“Clinically proven!” It is a phrase we hear used – and abused – so often in advertising that we tend to forget the real, important work that inspired its entry into our lexicon.
Clinical trials are voluntary research studies designed to answer specific questions about the safety and effectiveness of drugs, vaccines, and other therapies. They are the cornerstone of medical progress.
But clinical trials are expensive, and determining who pays can be tricky – especially for health insurers. Insurance claims professionals do not always understand what should be paid or where coverage stops. Digging deeper into the trial is often the only way to uncover what an insurance company needs to know.
Routine Costs vs. Investigational Services
With trial participants, the process of establishing which medical services are to be billed to insurance and which are to be covered by the study requires categorizing treatments as either routine costs or investigational services.
Routine costs apply to drugs, tests, and services that a subject would likely receive even if not part of the study. This includes items or services typically provided as part of conventional care. It also includes medical care needed in order to administer the study drug, such as premeds or adjunct therapies; clinical monitoring; and prevention and management of complications and side effects.
Investigational services, on the other hand, are the specific drugs, devices, and interventions being studied and should therefore be covered by the trial. Other costs considered investigational include:
- Items and services provided solely to determine eligibility
- Professional visits required by protocol that would not otherwise be part of standard treatment
- Study-related labs or tests
- Data collection and analysis
- Any items or services listed as free in the subject’s informed consent document
How to Avoid Overpaying
Far too often, insurers pay for investigational services that should be billed to the study. While intentional fraud may be at work in a very small percentage of cases, the usual culprits are unfamiliarity of how clinical trials work, inadequate billing practices, and lack of awareness of available resources. Fortunately, all are relatively simple to remedy.
It starts with knowing what to look for and asking the right questions. A new drug listed on a bill, an unfamiliar treatment at an academic medical center, a small mention within a provider’s clinical notes – all of these and many other cues may indicate participation in a clinical trial. Once a trial has been identified, it is time to ask questions: Is this drug part of a study? What is the name of the study? Is this a standard of care service? Actively looking for cues and asking questions can help identify investigational services and generate significant cost savings.
Case managers can open lines of communications among all parties – insurer, research team, health care provider, and the individual – to clarify coverage. For example, a cancer patient in a clinical trial on the effects of radiation may also be receiving chemotherapy. While the chemotherapy may be rightly covered by insurance as standard of care, the cost of the radiation should be paid by the trial.
It is also important to become as familiar as possible with clincaltrials.gov, the best clinical research resource available. This public site contains vital information on both current and closed trials and often outlines exactly which elements of a study fall under investigational services. The key is to explore the site and become expert at navigating to the information you need.
Health Services Consultants with RGA's ROSE® (Reinsurance Outcomes and Service Experts) Program can assist clients in navigating clincaltrials.gov and help make sense of entries that often prove hard to decipher. (Trial names alone are often a long paragraph unto themselves!) Experience in navigating the site speeds up this process of locating and interpreting the right information. ROSE consultants can also provide expert training in using the site to flag potential overpayments.
What about Obamacare?
The Affordable Care Act (ACA or “Obamacare”), which went into effect January 1, 2014, dictates:
Insurers will be prohibited from dropping or limiting coverage because an individual chooses to participate in a clinical trial. Applies to all clinical trials that treat cancer and other life-threatening diseases. (U.S. Department of Health & Human Services)
The ACA guarantees that an insurer may not prevent a qualified individual from participating in an approved clinical trial nor discriminate against a clinical trial participant. It also guarantees that an insurer must cover routine costs for services delivered in-network.
While payers must provide out-of-network benefits if a clinical trial is offered only outside of the patient’s state of residence, they can require that an individual use an in-network provider if that provider is a trial participant and will accept the patient. This is usually not the case, but is always worth looking into as it could significantly reduce claims costs.
What happens if the ACA is repealed and replaced? Only time will tell. Insurers should keep a close watch on how any new legislation impacts clinical trial coverage. Regardless, the sooner insurers increase their understanding of clinical trials, the better they’ll be able to control health care costs and protect plan assets – both now and in the future.