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.

To see current laws or agreements and their key provisions

• scroll down to browse a list, or
• click on a blue-highlighted state/location in the map below.

For more information about insurance coverage of clinical trial costs, see this feature's main page: States That Require Health Plans to Cover Patient Care Costs in Clinical Trials.

State: Arizona

Legislation: Senate Bill 1213

Effective: January 2001

What clinical trials are covered?

Phase I, II, III, and IV clinical trials for treatment, palliation (supportive care) (supportive care) or prevention of cancer approved by one of the following:

• National Institutes of Health (NIH)
• NIH cooperative group or center
• U.S. Food and Drug Administration (in the form of an Investigational New Drug Application)
• U.S. Department of Defense
• U.S. Department of Veterans Affairs
• A qualified research entity that meets NIH criteria for grant eligibility
• A panel of qualified clinical research experts from academic health institutions in the state.

Who is required to pay?

• Private insurers and managed care plans.

Other key provisions:

• Trial must be reviewed and approved by an Institutional Review Board of an institution in Arizona.
• Health professional must agree to accept reimbursement from the insurer as payment in full.
• There is no clearly superior, noninvestigational treatment alternative.
• Excludes coverage for trials outside of Arizona.

State: California

Legislation: Senate Bill 37

Effective: August 2001

What clinical trials are covered?

Phase I, II, III, and IV clinical trials with a therapeutic intent for patients with cancer and recommended by a treating physician. Trial must either involve a drug exempt from a New Drug Application (NDA) under federal regulations, or be 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

Who is required to pay?

All California insurers, including the state's Medicaid program and other medical assistance programs.

Other key provisions:

• Plan may restrict coverage to services in California unless protocol is not provided at a California hospital or by a California physician.

State: Connecticut

Legislation: Senate Bill 325

Effective: January 2002

What clinical trials are covered?

Clinical trials for treatment, palliation (supportive care), or prevention of cancer approved by one of the following:

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

Who is required to pay?

Private insurers, including individual and group health plans.

Other key criteria:

• Prevention 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 test results, and/or a summary of costs involved.

State: Delaware

Legislation: Senate Bill 181

Effective: July 2001

What clinical trials are covered?

Clinical trials for treatment, palliation (supportive care), or prevention of cancer approved by one of the following:

• National Institutes of Health (NIH)
• NIH cooperative group or center
• U.S. Department of Defense
• U.S. Department of Veterans Affairs
• Institutional Review Board that has a Multiple Project Assurance (MPA) from the U.S. Department of Health and Human Services' Office for Human Research Protections.
• A qualified research entity that meets the criteria for NIH Center Support grant eligibility.

Who is required to pay?

Every group or blanket policy.

Other key provisions:

• The trial must have therapeutic intent and enroll individuals diagnosed with the disease.
• The trial must not be designed exclusively to test toxicity or disease pathophysiology (the functional changes that accompany a particular syndrome or disease).

State: Georgia

Agreement: Georgia Cancer Coalition agreement

Effective: 2002

What clinical trials are covered?

Phase I, II, III or IV cancer clinical trials for patients with cancer and recommended by a treating physician. The 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 following:

• National Institutes of Health (NIH)
• an NIH-sponsored cooperative group or center
• U.S. Department of Defense
• U.S. Department of Veterans Affairs
• U.S. Food and Drug Administration
• An Institutional Review Board of any accredited school of medicine, nursing, or pharmacy in the State of Georgia

Who is required to pay?

• Kaiser
• BlueCross/BlueShield of Georgia
• United Health Care
• Aetna
• Humana
• Coventry
• OneHealth
• Cigna
• The Georgia Department of Community Health (which administers the State Health Benefit Plan, Medicaid, and PeachCare).

Other key provisions:

• The agreement also 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.

Legislation:

• The Georgia Cancer Coalition agreement covers both adults and children. There is also a law in effect for children only. The law (Senate Bill 603) was passed in 1998 and requires all health plans in Georgia to reimburse the patient care costs associated with a dependent child's participation in a phase II or phase III cancer clinical trial that is testing prescription drugs. The child has to have been diagnosed with cancer prior to his or her nineteenth birthday, and the trial has to have been approved by the U.S. Food and Drug Administration or the U.S. National Cancer Institute.

State: Louisiana

Legislation: Senate Bill 761

Effective: July 1999

What clinical trials are covered?

Phase II, III, and IV clinical trials for the treatment, supportive care, early detection, and prevention of cancer. The trial must be approved by one of the following:

• a cooperative group funded by a component of the National Institutes of Health
• U.S. Food and Drug Administration
• U.S. Department of Veterans Affairs
• U.S. Department of Defense
• a federally funded general clinical research center
• the Coalition of National Cancer Cooperative Groups

Also, the clinical trial protocol must have been reviewed and approved by a qualified Institutional Review Board (IRB) operating within the state that has a multiple project assurance contract approved by the Office of Protection from Research Risks, U.S. Department of Health and Human Services.

