Coverage Analysis

The Clinical Trials Office (CTO) is responsible for performing a Coverage Analysis (CA) on all studies under the CTO purview. Coverage Analysis is a two step process in which a research site determines if a study qualifies for coverage and who will be paying for each of the protocol-required items, services, and activities.

The origins of the Medicare Coverage Analysis (MCA) date back to the year 2000, when the Centers for Medicare and Medicaid Services first introduced the Clinical Trial Policy (National Coverage Determination on Routine Costs in Clinical Trials – NCD 310.1), which requires Medicare to cover routine care costs in qualifying clinical trials. Then, in 2014, The Affordable Care Act extended this requirement to all other insurers. While sponsors, particularly industry sponsors, often offer to cover all procedures in the study budget, many do not and expect that certain study procedures will be billed to a participant’s insurance. This is particularly common in cancer clinical trials, but is increasingly seen in other therapeutic areas.

The CA is one of the first study start-up tasks done, because it forms the basis for cost gathering and for negotiating the budget.

The first step in conducting an CA is to determine whether the study is “qualifying” per the Clinical Trial Policy’s criteria. This is a specific and detailed definition, but it essentially includes any study with “therapeutic intent,” where the objective is to evaluate the efficacy (as opposed to safety or dose tolerance) of the investigational drug. Furthermore, a study can be “deemed qualifying” if it is conducted under an IND or if it is funded by one of the branches of the federal government (i.e. NIH, CDC, AHRQ, CMS, DOD or the VA). Thus, most of the externally sponsored clinical trials conducted at Rutgers are “qualifying.”

The second step is to determine which procedures required in the study schedule of events would be considered “routine care,” meaning the procedures would be performed whether the patients were on a study or not (More information on RC vs. SOC here). Additionally, NCD 310.1 allows the costs of the administration of an investigational drug and the costs of monitoring for adverse events to be charged to Medicare.

The end result of an CA is the billing grid in OnCore. You’ll notice that each item on the schedule of events has a billing designation of either Routine Care (RC) or Pure Research (PR.) The billing grid then serves as the guide for how each of the charges should be billed (i.e. whether to the participant’s insurance or to the study.) As always, please shoot us an email at clinicaltrials@rbhs.rutgers.edu if you have any questions about this process or how to find your study’s CA.