376.429. Coverage for certain clinical trials for prevention, early detection and treatment of cancer, restrictions--definitions--exclusions.
Coverage for certain clinical trials for prevention, early detectionand treatment of cancer, restrictions--definitions--exclusions.
376.429. 1. All health benefit plans, as defined in section376.1350, that are delivered, issued for delivery, continued or renewed onor after August 28, 2006, and providing coverage to any resident of thisstate shall provide coverage for routine patient care costs as defined insubsection 7 of this section incurred as the result of phase II, III, or IVof a clinical trial that is approved by an entity listed in subsection 4 ofthis section and is undertaken for the purposes of the prevention, earlydetection, or treatment of cancer. Health benefit plans may limit coveragefor the routine patient care costs of patients in phase II of a clinicaltrial to those treating facilities within the health benefit plans'provider network; except that, this provision shall not be construed asrelieving a health benefit plan of the sufficiency of network requirementsunder state statute.
2. In the case of treatment under a clinical trial, the treatingfacility and personnel must have the expertise and training to provide thetreatment and treat a sufficient volume of patients. There must be equalto or superior, noninvestigational treatment alternatives and the availableclinical or preclinical data must provide a reasonable expectation that thetreatment will be superior to the noninvestigational alternatives.
3. Coverage required by this section shall include coverage forroutine patient care costs incurred for drugs and devices that have beenapproved for sale by the Food and Drug Administration (FDA), regardless ofwhether approved by the FDA for use in treating the patient's particularcondition, including coverage for reasonable and medically necessaryservices needed to administer the drug or use the device under evaluationin the clinical trial.
4. Subsections 1 and 2 of this section requiring coverage for routinepatient care costs shall apply to phase III or IV of clinical trials thatare approved or funded by one of the following entities:
(1) One of the National Institutes of Health (NIH);
(2) An NIH cooperative group or center as defined in subsection 7 ofthis section;
(3) The FDA in the form of an investigational new drug application;
(4) The federal Departments of Veterans' Affairs or Defense;
(5) An institutional review board in this state that has anappropriate assurance approved by the Department of Health and HumanServices assuring compliance with and implementation of regulations for theprotection of human subjects (45 CFR 46); or
(6) A qualified research entity that meets the criteria for NIHCenter support grant eligibility.
5. Subsections 1 and 2 of this section requiring coverage for routinepatient care costs shall apply to phase II of clinical trials if:
(1) Phase II of a clinical trial is sanctioned by the NationalInstitutes of Health (NIH) or National Cancer Institute (NCI) and conductedat academic or National Cancer Institute Center; and
(2) The person covered under this section is enrolled in the clinicaltrial. This section shall not apply to persons who are only following theprotocol of phase II of a clinical trial, but not actually enrolled.
6. An entity seeking coverage for treatment, prevention, or earlydetection in a clinical trial approved by an institutional review boardunder subdivision (5) of subsection 4 of this section shall maintain andpost electronically a list of the clinical trials meeting the requirementsof subsections 2 and 3 of this section. This list shall include: thephase for which the clinical trial is approved; the entity approving thetrial; the particular disease; and the number of participants in the trial.If the electronic posting is not practical, the entity seeking coverageshall periodically provide payers and providers in the state with a writtenlist of trials providing the information required in this section.
7. As used in this section, the following terms shall mean:
(1) "Cooperative group", a formal network of facilities thatcollaborate on research projects and have an established NIH-approved PeerReview Program operating within the group, including the NCI ClinicalCooperative Group and the NCI Community Clinical Oncology Program;
(2) "Multiple project assurance contract", a contract between aninstitution and the federal Department of Health and Human Services (DHHS)that defines the relationship of the institution to the DHHS and sets outthe responsibilities of the institution and the procedures that will beused by the institution to protect human subjects;
(3) "Routine patient care costs" shall include coverage forreasonable and medically necessary services needed to administer the drugor device under evaluation in the clinical trial. Routine patient carecosts include all items and services that are otherwise generally availableto a qualified individual that are provided in the clinical trial except:
(a) The investigational item or service itself;
(b) Items and services provided solely to satisfy data collection andanalysis needs and that are not used in the direct clinical management ofthe patient; and
(c) Items and services customarily provided by the research sponsorsfree of charge for any enrollee in the trial.
8. For the purpose of this section, providers participating inclinical trials shall obtain a patient's informed consent for participationon the clinical trial in a manner that is consistent with current legal andethical standards. Such documents shall be made available to the healthinsurer upon request.
9. The provisions of this section shall not apply to a policy, planor contract paid under Title XVIII or Title XIX of the Social Security Act.
10. Nothing in this section shall apply to any accident-only policy,specified disease policy, hospital indemnity policy, Medicare supplementpolicy, long-term care policy, short-term major medical policy of sixmonths or less duration, or other limited benefit health insurancepolicies.
11. The provisions of this section regarding phase II of a clinicaltrial shall not apply automatically to an individually underwritten healthbenefit plan, but shall be an option to any such plan.
(L. 2002 S.B. 1026, A.L. 2003 S.B. 407, A.L. 2006 S.B. 567 & 792)