Table One
Clinical Trials Laws
May 2006

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)
Senate Bill 1213
20-2328

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

Patient costs associated with participation in Phase I through IV cancer clinical trials.

Trial must be reviewed by an Institutions Review Board in AZ.
Health professional must agree to accept reimbursement from insurer as payment in full.
Only covers trial when no clearly superior nonivestigational treatment exists.
Trial must be in AZ.

California
(2000)
Senate Bill 37

All California insurers, including Medicaid and other medical assistance programs

Routine patient care costs associated with Phase I through IV cancer clinical trials.

May restrict coverage to services in CA.

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

Private insurers, individual and group health plans

Routine patient care costs associated with cancer clinical trials.

Prevention trials are covered only in Phase III and only if 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

Every group of blanket policy, including policies or contracts issued by health service corporations

Routine patient care costs for covered persons engaging in clinical trials for the treatment of life threatening diseases under specified conditions.

Trial must have therapeutic intent and enroll individuals diagnosed with the disease.
Trial must not be designed exclusively to test toxicity or disease pathophysiology.

Georgia*
(1998)
33-24-59.1

Insurers and the state health plan

Routine patient costs incurred in Phase II and III of prescription drug clinical trial programs for the treatment of children's cancer.

For the treatment of cancer that generally first manifests itself in children under the age of 19.

Illinois
(1999)
House Bill 1622
(amended 2004)
Senate Bill 2339
Public Act No. 93-1000
20 ILCS 1405/56.3**

HMOs and individual/group insurance policies to offer coverage to the applicant or policyholder
(2004 amendment: Plans may not be canceled or non renewed based on an individual's participation in a qualified clinical trial)

Routine patient care if the individual participates in an approved Phase II through IV cancer research trial.

Coverage benefit can have annual limit of $10,000.
Trial must be conducted at multiple sites in state.
Primary care MD must be involved in coordination of care.
Researchers must submit results of trial for publication in nationally recognized scientific literature.

Louisiana
(1999)
RS 22:230.4

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

Patient costs incurred in Phase II through IV cancer clinical trials.

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.
Patientmust sign an Institutional Review Board-approved consent form.

Maine
(2000)
24-A-4310

Managed care organizations and private insurers

Routine patient care costs associated with clinical trial.

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

Maryland***
(1998)
Chap 146-15-827

Private insurers and other specified managed care organizations.

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

There is no clearly superior, nonivestigational alternative.
The data provide a reasonable expectation that the treatment will be as least as effective as the alternative.

Massachusetts
(2002)
Chap 176A Sec 8X

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

Patient care services associated with all phases of qualified 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)
376.429

(2006)- Phase II
SB 567 & 792

All health benefit plans operating in the state

Routine patient care costs as the result of Phase II, III or IV clinical trials for the prevention, early detection, or treatment of cancer.

There must be identical or superior nonivestigational treatment alternatives available before providing clinical trial treatment, and there must be a reasonable expectation that the trial will be superior to the alternatives.
Requires coverage of FDA-approved drugs and devices even if they have not be approved for use in treatment of patient's particularcondition.

New Hampshire
(2000)
415:18

Private insurers and specified managed care plans

Medically necessary routine patient care costs incurred as a result of a treatment for Phase I through IV cancer clinical trial or trial for a life-threatening disease.

Coverage for Phases I or II decided on case-by-case basis.
Coverage is required for services needed to administer drug or device under evaluation.
Coverage is required for routine patient care associated with drugs or devices which are not subject of trial, as long as they have been approved by FDA.

Nevada
(2003)
(amended 2005)SB 29
NRS 695G.173

All health insurance insurers, medical service corporations, HMOs and managed care organizations

Patient costs associated with Phase I through IV cancer or chronic fatigue clinical trial

Healthcare facility and personnel must have experience and training to provide the treatment in a capable manner.
There must be no medical treatment available which is considered a more appropriate alternative medical treatment than the medical treatment provided in the clinical trial.
There must be a reasonable expectation based on clinical data that the medical treatment provided in the clinical trial or study will be at least as effective as any other medical treatment.
Amendment revises type of medical treatment covered.

New Mexico
(2002)
(amended 2004 to delay repeal until July 1, 2009)
59A-22-43

A health insurer;a nonprofit health service provider;a HMO;a managed care organization;a provider service organization; or the state's medical assistance program.

