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90_SB0438 215 ILCS 5/356t new 215 ILCS 125/5-3 from Ch. 111 1/2, par. 1411.2 215 ILCS 130/3009 from Ch. 73, par. 1503-9 215 ILCS 165/10 from Ch. 32, par. 604 Amends the Illinois Insurance Code, Health Maintenance Organization Act, Limited Health Service Organization Act, and Voluntary Health Services Plans Act. Provides that health benefit coverage under those Acts must include coverage for patient care provided pursuant to investigational cancer treatments. Defines terms. Effective January 1, 1998. LRB9002217JScbA LRB9002217JScbA 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, and methods for documenting and treating adverse 16 reactions; and 17 WHEREAS, It is the intent of the General Assembly to 18 recognize that virtually every major breakthrough for current 19 standard medical treatment has been developed through the 20 clinical 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 Illinois Insurance Code is amended by 27 adding Section 356t as follows: 28 (215 ILCS 5/356t new) 29 Sec. 356t. Coverage for investigational cancer -2- LRB9002217JScbA 1 treatments. 2 (a) An individual or group policy of accident and health 3 insurance issued, delivered, amended, or renewed in this 4 State after the effective date of this amendatory Act of 1997 5 must provide coverage for patient care of insureds, when 6 medically appropriate, to participate in an approved research 7 trial and shall provide coverage for the patient care 8 provided pursuant to investigational cancer treatments as 9 provided in subsection (b). 10 (b) Coverage must be included for an item or service 11 that would otherwise be covered, subject to the limitations 12 and cost sharing requirements applicable to the item or 13 service, when that item or service is provided to an insured 14 in the course of an investigational cancer treatment if: 15 (1) the treatment is a qualifying cancer 16 investigational treatment; and 17 (2) the cancer treatment is administered as part of 18 the medical management of a life-threatening disease, 19 disorder, or health condition. 20 Coverage must be included for an item or service when 21 that item or service is required to provide patient care 22 pursuant to the design of a research trial, except those 23 items or services normally paid for by other funding sources, 24 such as the costs of certain investigational agents, the 25 costs of any nonhealth services that might be required for a 26 person to receive cancer treatment, and the costs of managing 27 the research; items or services subject to this exception may 28 be covered in addition to patient care at the discretion of 29 the health plan. 30 (c) For purposes of this Section, (A) "qualifying 31 investigational cancer treatment" means a treatment (i) the 32 effectiveness of which has not been determined and (ii) that 33 is under clinical investigation as part of an approved cancer 34 research trial and (B) "approved cancer research trial" means -3- LRB9002217JScbA 1 (i) a cancer research trial approved by the U.S. Secretary of 2 Health and Human Services, the Director of the National 3 Institutes of Health, the Commissioner of the Food and Drug 4 Administration (through an investigational new drug exemption 5 under Section 505(1) of the federal Food, Drug and Cosmetic 6 Act or an investigational device exemption under Section 7 520(g) of that Act), the Secretary of Veterans Affairs, the 8 Secretary of Defense, or a qualified nongovernmental cancer 9 research entity as defined in guidelines of the National 10 Institutes of Health or (ii) a peer-reviewed and approved 11 cancer research program, as defined by the U.S. Secretary of 12 Health and Human Services, conducted for the primary purpose 13 of determining whether or not a cancer treatment is safe or 14 efficacious or has any other characteristic of a cancer 15 treatment that must be demonstrated in order for the cancer 16 treatment to be medically necessary or appropriate. 17 Section 10. The Health Maintenance Organization Act is 18 amended by changing Section 5-3 as follows: 19 (215 ILCS 125/5-3) (from Ch. 111 1/2, par. 1411.2) 20 Sec. 5-3. Insurance Code provisions. 21 (a) Health Maintenance Organizations shall be subject to 22 the provisions of Sections 133, 134, 137, 140, 141.1, 141.2, 23 141.3, 143, 143c, 147, 148, 149, 151, 152, 153, 154, 154.5, 24 154.6, 154.7, 154.8, 155.04, 355.2, 356m, 356t, 367i, 401, 25 401.1, 402, 403, 403A, 408, 408.2, and 412, paragraph (c) of 26 subsection (2) of Section 367, and Articles VIII 1/2, XII, 27 XII 1/2, XIII, XIII 1/2, and XXVI of the Illinois Insurance 28 Code. 29 (b) For purposes of the Illinois Insurance Code, except 30 for Articles XIII and XIII 1/2, Health Maintenance 31 Organizations in the following categories are deemed to be 32 "domestic companies": -4- LRB9002217JScbA 1 (1) a corporation authorized under the Medical 2 Service Plan Act, the Dental Service Plan Act, the Vision 3 Service Plan Act, the Pharmaceutical Service Plan Act, 4 the Voluntary Health Services Plan Act, or the Nonprofit 5 Health Care Service Plan Act; 6 (2) a corporation organized under the laws of this 7 State; or 8 (3) a corporation organized under the laws of 9 another state, 30% or more of the enrollees of which are 10 residents of this State, except a corporation subject to 11 substantially the same requirements in its state of 12 organization as is a "domestic company" under Article 13 VIII 1/2 of the Illinois Insurance Code. 14 (c) In considering the merger, consolidation, or other 15 acquisition of control of a Health Maintenance Organization 16 pursuant to Article VIII 1/2 of the Illinois Insurance Code, 17 (1) the Director shall give primary consideration 18 to the continuation of benefits to enrollees and the 19 financial conditions of the acquired Health Maintenance 20 Organization after the merger, consolidation, or other 21 acquisition of control takes effect; 22 (2)(i) the criteria specified in subsection (1)(b) 23 of Section 131.8 of the Illinois Insurance Code shall not 24 apply and (ii) the Director, in making his determination 25 with respect to the merger, consolidation, or other 26 acquisition of control, need not take into account the 27 effect on competition of the merger, consolidation, or 28 other acquisition of control; 29 (3) the Director shall have the power to require 30 the following information: 31 (A) certification by an independent actuary of 32 the adequacy of the reserves of the Health 33 Maintenance Organization sought to be acquired; 34 (B) pro forma financial statements reflecting -5- LRB9002217JScbA 1 the combined balance sheets of the acquiring company 2 and the Health Maintenance Organization sought to be 3 acquired as of the end of the preceding year and as 4 of a date 90 days prior to the acquisition, as well 5 as pro forma financial statements reflecting 6 projected combined operation for a period of 2 7 years; 8 (C) a pro forma business plan detailing an 9 acquiring party's plans with respect to the 10 operation of the Health Maintenance Organization 11 sought to be acquired for a period of not less than 12 3 years; and 13 (D) such other information as the Director 14 shall require. 15 (d) The provisions of Article VIII 1/2 of the Illinois 16 Insurance Code and this Section 5-3 shall apply to the sale 17 by any health maintenance organization of greater than 10% of 18 its enrollee population (including without limitation the 19 health maintenance organization's right, title, and interest 20 in and to its health care certificates). 21 (e) In considering any management contract or service 22 agreement subject to Section 141.1 of the Illinois Insurance 23 Code, the Director (i) shall, in addition to the criteria 24 specified in Section 141.2 of the Illinois Insurance Code, 25 take into account the effect of the management contract or 26 service agreement on the continuation of benefits to 27 enrollees and the financial condition of the health 28 maintenance organization to be managed or serviced, and (ii) 29 need not take into account the effect of the management 30 contract or service agreement on competition. 31 (f) Except for small employer groups as defined in the 32 Small Employer Rating, Renewability and Portability Health 33 Insurance Act and except for medicare supplement policies as 34 defined in Section 363 of the Illinois Insurance Code, a -6- LRB9002217JScbA 1 Health Maintenance Organization may by contract agree with a 2 group or other enrollment unit to effect refunds or charge 3 additional premiums under the following terms and conditions: 4 (i) the amount of, and other terms and conditions 5 with respect to, the refund or additional premium are set 6 forth in the group or enrollment unit contract agreed in 7 advance of the period for which a refund is to be paid or 8 additional premium is to be charged (which period shall 9 not be less than one year); and 10 (ii) the amount of the refund or additional premium 11 shall not exceed 20% of the Health Maintenance 12 Organization's profitable or unprofitable experience with 13 respect to the group or other enrollment unit for the 14 period (and, for purposes of a refund or additional 15 premium, the profitable or unprofitable experience shall 16 be calculated taking into account a pro rata share of the 17 Health Maintenance Organization's administrative and 18 marketing expenses, but shall not include any refund to 19 be made or additional premium to be paid pursuant to this 20 subsection (f)). The Health Maintenance Organization and 21 the group or enrollment unit may agree that the 22 profitable or unprofitable experience may be calculated 23 taking into account the refund period and the immediately 24 preceding 2 plan years. 25 The Health Maintenance Organization shall include a 26 statement in the evidence of coverage issued to each enrollee 27 describing the possibility of a refund or additional premium, 28 and upon request of any group or enrollment unit, provide to 29 the group or enrollment unit a description of the method used 30 to calculate (1) the Health Maintenance Organization's 31 profitable experience with respect to the group or enrollment 32 unit and the resulting refund to the group or enrollment unit 33 or (2) the Health Maintenance Organization's unprofitable 34 experience with respect to the group or enrollment unit and -7- LRB9002217JScbA 1 the resulting additional premium to be paid by the group or 2 enrollment unit. 3 In no event shall the Illinois Health Maintenance 4 Organization Guaranty Association be liable to pay any 5 contractual obligation of an insolvent organization to pay 6 any refund authorized under this Section. 7 (Source: P.A. 88-313; 89-90, eff. 6-30-95.) 8 Section 15. The Limited Health Service Organization Act 9 is amended by changing Section 3009 as follows: 10 (215 ILCS 130/3009) (from Ch. 73, par. 1503-9) 11 Sec. 3009. Point-of-service limited health service 12 contracts. 