JOURNAL ARTICLESDeveloping a ResearchFinancial and BillingCompliance PlanTracy Popp, MBA, CHRC, CRCP, CCRPEducator, A Clover Group LLCTracy Popp, MBA, CHRC, CRCP,CCRPAbstract: Clinical research professionals often 昀椀nd themselves apprehensive about research 昀椀nances and patientbilling. This article delineates controls that can be implemented to identify and mitigate 昀椀nancial and patient billingcompliance errors, thereby providing a framework for the development of guidelines for a 昀椀nancial and patientbilling compliance plan for clinical research sites.Introduction to the Financial andBilling Compliance PlanIn the realm of clinical research,compliance often carries a negativeconnotation, implying wrongdoingand potential consequences.Clinical research professionals mayonly encounter compliance teammembers when mistakes have beenmade. However, it is essential torecognize that clinical research is alsoa business balanced with science,where 昀椀nancial considerations playa crucial role. While patient billingcompliance has long been a focalpoint in conferences and publications,accounting/昀椀scal management isoften overlooked, even in discussionssurrounding budgeting and contracts.A comprehensive patient billingcompliance plan for clinical researchsites must encompass 昀椀nancialaspects as well.Finance and patient billing complianceconstitute distinct but equallysigni昀椀cant components (Table 1).Patient billing compliance involvesclaims and patient tracking, while the昀椀scal aspect encompasses invoicingTABLE 1Financial and Billing Components of Clinical Research••Financial component:o Final budgeto Final informed consent formo Budget negotiationso Clinical trial management system study build:- Financial side (stipends, revenue, and expense)o Accounts payableo Accounts receivableo Monthly reports:- Financial reports (income statement, balance sheet,and study funding)- Electronic medical record (EMR) activity- Stipend activityBilling compliance component:o Final budgeto Final informed consent formo Budget negotiationso Clinical trial management system study build:- Patient activity- Coverage analysiso Monthly reports:- EMR activity- Stipend activitySOCRA SOURCE © November 202423
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