Clinical trials are research studies to test new drugs orother treatments. These studies compare treatments that are in use today (standard treatments) with others that may be better. Before a new treatment is used on people, it is studied in the lab. If lab studies suggest the treatment will work, the next step is to test its value for patients. These human studies are called clinical trials.

Clinical trials are an important part of cancer care. As a result, over the past few years many states have passed laws about insurance coverage for clinical research studies. Usually when a patient enrolls in a clinical trial, the cost of tests, procedures, drugs, extra doctor visits and any research directly related to the study itself is covered by the group that sponsors the clinical trial. The sponsor of the clinical trial may be the government, a drug company, the National Cancer Institute, or some other agency.

Sometimes a health plan may define clinical trials as "experimental" or "investigational." When this happens, health insurance may not cover some of the costs of what is actually routine care. This routine care includes costs such as doctor visits and tests or treatments that you would have received even if you were not taking part in a clinical trial.

Because of the problems that patients sometimes face with coverage for clinical trials, some states have passed laws that require health insurance companies to provide coverage for clinical trials. It is important that cancer patients have insurance that covers clinical trials. Lack of insurance coverage can keep patients who might want to be in a clinical trial from taking part in it. In one survey, 60% of patients said they feared having their insurance denied as a major reason for not signing up to take part in a clinical trial. Another study found that there was only a slight increase in medical costs for adult clinical trial patients when compared with patients who were not in clinical trials.

Many states have enacted laws regarding clinical trials. The tables below contain the most current information available about laws and special agreements that require insurance plans to cover a patient's clinical trial expenses.

Clinical trials laws

Arizona	Maine	New Mexico	West Virginia
California	Maryland	North Carolina	Wisconsin
Connecticut	Massachusetts	Rhode Island	Wyoming
Delaware	Missouri	Tennessee
Georgia	Nevada	Vermont
Louisiana	New Hampshire	Virginia

Arizona (2000)
Senate Bill 1213
20-2328

Who is required to pay?	Hospital or medical service corporations, benefit insurers, health care service organizations, disability insurers, group disability insurers and accountable health plans
What services or benefits are covered?	Patient costs associated with participation in Phase I through IV clinical trials
Other key criteria	Clinical trial must be reviewed by an Institutions Review Board in AZ. Health professional must agree to accept reimbursement from insurer as payment in. Only covers study when no clearly superior non-investigational treatment exists. Clinical trial must be in AZ.

California (2000)
Senate Bill 37

Who is required to pay?	All California insurers, including Medicaid and other medical assistance programs
What services or benefits are covered?	Routine patient care costs associated with Phase I through IV cancer clinical trials
Other key criteria	May restrict coverage to services in CA

Connecticut (2001)
Senate Bill 325, Public Act 01-171

Who is required to pay?	Private insurers, individual and group health plans
What services or benefits are covered?	Routine patient care costs associated with cancer clinical trials
Other key criteria	Preventions clinical trials are covered only in Phase III and only if they involve therapeutic intervention. Insurer may require documentation of the likelihood of therapeutic benefit, informed consent, protocol information and/or summary of costs

Delaware (2001)
Senate Bill 181

Who is required to pay?	Every group of blanket policy, including policies or contracts issued by health service corporations
What services or benefits are covered?	Routine patient care costs for covered persons engaging in clinical trials for the treatment of life threatening diseases under specified conditions.
Other key criteria	For the treatment of cancer that generally first manifests itself in children under the age of 19.

Georgia (1998)
Senate Bill 603, Act 801

Who is required to pay?	Insurers and the state health plan
What services or benefits are covered?	Routine patient costs incurred in Phase II and III of prescription drug clinical trial programs for the treatment of children’s cancer.
Other key criteria	For the treatment of cancer that is most often found in children under the age of 19.

Louisiana (1999)
RS 22:230.4

Who is required to pay?	HMOs, PPOs, State Employee Benefits Program and other specified insurers
What services or benefits are covered?	Patient costs incurred in Phase II through IV cancer clinical trials.
Other key criteria	Only covers costs when no clearly superior, noninvestigational approach exists. Available data must support reasonable expectation that the treatment will be as effective as the noninvestigational alternative. Review Board-approved consent form.

Maine (2000)
24-a-4310

Who is required to pay?	Managed care organizations and private insurers
What services or benefits are covered?	Routine patient care costs associated with clinical trial.
Other key criteria	Participation must offer meaningful potential for significant clinical benefit. Referring physician must conclude that trial participation is appropriate.

Maryland (1998)
Chap 146 15-827

Who is required to pay?	Private insurers and other specified managed care organizations
What services or benefits are covered?	Patient costs for Phase I through IV cancer treatment, supportive care, early detection, and prevention trials. Phase II through IV for other life-threatening conditions, with Phase I considered on a case-by-case basis.
Other key criteria	There is no clearly superior, noninvestigational alternative. The data provide a reasonable expectation that the treatment will be as least as effective as the alternative.

Massachusetts (2002)
Chap 176A Sec 8X

Who is required to pay?	All health plans issued or renewed after Jan. 1. 2003
What services or benefits are covered?	Patient care services associated with all phases of qualified cancer clinical trials
Other key criteria	Insurers must provide payment for services that are consistent with the usual and customary standard of care provided under the trial’s protocol and that would be covered if the patient did not participate in the trial.

Missouri (2002)
376.429
(2006) Senate Bills 567 and 792

Who is required to pay?	All health benefit plans operating in the state
What services or benefits are covered?	Routine patient care costs as the result of Phase II, III, or IV clinical trials for the prevention, early detection, or treatment of cancer
Other key criteria	There must be identical or superior non-investigational treatment alternatives available before providing clinical trial treatment, and there must be a reasonable expectation that the study will be superior to the alternatives. Requires coverage of FDA-approved drugs and devices even if they have not been approved for use in treatment of patient’s particular condition.

Nevada (2003 amended 2005)
Senate Bill 29
NRS 695G,173

Who is required to pay?	All health insurance insurers, medical service corporations, HMOs and managed care organizations
What services or benefits are covered?	Patient costs associated with Phase I through IV cancer or chronic fatigue clinical trial
Other key criteria	Healthcare facility and personnel must have experience and training to provide the treatment in a capable manner. There must be no medical treatment available which is considered a more appropriate alternative medical treatment than the medical treatment provided in the clinical trial. There must be a reasonable expectation based on clinical data that the medical treatment provided in the clinical trial or study will be at least as effective as any other medical treatment. Amendment revises type of medical treatment covered.

New Hampshire (2000)
415:18

Who is required to pay?	Private insurers and specified managed care plans
What services or benefits are covered?	Medically necessary routine patient care costs incurred as a result of a treatment for Phase I through IV cancer clinical trial for a life-threatening disease.
Other key criteria	Coverage for Phases I or II decided on case-by-case basis. Coverage is required for services needed to administer drug or device under evaluation. Coverage is required for routine patient care associated with drugs or devices which are not subject of trial, as long as they have been approved by FDA.

New Mexico (2002, amended 2004)
59A-22-43

Who is required to pay?	Private insurers, specified managed care plans, and Medicaid and other state medical assistance programs
What services or benefits are covered?	Routine patient care costs incurred as result of Phase I through IV cancer clinical trial.
Other key criteria	Effective through July 1, 2009, Clinical trial must be a treatment study with a reasonable expectation that investigational treatment will be at least as effective as standard treatment.

North Carolina (2001)
58-3-255

Who is required to pay?	All health insurance plans and teachers’ and state employees’ comprehensive major medical plan.
What services or benefits are covered?	Medically necessary costs of health care services associated with Phase II through IV of covered clinical trials.
Other key criteria	Patients suffering from a life-threatening disease or chronic condition may designate a specialist who is capable of coordinating their health care needs.

Rhode Island (1994, 1997)
94-S 2623B
97-S 1A am

Who is required to pay?	Private insurers and specified managed care plans
What services or benefits are covered?	Coverage for new cancer therapies if treatment is provided under Phase II through IV cancer clinical trial
Other key criteria

Tennessee (2005)
House Bill 837

Who is required to pay?	All health benefit plans
What services or benefits are covered?	Routine patient care costs relate to Phase I through IV cancer clinical trial.
Other key criteria	Treatment must involve drug that is exempt under federal regulations from a new drug application, or approved by: NIH, FDA, in form of new drug application, DOD, or VA.

