House Study Bill 530 - Introduced HOUSE FILE _____ BY (PROPOSED COMMITTEE ON COMMERCE BILL BY CHAIRPERSON PETERSEN) A BILL FOR An Act requiring health benefit coverage for certain cancer 1 treatment delivered pursuant to approved cancer clinical 2 trials and providing an applicability date. 3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 4 TLSB 5238HC (8) 83 av/nh

H.F. _____ Section 1. NEW SECTION . 514C.26 Approved cancer clinical 1 trials coverage. 2 1. Definitions. For purposes of this section, unless the 3 context otherwise requires: 4 a. “Approved cancer clinical trial” means a scientific 5 study of a new therapy for the treatment of cancer in human 6 beings that meets the requirements set forth in subsection 3 7 and consists of a scientific plan of treatment that includes 8 specified goals, a rationale and background for the plan, 9 criteria for patient selection, specific directions for 10 administering therapy and monitoring patients, a definition of 11 quantitative measures for determining treatment response, and 12 methods for documenting and treating adverse reactions. 13 b. “Institutional review board” means a board, committee, or 14 other group formally designated by an institution and approved 15 by the national institutes of health, office for protection 16 from research risks, to review, approve the initiation of, 17 and conduct periodic review of biomedical research involving 18 human subjects. “Institutional review board” means the same 19 as “institutional review committee” as used in section 520(g) 20 of the federal Food, Drug, and Cosmetic Act, as codified in 21 21 U.S.C. § 301 et seq. 22 c. “Routine patient care costs” means physician fees, 23 laboratory expenses, and expenses associated with the 24 hospitalization, administration of treatment, and evaluation of 25 a patient during the course of treatment which are consistent 26 with usual and customary patterns and standards of care 27 incurred whenever an enrollee, subscriber, or insured receives 28 medical care associated with an approved cancer clinical trial, 29 and which would be covered if such items and services were 30 provided other than in connection with an approved cancer 31 clinical trial. 32 d. “Therapeutic intent” means that a treatment is aimed 33 at improving a patient’s health outcome relative to either 34 survival or quality of life. 35 -1- LSB 5238HC (8) 83 av/nh 1/ 4

H.F. _____ 2. Coverage required. Notwithstanding the uniformity of 1 treatment requirements of section 514C.6, a policy or contract 2 providing for third-party payment or prepayment of health or 3 medical expenses shall provide coverage benefits for routine 4 patient care costs incurred for cancer treatment in an approved 5 cancer clinical trial to the same extent that such policy or 6 contract provides coverage for treating any other sickness, 7 injury, disease, or condition covered under the policy or 8 contract, if the insured has been referred for such cancer 9 treatment by two physicians who specialize in oncology and 10 the cancer treatment is given pursuant to an approved cancer 11 clinical trial that meets the criteria set forth in subsection 12 3. Services that are furnished without charge to a participant 13 in the approved cancer clinical trial are not required to be 14 covered as routine patient care costs pursuant to this section. 15 3. Criteria. Routine patient care costs for cancer 16 treatment given pursuant to an approved cancer clinical 17 trial shall be covered pursuant to this section if all of the 18 following requirements are met: 19 a. The treatment is provided with therapeutic intent and is 20 provided pursuant to an approved cancer clinical trial that has 21 been authorized or approved by one of the following: 22 (1) The national institutes of health. 23 (2) The United States food and drug administration. 24 (3) The United States department of defense. 25 (4) The United States department of veterans affairs. 26 b. The proposed treatment has been reviewed and approved by 27 the applicable qualified institutional review board. 28 c. The available clinical or preclinical data indicate 29 that the treatment that will be provided pursuant to the 30 approved cancer clinical trial will be at least as effective 31 as the standard therapy and is anticipated to constitute an 32 improvement in therapeutic effectiveness for the treatment of 33 the disease in question. 34 4. Applicability. 35 -2- LSB 5238HC (8) 83 av/nh 2/ 4

H.F. _____ a. This section applies to the following classes of 1 third-party payment provider contracts or policies delivered, 2 issued for delivery, continued, or renewed in this state on or 3 after July 1, 2010: 4 (1) Individual or group accident and sickness insurance 5 providing coverage on an expense-incurred basis. 6 (2) An individual or group hospital or medical service 7 contract issued pursuant to chapter 509, 514, or 514A. 8 (3) An individual or group health maintenance organization 9 contract regulated under chapter 514B. 10 (4) Any other entity engaged in the business of insurance, 11 risk transfer, or risk retention, which is subject to the 12 jurisdiction of the commissioner. 13 (5) A plan established pursuant to chapter 509A for public 14 employees. 15 (6) An organized delivery system licensed by the director 16 of public health. 17 b. This section shall not apply to accident-only, 18 specified disease, short-term hospital or medical, hospital 19 confinement indemnity, credit, dental, vision, Medicare 20 supplement, long-term care, basic hospital and medical-surgical 21 expense coverage as defined by the commissioner, disability 22 income insurance coverage, coverage issued as a supplement 23 to liability insurance, workers’ compensation or similar 24 insurance, or automobile medical payment insurance. 25 EXPLANATION 26 This bill creates new Code section 514C.26 to require health 27 benefit coverage for cancer treatment delivered pursuant to an 28 approved cancer clinical trial. The bill defines “approved 29 cancer clinical trial” as a scientific study of a new therapy 30 for the treatment of cancer in human beings that meets 31 requirements specified in the bill and consists of a scientific 32 plan of treatment. 33 The bill requires that a policy or contract provide health 34 benefit coverage for routine patient care costs incurred for 35 -3- LSB 5238HC (8) 83 av/nh 3/ 4

H.F. _____ cancer treatment in an approved cancer clinical trial to the 1 same extent that the policy or contract provides coverage for 2 treating any other sickness, injury, disease, or condition 3 covered under the policy or contract, if the insured has been 4 referred for such cancer treatment by two physicians who 5 specialize in oncology, and the cancer treatment is given 6 pursuant to an approved cancer clinical trial as set forth in 7 the bill. 8 The bill applies to specified classes of third-party payment 9 provider contracts or policies delivered, issued for delivery, 10 continued, or renewed in this state on or after July 1, 2010. 11 -4- LSB 5238HC (8) 83 av/nh 4/ 4