il-v50i40-50-ill-adm-code-4530: 50 Ill. Adm. Code 4530 — Health Care External Review

1) Heading of the Part: Health Care External Review 2) Code Citation: 50 Ill. Adm. Code 4530 3) Section Numbers: Proposed Actions: 4530.40 Amendment 4530.APPENDIX C Amendment 4530.APPENDIX D Amendment 4) Statutory Authority: Implementing the Health Carrier External Review Act [215 ILCS 180] and authorized by Section 50(h) of that Act and Section 401 of the Illinois Insurance Code [215 ILCS 5/401]. 5) A Complete Description of the Subjects and Issues Involved: This rulemaking is filed pursuant to Section 5-15 of the Illinois Administrative Procedure Act and is only changing the address of the Department's Springfield Office to reflect the fact that the office is moving on September 23, 2026. Section 5-15 of the Illinois Administrative Procedure Act requires agencies to include a statement of how the proposed rule made under this Section satisfies the criteria established by subsections (a) and (b). The Department’s address is used by the public to obtain information from the Department and/or make submissions or requests of the Department. These members of the public may include insurance companies, persons licensed by the Department, and Illinois insurance consumers. The address provided in the rules should be accurate, otherwise such persons may go to or send correspondence to the wrong address. The decision to relocate the Springfield office was an internal management decision. The private rights of individuals are not affected by Department rules containing the accurate address, although having the incorrect address in rule will cause unnecessary confusion and delay for people seeking information from and/or making submissions to the Department in person or via mail. It is in the public interest to have the Department's office address published in the Illinois Administrative Code be correct. 6) Published studies or reports, and sources of underlying data, used to compose this rulemaking: Not required for Section 5-15 notices. 7) Will this proposed rulemaking replace an emergency rule currently in effect? Not required for Section 5-15 notices. 8) Does this rulemaking contain an automatic repeal date? Not required for Section 5-15 notices. 9) Do these proposed amendments contain incorporations by reference? Not required for Section 5-15 notices. 10) Are there any other proposed rulemakings pending on this Part? No 11) Statement of Statewide Policy Objectives: Not required for Section 5-15 notices. 12) Time, Place, and Manner in which interested persons may comment on this proposed rulemaking: Persons who wish to comment on this proposed rulemaking may submit written comments no later than 14 days after the publication of this Notice to: Kathryn Williams Department of Insurance 115 S. LaSalle Street, 13 Floor Chicago IL, 60603 (312) 814-8212 Kathryn.A.Williams@illinois.gov 13) Initial Regulatory Flexibility Analysis: Not required for Section 5-15 notices. A) Description of the type of small business, not for profit corporations or small municipalities subject to the proposed amendment: None B) Description of the proposed reporting, bookkeeping and other procedures required for compliance with the amendments: None C) Description of the types of professional skills necessary for compliance: None 14) Small Business Economic Impact Analysis: Not required for Section 5-15 notices. 15) Regulatory Agenda on which this rulemaking was summarized: Not required for Section 5-15 notices. 16) Any other information or justification for the proposed rule or amendment that the agency believes would be helpful to the public regarding the proposed rule or DEPARTMENT OF INSURANCE NOTICE OF PROPOSED AMENDMENTS amendment. For example, a discussion or analysis of the benefits of the proposed rule or amendment is projected to have on the Illinois public, consumers, investors or other similar groups. Not required for Section 5-15 notices. The full text of the Proposed Amendments begins on the next page: DEPARTMENT OF INSURANCE NOTICE OF PROPOSED AMENDMENTS TITLE 50: INSURANCE CHAPTER I: DEPARTMENT OF INSURANCE SUBCHAPTER ww: HEALTH CARE SERVICE PLANS PART 4530 HEALTH CARRIER EXTERNAL REVIEW Section 4530.10 Purpose 4530.20 Applicability and Scope 4530.30 Definitions 4530.40 Health Carrier Obligations 4530.50 Independent Review Organization Obligations 4530.60 Registration of Independent Review Organizations 4530.70 Operational Requirements 4530.80 Examination 4530.90 Random Selection of IROs by Director 4530.APPENDIX A IRO Notice of Decision Template – Non-Experimental and Investigational 4530.APPENDIX B IRO Notice of Decision Template – Experimental and Investigational 4530.APPENDIX C Independent Review Organizations – Application for Registration 4530.APPENDIX D Independent Review Organizations – Application