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90_SB0276 215 ILCS 125/2-1.1 new 215 ILCS 125/2-1.2 new 215 ILCS 125/2-1.3 new 215 ILCS 125/2-1.4 new 215 ILCS 125/2-1.5 new 215 ILCS 125/2-1.6 new 215 ILCS 125/2-1.7 new 215 ILCS 125/4-17 new 215 ILCS 125/Art. VII heading new 215 ILCS 125/7-1 new 215 ILCS 125/7-2 new 215 ILCS 125/7-3 new 215 ILCS 125/7-4 new 215 ILCS 125/7-5 new 215 ILCS 125/7-6 new 215 ILCS 125/7-7 new 215 ILCS 125/7-8 new 215 ILCS 125/7-9 new 215 ILCS 125/7-10 new 215 ILCS 125/7-11 new Amends the Health Maintenance Organization Act. Imposes certain requirements for holding a certificate of authority under which health care services are provided through the use of managed care, including disclosure standards, credentialing standards and an appeals process for providers, the development of community service plans, and that health maintenance organizations provide a point-of-service option. Provides for certification of utilization review agents by the Department of Insurance. Establishes criteria for obtaining a certificate. Requires the Director of Insurance to establish a statewide dispute resolution system. Provides penalties for violation. Effective immediately. LRB9002231JSmg LRB9002231JSmg 1 AN ACT concerning the regulation of health maintenance 2 organizations, amending a named Act. 3 Be it enacted by the People of the State of Illinois, 4 represented in the General Assembly: 5 Section 5. The Health Maintenance Organization Act is 6 amended by adding Sections 2-1.1, 2-1.2, 2-1.3, 2-1.4, 2-1.5, 7 2-1.6, 2-1.7, and 4-17 and Article VII as follows: 8 (215 ILCS 125/2-1.1 new) 9 Sec. 2-1.1. Requirements for holding a certificate of 10 authority. 11 (a) In addition to any other requirements of this Act, 12 beginning January 1, 1998 and annually thereafter, as a 13 condition for holding a certificate of authority issued 14 pursuant to this Act under which health care services are 15 provided through the use of managed care, the Director shall 16 require the disclosure of the following information to each 17 enrollee or prospective enrollee, upon request: 18 (1) a description of premiums, co-payments, 19 co-insurance and deductibles, covered benefits, 20 exclusions and limitations, including experimental or 21 investigational coverage exclusions for treatment, drugs 22 or devices; 23 (2) a description of limitations on an insured's 24 choice of a primary and specialist or other participating 25 provider, including notice of any financial 26 responsibilities for an insured such as co-insurance or 27 other expenditures that result from such choice; 28 (3) a description of all prior authorization or 29 other requirements for treatments and services and a 30 description of utilization review mechanisms used by the 31 health maintenance organization, including -2- LRB9002231JSmg 1 preauthorization review, concurrent review, post-service 2 review, post-payment review and any other procedures that 3 may cause an insured to be denied a referral or coverage 4 for a particular service; 5 (4) a description of any financial arrangements or 6 contractual provisions with participating providers or 7 utilization review agents, including withholds and 8 incentive payments to providers, which may restrict 9 referral or treatment options or limit the services 10 offered to an insured; 11 (5) a list, updated no less than annually, of the 12 name, address, telephone number, office hours, ability to 13 accept new enrollees, specialty, and professional 14 credentials; 15 (6) a description of the internal grievance 16 procedure to be used to resolve disputes between a health 17 maintenance organization and an enrollee or enrollee's 18 participating provider; 19 (7) a description of the procedures for providing 20 care and coverage for emergency health services received 21 outside of the health maintenance organization's service 22 area and any notification or other requirements for 23 enrollees; 24 (8) a summary of the health maintenance 25 organization's quality assurance procedures; 26 (9) a description of how the health maintenance 27 organization will address the needs of non-English 28 speaking enrollees; 29 (10) the ratio of participating providers, 30 including primary care physicians and specialists, to 31 enrollees, and the average length of time that passes 32 between the request for routine, specialty care, medical 33 test, or hospital services by an enrollee and when such 34 care is rendered; -3- LRB9002231JSmg 1 (11) the rate of disenrollment by enrollees and 2 participating providers; 3 (12) the governance structure of the health 4 maintenance organization and how enrollees and 5 participating providers may participate in the 6 development of the policies of the health maintenance 7 organization; and 8 (13) a description of how to obtain information 9 regarding a health maintenance organization, including 10 notice of a toll-free telephone number for inquiries. 11 Information required under this Section shall be provided 12 in a clear and coherent manner using words with common 13 everyday language. 14 (b) A health maintenance organization shall disclose to 15 the Director each year the following information: 16 (1) the location of its facilities; 17 (2) the names and credentials of all health care 18 providers that will provide services pursuant to contract 19 or other agreement; 20 (3) a statement of the process established to 21 credential health care providers; 22 (4) a description of the population to be enrolled 23 and the proposed service area; 24 (5) a statement of the times, places, and manner of 25 providing services under the plan; 26 (6) a statement of the services covered by the plan 27 and a description of the procedures to be followed in the 28 event that an enrollee receives emergency or other health 29 care services from a health care provider outside the 30 plan, including a statement of the additional costs to 31 the enrollee of such care; 32 (7) a statement of its quality assurance mechanisms 33 including peer review and utilization review procedures; 34 (8) a statement of the enrollee grievance system -4- LRB9002231JSmg 1 and complaint procedures to be followed by an enrollee, a 2 person acting on behalf of an enrollee, or a health care 3 provider, including a description of the mechanism which 4 may be used to seek reconsideration or appeal, from 5 adverse determination by the utilization review agent; 6 (9) a copy of any proposed contract to be made 7 between the plan organization and health care providers 8 and utilization review agents; 9 (10) the policies and procedures to ensure that all 10 applicable State and federal laws to protect the 11 confidentiality of individual medical and treatment 12 records are followed; and 13 (11) a copy of the materials provided to enrollees 14 and prospective enrollees of the plan pursuant to Section 15 2-1.3. 