13 (a) An LHSO that offers a POS contract: 14 (1) shall include as in-plan covered services all 15 services required by law to be provided by an LHSO; 16 (2) shall provide incentives, which shall include 17 financial incentives, for enrollees to use in-plan 18 covered services; 19 (3) shall not offer services out-of-plan without 20 providing those services on an in-plan basis; 21 (4) may limit or exclude specific types of services 22 from coverage when obtained out-of-plan; 23 (5) may include annual out-of-pocket limits and 24 lifetime maximum benefits allowances for out-of-plan 25 services that are separate from any limits or allowances 26 applied to in-plan services; 27 (6) shall include an annual maximum benefit 28 allowance not to exceed $2,500 per year that is separate 29 from any limits or allowances applied to in-plan 30 services; 31 (7) may limit the groups to which a POS product is 32 offered, however, if a POS product is offered to a group, -8- LRB9002217JScbA 1 then it must be offered to all eligible members of that 2 group, when an LHSO provider is available; 3 (8) shall not consider emergency services, 4 authorized referral services, or non-routine services 5 obtained out of the service area to be POS services; and 6 (9) may treat as out-of-plan services those 7 services that an enrollee obtains from a participating 8 provider, but for which the proper authorization was not 9 given by the LHSO. 10 (b) An LHSO offering a POS contract shall be subject to 11 the following limitations: 12 (1) The LHSO shall not expend in any calendar 13 quarter more than 20% of its total limited health 14 services expenditures for all its members for out-of-plan 15 covered services. 16 (2) If the amount specified in paragraph (1) is 17 exceeded by 2% in a quarter, the LHSO shall effect 18 compliance with paragraph (1) by the end of the following 19 quarter. 20 (3) If compliance with the amount specified in 21 paragraph (1) is not demonstrated in the LHSO's next 22 quarterly report, the LHSO may not offer the POS contract 23 to new groups or include the POS option in the renewal of 24 an existing group until compliance with the amount 25 specified in paragraph (1) is demonstrated or otherwise 26 allowed by the Director. 27 (4) Any LHSO failing, without just cause, to comply 28 with the provisions of this subsection shall be required, 29 after notice and hearing, to pay a penalty of $250 for 30 each day out of compliance, to be recovered by the 31 Director of Insurance. Any penalty recovered shall be 32 paid into the General Revenue Fund. The Director may 33 reduce the penalty if the LHSO demonstrates to the 34 Director that the imposition of the penalty would -9- LRB9002217JScbA 1 constitute a financial hardship to the LHSO. 2 (c) Any LHSO that offers a POS product shall: 3 (1) File a quarterly financial statement detailing 4 compliance with the requirements of subsection (b). 5 (2) Track out-of-plan POS utilization separately 6 from in-plan or non-POS out-of-plan emergency care, 7 referral care, and urgent care out of the service area 8 utilization. 9 (3) Record out-of-plan utilization in a manner that 10 will permit such utilization and cost reporting as the 11 Director may, by regulation, require. 12 (4) Demonstrate to the Director's satisfaction that 13 the LHSO has the fiscal, administrative, and marketing 14 capacity to control its POS enrollment, utilization, and 15 costs so as not to jeopardize the financial security of 16 the LHSO. 17 (5) Maintain the deposit required by subsection (b) 18 of Section 2006 in addition to any other deposit required 19 under this Act. 20 (d) An LHSO shall not issue a POS contract until it has 21 filed and had approved by the Director a plan to comply with 22 the provisions of this Section. The compliance plan shall at 23 a minimum include provisions demonstrating that the LHSO will 24 do all of the following: 25 (1) Design the benefit levels and conditions of 26 coverage for in-plan covered services and out-of-plan 27 covered services as required by this Article. 28 (2) Provide or arrange for the provision of 29 adequate systems to: 30 (A) process and pay claims for all out-of-plan 31 covered services; 32 (B) meet the requirements for a POS contract 33 set forth in this Section and any additional 34 requirements that may be set forth by the Director; -10- LRB9002217JScbA 1 and 2 (C) generate accurate data and financial and 3 regulatory reports on a timely basis so that the 4 Department can evaluate the LHSO's experience with 5 the POS contract and monitor compliance with POS 6 contract provisions. 7 (3) Comply initially and on an ongoing basis with 8 the requirements of subsections (b) and (c). 9 (e) A POS contract must comply with the requirements of 10 Section 356t of the Illinois Insurance Code. 11 (Source: P.A. 87-1079; 88-667, eff. 9-16-94.) 12 Section 20. The Voluntary Health Services Plans Act is 13 amended by changing Section 10 as follows: 14 (215 ILCS 165/10) (from Ch. 32, par. 604) 15 Sec. 10. Application of Insurance Code provisions. 16 Health services plan corporations and all persons interested 17 therein or dealing therewith shall be subject to the 18 provisions of Article XII 1/2 and Sections 3.1, 133, 140, 19 143, 143c, 149, 354, 355.2, 356r, 356t, 367.2, 401, 401.1, 20 402, 403, 403A, 408, 408.2, and 412, and paragraphs (7) and 21 (15) of Section 367 of the Illinois Insurance Code. 22 (Source: P.A. 89-514, eff. 7-17-96.) 23 Section 99. Effective date. This Act takes effect on 24 January 1, 1998.