Q. Does my insurance cover clinical trials?

A. Federal law requires most health insurance plans to cover routine patient care costs* in clinical trials under certain conditions. Such conditions include:

  • You must be eligible for the trial
  • The trial must be an approved clinical trial
  • The trial does not involve out-of-network doctors or hospitals, if out-of-network care is not part of your plan

Also, if you do join an approved clinical trial, most health plans cannot refuse to let you take part or limit your benefits. Please check with your Health Plan for specific detailed coverage policy

Q. Which costs are not covered?

A. Health plans are not required to cover the research costs of a clinical trial. Examples of these costs include extra blood tests or scans that are done purely for research purposes. Often, the trial sponsor will cover such costs.

Plans are also not required to cover out-of-network doctors or hospital costs if the plan does not usually do so. But if your plan does cover out-of-network doctors or hospitals, they are required to cover these costs if you take part in a clinical trial.

Emory Healthcare has a dedicated Clinical Trials Billing Department responsible for evaluating each charge and determines whether the service or item is covered by a trial sponsor. Those services and items that are not covered by the trial sponsor and are routine patient care costs would be included on a claim for third-party payer or patient bill.

Q. Which health plans are not required to cover clinical trials?

A. “Grandfathered” health plans are not required to cover routine patient care costs in clinical trials. These are health plans that existed in March 2010, when the Affordable Care Act became law. But, once such a plan changes in certain ways, such as reducing its benefits or raising its costs, it will no longer be a grandfathered plan. Then, it will be required to follow federal law.

Federal law also does not require states to cover routine patient care costs in clinical trials through their Medicaid plans.

Q. Will I have to pay for any part of the clinical research study?

Medicare: Original Medicare (Part A and/or Part B) pays for routine costs of items and services in certain covered clinical research studies. Examples of these items and services include:

  • Room and board for a hospital stay that Medicare would pay for even if you weren’t in a study
  • An operation to implant an item that’s being tested
  • Treatment of side effects and complications that may occur as a result of the study Original Medicare won’t pay for:
    • The new item or service that the study is testing unless Medicare would cover the item or service even if you weren’t in a study
    • Items and services the study gives for free (many times the treatment will be provided free by the study sponsor)
    • Items or services used only to collect data and not used in your direct health care (like monthly EKGs for a condition that usually requires only a yearly EKG)

If you’re concerned about paying for services Medicare won’t cover, talk to the study staff and see if they can help.

Commercial: Federal law requires most health insurance plans to cover routine patient care costs* in clinical trials. It depends on whether your plan exist before the Affordable Care Act become law in 2010. Please check with your Health Plan for your plan policy.

Q. I’m in a Medicare health plan, can I still be in a clinical research study?

A. Yes. If you’re in a Medicare Advantage Plan (like an HMO or PPO) or other Medicare health plan, you can get the same coverage for clinical research studies as a person in Original Medicare, as described in the previous section.  If you join certain covered clinical research studies, Medicare will pay for your covered services as if you were in Original Medicare. This means that your Medicare health plan can’t keep you from joining a clinical research study. However, you should tell your plan before you start a study.

Q. I am enrolled in Medicare Advantage plan, why I received an Explanation of Benefits (EOB) from Traditional Medicare?

A.Medicare traditional fee-for service reimburses qualifying clinical trial claims on behalf of the Medicare Advantage. Your provider likely has submitted a claim to Medicare Traditional based on the Centers for Medicare and Medicaid Services (CMS) guidelines. CMS waives the Part A and the Part B deductibles, but the EOB may still include the coinsurance or normal member copays for the incurred types of services. Your Medicare Advantage plan very likely may cover the coinsurance or normal member copays after Medicare Traditional process the claims. Please check with your Medicare Advantage plan for your plan policy.

*Routine patient care costs means the costs of any medically necessary health care service for which benefits are provided under a health benefit plan, without regard to whether the enrollee is participating in a clinical trial.