Among the critical components of life sciences compliance, speaker programs and healthcare professional (HCP) meals are two high-risk areas subject to regulatory scrutiny and governed by various applicable laws.
These initiatives are designed by life sciences companies to educate medical professionals about the development of new drugs and devices, ensuring they are well informed about the latest advancements. The purpose is to improve patient outcomes.
However, these programs also present compliance challenges with failure to adhere to regulatory standards, such as those mandated by the Sunshine Act, resulting in severe repercussions like financial penalties, reputational damage, and more.
Understanding and managing the compliance key risk indicators within these activities is essential for maintaining regulatory and ethical standards and operational integrity.
Background
Speaker programs and HCP meals, also known as ‘lunch and learn’ activities, have a marketing angle, as life sciences companies train professionals on the usage, benefits, risks, and more of certain drugs and devices.
The Sunshine Act requires the life sciences industry to report all transfers of value (ToVs) such as HCP spending, speaker programs expenses, and more to the Centers for Medicare and Medicaid Services (CMS).
This is the primary reason these activities pose a substantial risk if not properly monitored by compliance teams as they can lead to potential legal consequences for non-compliance.
qordata has compiled a document that covers key compliance risk indicators associated with Speaker programs and HCP meals cited by research backed by expert reports and information derived from regulatory documents. The document sheds light on:
- What about Speaker Programs that can land you in hot waters?
- What would be the best practice to mitigate risks associated with Speaker Programs?
- What risks do you mitigate for HCP Meals?
- What are the industry-wide best practices to mitigate risks?
To download, visit Key Risk Areas in Speaker Programs and HCP Meals to Keep an Eye On
Let us discuss the key compliance risk indicators, uncover insights from regulatory authorities, and see how life sciences companies are prioritizing the use of technology to enhance key compliance risk indicators ensuring adherence to the law.
Key Risk Indicator #1: Speaker Program Policy
A foundational element in managing compliance risks is the establishment of an effective speaker program policy.
Such a policy must be clear, comprehensive, and free from ambiguity to prevent misinterpretations that could lead to non-compliance.
A detailed speaker program policy should also specify the criteria for selecting speakers, outline the content and objectives of their presentations, and define the regulatory guidelines that must be adhered to.
By maintaining a policy that is both precise and up-to-date, organizations can significantly reduce the risk of compliance violations.
Compliance officers can also stay alert to incoming regulatory changes, i.e., updates to the laws that govern this area.
Regular training sessions for staff involved in these programs can also ensure that everyone understands and follows the established protocols, reinforcing the importance of enhancing compliance key risk indicators.
Key Risk Indicator #2: Honoraria and Expenses
Honoraria, as well as travel and lodging expenses, are areas ripe for potential compliance issues. Ensuring that these compensations are aligned with fair market value is crucial to avoid perceptions of undue influence.
Excessive payments or extravagant accommodations can raise red flags with regulators, suggesting that they are meant to induce favorable treatment rather than compensate for professional HCP services.
According to the Office of Inspector General (OIG), “when remuneration is paid purposefully to induce or reward referrals of items or services payable by a federal health care program, the anti-kickback statute is violated.”
Therefore, establishing clear, standardized guidelines for honoraria and related expenses helps mitigate these risks.
Compliance and finance teams can also leverage expense monitoring and auditing systems for auditing and monitoring expenses to enhance transparency and accountability.
Such a robust framework for managing commercial expenses can help companies uncover key compliance risk indicators and take timely action to address issues of non-compliance.
Key Risk Indicator #3: Educational Content
The educational content presented in speaker programs must be carefully curated to remain compliant.
Regulatory bodies such as OIG say that they are skeptical about the educational value of such programs. Their investigations have revealed that, often, HCPs receive generous compensation to speak at programs offered under circumstances that are not conducive to learning or to speak to audience members who have no legitimate reason to attend. – Special Fraud Alert: Speaker Programs
Read the blog to get more insights from the OIG’s updated Fraud Alert released in 2022
For this reason, the content should be educational rather than promotional. This means that presentations must be factual, unbiased, directly relevant to the therapeutic area being discussed, and focused on the betterment of healthcare and patient outcomes.
