There are two types of costs associated with a trial:
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.
Although health insurance companies and managed care companies usually decide which health care services they will cover, New Mexico lawmakers passed a law requiring that health insurance plans in New Mexico pay for routine costs associated with patient care resulting from a patient’s participation in cancer clinical trials.
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:
In general, cancer treatment and diagnosis trials are covered if:
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.