16 (c) Each year, a health maintenance organization must 17 provide documentation to the Director that it: 18 (1) demonstrates the capability of organizing, 19 managing, promoting, and operating an organization that 20 provides medical and other health care services that meet 21 quality, continuity, and other treatment standards 22 prescribed by the Director in a manner that is timely, 23 effective, and convenient for enrollees; 24 (2) includes a sufficient number of health care 25 providers within defined categories, including specialty 26 providers, throughout the proposed service area to meet 27 the needs of its enrollees and provides its enrollees 28 adequate flexibility to choose a health care provider; 29 (3) demonstrates that financial incentives offered 30 to health care providers to minimize improper 31 over-utilization or under-utilization of health care 32 services will not impair the quality or access to care 33 provided to plan enrollees nor interfere with health care 34 providers' adherence to appropriate professional -5- LRB9002231JSmg 1 standards; 2 (4) provides adequate methods to monitor quality of 3 care including peer review and utilization review and 4 establishes mechanisms to resolve complaints and 5 grievances initiated by any plan enrollee; 6 (5) agrees to provide ready access to the Director 7 of all data, records and information it collects and 8 maintains, and to provide such reports as the Director 9 shall reasonably require concerning medical and health 10 care services costs, quality, and utilization under this 11 Act to the extent that such access and reports are 12 required to enable the Director to perform his or her 13 responsibilities pursuant to this Act, provided that 14 patient identifying information shall only be disclosed 15 in compliance with applicable State or federal laws; 16 (6) complies with any other requirement the 17 Director determines is necessary to provide quality 18 medical and other health care services to enrollees; 19 (7) establishes procedures for managing the care of 20 individuals with chronic, degenerative, disabling, or 21 life threatening diseases or conditions, as defined by 22 the Director in consultation with consumers and providers 23 with expertise in the care and treatment of chronic 24 illnesses, which shall include special case managers or 25 the designation by a chronically ill individual of a 26 specialist as his or her primary care physician; 27 (8) offers enrollees or in groups of 3 or more 28 employees the choice of obtaining any or all medical or 29 health care services that are covered by the plan from 30 health care providers not participating in the plan 31 pursuant to contract, employment, or other association; 32 provided, however, that in no event shall an enrollee 33 elect to have a non-participating health care provider 34 serve as the enrollee's primary care practitioner -6- LRB9002231JSmg 1 responsible for supervising and coordinating the care of 2 the enrollee. For purposes of this item, such coverage 3 may be subject to reasonable, appropriate, and affordable 4 annual deductibles and co-insurance, subject to a 5 reasonable and affordable out-of-pocket limit, as 6 prescribed by the Director; and 7 (9) establishes procedures for managing and 8 providing for the care of non-English speaking persons. 9 (215 ILCS 125/2-1.2 new) 10 Sec. 2-1.2. Internal grievance procedures. The Director 11 shall issue rules for health maintenance organization 12 grievance procedures to be established by health maintenance 13 organizations. The rules shall establish standards for: 14 (1) the process for initiating a grievance, both 15 orally and in writing; 16 (2) notice to enrollees of their right to file 17 grievances and the procedures to initiate such a 18 grievance; 19 (3) reviews of grievances; and 20 (4) notification to enrollees of resolution of a 21 grievance, including appropriate time frames. 22 (215 ILCS 125/2-1.3 new) 23 Sec. 2-1.3. Disclosure to enrollees. 24 (a) A health maintenance organization shall provide all 25 of the following information to its enrolled members at the 26 time of enrollment and annually thereafter, with additional 27 updates provided as required by the Director, make the 28 information available to the general public on request, and 29 file copies of the information with the Director subject to 30 subsection (b) of this Section: 31 (1) All services and benefits provided under the 32 contract, including any service or benefit maximum, -7- LRB9002231JSmg 1 limitations and exclusions; and any services excluded on 2 the basis of being experimental or investigational and 3 the criteria used for that determination. The 4 information shall, on request, include any prescription 5 drug formulary. 6 (2) An explanation of procedures used in 7 authorizing, referring, certifying, approving, reviewing, 8 limiting and denying (including appeals) services or 9 benefits requested or used by a provider or enrollee. 10 This shall include the terms for access to providers 11 within the plan as well as providers outside the plan. 12 Criteria specific to a decision shall be provided in a 13 timely manner to the provider or enrollee on request; and 14 all criteria for decisions shall be filed with the 15 Director. 16 (3) A listing of all primary practitioners and 17 specialists available to an enrollee, with any 18 limitations on their availability. The listing shall 19 include each practitioner's name, address, telephone 20 number, licensure, specialty, board certification, and 21 hospital affiliation. On request, the information shall 22 include statistics on the frequency with which individual 23 practitioners have performed specific procedures and 24 treatments. 25 (4) Criteria and procedures for selection and 26 termination of providers for and from the health 27 maintenance organization, including statistics relating 28 to disenrollment of providers. 29 (5) Numbers and ratios of primary care 30 practitioners and specialists available under the plan to 31 the number of enrollees. 32 (6) A description of financial arrangements, 33 compensation, and incentives with providers within and 34 not within the plan, and with utilization review -8- LRB9002231JSmg 1 organizations. 2 (7) Procedures for enrollee and provider 3 grievances, including time periods for making decisions. 4 (8) A description of the plan's quality assurance 5 procedures. The plan's accreditation survey results and 6 outcomes reporting shall be available on request and 7 shall be filed with the Director. 8 (9) A statement of the enrollee's financial 9 responsibility for services and benefits, including 10 services provided by providers within and not within the 11 plan, including deductibles, co-payments, and 12 co-insurance. 13 (10) Statistics on enrollee satisfaction, including 14 reenrollment, disenrollment, complaints in specific 15 categories, and times required for getting access to 16 various services. 17 (11) The plan contract. 18 (12) The percentage of premium income expended on 19 health services for enrollees and administrative 20 services. 21 (13) Procedures and terms for enrollees selecting 22 and changing primary care practitioners and specialists. 23 (14) Procedures for protecting the confidentiality 24 of medical records and other patient information. 