Based on a new law signed on August 17, 2002, by acting Governor Jane Swift, cancer patients who join clinical trials no longer have to worry about losing health insurance coverage for their routine health care. Under the new law that takes effect January 1, insurers and health maintenance organizations must maintain coverage for routine patient care for patients involved in credible cancer studies. Similar legislation has been implemented in 16 other states.

It is important to note that employees under self-insured company plans are not protected by the state insurance laws that regulate typical group and individual health plans. The Employee Retirement Income Security Act (ERISA) governs employers who cover their employees with self-insured health care plans. ERISA overrides state laws such as this one.

The Massachusetts bill as first proposed in 1999 would have covered all clinical trials, but the final law only covers cancer trials since it was determined to be cost neutral. In the past, patients were concerned when deciding whether to take part in clinical trials because while payment for the experimental treatment is covered under the clinical trial, the clinical trial does not cover routine treatment. In some situations the patient's own insurer refused to cover routine treatment claiming that the symptoms requiring treatment were the result of the experimental treatment and therefore the insurer was not responsible.

In Massachusetts, most health plans already cover routine care in such situations. However, the new law, which was supported by the American Cancer Society, the Dana-Farber Cancer Institute, and the Massachusetts Association of Health Plans, eliminates any ambiguities that might prevent a patient from participating in such a qualified cancer trial.

Typically these trials are sponsored by either a research group or a pharmaceutical company. These clinical trials test the safety of emerging therapies, including the best dosages and schedules for treatments, and help with research that may benefit future patients. In Massachusetts, about 2,500 people take part in these clinical trials each year. In 2001, more than 400 medicines were tested, most of which were only available through the trials.

11/2002