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GA Cancer Coalition
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  Untitled Document

Georgia Clinical Trials Agreement

Agreement to Reduce Cancer Morbidity and Mortality in Georgia

The undersigned parties to this agreement acknowledge that Georgia ranks higher than the national average in the incidence and mortality of cancer. Cancer is the second leading cause of death in Georgia. The parties further acknowledge that many cancers can be treated successfully if detected early. The Georgia Cancer Coalition ("GCC"), a Georgia nonprofit corporation, has been formed to act as a catalyst and conduit for best practices in cancer screening, research, and treatment throughout the State of Georgia. The undersigned health insurers have a similar compelling interest in assisting the GCC to improve the methods of cancer detection, treatment, and prevention.

Purpose of this Agreement

The intent and purpose of this Agreement is to provide for insurance coverage for certain services related to cancer for those Georgians covered by the health insurance policies issued by the undersigned insurers. Such coverage will promote the health and welfare of the people of Georgia. There are two general areas covered pursuant to this Agreement: (1) coverage of the routine patient care costs for persons participating in cancer clinical trials within Georgia; and (2) coverage of screening tests as described in section 2.0 of this agreement.

1.0 Cancer Clinical Trials

1.0.1 Importance of Cancer Clinical Trials

All standard cancer treatments in use today began as clinical trials. Most of the advances in cancer therapies have occurred as a direct result of studies in which doctors have been able to determine the most effective forms of treatment. Although clinical research has improved patient care dramatically, only about three percent of those with cancer in Georgia participate in clinical trials. Without strong clinical trial participation, it will be impossible to evaluate and improve detection, treatment, and prevention options.

1.0.2 Clinical Trials Covered Pursuant to this Agreement
The parties to this Agreement agree that for all those insured, diagnosed with cancer, and accepted into a Phase I, Phase II, Phase III, or Phase IV clinical trial for cancer, all the insurance policies issued by the undersigned insurers that provide for hospital, medical, or surgical coverage in this state shall provide coverage for all routine patient care costs related to a clinical trial in cancer if a physician who is providing or is authorized to provide covered healthcare services to the insured under the insured’s health benefit plan contract recommends participation in the clinical trial. That determination must be made after determining that participation in the clinical trial has a meaningful potential to benefit the insured. A clinical trial’s endpoints shall not be defined exclusively to test toxicity, but shall have a therapeutic intent.

For purposes of this Agreement, a clinical trial must either (1) involve a drug that is exempt under federal regulations from a new drug application, or (2) be a trial that is approved by one of the following:

A. A Cooperative Group or one of the National Institutes of Health.
B. The federal Food and Drug Administration, in the form of an investigational new drug application.
C. The United States Department of Defense.
D. The United States Veterans' Administration.
E. The National Cancer Institute.
F. An Institutional Review Board of any accredited school of medicine, nursing or pharmacy in the State of Georgia.

1.0.3 Routine Patient Care Costs Defined
Routine patient care costs, for purposes of this Agreement, is defined as those costs associated with the provision of health care services, including drugs, items, devices, and services that would otherwise be covered under the plan or contract if those drugs, items, devices, and services were not provided in connection with an approved clinical trial program, including the following:

A. Health care services covered absent a clinical trial,
B. Health care services required solely for the provision of the investigational drug, item, device or service.
C. Health care services required for the clinically appropriate monitoring of the investigational item or service.
D. Health care services provided for the prevention of complications arising from the provision of the investigational drug, item, device or service.
E. Health care services needed for the reasonable and necessary care arising from the provision of the investigational drug, item, device, or service, including the diagnosis or treatment of the complications.

