||Clinical Trials And Insurance Coverage
A Resource Guide For Patients
As you consider enrolling in a clinical trial, you will face the critical issue of how to cover the costs of care. Even if you have health insurance, your coverage may not include some or all of the patient care costs associated with a clinical trial. This is because some health plans define clinical trials as "experimental" or "investigational" procedures. Because lack of coverage for these costs can keep people from enrolling in trials, the National Cancer Institute is working with major health plans and managed care groups to find solutions. In the meantime, there are strategies that may help you deal with cost and coverage barriers. This part of the cancerTrials site will answer frequently asked questions about insurance coverage for clinical trial participation and direct you to additional information resources.
The material here is mainly concerned with treatment clinical trials, since other types of trials (prevention, screening, etc.) are newer and generally not covered by health insurance at all. However, this guide may become more relevant for prevention and other types of trials as these trials grow more common.
If you do not have any health insurance, you may find this section helpful for understanding some of the costs that trials involve. In addition, you may want to explore possible sources of financial assistance.
1. Clinical Trials and Insurance Coverage
2. Coverage Strategies to Consider
3. Initiatives to Expand Coverage for Clinical Trials
Bibliography of sources used for this resource guide
1. Clinical Trials and Insurance Coverage
What costs do trials involve, and who is usually responsible for paying them?
There are two types of costs associated with a trial: patient care costs and research costs.
Patient care costs fall into two categories:
- Usual care costs, such as doctor visits, hospital stays, clinical laboratory tests, x-rays, etc., which occur whether you are participating in a trial or receiving standard treatment. These costs have usually been covered by a third-party health plan, such as Medicare or private insurance.
- Extra care costs associated with clinical trial participation, such as the additional tests that may or may not be fully covered by the clinical trial sponsor and/or research institution. The sponsor and the participant's health plan need to resolve coverage of these costs for particular trials.
Research costs are those associated with conducting the trial, such as data collection and management, research physician and nurse time, analysis of results, and tests purely performed for research purposes. Such costs are usually covered by the sponsoring organization, such as NCI or a pharmaceutical company.
What criteria do health plans use to make decisions about reimbursement for trials?
Health insurance companies and managed care companies decide which health care services they will pay for by developing coverage policy regarding the specific services. In general, the most important factor determining whether something is covered is a health plan's judgment as to whether the service is established or investigational. Health plans usually designate a service as established if there is a certain amount of scientific data to show that it is safe and effective. If the health plan does not think that such data exist in sufficient quantity, the plan may label the service as investigational.
Health care services delivered within the setting of a clinical trial are very often categorized as investigational and not covered. This is because the health plan thinks that the major reason to perform the clinical trial is that there is not enough data to establish the safety and effectiveness of the service being studied. Thus, for some health plans, any mention of the fact that the patient is involved in a clinical trial results in a denial of payment.
Your health plan may define specific criteria that a trial must meet before extending coverage, such as:
Some plans may only cover costs of trials sponsored by organizations whose review and oversight of the trial is careful and scientifically rigorous, according to standards set by the health plan.
- Trial phase and type:
Some plans may cover patient care costs only for the clinical trials they judge to be "medically necessary" on a case-by-case basis. Trial phase may also affect coverage; for example, while a plan may be willing to cover costs associated with Phase III trials, which include treatments that have already been successful with a certain number of people, the plan may require some documentation of effectiveness before covering a Phase I or II trial.
- While health plans are interested in efforts to improve prevention and screening, they currently seem less likely to have a review process in place for these trials. Therefore, it may be more difficult to get coverage for the care costs associated with them.
- See Understanding Clinical Trials: An Introduction for a description of the phases of cancer clinical trials.
Some plans, especially smaller ones, will not cover any costs associated with a clinical trial. Policies vary widely, but in most cases your best bet is to have your doctor initiate discussions with the health plan.
- Cost "neutrality":
Some health plans may limit coverage to trials they consider cost-neutral (i.e., not significantly more expensive than the treatments considered standard).
- Lack of standard therapy:
Some plans limit coverage of trials to situations in which no standard therapy is available.
- Facility and personnel qualifications:
A health plan may require that the facility and medical staff meet specific qualifications to conduct a trial involving unique services, especially intensive therapy such as a bone marrow transplant (high-dose chemotherapy with bone marrow/ stem cell rescue).
If you are interested in gathering more information about coverage issues, the following recent articles may help you get started:
- Eddy, DM. "Investigational Treatments. How Strict Should We Be?"Journal of the American Medical Association 1997 Jul 16; 278(3): 179-185.
- Fleming, I. "Barriers to Clinical Trials, Part I: Reimbursement Problems."Cancer Supplement 1994 Nov 1; 74(9): 2662-5.
