CHAPTER 25. COVERAGE FOR CARE RELATED TO CLINICAL TRIALS
IC 27-8-25
Chapter 25. Coverage for Care Related to Clinical Trials
IC 27-8-25-1
"Care method"
Sec. 1. As used in this chapter, "care method" means the use of aparticular drug or device in a particular manner.
As added by P.L.109-2009, SEC.3.
IC 27-8-25-2
"Clinical trial"
Sec. 2. As used in this chapter, "clinical trial" means a Phase I, II,III, or IV research study:
(1) that is conducted:
(A) using a particular care method to prevent, diagnose, ortreat a cancer for which:
(i) there is no clearly superior, noninvestigationalalternative care method; and
(ii) available clinical or preclinical data provides areasonable basis from which to believe that the caremethod used in the research study is at least as effective asany noninvestigational alternative care method;
(B) in a facility where personnel providing the care methodto be followed in the research study have:
(i) received training in providing the care method;
(ii) expertise in providing the type of care required for theresearch study; and
(iii) experience providing the type of care required for theresearch study to a sufficient volume of patients tomaintain expertise; and
(C) to scientifically determine the best care method toprevent, diagnose, or treat the cancer; and
(2) that is approved or funded by one (1) of the following:
(A) A National Institutes of Health institute.
(B) A cooperative group of research facilities that has anestablished peer review program that is approved by aNational Institutes of Health institute or center.
(C) The federal Food and Drug Administration.
(D) The United States Department of Veterans Affairs.
(E) The United States Department of Defense.
(F) The institutional review board of an institution locatedin Indiana that has a multiple project assurance contractapproved by the National Institutes of Health Office forProtection from Research Risks as provided in 45 CFR46.103.
(G) A research entity that meets eligibility criteria for asupport grant from a National Institutes of Health center.
As added by P.L.109-2009, SEC.3.
IC 27-8-25-3 "Contracted provider"
Sec. 3. As used in this chapter, "contracted provider" means ahealth care provider that has entered into an agreement underIC 27-8-11-3 with an insurer that issues a policy of accident andsickness insurance.
As added by P.L.109-2009, SEC.3.
IC 27-8-25-4
"Covered individual"
Sec. 4. As used in this chapter, "covered individual" means anindividual entitled to coverage under a policy of accident andsickness insurance.
As added by P.L.109-2009, SEC.3.
IC 27-8-25-5
"Noncontracted provider"
Sec. 5. As used in this chapter, "noncontracted provider" meansa health care provider that has not entered into an agreement to serveas a contracted provider.
As added by P.L.109-2009, SEC.3.
IC 27-8-25-6
"Policy of accident and sickness insurance"
Sec. 6. As used in this chapter, "policy of accident and sicknessinsurance" has the meaning set forth in IC 27-8-5-1.
As added by P.L.109-2009, SEC.3.
IC 27-8-25-7
"Routine care cost"
Sec. 7. As used in this chapter, "routine care cost" means the costof medically necessary services related to the care method that isunder evaluation in a clinical trial. The term does not include thefollowing:
(1) The health care service, item, or investigational drug that isthe subject of the clinical trial.
(2) Any treatment modality that is not part of the usual andcustomary standard of care required to administer or support thehealth care service, item, or investigational drug that is thesubject of the clinical trial.
(3) Any health care service, item, or drug provided solely tosatisfy data collection and analysis needs that are not used inthe direct clinical management of the patient.
(4) An investigational drug or device that has not been approvedfor market by the federal Food and Drug Administration.
(5) Transportation, lodging, food, or other expenses for thepatient or a family member or companion of the patient that areassociated with travel to or from a facility where a clinical trialis conducted.
(6) A service, item, or drug that is provided by a clinical trialsponsor free of charge for any new patient. (7) A service, item, or drug that is eligible for reimbursementfrom a source other than a covered individual's policy ofaccident and sickness insurance, including the sponsor of theclinical trial.
As added by P.L.109-2009, SEC.3.
IC 27-8-25-8
Coverage for routine care costs
Sec. 8. (a) A policy of accident and sickness insurance mustprovide coverage for routine care costs that are incurred in the courseof a clinical trial if the policy of accident and sickness insurancewould provide coverage for the same routine care costs not incurredin a clinical trial.
(b) The coverage that must be provided under this section issubject to the terms, conditions, restrictions, exclusions, andlimitations that apply generally under the policy of accident andsickness insurance, including terms, conditions, restrictions,exclusions, or limitations that apply to health care services renderedby contracted providers and noncontracted providers.
(c) This section does not do any of the following:
(1) Require an insurer that issues a policy of accident andsickness insurance to provide coverage for clinical trial servicesrendered by a contracted provider.
(2) Prohibit an insurer that issues a policy of accident andsickness insurance from providing coverage for clinical trialservices rendered by a contracted provider.
(3) Require reimbursement under a policy of accident andsickness insurance for services that are rendered in a clinicaltrial by a noncontracted provider at the same rate ofreimbursement that would apply to the same services renderedby a contracted provider.
As added by P.L.109-2009, SEC.3.
IC 27-8-25-9
No cause of action created by chapter
Sec. 9. This chapter does not create a cause of action against aperson for any harm to a covered individual resulting from a clinicaltrial.
As added by P.L.109-2009, SEC.3.