Introduction

Life sciences companies often engage with healthcare professionals (HCPs) and researchers for consulting activities and to speak about a medical device, product, or general disease state. In interactions with healthcare professionals (HCPs) for these activities, life sciences companies need to comply with Stark law and anti-kickback regulations. These laws assure the government and the public that key opinion leaders (KOLs) are fairly compensated for their services, at fair market value (FMV), and are not unduly influenced to promote specific products. [2] [1]

Pharma and medical device industries continue to face severe regulatory enforcement and fines related to payments to these KOLs. Year after year, the U.S. Department of Justice (DOJ) has recovered millions of dollars in settlements due to violations of the Anti-Kickback Statute, Stark Law, and False Claims Act. A frequent violation cited in these settlements is the compensation of KOLs for services above fair market value (FMV), thus constituting a kickback or inducement, whether the overpayment was intentional or not. Governing bodies are continuing to scrutinize these payments by ensuring KOLs are paid FMV for their services, following their level of expertise. [2]

To ensure fair compensation as per the law, pharmaceutical and medical device companies should adopt the Fair Market Value (FMV) Model of Compensation, which is based on effective tiering criteria and objective data analysis, by establishing the tiers to evaluate a physician's expertise, considering factors like experience, employment history, research, and industry involvement. This evaluation process is typically known as KOL tiering.[2] [3]

Some best practices include offering higher compensation for higher expertise, shorter negotiation cycles, and standardized FMV rate cards, which set benchmarks in auditing and compliance records. It is also a good business practice that gives the company more insight into how they spend their money. In a nutshell, this practice not only fulfills legal obligations but also promotes transparency and accountability in companies' expenditures.

For pharmaceutical companies and Medical Affairs teams, effectively engaging with the right KOLs is crucial for the success of research, marketing, and educational initiatives. However, one major challenge is the accurate identification and tiering of KOLs, which often requires a deep dive into vast data sets.[1]

This is where Artificial Intelligence (AI) steps in to transform the KOL tiering process, making it faster, more accurate, and more efficient. AI-powered tools are reshaping how Medical Affairs teams identify and engage with KOLs by automating tasks, improving data analysis, and offering more precise insights into KOL impact and influence.

What is tiering, and how is it done? 

Tiering is a process of evaluating the KOL’s experience and specialization against a standard set of criteria. The traditional approach to tiering employed by the life sciences industry has been a manual process usually owned by the medical affairs function, which keeps personnel with advanced degrees to review a KOL’s curriculum vitae (CV) and pick out key accomplishments and experiences. 

The Challenges in Traditional KOL Tiering

Historically, KOL tiering involved a manual assessment of various metrics publication records, participation in clinical trials, social media activity, and presentations at conferences. The tiering process itself could be labor-intensive, often requiring significant time and resources. The risk of bias and human error also added complexity, sometimes leading to the underestimation or overestimation of a KOL’s influence.

Additionally, the role of KOLs is no longer confined to academic or clinical achievements. Social media influence, virtual conference presentations, and contributions to disease awareness campaigns have also emerged as key metrics, making it harder to balance traditional and modern criteria in tiering methods.[3] 

How AI Revolutionizes KOL Tiering

AI offers the ability to gather and analyze a broader range of data, giving Medical Affairs teams a more holistic view of each KOL’s influence. Advanced algorithms can scan through vast amounts of information, from publications and citation records to online engagement metrics and real-time performance in disease awareness campaigns. AI provides a consistent, unbiased approach to evaluating these metrics, enhancing the precision of KOL tiering. [3]

By leveraging AI, Medical Affairs teams can:

• Analyze large datasets efficiently: AI can process and analyze thousands of data points at a speed nearly impossible for manual methods, ensuring that no critical information is overlooked.

• Eliminate bias: AI ensures more objective tiering, eliminating the human bias that may arise in traditional methods.

• Track real-time impact: AI tools can track KOLs' evolving influence in real-time, providing a dynamic tiering system that adapts to changes in the healthcare landscape.

• Incorporate diverse metrics: AI doesn’t just rely on traditional metrics like publications but also considers a KOL’s digital footprint, social media presence, and engagement in virtual platforms.

Integrating AI with ACMA's KOL Tiering Solution 

ACMA has developed AI tools that specifically address these challenges in the KOL tiering process. While the traditional methods rely on manual data collection, ACMA’s AI-driven platform can integrate data from diverse sources, applying advanced analytics to streamline the tiering process.

