Blog Contributor Amanda Miller, Training Manager, Clinical Research Administration, PFS Clinical
Spending a few days of February in Orlando was a welcome experience for the Wisconsinites of PFS Clinical. Even so, the knowledge my colleagues and I gained through the conversations and panels we enjoyed at the ExL Clinical Trial Billing and Research Compliance Conference was more valuable than the fortunate change in weather conditions. It was an eventful conference, which resulted in a lot of important takeaways that have kept us thinking. For those of you unable to attend—and for attendees who, like me, are still mulling things over-- here are some of the biggest clinical research billing and compliance lessons we learned from this event.
1.The answer to everything related to research billing compliance is, “it depends.”
Within just a few hours of the start of the conference, it became clear that the theme of the week would be: It depends.
Medicare rules are difficult to interpret and apply to the various clinical research protocol scenarios; thankfully, this conference welcomed experts ready to address these difficulties. Within our industry, we continuously seek clear-cut answers or interpretations regarding tricky Medicare rules and their application to study protocols. While not an exhaustive list, some of the most frequently asked questions within the industry include:
- When exactly are EKGs and thyroid tests billable to Medicare?
- How should items that fall under Coverage with Evidence Development be handled?
- What can be billed in a non-qualifying trial?
With so many intricate questions, I think all the conference attendees were excited to hear a Medicare contractor’s interpretations. Although we may have been hoping for direct answers to apply to our roles in research administration, within a few minutes of the contractor’s panel, it was apparent that concrete answers would not be our souvenirs from this trip. There are no clear answers for handling Medicare billing compliance, except for one: it depends.
The answer to any Medicare research billing compliance question will truly depend on the various factors involved in each particular study. Compliance cannot be met if details such as an individual study’s protocol, patient population, study product risks and toxicity profile, and sponsor budget are not considered. This means that as research billing compliance professionals, we all need to review coverage on a protocol-by-protocol basis. Just because something is covered under one protocol or has been commonly covered across various studies, we cannot assume that it will be covered in the context of the next protocol. Detailed analysis and critical thinking skills need to be applied to every protocol we encounter.
2. Coverage analysis has quickly become an industry standard.
The government does not mandate that all research organizations have a coverage analysis on file for all studies. Historically, this has meant that not all organizations have chosen to perform coverage analyses. When I attended the ExL Billing Compliance Conference in 2016, I talked to several organizations that had chosen not to include a coverage analysis in their studies. In fact, many had never heard of a coverage analysis. Now, two years later, nearly every attendee was familiar with the term, and the majority of organizations attending the conference regularly perform a coverage analysis for their studies.
3. CTMS software is everywhere, but how it is utilized is different for every research organization.
It is not an exaggeration to say that most institutions attending the conference have a CTMS. Some utilize all the system capabilities, while others have a system, but do not use it.
In many of the conversations that took place throughout the conference, several organizations talked about their experiences implementing and utilizing a CTMS. They indicated numerous institution-wide decisions that must be made before and during a CTMS implementation, such as (but certainly not limited to):
- How can/should the CTMS be integrated with other systems?
- Who should be responsible for data entry?
- Who needs access to the system, and what level of access should they have?
- What will the timelines be for data entry?
- Who builds the studies?
For a smooth implementation, research institutions must consider these items and decide how and where to structure policies to ensure all users have the information they need in the system. Hearing various organizations talk about their experiences with these systems, it was also clear that no CTMS is one-size-fits-all. The way certain functionalities are utilized may vary from one organization to the next. Institutions need to consider how the system will optimize their manual processes.
4. Disney adds a touch of magic to research billing compliance.
I am not sure I know anyone who would describe research billing compliance as magical, but talking about it in Disney World’s homebase really lightened up a somewhat dense topic. The fun was inescapable; we modeled Mickey Mouse ears and gloves, took time to enjoy the parks, and saw signs featuring Disney characters around every corner in the conference hotel. Even as we realized that the answer to our most challenging industry questions will always be, “it depends,” smiles never left the faces of anyone we encountered. It was a good reminder that our work in clinical research, while complex and often difficult, can be made more meaningful when we take the time to enjoy the people and places we come across in various explorations of our industry.
Now, if we could just wave a magic wand to solve all the research billing compliance challenges, we might have more time to spend in the Magic Kingdom.