Best Practices in Conflict of Interest Disclosure for Hospitals
Conflict of Interest (COI) is a critical ethical and compliance concern in the healthcare industry, particularly in hospitals where patient care and trust are of paramount importance. A COI occurs when the healthcare professional’s primary goal of protecting and improving the health of patients comes into conflict with any other secondary goal, especially that of personal or institutional financial gain. A conflict could jeopardize a healthcare organization’s reputation or have an impact on its federal funding for research, accreditation or tax-exempt status, but the effect on patient safety should be of the utmost concern.
To safeguard patient welfare and maintain public trust, hospitals must implement robust and transparent practices for disclosing and managing COI. Below are some best practices for hospitals to successfully navigate their COI disclosure function.
Develop comprehensive COI policies
The foundation of an effective COI disclosure program begins with the development of comprehensive policies. Hospitals should establish clear guidelines that outline what constitutes a COI, the disclosure process, and the consequences of failing to disclose a conflict. Policies should also detail the kinds of conflicts of interest that will require further management.
It is likely that there may be several policies that address COI for the different categories of individuals who will be disclosing their conflicts (employees, physicians, board members, advanced practice providers, volunteers, and contractors). These policies must be communicated to all employees, contractors, and volunteers to ensure a consistent understanding of the importance of transparency.
Then, these policies should not just “collect dust on a shelf.” They must be reviewed and updated regularly to ensure the organization’s internal and legal requirements are continuously being met. COI is a dynamic process because the individuals responsible for reporting their disclosures have ever-changing financial and professional activity.
A must for any COI disclosure program is an organizational commitment to compliance and buy-in from leadership on the importance of identifying and preventing conflicts of interest.
Identify potential conflicts of interest
Incorporate regular and ongoing disclosure requirements for all individuals involved in patient care, research, and decision-making processes. This should encompass healthcare professionals, administrators, researchers, and anyone who has decision-making authority in the hospital. Annual disclosures help ensure that potential conflicts are identified and addressed promptly. However, there also needs to be a process for individuals to report a conflict outside the annual timeframe so that an individual’s COI disclosure is always up to date.
A survey or questionnaire process is a valuable tool for identifying conflicts of interest. Surveys can be structured in a way that allows for easy completion with the ability for individuals to build on the initial disclosure year after year to report any potential conflicts of interest that arise.
There should be fields to capture financial, business, and personal interests of the individual and their immediate family members, research funding, relationships with pharmaceutical companies or medical device manufacturers, and other potential conflicts. Use of an electronic platform survey tool can facilitate management of the disclosure, analysis, and reporting ability. Also, using an automated system versus a paper-based system or spreadsheets helps to ensure confidentiality of the disclosures.
Another tool that can be used in the identification process of conflicts of interest is the CMS Open Payments database. This database is a searchable tool and national disclosure program that promotes transparency by publishing payments made by drug and medical device companies to physicians, physician assistants, advanced practice nurses, and teaching hospitals. Healthcare providers should be encouraged to query the database on their own to validate reported events, and compliance professionals should query the database as a regular part of the COI process.
Educate staff on COI
Mandatory education and training on COI should be provided to all hospital employees and medical staff upon orientation as well as periodically thereafter. Training sessions can help staff recognize potential conflicts and understand the significance of avoiding conflict, but also the importance of transparently disclosing conflict that can’t be avoided. Education sessions can address ways to mitigate conflicts appropriately.
Supervisors and managers should have separate training to help them identify and manage conflicts within their departments. The governing board would also likely have separate education sessions due to the unique potential for outside financial relationships.
Furthermore, all staff should be educated on the consequences of not disclosing known conflicts of interest or providing misleading answers to COI questions.
What are some examples of the most common conflicts of interest in healthcare?
- An ownership interest in a vendor or competitor of the hospital
- Board or committee memberships of entities that compete with the hospital
- Employment by another entity that conflicts with the hospital’s interests
- Accepting business gifts from vendors or other business associates of the hospital
- A family member who works for a key hospital vendor
Implement transparent decision-making processes in the mitigation of CIOs
Transparency in decision-making promotes trust and allows stakeholders to assess the potential impact of conflicts. The organization’s COI policies should describe the process for which type of conflicts will require mitigation and what those steps will be. It may be helpful for the organization to have a COI Committee where these decisions are made – this would help with consistency and transparency.
Reviewing the annual COI disclosures is an important compliance function. The risk of the potential conflict to the organization must be weighed against whether the individual has a genuine and harmless relationship. All relationships that meet a disclosure definition are not necessarily conflicts of interest (no biased decision-making would result), but every disclosure must be addressed for this determination. In addition, compliance staff needs to own the task of following up on surveys not returned and information on surveys that appears to be incomplete or inaccurate.
Once a disclosure is reviewed, investigated, and determined to be a COI, mitigation efforts should be documented in a written plan and provided to the employee and their manager. The employee may enter into an agreement for further oversight. Removal of a conflict may be as simple as not allowing the person with the conflict to participate in decisions related to that COI.
In addition to mitigating disclosed conflicts of interest, the hospital should address and establish disciplinary actions for individuals who fail to disclose conflicts or who deliberately provide misleading information. The biggest risk to the organization usually comes not from a disclosed risk, but from a conflict that is concealed or misrepresented.
How can an organization find conflicts of interest that employees fail to disclose? Employ the use of a compliance hotline, educate managers to be aware of signs of conflict/bias, use the Open Payments database, search physicians’ names on the internet for activities that may be conflicts, have an open-door compliance policy, and evaluate any unusual patterns of practice of physicians prescribing drugs or medical devices.
Periodic auditing and evaluation
Regular audits of the COI disclosure process can help identify any shortcomings and areas for improvement. An organization must follow its own policies and procedures for managing conflicts of interest. Hospitals should evaluate the effectiveness of their COI policies periodically to ensure they remain relevant and up to date. Make sure policies adequately reflect the current practice of the hospital regarding COI disclosure and that employees are transparently informed about the awareness of conflicts and of the consequences of failing to disclose them.
The organization should determine in an audit that all disclosures and missing surveys were appropriately followed up on. An audit would also uncover whether similar disclosures were handled in a similar way, to protect against allegations of discrimination.
Prioritize patient welfare
Hospitals and health systems play a vital role in maintaining trust and prioritizing patient care by establishing robust COI disclosure practices. By implementing comprehensive policies, educating staff, and fostering transparency, hospitals can effectively manage COI and ensure that the interests of the patients always come first. As healthcare organizations continue to adapt to evolving ethical challenges, ongoing commitment to ethical conduct will remain the backbone of quality patient care.