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91_HB1622enr HB1622 Enrolled LRB9104751JSpc 1 AN ACT concerning benefits for certain health treatments. 2 WHEREAS, It is the intent of the General Assembly to 3 recognize that cancer clinical trials are designed to compare 4 the effectiveness of the standard medical treatment with a 5 new therapy that researchers believe will prove more 6 effective, based on scientific evidence and that such 7 research provides the foundation for improved patient care 8 and decreased health care costs; and 9 WHEREAS, It is the intent of the General Assembly to 10 recognize that cancer clinical trials involve a rigorously 11 developed clinical protocol that includes goals, rationale 12 and background, criteria for patient selection, specific 13 directions for administering therapy and monitoring patients, 14 definition of quantitative measures for determining treatment 15 response, reporting of results, and methods for documenting 16 and treating adverse reactions; and 17 WHEREAS, It is the intent of the General Assembly to 18 recognize that virtually every major breakthrough for current 19 cancer treatment has been developed through the clinical 20 trial system; and 21 WHEREAS, It is the intent of the General Assembly to 22 acknowledge that cancer clinical trials can be cost neutral 23 in comparison to the standard therapy; therefore 24 Be it enacted by the People of the State of Illinois, 25 represented in the General Assembly: 26 Section 5. The Civil Administrative Code of Illinois is 27 amended by adding Section 56.3 as follows: 28 (20 ILCS 1405/56.3 new) 29 Sec. 56.3. Investigational cancer treatments; study. HB1622 Enrolled -2- LRB9104751JSpc 1 (a) The Department of Insurance shall conduct an 2 analysis and study of costs and benefits derived from the 3 implementation of the coverage requirements for 4 investigational cancer treatments established under Section 5 356y of the Illinois Insurance Code. The study shall cover 6 the years 2000, 2001, and 2002. The study shall include an 7 analysis of the effect of the coverage requirements on the 8 cost of insurance and health care, the results of the 9 treatments to patients, the mortality rate among cancer 10 patients, any improvements in care of patients, and any 11 improvements in the quality of life of patients. 12 (b) The Department shall report the results of its study 13 to the General Assembly and the Governor on or before March 14 1, 2003. 15 Section 10. The Illinois Insurance Code is amended by 16 adding Section 356y as follows: 17 (215 ILCS 5/356y new) 18 Sec. 356y. Coverage for investigational cancer 19 treatments. 20 (a) An insurer that issues, delivers, amends, or renews 21 an individual or group policy of accident and health 22 insurance in this State more than 120 days after the 23 effective date of this amendatory Act of the 91st General 24 Assembly must offer to the applicant or policyholder coverage 25 for routine patient care of insureds, when medically 26 appropriate and the insured has a terminal condition related 27 to cancer that according to the diagnosis of the treating 28 physician, licensed to practice medicine in all its branches, 29 is considered life threatening, to participate in an approved 30 cancer research trial and shall provide coverage for the 31 patient care provided pursuant to investigational cancer 32 treatments as provided in subsection (b). Coverage under HB1622 Enrolled -3- LRB9104751JSpc 1 this Section may have an annual benefit limit of $10,000. 2 (b) Coverage shall include routine patient care costs 3 such as blood tests, x-rays, bone scans, magnetic resonance 4 images, patient visits, hospital stays, or other similar 5 costs generally incurred by the insured party in standard 6 cancer treatment. Routine patient care costs specifically 7 shall not include the cost of any clinical trial therapies, 8 regimens, or combinations thereof, any drugs or 9 pharmaceuticals in connection with an approved clinical 10 trial, any costs associated with the provision of any goods, 11 services, or benefits that are generally furnished without 12 charge in connection with an approved clinical trial program 13 for treatment of cancer, any additional costs associated with 14 the provision of any goods, services, or benefits that 15 previously have been provided to, paid for, or reimbursed, or 16 any other similar costs. Routine patient care costs shall 17 specifically not include costs for treatments or services 18 prescribed for the convenience of the insured, enrollee, or 19 physician. It is specifically the intent of this Section not 20 to relieve the sponsor or a clinical trial program of 21 financial responsibility for accepted costs of the program. 