Routine patient care costs incurred as a result of the patient's participation in a phase II, III or IV cancer clinical trial.

Must be undertaken for the purposes of the prevention of reoccurrence of cancer, early detection or treatment of cancer for which no equally or more effective standard cancer treatment exists.
Must not be designed exclusively to test toxicity or disease pathophysiology and it has a therapeutic intent.
Must be provided as part of a scientific study of a new therapy or intervention and is for the prevention of reoccurrence, early detection, treatment or palliation of cancer in humans and in which includes specific provisions of scientific study.

New Mexico
(2001)
59A-22-43

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

Routine patient care costs incurred as result of Phase I through IV cancer clinical trial.

Effective through July 1, 2004.
Trial must have therapeutic intent.
Reasonable expectation that investigational treatment will be at least as effective as standard treatment.

North Carolina
(2001)
58-3-255

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

Medically necessary costs of health care services associated with Phase II through IV of covered 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.

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

Private insurers and specified managed care plans

Coverage for new cancer therapies if treatment is provided under Phase II through IV cancer clinical trial.

Tennessee
(2005)
HB 837

All health benefit plans

Routine patient care costs related to Phase I through IV cancer clinical trial.

Treatment must involve drug that is exempt under federal regulations from a new drug application, or approved by: NIH, FDA in form of new drug application, DOD, or VA.

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

All health insurance policies and health benefit plans, including Medicaid

Routine patient care costs incurred during the participation in a cancer clinical trial.

Providers and insurers required to participate in a cost analysis to determine impact of the program on health insurance premiums.
Amended law allows for participation in trial outside of Vermont if patient notifies health benefit plan prior to participation, and no clinical trial is available at Vermont or New Hampshire cancer care providers.

Virginia
(1999)
38.2-3418.8

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

Patient costs incurred during the participation in Phase II through IV cancer clinical trials.
Coverage provided on a case-by-case basis for Phase I.

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

West Virginia
(2003)
9-2-12

Individual and group insurers, health service corporations, health care corporations, HMOs, public employees insurance agency, Medicaid and the children's health insurance program

Patient costs associated with the participation in Phase II through IV clinical trial for treatment of life-threatening condition or the prevention, early detection and treatment of cancer.

Facility and personnel providing the treatment are capable of doing so by virtue of their experience, training and volume of patients treated to maintain expertise.
There must be no clearly superior, noninvestigational treatment alternative.
Data provide a reasonable expectation that the treatment will be more effective than the noninvestigational treatment alternative.

Wisconsin
AB 617
(2006)
Act 194

Any health insurance plan offered by the state, any self-insured plans

Routine patient care costs incurred during the participation in all phases of a cancer clinical trial.
No policy, plan, or contract may exclude coverage for the cost of any routine patient care that is administered to an insured in a cancer clinical trial satisfying the criteria under par. (c) and that would be covered under the policy, plan, or contract if the insured were not enrolled in a cancer clinical trial.

Trial must meet all criteria:
1.The purpose is to test whether the intervention potentially improves the trial participant’s health outcomes.
2. The treatment provided as part of the trial is given with the intention of improving the trial participant’s health outcomes.
3. The trial has therapeutic intent and is not designed exclusively to test toxicity or disease pathophysiology.
4. The trial does one of the following:
a. Tests how to administer a health care service, item, or drug for the treatment of cancer.
b. Tests responses to a health care service, item, or drug for the treatment of cancer.
c. 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.
d. Studies new uses of health care services, items, or drugs for the treatment of cancer.
5. The trial is approved by one of the following:
a. A National Institute of Health, or one of its cooperative groups or centers, under the federal department of health and human services; federal food and drug administration; federal department of defense; federal department of veterans affairs.

Table Two
Special Agreements

State
(Year Agreement Became Effective)
Web Address of Agreement

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 Phase I through IV cancer clinical trials.

Trials include those that involve a drug that is currently exempt under federal regulations from a new drug application or those that are approved by specified federal agencies or a local institutional review board.
Provides for the coverage of cancer screens and examinations in accordance with the most recently published guidelines and recommendations established by any nationally recognized health care organization.

Michigan
(2002)
Michigan Consensus Agreement

Private insurance plans, HMOs and Medicaid

Routine patient care costs associated with Phase II and III cancer clinical trials.

Coverage for Phase I trials is under consideration.

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 Phase II and III cancer treatment clinical trials.

Preauthorization is required for clinical trial participation.