NEWS & EVENTS

Balancing Commercial Needs and Compliance Controls for Effective HCP/O Engagements

For life science companies, paid engagements with healthcare professionals and organizations (HCP/O) are crucial to growing your business. However, with enforcers turning a closer eye to monitoring engagements, ensuring and maintaining compliance can slow down your process. How does your organization supercharge its business growth, but do so compliantly?

These paid engagements remain a key strategy among life science companies. Everyone from emerging biotechs launching their first drug, mature pharmaceutical companies marketing drugs in multiple therapeutic areas and medical device companies developing innovative technology that improve the lives of patients would agree that partnering with HCP/Os provides them with unparalleled insight and guidance regarding:

  • The drug development process
  • Regulatory requirements
  • Efficient and effective marketing strategies
  • Patient needs

These engagements are important for an organization to build, maintain and compliantly manage relationships with key opinion leaders and HCP/Os, but they’re met with increased scrutiny. For example, in December 2020, we saw the first special fraud alert in 6 years by the OIG outlining renewed interest in the policies and controls for paid speaker and promotional activities. Risks stemming from the Anti-Kickback Statue are broad in nature and require overarching controls. The impact to life science companies for non-compliant engagements go beyond paying fines. It may lead to costly consultants, IRO’s, monitoring, significant reduction in R&D investments and a negative impact to public reputation which can impact everything from accessing funding to hiring talent.

So, how do we ensure that all paid engagements with HCP/Os are done compliantly? The answer is through a combination of innovative technology and data driven insights which give your commercial team the freedom to plan their engagements with the embedded controls needed to give compliance peace of mind. Let’s take a deeper look into what this means.

In 2017, MediSpend launched Engagement Manager which is an innovative, SaaS-based solution designed to enable life sciences companies to plan, engage and pay HCP/Os for activities that meet company objectives such as advisory boards, speaker events and consulting arrangements. Engagement Manager was designed to provide life sciences companies with the strategic advantage of data-driven insights into these engagements that is needed to grow your business compliantly while also proactively monitoring risk associated with each paid activity type. Engagement Manager achieves this through three key steps:

  1. Embedded Compliance Controls:
    Engagement Manager enables life sciences companies to embed their policies, procedures and code of ethics as they relate to HCP/O engagements. For example, you may decide that each paid engagement be accompanied by an approved Needs Assessment to ensure there is a legitimate business need for the specific engagement type, and that legitimate payments are made to HCP/Os by utilizing only corporate approved Fair Market Value rates.

    Engagement Manager also allows you to embed Contracting controls to ensure legal oversight of all paid engagements, embed Payment Controls to provide financial oversight and embed Document Controls that provide a closed-loop process that centrally locates all company-wide paid engagement documentation for audits.

  2. Intuitive Task Driven Workflows
    Engagement Manager includes the ability to configure workflows based on your companies’ business processes to further ensure compliance. Once an end user who is planning an engagement completes a mandatory task, a notification is routed to the assigned stakeholder to review, approve and/or complete a specific task necessary to ensure proper oversight.

  3. Data Driven Insights & Analytics
    Engagement Manager allows you to easily analyze the data that is meaningful to your organization. Ad-hoc dashboards provide the ability to drill down and distill critical data while self-service report creation allows you to make iterations effortlessly as new data becomes available. Engagement Manager offers the capabilities needed to proactively monitor risk with each paid engagement while also serving up the insights needed to help inform future business decisions.

Growing your business through effective HCP/O engagements while adhering to compliance doesn’t have to be difficult. Compliance and commercial organizations can continue to collaborate in a manner to help grow the business compliantly without decreasing the number of paid engagements with the healthcare community. These engagements are important in growing your business and are very valuable in advancing healthcare to save lives. For more information, please visit MediSpend or contact me directly at shouston@medispend.com.

Seth Houston

Chief Commercial Officer


Posted on Apr 27, 2022 1:09:23 PM

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