Kaiser Permanente policy on conflicts of interest in research

1.0 Policy Statement

Kaiser Permanente (KP) employees are required to promptly disclose situations that may present a conflict of interest or the appearance of a conflict of interest. It is the policy of Kaiser Permanente to identify conflicts of interest and situations that may give rise to conflicts of interest and to address such situations to ensure decisions made on behalf of KP are made in the best interests of the organization, and its members and patients.

2.0 Purpose

The purpose of this policy is to address federal laws and regulations and accreditation standards for conflicts of interest (see Section 6.0, References/Appendices) by ensuring that processes are in place for the disclosure and management of situations that may lead to a conflict of interest.

3.0 Scope/Coverage

This policy applies to all employees who are employed by the following entities (collectively referred to as “Kaiser Permanente”):

3.1 Kaiser Foundation Health Plan, Inc., and Kaiser Foundation Hospitals (together “KFHP/H”);

3.2 KFHP/H subsidiaries;

3.3 The Permanente Medical Group, Inc. (TPMG) [NOTE: This policy does not apply to physicians, podiatrists, or vice presidents of TPMG, who are covered by separate TPMG policies]; and

3.4 Southern California Permanente Medical Group (SCPMG) [NOTE: This policy does not apply to physicians of SCPMG].

4.0 Definitions

4.1 Appearance of a Conflict of Interest – When it appears to a third person, regardless of whether a conflict exists, that an individual’s professional judgment or decision-making is influenced.

4.2 Conflict of Interest – A conflict of interest arises when personal or financial interests influence professional judgment or decision-making.

4.3 Conflicts of Interest Questionnaire (COI Questionnaire) – Questionnaire document(s) approved by the KFHP/H Board of Directors designed to facilitate written disclosure of existing or potential conflicts of interest. 4

4.4 Conflicts of Interest Selection Criteria Document – A listing of categories of employees covered by the requirement to complete a COI Questionnaire. (Appendix A).

4.5 Executives – KFHP/H employees whose compensation is administered through Executive Compensation.

4.6 Ongoing Conflicts of Interest Disclosures – Disclosures that are made by employees outside the annual Conflicts of Interest Questionnaire process.

4.7 Potential Conflict of Interest – A potential conflict of interest exists when personal or financial interests may, at some time in the future influence professional judgment or decision-making.

5.0 Provisions

Requirements for employee disclosures of potential conflicts of interest and accountabilities for the administration and management of the annual Conflicts of Interest Questionnaire are outlined below.

5.1  Ongoing Conflicts of Interest Disclosures

5.1.1  Employees covered by this policy have an ongoing duty to promptly disclose actual or potential conflicts of interest, and situations that may cause the appearance of a conflict of interest to designated individuals in accordance with the Principles of Responsibility and Reporting Compliance and Ethics Concerns policy (NATL.NCO.004).  Designated individuals include: supervisors; managers; human resources; local, regional, or national administration; medical center, regional, or national Compliance Officers; regional or national Special Investigations Units; and the Kaiser Permanente Compliance Hotline.  Standards for disclosure requirements are provided in Appendix B.

5.2 Conflicts of Interest Questionnaires

5.2.1  Annual Conflicts of Interest (COI) Questionnaires

5.2.1.1 A COI Questionnaire is required annually from employees selected in accordance with the Conflicts of Interest Selection Criteria Document. Administration and Accountabilities are described in Appendix C.

5.2.1.2 The Chief Compliance Officer administers the KFHP/H Conflicts of Interest Questionnaire program. 

5.2.1.3 Employees who are notified of the requirement to complete an annual COI questionnaire must complete the questionnaire and respond to requests for clarification or additional information regarding their disclosure as a condition of continued employment.

5.2.2 Executive Conflicts of Interest Questionnaires

5.2.2.1 Executives are required to complete a COI Questionnaire at the time of hire or promotion to executive level. Executives are required to complete the questionnaire and respond to requests for clarification as a condition of employment.

5.2.3 Other Required Conflicts of Interest Questionnaires

5.2.3.1 Employees may be required to complete a COI Questionnaire outside the annual process due to: changes in the regulatory requirements; the need to update status of previous disclosures of potential conflicts of interest; or for other disclosure requirements. Upon request of a Compliance Officer or designee, employees are required to complete the questionnaire and respond to requests for clarification. 

5.2.4 Review/Management/Resolutions of COI Disclosures

5.2.4.1 Disclosures received outside the annual COI Questionnaire process (see Section 5.1) are addressed by the employee’s manager or Compliance Officer. Any action taken for these disclosures are documented in the designated system of record.

5.2.4.2 Review/Management/Resolution of COI Questionnaire disclosures are made at the appropriate level of the organization.

