Medical research is highly dependent on clinical trials. However, such trials present an element of risk to each participant. Because of this, anyone considering taking part in a clinical trial should ensure they are fully covered in terms of their medical insurance.
Some healthcare insurance and financial assistance providers may not cover all of the costs should there be any repercussions following a clinical trial. Expenses can increase exponentially should an individual require a lengthy stay in the hospital, frequent visits to the doctor, or perhaps even a medical procedure.
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What is clinical trial insurance?
When participating in a medical research program such as a clinical trial, the correct insurance policy is required to ensure you are covered if there are any lasting effects as a result of the treatment. In many cases, clinical trial insurance is mandatory before any medical testing can be carried out.
Insurance would typically cover:
- Payments should a person be unable to work.
- Treatment expenses.
- Other expenses linked to medical care.
- Funeral expenses.
- Maintenance payments to any surviving dependents.
The Affordable Care Act (ACA)
The 2014 Patient Protection and Affordable Care Act dictates that new health insurance plans must cover the routine cost of care for anyone participating in a clinical trial, so long as it meets certain requirements or if the trial is related to the prevention, detection, or treatment of cancer or other life-threatening diseases.
Under this act, health insurers cannot drop or limit the coverage of anyone who is approved for a clinical trial. However, one exception is if the insurance plan is “grandfathered”. By law, coverage must be provided for phase I, II, III, or IV of clinical trials providing they are federally funded or are covered under an investigational new drug application (IND) that has been reviewed by the FDA.
What insurers don't need to pay for under ACA
Under ACA, insurers are not legally required to pay for the following:
- The treatment, device, or service that is being studied.
- Items and services that are only required for data collection purposes.
- Services that are not clearly in line with standards of care for certain cancer types.
Are clinical trials covered by insurance?
For a clinical trial participant to be covered by their insurance, certain conditions must be met.
These conditions include:
- The individual must be eligible for the trial.
- The trial must be clinically approved.
- Out-of-network doctors or hospitals have no involvement in the trial if out-of-network care is not included in your insurance plan.
What are routine patient care costs?
Routine patient care costs involve the fees for any services, tests, devices, or medication that are needed during a clinical trial, whether it is cancer-related or otherwise. This can include paying for visits to the doctor, hospital stays, lab testing, x-rays, and other types of testing.
If your current health plan requires you to pay copayments for medical expenses, or pay deductibles for services, then you would still be required to pay for these costs during a trial.
What are approved clinical trials?
Approved clinical trials are research studies that focus on the prevention, detection, and treatment of cancer or other life-threatening diseases. They are funded or approved by the federal government and an Investigational New Drug (IND) application has been submitted to the FDA.
Which health plans are not required to cover clinical trials?
Grandfathered health plans (health plans that existed before March 2010, before ACA) are not required to cover routine patient care costs during a clinical trial.
What does health insurance cover for participants in a clinical trial?
Any costs that the participant is required to pay will be outlined in a consent document that is issued before the trial begins, but some insurers may offer more coverage than others.
Insurance coverage for clinical trials can vary depending on the type of insurance policy taken out and the specific terms of coverage. However, it should be noted that there are some types of coverage that will almost certainly be included within a clinical trial insurance policy.
Property Damage
Should any property be damaged or destroyed during a clinical trial, most insurance plans would usually cover the cost of repairing or replacing the items in question.
Legal Defense Costs
Should a participant or a researcher be sued as a result of a clinical trial, then insurance can cover the legal defense costs. You may be able to get legal representation by agreeing to pay the legal team a portion of the money rewarded.
Compensation for Loss or Injury
Insurance can provide compensation for any loss or injury that is sustained during a clinical trial. This can include compensation for medical expenses, loss in wages, and pain or suffering that may have been inflicted.
Clinical trial insurance requirements
If you are considering participating in a clinical trial, it is crucial that you carefully review the requirements set out by your insurance. Failing to comply with these requirements would result in a participant not being fully protected or forced to pay unexpected costs.
Requirements include:
- Participant injury insurance to cover any harm or injury sustained by a participant during the trial.
- Travel insurance to cover unexpected travel-related expenses such as flight cancellations or lost luggage.
- Full awareness of informed consent before the trial.
- Access to medical care to cover potential expenses.
- Full disclosure of how insurance information will be used and disclosed during the trial.
How may a clinical trial affect your insurance?
Taking part in a clinical trial can affect certain health insurance plans, depending on the type of trial that the individual is participating in and the type of insurance that has been taken out. However, a healthy person who is not undergoing any tests or treatment should not experience any issues.
Life and critical illness insurance
Clinical trials should not affect a person’s existing life or critical illness insurance coverage. Generally, a person does not have to inform their insurer that they are taking part in a trial if they are found to have a condition that they were not previously aware of. Once a policy has started, it will continue until it is either canceled or a claim is made.
Income protection
Taking part in a clinical trial shouldn’t affect any income protection insurance that you already have. However, income protection coverage may be affected if a person takes part in a clinical trial of drugs that are considered experimental or new types of non-drug treatment. This might include surgery, radiotherapy, or other experimental medical procedures. The type of diagnosis may also be taken into account.
Private medical insurance
Private medical insurance would not usually cover the costs of a clinical trial or experimental treatment, although exceptions may be made on a case-by-case basis.
Will my insurance cover other costs of clinical trials?
Although not guaranteed, some clinical trial sponsors may cover additional costs such as travel time and mileage, but this is not always the case, and these costs are unlikely to be covered by any insurance plan.
