursuant to the Intermediate Sanctions Rules set forth in section 4958 of the Internal Revenue Code) before Lahey 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:
- The transaction must be approved by the Audit/Compliance Committee of the Board of Trustees. If any member of the Audit/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.
- The Audit/Compliance Committee must rely on objective data (such as independent appraisals, written offers, and independent compensation surveys).
- The Audit/Compliance Committee must adequately document the basis for its decision in minutes or other records that describe (i) the terms of the transaction and date of approval, (ii) the individuals who were present during the discussion of and/or vote on the transaction, (iii) the source and substance of the data relied upon, (iv) the actions taken with respect to any conflicts of interest, and (v) if the approved compensation or other payments are above or below the comparables, the reason for the discrepancy. To satisfy this requirement, the minutes or other records containing this information must be prepared by the next meeting of the Audit/Compliance Committee.
VII. Process for Handling Research-Related Conflicts of Interest
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 by submitting a Form via MassNet. 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. Investigators’ Forms will be referred to the Research Compliance Committee which 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.
Review and Action. The Research Compliance Committee must 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.
- Appeal. Decisions of the Research Compliance Committee may be appealed to the Corporate Compliance Committee and then to the Audit/Compliance Committee of the Board of Trustees.
VIII. Process for Handling Institutional Conflicts of Interest
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 Corporate Compliance Committee for a decision. Each Board Member and each Officer is also under an affirmative obligation to report any potential institutional conflict of interest to the Audit/Compliance Committee of the Board of Trustees as soon as he or she becomes aware of such conflict. Such reporting by Board Members and Officers may be either in writing or in a formal meeting of the Audit/Compliance Committee at which minutes are taken.
Regular Reviews. Lahey Clinic 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.
Contact: Corporate Compliance Officer
Cross-Reference: Consulting Policy
Gifts Solicitation Policy
Health Care & Corporate Compliance Plan
Intellectual Property and Technology Transfer Policy
Media Relations Policy
Name and Identity Standards Policy
Vendor Interactions Policy
Reference: Antikickback Statute; The Joint Commission Standards
LD. 02.02.01 and 04.02.01.
Origination Date: 1999
Reviewed/Revised: 2008, 2010
Approved by: Corporate Compliance Committee
Audit/Compliance Committee of the Board of Trustees