This week the University of Minnesota adopted a new Conflict of Interest Policy: Clinical Care – Patient Contact in the Academic Health Center.
Two years ago, the University of Minnesota medical school led an “effort to update the medical schools’ conflict-of-interest rules under former Dean Deborah Powell,” according to a recent article in the Star Tribune.
Eventually, the medical school’s policy “morphed into university wide guidelines, which have been under review by various constituencies since late 2009.” One of the reasons it has taken so long to finalize and implement the policy, according to university general counsel Mark Rotenberg, is because of “its complexity and cutting-edge nature, which tries to create an administrative policy that is wall-to-wall.” Rotenberg noted that the university hopes to finalize and implement the university wide policy by the end of the year, and according to the Star Tribune, “an end may be in sight.”
In fact, “a first set of rules addressing potential conflicts at the Academic Health Center” (AHC) went into effect and was released on Wednesday. The health center policy covers the schools of Medicine, Dentistry, Nursing and colleges of Pharmacy and Veterinary Medicine.
The policy focuses on how to manage and report faculty relationships with business entities that relate to their university expertise and responsibilities, including faculty who work with patients in clinical care. The policy deems those faculty involved in clinical care to be involved in higher-risk activities that necessitate more restrictive standards.
Reporting
The policy requires that annually, all covered faculty and staff, including those who are temporarily away from campus (e.g., leave, sabbatical), must complete a Report of External Professional Activities (REPA) to report financial, equity, royalty and business interests, including:
– All salary/payment for services (e.g., consulting fees, honoraria, paid authorship);
– The dollar value of all equity interests in both publicly traded and non-publicly traded entities;
– Royalties paid in connection with intellectual property rights such as patents and copyrights, including agreements to share in royalties related to such rights; and
– Business interests, which the policy defines as holding any executive position in a business or membership on a board of any business entity, including boards of trustees, scientific advisory boards, medical advisory boards, and boards of professional societies, whether or not such activities are compensated.
Faculty and staff are not required to report salary or other remuneration paid by the university to the covered individual, as well as:
· Income from seminars, lectures, or teaching engagements sponsored by governmental agencies and non-profit entities organized solely for educational, religious, philanthropic, or research purposes;
· Income when serving as a special reviewer or review panelist for a public (governmental) or nonprofit entity;
· Income from services provided to professional organizations;
· Income from a private practice plan or private professional practice plan pursuant to Board of Regents policies; and
· Royalties received under Board of Regents Policy: Commercialization of Intellectual Property Rights, where the covered individual who received the royalties does not have any other relationship with the business entity paying the royalties that could result in a conflict of interest.
Additionally, when a “substantial change” happens to a covered individual, such as an increase in the value of an existing financial interest to a value that qualifies it as a significant financial interest or the acquisition of a new financial interest, covered individuals must complete a REPA within 30 days of that substantial change. The policy defines a significant financial interest as payment of $10,000 or more, as well as equity interests in that amount or a stake of 5 percent of more in a company, and royalties for inventions.
Disclosure also applies to all adjunct faculty who are engaged in clinical research approved through the University’s Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) processes; or involved in technology commercialization through the University; or in a position to influence the content of health education.
Definition of COI
The policy defines conflict of interest as “a relationship between a covered individual’s private business or financial interests, or those of the covered individual’s family members, and the covered individual’s expertise and responsibilities such that an independent observer might reasonably question whether the individual’s objectivity in the performance of University responsibilities could be compromised by considerations of personal gain.”
In the context of research, the policy defines a financial conflict of interest as a significant financial interest that could directly and significantly affect the design, conduct, or reporting of the research.
In the context of clinical care, a conflict of interest exists under the policy when a secondary financial interest creates the risk that the primary duty to the patient and the delivery of optimal care will be improperly influenced by personal financial interests of the care provider
Enforcement
The policy addresses such conflicts by forwarding all covered individuals whose consulting income exceeds $100,000 in a calendar year from the Conflict of Interest Program to the individual’s dean for a “Conflict of Commitment” review under Administrative Policy: Outside Consulting and Other Commitments and Administrative Procedure: Outside Consulting and Other Commitments by Faculty and Academic Professional and Administrative (P&A) Staff.