5.2.4.2.1 Executives’ disclosures are addressed by the Chief Compliance Officer in consultation with the Vice President of Internal Audit Services.

5.2.4.2.2 Employee disclosures are reviewed by a Compliance Officer or designee.

5.2.4.2.3 Disclosures made by research investigators related to human subject research projects are addressed by the Research Conflicts of Interest Officer.

5.2.4.2.4 The COI Questionnaire disclosures and actions taken are documented in the designated system of record. Please refer to Appendix B – Standards for Disclosure, Assessment and Action regarding Conflicts of Interest.

5.3 Reports to the KFHP/H Boards 

The Chief Compliance Officer submits annual conflicts of interest reports to the KFHP/H Board of Directors. Reports summarize disclosures, trends, actions taken to manage/resolve identified conflicts of interest or potential conflicts of interest, and recommendations for program improvements.

6.0 References/Appendices

6.1  Appendix A – COI Questionnaire Process and Expectations

6.2  Appendix B – Standards for Disclosure, Assessment and Action regarding Conflicts of Interest

6.3  Appendix C – Conflicts of Interest Questionnaire Process

6.4  Policies

6.4.1 Auditor Independence - Hiring Employees of the Independent Auditor, NATL.FIN.ACCT.001

6.4.2 Charitable Contributions, NATL.CB.107

6.4.3 Contributions to Hospitals and Health Plans, NATL.FIN.ACCT.016

6.4.4 Employment of Relatives and Employees with Personal Relationships, NATL.HR.018

6.4.5 Financial Conflicts of Interest in Research, NATL.KFRI.001

6.4.6 Peer Review and Evaluation of Licensed Independent Practitioner Performance, NATL.DCSQ.002

6.4.7 Recognition Awards, Gifts, and Celebrations, NATL.HR.020

6.4.8 Reporting Compliance and Ethics Concerns, NATL.NCO.004

6.4.9 Vendor Relationships, NATL.NCO.016

6.5 Regulatory Information

6.5.1 The Joint Commission Standard LD.02.01

6.5.2 Medicare Part D Prescription Drug Benefit Manual (Chapter 6, Part D Drugs and Formulary Requirements, Section 30.1.2) of the Medicare Modernization Act.  42 C.F.R. § 423.120(b)(ii)

7.0 Approval

This policy was approved by the following representative of Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals, and their subsidiaries.

Daniel P Garcia, Senior Vice President and Chief Compliance Officer

Signature: ____Approval on file__________ Date:__11/1/14____

Policy Revision History

Appendix A: 2009 Annual Conflicts of Interest Questionnaire Selection Criteria

Introduction:

The National Compliance, Ethics and Integrity Office (NCO) administers the Conflicts of Interest Questionnaire to address regulatory and governance requirements, the following selection criteria reflect these diverse requirements.
 
External requirements include:

▪ Internal Revenue Service regulations for Tax-Exempt Status;
▪ Sarbanes-Oxley Act;
▪ Medicare Part D; Prescription Drug Benefit Manual;
▪ Food and Drug Administration and National Institutes of Health requirements for Clinical Researchers.

In addition, employees and others within Kaiser Permanente with authority and influence over decisions made on behalf of Kaiser Foundation Health Plan Inc., Kaiser Foundation Hospitals, and their subsidiaries are included in the questionnaire process.
 
The criteria used to identify employees and others required to complete a questionnaire to address multiple regulatory requirements and organizational risks.

Selection Criteria:

Each of the following persons must complete the 2009 Conflicts of Interest Questionnaire in 2010:

1. Persons with leadership and governance roles

• All members of the Boards of Directors of Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals, and their respective subsidiaries (together, KFHP/H).
• All officers of KFHP/H.
• All “Disqualified Persons” under IRS Rules for Tax-Exempt Charitable Organizations.
• All KFHP/H executives.
• All managers and supervisors (including those responsible for Medicare matters and setting policies or protocols).

2. Employees with contracting and procurement roles

• Exempt and Non-exempt employees who prepare, sign, or manage contracts on behalf of KFHP/H.
• Selected exempt and non-exempt employees who influence decisions regarding the purchase of materials, equipment, and pharmacy goods.

3. Research Investigators

• Employees and Permanente Medical Groups’ Physicians who are Principal Investigators or Co-Investigators on human research projects.

4. Employees in Selected Departments and Functional Areas

• Exempt employees working in the following departments or functional areas are considered at risk for conflicts of interest:

⁽²⁾ Includes Member Services Call Centers, Marketing and Internet Services, Product Development and Benefits Administration, Pricing, Actuarial Services, Provider Contracting, Membership Administration, Sales Operations, National Sales Accounts and Multi-State Account Management, Medicare & Government Programs, Claims.
 
