In the history of the impact of conflicts of interest (COI) in healthcare, the rise and fall of arthritis pain drug Vioxx was a watershed event. All the elements were there: a major drug company study, incomplete reporting of data by drug company employees, data oversight by someone with at least the appearance of a financial COI, and a failure to disclose adverse effects of the drug. Even the FDA bore some responsibility.
The resulting scandal damaged the reputation of the New England Journal of Medicine and Merck, an admired pharmaceutical company. Vioxx cost Merck over $5 billion in settlements.
An FDA whistleblower stated that 60,000 people died from heart attacks in the five years before Merck voluntarily withdrew the drug in late 2004. COI—even the appearance of COI—has the potential to seriously harm patients and damage healthcare institutions.
Not All COIs Result in Biased Decision-Making
COI exists when a person could derive personal benefit from actions or decisions made in his or her official capacity, but do all COIs require redress? According to Bill Sacks, co-founder of HCCS, “Relationships among physicians, hospitals and the medical industry are important. Industry contributes to medical education, funds clinical trials, and provides medications for the indigent. In short, they support the teaching, research and clinical missions of academic medicine.”
Typically, only 8 – 12 percent of disclosures require review by the compliance department or an internal COI committee, and only 1 – 2 percent may need recusal from decision-making or divestiture of stock. A potential COI disclosure risk, therefore, is the possibility of “throwing the baby out with the bathwater.” On the other hand, failure to adequately address COI exposes institutions and patients to risk.
Managing COI Risk
Regulatory compliance requires that healthcare organizations secure annual conflict of interest disclosures from physicians, APPs, board members, and hospital leaders at the director level and above. Effective disclosure requires a thorough questionnaire to guide discernment of any conflicts. The questionnaire must walk individuals through their business relationships, revealing the potential for COI. Conflicts must then be reported on a disclosure form.
Perhaps a physician is influencing the purchase of a medical device. Is the doctor’s recommendation the best possible choice, or is it because he receives speaking fees from the device manufacturer? Are stents selected by a hospital the best choice for patients, or was the purchase influenced by the cath lab director’s relationship with the sales representative? A hospital board member is the sister of a bank’s CEO. Did this relationship influence the selection of the bank as a lender?
Unknown and undisclosed conflicts can threaten an institution’s tax-exempt status, reputation, research funding, and most importantly, patient safety.
When a Disclosure Requires Action
COI Policies should define the types of disclosures that require a management and mitigation plan. The plan should prescribe the steps the organization will take to mitigate any bias or appearance of bias. The institution could ask the individual with a conflict to reduce the value of a financial relationship so that it falls below a threshold amount designated by policy. The individual could be required to forgo participation in committee votes, deliberations, or decisions about a topic related to that individual’s conflict of interest.
For research projects, it may make sense to modify the design of the project or have an independent researcher serve as the principal investigator. Another approach could be to provide an observer to monitor and evaluate any appearance of bias in the decisions made or influenced by the individual.
Managing and Monitoring Disclosures
The compliance director or the compliance committee must review and vet annual COI disclosures. An automated system, with an online COI questionnaire, simplifies this process significantly and reduces the possibility of overlooking important disclosures. Paper and pencil disclosure forms are more difficult to manage within policy expectations and are more difficult to secure for confidentiality.
Proper vetting looks at a variety of risks, especially any possible influence on medical judgment. The process must include evaluating whether any compensation is for bona fide work and whether it reflects fair market value. Appropriate review will reveal whether referrals were expected because of any gift or compensation. Implementing an organized—and automated—process prevents surprises by proactively managing any questionable relationships.
If your organization is looking for an automated, single-platform solution for managing COI, visit hccs.com/COI for information about COI-SMART, a cloud-based platform offering custom questionnaire design, best practice advice, management plan templates, and relevant subject matter.
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