Last month, Clinical Conductor CTMS hosted a webinar with Kelly Willenberg of Kelly Willenberg and Associates, to discuss what’s new for research billing in 2017. She discussed the updates to research billing regulations, went through new best practices in billing compliance, and taught listeners how to leverage tools and technology to minimize risk exposure.
As we begin 2017, we are aware that there are Medicare Advantage issues for both drug and device companies and that there would be continued progress with CTSU/NCI national coverage analysis. Pre-authorizations will be required by for clinical trial coverage and the unknown fate of the Affordable Care Act fills Willenberg with a sense of dread. The ACA could be repealed, and potentially replaced. Clinical trial coverage by clinical payers could be on the table, which is not ideal for those working in the clinical trial industry. The removal of coverage by clinical payers would be taking two steps backwards and would be detrimental for accrual.
With potential updates to regulations for billing compliance, Kelly discussed the clinical trial policy and what would happen if steps were taken to dismantle it. This would be detrimental to the clinical trial industry; even if the policy needs to be updated and clarified, the hope is that it would not be destroyed. Another potential update could be the final ruling update. ICF’s should include concise introductory information about the study to assist potential participants in their decision making. Would this impact billing? What about the expected cost section? Patients need to know what their liability is in an informed consent process.
So, what are some new best practices in billing compliance? Willenberg suggested that forecasting accrual for better accounting of expenses can strengthen a sites financial return. Research sites understand that they must have good budgeting to be successful, and know that investigator initiated trials and the impact they have the bottom line of a research department. Another best practice would be building sponsor relationships, with the cornerstone of that relationship being clinical trial billing compliance. These relationships are essential for any research site to maintain. Willenberg also suggested embracing coding team members and help them to understand the coverage analysis process.
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