- Grigsby, J. et. al. "Panel Discussion: Impact of Guidelines on Third-party Payors and HMOs."Oncology (Huntington) 1996 Nov; 10(11 Suppl): 195-201.
- Jenks, S. "Does Managed Care Jeopardize Cancer Research?"; "Some HMOs Embrace Clinical Trials."Journal of the National Cancer Institute (JNCI) 1995 Aug 2; 87(15): 1102-6.
- Kattlove, H. et. al. "Benefits and Costs of Screening and Treatment for Early Breast Cancer. Development of a Basic Benefit Package." Journal of the American Medical Association 1995 Jan 11; 273(2): 142-8.
- Monaco G.P. and P. Goldschmidt. "What is Proper Cancer Care in the Era of Managed Care?" Oncology 1997 Jan; 11(1): 65-71; discussion 72, 78.
- Nelson, N. "Physicians and Insurers Debate the Future of Clinical Trials."JNCI 1996 Sept 4; 88(17): 1186-8.
- Parkins, T. "Clinical Trial Reimbursement Reform Sought." JNCI 1993 Oct 6; 85(19): 1549-51.
- Simmons W.J. and L. Goforth. "The Impact of Managed Care on Cancer Care. Review and Recommendations." Cancer Practice 1997 Mar-Apr; 5(2): 111-8.
- Winslow, R. "Managed Care Trade Group Approves Plan to Spur Clinical Trials Involvement."Wall Street Journal 1 Jul 1997: B6.
- "Experts Moving Toward Consensus on Providing Access to Clinical Trials."Oncology News 1998 Mar; 7(3): 1,23.
2. Coverage Strategies to Consider
What can I do to increase the likelihood of coverage?
There are several steps you can follow to deal with coverage issues up front when deciding to enter a clinical trial. Along the way, enlist the help of family members and your doctor or other health professionals. You may find the following checklist useful:
- Understand the costs associated with the trial. Ask your doctor or the trial's contact person about the costs that must be covered by you or your health plan. Are these costs significantly higher than those associated with standard care? Also, inquire about the experience of other patients in the trial. Have their plans paid for their care? Have there been any persistent problems with coverage? How often have the trial's administrators been successful in getting plans to cover patient care costs?
- Understand your health plan. Be sure you know what's in your policy; request and carefully review the actual contract language. If there's a specific exclusion for "experimental treatment," look closely at the policy to see how the plan defines such treatment and under what conditions it might be covered. If it is not clearly defined, call the plan's customer service line, consult their Web site, and/or write to them. Ask for specific information about clinical trials coverage.
- Work closely with your doctor. Talk with your doctor about the paperwork he or she submits to your health plan. If there have been problems with coverage in the past, you might ask your doctor or the hospital to send an information package to the plan that includes studies supporting the procedure's safety, benefits, and medical appropriateness. This package might include:
- publications from peer-reviewed literature about the proposed therapy that demonstrate patient benefits;
- a letter that uses the insurance contract's own language to explain why the treatment, screening method, or preventive measure should be covered;
- letters from researchers that explain the clinical trial;
- support letters from patient advocacy groups.
Be sure to keep your own copy of any materials that the doctor sends to your health plan for future reference.
- Work closely with your company's benefits manager. This person may be helpful in enlisting the support of your employer to request coverage by the health plan.
- Give your health plan a deadline. Ask the hospital or cancer center to set a target date for the therapy. This will help to ensure that coverage decisions are made promptly.
What if my claim is denied after I begin participating in a trial?
If a claim is denied, read your policy to find out what steps you can follow to make an appeal. In What Cancer Survivors Need to Know about Health Insurance, the National Coalition for Cancer Survivorship suggests that you and your doctor demonstrate to the health plan that:
- the therapy is not just a research study, but also a valid procedure that benefits patients;
- your situation is similar to that of other patients who are participating in clinical trials as part of a covered benefit;
- possible complications have been anticipated and can be handled effectively.
You also may wish to contact your state insurance counseling hotline or insurance department for more help, or write your state insurance commissioner describing the problem.
Where else can I turn for assistance?
It's never easy to deal with financial issues when you or a loved one faces cancer. Unfortunately, costs can present a significant barrier to clinical trials participation.
