Date: February 28, 2007
For more information contact: Eileen Mallow, Assistant Deputy Commissioner, (608) 266-7843 or eileen.mallow@wisconsin.gov

Commissioner of Insurance reminds consumers of
Wisconsin Act affecting clinical trials

Madison, WI—The Office of the Commissioner of Insurance (OCI) reminds consumers of the Wisconsin Act that went into effect in November of 2006 regarding insurance coverage for cancer clinical trials.

The Wisconsin Act prohibits health care policies, plans or contracts from excluding coverage for the cost of any routine patient care that is administered to a patient in a cancer clinical trial that would otherwise be covered if the patient was not in the trial. In other words, insurers are not required to cover any drugs or treatments a patient is receiving solely because s/he is taking part in a clinical trial, yet the insurer is still required to cover treatments the patient would have received if s/he were not in the clinical trial.

Cancer clinical trials are studies of new drugs or procedures used by doctors to learn whether or not they are safe and effective in the treatment of patients. These studies are important in the development of new cancer treatments.

"This Act is important for cancer patients who are making the decision whether or not to participate in a clinical trial," said Sean Dilweg, Commissioner of Insurance. "The amount of insurance coverage a patient receives could play a crucial role in their decision."

The Act defines "routine patient care" as all health care services, items and drugs for the treatment of cancer, as well as those typically provided in health care. Insurers are not required to cover:

• The health care service, item or investigation drug that is the subject of the clinical trial.
• Any health care service, item or drug provided solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient.
• Investigational drugs or devices that have not been approved by the federal Food and Drug Administration (FDA).
• Transportation, food, or other patient and family expenses associated with travel to or from a facility providing the clinical trial.
• Any health care services, items or drugs provided to the patient free of charge.
• Any health care services, items or drugs that are eligible for reimbursement by a person other than the insurer, including the sponsor of the clinical trial.

"We encourage consumers considering participating in cancer clinical trials to check with their insurance policy to see what is covered and what is not," said Dilweg. "Planning ahead with your health plan can save a lot time and energy in the long run."

The coverage of cancer clinical trials is a mandated benefit for insurance policies sold in Wisconsin. These are benefits that an insurer must include in certain types of health insurance policies, including both policies sold to individuals and to groups. Most mandated benefits apply only to policies issued or renewed after a certain date.

An updated list of all mandated benefits in health insurance policies in Wisconsin can be viewed and printed online by visiting the OCI Web site at oci.wi.gov. Single copies of the "Fact Sheet on Mandated Benefits in Health Insurance Policies" can be ordered free from the office by filling out a request form found under Publications on the Web site, by writing to OCI Publications, P.O. Box 7873, Madison, WI 53707-7873 or calling 800-236-8517.

Created by the Legislature in 1871, Wisconsin's Office of the Commissioner of Insurance (OCI) is vested with broad statutory authority to ensure that the insurance market place is responsibly and adequately meeting the insurance needs of Wisconsin's citizens. OCI's mission is to lead the way in informing and protecting the public and responding to its insurance needs.