Advocacy > Coverage of Patient Care Costs for Clinical Trials

Last update: 10/20/2012

Routine patient costs in clinical trials

In any clinical trial, the patient is not expected to pay for the study drug or tests that are specific to the purpose of the trial -- such as tests, procedures, drugs, and extra doctor visits.  The expenses related to the study question are covered by the sponsors the clinical trial.

Routine patient costs are the usual costs of medical care, such as doctor visits, hospital stays, clinical laboratory tests, x-rays, etc.,  that you would receive whether or not you were participating in a clinical trial.  Some health plans don't cover these costs once you join a trial, even though studies have shown that they are not appreciably higher than costs for patients who are not enrolled in trials."
(See Cost of Clinical Trials.) ~ cancer.gov 

The Affordable Care Act - changes that take effect in 2014

"Once it does take effect the new law will offer a baseline of coverage for clinical trial participants in all 50 states and the District of Columbia and help plug some gaps in existing state-level laws and agreements. It requires, for example, coverage of routine care costs for clinical trial participants in “self-insured” plans—that is, plans typically offered and run by employers who are paying the full cost of providing the benefits—governed by the federal ERISA law, Brow said."   cancer.gov
 

Map of States paying for cost of routine care in clinical trials: cancer.gov

Information on Coverage by State provided by Cancer.gov:

Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois

Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana

Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico

Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington Washington, D.C. West Virginia Wisconsin Wyoming

Our Position Statement:  

The standard of care for many cancers often provides limited benefit and significant toxicities.  Progress against all cancers clearly depends on the patients who are willing to participate in clinical trials, which can also be the most appropriate care for patients in many clinical circumstances, such as when the disease is resistant to standard therapy, or not yet curative.

We believe that it's the moral and contractual responsibility of heath insurance providers to reimburse for "routine patient care"  whether the patient is receiving standard or certified investigational treatment for life-threatening conditions such as cancer.

Our state governments can accelerate progress against cancers - and come to the aid of the heroes that are willing to participate in clinical trials - by mandating coverage for costs related to routine care.

As of 2007, 23 states have acted by passing legislation to address this issue .

~ Patients Against Lymphoma

Common provisions of legislation:

	Coverage of routine care associated with Phase I, II, III, and IV clinical trials for treatment or prevention of cancer approved by one of the following: An Institutional Review Board National Institutes of Health (NIH) U.S. Food and Drug Administration  U.S. Department of Defense or Veterans Affairs U.S. Department of Veterans Affairs
	There is no clearly superior, non-investigational alternative.
	Data provide a reasonable expectation that the treatment will be at least as effective  as the alternative.