Conflict of Interest FAQs
FAQs Related to All Three Policies:
Q: Which Federal Regulations require the Outside Interest Disclosure?
A: Several federal regulations require that insitutions maintain a process for identifying and managing conflicts of interst. Those regulations include:
- Uniform Guidance
- Anti-Kickback Statute, (42 USC §1320a-7b(b))
- Stark Law, (42 USC § 1395nn)
- CMS -- Centers for Medicaid & Medicare Services
- IRS -- Form 990
- Public Health Service (PHS):42 CFS part 50 Subpart F
Q. What are my responsibilities related to Conflicts of Interest?
A. The employee is responsible for disclosing their relationships annually and within 30 days of a significant change in their relationship with industry, which could include (1) a new role with the outside entity or (2) a relationship with a new outside entity. The responsibility of the supporting administrative offices will include a discrete review of the disclosure along with other pertinent information, such as the employee's roles and responsibilities on behalf of the University. The Research Integrity and Safety Group supports employees who design, conduct or report on research while the Compliance Office supports Institutional Officials and employees who provide patient care. Finally, the corresponding Committee will make a determination if a COI exists, and then resolve the matter if deemed necessary.
Q. What is the Reporting Period?
A: Calendar Year 2016: January 1, 2016-December 31, 2016 and year to date 2017: January 1, 2017-Date of your Dislcosure.
Q: In which period should I report a payment from an Outside Entity for a speaking engagement that took place in June 2016, yet was not paid to me until January 2017?
A: The date of payment determines which year the funds are assigned, i.e., Cash Basis. If the activity took place in June 2016 and the payment was received in January 2017, then you would apply the payment to the 2017 reporting period.
FAQs Related to Patient Care COI:
Q: Which University healthcare employees are covered by the Policy on Medical Center Conflicts of Interest in Patient Care and Service?
A: The policy applies to health professions faculty and clinical, educational and research support staff (including full time, part time, adjunct, volunteer); as well as health professions trainees at the undergraduate, graduate and post graduate level, (including fellows and residents); Medical Center Administration.
Q: Is SLU's retirement plan administrator, TIAA-CREF, considered a Health Care Industry relationship?
Q: What is the pourpose of SLU's policy on Medical Center COI in Patient Care & Svc?
A: The purpose of SLU's Policy on Medical Center COI in Patient Care and Service describes the necessity for reporting, tracking, and monitoring relationships between Medical Center personnel and Healthcare products companies in order to protect the learning environment and the patient-centeredness focus of all practitioners.
Q: Why does LCME Accreditation require COI policies?
A: LCME Accreditation Standards expect a medical school to have effective policies and procedures for board members, faculty members, and any other individuals who participate in decision-making affecting the medical education program to avoid the impact of conflicts of interest in the operation of the medical education program, its associated clinical facilities, and any related enterprises.
Q. What is the law regarding inducements for referrals?
A: The Anti-Kickback Statute prohibits offering, paying, soliciting or receiving anything of value to induce or reward referrals or generate Federal health care program business.
Q. Can a physician refer Medicare/Medicaid patients for designated health services to an entity with which the physician, or his/her immediate family has a financial relationship?
A: No, the Stark Law prohibits a physician from this practice.
FAQs Related to Institutional COI:
Q: Who are Institutional Officials?
A: An Institutional Official (IO) is someone who can affect the strategic direction of the University through their organizational role. IO's include the President of Saint Louis University, our Provost, Vice Presidents, Associate and Assistant Vice Presidents, Deans, Associate and Assistant Deans, Academic and Clinical Department Chairs, Division Directors, Office Directors and other institutional adminstrators as determined by the University's executive leadership and the ICOI Review Committee.
Q: Would the University's Institutional Conflict of Interest Policy monitor a situation in which an Institutional Official disclosed a personal relationship with a company (such as a spouse working for a company) that also sponsors research being performed by a research team under their supervision or authority
Q: Would the University's Institutional Conflict of Interest Policy monitor a situation in which an Institutional Official disclosed a personal relationship with a company (such as a spouse working for a company) that also sponsors research being performed by a research team within a different department and not under their supervision or authority?
Q: Would the University's Institutional Conflict of Interest Policy monitor a situation in which an Institutional Official disclosed a personal relationship with a company (such as a minimal equity ownership in a company) that also is a referral site for clinical services by a provider under their supervision or authority
Q: Would the University's Institutional Conflict of Interest Policy monitor a situation in which an Institutional Official disclosed a personal relationship with a company (such as a minimal equity ownership in a company) that does not have any business overlap with the Institutional Official or any individual under their supervision or authority?
Q: Would the University's Institutional Conflict of Interest Policy monitor a situation in which an Institutional Official disclosed a personal relationship with a company (such as serving in a non-compensated leadership role for the company) that also is a supplier of devices to the department under their authority?
Q: What is the University's rationale for asking about my spouse's income?
A: The disclosure requirements for Immediate Family Members follow the Physician Payment Sunshine Act - Section 6002 of the Patient Protection and Affordable Care Act (PPACA), which also conforms with the Stark Law.
Federal Definition "Immediate Family Members"
The final rule of the Sunshine Act defines a physician's "immediate family members" in a manner similar to the Stark law regulations, specifically including a physician's spouse, parents, children, siblings, step-parents, step-siblings, in-laws, grandparents, spouses of grandparents and grandchildren, regardless of whether the person is a natural or an adopted family member.
University Definition "Immediate Family Members"
We, at the University, opt to follow the federal guidance as far as practical. Our Outside Interest Disclosure asks for relationships with Outside Entities including the individual, their spouse, dependent children, siblings, and any other person(s) residing in the individual's household.
We understand that there may be some uncertainty in disclosing the exact dollar amounts of one's immediate family member's income. If you are reticent to disclose dollar amounts, then we suggest selecting the "Value can not be determined" option on Question #5 which reads "Select the total value of your personal financial relationship with the entity". Our objective is to identify the significance of the relationship with the Outside Entity. In the absence of a stated value, we will assume that the relationship is significant.
For more information on the University's COI policies, look to the following site: https://sites.google.com/a/slu.edu/coi