Most health plans only cover treatments they think are medically proven to work. But, medicine is always changing. Opinions can differ about whether there is enough evidence to support a treatment. In such a case, an insurer may say no to paying for a treatment that it calls “experimental,” even though your doctor thinks the treatment is well supported. That can leave you with a big bill—unless you successfully appeal the insurer’s decision.
In other cases, an experimental, or investigational, treatment may be just what you want. You may have tried standard treatments without success. You may hear of a clinical trial—a study in humans—of a new treatment that has shown promise. You may want to take part in the trial, in hope of getting better. But, how do you learn more about such trials? And, will your insurance cover any of the costs?
This guide will show you:
Appealing Decisions That a Treatment Is Experimental
If your insurer denies your claim because it says the treatment is experimental, follow your insurer’s appeals process. Also, follow the advice in Appealing a Reimbursement Decision. Get as much information as possible about the decision in writing from the insurer. You’ll want to know how the insurer defines “experimental” and what specific grounds it has for believing your treatment is experimental.
Then, make clear to the insurer in writing why you believe your treatment is not experimental. Support your case as appropriate with a letter from your doctor. There are several kinds of evidence that might be persuasive. Cite journal articles showing that the treatment is safe and effective. Your doctor can detail his or her experience treating patients successfully with the treatment. Cite guidelines recommending the treatment and approvals by the Food and Drug Administration (FDA). Sometimes insurers might use data or documents that are out of date to rule a treatment experimental. If that’s the case here, point that out.
You’ll generally have three chances to appeal. Two phases are internal (appealing to people inside the insurance company) and one external (appealing to people independent of the company). If you need the treatment urgently, ask for an expedited review. That will get your appeal heard faster.
Seeking Clinical Trials
Suppose you’ve tried current treatments for your disease or condition, and they’re not working. Or suppose you’ve just been diagnosed with a serious disease, such as cancer. You want to know all the options available before you pick one. Then, you might be interested in learning about clinical trials.
The first place to start looking for such a trial is your doctor. Doctors often know about trials that might help you. They may be able to search for one for you. They can also talk over with you the pros and cons of enrolling in a trial. If your regular doctor doesn’t help, consider seeking a second opinion.
If you want to look for a trial yourself, try searching ClinicalTrials.gov, a service of the US National Institutes of Health. Or look for trials on websites associated with the type of disease you have. For example, for cancer, you can try the National Cancer Institute’s (NCI’s) database of NCI-supported clinical trials.
For each trial you’re interested in, read the protocol summary. This document contains such information as the purpose of the trial, the treatments being tested and the locations where the trial is taking place. Much of the information will be in medical language. So, if you’re having trouble understanding it, print it out and take it to your doctor to help you make sense of it.
The key questions to ask when you’re reading about a clinical trial include:
Learning More about a Clinical Trial
If you’ve decided you want to know more, call the trial team at the phone number listed in the protocol summary. Ask for the trial coordinator. If you prefer, have your doctor make the call.
Now, you’ll have another set of questions to ask—this time asking the trial team. These questions include:
Once you’ve gotten answers to all your questions, consider whether to enroll. If you decide you will enroll, make an appointment with the trial team.
What Will Your Insurer Pay?
Insurers won’t pay for experimental treatment. But, often, the trial sponsor will supply the investigational treatment free of charge. Usually, you’ll keep on getting routine care from your own doctor, and your insurer should continue to pay for that.
As for the care you get in the trial setting, current federal law requires most plans to pay for routine patient care costs under certain conditions. For example, you must be eligible for the trial. It must be for treatment of cancer or another life-threatening disease or condition. It must be a federally approved trial. And, it must not involve out-of-network care, unless such care is covered under your plan. If you join an approved trial, most health plans can’t limit your benefits or refuse to let you take part.
Health plans don’t have to cover the research costs of a clinical trial. That includes extra blood tests done only for research. Often, the trial sponsor will cover such costs.
If you’re not sure about what your health plan will pay, check with your plan representative to find out.
If You Can’t Get into a Clinical Trial
You may not be able to get into a clinical trial. Perhaps it’s because you don’t meet eligibility criteria or you live too far away. But, you may still be able to get the treatment under study.
The FDA has an Expanded Access or Compassionate Use program. Through that program, manufacturers make investigational medical products (such as drugs or medical devices) available to people who are seriously ill but can’t participate in a clinical trial. The patient must be someone for whom standard approved treatments don’t work or can’t be used. And, the probable risk from the investigational product can’t be greater than the probable risk from the illness. You may have to pay for the product, or the manufacturer may give it free of charge. For more information, see the FDA’s Expanded Access page.
Your Action Plan: Appealing an “Experimental Treatment” Denial; Joining a Clinical Trial
Here are some tips for approaching the subject of experimental treatments and clinical trials: