Clinical trials are research studies to test new drugs or 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 it 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. 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, hospital stays, 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 medical expenses during a clinical trial.

Clinical trials laws

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

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 care costs associated with Phase I through IV approved cancer 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?	Patient care costs associated with Phase I through IV approved 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?	Patient care costs associated with approved 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?	Patient care costs for covered persons engaging in approved clinical trials for the treatment of life threatening diseases under specified conditions.
Other key criteria	Clinical trial must have therapeutic intent and enroll individuals diagnosed with the disease. Clinical trial must not be designed exclusively to test toxicity or disease pathophysiology.

District of Columbia (2008)
Bill 17-469
(D.C. Law 17-166)

Who is required to pay?	All insurers in D.C.
What services or benefits are covered?	Routine patient care costs for people in approved clinical trials undertaken for prevention, early detection, treatment, or monitoring of cancer
Other key criteria	Insurers are not required to cover or reimburse: --tests or measurements done mainly for the purpose of the clinical trial involved --services or products provided only to collect or analyze data --services or products given free of charge to trial participants by the research sponsors

Georgia (1998)
Senate Bill 603, Act 801

Who is required to pay?	Insurers and the state health plan
What services or benefits are covered?	Patient care costs associated with Phase II and III of approved 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
SB 761

Who is required to pay?	HMOs, PPOs, State Employee Benefits Program and other specified insurers
What services or benefits are covered?	Patient care costs associated with Phase II through IV approved 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. Institutional Review Board-approved consent form must be used.

Maine (2000)
24-A-4310

Who is required to pay?	Managed care organizations and private insurers
What services or benefits are covered?	Patient care costs associated with an approved 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)
SB 137
HB 45
Chap 146 15-827

Who is required to pay?	Private insurers and other specified managed care organizations
What services or benefits are covered?	Patient care costs associated with an approved 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)
HB 4376 (Chap 257)
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 costs associated with all phases of approved 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)
SB 1026
376.429
(2006) - Phase II
SB 567 and 792

Who is required to pay?	All health benefit plans operating in the state
What services or benefits are covered?	Patient care costs associated with Phase II, III, or IV approved 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)
SB 29
NRS 695G173

Who is required to pay?	All private insurers and managed care plans
What services or benefits are covered?	Patient costs associated with Phase I through IV approved cancer clinical trials
Other key criteria	Healthcare facility and staff 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)
SB 409
415:18

Who is required to pay?	Private insurers and specified managed care plans
What services or benefits are covered?	Patient care costs associated with approved Phase I, II, III, and IV trials for cancer and other life-threatening conditions, with coverage for Phase I and II trials to be decided on a case-by-case basis. Coverage is also required for reasonable and medically necessary services to administer the drug or device under evaluation in the clinical trial.
Other key criteria	Clinical trials are covered when standard treatment has been or would be ineffective or does not exist, or when there is no clearly superior non-investigational alternative.

New Mexico (2002, amended 2004 to delay repeal until July 1 2009)
SB 240
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?	Patient care costs associated with the patient's participation in an approved Phase II, III, or IV cancer clinical trial.
Other key criteria	Clinical trial must have therapeutic intent. There must be a reasonable expectation that treatment will be at least as effective as standard or non-investigational cancer treatment. Payment is limited to in-state or in-network costs, unless the plan covers standard out-of-state or out-of-network treatment.

North Carolina (2001)
SB 199
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?	Patient care costs associated with Phase II through IV of approved 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.

Ohio (2008)
ORC Ann. 1751.01

Who is required to pay?	All health benefit plans including those for public employees.
What services or benefits are covered?	Medically necessary costs of health care services associated with any stage of an approved clinical trial.
Other key criteria	Insurers do not have to cover services or products that are part of the investigative trial, any item or procedure used only for data collection for the trial, any item not approved by FDA, and food, lodging, and transportation related to travel for participation in the trial.

Rhode Island (1994, 1997)
94-SB 2623
97-SB 1, HB 5062

Who is required to pay?	Private insurers and specified managed care plans
What services or benefits are covered?	Patient care costs associated with Phase II through IV cancer clinical trials
Other key criteria

Tennessee (2005)
HB 837

Who is required to pay?	All health benefit plans offered by an employer
What services or benefits are covered?	Patient care costs associated with Phase I through IV approved cancer clinical trials
Other key criteria	The subject of the trial must evaluate a drug, medical device or service that falls within a Medicare benefit category. Limits coverage to those drugs, medical devices, and services that have been approved by the FDA and that are used in the clinical management of the patient.

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

Who is required to pay?	All health insurance policies and health benefit plans in the state, including Medicaid
What services or benefits are covered?	Patient care costs associated with approved cancer clinical trials conducted through a Vermont or New Hampshire cancer care provider. If no suitable trial is available the law covers approved cancer clinical trials being administered by a hospital and its affiliated, qualified cancer care providers outside New Hampshire or Vermont.
Other key criteria	Participants in cancer trials located outside Vermont must provide notice to the health benefit plan prior to their participation. Health insurers may require patients taking part in a trial outside the provider network to get routine follow-up care within the plan's network, unless the patient's cancer care provider determines this would not be in the best interest of the patient. Providers and insurers must take part in a cost analysis to determine impact of the program on health insurance premiums.

