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Clinical Trials What are States Doing 2010

Clinical Trials: What are States Doing?
 

 September 2010 Update 

Stethoscope ImageWhat is a Clinical Trial?
A clinical trial is a research study on human patients to test the safety and effectiveness of new treatments.  These trials offer patients access to new and potentially life saving drugs and cures. 

The dramatic progress made in treating childhood cancers in recent years, is attributable, in part, to clinical trials, because 60 percent of all children with cancer are enrolled in some kind of trial.  A ten percent drop in breast cancer mortality for women  under the age of 50 is said to be the result of clinical trials research conducted in the 1970's. 

Who Enrolls in Clinical Trials?
Only two to three percent of eligible adult patients enroll in clinical trials.  For cancer patients, clinical trials are often the last resort after exhausting all other approved means of treatment.  
Insurance Coverage for Clinical Trials

Typically, when a patient enrolls in a clinical trial, the cost of tests, procedures, drugs and any research activity directly associated with the investigation, are covered by the group sponsoring the trial, such as a pharmaceutical company or the National Cancer Institute.   However, because some health plans define clinical trials as "experimental" or "investigational," health insurance coverage may or may not include some or all of the costs of  "routine patient care," such as the doctor visits, hospital stays, tests and x-rays, that a patient would normally receive whether or not they were enrolled in a trial. 

A growing number of states have passed legislation or instituted special agreements requiring health plans to pay the cost of the routine medical care a patient receives as a participant in a clinical trial.

Advantages:
For cancer patients, properly designed and conducted clinical trials represent an important therapeutic option, as well as a critical means of advancing medical knowledge.  Lack of insurance coverage is a barrier to patients who might otherwise participate.  Sixty percent of patients in one survey cited fear of insurance denial as a major reason for not participating in clinical trials.  And finally, a recent study found only a slight increase in treatment costs for adult clinical trial patients compared to nonparticipants-$35,418 versus $33,248.2 

Some large HMOs have computed costs associated with patients in clinical trials.  Kaiser Permanente discovered the cost of medical care for enrollees in clinical trials that haven't had bone marrow transplant were no higher than for patients who were not enrolled in a trial. The Kaiser report further states, “Kaiser has been participating in cancer clinical trials without substantial increases in the direct costs of medical care.”3

Researchers at the Mayo Clinic found that patient care costs for those enrolled in clinical trials is only slightly more than for patients who received standard therapy protocols.4

The Institutes of Medicine has also found the following:

  • The reimbursement costs are limited to the cost of “standard care” which would be covered if the patient were not enrolled in the trial;1
  • Only a small percentage (approximately 20%) of cancer patients are eligible to participate in a clinical trial and very few (approximately 3% of cancer patients and less than 0.5% of Medicare patients) currently enroll. Even if enrollment was increased to the full 20 percent, it is unlikely that these numbers will significantly impact overall costs to health plans;1 
  • Through clinical trials, we will be able to identify ineffective treatments, which could save health plans money and will benefit the nation as a whole.1

Disadvantages:
Even though the same recent study found only a slight increase in treatment costs, the 6.5 percent increase between participants and nonparticipants in clinical trials translated into an additional $16 million in 1999 spent on treatment costs for the 19,000 adult patients enrolled in National Cancer Institute-sponsored clinical trials.2  These additional insurance costs, like other mandated benefits and services, may result in higher insurance premium rates, which are often cost-shifted onto workers in the form of higher deductibles and copayments.  

For states without insurance mandates, it is possible that some physicians may enroll patients in clinical trials but not inform the patients' insurance companies, bypassing the reimbursement issue for the patient and potentially the physician.5

It may also be possible to encourage participation in clinical trials by working within networks of health care providers and industry, research facilities, patient groups, as well as major media outlets, without enacting a state wide insurance mandate.

Sources:
1. Aaron HJ, Gelband H, editors. Extending Medicare reimbursement in clinical trials. Washington, DC: National Academy Press; 2000. p 13.

2. Goldman DP, Berry SH, McCabe M, et al. Incremental Treatment Costs in National Cancer Institute–Sponsored Clinical Trials. JAMA. 2003;289(22):2970-2977 (doi:10.1001/jama.289.22.2970) http://jama.ama-assn.org/cgi/reprint/289/22/2970.pdf

3. Fireman BH, Fehrenbacher L, Gruskin EP, Ray GT. Cost of care for patients in cancer clinical trials. J Natl Cancer Inst 2000;92:136-42.

