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92_HB0050eng HB0050 Engrossed LRB9200810DJgc 1 AN ACT concerning tobacco settlement proceeds. 2 Be it enacted by the People of the State of Illinois, 3 represented in the General Assembly: 4 Section 1. Short title. This Act may be cited as the 5 Tobacco Settlement Proceeds for Investigational Clinical 6 Cancer Trials Act. 7 Section 5. Use of tobacco settlement proceeds. Because a 8 cure for cancer has not been discovered, up to 10% of the 9 amounts received by the State pursuant to a tobacco 10 settlement agreement shall be dedicated to assist in the 11 payment for services provided under a qualified 12 investigational clinical cancer trial program in Illinois. 13 Section 10. Definitions. In this Act: 14 "External independent review process" means the appeals 15 and external independent review process as provided in 16 Section 45 of the Managed Care Reform and Patient Rights Act. 17 "Physician" means a board certified oncologist. 18 "Program" means the qualified investigational clinical 19 cancer trial program established under Section 15. 20 "Qualified investigational clinical cancer trial" means a 21 treatment (i) the effectiveness of which has not been 22 determined and (ii) that is under clinical investigation as 23 part of an approved National Institutes of Health or National 24 Cancer Institute sponsored Phase III or Phase IV research 25 trial. 26 "Research costs" means costs that are (i) associated with 27 conducting the qualified investigational clinical cancer 28 trial, including but not limited to data collection and 29 management, physician and nurse research time, analysis of 30 results, and tests performed purely for research purposes and HB0050 Engrossed -2- LRB9200810DJgc 1 (ii) usually covered by the sponsoring organization. 2 "Routine patient care costs" means costs for those 3 medical services and supplies rendered pursuant to physician 4 orders which are necessary to conduct the qualified 5 investigational clinical trial. "Routine patient care costs" 6 do not include the following: 7 (1) The costs of items or services normally paid 8 for by other funding sources, such as the investigational 9 drugs, pharmaceuticals, or devices themselves, any 10 nonhealth services that might be required for a patient 11 to receive the cancer treatment, and the managing of the 12 research trial. 13 (2) Costs associated with the provision of any 14 goods, services, or benefits that generally are furnished 15 without charge in connection with such an investigational 16 clinical cancer trial program for treatment of cancer 17 costs. 18 (3) Costs related to any service, supply, or device 19 that has been ordered solely for the convenience of the 20 patient. 21 "Standard of care" means that level of care a physician 22 would provide under like or similar circumstances. 23 "Tobacco settlement agreement" means the Master 24 Settlement Agreement in the case of People of the State of 25 Illinois v. Philip Morris et al. (Circuit Court of Cook 26 County, No. 96-L13146). The term also includes any 27 settlement with or judgment against a tobacco product 28 manufacturer not participating in that Master Settlement 29 Agreement, if the settlement or judgment is in satisfaction 30 of a released claim as that term is defined in the Master 31 Settlement Agreement. 32 Section 15. Investigational clinical cancer trial 33 program. The Department of Public Health shall establish and HB0050 Engrossed -3- LRB9200810DJgc 1 administer a program to pay for patient care costs associated 2 with participation in a qualified investigational cancer 3 trial when those costs are not otherwise reimbursed. The 4 Department of Public Health shall establish eligibility 5 standards and an application process by rule. 6 Section 20. Participation in program. Participation in 7 the program shall be limited to persons who meet the 8 following criteria: 9 (1) The person is a cancer patient who, according 10 to the current diagnosis of the patient's physician, has 11 a high probability of death within 2 years. 12 (2) The patient's physician certifies that the 13 patient has the condition described in paragraph (1) and 14 all of the following situations are applicable: 15 (A) Standard therapies have not been effective 16 in improving the patient's condition. 17 (B) Standard therapies are not medically 18 appropriate for the patient. 19 (C) In the case of an insured patient, there 20 is no standard therapy covered by the health insurer 21 that is more beneficial than the therapy. 22 (3) The patient's physician has recommended a drug, 23 device, procedure, or other therapy that in the 24 physician's opinion would be more beneficial to the 25 patient. These recommendations must be based on the 26 physician's written certification based on the generally 27 accepted standard of care. 28 (4) The patient has been denied coverage by his or 29 her health insurance plan for a drug, device, procedure, 30 or other therapy recommended or requested pursuant to 31 paragraph (3) based on a finding by the health insurance 32 plan that the treatment was experimental or 33 investigational. HB0050 Engrossed -4- LRB9200810DJgc 1 (5) The patient has participated in an external 2 independent review process that has resulted in a finding 3 in favor of recommending the patient into a qualified 4 clinical trial. 5 (6) The patient is an Illinois resident who has 6 resided in Illinois for at least 12 months. 7 Section 17. Payments under the program. 8 (a) Payment shall be made under the program to or on 9 behalf of a program eligible patient only for costs not 10 reimbursed or eligible for reimbursement by any other third 11 party or governmental entity (including, without limitation, 12 private or group insurance, Medicaid, Medicare, and the 13 Veterans Administration). The Director of Public Health may, 14 however, waive this requirement in individually considered 15 cases if the Director determines that its enforcement will 16 deny services to a class of cancer patients because of 17 conflicting State or federal laws or regulations. 18 (b) The Director of Public Health may restrict or 19 categorize reimbursements to meet budgetary limitations. 20 Section 25. List of trials. The Director of Public Health 21 shall maintain a list of qualified investigational cancer 22 trials. The Director of Public Health shall establish an 23 internal review procedure for updating the list. The 24 procedure shall allow the addition and deletion of qualified 25 investigational clinical cancer trials to the list. The 26 internal review procedure shall take place at least once 27 during each fiscal year. 28 Section 30. Effect of Act. 29 (a) Nothing in this Act shall be construed to prohibit 30 any health insurance plan from applying cost sharing 31 arrangements, limitations, or exclusions. HB0050 Engrossed -5- LRB9200810DJgc 1 (b) This Act does not relieve the sponsor of a qualified 2 investigational clinical cancer trial program of financial 3 responsibility for the accepted costs of the program, such as 4 research costs. 5 (c) This Act does not relieve a health insurance plan of 6 financial responsibility for routine patient care costs for 7 the treatment of cancer if the health insurance plan provides 8 coverage for cancer. 9 Section 99. Effective date. This Act takes effect upon 10 becoming a law.