For instance, using the platform of ACMA medaffairsAI, one can measure the scientific contributions, digital presence, and influence on public opinion through a comprehensive report that accurately captures the current and future might of the KOL. It can also be customized based on the needs of the individual Medical Affairs teams for efficient solutions. The levels can therefore be designed for the specific requirements of each team to help them achieve their target goals.[4]

Moreover, medaffairsAI is integrated perfectly with current CRM systems. It would enable Medical Affairs professionals to understand their KOL engagements to much deeper levels without having to toggle between various systems. Teams can effectively keep track of real-time KOL influence and adjust their strategies appropriately through seamless integration.[4]

Increasing Efficiency and Effectiveness

Incorporating AI into the KOL tiering process does more than just save time it provides accuracy and depth of insight that can lead to better decision-making and resource allocation. The ability to rapidly identify high-impact KOLs allows Medical Affairs teams to prioritize engagements and focus on building more meaningful relationships.

This data-driven approach to tiering also enhances compliance, as AI tools ensure the information is analyzed objectively, reducing the risk of favoring KOLs based on subjective measures. Medical Affairs teams can be confident that their tiering decisions are supported by concrete data and analysis, minimizing potential legal and regulatory risks.[3]

AI-Enhanced KOL Tiering in Rare Diseases

An organization that specialized in rare pharmaceuticals used an AI platform to optimize its process for tiering KOL. The challenge was that, typically, KOLS in rare disease fields would publish less and have smaller networks compared with their colleagues in more common therapeutic areas. Traditional tiering strategies therefore ranked these KOLS too low because the volume of research done and outreach efforts was bound to be much smaller or limited.

The company’s AI platform incorporated non-traditional metrics, such as social media advocacy for rare diseases, participation in patient advocacy groups, and contributions to disease awareness campaigns. By factoring in these additional metrics, the AI platform was able to highlight several underrated  KOLs who were actively influencing patient communities and digital platforms. [4]

This new, AI-driven tiering strategy allowed the Medical Affairs team to identify niche experts, increasing engagement by 25% with previously under-recognized KOLs. The shift also supported their rare disease initiatives, as the company could better align with KOLs who were influential in advocacy and awareness, despite having fewer traditional scientific publications.

AI-Powered Medical Affairs Transformation in Cardiology

A large pharmaceutical company operating in the field of cardiology had inefficiencies within the KOL engagement strategy. Given that more and more data were coming from clinical trials, publications, and digital platforms, Medical Affairs could no longer manually tier and track engagement with KOLs effectively. It has an AI-based solution that automatically tiers KOLs. AI-driven tiering can automatically tier KOLs based on a broad spectrum of data points, ranging from traditional indicators like research output and participation in conferences to modern indicators like social media reach and influence online and more on fostering the collaborations that drive innovation in healthcare.

This broadened the scope of the company's reach and engagement strategy and allowed them to focus on the influencers who are driving the conversations and education among patients in the cardiology space. An AI-based approach led to better KOL targeting with a 40% improvement, a higher engagement, and the strength of their partnerships with a larger set of experts. [1]

Conclusion

In today’s complex healthcare environment, where KOLs have an increasingly multifaceted influence, AI-driven tools like medaffairsAI are essential for Medical Affairs teams. By automating the tiering process and offering real-time, objective insights, AI can significantly enhance the efficiency and accuracy of KOL engagements. With tools like these, Medical Affairs professionals can focus less on manual data collection and more on fostering the collaborations that drive innovation in healthcare.

This blend of advanced AI and human expertise can make all the difference in optimizing KOL engagement strategies and ensuring that Medical Affairs teams are always one step ahead in the evolving landscape of healthcare.

References: 

1. Automating the traditional KOL tiering process for life sciences companies

https://www.bakertilly.com/products/kolnow?utm_source=googleads&utm

2. Minimizing risk through effective engagement with KOLs and stakeholders

https://www.bakertilly.com/insights/minimizing-risk-through-effective-engagement

3. Fair Market Value & KOL Tiering

https://www.bakertilly.com/insights/automating-kol-tiering-process 4. ACMA digital solutions 

https://acmalifesciences.org/acma-ai/medaffairs-ai