Clinical Trial Billing FAQ

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

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.

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.

A. 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.