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The Affordable Care Act (Obamacare): If You Have Health Insurance

Clinical Trials

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Basically, the Act provides that effective 2014:

  • Insureds with a life-threatening condition can not be discriminated against for participating in a clinical trial.
  • The costs and services that would be covered by the plan if there were no clinical trial have to be covered.

If the law of the state in which you reside provides more protections about clinical trials, the state law prevails.


Both group and individual health insurance plans:

  • May not drop coverage just because an insured chooses to take part in a clinical trial.
  • May not prevent an insured from participating in a clinical trial.
  • Must cover routine patient costs for items and services furnished in connection with participation in a clinical trial. The costs to be covered are the type otherwise covered by the plan for a person who is not enrolled in a clinical trial. 
  • If the Plan has in network providers:
    • If  there is at least one provider who participates in a clinical trial, the plan may require that you enter the clinical trial through the in network provider if the provider will accept you as a participant in the clinical trial. 
    • The plan does not have to cover benefits outside of the network unless out-of-network benefits are otherwise provided under the plan.
  • Plans do not have  to cover:
    • The item, device or service being studied in the trial (for example, a drug being tested).
    • Services that are clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.

Who is covered

The Act only relates to "covered individuals" who are defined as:

  • People who are eligible to participate in a clinical trial according to the trial protocol with respect to treatment of cancer or other life-threatening disease or condition AND
  • The referring health care professional has concluded that your participation in the trial would be appropriate OR
  • You provide medical and scientific information establishing that your participation in the trial would be appropriate.

What trials are covered

phase I, II, III or IV clinical trial that is conducted in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition.

The trial must be funded or approved by a specified entities including:

  • The National Institutes of Health 
  • The Centers For Disease Control And Prevention 
  • The Agency for Health Care Research and Quality 
  • The Centers for Medicare & Medicaid Services 
  • A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.

Life-threatening defined

The Act defines "life-threatening" for purposes of the clinical trial provisions as "any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted."

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