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Managing billing compliance is one of the most widely discussed topics in the clinical research community. With dozens of potential issues associated with billing, it makes perfect sense why so many people take it so seriously. Effectively managing billing activity for clinical trials can be a difficult, time consuming and arduous process, with the potential for serious consequences that include lost revenue, fines, ethical and legal issues and damage to an organization’s reputation. There are many factors that lead to inaccuracies in the billing process, many of which revolve around the Medicare Coverage Analysis (MCA). The purpose and type of the clinical trial, the state in which research activities are taking place, the patient’s insurance company and the types of third parties that may be performing some of the services all influence what can and cannot be billed, in what amounts, and how that revenue must be tracked and reported. There are several options for technology-based solutions when it comes to managing billing activity; however, the ultimate tool is a clinical trial management system (CTMS). A CTMS is the ideal tool because not only will it track billing to the necessary levels of granularity, but it will also allow users to align specific clinical activities with specific billing actions.
One major concern for research organizations is MCA. Ensuring that each research activity is billed correctly is critical. A CTMS provides flexible mechanisms for configuring billing rules – whether they are as simple as one variable or complex and dependent on patient condition, history, treatment arms or geographic location.
Dealing with highly complex rules is another difficulty that billing and research professionals face with each study. When complex rules are present and billing decisions or judgment calls need to made, the CTMS should make billing rules available in an easily accessible, clear and unambiguous way. Additionally, when decisions or judgment calls need to be made, the CTMS should automatically capture as much supporting data as it can and, for the rest, prompt users for reasons and explanations. This data should then be available for audit and analysis purposes. This way, there is a complete record of all activity and the rationale behind each judgment call that was made.
Finally, tracking the compliance of third parties can be a nightmare. One way to avoid the headaches is to use a CTMS, which will help to keep a detailed record of all research activity that takes place between patients and third parties, such as labs or imaging centers. Additionally, providing “portals” for direct entry of services performed by third parties allows for real-time tracking, automated billing feedback and instant alerts.