For purposes of this Agreement and this Agreement only, routine patient care costs does not include the costs associated with the provision of any of the following:

i. Drugs or devices that have not been approved by the federal Food and Drug Administration associated with the clinical trial.
ii. Services other than health care services, such as travel, housing, companion expenses, and other no clinical expenses, that an insured may require as a result of the treatment being provided for purposes of the clinical trial.
iii. 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.
iv. Health care services which, except for the fact they are not being provided in a clinical trial, are otherwise specifically excluded from coverage under the insured’s health plan.
v. Health care services customarily provided by the research sponsors free of charge for any enrollee in the trial.

1.0.4 Payment Rate
In the case of health care services provided by a contracting provider, the payment rate shall be at the agreed-upon rate. In the case of a noncontracting provider, the payment shall be at the negotiated rate the insurer would otherwise pay to a contracting provider for the same services, less applicable copayments and deductibles. Nothing in this Agreement shall be construed to prohibit an insurer from restricting coverage for clinical trials to hospitals and physicians in Georgia unless the protocol for the clinical trial is not available at a Georgia hospital or Georgia-licensed physician.

2.0 Cancer Screenings

2.0.1 Importance of Early Detection

Despite remarkable treatment options available to cancer patients, one of the most important factors in five-year survival rates for cancer patients remains early detection. Early detection examinations are known to save lives, even in certain asymptomatic people. To that end, the American Cancer Society ("ACS"), the National Institutes of Health ("NIH"), the National Cancer Institute ("NCI") and the United States Public Health Service ("USPHS") and other nationally recognized health care organizations have established guidelines to detect cancer early. Additionally, the undersigned health plans provide benefits for certain cancer screenings. The ACS, NIH, NCI, USPHS and the undersigned plans unequivocally believe that early detection examinations and tests can help save lives. Some examples of such testing include mammography, the PAP test, the PSA blood test, skin examinations and colonoscopies. Early detection not only saves lives, but it also saves money. For cancers addressed by the ACS early detection guidelines, early detection can result in a relatively low-cost treatment option.

2.0.2 Those Screenings Covered by this Agreement

The parties to this Agreement agree that every health benefit policy shall provide coverage for cancer screenings and examinations in accordance with the most recently published guidelines and recommendations established by any of the following: ACS, NIH, NCI, USPHS or other nationally recognized health care organization. .

3.0 Miscellaneous Provisions

A. The provisions of services when required by this Agreement shall not, in itself, give rise to liability on the part of the insurer.
B. Nothing in this Agreement shall be construed to prohibit, limit, or modify an insured’s rights to the independent review process available under Chapter 20A of Title 33 of the Official Code of Georgia Annotated, the Patient’s Right to Independent Review Act.
C. Nothing in this Agreement shall be construed to otherwise limit or modify any existing requirements under state or federal law, or to prevent application of deductible or copayment provisions contained in a policy.
D. Copayments and deductibles applied to services delivered pursuant to this Agreement shall be the same as those applied to the same services if not delivered pursuant to this Agreement.
E. Nothing in this Agreement shall be construed to prohibit the parties to it from issuing or continuing to issue an accident and sickness insurance benefit plan, policy, or contract which has benefits that are greater than the minimum benefits required by this Agreement or from issuing or continuing to issue any accident and sickness insurance plan, policy, or contract which provides benefits which are generally more favorable to the insured than those required by this Agreement.
F. Each party to this Agreement will perform its activities as an independent contractor and not as a partner, agent or joint venturer with the other. Neither party will have the power to create obligations or liabilities for the other. Neither party will be bound by any representation, act or omission of the other.

Parties to this Agreement

In recognition of the importance of reducing the cancer morbidity and mortality rates in Georgia, and in an effort to establish a voluntary process to further participation in clinical trials as well as early detection of cancer, the organizations signing below agree to abide by the provisions of this Agreement, to make all best efforts to facilitate participation of their members in clinical trials, and to support the efforts of the Georgia Cancer Coalition. The parties reserve the right to review periodically the administration and efficacy of this agreement in order to suggest modifications in its terms or termination of the agreement in its entirety.

Participating Organizations

Blue Cross/Blue Shield
United Healthcare



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