The range of insurance issues and health plan contracts makes it impossible to deal with all of them here. You may wish to consult this partial list of publications, organizations, and Web sites for more information:
- What Cancer Survivors Need to Know about Health Insurance
- National Coalition of Cancer Survivorship
- http://www. cansearch. org/
- 1010 Wayne Avenue, 5th floor
- Silver Spring, MD 20910
- (301) 650-8868
- Cancer Treatments Your Insurance Should Cover
- The Association of Community Cancer Centers
- http://www. assoc- cancer- ctrs. org/
- 11600 Nebel Street, Suite 201
- Rockville, MD 20852
- (301) 984-9496
Publications order form
http://www.assoc- cancer-ctrs. org/orderpubs.html
- The Managed Care Answer Guide
- Patient Advocate Foundation
- 739 Thimble Shoals Boulevard, Suite 704
- Newport News, VA 23606
- (757) 873-6668
- email: email@example.com
- 1998 Guide to Health Insurance for People with Medicare, The Medicare Handbook
- Health Care Financing Administration
- New Medicare site
- View publications online or print out publications order form
Medicare Helpline: 1-800-444-4606
- Facing Forward: A Guide for Cancer Survivors (features a section on insurance issues)
- National Cancer Institute
- http://rex.nci. nih.gov/NCI_Pub_Interface /Facing_Forward/ faccont.html or by calling 1-800-4-CANCER
- Candlelighters Childhood Cancer Foundation
- Ombudsman Program
- 910 Woodmont Avenue, #4607
- Bethesda, MD 20814
- (301) 657-8401; 1-800-366-2223 (toll-free)
- email: firstname.lastname@example.org
- The 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 Advocate who works with the treatment center on behalf of families.
- Medical Care Management Corporation
- 5272 River Road, Suite 650
- Bethesda, MD 20816-1405
- (301) 652-1818
- email: email@example.com
- Working for a range of clients, including health plans, employers, and patients, MCMC conducts independent, objective reviews of high-technology medical care cases to assist in decision-making. While it does charge for its services, MCMC also offers a volunteer program for those who cannot afford to pay.
More Information Resources
- OncoLink, a service of the University of Pennsylvania Cancer Center.
- This cancer information web site features a section on financial issues for patients (http://oncolink. upenn.edu/ onco_bill) , which includes:
- Oncolink's Glossary of insurance terms
- http://oncolink.upenn. edu/ onco_bill/ glossary. html
- up-to-date insurance news,
- http://oncolink. upenn. edu/ onco_bill/ news/ index. html# insurance
- a listing of assistance programs,
- http://oncolink.upenn.edu/ onco_bill/ news/ index.html#assistance
- a billing forum, an interactive service that allows users to ask billing questions of an advisory panel. Recent questions and answers are posted on the site. The email address is firstname.lastname@example.org.
- http://oncolink.upenn.edu/ onco_bill/ about_oncobill.html
- American Association of Health Plans
- 1129 20th Street, NW, Suite 600
- Washington, DC 20036-3421
- (202) 778-3200
- The web site section "For Consumers" includes a fact sheet on clinical research that describes various health plans' efforts to support research initiatives and collaborate with academic health centers and universities.
- See the AAHP's Press Release (http://www.aahp.org/ services/ communications/ media/ 1997/ nih2.htm) about their involvement with clinical research sponsored by the National Institutes of Health, including the National Cancer Institute.
- Health Insurance Association of America
- 555 13th Street, NW
- Washington, DC 20004
- (202) 824-1600
3. Initiatives to Expand Coverage for Clinical Trials
The good news is that there has been a recent nationwide effort to assure clinical trials coverage, with NCI involved in several new initiatives.
- NCI-Department of Defense Agreement
- An innovative 1996 agreement between NCI and the Department of Defense (DoD) has given thousands of DoD cancer patients more options for care and greater access to state-of-the-art treatments. Patients who are beneficiaries of TRICARE/CHAMPUS, the DoD's health program, are covered for NCI-sponsored Phase II and Phase III clinical treatment trials. NCI and DoD are refining a system that allows physicians and patients to determine quickly what current trials meet their needs and where they are taking place.
- NCI-Department of Veterans Affairs Agreement
- A 1997 agreement with the Department of Veterans Affairs provides coverage for eligible veterans of the armed services to participate in NCI-sponsored prevention, diagnosis, and treatment studies nationwide.
See the VA/DoD Resources page on this website for additional information.
- Midwest Health Plans Agreement:
Some NCI Cooperative Groups have reached agreements with several insurers in Wisconsin and Minnesota to provide more than 200,000 people there with coverage for patient care costs if they participate in a cooperative group-sponsored trial.
- Pediatric Cancer Care Network::
This network, a cooperative agreement among the Children's Cancer Group, the Pediatric Oncology Group, and the Blue Cross Blue Shield System Association (BCBS) nationwide, will ensure that children of BCBS subscribers receive care at designated centers of cancer care excellence and may promote the enrollment of children in Cooperative Group clinical trials.