Patients should speak with their insurers in the early stages of finding a clinical trial in order to learn about the general coverage offered and which clinical trial phases it is offered for. Once a patient has been selected for, or chosen a trial, they should speak with members of the trial team as well as their insurance provider to determine which costs related to your participation are financed. Patients can also read through the “Experimental/ Investigational” or “Non-FDA Approved” section of their insurance documents for additional information.
Two major costs in a clinical trial are research and patient care. Research costs are often covered by the research institution or researchers. This can include the cost of testing the new treatment/device or conducting research. Patient care costs are often covered by the patient’s insurer or the patient, depending on the insurance provider. Patient care costs consist of routine care and ancillary care. Routine care is the care a patient would receive even if they were not in a clinical trial. This can consist of regular doctor visits, screenings, and any other care a patient may need to properly manage their condition. Coverage of clinical trials are mandated under the Affordable Care Act (ACA), and as a result, insurers and health plans are not allowed to discontinue or increase the cost of routine care when a patient joins an approved clinical trial. Approved clinical trials tend to be trials that are funded by federal institutions or organizations, or are for an approved drug application by the FDA. Clinical trials from centers and groups founded or funded by federal organizations might also be approved clinical trials.
Insurers cannot deny coverage or discontinue routine care when patients enroll in approved clinical trials; however, they are also not required to cover every cost. Coverage of ancillary care depends on the research institution and the patient’s insurance provider. Patients should be proactive in communicating with their health insurance provider for a clear understanding of their coverage should they enroll in a clinical trial. If you require more assistance and are already enrolled in a trial, the clinical trial coordinator should be able to facilitate communications with your insurance provider. Be sure to keep notes of these important conversations. Be sure to include dates and names of participants. Whenever unsure, ask the insurer to document all coverage eligibility determinations in writing.
Most insurers offer coverage for approved clinical trials, and coverage for unapproved trials are optional and rare. Again, approved clinical trials tend to be trials that are funded by federal institutions or organizations, or are an approved drug application by the FDA, or from centers and groups founded or funded by federal organizations.
Here is a list of organizations that have approved clinical trials:
- National Institutes of Health
- Agency for Health Care Research and Quality National Health Institute
- National Cancer Institute
- Department of Defense
- Department of Veterans Affairs
- Centers for Medicare and Medicaid Services
- Centers for Disease Control