25 (15) Telephone numbers for obtaining information 26 about the plan. 27 (16) Members of the governing body, officers, 28 senior administrative staff, and a description of the 29 ownership of the health maintenance organization, 30 including the identity of any person or entity owning 5% 31 or more of the equity of the entity and whether the 32 entity is owned and operated as a for-profit or 33 not-for-profit entity. 34 (17) A certified financial statement shall be -9- LRB9002231JSmg 1 provided on request and filed with the Director. 2 (18) Such other information as the Director shall 3 require. 4 (b) Enrollees shall be provided information relating to 5 the enrollee's contract. Enrollees and members of the 6 general public shall receive on request information as to any 7 contract offered by the health maintenance organization. The 8 Director shall receive for filing information as to all 9 contracts offered by the health maintenance organization. 10 The information provided, made available, and filed under 11 subsection (a) of this Section shall be subject to the rules 12 of the Director as to form, content, and frequency of 13 updating. It shall be fully and clearly stated, so as to 14 facilitate understanding and comparison, and shall exclude 15 information that is misleading or unreasonably confusing. 16 (215 ILCS 125/2-1.4 new) 17 Sec. 2-1.4. Credentialing process; appeal. 18 (a) A health maintenance organization shall establish a 19 credentialing process for all participating providers that 20 complies with all of the following: 21 (1) Credentials health care providers based on 22 objective standards of quality developed in consultation 23 with appropriately qualified health care providers. 24 (2) Affords all health care providers within the 25 plan's geographic service area the ability to apply for 26 credentials and to enter into a written contract with the 27 plan if the health care provider meets with the plan's 28 credentialing standards. When a health care provider is 29 denied credentials, the plan must apprise the health care 30 provider denied credentials of the grounds, including 31 economic considerations, for the denial in writing. 32 (3) Guarantees access to specialized treatment 33 expertise by entering into agreements with centers of -10- LRB9002231JSmg 1 specialized care to ensure that enrollees may elect to 2 receive the specialized treatment expertise of such 3 centers or by permitting enrollees to obtain specialized 4 treatment from such centers even in the event that the 5 health maintenance organization does not have agreements 6 with such centers or such centers are outside the network 7 of the plan. A managed care plan shall be deemed to be 8 in accordance with this item if the agreement of such 9 plan provides that, with respect to conditions within the 10 specialized treatment expertise of the center involved, 11 the plan, at the enrollee's election, will refer medical 12 cases involving such conditions to such center in a 13 timely manner, and will inform enrollees routinely of the 14 availability of referral care and has established an 15 appeal mechanism through which the enrollee may challenge 16 denials or referrals to such centers. For the purposes 17 of this Section, centers of specialized care shall 18 include, but are not limited to, National Cancer 19 Institute-designated cancer centers, hospital 20 AIDS-designated centers and other specialized centers as 21 may be designated by the Director. 22 (4) Includes a procedure for each health care 23 provider application to be reviewed by a credentialing 24 committee with appropriate representation of the health 25 care provider's specialty or professional discipline. 26 (5) Makes available to health care providers and 27 enrollees for inspection upon written request all 28 standards including economic consideration utilized as 29 part of the credentialing process. 30 (b) A health maintenance organization shall create 31 appeals mechanisms and procedures by which credential 32 denials, credential reductions, or provider terminations may 33 be challenged, including notice of the underlying complaint, 34 an opportunity to be heard and, where the plan seeks to -11- LRB9002231JSmg 1 terminate a provider, an opportunity to complete a corrective 2 action plan. No such opportunity shall be offered to any 3 provider where the termination is necessary to protect the 4 life, health or safety of plan enrollees. 5 (c) A health maintenance organization shall establish a 6 mechanism with defined rights under which health care 7 providers participating in the plan are assured input into 8 the plan's medical policy, utilization review, quality 9 assurance procedures, credentialing criteria, and medical 10 management procedures. 11 (d) A health maintenance organization is prohibited 12 from: 13 (1) using economic consideration or economic 14 profiling of providers unless such considerations or 15 profiles utilize objective criteria adjusted to recognize 16 case mix, severity of illness, age and provider practice 17 costs; 18 (2) terminating any health care provider from the 19 managed care plan without cause, provided that cause in 20 such an instance shall not include advocating for a 21 particular treatment or services on behalf of an 22 enrollee; and 23 (3) making any payment, either directly or 24 indirectly, to a health care provider or group of 25 providers as an inducement to reduce or to limit 26 medically necessary services provided to an enrollee. 27 (215 ILCS 125/2-1.5 new) 28 Sec. 2-1.5. Community service plans. A health 29 maintenance organization offering comprehensive health 30 benefits pursuant to this Act shall file by January 1, 1998, 31 and thereafter annually, a community service plan with the 32 Director which identifies the unmet health care needs of the 33 region or service areas the organization serves and the -12- LRB9002231JSmg 1 organization's efforts to meet such needs. Such efforts may 2 include, but shall not be limited to, outreach activities in 3 medically unserved or underserved communities such as health 4 education and counselling for such populations; primary and 5 preventive medicine such as immunization, mammography 6 testing, lead paint screening, blood pressure, cholesterol or 7 sexually-transmitted disease testing; and contracting with 8 health facilities that serve high percentages of uninsured 9 persons. Beginning January 1, 1998, and annually thereafter, 10 the plan shall detail the health maintenance organization's 11 financial commitment to meeting such needs. 12 (215 ILCS 125/2-1.6 new) 13 Sec. 2-1.6. Obligation to offer a comprehensive 14 point-of-service health benefits policy in the individual 15 market. 16 (a) For the purpose of this Section, a "comprehensive 17 point-of-service health benefits policy" shall mean a policy 18 in compliance with Article XX of the Illinois Insurance Code 19 that has been approved by the Director and that includes all 20 of the following features: 21 (1) Inpatient care, including: 22 (A) room, board and general nursing care for 23 an unlimited number of days; 24 (B) maternity care and routine nursery care 25 during mother's birth-related hospital confinement 26 for up to 30 days; 27 (C) psychiatric care for up to 30 inpatient 28 days per calendar year; and 29 (D) physical medicine and rehabilitation. 