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Clinical Trials: State Laws Regarding Insurance Coverage

Clinical trials are research studies to test new drugs ortreatments. 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 needed even if you were not taking part in a clinical trial.

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 one. 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


State (year of enactment), bill number* and/or citation Who is required to pay? What services or benefits are covered? Other key criteria
Arizona (2000)
SB 1213
20-2328 		Hospital or medical service corporations, benefit insurers, health care service organizations, disability insurers, group disability insurers, and accountable health plans Patient care costs associated with Phase I through IV approved cancer clinical trials Clinical trial must be reviewed by an Institutional Review Board in AZ. 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 AZ.
California (2000)
SB 37 		All California insurers, including Medicaid and other medical assistance programs Patient care costs associated with Phase I through IV approved cancer clinical trials May restrict coverage to services in CA.
Colorado (2009)
HB 09-1059 		All individual and group health insurers, including HMO, operating in Colorado Routine care costs: if the doctor believes the patient may benefit from the clinical trial; the trial is approved under Medicare; care is provided by licensed, registered, or certified providers; and the patient has a disabling, progressive, or life-threatening condition. Insurers may exclude coverage for: --Any part of a trial paid for by a government or commercial sponsor, including any drug or device paid for by others -- 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 (2001)
SB 325
Public Act 01-171 		Private insurers, individual and group health plans Patient care costs associated with approved cancer clinical trials 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 (2001)
SB 181 		Every group of blanket policy, including policies or contracts issued by health service corporations Patient care costs for covered persons in approved clinical trials for the treatment of life-threatening diseases under specified conditions 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) 		All insurers in D.C. Routine patient care costs for people in approved clinical trials undertaken for prevention, early detection, treatment, or monitoring of cancer 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)
SB 603,
Act 801 		All insurers and the state health plan Patient care costs associated with Phase II and III of approved prescription drug clinical trial programs for the treatment of children’s cancer The child has to have been diagnosed with cancer prior to his or her 19th birthday, and the trial has to have been approved by the FDA or the NCI
Indiana (2009)
HB 1382
Public Law 109 		State employee health plans, the state Medicaid program, policies of accident and sickness insurance, and HMO contracts Patient care costs associated with approved Phase I through IV cancer clinical trials if the insurer would provide coverage for the same routine care costs if they were not incurred in a clinical trial 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 may exclude coverage for: --The service, item, or drug that is 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 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
Louisiana (1999)
RS 22:230.4
SB 761 		HMOs, PPOs, State Employee Benefits Program, and other specified insurers Patient care costs associated with Phase II through IV approved cancer clinical trials 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. Institutional Review Board-approved consent form must be used.
Maine (2000)
24-A-4310 		Managed care organizations and private insurers Patient care costs associated with an approved clinical trial 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 		Private insurers and other specified managed care organizations Patient care costs associated with approved Phase I through IV cancer treatment, supportive care, early detection, and prevention trials; Phase II through IV for other life-threatening conditions; and Phase I considered on a case-by-case basis There is no clearly superior, non-investigational 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 		All health plans issued or renewed after Jan. 1, 2003 Patient care costs associated with all phases of approved cancer clinical trials 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 		All health benefit plans operating in the state Patient care costs associated with approved Phase II, III, or IV clinical trials for the prevention, early detection, or treatment of cancer 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. 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 is not mandatory but must be offered as an option.)
Nevada (2003, amended 2005)
SB 29
NRS 695G.173 		All private insurers and managed care plans Patient costs associated with approved Phase I through IV cancer clinical trials Health care 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. The trial must be conducted in Nevada.
New Hampshire (2000)
SB 409 415:18 		Private insurers and specified managed care plans 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 in the clinical trial. 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, 2009)
SB 240
59A-22-43
SB 42, Chapter 212 		Private insurers, specified managed care plans, and Medicaid or other state medical assistance programs; group health coverage, including any form of self-insurance, offered, issued or renewed under the Health Care Purchasing Act Patient care costs associated with the patient's participation in an approved Phase I through IV cancer clinical trial The clinical trial must be undertaken for the purposes of preventing cancer recurrence, early detection, 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 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 		All health insurance plans and teachers and state employees' comprehensive major medical plan Patient care costs associated with approved Phase II through IV clinical trials 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) SB 186 ORC Ann. 1751.01 All health benefit plans including those for public employees Medically necessary costs of health care services associated with any stage of an approved clinical trial 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.
Oregon (2010)
SB 316 Chapter 274 		All individual and group health benefit plans, including HMOs 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 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.
Rhode Island (1994, 1997)
94-SB 2623
97-SB 1,
HB 5062 		Private insurers and specified managed care plans Patient care costs associated with approved Phase II through IV cancer clinical trials
Tennessee (2005)
HB 837 		All health benefit plans offered by an employer Patient care costs associated with approved Phase I through IV cancer clinical trials 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 (2009)
SB 39, Chapter 719 		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 that are issued or renewed on or after January 1, 2010 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 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. Research institutions and health care professionals must accept reimbursement at insurers' usual rates as payment in full for routine patient care. Insurers do not have to pay for services that are part of the subject matter of the clinical trial, which are usually paid for by the research institution conducting the trial. Insurers are not required to provide benefits for: --Routine care provided outside of the plan's provider network, unless the plan normally covers out-of-network benefits --Health care services provided outside of Texas, unless the plan normally covers out-of-state health care services. Patients taking part in covered clinical trials 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 (2001, amended 2005 to remove March 1, 2005 sunset provision)
Chap 107 4088b
HB 6 		All health insurance policies and health benefit plans in the state, including Medicaid 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 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 		Private insurers, specified managed care plans, and public employee health plans Patient care costs associated with approved Phase II through IV cancer clinical trials; Phase I coverage is provided on a case-by-base basis 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 		Private insurers, managed care plans, Medicaid or state medical assistance, public employee health plans 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 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 		Any health insurance plan operating in the state, and any self-insured plans Patient care costs associated with all phases of approved cancer clinical trials 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 0024 		All health insurance policies, contracts, and certificates that cover any Wyoming resident Patient care costs associated with approved Phase II, III, or IV clinical trials for cancer treatment 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.

