Q&A: Applying metrics to financial performanc of clinical trial claims

Q: Are there are metrics we can use to determine whether our clinical trials are financially successful?

A: The commitment to clinical research while maintaining adequate financial performance for the entire healthcare system is difficult to achieve. The following group of metrics will help an institution evaluate the success of its current operational strategies:

• Insurance denials per trial: Data results from this metric will require further investigation should there be a higher denial rate than expected. Any one or more of the following elements associated with the trial may have contributed to increased denials:

1. Accuracy of the reimbursement analysis/MCA: If the denials data demonstrates a trend over time for a particular disease and/or procedure, then the organization should carefully evaluate the determinations denoted on the reimbursement analysis/MCA. Information gained from this evaluation will assist with future MCA developments on the next selection of clinical trials.
2. Accuracy of the ordering specifications: Understanding the intent of ordering the item or service helps downstream workflow, which enables more accurate and appropriate processing. If frequent errors are discovered due to how an item or service was ordered, the organization can correct those errors.
3. Medical documentation accuracy: Insurance reimbursements rely heavily on supporting accurate medical documentation. In clinical research care, the need for accurate documentation becomes critical because insurance is reluctant to reimburse for research-related procedures.
4. Clinical trial therapeutic area: Clinical trials for certain disease categories have higher expenses than those for other therapeutic areas. A more in-depth examination of the types of insurance denials in a given disease category for a particular item or service will help the investigator and the organization determine the financial feasibility of conducting similar trials in the future.

• Insurance denials by primary and secondary insurance: This metric is useful for an organization supporting clinical research, but the information acquired from this analysis must be used cautiously. A PI and/or facility must not give the appearance that it is selecting participants for clinical trials based on their insurance coverage or their ability to pay. Still, knowing when to expect difficulty receiving reimbursement from a certain insurance carrier helps to guide the MCA development for future clinical trials. It can also guide the organization in financial preauthorization consultations with patients who are interested in clinical trial participation.

For more information, see The Practical Guide to Clinical Trials Billing.