The purpose of clinical research studies, or clinical trials, is to test new cancer treatments or drugs to determine whether they are safe and effective for use in humans, and whether they are potentially better than the current standards of treatment. All clinical trials are based on a set of rules called a “protocol”. This protocol explains who is eligible or ineligible for the study, the length of the study, how often treatments or tests will be done and other details of the trial.
Patients may chose to join a clinical trial for a number of reasons. Some participants join because of their desire to access new treatments or drugs that are not yet available to the general public, while others are looking for additional options after standard treatment for their cancer has failed. The National Cancer Institute and/or various oncology groups or pharmaceutical companies sponsor these trials.
Mesothelioma patients who are on Medicare may have the option of joining some clinical research studies and Medicare may pay some of the costs, however, it is important for anyone who is considering participating in a clinical trial to have a complete understanding of what will and will not be covered.
In general, Medicare will pay for the routine costs of items and services including:
- Visits to the doctor’s office.
- Tests that are necessary for your medical care.
- Room and board for a hospital stay that Medicare would normally cover if the patient were not in a study.
- Treatment of any complications or side effects that occur as a result of trial care.
Medicare will not pay for:
- Items or services that the study is testing, unless Medicare would normally cover the item or service if the patient were not in a study.
- Items or services the study provides to the participant at no cost.
- Items or services provided for the sole purpose of collecting data, and not related to the participant’s direct health care, i.e., monthly CT scans for a condition that would normally require only a single scan.
- Coinsurance and deductibles.
If you are in a Medicare Advantage Plan, (for instance an HMO or a PPO), you can receive the same coverage for clinical trials as a person enrolled in the Original Medicare Plan. The Original Medicare Plan is a fee-for-service plan that covers numerous health care services and certain drugs. The enrollee pays a set amount (deductible) each year for their health care before Medicare pays its part of costs in excess of that amount. Medicare then pays its share, and the enrollee pays their share (co-insurance or co-payment) for covered services and supplies.
Medicare Advantage Plans, as well as other Medicare Health Plans, may cover more services than those covered under the Original Medicare Plan, and often have lower out-of-pocket costs. Medicare Health Plans will have one premium that includes coverage for Part A (hospital insurance) and Part B (medical insurance) benefits, Part D prescription drug coverage (if offered) and any additional benefits (if offered).
Some prescription drugs used in clinical trials may be covered under Medicare Part B. If the drug is not covered under Part B, it is possible that your Medicare Prescription Drug Plan may cover it. Check your formulary, and if the drug is not covered, you can ask your plan for an exemption to cover it, however, in most cases only prescription drugs that have already been approved by the Food and Drug Administration (FDA) are covered.
If you are considering entering a clinical trial and are unsure of what costs may or may not be covered, you can contact Medicare at 1-800-MEDICARE (1-800-633-4227).
(Click here for an explanation of the government’s clinical trial database.)