For more information about insurance coverage of clinical trial costs, see this feature's main page: States That Require Health Plans to Cover Patient Care Costs in Clinical Trials.
Legislation: House Bill 09-1059
Effective: August 5, 2009
What clinical trials are covered?
Insurers are required to provide coverage for routine patient care costs in clinical trials if
- The patient's doctor determines that the patient may benefit from enrolling in the trial and recommends participation
- The trial is approved under the 2000 Medicare National Coverage Decision (and subsequent amendments) regarding clinical trials
- The care is provided by a registered, licensed, or certified provider and the facility and personnel providing care are experienced and competent
- The patient has signed a statement of consent, indicating that he or she has been informed about the procedure to be undertaken, alternative methods of treatment, and the risks associated with participating in the trial
- The patient has a disabling, progressive, or life-threatening condition
Who is required to pay?
All individual and group health insurers, including health maintenance organizations, operating in Colorado
Other key provisions
Health insurers may exclude coverage for
- Any part of a trial paid for by a government or commercial sponsor
- Any drug or device paid for by its manufacturer, distributor, or provider
- Ancillary expenses such as travel and housing that a trial participant may incur
- Any item or service provided solely for purposes of data collection or analysis and not directly related to the patient's clinical management
- Costs for the management of the trial
- Any health care services specifically excluded under the patient's benefit plan