Covered individuals will also be referred to the Conflict of Interest Program for review when a financial interest in a business entity relates to the covered individual’s University expertise or responsibilities and meets the following thresholds:
· Remuneration and equity interests in a publicly traded business, when aggregated, annually exceeds $5,000 during one or both calendar years;
· Equity interests in a non-publicly traded business entity in any amount;
· With the exception of royalties exempted from the reporting requirements, the value of any royalties paid in connection with intellectual property rights, e.g., patents and copyrights, and any agreements to share in royalties related to such rights that, when aggregated, annually exceeds $5,000; and
· Any executive position in a business entity or membership on a board of a business
After this information is gathered, the AHC Conflict of Interest Review Committee confers with the covered individual, before determining a conflict exists, by evaluating the nature of the University activity, the nature of the financial interest or business interest, and how closely the interest is related to the covered individual’s University expertise or responsibilities.
If the Committee determines that a conflict of interest exists, it will determine whether the conflict must be eliminated, educed or effectively managed. In either circumstance, a conflict management plan will be developed in consultation with the covered individual and, in appropriate circumstances, with the covered individual’s dean, or administrative unit head. Management mechanisms that may be imposed include:
· Corroboration by a colleague of any prescription for a product of a commercial entity in which the provider has a significant financial interest and documenting this corroboration in the medical record;
· Appointment of an oversight committee to monitor practice patterns;
· Transfer a patient’s care to another colleague; and
· Cessation or modification of the relationship with a commercial entity.
In addition, covered individuals must confirm their compliance with conflict management plans in writing at least annually and, when required by the terms of a conflict management plan, must provide documentation demonstrating compliance. Such individuals also may not engage in University activities where a determination has been made that a conflict of interest exists, except in accordance with the terms of a University conflict management plan.
Consulting, Sales and Marketing Events
Covered individuals who provide consulting services related to their University expertise or responsibilities must enter into a signed, written agreement with the business entity prior to providing the consulting service. The written agreement must:
- State a need for the services provided;
- Describe the services and any deliverables to be provided;
- State the remuneration to be paid;
- State the timeframe covered by the agreement; and
- Make clear that the covered individual is acting solely in his or her individual capacity and is not speaking for, or acting on behalf of the University.
Professional fees paid for the consulting services provided must be consistent with and may not exceed the fair market value of the services provided. Covered individuals may also be reimbursed for reasonable and actual expenses for travel, meals, and lodging.
Documentation of the remuneration received, any travel expenses paid for or reimbursed to the covered individual, and the services provided must be maintained by the covered individual and include estimates of the time and effort committed to providing the services. This documentation must be retained for the duration of the consulting relationship plus two years.
Staff and faculty are allowed to give presentations at sales and marketing events sponsored by business entities under the policy where the subject matter of the event relates to the individual’s University expertise or responsibilities if:
- The information presented is evidence-based;
- The covered individual represents that the lecture materials fairly reflect their independent views and not solely the views of the business entity; and
- The presenter discloses to the audience their business or financial relationship with the business entity, if any; and a representation that they are speaking and acting solely in their individual capacity and not on behalf of the University.
Covered individuals may not accept meals, food, refreshments, entertainment, or similar benefits from a business entity either on or off-site, with the exception of modest meals offered to all attendees at educational events. But these restrictions do not apply to events sponsored by business entities to benefit students (e.g., recruiting events).
Faculty and staff may also not accept payment for promoting the products or services or other commercial interests of a business entity, except for individuals engaged in promotional activities on behalf of a business the individual created. The policy also bans ghostwriting, and requires that individuals provide a written disclosure to all patients for whom the individual prescribes a branded product of that business their business relationships. Whatever form of disclosure to the patient, documentation must be made in the medical record.
Disclosure of interests must also be made by individuals to sponsors of research, and must be disclosed to the editor of journals and information to news media.