Vermont (2001, amended 2005 to remove March 1, 2005 sunset provision)
Chap 107 4088b
House Bill 6

Who is required to pay?	All health insurance policies and health benefit plans, including Medicaid
What services or benefits are covered?	Routine patient care costs related to Phase I through IV cancer clinical trial.
Other key criteria	Providers and insurers required to participate in a cost analysis to determine impact of the program on health insurance premiums. Amended law allows for participation in trial outside of Vermont if patient notifies health benefit plan prior to participation, and no clinical trial is available at Vermont or New Hampshire cancer care providers.

Virginia (1999)
Senate Bill 1235
House Bill 871

Who is required to pay?	Private insurers, specified managed care plans, and public employee health plans
What services or benefits are covered?	Patient costs incurred during the participation in Phase II through IV cancer clinical trials. Coverage provided on a case-by-base basis for Phase I.
Other key criteria	There must be no clearly superior, non-investigational alternative. Data must provide a reasonable expectation that the treatment will be as least as effective as the alternative.

West Virginia (2003)
House Bill 2675

Who is required to pay?	Individual and group insurers, health service corporations, health care corporations, HMOs, public employees insurance agency, Medicaid and the children’s health insurance program
What services or benefits are covered?	Patient costs associated with the participation in Phase II through IV clinical trial for treatment of life-threatening condition or the prevention, early detection and treatment of cancer.
Other key criteria	Facility and personnel providing the treatment are capable of doing so by virtue of their experience, training and volume of patients treated to maintain expertise. There must be no clearly superior, non-investigational treatment alternative. Data provide a reasonable expectation that the treatment will be more effective than the non-investigational treatment alternative.

Wisconsin (2006)
AB 617
Act 194

Who is required to pay?	Any health insurance plan offered by the state, any self-insured plans
What services or benefits are covered?	Routine patient care costs incurred during the participation in all phases of a cancer clinical trial. No policy, plan, or contract may exclude coverage for the cost of any routine patient care that is administered to an insured patient in a cancer clinical trial satisfying the required criteria for clinical trials. (c) and that would be covered under the policy, plan, or contract if the insured were not enrolled in a cancer clinical trial.
Other key criteria	Trial must meet all criteria: The purpose is to test whether the intervention potentially improves the trial participant’s health outcomes. The treatment provided as part of the trial is given with the intention of improving the trial participant’s health outcomes. The trial has therapeutic intent and is not designed exclusively to test toxicity or disease pathophysiology. The trial does 1 of the following: Tests how to administer a health care service, item, or drug for the treatment of cancer. Tests responses to a health care service, item, or drug for the treatment of cancer. Compares the effectiveness of health care services, items, or drugs for the treatment of cancer with that of other health care services, items, or drugs for the treatment of cancer. Studies new uses of health care services, items, or drugs for the treatment of cancer. The trial is approved by one of the following: The National Institute of Health, or one of its cooperative groups or centers, under the federal Department of Health and Human Services; the Federal Food and Drug Administration; the Federal Department of Defense; or the Federal Department of Veterans Affairs.

Wyoming (2008)
Original Senate File 0024
Enrolled Act No. 39, Senate

This law becomes effective July 1, 2008

Who is required to pay?	All health insurance policies, contracts, and certificates that cover any Wyoming resident.
What services or benefits are covered?	Routine patient care for a patient enrolled in a Phase II, III, or IV clinical trials for cancer treatment, as approved by one of the following: National Institutes of Health (NIH), U.S. Food and Drug Administration, U.S. Department of Defense, U.S. Department of Veterans Affairs, or a qualified research entity that meets the NIH criteria for grant eligibility
Other key criteria	The medical treatment must be given by a licensed health care provider operating within the scope of his/her license in a facility whose staff has the experience and training necessary to provide competent treatment. The patient must have signed an informed consent before starting the clinical trial.

Additional Georgia Information: In 2002, all major insurers in Georgia agreed to cover routine patient care costs associated with Phase I, II, III, or IV cancer clinical trials. Clinical trials include those that involve a drug that is currently exempt under federal regulations from a new drug application or those that are approved by specified federal agencies or a local institutional review board. The agreement also provides for the coverage of cancer screenings and exams that go along with the most recently published guidelines and recommendations established by any nationally recognized health care organization.

