Many states have laws that require insurance companies to cover costs related to certain kinds of clinical trials. A few states without such laws have groups of health insurers that voluntarily signed agreements for their companies to cover clinical trials. This legal agreement binds all the insurers that sign on, although in some states they can later withdraw from the agreement.

This is an alphabetical list of states that have laws and/or agreements regarding health insurance coverage of clinical trials. If your state is not on the list, no such laws or agreements existed at the time this information was last updated.

The most current and detailed information on your state’s coverage requirements, including 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” which can be read online at www.cancer.gov/clinicaltrials/education/laws.

Alaska

Year law was enacted, bill number and/or citation

2010, Senate Bill 10

Who must pay

Individual and group insurers, including HMO and public employee health plans

Covered services or benefits

Patient care costs related to approved clinical trials for the prevention, diagnosis, treatment, and palliative care of cancer, including leukemia, lymphoma, and bone marrow stem cell disorders

Other provisions

Only covers study when no clearly superior non-investigational treatment exists.

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 other known medical treatments.

The usual deductible, co-insurance, and/or co-pays apply.

Arizona

Year law was enacted, bill number and/or citation

2001, Senate Bill 1213

Who must pay

Hospital or medical service corporations, benefit insurers, health care service organizations, disability insurers, group disability insurers, private insurers, managed care plans, and accountable health plans

Covered services or benefits

Patient care costs associated with Phase I through IV approved cancer clinical trials

Other provisions

Clinical trial must be reviewed by an Institutional Review Board in Arizona.

Health professional must agree to accept reimbursement from insurer as payment in full.

Only covers study when no clearly superior non-investigational treatment exists.

Clinical trial must be in Arizona.

California

Year law was enacted, bill number and/or citation

2001, Senate Bill 37

Who must pay

All California insurers, including Medicaid and other medical assistance programs

Covered services or benefits

Routine patient care costs associated with Phase I through IV approved cancer clinical trials for people with cancer and when recommended by a treating doctor

Other provisions

May restrict coverage to services in California

Colorado

Year law was enacted, bill number and/or citation

2009, House Bill 09-1059

Who must pay

All individual and group health insurers in Colorado, including HMOs

Covered services or benefits

Routine patient care costs if all of these apply:

• The patient’s doctor believes the patient may benefit from and recommends the clinical trial
• The trial is approved under Medicare
• Care is provided by licensed, registered, or certified providers
• The patient has given signed informed consent
• The patient has a disabling, progressive, or life-threatening condition

Other provisions

Insurers do not have to cover:

• Any part of a trial paid for by a government or commercial sponsor, such as a drug or device
• Housing and travel expenses
• Any item or service used solely to collect or analyze data not directly related to the patient’s care
• Trial management costs
• Any health care services specifically excluded under the patient’s benefit plan

Connecticut

Year law was enacted, bill number and/or citation

2002, Senate Bill 325

Who must pay

Private insurers, individual and group health plans

Covered services or benefits

Routine patient care costs associated with approved clinical trials for treatment, palliation (supportive care), or prevention of cancer

Other provisions

Prevention 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

Year law was enacted, bill number and/or citation

2001, Senate Bill 181

Who must pay

Every group or blanket policy

Covered services or benefits

Routine patient care costs for covered people in approved clinical trials for treatment, palliative (supportive) care, or prevention of cancer

Other provisions

The trial must have therapeutic intent and enroll people diagnosed with the disease.

The trial must not be designed only to test toxicity or disease pathophysiology (the functional changes that accompany a particular syndrome or disease).

District of Columbia

Year law was enacted, bill number and/or citation

2008, Bill 17-469, DC Law 17-166

Who must pay

All insurers in DC

Covered services or benefits

Routine patient care costs for people in approved clinical trials undertaken for prevention, early detection, treatment, or monitoring of cancer

Other provisions

Insurers do not have to cover or reimburse:

• Tests done mainly for the purpose of the clinical trial
• Services or products provided only to collect or analyze data
• Services or products given free of charge to trial participants by the research sponsors

Florida

Year agreement was enacted, name

2010, Florida Cancer Clinical Trial Compact

Who must pay

All insurers who voluntarily signed the compact

Covered services or benefits

Routine patient care costs for people in approved Phase II, Phase III, or Phase IV clinical trials if the trial is recommended by a doctor whose health care services are covered by the patient’s health insurance.

The clinical trial must have therapeutic intent; it must not be designed only to test toxicity.

Other provisions

“Routine patient care costs” means the costs of health care services, including drugs, items, devices, and services that would be covered under the patient’s health plan if they were provided outside of a cancer clinical trial.

Insurers do not have to pay for:

• Drugs or devices not approved by the FDA for use associated with the cancer clinical trial
• Travel, food, housing, and other travel expenses
• Items or services needed only for data collection and analysis
• Health care services that would otherwise not be covered under the patient’s health plan for other conditions
• Health care services usually provided free of charge to trial enrollees by the trial sponsors
• The cost of the cancer treatment drug, if the clinical trial’s purpose is to study the use of the drug in a certain cancer or to study a new way to give the drug.

Deductibles or co-pays may apply to routine patient care costs

Insurers may restrict coverage for cancer clinical trials to hospitals and doctors in Florida unless the trial protocol for the cancer clinical trial is not available at a Florida hospital or with a Florida-licensed doctor.

Insurers are not required to pay for the services of an out-of-network provider unless the patient’s health plan covers out-of-network services.

Georgia

Year law was enacted, bill number and/or citation

1998 – covers children only (see second entry below for the agreement that covers adults), Senate Bill 603

Who must pay

All health plans in Georgia

Covered services or benefits

Routine patient care costs associated with Phase II or III trial of approved prescription drug clinical trial programs for the treatment of cancer diagnosed before age 19

Other provisions

The trial has to have been approved by the FDA or the NCI.

Year agreement was enacted, name

2002 – covers adults, Georgia Clinical Trials agreement (also called the Georgia Cancer Coalition Agreement)

Who must pay

Major insurers who signed the agreement

Covered services or benefits

Routine patient care costs associated with approved Phase I through IV clinical trials for cancer patients; the trial must be recommended by a treating physician.

Coverage of cancer screenings and exams that follow the most recently published guidelines and recommendations from any nationally recognized health care organization.

Other provisions

The clinical trial must either

• Involve a drug that currently is exempt under federal regulations from a new drug application

or

• Be a study that is approved by one of the specified federal agencies or a Georgia institutional review board

Indiana

Year law was enacted, bill number and/or citation

2009, House Bill 1382

Who must pay

State employee health plans, the state Medicaid program, policies of accident and sickness insurance, and HMO contracts

Covered services or benefits

Routine patient care costs of approved Phase I through IV clinical trials done to prevent, diagnose, or treat cancer, as long as the insurer would cover the same costs if the patient were not in a clinical trial

Other provisions

There must be no clearly superior, non-investigational alternative care method; and data must show that the care method used in the research study is likely to work as well as approved care.

With slight variations for Medicaid, health plans do not need to cover:

• The service, item, or drug that’s being tested
• Treatments that are not part of the usual and customary standard of care
• Health care services, items, or drugs used solely for data collection or analysis and not in the direct care of the patient
• Investigational drugs or devices not approved by the FDA
• Travel, food, and lodging
• Services, items, or drugs provided by the clinical trial sponsors
• Services, items, or drugs that are eligible for reimbursement from other sources

Iowa

Year law was enacted, bill number and/or citation

2010, House File 2075

Who must pay

Individual or group third-party provider contracts or policies

Covered services or benefits

Routine patient care costs of an approved cancer clinical trial if the insurer would cover the same costs if the patient was not in a clinical trial; the trial must be aimed at improving the patient’s survival or quality of life

Other provisions

Available data must show that the treatment will be at least as effective as the standard therapy and is expected to be an improvement in the treatment of the disease in question.

The patient must be referred to the cancer clinical trial by 2 doctors who specialize in cancer care.

Health plans do not need to cover:

• The treatments, procedures, drugs, devices, services, or items that are being tested
• Costs associated with managing the trial or collecting and analyzing data
• Transportation, lodging, food, or other travel expenses
• Services, items, or drugs that are eligible for reimbursement from a source other than a patient’s contract or policy, including the sponsor of the clinical trial

Kentucky

Year law was enacted, bill number and/or citation

2010, Senate Bill 18

Who must pay

All health benefit policies, plans, and contracts

Covered services or benefits

Routine patient care costs of an approved cancer clinical trial if the insurer would cover the same costs if the patient was not in a clinical trial as long as the trial does one of these:

• 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

Other provisions

Health plans do not need to cover:

• The treatments, drugs, services, or items that are being tested
• An investigational drug or device not approved for marketing by the FDA
• Costs associated with managing the trial or collecting and analyzing data
• Transportation, lodging, food, or other travel expenses
• Services, items, or drugs that are eligible for reimbursement from a source other than a patient’s contract or policy, including the sponsor of the clinical trial

Coverage of routine costs is subject to all terms, conditions, restrictions, exclusions, and limitations that apply to other coverage under the patient’s policy, plan, or contract.

Health benefit policies, plans, or contracts are not required to reimburse services performed in a cancer clinical trial by a non-participating provider at the same rate as services performed by a participating provider.

Louisiana

Year law was enacted, bill number and/or citation

1999, Senate Bill 761

Who must pay

HMOs, PPOs, State Employee Benefits Program, and other specified insurers

Covered services or benefits

Patient care costs associated with Phase II through IV approved clinical trials for the treatment, supportive care, early detection, and prevention of cancer

Other provisions

Only covers costs when no clearly superior, non-investigational approach exists.

Available data must support reasonable expectation that the treatment will be as effective as the non-investigational alternative.

State Institutional Review Board approval is needed, and the consent form must be IRB approved.

Maine

Year law was enacted, bill number and/or citation

1999, 24-A: Maine Insurance Code

Who must pay

Managed care organizations and private insurers

Covered services or benefits

Patient care costs associated with an approved clinical trial for patients who have a life-threatening or serious illness for which no standard treatment is effective

Other provisions

Participation must offer meaningful potential for significant clinical benefit.

The referring doctor must conclude that trial participation is appropriate.

Maryland

Year law was enacted, bill number and/or citation

1998, Senate Bill 137, House Bill 45

Who must pay

Private insurers and other specified managed care organizations

Covered services or benefits

Patient care costs of approved Phase I through IV cancer treatment, supportive care, early detection, and prevention trials; Phase II through IV for other life-threatening conditions

Other provisions

There is no proven treatment that is clearly superior.

The data provide a reasonable expectation that the treatment will work at least as well as the alternative.

Massachusetts

Year law was enacted, bill number and/or citation

2003, House Bill 4376 (Chap 257)

Who must pay

Individual and group insurers, including HMOs

Covered services or benefits

Patient care costs of all phases of approved cancer clinical trials

Other 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 take part in the trial.

Michigan

Year agreement was enacted, name

2002, Consensus Guidelines for Healthcare Coverage of Routine Patient Care Costs Associated with Oncology Clinical Trials

Who must pay

Private insurance plans, HMOs, and the Michigan Medicaid Program

Covered services or benefits

Phase II and III approved cancer clinical trials, as well as any side effects from the clinical trial treatment, including hospitalization

Other provisions

None

Missouri

Year law was enacted, bill number and/or citation

2002, Senate Bill 1026

2006, Senate Bills 567 & 792

Who must pay

Specified insurers, including HMOs

Covered services or benefits

Routine patient care costs associated with approved Phase II, III, or IV clinical trials for the prevention, early detection, or treatment of cancer

Other provisions

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 treatment 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 the patient’s particular condition.

Health benefit plans may limit coverage of routine care costs of patients in Phase II trials to those facilities within the plans’ provider network.

For individually underwritten health plans, the Phase II provision isn’t mandatory but must be offered as an option.

Nebraska

Year agreement was enacted, name

2009, Nebraska Insurance Federation Agreement

Who must pay

Health benefit providers who are voluntary members of the Nebraska Insurance Federation

Covered services or benefits

Routine patient care costs associated with approved Phase II, III, or IV clinical trials that would be covered by the health benefit plan outside of a clinical trial

Other provisions

Health plans do not need to cover:

• The item or service that is being investigated, unless it would be covered outside of the clinical trial
• Items or services used solely for data collection purposes, to determine eligibility, or that would be paid for or provided free by the trial sponsor in the absence of insurance coverage

Deductibles or co-pays may apply, subject to the terms of the patient's benefit plan.

Nevada

Year law was enacted, bill number and/or citation

2004, amended 2006, Senate Bill 29

Who must pay

All private insurers and managed care plans

Covered services or benefits

Patient costs associated with approved Phase I through IV cancer treatment clinical trials

Other provisions

There must be no medical treatment available which is considered a more appropriate alternative than the medical treatment provided in the clinical trial.

The trial must be conducted in Nevada.

New Hampshire

Year law was enacted, bill number and/or citation

2001, Senate Bill 409

Who must pay

Private insurers and specified managed care plans

Covered services or benefits

Patient care costs associated with approved Phase I through 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.

Other provisions

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 Jersey

Year agreement was enacted, name

1999, Consensus Document of the New Jersey Working Group to Improve Outcomes in Cancer Patients

Who must pay

All insurers in the state, including those affiliated with the New Jersey Association of Health Plans, have agreed to pay for the cost of the standard of care in covered cancer clinical trials.

Covered services or benefits

Patient care costs associated with approved Phase I through IV cancer clinical trials

Other provisions

None

New Mexico

Year law was enacted, bill number and/or citation

2009, Senate Bill 42, Chapter 212

Who must pay

Group health plans, including HMOs and the state's medical assistance program

Covered services or benefits

Patient care costs of taking part in an approved Phase I through IV cancer clinical trial

Other provisions

The clinical trial must be undertaken for the purposes of preventing cancer recurrence, early detection, palliation (supportive care), or treatment of cancer for which there is no equally or more effective standard cancer treatment.

The trial must have therapeutic intent.

There must be a reasonable expectation that treatment will be at least as effective as standard 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.

Does not cover:

• Cost of an investigational drug, device, or procedure
• Costs of non-health care services that the patient needs because of clinical trial participation
• Costs associated with managing the research that is part of the clinical trial
• Costs that would not be covered by the patient’s health plan if standard treatments were provided
• Costs of extra tests that would not be done except for participation in the clinical trial
• Costs paid or not charged for by the clinical trial providers

Deductibles, co-insurance, or other standard cost-sharing provisions may apply

North Carolina

Year law was enacted, bill number and/or citation

2002, Senate Bill 199

Who must pay

All health insurance plans

Covered services or benefits

Patient care costs associated with approved Phase II through IV clinical trials for all people diagnosed with a life-threatening condition

Other provisions

Patients suffering from a life-threatening disease or chronic condition may designate a specialist who is capable of coordinating their health care needs.

Ohio

Year law was enacted, bill number and/or citation

2008, Senate Bill 186

Who must pay

All health benefit plans, including those for public employees

Covered services or benefits

Medically necessary costs of health care services associated with any stage of an approved clinical trial; pre-authorization may be needed

Other provisions

Insurers do not have to cover:

• Services or products that are being tested in the clinical trial
• Any item or procedure not used in the direct clinical management of the patient
• Any item not approved by the FDA
• Food, lodging, and transportation
• Services or products provided free of charge or eligible for reimbursement by a party other than the health insurer, including the clinical trial sponsor

Oregon

Year law was enacted, bill number and/or citation

2010, Senate Bill 316

Who must pay

All individual and group health benefit plans, including HMOs

Covered services or benefits

Routine patient care costs associated with approved Phase I through IV cancer clinical trials that would be covered by the health benefit plan outside of a clinical trial

Other provisions

Patients taking part in covered clinical trials pay the same deductibles, co-pays, co-insurance, and other fees associated with their care that they would pay if they were not taking part in a clinical trial.

Insurers do not have to cover:

• Services or products that are being tested in the clinical trial
• Any item or procedure used for data collection and analysis
• Services or products usually provided free of charge

Rhode Island

Year law was enacted, bill number and/or citation

1995, Senate Bill 2623

1998, Senate Bill 1, House Bill 5062

Who must pay

Private insurers and specified managed care plans

Covered services or benefits

Patient care costs associated with approved Phase II through IV cancer clinical trials

Other provisions

None

South Carolina

Year agreement was enacted, name

2010, South Carolina Clinical Trials Agreement

Who must pay

Health insurers, HMOs, and self-insured governmental employers who have voluntarily signed the agreement

Covered services or benefits

Routine patient care costs associated with approved Phase II through IV cancer clinical trials or cancer clinical trials involving a drug that is exempt under federal regulations from a new drug application

Other provisions

A doctor who is authorized to provide health care services to the insured according to the insured’s health plan contract must recommend participation in the cancer clinical trial

The trial must have therapeutic intent; it cannot be designed only to test toxicity.

Insurers do not have to cover:

• Services or products that are being tested in the clinical trial
• Any item or procedure used for data collection and analysis
• Services or products usually provided free of charge
• Travel and housing costs
• The cost of an oncology drug, if the trial’s purpose is to study the use of the drug in the particular cancer in question or to study a new way to give the drug

Tennessee

Year law was enacted, bill number and/or citation

2005, House Bill 837

Who must pay

All health benefit plans offered by an employer; excludes individually underwritten health insurance policies

Covered services or benefits

Patient care costs associated with approved Phase I through IV cancer clinical trials

Other 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 management of the patient.

