Building a transparency reporting program is easy. Building an effective transparency reporting program, however, is much more challenging. Partnering with over a hundred medical device and pharmaceutical companies, I have had a first-hand opportunity to build from scratch, enhance and overhaul numerous transparency programs focused on U.S. and global reporting requirements. Through my experience, I found a few consistencies that always hold true.
Education is crucial. You can be as knowledgeable of the global transparency requirements as you want but, if those in the field working with healthcare professionals (HCPs), managing events or the third parties you engage with don’t have clear expectations on what they need to capture, then you will have a long road ahead filled with risk and uncertainty. Clearly outlining your company’s definition of an HCP and how that definition may change per region (i.e. New England with MA, VT, CT) is a great start to ensuring interactions are captured in detail for those whom would require reporting.
When your organization has a solid understanding on what is reportable, it is important to track the trends of where you are spending. In short, analytics are your friend. Not only do some jurisdictions offer guidelines of what you can do, they often provide you with expectations on what you can’t do. Having immediate visibility into potential red flags allows you to proactively remediate these risk areas prior to any submission requirements.
Understanding the full picture of your data may be the single most important part of building an effective transparency reporting program. I typically see this in four main components:
- Ensuring you have a comprehensive list of every internal and external data source (or provider) that captures transfers of value with HCP’s (i.e. your ERP System, T&E System, Reprints, CRO’s). You would be surprised, when you start digging around, just how many systems and vendors there are.
- Ensuring you have collected all transfers of value from all systems and sources, both internal and external, for the calendar year (or semester/month, depending on the global jurisdiction) into a centralized location. When you identify the systems, you need a way to track and confirm you have all the data from each.
- Cleansing the data to ensure you have all the necessary data elements to submit to each jurisdiction successfully. Managing all those different rules per jurisdiction is a job of its own, but the cleansing and analysis helps ensure smoother operation.
- Auditing each transaction to determine what is reportable and what isn’t (better yet, if you can outline why). Transparency reporting is all about trends, visibility and completeness. Having a 360-degree view of your data’s reportability across the globe makes you audit ready, if ever needed.
By working through the above steps, you are well on your way to building an effective transparency reporting program!
If you are interested in learning more about current transparency reporting requirements and how emerging organizations can use a flexible and scalable approach to take the burden out of meeting those requirements, click here to download our webinar Building An Effective Transparency Reporting Program (From the Ground Up).