Are clinical trials covered by insurance?

California law requires most health plans to cover "routine patient care costs" involved in a cancer clinical trial. It's called SB-37 and it took effect on Jan. 1, 2002.

SB-37 covers cancer patients who participate in Phase I, II, III or IV cancer treatment trials approved by the National Institutes of Health, the U.S. Food and Drug Administration, U.S. Department of Defense or Department of Veterans Affairs. This includes most cancer clinical trials.

The law gives cancer patients the freedom to think about taking part in a cancer clinical trial without having to worry about how they will pay for it.

What are "routine patient care costs"?

“Routine patient care costs” are the fees for any services, tests, devices or medications you would need whether or not you participate in a cancer clinical trial. These include doctor visits, hospital stays, lab tests, X-rays and other tests, and any medications or treatments that would be covered if you were not in a trial. These also include tests needed to see if a treatment is controlling your cancer. “Routine patient care costs” also include the fees for any treatment you might need in order to prevent, diagnose or treat another medical problem while you are in a clinical trial.

Health plans do not have to pay for anti-cancer agents that are not yet approved by the U.S. Food and Drug Administration or tests or procedures done solely for research purposes. But in most cases these drugs, tests and procedures are given to clinical trial participants at no cost by the government agency, university medical center or pharmaceutical company that sponsors the trial. Health insurers also are not required to pay for items or services that are not included in your health plan. For example, if your health plan doesn’t include coverage for home health visits, your insurer would not have to cover these costs. And, if your health plan requires you to make copayments or pay deductibles for hospital or doctor services, medical testing or prescriptions, you would still have to pay those expenses.

Thanks to California’s clinical trials law, participating in a cancer clinical trial should cost you no more than receiving standard therapy.

Additional resources

“California’s Cancer Clinical Trial Law: What it Means for Physicians”
Download the brochure (PDF)

California Department of Managed Health Care
Website: www.hmohelp.ca.gov
Email: contact their Help Center
Phone: 888-466-2219

California Department of Insurance
Website: www.insurance.ca.gov
Phone: 800-927-4357

California Department of Health Services
Website: www.dhcs.ca.gov/Pages/default.aspx
Phone: 916-657-1460

National Patient Advocate Foundation
Website: www.npaf.org
Email: action@npaf.org
Phone: 202-347-8009

Patient Advocate Foundation
Website: www.patientadvocate.org
Phone: 800-532-5274

Medicare
Website: www.medicare.gov