Score a home run when resolving clinical research trial claim edits

Clinical research studies can offer enormous benefits for patients and provider organizations. But managing charges and submitting claims for clinical research can throw a curveball at revenue integrity teams. Without efficient charge and edit management processes, revenue integrity could find itself striking out.

At SCL Health, a multistate health system based in Broomfield, Colorado, Valerie Clark, MBA, CPC, CPCO, compliance-privacy officer, acute revenue cycle, directs the clinical research work queue. As director of revenue integrity, she oversees a team of revenue integrity coordinators who work through the sometimes-tricky clinical research edits. Solving edits that trigger within the middle of the revenue cycle process and ensuring clean claims are submitted for payment requires that Clark and the revenue integrity team be looped in from the first pitch—when the research study is initiated.

“When we contract with an entity for research, we get a number of different things from that entity. We get what CPT® codes they will cover, what we should bill, all the protocols of the research study,” Clark says.

For a smooth and accurate pitch, it’s key that research program staff at the operational level enter accurate and complete contract information into the Epic-tied research module. The clinical research payment schedule is connected to SLC’s chargemaster. However, the facility’s standard charge typically does not match the expected contracted payment, so a few extra steps must be taken to adjust charges to fit the contract billing protocols, Clark says.

SLC’s standard charge for a service might be $200, but the research contract might stipulate that SLC bill $150 for the service. Epic pulls SCL’s standard $200 charge from the chargemaster, and then triggers an automatic system adjustment to net down total charges to the contracted fee. This prorated adjustment on the front-end reduces the manual work for revenue integrity staff. However, it still triggers a claim edit if the charge isn’t correctly adjusted; therefore, the claim is caught for review on the back-end of the revenue cycle.  

The nature of clinical research means an extra layer of refinement must be added to charge management. Many patients who opt into a clinical research study will be established patients at the facility and will continue to receive care outside of the research study. Sometimes, a patient might receive treatment as part of a clinical research study on the same day as an appointment for an unrelated condition, Clark says. For example, a patient participating in a breast cancer clinical research study might be seen as part of the study in the morning and then be treated for a heart condition later that day. The second, non-research related encounter must be kept partitioned off from the research encounter, Clark says.

So how can these encounters be separated? Epic’s research module can be designed to trigger edits within patient accounts based on CPT codes flagged for clinical research studies, but that’s a broad approach that could inadvertently catch unrelated accounts, Clark says. To help refine the process, providers participating in the clinical research study must mark the account as research-related in their documentation so that information is recorded within the patient account in Epic.

Then the claim will pass through a defined set of edits in Epic based on contractual specifics. If edit conditions are met, Epic drops the claim to the research work queue to be reviewed by revenue integrity. For example, if an account includes CPT codes tied to a clinical research contract but the charge is missing a modifier, the CPT is not accurate based on medical record documentation, or there is incorrect chargemaster linkage, it will hit an edit and the charges will stop in the revenue integrity research work queue to be reviewed, Clark says.

“It may be that on the operational end a CPT code for an ultrasound was used but that’s not the appropriate CPT based on the research protocols,” Clark says. “Or it may have been the right CPT code and it was marked as a research service when it shouldn’t have been.” Edits are set for various scenarios where charging does not quite match up with the protocols entered in the research module. When triggered the edits move the questionable charges to a work queue where a revenue integrity coordinator reviews charging and medical record documentation.

The revenue integrity coordinator reviews the reason the charges erred, the corresponding medical record documentation, and the study protocols to ensure that charges are accurate. The edit might note that a research-related claim for an ultrasound shows a CPT code mismatch, meaning that the provider marked the account as related to a particular clinical research study but none of the covered study’s CPT codes are charged, Clark says. The revenue integrity coordinator will then look up the CPT codes covered within the clinical research contract to see where the mismatch occurred.

The coordinator might see that, per the terms of the contract, the wrong ultrasound code was used. The analyst reviews the ultrasound documentation to determine whether the appropriate code was selected based on documentation. “They’ll see if the correct code was selected and then make a decision on whether or not that’s outside the research protocols and they need to unclick the research box on the patient account or note that coding picked up the wrong code,” Clark says.

In some cases, it is determined that research charges need to be moved to a client account bill so that a statement is sent to the research entity rather than a claim form and only charges performed outside the research study are billed on a claim to the patient’s insurance carrier, she adds.

If charging is accurate based on the contract information, charges are released from the work queue and moved to claim production, according to Clark. If charges are inaccurate, the revenue integrity coordinator contacts research administration at the care site. They review the documentation together and discuss the changes that need to be made to the account and then the operational staff make the necessary charging corrections. This extra step of reaching out to the research administration allows for internal audit controls to be met. Once the edit is resolved, the claim will be released to move through the rest of the billing process and released to the payer.

Another nuance occurs when a federally approved research study with registry requirements is identified such as when charging information must be reported to CMS, Clark notes. When a study is registered with CMS, the charges cannot be split so different variables are validated by the revenue integrity coordinator. These types of charges must have specific value codes, transaction identifiers, and modifiers added before the claim can be submitted to the Medicare Administrative Contractor for payment.

With so many variables, research claims can be complex to manage. But an efficient, informed revenue integrity team can resolve edits to score a win for the entire organization.