30 (2) Outpatient care, including: 31 (A) ambulatory surgery; 32 (B) surgery; 33 (C) mammography screening; -13- LRB9002231JSmg 1 (D) blood; 2 (E) treatment of initial visit for sudden and 3 serious illness and accidental injury; 4 (F) presurgical testing; 5 (G) chemotherapy; 6 (H) radiation therapy; 7 (I) physical therapy for up to 90 visits per 8 calendar year following surgery or hospitalization; 9 (J) outpatient kidney dialysis; and 10 (K) diagnostic x-rays and laboratory services. 11 (3) Special care, including: 12 (A) home health care for up to 200 visits per 13 calendar year; 14 (B) hospice care for up to 210 days; and 15 (C) skilled nursing facility for up to 365 16 days when preceded by a hospital stay. 17 (4) Physician services, including: 18 (A) surgery; 19 (B) anesthesia; 20 (C) surgical assistance; 21 (D) maternity care; 22 (E) primary and preventive care and well-baby 23 and well-child care; 24 (F) consultation services of one for each 25 specialty; 26 (G) in-hospital doctor visits; 27 (H) home and office visits; 28 (I) psychiatric care for up to 30 inpatient 29 visits per calendar year and outpatient psychiatric 30 care and psychiatric emergency visits; and 31 (J) second surgical opinion. 32 (5) Other professional services and supplies, 33 including: 34 (A) x-ray, radium, and radionuclide therapy; -14- LRB9002231JSmg 1 (B) electroconvulsive therapy; 2 (C) diagnostic x-ray and laboratory services; 3 (D) chemotherapy; 4 (E) supplies and medical equipment; 5 (F) private duty nursing, when pre-approved, 6 up to $5,000 per calendar year and $10,000 lifetime; 7 (G) prosthetic and orthotic appliances and 8 durable medical equipment; 9 (H) ambulance services; 10 (I) outpatient physical therapy visits; 11 (J) inpatient physician medicine and 12 rehabilitation; and 13 (K) mammography screening. 14 (6) Insulin and prescription drugs subject to a 15 deductible not to exceed $10 per prescription and $100 16 per covered person per calendar year or $300 per covered 17 family per calendar year. A policy issued pursuant to 18 this Section may require that such drugs be obtained 19 through a participating or in-house pharmacy or through 20 the mail, provided that the Director determines that such 21 arrangement does not impose an undue burden on a 22 consumer. 23 (7) The ability to receive services out of network, 24 subject to a deductible not to exceed $1,000 per 25 individual and $2,000 per family and co-insurance 26 payments at a ratio of 80:20, provided that out-of-pocket 27 costs for co-insurance and deductibles do not exceed 28 $2,500 per individual or $5,000 per family annually, and 29 provided further that a lifetime maximum for 30 out-of-network benefits of no less than $500,000 may be 31 imposed and that co-insurance payments shall be based on 32 a usual, customary, or reasonable fee schedule filed with 33 the Department or a comparable index used for 34 out-of-network benefits for small groups. -15- LRB9002231JSmg 1 (8) For in-network services, a co-payment not to 2 exceed $10 per visit. 3 (b) Notwithstanding any other provision of law, every 4 health maintenance organization engaged in writing or 5 renewing comprehensive health services policies shall offer a 6 comprehensive point-of-service health benefits policy 7 approved by the Director to individuals within its service 8 area on or before July 1, 1998. 9 (c) The Director shall develop a plan for the marketing 10 to individuals of comprehensive point-of-service health 11 benefits policies offered to individuals under this Section. 12 The plan shall include the publication, no less than 13 semi-annually, of a manual containing the names, addresses, 14 and telephone numbers of the health maintenance organizations 15 offering the policies and a description of the benefits and 16 premiums in such a manner that facilitates consumer 17 comparison. The Director shall also establish and maintain a 18 toll-free telephone number at the Department to provide 19 information about the policies. 20 (d) Before December 1, 1997, and not less than annually 21 thereafter, the Director shall conduct hearings in various 22 areas of the State to solicit testimony related to the 23 affordability of such policies and the adequacy of benefits. 24 (215 ILCS 125/2-1.7 new) 25 Sec. 2-1.7. Reimbursement for emergency room care. The 26 Director shall issue uniform rules for the reimbursement of 27 emergency care rendered in emergency rooms of general 28 hospitals. The rules shall include, but not be limited to, 29 standards delineating the responsibilities for notification 30 between health care providers and health maintenance 31 organizations; standards for treatment and payment for stable 32 and nonstable cases; and, resolution of disputes between 33 general hospitals, patients, and health maintenance -16- LRB9002231JSmg 1 organizations. For the purposes of this Section, "emergency 2 care" means those health care procedures, treatments, or 3 services, including psychiatric stabilization and medical 4 detoxification from drugs or alcohol, that are provided after 5 the sudden onset of what reasonably appears to be a medical 6 condition that manifests itself by symptoms of sufficient 7 severity, including severe pain, that the absence of 8 immediate medical attention could reasonably be expected by a 9 prudent layperson, who possesses an average knowledge of 10 health and medicine, to result in: 11 (1) placing the patient's health in serious 12 jeopardy; 13 (2) serious impairment to bodily functions; or 14 (3) serious dysfunction of any bodily organ or 15 part. 16 (215 ILCS 125/4-17 new) 17 Sec. 4-17. Drug; use for other purpose; clinical trials. 18 (a) No contract or evidence of coverage amended, 19 delivered, issued, or renewed in this State after the 20 effective date of this amendatory Act of 1997 which provides 21 coverage for prescribed drugs or devices approved by the Food 22 and Drug Administration of the United States government shall 23 exclude coverage of any such drug or device on the basis that 24 such drug or device has not been specifically approved by the 25 Food and Drug Administration for treatment of the disease or 26 condition for which it has been prescribed, provided, 27 however, that such drug or device must: 28 (1) be recognized for treatment of the specific 29 disease or condition in the American Medical Association 30 Drug Evaluation, the American Hospital Formulary Service 31 Drug Information, or the United States Pharmacopoeia Drug 32 Information; 33 (2) be covered for reimbursement by the Illinois -17- LRB9002231JSmg 1 Department of Public Aid under Article V of the Illinois 2 Public Aid Code; or 3 (3) be recommended for such use by article and or 4 editorial comment in a peer-reviewed medical or 5 scientific journal. 