Trials involving human patients are crucial to the advancement of clinical science. But they’re not without risk. Fortunately, insurers are willing to cover them.
Westhill Insurance Consulting, one of the most trusted on-line insurance consultant that offer consumer information on reasonably priced health and medical coverage has these following things to review if you are planning to take part in a clinical test.
Here are the conditions the federal law requires for a health insurance to cover: • You must be eligible for the trial • The trial must be an approved clinical trial
The trial does not involve out-of-network doctors or hospitals, if out-of-network care is not part of your plan • Also, if you do join an approved clinical trial, most health plans cannot refuse to let you take part or limit your benefits.
Approved clinical trials are research studies that: Test ways to prevent, detect, or treat cancer or other life-threatening diseases.
Are funded or approved by the federal government, have submitted an IND application to the FDA , or are exempt from the IND requirements. IND stands for Investigational New Drug. In most cases, a new drug must have an IND application submitted to the FDA in order to be given to people in a clinical trial.
Health plans are not required to cover the research costs of a clinical trial. Examples of these costs include extra blood tests or scans that are done purely for the sake of the clinical trial. Often, the research sponsor will cover such costs. Warnings must be posted days before the outcome to prevent further complaints from both the sponsor and the insurance company.
Plans are also not required to cover the costs of out-of-network doctors or hospitals, if the plan does not usually do so. But if your plan does cover out-of-network doctors or hospitals, they are required to cover these costs if you take part in a clinical trial. Clinical tests which are made in a different city such as those in Tokyo, Japan, Jakarta, Indonesia and Kuala Lumpur, Malaysia may not be included in the coverage as well.
Challenging trials One challenge for underwriters is the relatively small premium base measured against a trend for higher [insured] limits to be requested. Clinical trials policies normally have “claims made” wordings which means that insurance coverage does not automatically extend beyond the trial dates. The potential gap is where you arrange insurance, let the policy end and have no insurance for an event which may occur sometime in the future that can be attached to the clinical trial.
Serious problems in clinical trials are rare, as Rossano points out. “But what I would say is that clinical trials are not without risk. The risk of a clinical trial is that the human body is very complex and in rare cases there can be unforeseen outcomes, as happened in cases like TeGenaro.”