Last month, Clinical Conductor CTMS hosted a webinar with Amanda Miller and Jill Surfus of PFS Clinical to discuss how to edit budgets for better billing compliance. They discussed the basics of billing compliance, budget overviews, common issues in sponsor budgets and document sync.
The webinar started by going over research billing and compliance basics, and discussing the research compliance process. In the research billing compliance process, the first step is receiving the budget and the contract from the sponsor. From there, a coverage analysis and internal budget is developed, that budget and contract are negotiated and the potential CTMS build is completed. Finally, the study opens and the billing begins! A review of coverage analysis should occur prior to billing the patient and invoicing the sponsor. Jill and Amanda also went over coverage analysis goals, which are used to determine if the study sponsor or insurance will pay for the items or service required by the study. If the insurance company pays for the item or service, then justification for billing should be provided. This is important from a billing compliance perspective because your site cannot receive payment from the patient and the sponsor for the same item. From a financial perspective, your site needs coverage analysis to ensure that each protocol driven item has a payer.
Jill and Amanda also dove into budget overviews. Sites should develop an internal budget to allow sites to see the actual cost to conduct the study. This should be more detailed than the sponsor budget, and could be built in Excel or a clinical trial management system depending on the sites needs. They recommended that it include additional comments and clarifications, and can be formatted to meet internal needs.
The webinar presented an overview of internal budget process requirements. Jill and Amanda recommend using standard template to simplify the process and maintain consistency. Larger systems may need more than one template depending on how the pricing is structured. They suggest researching the pricing for common items and services required by the protocol, record the staff hourly rates or average hourly rates, and include a list of standard administration fees to request.
Jill and Amanda outlined an example internal budget process for the webinar attendees. Organizations can start with the Coverage Analysis Grid, where they follow coverage analysis designations and are unable to budget for items marked as SOC. Next, an internal budget is created, which is used to calculate the actual costs of completing the trial. Then, the sponsor budget needs to be updated; edit the sponsor budget as required based on the internal budget and coverage analysis. Next, negotiate with the sponsor until the budget is approved and compliant with all rules and regulations. Finally, Jill and Amanda say to update documents and make sure that the internal budget, sponsor budget, coverage analysis, and consent documents are consistent.
Finally, Jill and Amanda gave a variety of examples of common compliance edits in sponsor budgets. They took attendees through multiple scenarios of sponsor budgets and then identified the issues with each example. This gave attendees the ability to view example budgets and see where errors could occur.
Interested in learning more about Clinical Trial Software and editing budgets for better billing compliance? Click here to listen to the entire webinar feature Jill Surfus and Amanda Miller of PFS Clinical.
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