6 (b) Every contract or evidence of coverage amended, 7 delivered, issued, or renewed in this State that provides 8 hospital, medical or surgical, or prescription drug coverage 9 shall cover the patient costs incurred in clinical trials of 10 treatments for life-threatening, degenerative, or permanently 11 disabling conditions or a condition associated with or a 12 complication of such a condition, to the extent such costs 13 would be covered for noninvestigational treatments, providing 14 that all of the following conditions are satisfied: 15 (1) treatment is provided with a therapeutic or 16 palliative intent; 17 (2) treatment is being provided pursuant to a 18 clinical trial approved by one of the National Institutes 19 of Health (NIH), an NIH cooperative group or an NIH 20 center, the FDA in the form of an investigational new 21 drug (IND) exemption, the Department of Veterans Affairs, 22 or a qualified nongovernmental research entity as 23 identified in guidelines issued by individual NIH 24 Institutes for center support grants; 25 (3) the proposed therapy has been reviewed and 26 approved by a qualified institutional review board (IRB); 27 (4) the facility and personnel providing the 28 treatment are capable of doing so by virtue of their 29 experience and training; 30 (5) there is no clearly superior, 31 noninvestigational alternative to the protocol treatment; 32 and 33 (6) the available clinical or preclinical data 34 provide a reasonable expectation that the protocol -18- LRB9002231JSmg 1 treatment will be at least as efficacious as the 2 alternative. 3 (c) As used in this Section, "cooperative groups" mean 4 formal networks of facilities that collaborate on research 5 projects and have an established, NIH-approved peer review 6 program operating within their groups. These include, but 7 are not limited to, the National Cancer Institute (NCI) 8 Clinical Cooperative Groups, the NCI Community Clinical 9 Oncology Program (CCOP), the AIDS Clinical Trials Group 10 (ACTG), and the Community Programs for Clinical Research in 11 AIDS (CPCRA). 12 As used in this Section, patient costs shall include all 13 costs of health services required to provide treatment 14 according to the design of the trial. Such costs shall not 15 include the costs of any investigational drugs or devices 16 themselves, the costs of any nonhealth services that might be 17 required for a person to receive the treatment, the costs of 18 managing the research, or costs that would not be covered 19 under the contract for noninvestigational treatments. The 20 costs of drugs and devices that have been approved for sale 21 by the Food and Drug Administration shall be covered whether 22 or not the Food and Drug Administration has approved the drug 23 or device for use in treating the patient's particular 24 condition. 25 (215 ILCS 125/Art. VII heading new) 26 ARTICLE VII. UTILIZATION REVIEW 27 (215 ILCS 125/7-1 new) 28 Sec. 7-1. Definitions. For purposes of this Article, 29 unless the context clearly requires otherwise: 30 "Adverse determination" means a determination by a 31 utilization review agent that proposed or provided health 32 care procedures, treatments, or services are not medically -19- LRB9002231JSmg 1 necessary or appropriate, are considered experimental, are 2 not approved or authorized for a specific level of care, or 3 are otherwise denied. 4 "Certificate" means a certificate of registration granted 5 by the Director to a utilization review agent pursuant to the 6 provisions of this Article. 7 "Enrollee" means a person covered by a health plan and 8 includes a person who is covered as an eligible dependent of 9 another person. 10 "Health care procedures, treatments, and services" 11 include services rendered by a person or entity duly licensed 12 or legally authorized to provide health care services. 13 "Utilization review agent" means any person or entity, 14 not affiliated with a facility, performing utilization review 15 that is either a component of, affiliated with, under 16 contract with, or acting on behalf of: 17 (1) an employer or any other entity that provides, 18 offers to provide, or administers health care benefits 19 for persons in this State, including, but not limited to, 20 preferred provider organizations; 21 (2) a self-insured health insurance plan; or 22 (3) a third party that provides or administers 23 health benefits, including: 24 (A) a health maintenance organization licensed 25 under this Act; or 26 (B) a utilization review agent located outside 27 of this State, if it conducts utilization review 28 activities relating to persons in this State. 29 "Utilization review" means the review to determine 30 whether health care procedures, treatments, or services that 31 have been provided, are being provided, or are proposed to be 32 provided to a patient or a group of patients, whether 33 undertaken prior to, concurrent with, or subsequent to the 34 delivery of such procedures, treatments, and services, are -20- LRB9002231JSmg 1 medically necessary, appropriate, considered experimental, 2 not approved for or authorized for a specific level of care, 3 or are otherwise denied. For the purposes of this Article 4 none of the following shall be considered utilization review: 5 (1) denials based on failure to obtain procedures, 6 treatments, or services from a designated or approved 7 provider as required under the health benefit plan of 8 coverage; 9 (2) any review or determination where the dispute 10 resolution process of Section 4-6 applies; 11 (3) the determination of any plan of coverage 12 issues other than issues of whether health care 13 procedures, treatments, or services are medically 14 necessary or appropriate, are considered experimental, 15 are not approved or authorized for a specific level of 16 care, or are otherwise denied. 17 "Emergency care" means those health care procedures, 18 treatments, or services, including psychiatric stabilization 19 and medical detoxification from drugs or alcohol, that are 20 provided after the sudden onset of what reasonably appears to 21 be a medical condition that manifests itself by symptoms of 22 sufficient severity, including severe pain, that the absence 23 of immediate medical attention could reasonably be expected 24 by a prudent layperson, who possesses an average knowledge of 25 health and medicine, to result in: 26 (1) placing the patient's health in serious 27 jeopardy; 28 (2) serious impairment to bodily function; or 29 (3) serious dysfunction of any bodily organ or 30 part. 31 (215 ILCS 125/7-2 new) 32 Sec. 7-2. Application for certificate. 33 (a) A utilization review agent may not conduct -21- LRB9002231JSmg 1 utilization review unless it has been granted a certificate 2 by the Director pursuant to this Article. 