for Reapproving Independent Review Organizations 4530.APPENDIX E Illinois or NAIC Biographical Affidavit (Repealed) AUTHORITY: Implementing the Health Carrier External Review Act [215 ILCS 180] and authorized by Section 50(h) of that Act and Section 401 of the Illinois Insurance Code [215 ILCS 5/401]. SOURCE: Adopted at 34 Ill. Reg. 10741, effective July 19, 2010; amended at 39 Ill. Reg. 4077, effective September 1, 2015; amended at 39 Ill. Reg. 12577, effective September 1, 2015; recodified from 50 Ill. Adm. Code 5430 to 50 Ill. Adm. Code 4530 at 41 Ill. Reg. 4990; amended at 42 Ill. Reg. 20426, effective November 1, 2018; amended at 43 Ill. Reg. 11502, effective September 24, 2019; amended at 50 Ill. Reg. ______, effective ____________. Section 4530.40 Health Carrier Obligations DEPARTMENT OF INSURANCE NOTICE OF PROPOSED AMENDMENTS a) Each health carrier shall maintain written records in the aggregate, by state, and for each type of health benefit plan offered by the health carrier on all requests for external review for which the health carrier received notice from the Director for each calendar year. The health carrier shall submit, electronically, a report to the Director, in the format specified by the Director, by June 1 of each year. b) A health carrier must file with the Director for approval sample copies of: 1) All notices and forms that carriers must provide to covered persons under Sections 20, 25, 35, 40 and 42 of the Act. In addition to those statutory requirements, the following information must be included on notices sent to members in response to member appeals: A) All notices and forms must prominently display the name, address, toll-free phone number, fax number and appeal email address of the carrier or administrator that handles appeals; B) All notices and forms shall be specific and limited to information regarding appeals and external review procedures for the member's plan; C) All notices shall state the number of levels of appeals available (no more than two levels for group and one level for individual) under the plan and will state which level of appeal is applicable to the adverse determination within the notice; D) All notices shall include the date, including month, day and year, of the adverse determination and, if applicable, the date of the final adverse determination, including month, day and year; E) All notices shall inform covered persons that the deadlines for filing an appeal or external review request are not postponed or delayed by health care provider appeals unless the health care provider is acting as an authorized representative for the covered person; i.e., the covered person should be filing internal appeals independently and concurrently unless the health care provider has been designated in writing as the authorized representative; DEPARTMENT OF INSURANCE NOTICE OF PROPOSED AMENDMENTS F) All notices shall indicate whether the adverse determination relates to a member appeal (filed by the member or authorized representative who may be the health care provider) or a provider appeal (pursuant to the provider contract) and shall explain timeframes from the date of the adverse determination for the member to appeal and to file an external review regardless of the status of a provider appeal; G) Upon exhaustion of provider appeals, the notice (which is copied to the member) shall specify timeframes from the date of the final adverse determination for the member to file an appeal or file an external review; H) Upon exhaustion of internal appeals by the member, the final adverse determination notice shall clearly state that it is the final adverse determination, that all internal appeals have been exhausted, and that the member has 4 months from the date of the letter to file an external review; I) All notices shall include the following contact information for the Department of Insurance: Illinois Departments of Insurance Office of Consumer Health Insurance External Review Unit 4800 Wabash Ave.320 W. Washington Street Springfield IL 6271162767 Toll-free Telephone: (877) 850-4740 Fax: (217) 557-8495 Email: doi.externalreview@illinois.gov Website: https://mc.insurance.illinois.gov/messagecenter.nsf 2) Descriptions for both the required standard external review and expedited external review procedures as set forth within Section 20 of the Act. 3) Statements informing the covered person and any authorized representative that a standard external review request deemed to be ineligible for review by the plan or its representative may be appealed to the Director by filing a complaint with the Director. The health carrier DEPARTMENT OF INSURANCE NOTICE OF PROPOSED AMENDMENTS shall use the following address and provide the following contact information when directing the covered person or authorized representative to appeal initial