National Cancer Institute National Cancer Institute
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Clinical Trials and Insurance Coverage - A Resource Guide
    Posted: 12/30/1999    Updated: 01/30/2002
Clinical Trials and Insurance Coverage - A Resource Guide

As you consider enrolling in a clinical trial, you will face the critical issue of how to cover the costs of care. Even if you have health insurance, your coverage may not include some or all of the patient care costs associated with a clinical trial. This is because some health plans define clinical trials as "experimental" or "investigational" procedures.

A growing number of states have passed legislation or instituted special agreements requiring health plans to pay the cost of routine medical care you receive as a participant in a clinical trial. For more information, see States That Require Health Plans to Cover Patient Care Costs in Clinical Trials 1.

Because lack of coverage for these costs can keep people from enrolling in trials, the National Cancer Institute is working with major health plans and managed care groups to find solutions. In the meantime, there are strategies that may help you deal with cost and coverage barriers. This guide answers frequently asked questions about insurance coverage for clinical trial participation and directs you to additional information resources.

The material here is mainly concerned with treatment clinical trials, since other types of trials (prevention, screening, etc.) are newer and generally not covered by health insurance at all. However, this guide may become more relevant for prevention and other types of trials as these trials grow more common.

In 2000, Medicare began covering beneficiaries' patient care costs in clinical trials. Up-to-date information about what Medicare will cover can be found on the Web site of the Centers for Medicare & Medicaid 2 (formerly the Health Care Financing Administration). A summary of Medicare coverage as of January 2001 is included in this guide.

If you do not have any health insurance, you may find this section helpful for understanding some of the costs that trials involve.




Glossary Terms

clinical trial
A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.


Table of Links

1http://www.cancer.gov/clinicaltrials/developments/laws-about-clinical-trial-cos
ts
2http://www.cms.hhs.gov