3 (b) The application for a certificate shall be submitted 4 to the Director on forms prescribed by the Director and 5 accompanied by supporting documentation which shall include 6 the following: 7 (1) a utilization review plan which shall include: 8 (A) the specific review standards, criteria, 9 and procedures to be used in evaluating proposed or 10 delivered health care procedures, treatments, and 11 services that have been provided, are being 12 provided, or are proposed to be provided, including 13 provision for access to such review standards, 14 criteria, and procedures by providers and recipients 15 of such proposed or delivered procedures, treatments 16 and services; 17 (B) a description of the procedure by which 18 such review standards, criteria, and procedures 19 shall be established, evaluated, and periodically 20 updated under the supervision of licensed health 21 care professionals with demonstrated experience and 22 expertise in the relevant field and shall be in 23 compliance with the operating regulations of the 24 relevant agency which licenses the health care 25 facility or program; 26 (C) those circumstances, if any, under which 27 utilization review may be delegated to a licensed 28 facility's utilization review program; 29 (D) the provisions by which an enrollee, a 30 person acting on behalf of an enrollee, or the 31 enrollee's health care provider may seek 32 reconsideration of or appeal from adverse 33 determinations by the utilization review agent, 34 including provisions to ensure a timely appeal and -22- LRB9002231JSmg 1 that enrollees, people acting on behalf of 2 enrollees, or the enrollee's health care provider 3 are informed of their right to appeal adverse 4 determinations; 5 (E) procedures by which a decision on a 6 request for utilization review for services 7 requiring preauthorization shall comply with time 8 frames as prescribed by the Director by rule; and 9 (F) A description of an emergency care policy, 10 which shall include the procedures under which an 11 emergency admission shall be made or emergency 12 treatment shall be given; 13 (2) the qualifications of the personnel either 14 employed to perform or under contract to perform the 15 utilization review, including provisions that require 16 that any adverse determinations shall be made by health 17 care professionals with demonstrated experience in the 18 health care procedure, treatment, or service under 19 review; 20 (3) provisions to ensure that appropriate personnel 21 of the utilization review agent are reasonably accessible 22 by toll-free telephone at times to be prescribed by the 23 Director by rule, but in no event less than 40 hours per 24 week during normal business hours, to discuss patient 25 care and allow response to telephone requests, to ensure 26 that such utilization review agent has a telephone system 27 capable of accepting, recording, or providing 28 instructions to incoming telephone calls during other 29 than normal business hours, and to ensure response to 30 accepted or recorded messages not less than one working 31 day after the date on which the call was received; 32 (4) the policies and procedures to ensure that all 33 applicable State and federal laws to protect the 34 confidentiality of individual medical and treatment -23- LRB9002231JSmg 1 records are followed; 2 (5) a copy of the materials designed to inform 3 applicable patients and providers of the requirements of 4 the utilization review plan, including, when requested, 5 the specific review standards, criteria, and procedures 6 used by the utilization review agent relevant to the 7 matter under review, and provisions that such materials 8 shall be made available to patients and providers by the 9 utilization review agent at a reasonable charge; 10 (6) a list of the third party payors for which the 11 utilization review agent is performing utilization review 12 in this State; and 13 (7) such other information as the Director may 14 reasonably require. 15 (c) Applications for certifications pursuant to this 16 Section and certification renewals pursuant to Section 7-3 of 17 this Article shall be accompanied by an application fee or 18 certification renewal fee. The Director shall determine such 19 fee which will reasonably cover the costs to the Department 20 of administering this Article. 21 (215 ILCS 125/7-3 new) 22 Sec. 7-3. Issuance of certificate. 23 (a) The Director shall review an application and issue a 24 certificate to an applicant that has complied with the 25 requirements of Section 7-2 of this Article and has met the 26 following criteria for utilization review agents: 27 (1) employs or will otherwise secure the services 28 of adequate personnel qualified within the relevant field 29 to determine the necessity of health care procedures, 30 treatments, and services as defined in Section 7-1 of 31 this Article; 32 (2) demonstrates the ability to render utilization 33 review decisions and appeals to review decisions in a -24- LRB9002231JSmg 1 timely manner as provided in this Section; 2 (3) agrees to provide ready access to the Director 3 to all data, records, and information it collects and 4 maintains and to provide such reports, as the Director 5 shall reasonably require, to the Director concerning its 6 utilization review activities under this Article to the 7 extent such access and reports are required to enable the 8 Director to perform his or her responsibilities pursuant 9 to this Article, provided that patient identifying 10 information shall only be disclosed in compliance with 11 applicable State or federal laws; and 12 (4) provides assurances that the utilization review 13 personnel shall not have a conflict of interest based on 14 hospital or professional affiliation in conducting 15 utilization review. 16 (b) A certificate issued under this Article is not 17 transferable. 18 (c) A certificate issued under this Article is valid for 19 a period of not more than 2 years and may be renewed for 20 additional periods of 2 years. 21 (d) A certificate may be renewed for an additional 2 22 year period if the applicant is otherwise entitled to a 23 certificate and submits to the Director a renewal 24 application, on forms prescribed by the Director, setting 25 forth the information that is required to be submitted 26 pursuant to this Article and satisfactory evidence of 27 compliance with the requirements of this Article. 28 (e) The Director may grant an individual health 29 maintenance organization licensed pursuant to this Act a 30 waiver from any requirements of Section 7-2 of this Article 31 on a finding that the health maintenance organization has 32 practices that substantially accomplish the purposes of the 33 waived requirement and that the waiver is consistent with the 34 purposes of this Article. -25- LRB9002231JSmg 1 (215 ILCS 125/7-4 new) 2 Sec. 7-4. Denial or revocation of certificate. 3 (a) The Director shall deny a certificate to any 4 applicant if: 5 (1) the utilization review plan fails to contain 6 all the information required under Section 7-2 of this 7 Article; or 8 (2) the applicant fails to meet all requirements of 9 Sections 7-2 and 7-3 of this Article. 10 (b) The Director may revoke a certificate if the holder 11 does not comply with performance assurances under this 12 Article, fails to continue to meet approval criteria 13 established pursuant to Section 7-3 of this Article, or 14 violates any provision of this Article. 15 (c) Before denying or revoking a certificate under this 16 Article, the Director shall provide the applicant or 17 certificate holder reasonable time to supply additional 18 information demonstrating compliance with this Article. 