Basics

What costs do trials involve, and who is usually responsible for them? What criteria do health plans use to make decisions about coverage for trials? Medicare coverage

Strategies

What can I do to increase the likelihood of coverage? What if my claim is denied after I begin participating in a trial? Where else can I turn for assistance?

Initiatives to Expand Coverage

NCI's Department of Defense Agreement NCI's Department of Veterans Affairs Agreement Other Developments

Clinical Trials and Insurance Coverage - A Resource Guide

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.

A growing number of states have passed legislation or instituted special agreements requiring health plans to pay the cost of routine medical care you receive as a participant in a clinical trial. For more information, see States That Require Health Plans to Cover Patient Care Costs in Clinical Trials ¹.

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 guide answers frequently asked questions about insurance coverage for clinical trial participation and directs 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.

In 2000, Medicare began covering beneficiaries' patient care costs in clinical trials. Up-to-date information about what Medicare will cover can be found on the Web site of the Centers for Medicare & Medicaid ² (formerly the Health Care Financing Administration). A summary of Medicare coverage as of January 2001 is included in this guide.

If you do not have any health insurance, you may find this section helpful for understanding some of the costs that trials involve.

What costs do trials involve, and who is usually responsible for paying them?

There are two types of costs associated with a clinical 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 the National Cancer Institute (NCI) or a pharmaceutical company.

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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 a 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:

• Sponsorship:
  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 phase 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 What is a Clinical Trial? ³ 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 start 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 high-dose chemotherapy with bone marrow or stem cell transplantation.

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Medicare Coverage

For up-to-date information about Medicare coverage of clinical trials, go to the Web site for the Centers for Medicaid & Medicare ⁴ (formerly the Health Care Financing Administration). As of January 2001, the following information was accurate:

If I'm in a clinical trial, what will Medicare pay?

• Anything normally covered is still covered when it is part of a clinical trial. This includes test, procedures, and doctor visits that are ordinarily covered.

• Anything normally covered even if it is a service or item associated with the experimental treatment. For example, Medicare will pay for the intravenous administration of a new chemotherapy drug being tested in a trial, including any therapy to prevent side effects from the new drug.

• Anything normally covered even if it resulted from your being in the clinical trial. For example, a test or hospitalization resulting from a side effect of the new treatment that Medicare would ordinarily cover.

What costs are not covered?

• Investigational items or services being tested in a trial. Sponsors of clinical trials often provide the new drug free, but make sure you ask your doctor before you begin.

• Items or services used solely for the data collection needs of the trial.

• Anything being provided free by the sponsor of the trial.

What kinds of clinical trials are covered?

The National Cancer Institute's Cancer Information Service has provided a fact sheet for Medicare beneficiaries (see More Choices in Cancer Care: Information for Beneficiaries on Medicare Coverage of Cancer Clinical Trials ⁵). In general, cancer treatment and diagnosis trials are covered if:

• They are funded by the National Cancer Institute (NCI), NCI-Designated Cancer Centers, NCI-Sponsored Clinical Trials Cooperative Groups and all other federal agencies that fund cancer research. Other trials may be eligible for coverage and doctors can ask Medicare to pay the patients' costs. Ask your doctor about this before you begin.

• They are designed to treat or diagnose your cancer.

• The purpose or subject of the trial is within a Medicare benefit category. For example, cancer diagnosis and treatment are Medicare benefits, so these trials are covered. Cancer prevention trials are not currently covered.

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 therapy? 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.

• Take advantage of all information resources available to you.

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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 the book called What Cancer Survivors Need to Know about Health Insurance ⁶, 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.

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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:

Publications

What Cancer Survivors Need to Know about Health Insurance

National Coalition for Cancer Survivorship ⁷

http://www. cansearch. org/

1010 Wayne Avenue, 5^th floor

Silver Spring, MD 20910

(301) 650-8868

Cancer Treatments Your Insurance Should Cover

The Association of Community Cancer Centers ⁸

http://www.accc-cancer.org/main2001.shtml

11600 Nebel Street, Suite 201

Rockville, MD 20852

(301) 984-9496

The Managed Care Answer Guide

Patient Advocate Foundation

739 Thimble Shoals Boulevard, Suite 704

Newport News, VA 23606

(757) 873-6668

email: ndepaf@pinn.net

Publications about Medicare ⁹ from the Centers for Medicare and Medicaid Services ¹⁰

New Medicare site ¹¹

http://www.medicare.gov/

Medicare Helpline: 1-800-444-4606

Facing Forward Series: Life After Cancer Treatment (features a section on insurance issues)