Who is required to pay?

Health maintenance organizations, preferred provider organizations, the State Employee Benefits Group Program, other specified insurers.

Other key provisions:

• There is no clearly superior, noninvestigational approach.
• The available clinical or preclinical data provide a reasonable expectation that the treatment will be as effective as the noninvestigational alternative.
• The patient has signed an IRB-approved informed consent form.

State: Maine

Legislation: 24-A: Maine Insurance Code

Effective: 1999

What clinical trials are covered?

Clinical trials enrolling individuals who have a life-threatening or serious illness for which no standard treatment is effective. Trial must be approved and funded by any one of the following:

• National Institutes of Health (NIH)
• an NIH-sponsored cooperative group or center
• U.S. Department of Health and Human Services

Who is required to pay?

Managed care organizations and private insurers.

Other key provisions:

• Participation must offer meaningful potential for significant clinical benefit to the enrollee.
• Referring physician must conclude that trial participation is appropriate.

State: Maryland

Legislation: Senate Bill 137, House Bill 45

Effective: July 1998

What clinical trials are covered?

Phase I, II, III, and IV cancer treatment, supportive care, early detection, and prevention trials. Phase II, III, and IV trials for other life-threatening conditions, with Phase I trials considered on a case-by-case basis.

Trial must be conducted by an academic medical center in Maryland or approved by one of the following:

• National Institutes of Health (NIH)
• an NIH-sponsored cooperative group or center
• U.S. Department of Veterans Affairs
• U.S. Food and Drug Administration

Who is required to pay?

Private insurers and other specified managed care plans.

Other key provisions:

• 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.

State: Massachusetts

Legislation: House Bill 4376 (Chapter 257)

Effective: January 2003

What clinical trials are covered?

All phases of cancer treatment trials.

Trial must be peer-reviewed and approved by one of the following:

• National Institutes of Health (NIH)
• an NIH-sponsored cooperative group or center
• U.S. Department of Defense
• U.S. Department of Veterans Affairs
• U.S. Food and Drug Administration
• A qualified non-government research entity

Who is required to pay?

All health plans issued or renewed after January 1, 2003.

Other key provisions:

• 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.

State: Michigan

Agreement: Michigan consensus agreement

Effective: February 2002

What clinical trials are covered?

Phase II and III cancer clinical trials that are sponsored or approved by any one of the following:

• National Institutes of Health (NIH)
• National Cancer Institute
• U.S. Food and Drug Administration
• U.S. Department of Defense
• U.S. Department of Veterans Affairs
• Centers for Medicare and Medicaid Services
• Centers for Disease Control and Prevention

The agreement also would cover any side effects from the clinical trial treatment, including hospitalization costs.

Who is required to pay?

Private insurance plans, HMOs and the Michigan Medicaid Program.

Other key provisions:

• Coverage for Phase I trials is under consideration.

State: Missouri

Legislation: Senate Bill 1026

Effective: August 28, 2002

What clinical trials are covered?

Phase III or IV clinical trials for the prevention, early detection, or treatment of cancer, as approved or funded by one of the following:

• National Institutes of Health (NIH)
• NIH Cooperative Group or Center
• U.S. Food and Drug Administration
• U.S. Department of Defense
• U.S. Department of Veterans Affairs
• An Institutional Review Board in Missouri that has been approved by the U.S. Department of Health and Human Services
• A qualified research entitity that meets the criteria for NIH Center support grant eligibility

Who is required to pay?

All health benefit plans operating in the state.

Other key provisions:

• There must be identical or superior noninvestigational treatment alternatives available before providing clinical trial treatment, and there must be a reasonable expectation that the clinical trial treatment will be superior to the noninvestigational alternatives.
• Requires coverage of FDA-approved drugs and devices used in cancer clinical trials even if those drugs and devices have not been approved for use in treatment of the patient's particular condition.
• Coverage for Phase I and II cancer trials is under consideration.

State: Nevada

Legislation: Senate Bill 29

Effective: January 1, 2006 (extends legislation in effect since January 2004 to include phase I cancer clinical trials)

What clinical trials are covered?

Phase I clinical trials for the treatment of cancer, and phase II, III, and IV clinical trials for the treatment of cancer or chronic fatigue syndrome that are approved by one of the following:

• National Institutes of Health (NIH)
• NIH cooperative group
• U.S. Food and Drug Administration (FDA)
• U.S. Department of Veterans Affairs
• U.S. Department of Defense

Who is required to pay?

