Participating in Qualifying Clinical Trials? Implement These Best Practices to Ensure Compliance

By Kayla Leverton | Director of Sales & Marketing for Community Sites, Forte Research Systems
January 5th, 2017


Summary: Billing compliance can be particularly difficult for clinical research sites participating in qualifying clinical trials. Use these tips to decrease your risk for non-compliance and gain the revenue you rightfully earn.

Estimated reading time: 3 minutes

Billing compliance is one of the biggest challenges in clinical research, particularly for small- to mid-sized clinical research sites. That holds especially true in the case of qualifying clinical trials, or clinical trials where insurance providers cover routine costs required by a protocol. In these situations, Medicare and Medicaid are considered the standard on which clinical research billing decisions should be based. If Medicare/Medicaid would cover the cost of a study-related procedure, or a procedure considered a “routine cost,” a site should bill a subject’s insurance provider for the cost of that procedure instead of billing the sponsor.

Qualifying clinical trials introduce even more complexity into the already-difficult process of accurately billing for the research your site completes. Inaccurately billing an insurance provider for study-related expenses could result in insurance fraud charges under the False Claims Act, which could lead to consequences as dire as a research site being forced to shut down its practice entirely.

When faced with this risk, sites without reliable internal compliance processes often forego billing insurance providers altogether. Without processes in place to delineate which study-related charges are considered routine and which are not and should therefore be billed to the sponsor, sites tend to err on the side of caution. Research organizations often opt to bill the sponsor for all study-related charges to avoid the possibility of inaccurately billing insurance. However, because sponsors aren’t responsible for covering routine costs for qualifying clinical trials, they forego payment on those items when billed.

In short, if your research site doesn’t have a standard process for earmarking and billing insurance providers for routine costs when participating in qualifying clinical trials, you’re likely missing out on significant revenue you’ve rightfully earned. Here are some basic clinical research billing tips you should consider implementing, particularly if your site participates in qualifying clinical trials:

Make internal education a priority

The first step to clinical research billing compliance is ensuring your staff understands what compliance involves, along with the risks associated with non-compliance. Develop a plan you’ll follow to educate your staff on clinical research billing compliance, and stick to it. This may involve sending your staff to an external training, or bringing in an expert to help your organization get a plan in place. While the cost of billing compliance training can be significant, you should ultimately view the cost as an investment in your site’s future that will inevitably pay for itself.

Clearly define compliance processes, roles and responsibilities

How will the clinical staff communicate to the people managing charges who should be billed for which procedures? What steps do you expect your staff to follow to prevent double-billing? It’s important to clearly outline your organization’s method for ensuring clinical research billing compliance.

Consider streamlining compliance workflows through the use of a CTMS

Thankfully, managing your clinical research billing doesn’t have to be an entirely manual process any longer. Allegro CTMS is now equipped with functionality that allows users to easily indicate which agencies should be billed for which protocol events. This new functionality makes the process of billing for qualifying clinical trials more streamlined than ever.

Billing compliance is just one area where a CTMS can help your site streamline operational workflows. Check out this overview document for a summary of all the benefits Allegro offers sites. If you’re ready to implement a CTMS and optimize your site’s operations, contact us today to attend a demo, so you can see Allegro’s full range of functionality in action.

About the Author

Kayla is the Director of Sales & Marketing for Community Sites. In this role, she drives the strategy for promoting Forte’s ecosystem of products to the community site market. Kayla works directly with research sites to understand their operational challenges, and to offer education and software solutions to resolve those challenges. Kayla is an active contributor to Forte’s content team.

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