19 In denying a certificate to an applicant, the Director 20 shall provide to the applicant a notice detailing the 21 specific deficiencies identified consistent with the 22 standards set forth in this Section. 23 Within 15 days of the date of a notice of rejection or 24 revocation from the Director pursuant to this Section, an 25 applicant or certificate holder may request a hearing 26 pursuant to the Illinois Administrative Procedure Act. The 27 Director shall notify the applicant or certificate holder of 28 a date and place for a hearing to be commenced not later than 29 60 days from the date of such notification. 30 Any rejection or revocation by the Director is reviewable 31 under the Administrative Review Law. 32 (215 ILCS 125/7-5 new) 33 Sec. 7-5. Reporting requirements. The Director shall -26- LRB9002231JSmg 1 establish reporting requirements to evaluate the 2 effectiveness of utilization review agents and to determine 3 if the utilization review programs are in compliance with the 4 provisions of this Article and applicable rules. 5 (215 ILCS 125/7-6 new) 6 Sec. 7-6. Notice of adverse determinations made by 7 utilization review agents. 8 (a) A utilization review agent shall notify the 9 enrollee, or a person acting on behalf of the enrollee, and 10 the enrollee's health care provider of an adverse 11 determination made in a utilization review. 12 (b) The notification required by this Section shall be 13 consistent with rules promulgated by the Director as to time 14 and manner, but shall be transmitted within no more than 3 15 working days if the enrollee is not hospitalized and in no 16 more than one working day if the enrollee is hospitalized at 17 the time of the adverse determination. 18 (c) The notification by the utilization review agent 19 must include: 20 (1) the clinical basis for the adverse 21 determination; and 22 (2) a description of the procedure for a timely 23 appeal, including information on how to obtain the 24 specific review standards, criteria, and procedures used 25 in making the adverse determination. 26 (215 ILCS 125/7-7 new) 27 Sec. 7-7. Appeal of adverse determinations of utilization 28 review agents. 29 (a) A utilization review agent shall maintain and make 30 available a written description of the appeal procedure of an 31 adverse determination. 32 (b) The procedures for appeals shall be reasonable and -27- LRB9002231JSmg 1 timely and shall include the following: 2 (1) a provision that an enrollee, a person acting 3 on behalf of the enrollee, or the enrollee's health care 4 provider may appeal the adverse determination and shall 5 be provided, on request, a clear and concise statement of 6 the clinical basis for the adverse determination and the 7 procedures to be followed in undertaking the appeal; 8 (2) a provision that a decision on an appeal shall 9 be made in consultation with a health care provider who 10 has expertise in managing the medical condition, 11 procedure, or treatment under appeal for review of the 12 adverse determination, who is in the same licensed 13 profession as the health care provider who proposed or 14 delivered such health care procedures, treatments, or 15 services, and who has not previously reviewed the case, 16 and in the case that the provider is a physician in a 17 specialty who was acting in that specialty, the decision 18 on appeal shall be made by another physician in the same 19 or similar specialty; 20 (3) a method for an expedited appeal procedure for 21 denials of continued stays for hospitalized and 22 residential care patients; and 23 (4) written notification to the appealing party of 24 the determination of the appeal, as soon as practicable, 25 but in no case later than 14 days after receiving all the 26 required documentation of the appeal. If the appeal is 27 denied, the written notification shall include the 28 clinical basis for the appeal's denial, licensure and 29 area of expertise of the health care provider making the 30 denial, in the case of a physician making the denial the 31 specialty of the physician, and a description of the 32 procedure for initiating dispute resolution under Section 33 7-8 of this Article. -28- LRB9002231JSmg 1 (215 ILCS 125/7-8 new) 2 Sec. 7-8. Dispute resolution system. 3 (a) The Director shall establish a statewide utilization 4 review dispute resolution system composed of regional 5 organizations to resolve disputes between a utilization 6 review agent or a managed care entity and an enrollee, a 7 person acting on behalf of an enrollee, or the enrollee's 8 health care provider. The Director shall enter into 9 agreements with an independent entity or entities to 10 administer the dispute resolution system. 11 (b) The Director shall adopt uniform and necessary rules 12 for the regional organizations including, but not limited to: 13 (1) procedures and time limits to initiate dispute 14 resolution proceedings; 15 (2) procedures for notification of all parties 16 involved in the dispute upon initiation and determination 17 of a dispute resolution proceeding; 18 (3) time limits for resolving disputes; 19 (4) required documents to be submitted, including, 20 but not limited to, those required under Section 7-7 of 21 this Article; 22 (5) procedures for regular review of compliance 23 with regional organization determinations; and 24 (6) procedures to ensure maintenance of 25 confidentiality pursuant to this Act and other applicable 26 law. 27 (c) To be approved as a regional organization for 28 utilization review dispute resolution, an entity must meet 29 the following criteria: 30 (1) it shall employ or otherwise secure the 31 services of adequate personnel qualified to review such 32 disputes; 33 (2) it shall demonstrate the ability to render 34 determinations in a timely manner and independently of -29- LRB9002231JSmg 1 conflicts of interests; 2 (3) it shall provide ready access by the Director 3 to all data, records, and information it collects and 4 maintains concerning its dispute resolution activities; 5 and 6 (4) it shall agree to provide to the Director such 7 data, information, and reports as the Director determines 8 necessary to evaluate the dispute resolution process 9 provided pursuant to this Article. 10 (d) When a final determination has been made by a 11 utilization review agent pursuant to Section 7-7 of this 12 Article, the enrollee, a person acting on behalf of an 13 enrollee, or the enrollee's health care provider may appeal 14 the decision to the regional organization. 15 (e) All determinations by regional organizations for 16 utilization review dispute resolution shall be binding upon 17 the parties, subject to judicial review. 18 (215 ILCS 125/7-9 new) 19 Sec. 7-9. Required and prohibited practices. 20 (a) A utilization review agent shall have written 21 procedures for assuring that patient-specific information 22 obtained during the process of utilization review will be: 23 (1) kept confidential in accordance with applicable 24 State and federal laws; 25 (2) used solely for the purpose of utilization 26 review, quality assurance, and discharge planning and 27 catastrophic case management; and 28 (3) shared only with those who are authorized in 29 writing by the enrollee or a person acting on behalf of 30 the enrollee to receive such information or where 31 otherwise permitted or required by law. 32 (b) Summary data shall not be considered confidential if 33 it does not provide information to allow identification of -30- LRB9002231JSmg 1 individual patients. 