Beginner’s Guide to Clinical Trial Billing Compliance

Ensuring proper billing compliance within clinical trials is often a confusing, but a very consequential task for research teams. Knowing applicable regulations and policies (e.g. national coverage determinations [NCDs]) and how certain items or services fall under these policies can greatly impact an organization, as well as their trial participants. This blog provides a beginner’s overview of clinical trial billing compliance and best practices to ensure charges and claims are properly routed to the correct billing entity.

What is Clinical Trial Billing Compliance?

Clinical trial billing compliance is the act of ensuring charges – such as therapies or treatments – in a clinical trial are routed to the responsible party. This may be a third party or a research account in accordance with applicable federal rules and state laws. Essentially, clinical trial billing compliance ensures you are charging the right party when someone is enrolled in a trial.

Why we Need Clinical Trial Billing Compliance

If clinical trial billing compliance is conducted improperly, sites may face financial penalties as a result. Furthermore, incorrect billing may trigger the False Claims Act at the federal level, as well as other fraud type occurrences at the state and local levels. It’s important to get billing compliance right to put participants who are volunteering for a trial at ease. They should not be burdened with an additional item that they don’t have much control over. While many are giving their time and effort to be part of a trial, if they get an unforeseen bill, that’s another hurdle or burden that’s put on them, and it shouldn’t have to be that way.

What are the “Rules” to Clinical Trial Billing Compliance?

In 2000, the Centers for Medicare and Medicaid Services (promulgated a rule stating Medicare will cover some charges for those beneficiaries enrolled in clinical research. While this rule was updated in 2007, prior to 2000, this wasn’t allowed, but Medicare now ensures costs are covered if someone were to enroll in a clinical trial. This new rule uncovered an entirely new allowance on coverage and reimbursement, as well as opened up new demographics for sites seeking new trial participants.

Medicare and Medicaid have provided the most specific rules to date, and as a result, most insurers comply with these rules. Generally speaking, if you are billing in compliance with Medicare rules, you are compliant everywhere.

In addition, in 2010, the Affordable Care Act provided provisions to allow third-party payors to cover some items and services in the context of a clinical trial. This allowed for further clarification from both Medicare and commercial payers to outline what exactly they will or will not pay for.

Best Practices to Following These Rules

Becoming aware of these rules can save your institution and your participants money and time in the long run. The best thing you can do is educate yourself on the rules surrounding research billing compliance. In addition to Medicare, there are state-level and Medicaid rules to understand, although for the most part, they mirror Medicare rules. However, there may be nuances between the different levels, and it’s important to understand where those nuances may apply.

It’s also helpful to identify when your participants are being treated. There’s no way to bill properly if you don’t know if a patient is coming in for research purposes or a normal healthcare visit. Once you have identified each visit, make sure the charges flow in accordance with the established Medicare and Affordable Care Act rules.

Lastly, release the charge in a manner the payor accepts. Medicare has specific rules on what types of codes and modifiers need to be added to a charge when it’s submitted for reimbursement. Knowing these ahead of time will save you time, as well as advance timely payments for submitted charges.

For the most reliable information on clinical trial billing compliance, it’s helpful to check first with the organization’s billing entity. If they aren’t able to provide clarity, the next step is to seek guidance from a compliance official or a general counsel.

What does Regulatory Enforcement Look Like?

There haven’t been a lot of for-cause audits specifically due to research billing from the government. Since 2000, the government put other checks in place, such as coding and modifiers to append. Through these mechanisms, they can monitor compliance at institutions.

Instead of anticipating a for-cause audit specifically for research billing fines, there’s a more pragmatic approach to take. Putting your participants first will change the focus on how to conduct proper billing compliance.

One way to develop an effective regulatory compliance framework is having an easy-to-use set of tools ready for your team. Developing coverage analysis to identify responsible payers for treatment in a clinical trial is a good start. In addition, healthcare providers can use their electronic medical record (EMR) and billing system as well as leverage their clinical trial management system (CTMS) patient tracking functionality. Through a CTMS, staff can identify the patient and their research items or services before they walk through the door. A good CTMS tool can enable staff to identify what can be billed through the coverage analysis process.

While billing compliance may seem like a complicated task, research operations teams taking the time to stay educated on local regulations as well as Medicare rules will equip their organization for billing compliance success. Keeping the participant’s safety at the forefront of a regulatory compliance framework ensures accurate and timely billing is always conducted.

Back to Resources