*SB = Senate bill; HB = House bill.
+Additional Maryland information: A 2003 Maryland law (S 128) repealed a reporting requirement for insurers, non-profit health service plans, and HMOs to submit a report that described the trials covered during the previous year.

(Table adapted from National Conference of State Legislatures ©, 2010)

Special agreements

State (year agreement became effective) Who is required to pay? What services or benefits are covered? Other key criteria
Georgia (2002) Georgia Cancer Coalition All major insurers Routine patient care costs associated with approved Phase I through IV clinical trials for cancer patients and 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. 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 Private insurance plans, HMOs, and Medicaid Routine patient care costs associated with approved Phase II and III cancer clinical trials. Coverage for Phase I clinical trials is under consideration
Nebraska (2009) Nebraska Insurance Federation Agreement Health benefit providers who are members of the Nebraska Insurance Federation have voluntarily agreed to provide this coverage as part of health insurance contracts that they underwrite Routine patient care costs associated with approved Phase II through IV clinical trials Routine patient care costs means the costs associated with health care services that would be covered by the health plan outside of a clinical trial, including items or services that are typically covered by the plan outside of a clinical trial. It excludes the investigational item or service itself, unless it would be covered outside of the clinical trial items; services needed only to collect data or determine eligibility; or services that would be paid for by the trial sponsor in the absence of insurance coverage. Deductibles or co-pays may apply to routine patient care costs in a clinical trial, subject to the terms of the patient's benefit plan. Members of the Nebraska Insurance Federation reserve the right to review the administration and efficacy of this agreement and may modify or terminate it.
New Jersey (1999) New Jersey Consensus Agreement All insurers Routine patient care costs associated with all phases of cancer clinical trials
Ohio (1999) Ohio Med Plan State employees on Ohio Med Plan Routine patient care costs associated with approved Phase II and III cancer treatment clinical trials Pre-authorization is required for clinical trial participation.

(Table adapted from National Conference of State Legislatures ©, 2010)

These special agreements are made between the state and the insurance companies to voluntarily provide coverage for clinical trials. They are not like the laws, which say what types of coverage must be provided. Special agreements 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.")

Approved clinical trials and other state requirements

Some states require certain agencies to 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 (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

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 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 Disease Control and Prevention Web site at www.cdc.gov/mmwr/international/relres.html. 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 Web site of the National Association of Insurance Commissioners 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 insurance 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).

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
Has complete and up-to-date information on Medicare and can give you contact information for Medicaid and State Children’s Health Insurance Program (SCHIP), which are state-run programs

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
Provides a map of the United States to find your state's Commissioner of Insurance/Insurance department

National Cancer Institute
Toll-free number: 1-800-422-6237 (1-800-4-CANCER)
Web site: www.cancer.gov
For accurate, up-to-date information about cancer for patients, their families, and the general public; also provides information on understanding clinical trials, deciding whether to take part in trials, finding specific trials, plus research news, and other resources

No matter who you are, we can help. Contact us anytime, day or night, for information and support. Call us at 1-800-227-2345 or visit www.cancer.org.

References

American Cancer Society Cancer Action Network. How Do You Measure Up? A Progress Report on State Legislative Activity to Reduce Cancer Incidence and Mortality. July 2009.

Centers for Medicare and Medicaid Services. Medicare and Clinical Research Studies. Accessed at www.medicare.gov/Publications/Pubs/pdf/02226.pdf on February 10, 2010.

National Association of Insurance Commissioners. State Insurance Department Websites. Accessed at www.naic.org/state_web_map.htm on February 10, 2010.

National Cancer Institute. State Cancer Legislative Database Program. Accessed at www.scld-nci.net/index.cfml on February 10, 2010.

National Cancer Institute. States That Require Health Plans to Cover Patient Care Costs in Clinical Trials. Accessed at www.cancer.gov/clinicaltrials/ctlaws-home#Anchor-33277 on February 10, 2010.

National Conference of State Legislatures. Clinical Trials: What are States Doing? August 2009 Update. Accessed at www.ncsl.org/IssuesResearch/Health/ClinicalTrialsWhatareStatesDoing2008/tabid/14331/Default.aspx on February 10, 2010.

Last Medical Review: 02/24/2010
Last Revised: 02/24/2010

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