4. Wagner JL, Alberts SR, Sloan JA, et al. Incremental costs of enrolling cancer patients in clinical trials: a population-based study. J Natl Cancer Inst 1999;91:847-53.

5. McBride G, More States Mandate Coverage of Clinical Trial Costs, But Does It Make a Difference?, JNCI Journal of the National Cancer Institute 2003 95(17):1268-1269; doi:10.1093/jnci/95.17.1268
 

Definitions of Phases:
A clinical trial study is conducted in four phases.

Phase I:  Research is conducted on a small group of volunteers (20 to 80 people) for the first time to evaluate its safety, determine a safe dosage range and identify side effects.

Phase II: The experimental drug or treatment is given to or a procedure is performed on a larger group of people (100 to 300 individuals) to further measure its effectiveness and safety.

Phase III:  Further research is conducted to confirm the effectiveness of the drug, treatment or procedure, monitor the side effects, compare commonly used treatments and collect information on safe use.  Phase III trials are typically conducted on 1,000 to 3,000 individuals.

Phase IV:  After the drug, treatment or medical procedure is marketed, investigators continue testing to determine the effects on various populations and whether there are side effects associated with long-term use.

Summary of State Laws as of September 2010

Table One provides a summary of the 27 states and District of Columbia that have enacted laws to mandate the coverage of, or insurers have agreed to cover, clinical trials.

 

Table One: Clinical Trials

State
Year of Enactment
Bill Number and/or Citation
Who is required to pay?
What services or benefits are covered?
Other key criteria?
 Alaska
 (2010)
 Senate Bill 10
 Chapter No. 117
Health care insurers

1. Prevention, diagnosis, treatment, and palliative care of cancer;
2. Medical care for an approved clinical trial related to cancer that would otherwise be covered under a health care insurance plan if the medical care were not in connection with an approved clinical trial related to cancer;
3. Items or services necessary to provide an investigational item or service;
4. The diagnosis or treatment of complications;
5. A drug or device approved by the United States Food and Drug Administration without regard to whether the United States Food and Drug Administration approved the drug or device for use in treating a patient's particular condition, but only to the extent that the drug or device is not paid for by the manufacturer, distributor, or provider of the drug or device;
6. Services necessary to administer a drug or device under evaluation in the clinical trial; and
7. Transportation for the patient that is primarily for and essential to the medical care.

 

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.

District of Columbia
(2008)
Bill 17-469
(D.C. Law 17-166)
 
All insurers in the District Routine patient care costs for people in 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, or nongovernmental research entity that has been awarded a National Cancer Institute support grant.

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.

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 not 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.

Indiana
(2009)
House Bill 1382
Public Law 109
State employee health plan, the state Medicaid program, a policy of accident and sickness insurance, and a HMO contract Requires coverage for routine patient care related to Phase I through IV clinical trials approved by NIH, FDA, VA or DoD.

(1) Require an insurer that issues a policy of accident and sickness insurance to provide coverage for clinical trial services rendered by a contracted provider.

(2) Prohibit an insurer that issues a policy of accident and sickness insurance from providing coverage for clinical trial services rendered by a contracted provider.

(3) Require reimbursement under a policy of accident and sickness insurance for services that are rendered in a clinical trial by a noncontracted provider at the same rate of reimbursement that would apply to the same services rendered by a contracted provider.

 Iowa
 (2009)
 HF 2075
 

Health insurance companies that provide a policy or contract providing for third-party payment or prepayment of health or medical expenses

Individual or group accident and sickness insurance providing coverage on an expense-incurred basis

An individual or group hospital or medical service contract issued

An individual or group health maintenance organization contract

Any other entity engaged in the business of insurance,
risk transfer, or risk retention, which is subject to the jurisdiction of the commissioner

A plan established for public
employees 

An organized delivery system licensed by the director of public health

"Routine patient care costs" means medically necessary services or treatments that are a benefit under a contract or policy providing for third-party payment or prepayment of health or medical expenses that would be covered if the patient were receiving standard cancer treatment...shall provide coverage benefits for routine patient care costs incurred for cancer treatment in an approved cancer clinical trial to the same extent that such policy or contract provides coverage for treating any other  sickness, injury, disease, or condition covered under the policy or contract, if the insured has been referred for such cancer treatment by two physicians who specialize in oncology and the cancer treatment is given pursuant to an approved cancer clinical trial that meets the criteria set forth.

