In 2021 alone, the FDA approved 50 new drugs. Before getting approval, drugs must go through clinical trials. Clinical trials allow doctors to test new drugs on patients through a controlled study.
Many patients are eager to take part in clinical trials because they want access to innovative treatments as early as possible. But, if not covered by insurance, clinical trials can be a huge financial burden on the patient. Before you take part in a clinical trial, it’s important to understand what parts of it- if any- your insurance will cover.
Federal Regulations for Clinical Trials
The idea that clinical research is not covered by insurance is one of many myths surrounding the clinical trial process. Federal law requires that most health plans must cover the routine patient costs in clinical trials. However, this does not mean that all costs are covered.
The patient may still be responsible for some costs, such as travel expenses. It is important to check with your insurance provider to see what is covered before you enroll in a clinical trial.
The main law that governs private insurance carriers in regard to clinical trials is the “Patient Protection and Affordable Care Act.” Shortened to the ACA, this law states that private insurers may not:
- Prevent patients from joining clinical trials
- Deny or limit routine coverage of medical costs for those in clinical trials
- Increase the cost of insurance because a patient joins a clinical trial
These regulations apply to all clinical trial phases. However, your health plan is exempt from these regulations if it existed before March 23, 2010, and has not changed since then. Finally, the clinical trial must have federal approval to count under this law.
What Is and Isn’t Covered by Insurance?
The ACA states that insurance must cover the routine costs of treatment under a clinical trial, but insurance companies won’t pay for everything. Knowing what is and isn’t covered during a clinical trial is as easy as understanding the basics of your health insurance. So, expect to pay more if:
- You haven’t reached your out-of-pocket maximum
- You are seeing out-of-network doctors
- Your health plan is older than or hasn’t changed since March 2010
Also, remember that you must meet your deductible for eligible care as well. Other expenses you can expect to pay are non-routine costs like travel or hotel stays.
Research Study vs. Clinical Trial: What You Should Know
The terms research study and clinical trial are often used as synonyms. But, there are subtle differences between the two.
Often, research studies are observational. They take a group of similar participants and observe changes over time. They do not intervene with novel drugs, which removes some of the benefits of clinical trials.
Clinical studies, on the other hand, do practice intervention with some participants. In studies that use placebos and drugs, the control group does not get intervention while the variable group does.
The most important difference between the two is that most research studies are either free to participate in or paid. However, only some clinical trials are free or paid while others cost money to participate in.
Learn More About Paid Clinical Trials
Cullman Regional is an experienced clinical trial research center that understands the hassles of insurance in regard to clinical trials. Sometimes, if not covered by insurance, patients get denied life-saving treatments. Our dedicated team of healthcare professionals finds that unfair and inhumane.