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90_SB0447 215 ILCS 5/356t new 215 ILCS 125/5-3 from Ch. 111 1/2, par. 1411.2 215 ILCS 130/4003 from Ch. 73, par. 1504-3 215 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 Plan Act. Provides that coverage under those Acts shall include coverage for drugs when prescribed for a use that is not approved by the Food and Drug Administration if the medical literature supports the use. Requires the Director of Insurance to create a panel of experts to advise on off-label uses. LRB9002987JSgc LRB9002987JSgc 1 AN ACT concerning insurance coverage for drug therapy, 2 amending named Acts. 3 Be it enacted by the People of the State of Illinois, 4 represented in the General Assembly: 5 Section 5. The Illinois Insurance Code is amended by 6 adding Section 356t as follows: 7 (215 ILCS 5/356t new) 8 Sec. 356t. Drugs; alternative indications. 9 (a) An individual or group policy of accident and health 10 insurance amended, delivered, issued, or renewed after the 11 effective date of this amendatory Act of 1997 may not exclude 12 coverage for a drug for a particular indication on the ground 13 that the drug has not been approved by the federal Food and 14 Drug Administration for that indication if the drug is 15 recognized for treatment of that indication in one of the 16 standard reference compendia, in the medical literature, or 17 by the Director. Coverage required under this Section for a 18 drug shall also include medically necessary services 19 associated with the administration of the drug. This Section 20 does not require coverage for drugs that: 21 (1) have not been approved by the federal Food and 22 Drug Administration; 23 (2) the federal Food and Drug Administration has 24 determined the use of is contra-indicated; or 25 (3) are experimental drugs not otherwise approved 26 for any indication by the federal Food and Drug 27 Administration. 28 (b) As used in this Section, "medical literature" means 29 published studies in any peer-reviewed national professional 30 journal and "standard reference compendia" means the United 31 States Pharmacopeia Drug Information, the American Medical -2- LRB9002987JSgc 1 Association Drug Evaluations, or the American Hospital 2 Formulary Service Drug Information. 3 (c) The Director shall create a panel of 7 medical 4 experts to review off-label uses not included in any of the 5 standard reference compendia or in the medical literature and 6 to advise the Director in those instances whether a 7 particular off-label use is medically appropriate. The panel 8 shall make its recommendations periodically and whenever a 9 particular dispute about payment for off-label use is brought 10 to the Director. The panel shall include 3 medical 11 oncologists, 2 specialists in the management of AIDS 12 patients, one specialist in heart disease, and one general 13 practitioner. The Department shall enforce the provisions of 14 this Section. 15 Section 10. The Health Maintenance Organization Act is 16 amended by changing Section 5-3 as follows: 17 (215 ILCS 125/5-3) (from Ch. 111 1/2, par. 1411.2) 18 Sec. 5-3. Insurance Code provisions. 19 (a) Health Maintenance Organizations shall be subject to 20 the provisions of Sections 133, 134, 137, 140, 141.1, 141.2, 21 141.3, 143, 143c, 147, 148, 149, 151, 152, 153, 154, 154.5, 22 154.6, 154.7, 154.8, 155.04, 355.2, 356m, 356t, 367i, 401, 23 401.1, 402, 403, 403A, 408, 408.2, and 412, paragraph (c) of 24 subsection (2) of Section 367, and Articles VIII 1/2, XII, 25 XII 1/2, XIII, XIII 1/2, and XXVI of the Illinois Insurance 26 Code. 27 (b) For purposes of the Illinois Insurance Code, except 28 for Articles XIII and XIII 1/2, Health Maintenance 29 Organizations in the following categories are deemed to be 30 "domestic companies": 31 (1) a corporation authorized under the Medical 32 Service Plan Act, the Dental Service Plan Act, the Vision -3- LRB9002987JSgc 1 Service Plan Act, the Pharmaceutical Service Plan Act, 2 the Voluntary Health Services Plan Act, or the Nonprofit 3 Health Care Service Plan Act; 4 (2) a corporation organized under the laws of this 5 State; or 6 (3) a corporation organized under the laws of 7 another state, 30% or more of the enrollees of which are 8 residents of this State, except a corporation subject to 9 substantially the same requirements in its state of 10 organization as is a "domestic company" under Article 11 VIII 1/2 of the Illinois Insurance Code. 12 (c) In considering the merger, consolidation, or other 13 acquisition of control of a Health Maintenance Organization 14 pursuant to Article VIII 1/2 of the Illinois Insurance Code, 15 (1) the Director shall give primary consideration 16 to the continuation of benefits to enrollees and the 17 financial conditions of the acquired Health Maintenance 18 Organization after the merger, consolidation, or other 19 acquisition of control takes effect; 20 (2)(i) the criteria specified in subsection (1)(b) 21 of Section 131.8 of the Illinois Insurance Code shall not 22 apply and (ii) the Director, in making his determination 23 with respect to the merger, consolidation, or other 24 acquisition of control, need not take into account the 25 effect on competition of the merger, consolidation, or 26 other acquisition of control; 27 (3) the Director shall have the power to require 28 the following information: 29 (A) certification by an independent actuary of 30 the adequacy of the reserves of the Health 31 Maintenance Organization sought to be acquired; 32 (B) pro forma financial statements reflecting 33 the combined balance sheets of the acquiring company 34 and the Health Maintenance Organization sought to be -4- LRB9002987JSgc 1 acquired as of the end of the preceding year and as 2 of a date 90 days prior to the acquisition, as well 3 as pro forma financial statements reflecting 4 projected combined operation for a period of 2 5 years; 6 (C) a pro forma business plan detailing an 7 acquiring party's plans with respect to the 8 operation of the Health Maintenance Organization 9 sought to be acquired for a period of not less than 10 3 years; and 11 (D) such other information as the Director 12 shall require. 