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Getting the insurance information you need
It is important to speak to each relevant party to clarify what costs you may be eligible to pay during a clinical trial.
To obtain this information, you might consider speaking to:
- Your doctor, nurse, or study contact to find out whether the trial drug is provided for free or at a reduced cost.
- Healthcare providers and insurance representatives to confirm what expenses will be covered in your insurance plan.
- A Medicare or Medicaid representative to find out what clinical trial costs will be covered.
Medicare coverage for clinical trial participants
Medicare is health insurance provided by the government for people aged 65 and above. This covers routine patient costs for clinical trials, including drugs, procedures, and services that would normally be covered outside of a clinical trial. In addition, any health complications or side effects would also be included within a Medicare policy.
Medicaid coverage for clinical trial participants
Medicaid is a government-funded health insurance program for low-income people and their families. As of January 1, 2022, it is required by law that all state Medicaid plans cover the routine patient care costs for members who are in qualifying clinical trials.
Which costs are not covered?
Before agreeing to participate in a clinical trial, you should contact your insurer to establish what costs might not be covered by your policy.
These costs usually include:
- Research costs, such as additional blood tests or scans.
- Out-of-network doctors and hospitals unless included in the health plan.
- Extra doctor visits.
- Extra lab tests.
- Data collection activities.
Planning and organizing other costs
Other costs may arise during a clinical trial, such as transportation and lodging costs, which may need to be planned for in advance.
Travel costs
Policies can vary from study to study, and any costs should be discussed with you during the informed consent process. Generally, travel costs will either be directly paid for by the sponsor, or there will be payments made based on the time spent traveling. Some trials might offer a set stipend (fixed sum) for all participants.
Overnight stays
Some clinical trials may require an overnight stay, these costs will be covered by the sponsor if it is not possible to stay at the trial site.
Dealing with your insurance company
Before participating in a clinical trial, a candidate must be fully aware of the benefits included in their health plan.
Explanation of Benefits (EOB) forms
EOB forms are issued by the insurance provider and disclose information such as the cost of treatments and how much will be paid by the insurer. Some aspects of the trial may not be covered in a health plan, and participants may need to request that their doctor writes a letter to explain why certain tests or procedures are required. This will then be reviewed by your case manager.
What do I do if I need to claim on my clinical trial insurance?
When making a claim, you should:
- Contact your insurance provider as soon as possible.
- Send the requested documentation.
- Include all medical records and receipts for expenses.
- Follow the claims process carefully to ensure it is processed quickly.
Denial of coverage
According to the ACA, health insurers cannot deny coverage for participating in an approved clinical study for cancer or another life-threatening disease or condition, as long as the individual is:
- Eligible to participate according to the study protocol.
- Referred to the study by a participating provider of the insurance company.
- Provides medical and scientific information that establishes that participation in the study is appropriate.
What if I don't have insurance?
Even if you do not have medical insurance, there are still options that could allow you to participate in a clinical trial. Most trials offer candidates participant injury insurance that covers medical expenses, while there are also insurance options that are designed specifically for clinical trials.
Before you take out insurance
Before taking out insurance, you should check if you are currently covered by your personal or work insurance, or if the clinical trial has an insurance policy that includes candidate expenses.
Questions an insurance company might ask
To understand your case in more detail, your insurance company may ask the following questions.
- What were the results of any tests carried out?
- Can you provide more details about the tests administered in the trial?
- Can you disclose the genetic test results from when you were diagnosed?
- What was your diagnosis?
- What treatment or advice has been given outside of the clinical trial?
Factors to consider when evaluating insurance options
When selecting a health plan, even if you are not planning to take part in a clinical trial, there are a number of factors that need to be considered to ensure you are fully covered.
Coverage limits and exclusions
When evaluating possible insurance options, it is important to know the extent of the coverage that is offered. The policy should cover all potential risks that could be associated with a clinical trial, including injury, property damage, and third-party liabilities.
The cost of insurance
When considering the cost of insurance, you should determine the cost of the policy itself and any ‘out-of-pocket’ costs such as deductibles, coinsurance, or copayments.
Premiums and deductibles
When comparing the market to find a suitable insurance plan, consider the premiums to ensure they are reasonable and competitive. The deductible amount should always be affordable and not exceed the budget of the clinical trial.
Choosing a reputable insurance provider
Take the time to research any potential insurer to determine whether they are reputable and financially stable. Some clinical trials may require insurance from specific providers, so speak to the trial provider about your options.
The claims process
Before selecting an insurance policy, make sure you understand the company’s claims process to avoid any delays or unexpected obstacles.
Can I get financial assistance to take part in a clinical trial?
If a candidate is uninsured or underinsured, they may qualify for financial assistance to cover the costs of a clinical trial.
Taking out insurance after taking part in a trial
If a person is diagnosed with health problems as a result of taking part in a clinical trial, then this may affect the terms that are offered when they try to take out health insurance in the future. Any genetic conditions that are diagnosed during clinical research should also be disclosed to your insurer, which might result in an amendment of the terms offered.
Conclusion
In most cases, the bulk of the costs will be covered by the trial sponsor, and any additional costs are likely to be covered by a person’s insurance provider, providing the trial and candidate meet the requirements stipulated by the Affordable Care Act (ACA).
Even if a person is uninsured, it may still be possible to participate in a clinical trial by applying for financial assistance. However, it is strongly advised to always consult with the relevant parties to confirm what costs may not be covered during or after the trial.