Additional Maryland Information: A 2003 Maryland law repealed a reporting requirement for insurers, nonprofit health service plans, and HMOs to submit a report that described the trials covered during the previous year.

Special agreements

Georgia

Michigan

New Jersey

Ohio

Georgia (2002)
Georgia Cancer Coalition

Who is required to pay?	All major insurers
What services or benefits are covered?	Routine patient care costs associated with Phase I through IV cancer clinical trials
Other key criteria	Clinical trials include those that involve a drug that is currently exempt under federal regulations from a new drug application or those that are approved by specified federal agencies or a local institutional review board. Provides for the coverage of cancer screens and examinations in accordance with the most recently published guidelines and recommendations established by any nationally recognized health care organization.

Michigan (2002)
Michigan Consensus Agreement

Who is required to pay?	Private insurance plans, HMOs and Medicaid
What services or benefits are covered?	Routine patient care costs associated with Phase II and III cancer clinical trials.
Other key criteria	Coverage for Phase I clinical trials is under consideration.

New Jersey (1999)
New Jersey Consensus Agreement

Who is required to pay?	All insurers
What services or benefits are covered?	Routine patient care costs associated with all phases of cancer clinical trials.

Ohio (1999)
Ohio Med Plan

Who is required to pay?	State employees on Ohio Med Plan
What services or benefits are covered?	Routine patient care costs associated with Phase II and III cancer treatment clinical trials
Other key criteria	Preauthorization is required for clinical trial participation.

These special agreements, like the laws, vary from state to state. To learn more, contact your state insurance department (see "How to find out more about your health plan's clinical trial coverage"). (Tables are products of National Conference of State Legislatures^©, 2008)

Medicare and Medicaid coverage

In 2000, Medicare began covering patient care costs in clinical trials. Also, many state Medicaid programs cover all or some of the costs of clinical trials.

How to find out more about your health plan's clinical trial coverage

If you are thinking about entering a clinical trial, you may want to contact your state insurance department to learn the details of any laws specific to your state. State insurance departments can also take reports of insurance fraud, and can often give you more information about what is required of your insurance company. You can find your state's insurance department in the blue pages of your local phone book, or visit the National Association of Insurance Commissioners on the Web at:www.naic.org/state_web_map.htm.

Living in a state that does not require clinical trials coverage doesn't necessarily mean your insurance provider will not offer coverage. In any event, it is always a good idea to contact your insurer to find out what they will cover before you get involved in a clinical trial.

For further questions about your state coverage and clinical trials, contact the American Cancer Society's clinical trials team directly at 1-800-303-5691. They can help answer your questions about your state's health coverage of clinical trials.

Additional resources

More information from your American Cancer Society

The following information may also be helpful to you. These materials may be ordered from our toll-free number, 1-800-ACS-2345.

• Clinical Trials: What You Need to Know (also available in Spanish)

• Learning About New Cancer Treatments

• Medical Insurance and Financial Assistance for the Cancer Patient (also available in Spanish)

National organizations and Web sites

In addition to the American Cancer Society, other sources of patient information and support include:

National Cancer Institute
Telephone: 1-800-422-6237 or 1-800-4-CANCER
Internet address: www.cancer.gov

No matter who you are, we can help. Contact us anytime, day or night, for information and support. Call us at 1-800-ACS-2345 or visit www.cancer.org.

References

American Cancer Society National Government Relations Department. How Do You Measure Up? A Progress Report on State Legislative Activity to Reduce Cancer Incidence and Mortality. July 2003.

National Association of Insurance Commissioners. State Insurance Department Websites. Available online at: www.naic.org/state_web_map.htm. Accessed February 21, 2008.

National Cancer Institute. State Cancer Legislative Database Program. Available at: www.scld-nci.net/index.cfml. Accessed February 21, 2008.

National Cancer Institute. States That Require Health Plans to Cover Patient Care Costs in Clinical Trials. Available online at: www.cancer.gov/clinicaltrials/developments/laws-about-clinical-trial-costs. Accessed June 11, 2008.

National Conference of State Legislatures. Clinical Trials: What are States Doing? September 2007 Update. Available at: www.ncsl.org/programs/health/clinicaltrials.htm. Accessed February 21, 2008.

Last Medical Review: 03/30/2008
Last Revised: 06/12/2008