Private insurers and managed care plans.

Other key provisions:

• There is no medical treatment available that is considered more appropriate treatment than the treatment provided in the clinical trial.
• Trial must be conducted in Nevada

State: New Hampshire

Legislation: Senate Bill 409

Effective: January 2001

What clinical trials are covered?

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 required for clinical trials that are approved by:

• National Institutes of Health (NIH)
• NIH cooperative group or center
• U.S. Food and Drug Administration
• U.S. Department of Veterans Affairs
• U.S. Department of Defense
• An Institutional Review Board of an institution in New Hampshire with a Multiple Project Assurance (MPA) from the U.S. Department of Health and Human Services' Office for Human Research Protections

Coverage is also required for reasonable and medically necessary services to administer the drug or device under evaluation in the clinical trial.

Who is required to pay?

Private insurers and specified managed care plans.

Other key provisions:

• Trials are covered when standard treatment has been or would be ineffective or does not exist, or when there is no clearly superior noninvestigational alternative.

State: New Jersey

Agreement: New Jersey consensus agreement

Effective: December 1999

What clinical trials are covered?

All phases of cancer clinical trials run by:

• National Institutes of Health (NIH)
• NIH cooperative group or center
• U.S. Food and Drug Administration
• U.S. Department of Defense
• U.S. Department of Veterans Affairs

Who is required to pay?

All insurers in the state, including those affiliated with the New Jersey Association of Health Plans.

State: New Mexico

Legislation: Senate Bill 240

Effective: March 14, 2001

What clinical trials are covered?

Phase I, II, III, and IV clinical trials for the early detection, treatment, palliation (supportive care), or prevention of recurrence of cancer. Trials must be approved by one of the following:

• National Institutes of Health (NIH)
• NIH cooperative group or center
• U.S. Food and Drug Administration (under an Investigational New Drug application)
• U.S. Department of Defense
• U.S. Department of Veterans Affairs
• Research entities meeting NIH grant standards.

Who is required to pay?

Private insurers, specified managed care plans, and Medicaid and other state medical assistance programs.

Other key provisions:

• Legislation is effective through July 1, 2009 (as per Senate Bill 73).
• Trial must have therapeutic intent.
• There must be a reasonable expectation that treatment will be at least as effective as standard or noninvestigational 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.

State: North Carolina

Legislation: Senate Bill 199

Effective: January 2002

What clinical trials are covered?

The law extends coverage to all people diagnosed with a life-threatening condition who choose to enroll in a Phase II, III, or IV clinical trial. Includes clinical trials approved and funded by any one of the following:

• National Institutes of Health (NIH)
• NIH cooperative group or center
• U.S. Food and Drug Administration
• Centers for Disease Control and Prevention
• Agency for Healthcare Research and Quality
• U.S. Department of Defense
• U.S. Department of Veterans Affairs

Who is required to pay?

All health insurance plans and the teachers' and state employees' comprehensive major medical plan.

Other key provisions:

• Mandated coverage is effective for health plans that are in effect or renewed on or after March 1, 2002.
• Patients suffering from a life-threatening disease or chronic condition may designate a specialist who is capable of coordinating their health care needs as their primary care physician. The law also established an Office of Managed Care Patient Assistance.

State: Ohio

Agreement: Ohio Med Plan

Effective: March 1999

What clinical trials are covered?

National Cancer Institute-sponsored Phase II and III cancer treatment clinical trials for Ohio state employees enrolled in the Ohio Med Plan.

Who is required to pay?

The state's Ohio Med Plan.

Other key provisions:

• Preauthorization is required for clinical trial participation.

State: Rhode Island

Legislation: Senate Bill 2623; Senate Bill 1, House Bill 5062

Effective: 1995 (SB 2623); 1998 (SB1, HB 5062)

What clinical trials are covered?

Phase II, III, and IV cancer clinical trials approved by one of the following:

• National Institutes of Health (NIH)
• A community clinical oncology program
• U.S. Food and Drug Administration
• U.S. Department of Veterans Affairs
• A qualified nongovernmental research entity, as identified by an NIH support grant.

Who is required to pay?

Private insurers and specified managed care plans.

State: Tennessee

Legislation: House Bill 837

Effective: July 2005

What clinical trials are covered?

Phase I, II, III, and IV clinical trials for the treatment of cancer approved by one of the following:

• National Institutes of Health (NIH)
• U.S. Food and Drug Administration (FDA), in the form of an Investigational New Drug Application
• U.S. Department of Defense
• U.S. Department of Veterans Affairs

Who is required to pay?

• Any health benefit plan offered by an employer; excludes individually underwritten health insurance policies.

