Speaker engagements offer the healthcare ecosystem opportunities to learn about new drug therapies, medical devices, and cutting-edge procedures. Life sciences rely on them as a way to spread the word about innovative practices that can improve patient care. However, regulators affixed a target on these programs, monitoring them to ensure compliance. Thus, it makes sense for organizations to employ speaker management software.
In many cases, pharmaceutical companies and medical device managers develop programs to educate healthcare professionals (HCPs). However, it can be an avenue for abuse. This post will break down the areas of risk for speaker programs and how software for managing speaker programs is an effective risk mitigation solution.
OIG Issues Special Fraud Alert on Speaker Programs In November of 2020, the U.S. Dept. of Health and Human Services, Office of Inspector General (OIG) issued a Special Fraud Alert regarding speaker programs. In the memo, the OIG called speaker programs "inherently risky."
Further, they question the educational value of them. It also identified "suspect characteristics" of speaker programs that elevate the risk of anti-kickback statute (AKS) and False Claim Act (FCA) violations. As you're aware, the AKS prohibits the exchange of remuneration for prescribing medications or recommending devices. Those characteristics include:
The OIG's move to publish the alert comes after reviewing studies that confirm HCPs who receive payments are more likely to prescribe or purchase from the payer. The alert ended with these words of advice, maintaining that risks remain, even though in-person programs have been on pause during the pandemic. The OIG urged life sciences companies to "assess the need for in-person programs given the risks associated."
The OIG has always targeted speaker programs, recovering settlements, and filing civil and criminal charges against companies. Two recent examples foreshadowed the publication of the Special Fraud Alert.
In June of 2019, they announced a $225 million settlement against opioid manufacturer Insys Therapeutics . Some of those allegations revolved around sham speaker events. The DOJ found that the programs were merely a vehicle to funnel money to practitioners in exchange for prescribing their drug Subsys. In one example, a physician assistant who had never prescribed the medication before wrote over 672 prescriptions for it after they joined the program.
In June 2020, the DOJ confirmed a $642 million settlement with Novartis relating to claims of violating the FCA. Part of this agreement was to settle allegations they hosted lavish social events, not educational programs. Novartis is also now under a Corporate Integrity Agreement (CIA) that will dictate future speaker events.
Regulators are paying very close attention to speaker programs to ensure they comply with laws and are legitimate. How can your organization continue to run a speaker program that's lawful and impactful? Speaker program software is an excellent solution for tracking and monitoring.
Technology is a tool that simplifies complex processes, so it should be a crucial aspect of your speaker program. With speaker program software, you'll have one central place for all event details. Such a program is complex from a logistics, planning, and compliance aspect. Thus, your software should support all these.
Reporting Financial Relationships Is a Requirement
Pharmaceutical companies are well aware of their healthcare compliance obligations, especially those regarding their financial relationships with providers. The Sunshine Act made the open reporting of these a mandate. However, just because you report them doesn't mean they are compliant.
An integrated platform offers peace of mind, transparency, and organization. Here are some of the important features you'll want to seek.
With all the data about the event, including HCP engagement, attendees, and costs, you'll be able to create compliance reports with ease. This reporting can identify potential risks and mitigate them based on regulatory guidelines. The data points that should be caputred by the software for compliance and reporting include:
Users will appreciate solutions with an intuitive dashboard that offers fast access to data analytics and reporting tools.
Managing speakers is another must-have for your software. It should enable Key Opinion Leader (KOL) oversight by securely capturing and storing profile information and product usage. Speakers and KOLs can also benefit from access to pre-approved decks, training materials, and other resources through the platform.
Additionally, the feature should provide robust tracking of honoraria payments and expenses to comply with the Sunshine Act. Beyond your reporting, look for a solution that lets HCPs search and compile their own compliance reports and register for events.
Speaker programs are events, and lots of work goes into making them a success. Managing those aspects within one platform is a win-win for organizations. Opt for software that helps your team be more productive. Here are some must-have functions for this category:
A speaker program can still be an effective channel for education and information. While COVID-19 prevented many events from occurring in 2020, there's hope on the horizon for in-person interaction. As you plan the next steps of your speaker program, move forward with practical software. You can't afford not to, as financial and reputational harm are real, serious consequences.
Explore our speaker program software today by requesting a demo. It delivers everything you need to manage events and ensure compliance.
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