Ensure access to participation in cancer clinical trials.
Ensure that health benefit plans continue to provide coverage under the plans’ existing terms when individuals elect to participate in cancer clinical trials.
NOTE: The purpose of this requirement is to eliminate differential insurance coverage as a factor in a covered individual’s decision to participate or not in a cancer clinical trial.
An approved cancer clinical trial:
Tests prevention, detection, or treatment of cancer.
Is either federally funded; conducted under an Investigational New Drug (IND) application reviewed by the Food and Drug Administration (FDA); or is a trial that is exempt from the requirement of an IND application.
- Operates under an official Institutional Review Board (IRB). An IRB is a group of scientists, doctors, and other professionals that may include clergy, bioethicists, nurses, data managers and patient advocates, who review and approve the detailed plan for every cancer clinical trial. They check to see that the trial is well-designed, legal, ethical, does not involve unneeded risks, and includes a safety plan for patients
NOTE: Costs of investigational drugs or agents associated with the trial, or other direct costs related to the research being pursued in the trial (such as extra blood tests or scans that are done purely for the sake of the clinical trial) are typically paid for by the clinical trial sponsor, and are not the responsibility of the health benefit plan(s).
The choice of whether or not to participate is always up the patient and his or her physician, however, educating employees and raising awareness about the cancer clinical trials is an important first step.