determinations of ineligibility for standard external review: The Illinois Department of Insurance Office of Consumer Health Insurance External Review Unit 4800 Wabash Ave.320 West Washington Street Springfield IL 6271162767 Toll-free Telephone: (877) 527-9431 Fax: (217) 557-8495 Email: doi.externalreview@illinois.gov Website: https://mc.insurance.illinois.gov/messagecenter.nsf 4) Statements informing the covered person and any authorized representative that an expedited external review request deemed to be ineligible for review by the plan or its representative may be appealed to the Director by filing a complaint with the Director. The health carrier shall use the following address when directing the covered person or authorized representative to appeal initial determinations of ineligibility for expedited external review: The Illinois Department of Insurance Office of Consumer Health Insurance External Review Unit 4800 Wabash Ave.320 West Washington Street Springfield IL 6271162767 Toll-free Telephone: (877) 850-4740 Fax: (217) 557-8495 Email: doi.externalreview@illinois.gov Website: https://mc.insurance.illinois.gov/messagecenter.nsf 5) Special Rules for Multi-State Plans Under the Marketplace Pursuant to the U.S. Office of Personnel Management's (OPM) Multi-State Plan Program regulation at 45 CFR 800.5023, OPM administers the External Review Process for disputed adverse benefit determinations submitted by enrollees in Multi-State Plan health insurance options. DEPARTMENT OF INSURANCE NOTICE OF PROPOSED AMENDMENTS (Source: Amended at 50 Ill. Reg. ______, effective ____________) Section 4530.APPENDIX C Independent Review Organizations – Application for Registration INDEPENDENT REVIEW ORGANIZATION Registration Form [Today's Date] 1. Name of Independent Review Organization DBA Type of Applicant (check one): Corporation Partnership Limited Liability Other (Describe) FEIN: Contact Person: Business Telephone Number: ( ) Fax Number: ( ) Email Address: 2. Business Address: Street (Do Not Use P.O. Box): City: State: Zip: Telephone Number: ( ) Website: 3. Mailing Address (If Different from Business Address): Street (Do Not Use P.O. Box): City: State: Zip: 4. Contact Information To Be Used on the Department's Website of Approved Independent Review Organizations: Contact Person: Business Telephone Number: ( ) Fax Number: ( ) Street (Do Not Use P.O. Box): City: State: Zip: 5. Agent for Service of Process in Illinois Department of Insurance: Name: Street (Do Not Use P.O. Box): City: State: Zip: 6. For Each Independent Review Program supply the following information: a. The name, address, telephone number and hours of operation for the independent review program. b. The organization and governing structure of the independent review program. c. The number of reviews in Illinois for which an independent review is conducted by each independent review program for the current year. d. Number of reviews in Illinois for which an independent review was conducted for the previous calendar year for each independent review program. e. A copy of your most recent certificate from American Accreditation Healthcare Commission (URAC) Standards for Independent Review Organizations, if applicable. f. Written policies and procedures for protection of confidential information according to applicable State and federal laws for each independent review program. g. Biographical information for organization officers and directors. The biographical affidavits shall include, but not be limited to, the following information: identifying information; affiant's identifying and contact information; affiant's educational, residential and employment history; affiant's professional, business and technical licenses and memberships; a complete history of affiant's fidelity bonding; criminal charges and convictions; civil, regulatory, administrative and disciplinary actions in an individual or corporate capacity; a complete history of affiant's bankruptcy, insolvency, liens and foreclosures in an individual or corporate capacity; affiant's consent to release background reports to the Department and consent for third parties to cooperate in the gathering of background information; and affiant's and his or her immediate family's equity holdings in any entity subject to insurance regulation. The Department will accept the biographical affidavit, and any supplement to that affidavit, that is obtained DEPARTMENT OF INSURANCE NOTICE OF PROPOSED AMENDMENTS from the website of the NAIC or the Department. Biographical affidavits shall be stamped "confidential" by the independent review organization. h. A list of all contracted reviewers, the physician's license number of each reviewer and his or her contact information and area of clinical expertise. i. All information required in 7 below. 