Kelly Willenberg & Associates

Medical Documentation in Billing Compliance

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Good documentation related to medical necessity is your defense for billing compliance when you have a solid coverage analysis to back up how you intended to bill before your study started. When there is a review in billing routine costs in a qualifying trial, the medical documentation matching up with proper orders helps a tie everything together. Study coordinators can sometimes assist a physician to address documentation in the electronic medical records surrounding the clinical trial. Every piece of information can be utilized for the case report forms and the competency of the care when you have good documentation.

Utilizing your study calendar, coverage analysis or grid within a CTMS can help to describe events accurately and objectively. Documenting the consent process and assessments help with the overall review of a patient’s complete disease process. Describing in the patient’s own words or their understanding of the consent can also confirm the patient made a well-informed decision about participation in the trial.

Consider how you document late entries or protocol deviations as well, as they can impact something on a study calendar. This information can sometimes be helpful when clarifying what actually occurred with the patient. Good documentation can be a coordinator and PI’s best defense when a claim is denied or reviewed. Document wisely!