2 (c) A utilization review agent shall not, with respect 3 to utilization review activities, permit or provide 4 compensation or anything of value to its employees or agents, 5 condition employment of its employees or agents, set its 6 employee or agent evaluations, or set its employee or agent 7 performance standards based on the value or volume of adverse 8 determinations, deductions, or limitations on lengths of 9 stay, benefits, services, or charges or on the number or 10 frequency of telephone calls or other contacts with health 11 care providers or patients. A utilization review agent shall 12 not permit or provide compensation or anything of value to 13 any health care provider in a manner that would discourage a 14 health care provider from providing appropriate patient care. 15 (d) If a health care procedure, treatment, or service 16 has been preauthorized or approved for a patient by a 17 utilization review agent, the utilization review agent shall 18 not subsequently revise or modify the specific standards 19 criteria, and procedures used for the utilization review for 20 services delivered to that patient. 21 (e) In no event shall utilization review for purposes of 22 continuing payment be requested of a patient or provider or 23 facility providing services to be undertaken more frequently 24 than is reasonably required to assess whether the health care 25 procedures, treatments, or services under review are 26 medically necessary or appropriate, considered experimental, 27 not approved or authorized for a specific level of care, or 28 otherwise denied. 29 (f) Utilization review agents shall collect only such 30 information as is necessary to make a utilization review 31 determination and shall not routinely request copies of 32 medical records of all patients in connection with reviews 33 conducted concurrently with or prior to the delivery of 34 health care procedures, treatments, and services. Record -31- LRB9002231JSmg 1 requests shall be made on a reasonable basis relating to 2 characteristics of the patient, provider, condition, or 3 health care procedure, treatment, or service. 4 (g) In no event shall information be obtained from the 5 providers of health care procedures, treatments, or services 6 for the use of the utilization review agent by persons other 7 than physicians, registered nurses, physician assistants, 8 other health care providers, medical record technologists, or 9 administrative personnel who have received appropriate formal 10 orientation and training. 11 (h) The utilization review agent shall not undertake 12 utilization review and managed care at the site of the 13 provision of health care procedure, treatment, or service 14 unless the utilization review agent: 15 (1) identifies himself or herself by name and the 16 name of his or her organization, including displaying 17 photographic identification which includes the name of 18 the employer and clearly identifies the individual as an 19 employee of the utilization review agent; 20 (2) whenever possible, schedules reviews at least 21 one business day in advance with the appropriate health 22 care provider; 23 (3) if requested by a health care provider, assures 24 that the on-site review staff register with the 25 appropriate contact person, if available, prior to 26 requesting any clinical information or assistance from 27 the health care provider; and 28 (4) obtains written consent from the enrollee, 29 person acting on behalf of the enrollee, or enrollee's 30 health care provider before interviewing the patient or 31 the patient's family or observing or participating in any 32 health care procedure, treatment, or service being 33 provided to the enrollee. 34 (i) A utilization review agent shall not base an adverse -32- LRB9002231JSmg 1 determination on a refusal to consent to observing or 2 participating in any health care procedure, treatment, or 3 service. 4 (j) A utilization review agent shall not base an adverse 5 determination on lack of reasonable access to a health care 6 provider's medical or treatment records unless the 7 utilization review agent has provided reasonable notice to 8 the health care provider and has complied with all provisions 9 of subsection (h) of this Section. 10 (k) Neither the utilization review agent nor the entity 11 for which the agent provides utilization review shall take 12 any action with respect to a patient or provider of health 13 care procedures, treatments, or services that is intended to 14 penalize such enrollee, person acting on behalf of the 15 enrollee, or the enrollee's health care provider for, or to 16 discourage such enrollee, person acting on behalf of an 17 enrollee, or the enrollee's health care provider from 18 undertaking an appeal, dispute resolution, or judicial review 19 of an adverse determination. 20 (l) A decision to approve or deny an enrollee continued 21 inpatient treatment shall be communicated to the enrollee's 22 health care provider within 24 hours after a properly 23 documented request is submitted to the utilization review 24 agent, regardless of whether that request is made before the 25 end of the previously certified treatment period. 26 (m) In no event shall an enrollee, a person acting on 27 behalf of an enrollee, an enrollee's health care provider, 28 any other health care provider, or any other person or entity 29 be required to inform or contact the utilization review agent 30 prior to the provision of emergency care, including emergency 31 treatment or emergency admission. 32 (215 ILCS 125/7-10 new) 33 Sec. 7-10. Penalties. -33- LRB9002231JSmg 1 (a) Any person or utilization review agent who shall 2 disclose, compel another person to disclose, or procure the 3 disclosure of confidential patient information in violation 4 of this Article shall be subject to a civil penalty not to 5 exceed $5,000 for each occurrence. 6 (b) Any person engaged in utilization review activity 7 under this Article who willfully violates any law or rule 8 relating to patient information with respect to patient 9 information acquired in the course of utilization review 10 shall be guilty of a Class A misdemeanor. 11 (215 ILCS 125/7-11 new) 12 Sec. 7-11. Rules. 13 (a) The Director shall promulgate such rules as are 14 necessary to implement the provisions of this Article. 15 (b) In developing the rules, the Director shall consider 16 the recommendations of health care providers, utilization 17 review agents, and payors and consumers of health care 18 services, resources, and treatments. 19 (c) The Director shall maintain and regularly update and 20 make available to providers of health care procedures, 21 treatments, and services, and to the public, upon request, a 22 list of utilization review agents that have received 23 certificates in accordance with this Article. 24 Section 99. Effective date. This Act takes effect upon 25 becoming law.