7. Minimum Qualifications for Independent Review Organizations: a. To be approved to conduct external reviews, an independent review organization shall have and maintain written policies and procedures that govern all aspects of both the standard external review process and the expedited external review process set forth in the Act that include, at a minimum: i. A quality assurance mechanism that ensures that: A. External reviews are conducted within the specified timeframes and required notices are provided in a timely manner; B. Selection of qualified and impartial clinical reviewers to conduct external reviews on behalf of the IRO and suitable matching of reviewers to specific cases and that the independent review organization employs or contracts with an adequate number of clinical reviewers to meet this objective; C. For adverse determinations involving experimental or investigational treatments, in assigning clinical reviewers, the independent review organization selects physicians or other health care professionals who, through clinical experience in the past 3 years, are experts in the treatment of the covered person's condition and knowledgeable about the recommended or requested health care service or treatment; D. The health carrier, the covered person, and the covered person's authorized representative shall not choose or control the choice of the physicians or other health care professionals to be selected to conduct the external review; DEPARTMENT OF INSURANCE NOTICE OF PROPOSED AMENDMENTS E. Confidentiality of medical and treatment records and clinical review criteria; F. Any person employed by or under contract with the independent review organization adheres to the requirements of the Act; ii. A toll-free telephone service and email address operating on a 24 hours/day, 7 days/week basis that accepts, receives, and records information related to external reviews and provides appropriate instructions; iii. Name, phone number and direct email address of contact persons who will be responsible for handling assignments of external reviews; and iv. An agreement to maintain and provide to the Director the information set out in Section 65 of the Act. b. All clinical reviewers assigned by an independent review organization to conduct external reviews shall be physicians or other appropriate health care providers who meet the following minimum qualifications: i. Be an expert in the treatment of the covered person's medical condition that is the subject of the external review; ii. Be knowledgeable about the recommended health care service or treatment through recent or current actual clinical experience treating patients with the same or similar medical condition as the covered person; iii. Hold a non-restricted license in a state of the United States and, for physicians, a current certification by a recognized American medical specialty board in the area or areas appropriate to the subject of the external review; and iv. Have no history of disciplinary actions or sanctions, including loss of staff privileges or participation restrictions, that have been taken or are pending by any hospital, governmental agency or unit, or regulatory body that raise a substantial question as to the clinical reviewer's physical, mental, or professional competence or moral character. DEPARTMENT OF INSURANCE NOTICE OF PROPOSED AMENDMENTS c. In addition to the requirements set forth in subsection (a), an independent review organization may not own or control, be a subsidiary of, or in any way be owned or controlled by, or exercise control with, a health benefit plan, a national, State, or local trade association of health benefit plans, or a national, State, or local trade association of health care providers. d. Conflicts of interest are prohibited. In addition to the requirements set forth in 7a, 7b and 7c of this Section, to be approved pursuant to the Act to conduct an external review of a specified case, neither the independent review organization selected to conduct the external review nor any clinical reviewer assigned by the IRO to conduct the external review may have a material professional, familial or financial conflict of interest with any of the following: i. The health carrier that is the subject of the external review; ii. The covered person whose treatment is the subject of the external review or the covered person's authorized representative; iii. Any officer, director or management employee of the health carrier that is the subject of the external review; iv. The health care provider, the health care provider's medical group or independent practice association recommending the health care service or treatment that is the subject of the external review; v. The facility at which the recommended health care service or treatment would be provided; or vi. The developer or manufacturer of the principal