⁽³⁾ Pharmacy exempt and non-exempt employees in the following categories:

▪ Pharmacy Benefits and Claims
▪ National Pharmaceutical Contracting Department
▪ Pharmacy Over the Counter (OTC) Coordinators
▪ Employees in Pharmacy Strategy and Operations administrative offices (Drug Information and Drug Utilization Management) that influence or have the potential to influence formulary decisions, the selection of pharmaceuticals, and related products for drug formularies as deemed by the Vice President of Pharmacy Operations or designee.

5. Committee Members

Employees, physicians, and community members who are members of the following committees:

▪ National Products Council
▪ National Materials Leadership Team
▪ Interregional New Technology Committee
▪ Care Management Institute Guidelines Teams
▪ Pharmacy & Therapeutics (P&T) Committees, including consultants and advisors to the committees, and individuals who materially influence the decisions of a Regional or Medical Center P&T Committee
▪ Northern California Drug Utilization Group (DRUG) and Southern California Drug Utilization Action Teams (DUAT)
▪ Biotechnology and Emerging Pharmaceutical Technology Assessment Committee (BEPTAC)
▪ Pharmaceutical Outcomes Research Group (PORG)
▪ National, Regional, and Local Community Benefit committees
▪ KP-IT Portfolio Approval Councils (PACs)

 References

▪ Kaiser Foundation Health Plan Inc. Kaiser Foundation Hospitals. Charter, Governance, Accountability, and Nominating Committee.
▪ Medicare Part D Prescription Drug Benefit Manual, 2006. Chapter 9 50.2.1.2 Policies and Procedures
▪ IRS Form 990 OMB no 1545-0047 Part IV
▪ IRS Form 990 OMB no 1545-0047 Part V 
▪ 15 USC 7264. Section 406 (SOX)
▪ Joint Commission Standard R1.1.20.1-4
▪ FDA Conflicts of Interest (21 C.F.R. Part 54)
▪ 42 C.F.R. § 50.604

Appendix B: Standards for Disclosure, Assessment and Action regarding Conflicts of Interest

1.0 Disclosure and Reporting

In addition to the Conflicts of Interest Questionnaire, two methods are available for employees to disclose situations which may present a conflict of interest for them. A third mechanism for reporting is available for employees who become aware of a potential conflict involving other employees. Combined, they ensure complete and timely disclosure of potential conflict situations within the program.

1.1 Consultation with Supervisor

1.1.1 Employees are required to report potential conflict of interests, and are encouraged to consult with their supervisor to clarify potential conflict situations.

1.2 Written Disclosure of Potential Conflicts

1.2.1 In circumstances where required by the Principles of Responsibility, employees must make Written Disclosure to their supervisor of Conflicts of Interest as they arise during the course of the year.

1.2.2 Employees who want to participate on Vendor Advisory Boards or must disclose their interest and seek approval from their National Leadership Team Member or their Regional President, and notify NCO if approval is received. Please Refer to Appendix C for additional guidance.

1.3 Reporting Concerns about Potential Conflicts

1.3.1 Employees aware of a Potential Conflict of Interest situation within the organization are required to report in accordance with the Principles of Responsibility and the Reporting Compliance and Ethics Concerns policy (NATL.NCO.004).

2.0 Assessing Conflicts of Interest

Each conflict of interest situation is unique and is assessed as such. Not every situation involving a potential conflict or a conflict of interest warrants action. Each situation is assessed independently to determine if personal interests have the potential to compromise professional roles, responsibilities, or judgment. Assessment should be conducted by the appropriate persons. Consultation is required. Assessment should be conducted in accordance with KP guidelines available from NCO or online at: http://kpnet.kp.org/national/compliance/program/compliance_program/conflicts_ reporting.html

2.1 Criteria to determine whether action is warranted will vary since each situation presents unique issues. The intent should be to;

a) Protect the business interests of the organization.
b) Protect the integrity of individuals acting on the organization’s behalf.
c) Uphold the core values and mission of the organization.

2.2 Depending on the situation, the following criteria may be considered during the assessment;

a) Should tax exemption or other legal issues be considered?
b) How would the conflict be perceived by employees, members, or the public at large? The appearance of impropriety is considered in the assessment of the conflict.
c) Is an individual (or particular set of individuals benefiting) from this practice or is it the organization at large?
d) What are the risks of this practice? What are the benefits? Are the risks to the organization worth the benefits?
e) Is this a practice the organization wants to uphold in the future?

3.0 Determining Appropriate Action

3.1 For conflicts of interest that do warrant action, such appropriate action is taken to protect the interests of the organization.