National Cancer Institute

Facing Forward ¹² or by calling 1-800-4-CANCER

Assistance Programs

Candlelighters Childhood Cancer Foundation ¹³

http://www.candlelighters.org

Ombudsman Program

910 Woodmont Avenue, #4607

Bethesda, MD 20814

(301) 657-8401; 1-800-366-2223 (toll-free)

email: info@candlelighters.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 ¹⁴

http://www.mcman.com/

5272 River Road, Suite 650

Bethesda, MD 20816-1405

(301) 652-1818

email: mcman@mcman.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 ¹⁵, a service of the University of Pennsylvania Cancer Center.
http://www.oncolink.com/

In addition to general cancer information, this Web site features a section on financial information for patients ¹⁶ (http://www.oncolink.com/resources/resources.cfm?c=6). Among the topics: viatical settlements, life insurance, a glossary of financial and medical terms, and news about billing and insurance.

AAHP-HIAA ¹⁷

http://www.aahp.org/

601 Pennsylvania Avenue, NW

South Building, Suite 500

Washington, DC 20004

(202) 778-3200

In October 2003, the American Association of Health Plans merged with the Health Insurance Association of America to form the AAHP-HIAA, the national trade association representing the private sector in health care.

• Consumer Information ¹⁸

American Academy of Family Physicians (AAFP) ¹⁹

http://www.aafp.org/

P.O. Box 11210

Shawnee Mission, KS 66207-1210

The AAFP's mission is to preserve and promote the science and art of family medicine and to ensure high-quality, cost-effective health care for patients of all ages.

• State Health Insurance Counseling Programs ²⁰

National Association of Insurance Commissioners (NAIC) ²¹

http://www.naic.org/index.htm

2301 McGee Street

Suite 800

Kansas City, MO 64108-2662

• State Insurance Department Web Sites ²²

The good news is that there has been a recent nationwide effort to assure clinical trials coverage, with the National Cancer Institute (NCI) involved in several new initiatives.

NCI's 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. See the VA/DoD Beneficiaries Digest Page 23 for additional information. Back to Top NCI's Department of Veterans Affairs Agreement A 1997 agreement with the Department of Veterans Affairs 24 provides coverage for eligible veterans of the armed services to participate in NCI-sponsored prevention, diagnosis, and treatment studies nationwide. http://www.va.gov/cancer.htm See the VA/DoD Beneficiaries Digest Page 23 for additional information. Back to Top Other Developments Midwest Health Plans Agreement: Some NCI Cooperative Groups 25 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.

Glossary Terms

A procedure to replace bone marrow that has been destroyed by treatment with high doses of anticancer drugs or radiation. Transplantation may be autologous (an individual's own marrow saved before treatment), allogeneic (marrow donated by someone else), or syngeneic (marrow donated by an identical twin).

Treatment with drugs that kill cancer cells.

A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.

The process of identifying a disease, such as cancer, from its signs and symptoms.

Into or within a vein. Intravenous usually refers to a way of giving a drug or other substance through a needle or tube inserted into a vein. Also called I.V..

A person who helps a patient work with others who have an effect on the patient's health, including doctors, insurance companies, employers, case managers, and lawyers. A patient advocate helps resolve issues about health care, medical bills, and job discrimination related to a patient's medical condition. Cancer advocacy groups try to raise public awareness about important cancer issues, such as the need for cancer support services, education, and research. Such groups work to bring about change that will help cancer patients and their families.

The first step in testing a new treatment in humans. These studies test the best way to give a new treatment (for example, by mouth, intravenous infusion, or injection) and the best dose. The dose is usually increased a little at a time in order to find the highest dose that does not cause harmful side effects. Because little is known about the possible risks and benefits of the treatments being tested, phase I trials usually include only a small number of patients who have not been helped by other treatments.

A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.

A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

Checking for disease when there are no symptoms. Since screening may find diseases at an early stage, there may be a better chance of curing the disease. Examples of cancer screening tests are the mammogram (breast), colonoscopy (colon), Pap smear (cervix), and PSA blood level and digital rectal exam (prostate). Screening can also include checking for a person’s risk of developing an inherited disease by doing a genetic test.

A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

In medicine, treatment that experts agree is appropriate, accepted, and widely used. Health care providers are obligated to provide patients with standard therapy. Also called best practice and standard of care.

A method of replacing immature blood-forming cells that were destroyed by cancer treatment. The stem cells are given to the person after treatment to help the bone marrow recover and continue producing healthy blood cells.