Are Clinical Trials Free? Exploring the Costs of Joining a Trial
Clinical trials provide access to the most innovative medical interventions that may improve the health conditions of the participants. However, a pressing question is: “Are clinical trials free?” When you think about participating in a clinical trial, then you will need to consider how to cover the costs. Let’s discuss some key factors about the costs of participating in clinical trials.
Types of Costs in Clinical Trials
Clinical trials have two main categories of costs: (a) patient care costs (for your standard medical care during the trial) and (b) research costs (for participating in the study).
Depending on the type of disease, these patient costs may include doctor visits, hospital stays, standard medical interventions, blood tests, lab tests, x-rays, and other imaging tests.
The research costs include items such as the cost of the study’s drug or medical device, as well as the lab tests, x-rays, and imaging tests conducted only for research purposes. Also, you may have extra doctor visits to monitor your health during your participation in the trial. These extra trips to the doctor will increase your transportation costs, housing (to be close to the study’s site), and child care arrangements.
Although these research costs aren’t usually covered by health insurance, they are often borne by the clinical trial’s sponsor.
Do Insurance Companies Pay For Clinical Trials?
US federal law mandates that most health insurance plans cover the standard patient care costs in clinical trials when the following conditions are met:
You must be eligible for the clinical trial;
The trial must be approved by the FDA;
The clinical trial doesn’t use out-of-network doctors or hospitals (if your plan doesn’t cover out-of-network healthcare)
Furthermore, if you join an approved clinical trial, then most health plans can’t stop you from using your benefits, and/or limit them.
Approved Clinical Trials
Clinical trials are closely regulated by federal laws. What are these approved clinical trials? These are research studies that test ways to prevent, detect, or manage life-threatening diseases like Alzheimer’s disease. They must be funded or approved by the federal government, and have applied to the FDA (or not, if the study is exempt).
For mental health diseases, you may visit the relevant association’s website for a list of approved clinical trials. Or, you could search for clinical trials near you, find a trial, and then check it against the list of approved trials that are listed on the specific association’s website.
Costs That Are Not Covered
There are some costs that health insurance plans are not mandated to cover. These are the research costs of a trial or those extra blood tests and scans that are conducted only for research purposes. However, as we said before, the trial’s sponsor will likely cover those costs.
Furthermore, plans don’t have to cover costs arising from your use of out-of-network doctors or hospitals (if the plan doesn’t usually cover them). But, if your plan usually covers out-of-network healthcare, then these costs are still covered during your participation in a clinical trial.
Health Plans That Don’t Have to Cover Any Clinical Trials At All
Some health insurance plans are not required to cover clinical trials at all. These grandfathered plans don’t cover standard patient care costs in trials. This is because these plans existed before March 2010 when the Affordable Care Act became law.
However, once these plans are modified -for example decreasing its benefits or increasing its costs-then they lose their grandfathered status. Then, such plans will need to follow the full federal mandate and cover the relevant costs of you participating in a clinical trial.
Figuring Out Which Costs are Covered by Your Health Insurance
Either you, your regular doctor or a member of the trial’s research team should check your health insurance plan to figure out the details of your coverage.
There are several methods that you can use to discover if your health insurance covers patient care costs in your trial. Keep reading for a few ideas about who you should contact for assistance, ask questions, and what info you need to collect and keep if you decide to participate in the clinical trial.
Speak With Your Doctor to Identify Resource Personnel
We recommend asking your doctor if an admin member can help you figure out your health plan. This staff member may be a financial counselor or a research coordinator. Whoever your doctor recommends, work closely with them.
Ask the staff member about the challenges that previous trial participants encountered in getting their health plans to cover standard patient care costs. If you discover similar issues with your specific plan, then you can ask the staff member to help you send information to your health insurance company that explains the possible benefits of the clinical trial for your health. They may send the following items (which is not exhaustive):
Medical journal articles that discuss the possible patient benefits from getting access to the medical intervention being tested.
A letter from your physician explaining the details of the trial and why it is a medical necessity for you.
Letters of support from patient advocacy groups.
Always keep personal copies of all materials submitted to your health insurance company.
Speak With Your Health Insurance Company
Don’t be afraid to speak with representatives from your health insurance company. Simply call the customer service number on the back of your health insurance card. Next, ask to speak with someone in your plan’s benefits department. Here are some important questions to ask:
Does your health plan cover standard patient care costs for clinical trial participants? If so, is pre-authorization required? Preauthorization just means that your health insurance company will review information about your chosen clinical trial before deciding to cover your patient care costs.
If pre-authorization is necessary, then what information should you provide? Examples of such info include copies of your medical records, a letter from your doctor, and a copy of the informed consent form from your chosen clinical trial.
If pre-authorization isn’t necessary, then you are home-free! There’s nothing else to do. However, err on the side of caution and ask that your health insurance company provide a letter that states that pre-authorization isn’t necessary for you to participate in the clinical trial.
Note the name and department of the person you spoke with, as well as the date, and the time of your call. You always want to have as many details available should any misunderstandings arise in the future about your health coverage.
Clearly Understand all Costs Associated With the Trial
You don’t want any unpleasant surprises about the costs associated with your clinical trial. So ask the trial coordinator to give you a full breakdown of all the costs that you will be expected to cover for each phase of the clinical trial.
Work With Your Employer’s Benefits Manager
Another person that you’ll want to speak with is your company’s benefits manager in the HR department. This person will help you understand your health plan and also see if there are benefits that you hadn’t accounted for as yet.
Provide Your Health Insurance Company With a Deadline
You will need to have all your finances in place before starting your clinical trial. To ensure that all is on track, ask your doctor or the trial’s research coordinator about when you begin the process. Then communicate that date to your health insurance company to be sure of full coverage at the start and duration of your clinical trial.