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