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    Clinical Trial Financial and Insurance Considerations

    You’ll understandably want to know who will pay for your clinical trial treatment. You should also ask whether you will receive payment for your time and efforts.

    Clinical trial costs

    Clinical trials have both patient care and research costs.

    • Patient care costs: These costs are associated with the treatment of your leukemia. Most of the time, your insurance will cover these costs, including:
      • Doctor appointments
      • Hospital stays
      • Laboratory testing
      • Imaging studies, such as X-rays or MRIs
      • Leukemia treatments
      • Treatments for any side effects from the cancer treatment
    • Research costs: These costs are associated with the clinical trial itself. Most of the time, insurance does not cover these trial-related expenses, but trial sponsors do. Sponsors can include individual people, private companies, government agencies, institutions, and organizations that fund (but don’t participate in) the research. Trial sponsors may cover trial-related costs, including:
      • The new treatment being tested in the clinical trial
      • Laboratory tests to obtain research data
      • Imaging studies performed specifically for the clinical trial

    Additional costs to you as a trial participant may include lodging or transportation. You may need to stay in a hotel or temporary housing for non-local clinical trials. You may also need to travel to and from the trial facility if it is within a reasonable driving distance. Trial sponsors may reimburse these out-of-pocket expenses.

    Before deciding to join a clinical trial, you will need to find out:

    • What is covered by your health insurance
    • Is a trial sponsor is covering any or all research costs
    • What you might need to pay for out-of-pocket and if this can be reimbursed
    • If you will be paid for participating in the clinical trial

    Does insurance cover clinical trials?

    In the United States, federal law requires health insurance to cover the cost of routine care received during clinical trials. The Patient Protection and Affordable Care Act (ACA) regulates many United States private health care insurance plans. This law prevents insurance companies or health care plans from:

    • Denying coverage of routine costs for people in approved clinical trials
    • Increasing cost of coverage because people take part in clinical trials
    • Preventing people from taking part in clinical trials

    For your health insurance to cover clinical trial costs, the following conditions must be met:

    • The providers and facility where you receive care must be in-network. However, your healthcare plan might have out-of-network coverage, so you should check to see what your plan covers.
    • The clinical trial researchers must confirm your eligibility for the study.
    • The clinical trial must be approved.

    Approved clinical trials must meet at least one of the following requirements:

    • Receive federal funding or approval from organizations such as:
      • The National Institutes of Health (NIH) or organizations listed within the NIH, including the National Cancer Institute (NCI)
      • Any organizations funded by the NIH or NCI, such as academic institutions, designated cancer centers, or cooperative groups
      • The Centers for Disease Control and Prevention (CDC)
      • The Center for Medicare and Medicaid Services (CMS)
      • The Agency for Health Care Research and Quality (ARHQ)
      • The Department of Veterans Affairs, Department of Defense, or the Department of Energy
    • Receive approval from the United States Food and Drug Administration (FDA) through an investigational new drug (IND) application
    • Have an exemption from IND requirements
      • This may be the case when drug makers want to change the labeling or advertising for an existing drug. The FDA must approve changes to a current drug’s labeling or advertising. Drug dosage or delivery method changes must be tested to ensure patient safety.

    Do you get paid to participate in clinical trials?

    Clinical trials often pay participants for their time, travel, lodging, parking, and other reasons. There may also be a bonus for completing the trial in its entirety.

    The FDA agrees that payment for research participation is a recruitment incentive. It should be a just and fair amount, but this payment should never be coercive or cause inappropriate amounts of influence. Payment incentives may also address financial barriers that can impact diversity of study participants.

    The Institutional Review Board (IRB) sets the amount of payment or reimbursement a trial participant receives. The clinical trial team will review payment and reimbursement information with prospective participants at the informed consent meeting.

    Questions to ask the clinical trial team

    During the informed consent meeting, you can ask questions about the clinical trial costs and whether you will receive payment. You may want to ask the following questions:

    • What costs are covered by the clinical trial sponsor?
    • What costs are covered by my health insurance company?
    • What costs will I need to pay out-of-pocket?
    • Can these out-of-pocket expenses be reimbursed?
    • Will I receive any additional payment for participating in this research?
    • Does this clinical trial treatment cost more than the recommended available treatment for my condition?
    • Are there any available financial resources to help with transportation and childcare costs while I participate in this study?
    • Is there a financial counselor with whom I can speak about my concerns?



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