Health Insurance & Clinical Studies
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.
Clinical Study Costs
The costs of care for clinical study participants fall into two categories—routine care costs and research costs.
- 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 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.
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.
Your insurance company may consider a number of factors 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—or 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.