National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
January 10, 2012 • Volume 9 / Number 1

Legislative Update

Most States Fall Short of Requirements for Insurance Coverage of Cancer Clinical Trials

U.S. map showing states that have passed legislation or instituted special agreements requiring health plans to pay for clinical trial participants' medical costs.The states shaded in blue have passed legislation or instituted special agreements requiring health plans to pay the cost of routine medical care for clinical trial participants.

Clinical trials are the primary vehicle for advancing the treatment, detection, and prevention of cancer. Participation is low, however, with only about 3 percent of adult patients taking part in clinical trials. Many different factors have been identified that contribute to this low participation rate. But for some patients, lack of insurance coverage for care provided in a clinical trial is a barrier to trial enrollment.

The Patient Protection and Affordable Care Act (PPACA), enacted by Congress in March 2010, requires health insurers to provide coverage for routine patient care costs for patients taking part in federally funded or approved cancer clinical trials or in trials conducted under, or exempt from, FDA investigational new drug applications. Routine patient care costs include doctor visits, hospital stays, clinical laboratory tests, and x-rays that would normally be covered under the individual's plan, but not the drug, device, or intervention being studied. These requirements apply to health plans and coverage sold after 2013.

Although many states have enacted laws that mandate some coverage for care provided in cancer clinical trials, a study published online December 27 in the Journal of Clinical Oncology concluded that most states do not meet the PPACA requirements and will need to make changes to comply with the federal law by 2014.

Researchers surveyed existing laws and agreements in all 50 states and the District of Columbia concerning coverage of patient care costs in cancer clinical trials. They found that 30 have coverage mandates for cancer clinical trials and six more have voluntary agreements with health insurers. 

In 17 states and the District of Columbia, existing mandates or agreements meet the PPACA's requirements. Of the 33 states that do not meet the PPACA's requirements, 15 have no existing laws or agreements in place regarding coverage of patient care costs in cancer clinical trials, and the remainder provide for coverage that falls short of the PPACA's requirements. The most common deficiencies are lack of coverage for phase I trials and for trials not focused on cancer treatment, such as prevention studies.

The researchers also note that the new federal requirements do not apply to "grandfathered" health plans, defined as any plan or coverage in which an individual was enrolled on or before March 23, 2010, when the PPACA was enacted.

"Given that initially the vast majority of group health plans and health insurance coverage will be grandfathered, it may be some time before most Americans benefit from the clinical trials coverage requirement," wrote Dr. Al B. Benson III of Northwestern University and his colleagues.

Further reading: "Insurance Coverage Expanding for Cancer Clinical Trials" and "States That Require Health Plans to Cover Patient Care Costs in Clinical Trials"