Companies should implement a review process to vet all materials before they are used in programs. Proper documentation of these materials serves a dual purpose: it ensures compliance with regulatory standards and provides evidence that the program’s primary intent is educational.
This proactive approach to managing educational content is a critical compliance key risk indicator and should be considered vital for assuring compliant engagement of HCPs and organizing speaker programs.
Key Risk Indicator #4: Venue and Entertainment
The choice of venue and the provision of entertainment during speaker programs can also pose significant compliance risks.
Venues should be appropriate for educational activities, avoiding any perception of luxury or extravagance.
Similarly, entertainment should be modest and related to the educational focus of the event.
Establishing specific criteria for venue selection and entertainment options, coupled with real-time monitoring, can help ensure that these elements remain within acceptable bounds.
By focusing on these aspects as compliance key risk indicators, companies can safeguard their programs against potential compliance breaches.
Key Risk Indicator #5: Legitimacy of Attendees
Ensuring the legitimacy of attendees is another critical component of managing compliance in speaker programs.
Attendees should be qualified healthcare professionals with a genuine interest in the topic being presented.
Companies must be vigilant in preventing repeated or inappropriate attendees who could compromise the integrity of the program.
Implementing technological solutions to verify attendee credentials and track participation can enhance the legitimacy and effectiveness of these initiatives.
According to the OIG, “inviting an audience of HCP attendees who had previously attended the same program or HCPs’ friends, significant others, or family members who did not have a legitimate business reason to attend the program” – Special Fraud Alert: Speaker Programs
Maintaining thorough records of attendance and participation is essential for demonstrating compliance with regulatory demands and addressing this compliance key risk indicator.
Regulatory Authorities Provide Guidance to Assure Compliance
In the ECCP 2024, the U.S. Department of Justice provides guidance for prosecutors on identifying non-compliant engagement of third parties.
Key indicators include discrepancies in expense reporting, inadequate documentation of speaker engagements, and signs of undue influence in the selection of speakers.
Prosecutors are advised to examine the transparency of financial transactions and the validity of educational content.
Even though the guidance provides directions for prosecutors, compliance officers, and life sciences companies can leverage it to improve their internal compliance controls and function to assure adherence to the legal standards.
By focusing on these compliance key risk indicators, regulatory authorities aim to uphold ethical standards and ensure that companies comply with legal obligations, thereby maintaining the integrity of industry practices.
How Life Sciences Companies are Leveraging Technologies to Improve Compliance Key Risk Indicators
To address compliance challenges, life sciences companies are adopting advanced technologies that enhance their ability to monitor and manage compliance risks.
Artificial intelligence, machine learning, computer vision, and other technologies are being used to enhance compliance programs’ effectiveness. Here are a few statistics you might want to consider:
According to a survey:
Artificial intelligence and machine learning technologies are employed to monitor interactions and flag potential compliance risks in real time.
By integrating such technologies into their compliance programs, companies can improve efficiency, ensure effective key compliance risk indicators are in place, and reduce the likelihood of human error involved in managing compliance.
Key Takeaways + Conclusion
- Establishing a clear speaker program policy is essential for compliance.
- Honoraria and expenses must be in line with fair market value.
- Educational content should be non-promotional and compliant with guidelines.
- Venue and entertainment choices must prioritize educational objectives.
- Ensuring the legitimacy of attendees is crucial for maintaining program integrity.
- Regulatory authorities emphasize transparency and documentation for compliance.
- Leveraging technology enhances compliance monitoring and risk mitigation.
For a deeper understanding and access to additional best practices, download our comprehensive guide. It offers detailed strategies and insights to effectively navigate the complexities of compliance in speaker programs HCP meals and more.
Schedule a demo today to see how qordata’s data-driven compliance platform helps life sciences companies to remediate commercial compliance paint points.
