|Oregon Mandates Clinical Trials be Covered by Health Insurance Companies |
Routine costs for the care of a member who is enrolled in or participating in qualifying clinical trials are covered under the Plans. Routine costs mean medically necessary conventional care, items or services covered by the Plans if typically provided absent a clinical trial. Coverage under this section will be subject to the provisions of the health plan that apply to other benefits within the same category, including but not limited to deductibles, copayments and coinsurance. The Plans are not liable for any adverse effects of the clinical trials.
Qualifying clinical trials are limited to those:
Funded by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Agency for Healthcare Research and Quality (AHRQ), the Centers for Medicare and Medicaid Services (CMMS), the U.S. Department of Defense (DOD) or the U.S. Department of Veteran Affairs (VA);
Supported by a center or cooperative group that is funded by the NIH, CDC, AHRQ, DOD or VA;
Conducted as an investigational new drug application, an investigational new drug application to the U.S. Food and Drug Administration (FDA); or
Exempt by federal law from the requirement to submit an investigational new drug application to the U.S. FDA.
The Plans do not cover:
The drug, device or service being tested in the clinical trial unless the drug, device or service would be covered by the Plans if provided outside of a clinical trial;
Items or services required solely for the provision of the drug device or service being tested in the clinical trial;
Items or services required solely for the clinically appropriate monitoring of the drug, device or service being tested in the clinical trial;
Items or services required solely for the prevention, diagnosis or treatment of complications arising from the provision of the drug, device or service being tested in the clinical trial;
Items or services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the member;
Items or services customarily provided by a clinical trial sponsor free or charge to any person participating in the clinical trial; or
Items or services that are not covered by the Plans if provided outside of the clinical trial.
Services and supplies not rendered by an accredited institution, physician or provider within the U.S. or by one that has not demonstrated medical proficiency in the rendering of the service or supplies;
Services and supplies that are not recognized by the medical community in the service area in which they are received;
Services and supplies that involve a treatment for which the approval of one or more government agencies is required, but has not been obtained at the time the services and supplies are rendered or are to be rendered;
Services and supplies that involve a treatment for which scientific or medical assessment has not been completed, or the effectiveness of the treatment has not been generally established; and
Services and supplies that are available in the United States only as part of a clinical trial or research program for the illness or condition being treated, except for routine costs of qualifying clinical trials.
Additionally, the Plans do not provide coverage for any expenses incidental to or incurred as a direct consequence of experimental or investigational procedures.