Texas

Year law was enacted, bill number and/or citation

2009, Senate Bill 39, Chapter 719

Who must pay

All individual and group health benefit plans, including HMOs, state Medicaid and Medicaid managed care organizations (to the extent allowed by federal law), and state employee health benefit plans

Covered services or benefits

Patient care costs associated with approved Phase I through IV clinical trials are covered provided that they are conducted to prevent, detect, or treat a life-threatening disease or condition

Other provisions

Routine patient care costs means the costs of medically necessary health care services that would be covered by the health benefit plan outside of a clinical trial, except for the costs of:

• Drugs or devices not approved by the FDA, including the drug or device being studied
• Non­health care services
• Health care services that are specifically excluded from coverage under a health plan
• Costs associated with managing the research that is part of the clinical trial

Research institutions and health care professionals must accept reimbursement at insurers’ usual rates as payment in full for routine patient care.

Insurers do not need to pay for:

• Routine care provided outside of the plan’s provider network, unless the plan normally covers out-of-network benefits
• Services that are part of the subject of the clinical trial and usually paid for by the research institution conducting the trial.
• Health care services provided outside of Texas, unless the plan normally covers out-of-state health care services.

Patients pay the same deductibles, co-pays, co-insurance, and other fees that they would pay if they were not in a clinical trial.

Insurers cannot cancel or refuse to renew coverage under a plan solely because an enrollee in the plan takes part in a clinical trial.

Vermont

Year law was enacted, bill number and/or citation

2001, amended 2005, House Bill 6

Who must pay

All health insurance policies and health benefit plans in the state, including Medicaid

Covered services or benefits

Patient care costs associated with approved cancer clinical trials conducted through the Vermont Cancer Center at Fletcher Allen Health Care or the Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center. If no suitable trial is available at these locations, the law covers approved cancer clinical trials being administered by a hospital and its affiliated, qualified cancer care providers outside Vermont

Other provisions

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.

Virginia

Year law was enacted, bill number and/or citation

1999, Senate Bill 1235, House Bill 871

Who must pay

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

Covered services or benefits

Patient care costs associated with approved Phase II through IV cancer treatment clinical trials; Phase I coverage is provided on a case-by-case basis

Other provisions

There must be no clearly superior, non-investigational alternative.

Data must provide a reasonable expectation that the treatment will be at least as effective as the alternative.

Washington

Year law was enacted, bill number and/or citation

October 2012, Washington Administrative Code Chapter 284-43, 284-43-850 Clinical trials

Who must pay

All health plans and all health carriers subject to the jurisdiction of the state of Washington

Covered services or benefits

Routine patient care costs associated with approved Phase I through IV cancer prevention, detection, or treatment clinical trials. Service must be consistent with widely accepted and established standards of care.

Other provisions

Routine patient care costs means items and services delivered to the enrollee that are typically covered by the plan or coverage for an enrollee who is not enrolled in a clinical trial.

Insurers do not need to pay for:

• The investigational item, device, or service being tested in the clinical trial
• Any items or services not used in the direct clinical management of the patient
• Costs associated with collecting data or managing the clinical trial research
• Routine care provided outside of the plan’s provider network, unless the plan normally covers out-of-network benefits

The clinical trial must be a study that is approved by one of the specified federal agencies or a local institutional review board.

West Virginia

Year law was enacted, bill number and/or citation

2003, House Bill 2675

Who must pay

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

Covered services or benefits

Patient care costs associated with approved Phase II through IV clinical trials for the prevention, early detection, or treatment of cancer or any other life-threatening condition

Other provisions

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.

Insurers do not need to pay for clinical trials done 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

Wisconsin

Year law was enacted, bill number and/or citation

2006, Assembly Bill 617

Who must pay

Any health insurance plan offered by the state and specified insurers

Covered services or benefits

Patient care costs associated with all phases of approved cancer clinical trials

Other provisions

Trial must intend to improve the trial participant’s health outcomes and not be designed only to test toxicity or disease pathophysiology (the functional changes that accompany a particular syndrome or disease).

Wyoming

Year law was enacted, bill number and/or citation

2008, Senate File 0024

Who must pay

All health insurance policies, contracts, and certificates that cover any Wyoming resident

Covered services or benefits

Routine patient care costs associated with approved Phase II, III, or IV clinical trials for cancer treatment

Other provisions

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.

Approved clinical trials and other state requirements

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

• National Institutes of Health (NIH)
• NIH cooperative group or center
• Centers for Disease Control and Prevention (CDC)
• Agency for Health Care Research and Quality
• Centers for Medicare and Medicaid Services
• National Cancer Institute (NCI) cooperative group or center
• The Coalition of National Cancer Cooperative Groups
• US Food and Drug Administration (FDA)
• US Department of Defense
• US Department of Veterans Affairs
• US Department of Energy