Patient Guide to Clinical Trials

Health insurance and clinical trials

Whether you are thinking about participating in a clinical study or not, health care costs and insurance coverage are major concerns for many patients and their families. An important factor in deciding to join a clinical study may be whether your health insurance will cover the costs.

A common myth is that health insurance won’t cover the cost of treatment provided through a clinical study. Some people might not enroll in a study because of coverage concerns. In fact, the majority of participants in clinical studies do receive at least some reimbursement from their health insurance for routine care, and the study often provides research procedures and the investigational agent for study participants. But health insurance may not pay all the costs.

To help you make an informed decision about enrolling in a study, review the information in this section, and ask your health insurance company and Seattle Cancer Care Alliance (SCCA) staff in advance for help in determining what costs are likely to be covered.

An SCCA Patient Financial Services (PFS) coordinator may be able to help you understand your insurance coverage.You may call them directly or ask your SCCA clinic scheduler to set up an appointment with your PFS coordinator. 

SCCA Patient Financial Services
phone (800) 804-8824
Ask to be transferred to a PFS coordinator.

Clinical trial costs

The costs of care for clinical study participants fall into two categories—routine care costs and research costs directly related to the clinical study.

  • Routine care costs, also called standard-of-care charges, are those you would incur for treatment of your disease even if you weren’t in a study. These costs may include doctor visits, hospital stays, and lab and imaging tests.
  • Research costs, also known as "study-billable" costs, are those related specifically to taking part in the study. These costs may include the investigational intervention (such as the drug being tested), extra doctor visits, and lab and imaging tests performed solely for research purposes.

When you take part in a study, you may also incur related personal expenses. For example, you may have extra transportation and childcare costs if you have extra doctor visits that you would not have with standard treatment.

What health insurance covers

Health insurance coverage for clinical studies is broader than in the past. Routine care costs are usually covered by health insurance. Research costs are usually not covered by health insurance; however, the study sponsor may cover these costs, which would mean you don’t have to pay them. About 80 percent of cancer clinical study participants have health insurance that pays for at least part of their care in the study.

Coverage varies by state, by health insurance company, and even by plan within a health insurance company. Most states have passed legislation requiring health plans to pay the routine care costs for patients in clinical studies; however, Washington state is not among them. Some federal programs, such as Medicare, TRICARE, and Veterans Affairs, help pay the costs of care in clinical studies for their enrollees.

Billing for people enrolled in Medicare Advantage Plans

If you are enrolled in a Medicare Advantage Plan your participation in a clinical trial requires a change in how research costs   are billed. According to Medicare rules, Original Medicare (also known as Medicare Part A and Part B) pays for routine costs   in covered research studies. Routine costs related to the study will be billed to Original Medicare and your Medicare Advantage Plan will become the secondary payer. Examples of routine costs include:

  • Administration of the study drug
  • Other drugs, supplies, or services in support of the study drug
  • Tests to monitor your health
  • Radiology tests used to stage cancer 
  • Treatment of side effects and complications that may occur because of the study

While you are participating in a clinical trial you may:

  • be asked to provide your Original Medicare ID to registration 
  • have “Medicare” or “CTP Medicare” verified as your payer when you check in or if you call into SCCA Customer Service (CTP is Clinical Trial Policy)
  • receive an Explanation of Benefits from Original Medicare

When your research-related treatment ends, either at the completion of the study or your withdrawal from the study, billing for services at SCCA will revert to your MedAdvantage Plan. If at any time you are seen for services within UW Medicine (Harborview, UW Medical Center-Northwest) that are not related to the clinical trial, billing for those services will be sent to your MedAdvantage Plan.

Frequently asked questions

What clinical trial services are ‘routine services’, billable to Original Medicare?

These services are often described in the Cost section of the informed consent for the study. They are generally services or items that would be provided to you if you were not involved in the clinical trial. Your study team will also be able to describe these services.

Does this mean I will have additional out of pocket expenses when Medicare is billed first?

No.  Effective January 1, 2011, Medicare has directed that any additional out of pocket expense associated with billing Original Medicare directly must be paid for by your Medicare Advantage Plan.

I have a question related to a bill for ‘routine services’ that were billed to Medicare , who do I contact?

SCCA Customer Service can answer questions related to SCCA bills. They can be contacted at (206) 606-6226. If your research-related services are provided at the University of Washington Medical Center or other hospitals, you will need to contact their billing departments as identified on the bills you receive.

The Affordable Care Act

The federal health care law passed in 2010, known as the Affordable Care Act (ACA), offers a baseline of coverage for clinical study participants in the United States and helps address some of the gaps in existing state laws. For people with cancer, some of the most important provisions of the ACA are those that eliminate lifetime maximums, ensure coverage for pre-existing conditions, and improve access to clinical studies.

Starting in 2014, the ACA requires all health insurers to pay for routine care for people participating in approved, federally funded clinical studies for cancer and other life-threatening diseases, unless a policy was grandfathered in and is not subject to the reforms. This includes Phase I through Phase IV treatment, prevention, and early-detection studies.

Dealing with your insurance company

In order to know for sure whether your treatment will be covered, you must be knowledgeable about your health insurance benefits — both now and if your health insurance changes in the future. When you contact your health insurance company to find out more about your benefits, you may want to use the Clinical Study Insurance Coverage Worksheet. It is a good starting point to help ensure you get your questions answered and get all the information you may need.

Clinical Study Insurance Coverage Worksheet (PDF)

Your insurance company may consider a number of things in determining whether to cover the cost of a clinical study, including these factors:

  • Whether the study is medically necessary (often decided on a case-by-case basis)
  • The phase of the study—for example, whether the study is a Phase I, II, III, or IV trial
  • Whether there is a reasonable expectation that the treatment being studied will be at least as effective as standard treatment
  • Whether the routine care costs in the study are about the same as the routine care costs for standard treatment
  • Whether there is a standard treatment for your type and stage of disease
  • Which organization approved or is conducting the study; for example, whether the study is sponsored by the National Cancer Institute
  • Whether the facility and staff meet the health plan’s qualifications for performing any specialty procedures, such as bone marrow transplants, that are required as part of the study

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, and is referred to the study by a participating provider (of the insurance company) or provides medical and scientific information that establishes that participation in the study is appropriate. However, the ACA does not apply to Medicaid, and coverage of routine care may vary by state.

If you are denied coverage, in some cases it helps to have your doctor talk to or file a written appeal with the health plan’s representative or medical director. At SCCA, your doctor will discuss this option with you, taking into consideration your current clinical status, treatment alternatives, and how soon you need treatment.