Insurance Coverage of Clinical Trials

For people interested in enrolling in a clinical trial, one of the primary concerns is covering the trial’s costs. This section will help you understand the different costs associated with clinical trials and direct you to credible sources of information that will help you determine if some or all your participation will be covered.

Because some health plans consider clinical trials to be “experimental” or “investigational” procedures, even if you have health insurance your coverage may not include all of your patient care expenses associated with a clinical trial.

Lack of coverage is a serious barrier to clinical trial participation for many people. Several organizations and patient-advocacy groups are working improve coverage for clinical trials in hopes of making future trials financially accessible to more people.

Although different health plans have different policies for paying for cancer-related clinical trials, at this time most will cover only treatment, early-detection or diagnosis trials. Prevention trials are newer innovations and are generally not covered.

Costs associated with clinical trials

Clinical trials involve two types of costs: patient care costs and research costs.

Patient care costs involve usual care costs—the doctor, hospital, and laboratory expenses that a participant would have even if he or she were not enrolled in a trial—and extra care costs that come from additional tests and procedures included in the trial.

Third-party insurers almost always cover usual care costs and may cover some extra care costs. The clinical trial sponsor or research institution works with participants’ health plans to resolve coverage of the extra care costs.

The costs involved with collecting and analyzing the trial’s data for research purposes are called research costs. These costs are typically covered by the organization sponsoring the trial.

What does Medicare cover?

As of 2000, Medicare, the federal program that provides health insurance for Americans who are 65 or over or who have certain disabilities, covers patient care costs associated with clinical trial participation.

Medicare covers the care administered to its beneficiaries enrolled in trials—including even hospitalization and for side effects and therapies to prevent side effects—but will not pay for the actual experimental agent (drug, device, etc.).

Sponsors of clinical trials usually supply drugs to participants at no cost, but ask your doctor to verify that the agents are free.

For the latest information regarding Medicare’s coverage of clinical trial costs, visit the Centers for Medicaid & Medicare Services (formally the Health Care Financing Administration) Web site, and click here for the White House release about the initial coverage decision.

Factors affecting other third-party payers’ coverage

• Trial sponsorship and personnel qualifications: Health plans are interested in answers to the following questions: Which organization is sponsoring a trial? Has the protocol been thoroughly reviewed? Who is overseeing the administration of care? Has the facility received accreditation? Have the personnel received specialized training for new, experimental procedures?
• Trial phase: Some health plans are more likely to cover a Phase III trials since, to reach this stage, the investigational therapy has been effective in earlier (Phase I and II) trials.
• “Medical necessity”: Some insurers only cover trial costs they deem medically necessary for patients on a case-by-case basis. One instance that would qualify as a medical necessity is a case for which no standard therapy is available.
• “Cost neutrality”: Another criteria by which insurers limit coverage is cost-neutrality. What this means is that they will pay for treatment trials that are not significantly more expensive than the standard treatment.

What can I do to increase my chances of receiving coverage?

• Ask your doctor or the trial coordinator about the costs that you or your health plan must pay. Have other participants in the trial had success in getting their insurance to cover costs? Are the costs higher than those associated with standard care? Can the trial coordinators do anything to get your plan to cover the costs?
• Review all information you have about your health plan. Read your policy, and call a customer service representative from your plan if you have questions about the legal jargon or how it applies to your particular case.
• Use your doctor as a resource. Learn about the types of paperwork he or she submits to insurers, and request that an information packet that explains the trial’s protocol, safety procedures, benefits and medical appropriateness be sent to your health plan. Be sure to keep copies of all these documents for your own reference.
• Work with your company’s benefits manager, who will be able to advise you about steps you should take to formally request coverage from your health insurance.
• Give your health plan a deadline for making a decision. Talk with the trial coordinator to designate a “target date” for beginning therapy to facilitate the review process.

Sources of additional information about clinical trial coverage

What Cancer Survivors Need to Know about Health Insurance
National Coalition of Cancer Survivorship
www.cansearch.org/
(301) 650-8868

Cancer Treatments Your Insurance Should Cover
The Association of Community Cancer Centers
(301) 984-9496

The Managed Care Answer Guide
Patient Advocate Foundation
(757) 873-6668

The Medicare Handbook
Center for Medicare Services
www.medicare.gov/
1-800-444-4606

Facing Forward: A Guide for Cancer Survivors
National Cancer Institute
http://cancernet.nci.nih.gov/facing_forward/faccont.html
1-800-4-CANCER

Candlelighters Childhood Cancer Foundation
The Candlelighter Ombudsman Program helps families of children with cancer and survivors of childhood cancer resolve a range of problems, including insurance coverage difficulties. Local groups appoint a Parent Advocat who works on behalf of families.
http://www.candlelighters.org
1-800-366-2223

OncoLink a service of the University of Pennsylvania Cancer Center, is a cancer information web site that features a section that addresses financial issues, including; a glossary of insurance terns, a list of assistance programs and an interactive billing forum.
http://www.oncolink.upenn.edu/onco_bill/

Health Insurance Association of America
http://www.hiaa.org/cons/cons.htm
(202) 824-1600
Information includes insurance counseling hotlines by state and state insurance contacts.