drug, device, procedure, or other therapy being recommended for the covered person whose treatment is the subject of the external review. e. An independent review organization shall be unbiased. An IRO shall establish and maintain written procedures to ensure that it is unbiased in addition to any other procedures required under this Section. f. Nothing in this Section precludes or shall be interpreted to preclude a health carrier from contracting with approved independent review organizations to conduct external reviews assigned to it from the health carrier. DEPARTMENT OF INSURANCE NOTICE OF PROPOSED AMENDMENTS g. An independent review organization that meets or exceeds the accreditation standards for Independent Review Organizations set forth by the American Accreditation Healthcare Commission (URAC) and otherwise meets the qualifications of this Section shall be presumed to be in compliance with this Section and shall be eligible for approval. 8. Check Enclosed (Please make checks payable to Director of Insurance) a. Accredited entity fee of $1000 biennially. b. Unaccredited entity fee of $1500 biennially in the event that the Director determines that there are no acceptable nationally recognized private accrediting entities providing independent review organization accreditation. 9. Affirmation (to be signed by an officer or director of the independent review organization only): I, do hereby certify that (Typed name, title) (Independent Review Organization) complies with the Independent Review Organization Standards of the American Accreditation Healthcare Commission (URAC) and has submitted evidence of accreditation by URAC for Independent Review, and that the persons responsible for the conduct of (Independent Review Organization) are competent, trustworthy, and possess good reputations, and have appropriate experience, training or education and do hereby affirm that all of the information presented in this application is true and correct. (Signature) (Date) Please mail completed application to: Illinois Department of Insurance Utilization Review Unit 4800 Wabash Ave.320 West Washington Street Springfield IL 6271162767-0001 (217) 558-2309 (Source: Amended at 50 Ill. Reg. ______, effective ____________) Section 4530.APPENDIX D Independent Review Organizations – Application for Reapproving Independent Review Organizations INDEPENDENT REVIEW ORGANIZATION Renewal Registration Form [Today's Date] Company Name: FEIN: Contact Person: Telephone: ( ) Email Address: Street Address: City, State, Zip: Renewal registration for Independent Review Organization covering period __/__/__ through __/__/__. Instructions for completing renewal registration: 1. Please verify all information regarding company name, contact person and address to be complete and accurate; 2. Submit a current copy of the applicable accreditation certificate from the American Accreditation Healthcare Commission (URAC) if applicable; 3. Submit any material changes to the information filed under your prior registration: a. Verify toll-free telephone service and email address operating on a 24 hours/day, 7 days/week basis that accepts, receives and records DEPARTMENT OF INSURANCE NOTICE OF PROPOSED AMENDMENTS information related to external reviews and provides appropriate instructions; b. Verify name, phone number and direct email address of contact persons who will be responsible for handling assignments of external reviews; 4. Submit a check for renewal registration: $1000 if your company is accredited by URAC. In the event that the Director determines that there are no acceptable nationally recognized private accrediting entities providing independent review organization accreditation, a renewal fee of $1500; and 5. Affirmation (to be signed by an officer or director of the independent review organization only): I, do hereby certify that (Typed name, title) (Independent Review Organization) complies with the Independent Review Organization Accreditation Standards of the American Accreditation Healthcare Commission (URAC) and has submitted evidence of accreditation by URAC for Independent Review, and that the persons responsible for the conduct of (Independent Review Organization) are competent, trustworthy, and possess good reputations, and have appropriate experience, training or education and do hereby affirm that all of the information presented in this application is true and correct. (Signature) (Date) Please mail completed renewal application to: Illinois Department of Insurance Utilization Review Unit 4800 Wabash Ave.320 West Washington Street Springfield IL 6271162767-0001 (217) 558-2309 DEPARTMENT OF INSURANCE NOTICE OF PROPOSED AMENDMENTS (Source: Amended at 50 Ill. Reg. ______, effective ____________) CHIEF PROCUREMENT OFFICER FOR PUBLIC INSTITUTIONS OF HIGHER EDUCATION NOTICE OF ADOPTED AMENDMENTS