Virginia (1999)
SB 1235
HB 871
38.2-3418.8

Who is required to pay?	Private insurers, specified managed care plans, and public employee health plans
What services or benefits are covered?	Patient care costs associated with Phase II through IV cancer clinical trials. Phase I coverage provided on a case-by-base basis.
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)
HB 2675
9-2-12

Who is required to pay?	Private insurers, managed care plans, Medicaid or state medical assistance, public employee health plans
What services or benefits are covered?	Patient care costs associated with Phase II through IV approved clinical trials for the prevention, early detection, or treatment of cancer or any other life-threatening condition.
Other key criteria	Facility and staff providing the treatment are capable of doing so by virtue of their training, experience, and volume of patients treated to maintain expertise. The treatment must have therapeutic intent. 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, and any self-insured plans
What services or benefits are covered?	Patient care costs associated with all phases of approved cancer clinical trials
Other key criteria	Trial must intend to improve the trial participant’s health outcomes and not be designed only to test toxicity or disease pathophysiology.

Wyoming (2008)
SF 024

Who is required to pay?	All health insurance policies, contracts, and certificates that cover any Wyoming resident.
What services or benefits are covered?	Patient care costs associated with Phase II, III, or IV approved clinical trials for cancer treatment
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 Maryland Information: A 2003 Maryland law (S 128) 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 approved clinical trials for patients with cancer and recommended by a treating physician. 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.
Other key criteria	The clinical trial must either (1) involve a drug that is currently exempt under federal regulations from a new drug application or (2) be a trial that is approved by one of the specified federal agencies or a local institutional review board.

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.

insurance companies to voluntarily provide coverage for clinical trials. Like the laws, they vary from state to state. To learn more, contact your state insurance department. (See the section, "How to find out more about your health plan's clinical trial coverage," below.)

(Tables are products of National Conference of State Legislatures^©, 2008)

Approved clinical trials and other state requirements

Some states require that certain agencies approve a clinical trial before the insurance company is required to cover related expenses. Examples of these approval agencies are:

• National Institutes of Health (NIH)
• NIH cooperative group or center
• National Cancer Institute cooperative group or center
• the Coalition of National Cancer Cooperative Groups
• U.S. Food and Drug Administration (FDA)
• U.S. Department of Defense
• U.S. Department of Veterans Affairs

More detailed information on your state's coverage requirements, including the lists of agencies that must approve the clinical trial, and links to some of the legislative documents can be found at the National Cancer Institute's "States That Require Health Plans to Cover Patient Care Costs in Clinical Trials" list at http://www.cancer.gov/clinicaltrials/ctlaws-home#Anchor-33277.

Medicare and Medicaid coverage

Medicare

If you take part in an approved clinical trial, Medicare covers routine costs for items and services, such as:

• doctor visits and tests
• room and board for a hospital stay that Medicare would pay for even if you weren't in a study
• an operation to implant an item that is being tested
• treatment of side effects and problems caused by the new care

In most cases, Medicare does not pay for these things:

• the experimental item or service being tested -- unless Medicare would cover it even if you weren’t in a clinical trial
• items and services the study gives you for free
• items or services used only to collect data and not needed as part of your direct health care, such as monthly CT scans for a condition that usually requires one scan
• co-insurance and deductibles

Keep in mind that you will have to pay the part of the charge that you would normally pay for Medicare covered services.

For more information, please call 1-800-633-4227 (1-800-MEDICARE).

Medicaid

Many state Medicaid programs cover all or some of the costs of clinical trials. Coverage is determined by each state, but many follow guidelines much like those listed above for Medicare. Contact your State Department of Health to find out the coverage in your state.

You can find the number of your state's health department in the blue pages of your phone book or at the Centers for Medicare and Medicaid Services Web site at www.cms.hhs.gov/ContactCMS/. Scroll down to "Medicaid - List of State Health Departments" and click for an ABC list of states.

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 and the most up-to-date 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 mean your insurance provider will not offer coverage. 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.

If you have more 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 (1-800-227-2345).

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

• Informed Consent

• Learning About New Cancer Treatments

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

• Off-Label Drug Use

National organizations and Web sites

Along with the American Cancer Society, other sources of information and support include:

Centers for Medicare & Medicaid Services (CMS) - HHS
Toll-free number: 1-800-633-4227 (1-800-MEDICARE)
TTY: 1-877-486-2048
Web site: www.cms.hhs.gov

National Association of Insurance Commissioners (to find your state's Department of Insurance)
Toll-free number: 1-866-470-6242
Web site: www.naic.org/state_web_map.htm

National Cancer Institute
Toll-free number: 1-800-422-6237 (1-800-4-CANCER)
Web site: 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.

Centers for Medicare and Medicaid Services. Medicare and Clinical Research Studies. Accessed at www.medicare.gov/Publications/Pubs/pdf/02226.pdf on February 23, 2009.

National Association of Insurance Commissioners. State Insurance Department Websites. Accessed at www.naic.org/state_web_map.htm on February 23, 2009.

National Cancer Institute. State Cancer Legislative Database Program. Accessed at www.scld-nci.net/index.cfml on February 20, 2009.

National Cancer Institute. States That Require Health Plans to Cover Patient Care Costs in Clinical Trials. Accessed at http://www.cancer.gov/clinicaltrials/ctlaws-home on February 19, 2009.

National Conference of State Legislatures. Clinical Trials: What are States Doing? Accessed at www.ncsl.org/programs/health/clinicaltrials.htm on February 23, 2009.

Last Medical Review: 03/01/2009
Last Revised: 03/01/2009