What constitutes routine costs? This is an important question to ask with each clinical trial. Understanding what constitutes routine costs prevents providing erroneous information to the patient, or even inadvertently to a payor, about the services the clinical trial sponsor is providing. Routine costs include the following items.
• Items and services typically provided absent a clinical trial (ie, routine care)
• Items and services required solely for the provision of the investigational item or service (ie, agents, equipment, and clinic time used in the administration of the investigational drug)
• Items and services used for the clinically appropriate monitoring of the effects of the item or service, or to prevent complications
• Items and services needed for the reasonable and necessary care arising from the provision of the investigational item or service, in particular diagnosis or treatment of complications.
For example, if administration of an investigational drug causes liver toxicities, all laboratory tests performed to monitor that toxicity are considered routine care and are billable to Medicare or other third-party payor under the national coverage determination (NCD). The tests are coded for billing as routine care. However, if the trial sponsor promises to pay for all laboratory tests performed in a clinical trial, Medicare or other third-party payor should not be billed for the laboratory tests.
Coordination of medical bills is sometimes very cumbersome. In many institutions, hospital and clinic billing is based on who ordered the item or service. Physician practices bill for the professional fees, while the hospital bills for the facility or technical portion. This is a crucial point in billing, as billing errors within clinical trials often occur at this point. An innocent error can result in an investigation of the facility or practice by the Office of Inspector General or the Department of Justice.
The clinical staff is charged with identifying what constitutes routine care and what is for the purposes of research only when ordering or scheduling items and services for clinical trial participants. The coverage analysis is essential to make this determination accurately. Separating the charges for routine care from the charges for research-only items and services is significant and must not be ignored. Further complicating the coordination and monitoring of billing, professional billing and facility billing do not always occur concurrently; invoices may be sent to payors upon the reporting of test results or later after a long hospital admission.
Billing issues are also complicated by statutory laws. The sponsor of a clinical trial does not pay for every item and service provided to participants, especially in the case of clinical trials for cancer treatment. Research costs associated with conducting clinical trials are covered by the trial sponsor, such as the National Cancer Institute (NCI) or a pharmaceutical company. Thirty-six states have statutes that require health plans to cover certain clinical trial costs, but these statutes vary by state. Alarmingly, health insurance companies are not required to cover the routine costs for patients participating in a clinical trial in 14 states.1 However, the laws are in transition to comply with the Affordable Care Act (ACA). Oncology nurses should prepare to keep appraised of potential changes to clinical trial coverage laws. Based on what is known when this article went to press, the ACA will prohibit insurance companies from denying coverage for routine costs in a qualifying clinical trial.
The Centers for Medicare and Medicaid Services (CMS) NCD for clinical trials clearly delineates what can be billed to Medicare within a clinical trial schedule of events. CMS ensures Medicare will cover costs for routine care rendered during qualifying clinical trials provided the care falls within a Medicare benefit category and is not statutorily excluded for coverage. Many large commercial payors follow the practices of Medicare when determining coverage. However, there are so many variations in insurance policies that the determined coverage may vary.