3.1.1 Depending on the situation, the following criteria may be helpful in determining what action should be taken.

a) Did the individual/s involved receive Principles of Responsibility training?
b) Did the individual/s attest to reading the Principles of Responsibility?
c) Did the individual/s involved self-disclose at the appropriate time?
d) What is the severity of risk the conflict posed to the business interests of the organization?
e) What is the severity of risk the conflict posed to the professional objectivity of the individual/s involved?
f) What is the severity of risk the conflict posed to the core values and reputation of the organization?

3.2 Action may include, but is not limited to:

a) Removal from the decision-making process.
b) A change of roles and/or responsibilities.
c) Removal from specific roles and/or responsibilities.
d) A prohibition on similar activities in the future.
e) Adding clarity through new or modified policies.
f) Disciplinary action, up to and including termination.

Appendix C: Conflicts of Interest Questionnaire Process

A. Process Accountabilities

1. The Governance, Accountability and Nominating Committee of the KFHP&H Board of Directors is accountable for ensuring Conflicts of Interest for Directors and Officers are managed, as required by the Governance Charter. In addition, the Governance Accountability and Nominating Committee is responsible for approving the questionnaire to be used in the Annual process, and for reviewing the Criteria document in which describes the positions and roles to be covered by the Annual Conflicts of Interest questionnaire process.
 
2. The National Compliance, Ethics and Integrity Office (NCO), accountable for administration Conflicts of Interest Questionnaire systems and processes, notification of employees who need to complete a questionnaire, distribution of questionnaires, data maintenance, and oversight of the Annual Conflicts of Interest questionnaire process.
 
3. National Function Compliance Offices are accountable for implementing the Conflicts of Interest questionnaire process in partnership with the NCO where appropriate.
 
4. Regional Compliance Offices are accountable for implementing the conflicts of interest questionnaire process in each region. This accountability includes:

▪ identifying the individuals that meet the Board criteria for a questionnaire,
▪ communicating the requirements in the region,
▪ ensuring that questionnaire responses are collected in a timely manner,
▪ overseeing discipline for employees who do not comply as required,
▪ resolving potential conflicts in partnership with operational management, Human Resources, and others, as appropriate, and
▪ documentation of the resolution in the system of record (currently TrakWeb).

5. Where Conflicts of Interest questionnaires are required for members of KP committees, designated compliance representatives for the committee are responsible for providing names of committee members to NCO and for resolving potential conflicts disclosed in the questionnaire. (Examples are the Sourcing and Standards Team of the National Products Council.
 
6. Human Resources is responsible for providing lists of active executive and nonexecutive employees and terminations as required Conflicts of Interest Questionnaire administration.
 
7. Managers, in partnership with their compliance officer are accountable for communicating the requirement to complete the questionnaire to employees and for participating in the resolution of identified potential conflicts.

8. Employees, when asked to complete a conflicts of interest questionnaire are responsible for completing the questionnaire by the required deadline, and for responding in a timely manner to follow-up requests for clarification, or for additional information.

B: Questionnaire Administration

1. The Annual Conflicts of Interest Questionnaire serves as one method to identify conflicts of interest, it is distributed to selected employee on an annual basis and as required by changes in roles and responsibilities throughout the year.
 
2. The selected employees are those who have positions and roles described in the Criteria document reviewed by the Board. They include those individuals in positions that, relative to others in the organization, have the most impact on the organization’s interests. Key individuals include, but are not limited to individuals with:

• Leadership or management position
• Involved in a governance function
• Ability to make or influence business decisions
• Involved in a function in which integrity is paramount to the financial, legal, or operational interests of the organization

3. Disclosures are considered confidential. Information is shared on a need to know basis as determined by NCO. (Examples: Resolution of potential conflicts, regulatory disclosure requirements, fraud investigations.)

C. Assessment and Action

 1. Each questionnaire and response is assessed on a case-by-case basis.
 
2. NCO screens responses and refers responses to Regional or National Department Compliance Officers for assessment and action.
 
3. NCO, Regional and National Department Compliance Officers screens responses to questionnaires and works with Internal Audit Services (IAS), Legal and the Government Relations Department (Legal) and Human Resources (HR), and Regional Compliance Officers (RCO), as appropriate.
 
4. Legal, HR, IAS, RCO, and NCO communicate with the individual who completed the questionnaire, management and leadership, as needed and as appropriate, to properly assess the disclosures.
 
5. When action is warranted, (based on the standards in Appendix B) management and leadership address the conflict identified.
 
6. NCO reports to the Board, as appropriate, regarding the conflict of interest questionnaire process, outcomes, and resulting actions.