State of Indiana Adopts Clinical Trials Coverage Law

On May 7, 2009, Gov. Mitch Daniels signed into law HB 1382 that requires health insurers to provide coverage for the routine costs associated with participation in a clinical trial. The new law applies to insurers who are regulated by the state of Indiana, along with those participating in the state employee health program and the Medicaid program. The law takes effect July 1.

The coverage applies to phase I, II, III, and IV clinical trials examining methods to prevent, diagnose, or treat cancer. The trial must be approved or funded by one of the following:

• NIH
• Cooperative group or research facility with a peer review program approved by NIH
• FDA
• Department of Veterans Affairs
• Department of Defense
• Institutional review board of an Indiana-based institution with federal oversight
• Research entity that meets NIH-grant criteria.

The coverage includes the cost of routine services otherwise provided by the insurer. It does not include research-related costs, such as the drug or device under investigation and items and services provided 1) solely for research purposes, 2) customarily provided free of charge by the trial sponsor; 3) used solely to determine eligibility for the trial.

The law was adopted due to the advocacy efforts of individual researchers and patients, as well as organizations including the Indiana Cancer Consortium, the Northern Indiana Cancer Research Consortium, and the American Cancer Society in Indianapolis.

Indiana becomes the 23rd state to pass a clinical trials coverage requirement. Another three states have cooperative agreements for coverage. Information about the state laws and agreements is available on the NCI website.