13 (d) The provisions of Article VIII 1/2 of the Illinois 14 Insurance Code and this Section 5-3 shall apply to the sale 15 by any health maintenance organization of greater than 10% of 16 its enrollee population (including without limitation the 17 health maintenance organization's right, title, and interest 18 in and to its health care certificates). 19 (e) In considering any management contract or service 20 agreement subject to Section 141.1 of the Illinois Insurance 21 Code, the Director (i) shall, in addition to the criteria 22 specified in Section 141.2 of the Illinois Insurance Code, 23 take into account the effect of the management contract or 24 service agreement on the continuation of benefits to 25 enrollees and the financial condition of the health 26 maintenance organization to be managed or serviced, and (ii) 27 need not take into account the effect of the management 28 contract or service agreement on competition. 29 (f) Except for small employer groups as defined in the 30 Small Employer Rating, Renewability and Portability Health 31 Insurance Act and except for medicare supplement policies as 32 defined in Section 363 of the Illinois Insurance Code, a 33 Health Maintenance Organization may by contract agree with a 34 group or other enrollment unit to effect refunds or charge -5- LRB9002987JSgc 1 additional premiums under the following terms and conditions: 2 (i) the amount of, and other terms and conditions 3 with respect to, the refund or additional premium are set 4 forth in the group or enrollment unit contract agreed in 5 advance of the period for which a refund is to be paid or 6 additional premium is to be charged (which period shall 7 not be less than one year); and 8 (ii) the amount of the refund or additional premium 9 shall not exceed 20% of the Health Maintenance 10 Organization's profitable or unprofitable experience with 11 respect to the group or other enrollment unit for the 12 period (and, for purposes of a refund or additional 13 premium, the profitable or unprofitable experience shall 14 be calculated taking into account a pro rata share of the 15 Health Maintenance Organization's administrative and 16 marketing expenses, but shall not include any refund to 17 be made or additional premium to be paid pursuant to this 18 subsection (f)). The Health Maintenance Organization and 19 the group or enrollment unit may agree that the 20 profitable or unprofitable experience may be calculated 21 taking into account the refund period and the immediately 22 preceding 2 plan years. 23 The Health Maintenance Organization shall include a 24 statement in the evidence of coverage issued to each enrollee 25 describing the possibility of a refund or additional premium, 26 and upon request of any group or enrollment unit, provide to 27 the group or enrollment unit a description of the method used 28 to calculate (1) the Health Maintenance Organization's 29 profitable experience with respect to the group or enrollment 30 unit and the resulting refund to the group or enrollment unit 31 or (2) the Health Maintenance Organization's unprofitable 32 experience with respect to the group or enrollment unit and 33 the resulting additional premium to be paid by the group or 34 enrollment unit. -6- LRB9002987JSgc 1 In no event shall the Illinois Health Maintenance 2 Organization Guaranty Association be liable to pay any 3 contractual obligation of an insolvent organization to pay 4 any refund authorized under this Section. 5 (Source: P.A. 88-313; 89-90, eff. 6-30-95.) 6 Section 15. The Limited Health Service Organization Act 7 is amended by changing Section 4003 as follows: 8 (215 ILCS 130/4003) (from Ch. 73, par. 1504-3) 9 Sec. 4003. Illinois Insurance Code provisions. Limited 10 health service organizations shall be subject to the 11 provisions of Sections 133, 134, 137, 140, 141.1, 141.2, 12 141.3, 143, 143c, 147, 148, 149, 151, 152, 153, 154, 154.5, 13 154.6, 154.7, 154.8, 155.04, 355.2, 356t, 401, 401.1, 402, 14 403, 403A, 408, 408.2, and 412, and Articles VIII 1/2, XII, 15 XII 1/2, XIII, XIII 1/2, and XXVI of the Illinois Insurance 16 Code. For purposes of the Illinois Insurance Code, except 17 for Articles XIII and XIII 1/2, limited health service 18 organizations in the following categories are deemed to be 19 domestic companies: 20 (1) a corporation under the laws of this State; or 21 (2) a corporation organized under the laws of 22 another state, 30% of more of the enrollees of which are 23 residents of this State, except a corporation subject to 24 substantially the same requirements in its state of 25 organization as is a domestic company under Article VIII 26 1/2 of the Illinois Insurance Code. 27 (Source: P.A. 86-600; 87-587; 87-1090.) 28 Section 20. The Voluntary Health Services Plans Act is 29 amended by changing Section 10 as follows: 30 (215 ILCS 165/10) (from Ch. 32, par. 604) -7- LRB9002987JSgc 1 Sec. 10. Application of Insurance Code provisions. 2 Health services plan corporations and all persons interested 3 therein or dealing therewith shall be subject to the 4 provisions of Article XII 1/2 and Sections 3.1, 133, 140, 5 143, 143c, 149, 354, 355.2, 356r, 356t, 367.2, 401, 401.1, 6 402, 403, 403A, 408, 408.2, and 412, and paragraphs (7) and 7 (15) of Section 367 of the Illinois Insurance Code. 8 (Source: P.A. 89-514, eff. 7-17-96.)