Education
Staff and faculty may use educational materials developed and provided by business entities in connection with University activities, but may not use educational materials that advertise or otherwise promote a product or service of the business. When using materials for teaching purposes, covered individual must disclose the name of the business entity that developed the materials to students, if known.
With the exception of textbooks, software and related educational items that are provided in limited quantity to covered individuals to review for potential course adoption, and laboratory supplies or reagents also provided in limited quantity for evaluation purposes, covered individuals may not accept free or discounted samples and demonstration items provided by a business entity. Instead, units must centrally receive these items and document the receipt and dissemination of them to their departments, divisions and programs. In the clinical context however, the policy allows the use of a product or product insert information branded with the name of the business for patients for whom the product has been prescribed for demonstration and educational purposes.
The policy allows faculty and staff to attend on-site and off-site education and training events sponsored by business entities, but the deans of the colleges and schools within the AHC will determine whether it is appropriate for the University or the sponsoring business entity to pay for or reimburse the covered individual for the expenses associated with a covered individual’s attendance at such events.
The deans will consider (a) the educational value of the event; and (b) whether the commercial interests of the company served by the participation of the covered individual outweigh the educational benefit to be derived by the covered individual from attendance at the event. Other factors include the frequency of the same or similar sponsored trainings; the venue; and the substance of the agenda. Consequently, the policy allows payment for or reimbursement of expenses may be permitted where training is mandated by law.
Covered individuals may not accept compensation (e.g., an honorarium or consulting fees) simply for attending an education or training event sponsored by a business entity, listening to an audio presentation, or reviewing web based training developed by an business entity unless this activity is conducted in the context of a written consulting agreement and the activity has been approved by the dean or designee.
The policy allows business entities to fund continuing medical education events if:
· The funding is in the form of a grant to the unit;
· The grant is unrestricted as to content and format;
· The University co-sponsor retains ultimate control with respect to the final selection of speakers, the order of presentations, and their content; and
· The event meets the requirements of the Accreditation Council for Continuing Medical Education.
Accordingly, AHC will maintain a public website on which covered individuals may voluntarily disclose compensation, royalty income, and any equity interest held in a business entity where the products or services of the entity relate to the covered individual’s University expertise or responsibilities. Individuals who are required to report business and financial interests on a REPA will also be required to complete training on the University’s policies and procedures on individual conflicts of interest and any applicable state and federal laws at least every three years.
Impact of Policy
With university officials describing the policy as “far stricter than a policy covering other areas of the university,” just exactly what benefits will this policy hold for advancing medicine and progressing innovation in science and research? Does the university have any evidence to support its policy that commercial support of education or interaction with faculty has harmed patients? We know of none.
Accordingly, if the goal of this policy is to impede relationships and collaboration between physicians and industry, it will leave health care providers at Minnesota with fewer opportunities to learn about breakthroughs and advances in medicine and treatment.
The addition of all these rules only leads to a rise in a bureaucracy to manage and control physician’s actions. These rules have a tradeoff taking time away from medical practice and research to filling out forms and justifying all relationships with leadership. There has never been any thought to the benefit that all this disclosure and oversight actually has to the overall health of the patient. As always they site an example of one successful physician on staff who made it big with industry and subsequently criticized by politicians, but fail to discuss the benefits that those relationships.
The reality is, interaction with business does not “sway doctors from the best interests of patients.” Working with industry is in the best interest of patients because it has led to the most innovative advances in medicine and technological progress for decades, and has led to healthier, longer lives for all Americans. Changing the balance of this partnership now will have unintended and harmful consequences to the training of physicians and the outcomes of patients, the likes of which no university policy alone will be able to fix.
This policy is shamefully inadequate. To put this in perspective, Federal employees are not permitted to accept gifts in excess of $25, and have to report even those. Why? Because any financial inducement is considered by our government and voters as likely to corrupt. By setting the reporting standard at $10,000, the UMinn assumes that a researcher would not be influenced by $9999. This is preposterous on its face, as Dr. Schultz’s actions have amply demonstrated.
The flagrant self-serving conflict permissible under your “conflict of interest” policy is absolutely sickening.