Other key provisions:

• 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 managment of the patient.

State: Vermont

Legislation: House Bill 6

Effective: February 24, 2005 (extends and modifies legislation in effect since March 2002)

What clinical trials are covered?

Approved cancer clinical trials conducted under the auspices of the following cancer care providers:

• The Vermont Cancer Center at Fletcher Allen Health Care
• The Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center.

If no suitable trial is available at the above locations, the law covers approved cancer clinical trials being administered by a hospital and its affiliated, qualified cancer care providers in or outside the state of Vermont.

Who is required to pay?

All health insurance policies and health benefit plans issued in Vermont, including the Vermont Medicaid program.

Other key provisions:

• Participants in cancer trials located outside Vermont must provide notice to the health benefit plan prior to their participation.
• Health insurers are permitted to require patients participating in a trial outside the provider network to receive 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.
• Cancer care providers and the state's four largest health insurers are required to participate in a cost analysis to determine the impact of the program on health insurance premiums.

State: Virginia

Legislation: Senate Bill 1235, House Bill 871

Effective: July 1999

What clinical trials are covered?

Phase II, III and IV cancer treatment trials, with Phase I trials covered on a case-by-case basis. Trial must be approved by one of the following:

• National Cancer Institute (NCI)
• NCI cooperative group or center
• U.S. Food and Drug Administration
• U.S. Department of Defense
• U.S. Department of Veterans Affairs
• An Institutional Review Board of a Virginia institution with a Multiple Project Assurance (MPA) from the U.S. Department of Health and Human Services' Office for Human Research Protections.

Who is required to pay?

Private insurers, specified managed care plans, and public employee health plans.

Other key provisions:

• There is no clearly superior, noninvestigational alternative.
• Data provide a reasonable expectation that the treatment will be at least as effective as the alternative.

City: Washington, D.C.

Agreement: Bill 17-469 (D.C. Law 17-166) Clinical Trials Insurance Coverage Act of 2008

Effective: June 5, 2008

What clinical trials are covered?

Clinical trials undertaken for prevention, early detection, treatment, or monitoring of cancer and approved or funded in full or in part by one of the following:

• National Institutes of Health or one of its cooperative groups or centers
• Centers for Disease Control and Prevention
• Agency for Health Care Research and Quality
• Centers for Medicare and Medicaid Services
• U.S. Food and Drug Administration (FDA)
• U.S. Department of Defense
• U.S. Department of Veterans Affairs
• U.S. Department of Energy
• A nongovernmental research entity that has been awarded a National Cancer Institute support grant

Who is required to pay?

All health insurers in the District of Columbia.

Other key provisions:

Routine patient care costs shall not include

• tests or measurements conducted primarily for the purpose of the clinical trial involved.
• services or products provided solely for data collection and analysis purposes.
• services or products customarily provided free of charge to trial participants by the research sponsors.

State: West Virginia

Legislation: House Bill 2675

Effective: June 2003

What clinical trials are covered?

Phase II, III, or IV clinical trials for the prevention, early detection, or treatment of cancer, or for the treatment of any other life-threatening condition.

The clinical trial must be approved by one of the following:

• National Institutes of Health (NIH)
• NIH-sponsored cooperative group or center
• U.S. Food and Drug Administration (FDA)
• U.S. Department of Veterans Affairs
• The Institutional Review Board (IRB) of an institution in West Virginia that has a multiple project assurance contract approved by the NIH Office of Protection from Research Risks

Who is required to pay?

Private insurers, managed care plans, Medicaid or state medical assistance, public employee health plans.

Other key provisions:

• The treatment must have therapeutic intent.
• There is no clearly superior noninvestigational alternative.
• The available clinical or pre-clinical data provide a reasonable expectation that the treatment will be more effective than the noninvestigational treatment alternative.
• Does not require reimbursement for clinical trials intended to:
  • Extend the patent of any existing drug.
  • Gain approval of or coverage for a metabolite of an existing drug.
  • Gain approval or coverage relating to additional clinical indications for an existing drug.
  • Keep a generic version of a drug from coming to market.
  • Gain approval of or coverage for reformulated or repackaged version of an existing drug.

State: Wisconsin

Legislation: Assembly Bill 617

Effective: Nov. 1, 2006

What clinical trials are covered?

All phases of cancer clinical trials, as approved by one of the following:

• National Institutes of Health (NIH)
• NIH Cooperative Group or Center
• U.S. Food and Drug Administration
• U.S. Department of Defense
• U.S. Department of Veterans Affairs

Who is required to pay?

All health benefit plans operating in the state, including self-insured plans.

Other key provisions:

• The cancer trial must have therapeutic intent, not exclusively testing toxicity or disease pathophysiology.