514C.26 Approved cancer clinical trials coverage. 1. Definitions. For purposes of this section, unless the context otherwise requires:a. 'Approved cancer clinical trial' means a scientific study of a new therapy for the treatment of cancer in human beings that meets the requirements set forth in subsection 3and consists of a scientific plan of treatment that includes specified goals, a rationale andbackground for the plan, criteria for patient selection, specific directions for administeringtherapy and monitoring patients, a definition of quantitative measures for determiningtreatment response, and methods for documenting and treating adverse reactions. b. 'Institutional review board' means a board, committee, or other group formally designated by an institution and approved by the national institutes of health, office forprotection from research risks, to review, approve the initiation of, and conduct periodicreview of biomedical research involving human subjects. 'Institutional review board' meansthe same as 'institutional review committee' as used in section 520(g) of the federal Food,Drug, and Cosmetic Act, as codified in 21 U.S.C. §301 et seq. c. subjects. 'Institutional review board' meansthe same as 'institutional review committee' as used in section 520(g) of the federal Food,Drug, and Cosmetic Act, as codified in 21 U.S.C. §301 et seq. c. (1) 'Routine patient care costs' means medically necessary services or treatments that are a benefit under a contract or policy providing for third-party payment or prepaymentof health or medical expenses that would be covered if the patient were receiving standardcancer treatment. (2) 'Routine patient care costs' does not include any of the following:(a) Costs of any treatments, procedures, drugs, devices, services, or items that are the subject of the approved cancer clinical trial or any other investigational treatments,procedures, drugs, devices, services, or items. (b) Costs of nonhealth care services that the patient is required to receive as a result of participation in the approved cancer clinical trial. (c) Costs associated with managing the research that is associated with the approved cancer clinical trial. (d) Costs that would not be covered by the third-party payment provider if noninvestigational treatments were provided. naging the research that is associated with the approved cancer clinical trial. (d) Costs that would not be covered by the third-party payment provider if noninvestigational treatments were provided. (e) Costs of any services, procedures, or tests provided solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient participatingin an approved cancer clinical trial. (f) Costs paid for, or not charged for, by the approved cancer clinical trial providers.(g) Costs for transportation, lodging, food, or other expenses for the patient, a family member, or a companion of the patient that are associated with travel to or from a facilitywhere an approved cancer clinical trial is conducted. (h) Costs for services, items, or drugs that are eligible for reimbursement from a source other than a patient’s contract or policy providing for third-party payment or prepayment ofhealth or medical expenses, including the sponsor of the approved cancer clinical trial. (i) Costs associated with approved cancer clinical trials designed exclusively to test toxicity or disease pathophysiology. ical expenses, including the sponsor of the approved cancer clinical trial. (i) Costs associated with approved cancer clinical trials designed exclusively to test toxicity or disease pathophysiology. (j) Costs of extra treatments, services, procedures, tests, or drugs that would not be performed or administered except for participation in the cancer clinical trial. Nothing inthis subparagraph division shall limit payment for treatments, services, procedures, tests, ordrugs that are otherwise a covered benefit under subparagraph (1). d. 'Therapeutic intent' means that a treatment is aimed at improving a patient’s health outcome relative to either survival or quality of life. 2. Coverage required. Notwithstanding the uniformity of treatment requirements of section 514C.6, a policy or contract providing for third-party payment or prepayment ofhealth or medical expenses shall provide coverage benefits for routine patient care costsincurred for cancer treatment in an approved cancer clinical trial to the same extent thatsuch policy or contract provides coverage for treating any other sickness, injury, disease,or condition covered under the policy or contract, if the insured has been ical trial to the same extent thatsuch policy or contract provides coverage for treating any other sickness, injury, disease,or condition covered under the policy or contract, if the insured has been referred for suchcancer treatment by two physicians who specialize in oncology and the cancer treatmentis given pursuant to an approved cancer clinical trial that meets the criteria set forth insubsection 3. Services that are furnished without charge to a participant in the approved Sat Dec 23 00:45:13 2023 Iowa Code 2024, Section 514C.26 (24, 0) §514C.26, SPECIAL HEALTH AND ACCIDENT INSURANCE COVERAGES 2 cancer clinical trial are not required to be covered as routine patient care costs pursuant tothis section. 3. Criteria. Routine patient care costs for cancer treatment given pursuant to an approved cancer clinical trial shall be covered pursuant to this section if all of the followingrequirements are met: a. The treatment is provided with therapeutic intent and is provided pursuant to an approved cancer clinical trial that has been authorized or approved by one of the following: (1) The national institutes of health.(2) The United States food and drug administration.(3) The United an approved cancer clinical trial that has been authorized or approved by one of the following: (1) The national institutes of health.(2) The United States food and drug administration.(3) The United States department of defense.(4) The United States department of veterans affairs.b. The proposed treatment has been reviewed and approved by the applicable qualified institutional review board. c. The available clinical or preclinical data indicate that the treatment that will be provided pursuant to the approved cancer clinical trial will be at least as effective as the standardtherapy and is anticipated to constitute an improvement in therapeutic effectiveness for thetreatment of the disease in question. 4. Notice. As soon as practical after the insured provides written consent to participate in an approved cancer clinical trial, the physician shall provide notice to the third-party paymentprovider of the insured’s intent to participate in an approved cancer clinical trial. Failure toprovide such notice to the third-party payment provider shall not be the basis for denying thecoverage required under subsection 2. 5. Applicability.a. in an approved cancer clinical trial. Failure toprovide such notice to the third-party payment provider shall not be the basis for denying thecoverage required under subsection 2. 5. Applicability.a. This section applies to the following classes of third-party payment provider contracts or policies delivered, issued for delivery, continued, or renewed in this state on or after July1, 2010: (1) Individual or group accident and sickness insurance providing coverage on an expense-incurred basis. (2) An individual or group hospital or medical service contract issued pursuant to chapter 509, 514, or 514A. (3) An individual or group health maintenance organization contract regulated under chapter 514B. (4) Any other entity engaged in the business of insurance, risk transfer, or risk retention, which is subject to the jurisdiction of the commissioner. (5) A plan established pursuant to chapter 509A for public employees.b. This section shall not apply to accident-only, specified disease, short-term hospital or medical, hospital confinement indemnity, credit, dental, vision, Medicare supplement,long-term care, basic hospital and medical-surgical expense coverage as defined by disease, short-term hospital or medical, hospital confinement indemnity, credit, dental, vision, Medicare supplement,long-term care, basic hospital and medical-surgical expense coverage as defined by thecommissioner, disability income insurance coverage, coverage issued as a supplement toliability insurance, workers’ compensation or similar insurance, or automobile medicalpayment insurance. 2010 Acts, ch 1013, §1; 2010 Acts, ch 1193, §61; 2017 Acts, ch 148, §78 Sat Dec 23 00:45:13 2023 Iowa Code 2024, Section 514C.26 (24, 0)
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