Coverage Analysis for Non-Qualifying Clinical Trials

Centers for Medicare and Medicaid Services’(CMS) National Coverage Determination (NCD) 310.1 outlines the qualifying criteria to determine for which trials Medicare coverage “routine costs in clinical trials” applies. The first step in completing a coverage analysis is usually determining if the study meets these qualifying criteria. One of the common questions we hear is, what should we do if a trial does not meet the qualifying criteria?

Like other areas, CMS does not provide explicit guidance to answer this question. Some institutions choose to take a relatively conservative approach and decide they will not bill Medicare for any items or services required on a non-qualifying trial. This approach, however, presents operational and consistency issues when faced with studies where there is no external funding or when the sponsor refuses to pay for these items in their budgets. Institutions who choose this approach are often faced with the dilemma of either turning down studies or opening studies that don’t have sufficient funding to cover costs.

More commonly, we see institutions determine that they may bill Medicare for items and services that would be covered outside the context of a clinical trial. For example, if a patient with lung cancer is receiving regular CT scans, an institution following this approach may continue to bill Medicare for those CT scans during a non-qualifying trial, as long as the protocol does not require scans more frequent than the patient’s standard care dictates. The underlying argument is that this patient would have received the scans regardless of enrolling in a clinical trial, and there is no regulation limiting coverage just because it is also being done as part of a trial.

When choosing this approach, it is important to also consider the impact to research modifiers (e.g. Q1 and Q0).  These research specific modifiers are only applicable for qualifying clinical trials. As such, if an institution chooses to bill Medicare for items and services in a non-qualifying trial, they would not use the Q1 or Q0 modifiers on the claims.

Also note, that under this approach for non-qualifying trials you cannot bill Medicare for any items and services that are only covered based on NCD 310.1. Coverage for services such as the IV administration of an investigational drug are only supported by NCD 310.1 and would not normally be covered outside a qualifying clinical trial. Therefore, you would not have any supporting justification to bill Medicare for the IV administration of an investigational item in a non-qualifying clinical trial.  The same logic applies for tests done to monitor potential complications of the study drug. This is expanded coverage supported only through NCD 310.1. Unless those tests would have been done as part of the patient’s standard care, they are typically not billable to insurance if required by a non-qualifying clinical trial.

Like anything you do related to coverage analysis, it is important to consider this topic when developing policies and procedures. Your approach to this issue will have ramifications that carry through to budgeting and billing for the services in the study. Having a plan in place for addressing non-qualifying clinical trials will help maintain consistency within your entire research billing workflow.