The treatment is provided with therapeutic intent and is provided pursuant to an approved cancer clinical trial that has been authorized or approved by one of the following:

   (1)  The national institutes of health.
   (2)  The United States food and drug administration.
   (3)  The United States department of defense.
   (4)  The United States department of veterans affairs.

The proposed treatment has been reviewed and approved by the applicable qualified institutional review board.

The available clinical or preclinical data indicate that the treatment that will be provided pursuant to the approved cancer clinical trial will be at least as effective as the standard therapy and is anticipated to constitute an improvement in therapeutic effectiveness for the treatment of the disease in question.

 

Kansas 
K.A.R. 40-4-43

HMOs, health insurance plans, and other specified insurers

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

The insured or prospective insured has been diagnosed with cancer and accepted into a phase I, phase II, phase III, or phase IV clinical trial for cancer.

(2) The treating physician who is providing covered health care services to the insured recommends participation in the clinical trial after determining that participation in the clinical trial has a meaningful potential to benefit the insured.

(b) Each policy or certificate covered by this regulation shall provide coverage for all routine patient care costs associated with the provision of health care services, including drugs, items, devices, treatments, diagnostics, and services that would otherwise be covered under the insurance policy or certificate if those drugs, items, devices, treatments, diagnostics, and services were not provided in connection with an approved clinical trial program, including health care services typically provided to patients not participating in  a clinical trial.

 (c) For purposes of this regulation, "routine patient care costs" shall not include the costs associated with the provision of any of the following:

For purposes of this regulation, "routine patient care costs" shall not include the costs associated with the provision of any of the following:

 (1) Drugs or devices that have not been approved by the federal food and drug administration and that are associated with the clinical trial;

 (2) services other than health care services, including travel, housing, companion expenses, and other nonclinical expenses, that an insured could require as a result of the treatment being provided for purposes of the clinical trial;

 (3) any item or service that is provided solely to satisfy data collection and analysis needs and that is not used in the clinical management of the patient;

(4) health care services that, except for the fact that they are being provided in a clinical trial, are otherwise specifically excluded from coverage under the insured’s hospital, medical, or surgical expense policy or certificate; or

(5) health care services customarily provided by the research sponsors of a trial free of charge for any insured in the trial.

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.

Patient must  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 particular condition. 

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)**

B 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.

New Mexico
(2009)
SB 42
Chap 2009-212
Group health coverage, including any form of self-insurance,
offered, issued or renewed under the Health Care Purchasing Act shall provide coverage pursuant to Section 59A-22-43 NMSA 1978
Routine patient care costs as a result of the patient's participation in a clinical trial. 1) A medical service or treatment that is a benefit under a health plan that would be covered if the patient were receiving standard cancer treatment; or 2) a drug provided to a patient during a cancer clinical trial if the drug has been approved by the federal food and drug administration, whether or not that organization has approved the drug for use in treating the patient's particular condition, but only to the extent that the drug is not paid for by the manufacturer, distributor or provider of the drug.

Does not include:

The cost of an investigational drug, device or procedure;

The cost of a non-health care service that the patient is required to receive as a result of participation in the cancer clinical trial;

Costs associated with managing the research that is associated with the cancer clinical trial;

Costs that would not be covered by the patient's health plan if non-investigational treatments were provided;

Costs of those extra tests that would not be performed except for participation in the cancer clinical trial; and

Costs paid or not charged for by the cancer clinical trial providers.

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.

Ohio
(2008)
ORC Ann. 1751.01  (2008)
All health benefit plans including those for public employees Medically necessary costs of health care services associated with any stage of clinical trial.

Trial must be approved by NIH or another group under HHS, FDA, DoD or VA. May exclude coverage for service or product that is part of the investigative trial, item or procedure used only for data collection for the trial, item not approved by FDA, and transportation, lodging and food related to travel for participation in the trial.

