As healthcare’s regulatory landscape continues to change in unprecedented ways, significant financial interests and potential commercial conflicts held by physicians are garnering much attention and scrutiny. A recent Wall Street Journal article underscored the significance of potential reputational risk of physician-industry relationships by detailing the payments made by GlaxoSmithKline to a high-profile celebrity doctor that surfaced as the result of the recent record-setting settlement with the DOJ. In addition, the DOJ has stepped up its scrutiny of medical device implantations due to concerns of over-utilization and medical necessity, and the surgeons performing those cases may have significant relationships with the manufacturers of those products – oftentimes for very good reasons (collaboration to invent new products and conduct innovative clinical trials), but sometimes under-managed, nonetheless.
At Kyruus, we use Big Data and analytics to solve a host of health care challenges, and with many of our hospital and health system clients, we are currently tackling this hotly debated topic of conflict-of-interest management. While technology can play a central role in COI management, establishing and communicating the right policies clearly and effectively to medical staff members, AND providing them with efficient, well-defined processes to maintain compliance, are equally essential to the success of a program.
To better understand how institutions have traditionally handled conflict-of-interest management, the team here at Kyruus recently conducted an analysis of a set of publicly-available hospital COI policies to evaluate the commonalities across institutions. Our team sampled COI policies from 22 institutions across all major geographic regions of the country, and parsed out the individual provisions that were addressed by each institution. For instance, did the institution have a provision covering the management of gifts from life science representatives? Did the institution have a monetary threshold for requiring disclosure to the compliance department? The graph below depicts the percentage of institutions that addressed specific provisions in their COI policies.
While some provisions were consistently addressed across the board, others were less systematic. For example, consider the “no samples” policy provision – only 6 out of 22 institutions had a policy in place that prohibited physicians from taking samples from pharmaceutical and medical device companies. Despite the fact that this topic has grabbed the attention of both physicians and pharmaceutical companies, as discussed in a recent AMA article that states that 23% of doctors refuse samples, it appears that institutions may not be providing enough policy guidance to physicians to be able to deal productively with this issue. Another interesting finding from our study is that only 9 out of 22 institutions provided guidelines for on-site presence of life science industry representatives. While institutions are entitled to set their own policies, the Office of the Inspector General (OIG) provides useful guidance on its website for physicians on this topic.
In addition, 15 out of 22 policies reviewed did not have a provision requiring an annual COI disclosure report. The low percentage is not shocking considering the functional challenges involved in operating and maintaining a robust annual disclosure process. Many institutions struggle with the handling of disparate siloes of physician data, multiple hospital departments who care about different aspects of industry relationships, and even the basic maintenance of staff lists that would be required to support a regular annual COI disclosure process. However, in this day and age of transparency, where more data about physician-industry relationships are being pushed into the public domain, it is imperative for institutions to maintain a single source of truth of their physicians’ professional activities and industry relationships so that they are not caught by surprise when public scrutiny hits their organization. Programs such as the Pew Prescription Project are addressing this issue in their work, conducting research to help institutions create pragmatic policies.
What do these findings mean, and more importantly, what’s next? As we move forward in defining the “best practices” of COI policies and COI management programs, there are a number of future events to consider. Perhaps most relevant is the Physician Payment Sunshine Act (PPSA), which will exponentially increase the amount of physician-industry interaction data available for public review by outside stakeholders. Physicians, life sciences companies, and teaching hospitals have expressed concern to CMS about the daunting task ahead: ensuring the accuracy and appropriate contextualization of these interaction reports. Only with state-of-the-art data integration, disambiguation, and analytics platforms will organizations and individuals be able to effectively manage this deluge of potentially controversial information.
Another policy of relevance is the new NIH FCOI regulation, going into effect on August 24, which creates a new burden for institutions to proactively identify, manage, and respond to public requests for disclosure of significant industry relationships amogst individuals involved in federally-funded research. Again, without the ability to apply real-time analytics to identify potential areas of risk across large populations of physicians and researchers, institutions may struggle to comply with these stringent laws.
Our clients are already beginning to take advantage of the insights generated through this COI policy analysis, as well as leveraging our national benchmark database of physician-industry relationships to project the operational burden that their organizations will face under these new laws. Are you facing similar issues? We’d love to talk – please contact us to schedule some time with our subject matter experts and we'll review these learnings in more detail.
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