22 (c) For purposes of this Section, coverage is provided 23 only for cancer trials that meet each of the following 24 criteria: 25 (1) the effectiveness of the treatment has not been 26 determined relative to established therapies; 27 (2) the trial is under clinical investigation as 28 part of an approved cancer research trial in Phase II, 29 Phase III, or Phase IV of investigation; 30 (3) the trial is approved by the U.S. Secretary of 31 Health and Human Services, the Director of the National 32 Institutes of Health, the Commissioner of the Food and 33 Drug Administration (through an investigational new drug 34 exemption under Section 505(l) of the federal Food, Drug, HB1622 Enrolled -4- LRB9104751JSpc 1 and Cosmetic Act or an investigational device exemption 2 under Section 520(g) of that Act), or a qualified 3 nongovernmental cancer research entity as defined in 4 guidelines of the National Institutes of Health or a peer 5 reviewed and approved cancer research program, as defined 6 by the U.S. Secretary of Health and Human Services, 7 conducted for the primary purpose of determining whether 8 or not a cancer treatment is safe or efficacious or has 9 any other characteristic of a cancer treatment that must 10 be demonstrated in order for the cancer treatment to be 11 medically necessary or appropriate; 12 (4) the trial is being conducted at multiple sites 13 throughout the State; 14 (5) the patient's primary care physician, if any, 15 is involved in the coordination of care; and 16 (6) the results of the investigational trial will 17 be submitted for publication in peer-reviewed scientific 18 studies, research, or literature published in or accepted 19 for publication by medical journals that meet nationally 20 recognized requirements for scientific manuscripts and 21 that submit most of their published articles for review 22 by experts who are not part of the editorial staff. 23 These studies may include those conducted by or under the 24 auspices of the federal government's Agency for Health 25 Care Policy and Research, National Institutes of Health, 26 National Cancer Institute, National Academy of Sciences, 27 Health Care Financing Administration, and any national 28 board recognized by the National Institutes of Health for 29 the purpose of evaluating the medical value of health 30 services. 31 (d) This Section is repealed on January 1, 2003. 32 Section 15. The Health Maintenance Organization Act is 33 amended by changing Section 5-3 as follows: HB1622 Enrolled -5- LRB9104751JSpc 1 (215 ILCS 125/5-3) (from Ch. 111 1/2, par. 1411.2) 2 Sec. 5-3. Insurance Code provisions. 3 (a) Health Maintenance Organizations shall be subject to 4 the provisions of Sections 133, 134, 137, 140, 141.1, 141.2, 5 141.3, 143, 143c, 147, 148, 149, 151, 152, 153, 154, 154.5, 6 154.6, 154.7, 154.8, 155.04, 355.2, 356m, 356v, 356w, 356x, 7 356y, 367i, 401, 401.1, 402, 403, 403A, 408, 408.2, 409, 412, 8 444, and 444.1, paragraph (c) of subsection (2) of Section 9 367, and Articles VIII 1/2, XII, XII 1/2, XIII, XIII 1/2, 10 XXV, and XXVI of the Illinois Insurance Code. 11 (b) For purposes of the Illinois Insurance Code, except 12 for Sections 444 and 444.1 and Articles XIII and XIII 1/2, 13 Health Maintenance Organizations in the following categories 14 are deemed to be "domestic companies": 15 (1) a corporation authorized under the Dental 16 Service Plan Act or the Voluntary Health Services Plans 17 Act; 18 (2) a corporation organized under the laws of this 19 State; or 20 (3) a corporation organized under the laws of 21 another state, 30% or more of the enrollees of which are 22 residents of this State, except a corporation subject to 23 substantially the same requirements in its state of 24 organization as is a "domestic company" under Article 25 VIII 1/2 of the Illinois Insurance Code. 26 (c) In considering the merger, consolidation, or other 27 acquisition of control of a Health Maintenance Organization 28 pursuant to Article VIII 1/2 of the Illinois Insurance Code, 29 (1) the Director shall give primary consideration 30 to the continuation of benefits to enrollees and the 31 financial conditions of the acquired Health Maintenance 32 Organization after the merger, consolidation, or other 33 acquisition of control takes effect; 34 (2)(i) the criteria specified in subsection (1)(b) HB1622 Enrolled -6- LRB9104751JSpc 1 of Section 131.8 of the Illinois Insurance Code shall not 2 apply and (ii) the Director, in making his determination 3 with respect to the merger, consolidation, or other 4 acquisition of control, need not take into account the 5 effect on competition of the merger, consolidation, or 6 other acquisition of control; 7 (3) the Director shall have the power to require 8 the following information: 9 (A) certification by an independent actuary of 10 the adequacy of the reserves of the Health 11 Maintenance Organization sought to be acquired; 12 (B) pro forma financial statements reflecting 13 the combined balance sheets of the acquiring company 14 and the Health Maintenance Organization sought to be 15 acquired as of the end of the preceding year and as 16 of a date 90 days prior to the acquisition, as well 17 as pro forma financial statements reflecting 18 projected combined operation for a period of 2 19 years; 20 (C) a pro forma business plan detailing an 21 acquiring party's plans with respect to the 22 operation of the Health Maintenance Organization 23 sought to be acquired for a period of not less than 24 3 years; and 25 (D) such other information as the Director 26 shall require. 