Oregon
(2009)
SB 316
Chap 274

Requires health benefit plan to provide coverage of routine costs of care in qualifying clinical trials subject to copayment and other cost sharing requirements

Covers 'routine costs':

(a) Means medically necessary conventional care, items or services covered by the health benefit plan if typically provided absent a clinical trial. Trial must be funded by the National Institutes of Health, the Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality, the Centers for Medicare and Medicaid Services, the United States Department of Defense or the United States Department of Veterans Affairs; or 

(b) supported by a center or cooperative group that is funded
by one of the above agencies.

(c) Conducted as an investigational new drug application, an investigational device exemption or a biologics license application subject to approval by the United States Food and Drug Administration; or

(d) Exempt by federal law from the requirement to submit an investigational new drug application to the United States Food and Drug Administration.
 

 Does not include:

The drug, device or service being tested in the clinical trial unless the drug, device or service would be covered for that indication by the health benefit plan if provided outside of a clinical trial;

Items or services required solely for the provision of the drug device or service being tested in the clinical trial;

Items or services required solely for the clinically appropriate monitoring of the drug, device or service being tested in the clinical trial;

Items or services required solely for the prevention, diagnosis or treatment of complications arising from the provision of the drug, device or service being tested in the clinical trial;

Items or services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient;

Items or services customarily provided by a clinical trial sponsor free of charge to any participant in the clinical trial;

Items or services that are not covered by the health plan if provided outside of the clinical trial.

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
Sec. 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)
Section 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:

The purpose is to test whether the intervention potentially improves the trial participant’s health outcomes.

The treatment provided as part of the trial is given with the intention of improving the trial participant’s health outcomes.

The trial has therapeutic intent and is not designed exclusively to test toxicity or disease pathophysiology.

The trial does one of the following:

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.

The trial is approved by one of the following: The 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.

Wyoming
SF 024
(2008 budget session)

All health insurance policies, contracts, and certificates providing coverage to any resident of this state  Routine patient care for a person enrolled in a Phases II through IV clinical trial.  Includes a medical service or treatment that is a benefit under a health plan that would be covered if the patient were receiving standard cancer treatment; or a drug provided to a patient during a cancer clinical trial, other than the drug that is the subject of the clinical trial, if the drug has been approved by the federal food and drug administration for use in treating the patient's particular condition.

Trial must also be approved by NIH, FDA, Dept. of Defense, or Dept. of Veterans Affairs. 

The medical treatment must be provided by a licensed health care provider operating within the scope of his/her license in a facility whose personnel has the experience and training necessary to provide the treatment in a competent manner.

The clinical trial participant must have signed an informed consent document prior to starting the trial.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

*In 2002, all major insurers in Georgia agreed to cover routine patient care costs associated with Phase I, II, III, or 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.  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 (see below).

**Illinois Executive Branch Administrative Code (20 ILCS 1405/1405-20) required the Department of Insurance to conduct an analysis and study of costs and benefits derived from the implementation of the coverage requirements for investigational cancer treatments. The study covered the years 2000 through 2002 and included an analysis of the effect of the coverage requirements on the cost of insurance and health care, the results of the treatments to patients, the mortality rate among cancer patients, any improvements in care of patients, and any improvements in the quality of life of patients.

***A 2003 Maryland law (S 128) repealed a reporting requirement for insurers, nonprofit health service plans, and HMOs to submit a report that described the trials covered during the previous year.

Sources: National Cancer Institute, Health Policy Tracking Service.

Summary of Other Actions

Table Two summarizes the special agreements some states have arranged with insurance companies to voluntarily provide coverage for clinical trials. 

 

Table Two: 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 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.

 Federal Activity

In 2000, Medicare began covering beneficiaries patient care costs in clinical trials.  While many state Medicaid programs have no legal requirements to cover clinical trials costs, many do cover all or some of the costs.

Additional Resources

National Cancer Institue, States That Require Health Plans to Cover Patient Care Costs in Clinical Trials. Information and Overview: http://www.cancer.gov/clinicaltrials/ctlaws-home

To legislators and legislative staff: For more information please contact NCSL at health-info@ncsl.org

This web page is supported in part by an award from the American Cancer Society Cancer Action Network, 2009.

 

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