In the biopharmaceutical industry, phases of innovation and change are often driven by regulatory action. The Office of the Inspector General’s (OIG) 2020 special fraud alert, focused on Speaker Programs, explicitly states that the OIG is “skeptical about the educational value of such programs.”
As a result, there have been some important updates to the PhRMA Code, as well as shifts in how we plan and manage Speaker Programs. These updates include prohibitions on companies providing alcohol at events, restrictions on attendance by health-care practitioners (HCPs) to substantially similar programs, and establishment of the importance of a bona fide education need.
Back to Basics: Assessing the Need for a Speaker Bureau
Formal, written needs assessments should be a foundational exercise for Speaker Bureaus, just as they are for medical education and continuing medical education. Speaker Bureau Compliance Director Jenny Murphy at ClinicalMind notes, “A needs assessment is an ever-important first step to ensure program compliance, and it can serve as a useful road map to help teams simplify communication, effectively implement and execute programs, track adherence, and guide future program development. Furthermore, it is a best practice to review and reassess annually.”
Here are four essential considerations for Speaker Bureau and how they can simplify compliance:
1: Content and Program Format
“Last year’s topic, with a twist” does not cut it for Speaker Program content. Assessing and documenting the need to educate HCPs who treat the patient population you serve is the foundation on which a Speaker Bureau needs assessments should be built.
A collaborative approach to defining the educational need works best. Combine the expertise of compliance professionals, scientific staff, data analysts, operations management, and a learning design team to create thoughtful rationales for each Speaker Bureau. Following are a few questions to ask:
- What new science, indications, or emerging data must be understood for HCPs to improve patient care? This question should be in the initial assessments and reassessments because the OIG fraud alert specifically questions the continuation of programs when “there has been a significant period of time with no new medical or scientific information nor a new FDA-approved or cleared indication for the product.”
- Have there been shifts in the system of care that require understanding older data in a new context? For example, have new clinical guidelines been released? Are the various roles in patient care evolving?
- Are there significant, empirically demonstrated gaps in care that need to be addressed (e.g., racial disparities)?
2: Match Curriculum Design with the Program Format
There’s no escaping it: everyone consumes information and learns in quite different ways than in previous times, including HCPs. The OIG recognizes this, noting, “HCPs can access the same or similar information provided in a speaker program using various online resources, the product’s package insert, third-party educational conferences, medical journals, and more.”
We understand that reading a package insert, while informative and important, may not necessarily be an engaging or complete educational experience. When addressing important issues of patient care, both the didactic and human elements of the content are important.
Decisions about learning format (e.g., in-person, live, virtual, on-demand, asynchronous) are deeply connected to educational effectiveness. For example, content is easier to defend when the educational design specifically encourages or requires faculty and attendee interaction and engagement.
Being creative with curriculum design and using modern, validated teaching techniques help establish the need for specific learning formats. According to Ms. Murphy, “Thoughtful curriculum design better engages audiences, fosters collaboration and learning, and supports the continued need for in-person education.”
3: Speaker Nomination and Selection
The selection of program faculty is another area of intense scrutiny. The OIG states a “suspect characteristic” of a Speaker Bureau is when a “company’s sales or marketing business units influence the selection of speakers” for the bureau.
As a result, it’s critical to establish clear guidelines for speaker selection separate from commercial interests. Today, artificial intelligence and data science techniques simplify this. Christy King, head of Data Science at ClinicalMind notes, “Speaker selection used to rely on very few variables. Today, we have access to a wealth of data and smart algorithms that can help companies paint a multidimensional picture of potential speakers that’s objective, compliant, and highly effective.”
Implementing a systematic, technology-driven nomination process is a best practice. ClinicalMind, for example, developed an automated Speaker Nomination tool for our cloud-based engagement platform, CMGO. According to Shirin Masica, director of Speaker Bureau management for CM, “Speaker nomination can be a very labor-intensive, time-consuming process. The automation that CMGO provides really takes a burden off our clients and offers a careful record of compliance criteria and approvals.”
4: How Will Compliance Be Tracked and Reported?
Tracking and documenting program compliance, especially across multiple products or franchises, has traditionally been a spreadsheet-fueled challenge. Part of a program plan must include how data are collected, reviewed, stored, and available for audit. Fortunately, Speaker Bureau management technology has evolved rapidly. Newer systems, such as CMGO, have transformed Speaker Bureau technology from a loose collection of siloed systems into one system with powerful automated compliance and reporting tools built right in to manage everything from compliant venue selection and attendee data across an organization to speaker nomination, contracting, training, and utilization.
ClinicalMind is a rapidly growing health-care communications company known for providing innovative technology solutions, outstanding scientific storytelling, and an exceptional client experience. ClinicalMind combines a diverse portfolio of capabilities into a seamlessly integrated set of solutions for biotechnology and pharmaceutical clients. For more information, visit http://www.clinicalmind.com.