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,
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.
1.0.1 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
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
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
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
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
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.
Blue Cross/Blue Shield