Aegis Compliance & Ethics Center, LLP
Standards for Billing Grid Development
Your Medicare Coverage Analysis (“MCA”) may not be mitigating as much billing risk as you think.
While many resources discuss a process for determining the coverage of specific items and services performed during a clinical research trial, few outline or offer guidance as to how the Billing Grid should be developed. This lack of standards could lead to Protocol required items and services being left off the Billing Grid, which could potentially leave your research program susceptible to billing risks.
Why Don’t Standards Exist?
As convenient as it would be to have universal standards, that is just not plausible in the current Clinical Research Billing (“CRB”) environment. Too many variables and institutional preferences exist that organizations must account for. For example, are your MCAs developed in Excel or built directly into a Clinical Trials Management System (“CTMS”)? From a build perspective, there’s much more flexibility when developed in Excel, whereas a CTMS would require a more rigid and calendar-like structure. It’s also important to understand how the MCA will be used by other departments or teams within your institution once it is completed. An MCA only used for directing charges may look different than one that is also used by the Study Team to track patient visits and study data. Additionally, the way in which repeating treatment cycles, unscheduled visits, laboratory panels, conditional items, and bundled services are included on the Billing Grid can impact the development process. These are just a few of the many decisions that must be thought through during the build-out process.
Common Pitfalls in Grid Development
While no exact formula for developing a Billing Grid exists, organizations can take certain steps and avoid certain pitfalls in order to ensure the most accurate grid possible. First, it should never be assumed that the Protocol’s Schedule of Events (“SOE”) is adequate enough on its own to act as the Billing Grid. This is often a great place to start the development process, but it rarely contains all of the information regarding specific items/services and the time points at which they occur. In addition to the Protocol, it is important to review the Informed Consent Form (“ICF”) and Budget for items/services that the research team will utilize or perform during the trial. These documents are often tailored towards the specific site conducting the research study and may include items or tests required by the institution that are not set-out in the Protocol. If these services are promised free in the ICF or paid for by the Budget, their inclusion on the MCA is pivotal. Next, visits to confirm disease progression are often not included in the SOE and, subsequently, left off of many Billing Grids. This time point resides in many oncology trials and can be one of the more difficult to address as the timing of it may vary by patient. Another pitfall to avoid is using generic lines or descriptions to capture multiple services that are separately billable. For example, instead of adding a line for “Imaging Assessments,” best practice calls for breaking this out by imaging modality (MRI, CT, X-Ray, etc.) and body area. In the event that the clinical guidelines support coverage for some but not all Protocol required scans, different billing designations can be applied appropriately. Conversely, using the generic line could lead to A) requiring more funds from the sponsor if all scans are designated as not billable, or B) incorrectly billing for scans that are not covered if designated as billable. In this scenario, outcome “B” poses a much greater compliance risk. Laboratory assessments present another area where generic lines are commonly found. It is best practice to break these out into individual lines or panels (if all of the components of the panel are listed).
Researchers do not write protocols with billing in mind, so it can be difficult to parse through and extract the information needed to create an accurate Billing Grid and MCA. And while universal standards may not exist, it is important for institutions to understand how their MCAs are being used and develop internal standards that facilitate consistency and compliant billing.