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Clinical Trials and Financials

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Under the Affordable Care Act, all insurance companies must cover the routine patient costs from an in-network provider associated with an approved clinical trial, making clinical trials much more affordable.

An approved trial is defined as a trial in any phase that is aimed at preventing, detecting, or treating cancer or another life-threatening disease. The clinical trial must be either federally funded or approved, be conducted under an FDA investigational new drug application, or be exempt from the necessity of an FDA investigational new drug application. If you want to participate in an unapproved clinical trial, your insurance may refuse to cover it. Always talk to your insurance provider before participating.

The healthcare costs associated with your medical care while participating in a clinical trial include:

  • Patient care costs: costs associated with normal treatment plans associated with your diagnosis and/or general ailments. These costs include going to the doctor, any stays in the hospital, and certain testing procedures that are covered by your insurance provider.
  • Research costs: These are costs that are directly related to the clinical trial study, such as study drugs, study-related procedures, testing performed for research purposes, and additional doctor visits. These costs are covered by the clinical trial sponsor.

Always ask for a detailed list of all the costs associated with the clinical trial from the trial sponsor. Your insurance provider may not cover follow-up tests and scans needed solely for data collection and analysis as part of routine patient costs.

NOTE: The federal requirements associated with the Affordable Care Act do not apply to grandfathered health plans. The federal law does not pre-empt any state laws that require a clinical trial policy for state-regulated plans. The federal requirements are minimums, but states may impose additional requirements.

Where to Find Clinical Trials

Here are some resources to help you find clinical trials, though many more options are available beyond this list.

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