This blog post is based on the article, Where We Stand with Healthcare Conflict of Interest (COI) Compliance, written by Bill Sacks, former Vice President of COI Management at HCCS, A HealthStream Company.
A conflict of interest in healthcare can range from the most simple and obvious to extraordinarily complex, as the few examples below can demonstrate. One healthcare meeting planner was found to be regularly sending business to a restaurant owned by her husband while neglecting to disclose the relationship as required. In another case, a department manager hired her husband, who was subsequently paid significant overtime, all while maintaining a full time job outside the university. In a particularly egregious example, a salaried Chief Compliance Officer (CCO) contracted with an outside firm—where she was the only employee—to provide compliance services normally provided by the CCO. These were clear conflicts, some of which amounted to outright fraud.
Other COI situations can be far more complex. One former CCO recounted the story of a clinical staff member who developed a software solution, retaining ownership with leadership approval. Under that arrangement no royalty payments were received from the healthcare institution. Shortly thereafter, the product was picked up by a third-party distributor, resulting in a “spider web” of ownership, financial, and management issues that needed to be untangled.
While some providers demonstrate total commitment to disclosure and seek to avoid even an appearance of conflict (an example being “I think I accidentally accepted a sandwich from Merck!”), others will “forget” or claim ignorance of disclosure requirements. In those cases, compliance officers can employ various tools to assess the accuracy of disclosures. The open payments database may be the most well-known resource, but savvy compliance officers will periodically Google the names of their most prominent physicians to identify relationships from press releases, conference agendas, etc.
A scandal involving a conflict of interest in healthcare can be significant and damaging. In the case of Memorial Sloan Kettering Cancer Center in New York, The New York Times and ProPublica revealed in September 2018 that its medical director failed to disclose substantial financial ties and corporate pharmaceutical backing related to medical conference appearances and scientific journal publications. The lack of disclosure was questionable, given that co-authors disclosed connected financial interests when applicable. The director ended up resigning, and the scandal widened to touch other executives at the organization and elsewhere in academic and research medicine. As a result of this scandal, Memorial Sloan Kettering announced a large-scale change in policy. Other similar organizations are examining their own policies and are expected to follow suit, both to protect public perceptions and mollify employee morale.
Perhaps it is long overdue for leading healthcare institutions to admit that when doctors enter into financial relationships with companies, the concern is that these ties can shape the way studies are designed and medications are prescribed to patients, potentially allowing bias to influence medical practice. Stronger policies are a way to reestablish the link to education and research, and away from industry influence.
Sacks offers the following advice for Improving COI Compliance:
Remember that only a small percentage of financial relationships and reported payments are problematic. Sacks offers that “ Most potential conflicts are addressed by the disclosure itself or by agreements for additional oversight.”
As stated earlier, well defined policies and procedures can provide a template for improved understanding and compliance with conflict of interest policies. Even the best designed policies and rules cannot anticipate every possible situation. One compliance officer from horse country recounted a conversation with one of her physicians, who complained that there was no specific rule prohibiting the action he had been called to task on. She told him: “There is no rule that says not to bring your horse to work, but… DON’T bring your horse to work!”
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