27 (d) The provisions of Article VIII 1/2 of the Illinois 28 Insurance Code and this Section 5-3 shall apply to the sale 29 by any health maintenance organization of greater than 10% of 30 its enrollee population (including without limitation the 31 health maintenance organization's right, title, and interest 32 in and to its health care certificates). 33 (e) In considering any management contract or service 34 agreement subject to Section 141.1 of the Illinois Insurance HB1622 Enrolled -7- LRB9104751JSpc 1 Code, the Director (i) shall, in addition to the criteria 2 specified in Section 141.2 of the Illinois Insurance Code, 3 take into account the effect of the management contract or 4 service agreement on the continuation of benefits to 5 enrollees and the financial condition of the health 6 maintenance organization to be managed or serviced, and (ii) 7 need not take into account the effect of the management 8 contract or service agreement on competition. 9 (f) Except for small employer groups as defined in the 10 Small Employer Rating, Renewability and Portability Health 11 Insurance Act and except for medicare supplement policies as 12 defined in Section 363 of the Illinois Insurance Code, a 13 Health Maintenance Organization may by contract agree with a 14 group or other enrollment unit to effect refunds or charge 15 additional premiums under the following terms and conditions: 16 (i) the amount of, and other terms and conditions 17 with respect to, the refund or additional premium are set 18 forth in the group or enrollment unit contract agreed in 19 advance of the period for which a refund is to be paid or 20 additional premium is to be charged (which period shall 21 not be less than one year); and 22 (ii) the amount of the refund or additional premium 23 shall not exceed 20% of the Health Maintenance 24 Organization's profitable or unprofitable experience with 25 respect to the group or other enrollment unit for the 26 period (and, for purposes of a refund or additional 27 premium, the profitable or unprofitable experience shall 28 be calculated taking into account a pro rata share of the 29 Health Maintenance Organization's administrative and 30 marketing expenses, but shall not include any refund to 31 be made or additional premium to be paid pursuant to this 32 subsection (f)). The Health Maintenance Organization and 33 the group or enrollment unit may agree that the 34 profitable or unprofitable experience may be calculated HB1622 Enrolled -8- LRB9104751JSpc 1 taking into account the refund period and the immediately 2 preceding 2 plan years. 3 The Health Maintenance Organization shall include a 4 statement in the evidence of coverage issued to each enrollee 5 describing the possibility of a refund or additional premium, 6 and upon request of any group or enrollment unit, provide to 7 the group or enrollment unit a description of the method used 8 to calculate (1) the Health Maintenance Organization's 9 profitable experience with respect to the group or enrollment 10 unit and the resulting refund to the group or enrollment unit 11 or (2) the Health Maintenance Organization's unprofitable 12 experience with respect to the group or enrollment unit and 13 the resulting additional premium to be paid by the group or 14 enrollment unit. 15 In no event shall the Illinois Health Maintenance 16 Organization Guaranty Association be liable to pay any 17 contractual obligation of an insolvent organization to pay 18 any refund authorized under this Section. 19 (Source: P.A. 89-90, eff. 6-30-95; 90-25, eff. 1-1-98; 20 90-177, eff. 7-23-97; 90-372, eff. 7-1-98; 90-583, eff. 21 5-29-98; 90-655, eff. 7-30-98; 90-741, eff. 1-1-99; revised 22 9-8-98.) 23 Section 20. The Voluntary Health Services Plans Act is 24 amended by changing Section 10 as follows: 25 (215 ILCS 165/10) (from Ch. 32, par. 604) 26 Sec. 10. Application of Insurance Code provisions. 27 Health services plan corporations and all persons interested 28 therein or dealing therewith shall be subject to the 29 provisions of Article XII 1/2 and Sections 3.1, 133, 140, 30 143, 143c, 149, 354, 355.2, 356r, 356t, 356u, 356v, 356w, 31 356x, 356y, 367.2, 401, 401.1, 402, 403, 403A, 408, 408.2, 32 and 412, and paragraphs (7) and (15) of Section 367 of the HB1622 Enrolled -9- LRB9104751JSpc 1 Illinois Insurance Code. 2 (Source: P.A. 89-514, eff. 7-17-96; 90-7, eff. 6-10-97; 3 90-25, eff. 1-1-98; 90-655, eff. 7-30-98; 90-741, eff. 4 1-1-99.) 5 Section 99. Effective date. This Act takes effect on 6 January 1, 2000.