House Study Bill 85 HOUSE FILE BY (PROPOSED COMMITTEE ON COMMERCE BILL BY CHAIRPERSON PETERSEN) Passed House, Date Passed Senate, Date Vote: Ayes Nays Vote: Ayes Nays Approved A BILL FOR 1 An Act requiring health benefit coverage for certain cancer 2 treatment delivered pursuant to approved cancer clinical 3 trials and providing an applicability date. 4 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 5 TLSB 1286YC 83 6 av/nh/8 PAG LIN 1 1 Section 1. NEW SECTION. 514C.24 APPROVED CANCER CLINICAL 1 2 TRIALS COVERAGE. 1 3 1. DEFINITIONS. For purposes of this section, unless the 1 4 context otherwise requires: 1 5 a. "Approved cancer clinical trial" means a scientific 1 6 study of a new therapy for the treatment of cancer in human 1 7 beings that meets the requirements set forth in subsection 3 1 8 and consists of a scientific plan of treatment that includes 1 9 specified goals, a rationale and background for the plan, 1 10 criteria for patient selection, specific directions for 1 11 administering therapy and monitoring patients, a definition of 1 12 quantitative measures for determining treatment response, and 1 13 methods for documenting and treating adverse reactions. 1 14 b. "Institutional review board" means a board, committee, 1 15 or other group formally designated by an institution and 1 16 approved by the national institutes of health, office for 1 17 protection from research risks, to review, approve the 1 18 initiation of, and conduct periodic review of biomedical 1 19 research involving human subjects. "Institutional review 1 20 board" means the same as "institutional review committee" as 1 21 used in section 520(g) of the federal Food, Drug, and Cosmetic 1 22 Act, as codified in 21 U.S.C. } 301 et seq. 1 23 c. "Routine patient care costs" means physician fees, 1 24 laboratory expenses, and expenses associated with the 1 25 hospitalization, administration of treatment, and evaluation 1 26 of a patient during the course of treatment which are 1 27 consistent with usual and customary patterns and standards of 1 28 care incurred whenever an enrollee, subscriber, or insured 1 29 receives medical care associated with an approved cancer 1 30 clinical trial, and which would be covered if such items and 1 31 services were provided other than in connection with an 1 32 approved cancer clinical trial. 1 33 d. "Therapeutic intent" means that a treatment is aimed at 1 34 improving a patient's health outcome relative to either 1 35 survival or quality of life. 2 1 2. COVERAGE REQUIRED. Notwithstanding the uniformity of 2 2 treatment requirements of section 514C.6, a policy or contract 2 3 providing for third=party payment or prepayment of health or 2 4 medical expenses shall provide coverage benefits for routine 2 5 patient care costs incurred for cancer treatment in an 2 6 approved cancer clinical trial to the same extent that such 2 7 policy or contract provides coverage for treating any other 2 8 sickness, injury, disease, or condition covered under the 2 9 policy or contract, if the insured has been referred for such 2 10 cancer treatment by two physicians who specialize in oncology 2 11 and the cancer treatment is given pursuant to an approved 2 12 cancer clinical trial that meets the criteria set forth in 2 13 subsection 3. Services that are furnished without charge to a 2 14 participant in the approved cancer clinical trial are not 2 15 required to be covered as routine patient care costs pursuant 2 16 to this section. 2 17 3. CRITERIA. Routine patient care costs for cancer 2 18 treatment given pursuant to an approved cancer clinical trial 2 19 shall be covered pursuant to this section if all of the 2 20 following requirements are met: 2 21 a. The treatment is provided with therapeutic intent and 2 22 is provided pursuant to an approved cancer clinical trial that 2 23 has been authorized or approved by one of the following: 2 24 (1) The national institutes of health. 2 25 (2) The United States food and drug administration. 2 26 (3) The United States department of defense. 2 27 (4) The United States department of veterans affairs. 2 28 b. The proposed treatment has been reviewed and approved 2 29 by the applicable qualified institutional review board. 2 30 c. The available clinical or preclinical data indicate 2 31 that the treatment that will be provided pursuant to the 2 32 approved cancer clinical trial will be at least as effective 2 33 as the standard therapy and is anticipated to constitute an 2 34 improvement in therapeutic effectiveness for the treatment of 2 35 the disease in question. 3 1 4. APPLICABILITY. 3 2 a. This section applies to the following classes of 3 3 third=party payment provider contracts or policies delivered, 3 4 issued for delivery, continued, or renewed in this state on or 3 5 after July 1, 2009: 3 6 (1) Individual or group accident and sickness insurance 3 7 providing coverage on an expense=incurred basis. 3 8 (2) An individual or group hospital or medical service 3 9 contract issued pursuant to chapter 509, 514, or 514A. 3 10 (3) An individual or group health maintenance organization 3 11 contract regulated under chapter 514B. 3 12 (4) Any other entity engaged in the business of insurance, 3 13 risk transfer, or risk retention, which is subject to the 3 14 jurisdiction of the commissioner. 3 15 (5) A plan established pursuant to chapter 509A for public 3 16 employees. 3 17 (6) An organized delivery system licensed by the director 3 18 of public health. 3 19 b. This section shall not apply to accident=only, 3 20 specified disease, short=term hospital or medical, hospital 3 21 confinement indemnity, credit, dental, vision, Medicare 3 22 supplement, long=term care, basic hospital and 3 23 medical=surgical expense coverage as defined by the 3 24 commissioner, disability income insurance coverage, coverage 3 25 issued as a supplement to liability insurance, workers' 3 26 compensation or similar insurance, or automobile medical 3 27 payment insurance. 3 28 EXPLANATION 3 29 This bill creates new Code section 514C.24 to require 3 30 health benefit coverage for cancer treatment delivered 3 31 pursuant to an approved cancer clinical trial. The bill 3 32 defines "approved cancer clinical trial" as a scientific study 3 33 of a new therapy for the treatment of cancer in human beings 3 34 that meets requirements specified in the bill and consists of 3 35 a scientific plan of treatment. 4 1 The bill requires that a policy or contract provide health 4 2 benefit coverage for routine patient care costs incurred for 4 3 cancer treatment in an approved cancer clinical trial to the 4 4 same extent that the policy or contract provides coverage for 4 5 treating any other sickness, injury, disease, or condition 4 6 covered under the policy or contract, if the insured has been 4 7 referred for such cancer treatment by two physicians who 4 8 specialize in oncology, and the cancer treatment is given 4 9 pursuant to an approved cancer clinical trial as set forth in 4 10 the bill. 4 11 The bill applies to specified classes of third=party 4 12 payment provider contracts or policies delivered, issued for 4 13 delivery, continued, or renewed in this state on or after July 4 14 1, 2009. 4 15 LSB 1286YC 83 4 16 av/nh/8