There are two types of costs associated with a trial:

• Patient care costs
• Research costs

Patient care costs: These are costs associated with providing medical goods and services to each patient. Usual care costs include doctor visits, hospital stays, clinical laboratory tests, x-rays, and any other medical costs that occur regardless of whether a patient is participating in a clinical trial or receiving standard treatment. These costs are usually covered by a third-party health plan, such as Medicare or private insurance.

Research costs: Research costs are costs that are associated with clinical trial participation, such as data collection and management, research physician and nurse time, analysis of results, and tests performed purely for research purposes. Such costs are usually covered by the sponsoring organization, such as a pharmaceutical company. The sponsor and the participant's health plan need to resolve coverage of these costs for particular trials. Be sure to consult with your physician about the financial aspects of any trial you are evaluating.

Health insurance companies and managed care companies decide which health care services they will pay for by developing coverage policies regarding the specific services. In general, the most important factor determining whether something is covered is a health plan's judgment as to whether the service is established or investigational. Health plans usually designate a service as established if there is a certain amount of scientific data to show that it is safe and effective. If the health plan does not think that such data exists in sufficient quantity, the plan may label the service as investigational.

Health care services delivered within the setting of a clinical trial are very often categorized as investigational and are not covered. This is because the health plan thinks that the major reason to perform the clinical trial is that there is not enough data to establish the safety and effectiveness of the service being studied. Thus, for some health plans, any mention of the fact that the patient is involved in a clinical trial results in a denial of payment.

Health plans may define specific criteria that a trial must meet before extending coverage. Some plans, especially smaller ones, will not cover any costs associated with a clinical trial, while other, larger managed care plans have recently announced at least partial coverage of costs associated with clinical research. Policies vary widely, but in most cases the best strategy is to have a doctor initiate discussions with the health plans.

Medicare Coverage

For up-to-date information about Medicare coverage of clinical trials, visit the Web site http://www.cms.hhs.gov/ClinicalTrialPolicies/ to view the Medicare Clinical Trials Quick Reference Guide. As of January 2001, the following information was accurate:

Medicare Approved Clinical Trials

In general, cancer treatment and diagnosis trials are covered if:

1. The trial is funded by the National Cancer Institute (NCI), NCI-Designated Cancer Centers, NCI-Sponsored Clinical Trials Cooperative Groups and all other Federal agencies that fund cancer research. Other trials may be eligible for coverage and doctors can ask Medicare to pay the patients' costs. Patients should ask their doctor about this before beginning a clinical trial.
2. The purpose or subject of the trial is within a Medicare benefit category. For example, clinical trials focused on the diagnosis and treatment of cancer are Medicare benefits, so these trials are covered. Cancer prevention trials are not currently covered.

Medicare patients who wish to participate in a clinical trial that is not described above, or patients who are unsure whether their trial meets all of the requirements should discuss these concerns with their doctor or visit http://www.hcfa.gov/medlearn/refctmed.htm for the Medicare Clinical Trials Quick Reference Guide. Often, there are other available trials that might be covered, so it is important that patients consult with their physician to evaluate their options before beginning a clinical trial that is not covered.

Medicare Covered Costs

• Any medical service normally covered by Medicare (usual care costs) is still covered when it is provided as part of a clinical trial, including tests, procedures, and doctor visits.
• Usual care costs, even if it is a service or item used in the experimental treatment, are covered. For example, Medicare will pay for the intravenous administration of a new chemotherapy drug being tested in a trial, including any therapy to prevent side effects from the new drug. Also, a test or hospitalization that Medicare would ordinarily cover for a cancer patient would still be covered, even though the services required resulted from a side effect from the experimental drug or treatment. Medicare Non-Covered Costs
• Investigational items or services being tested in a trial (research costs) are typically not covered. Sponsors of clinical trials often provide the new drug free, but patients should be sure to determine whether this is the case before beginning a trial.
• Items or services used solely for the data collection needs of the trial (research costs) are typically not covered. For example, lab tests, x-rays or CT scans that are required more frequently than usual for the purpose of research are not covered.
• Items provided free by the sponsor of the trial, such as drugs or specialized procedures are typically not covered.