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304.17A-136 Coverage for cancer clinical trials.
(1)
(2)
As used in this section, unless the context requires otherwise:
(a) "Cancer clinical trial" means a clinical trial that:
1.
Is approved by:
a.
The National Institutes of Health, or any institutional review
board recognized by the National Institutes of Health;
b.
The United States Food and Drug Administration;
c.
The United States Department of Defense; or
d.
The United States Veterans Administration; and
2.
Does one (1) 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; or
d.
Studies new uses of health care services, items, or drugs for
the treatment of cancer; and
(b) "Routine patient healthcare costs" means all healthcare services, items,
and drugs for the treatment of cancer, except for the following:
1.
The health care service, item, or investigational drug that is the
subject of the cancer clinical trial;
2.
Any treatment modality outside the usual and customary standard of
care required to administer or support the healthcare service, item,
or investigational drug that is the subject of the cancer clinical trial;
3.
Any healthcare service, item, or drug provided solely to satisfy data
collection and analysis needs that are not used in the direct clinical
management of the patient;
4.
An investigational drug or device that has not been approved for
market by the United States Food and Drug Administration;
5.
Transportation, lodging, food, or other expenses for the patient or a
family member or companion of the patient that are associated with
travel to or from a facility providing the cancer clinical trial;
6.
Any services, items, or drugs provided by the cancer clinical trial
sponsors free of charge for any new patient; or
7.
Any services, items, or drugs that are eligible for reimbursement by
a person other than the insurer, including the sponsor of the clinical
trial.
A health benefit plan shall not exclude coverage for routine patient healthcare
costs that are incurred in the course of a cancer clinical trial if the health benefit
plan would provide coverage for the routine patient healthcare costs had they
not been incurred in a cancer clinical trial.
(3)
(4)
(5)
The coverage that may not be excluded under this section shall be subject to
all terms, conditions, restrictions, exclusions, and limitations that apply to any
other coverage under the policy, plan, or contract, including the treatment
under the policy, plan, or contract of services performed by participating and
nonparticipating providers.
(a) Nothing in this section requires a policy, plan, or contract to offer cancer
clinical trial services by a participating provider.
(b) Nothing in this section prohibits a policy, plan, or contract from offering
cancer clinical trial services by a participating provider.
(c) Nothing in this section requires services that are performed in a cancer
clinical trial by a nonparticipating provider of a policy, plan, or contract to
be reimbursed at the same rate as those performed by a participating
provider of the policy, plan, or contract.
Nothing in this section shall be construed as imposing a new health benefit
mandate.
Effective:July 15, 2010
History: Created 2010 Ky. Acts ch. 23, sec. 1, effective July 15, 2010.
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