Section 4530.10  Purpose

 

This Part will implement the Health Carrier External Review Act [215 ILCS 180] in order to assure uniform standards for the establishment and maintenance of external review procedures, to assure that covered persons have the opportunity for an independent review of an adverse determination or final adverse determination and provide appropriate registration standards and oversight of health care plans by the Department of Insurance for the review of adverse and final adverse determinations.

 

Section 4530.20  Applicability and Scope

 

a)         Except as provided in subsection (b), the requirements of this Part are applicable to all health carriers.

 

b)         The provisions of this Part shall not apply to:

 

1)         A policy or certificate that provides coverage only for a specified disease, specified accident or accident-only coverage, credit, dental, disability income, hospital indemnity, long-term care insurance as defined by Article XIXA of the Illinois Insurance Code, vision care, or any other limited supplemental benefit;

 

2)         A Medicare supplement policy of insurance as defined by the Director in 50 Ill. Adm. Code 2008.40;

 

3)         Coverage under a plan through Medicare, Medicaid, or the federal employees health benefits program;

 

4)         Any coverage issued under 10 USC 55 and any coverage issued as supplement to that coverage;

 

5)         Any coverage issued as supplemental to liability insurance, workers' compensation, or similar insurance; or

 

6)         Automobile medical-payment insurance or any insurance under which benefits are payable with or without regard to fault, whether written on a group blanket or individual basis.

 

Section 4530.30  Definitions

 

"Act" means the Health Carrier External Review Act [215 ILCS 180].

 

"Adverse Determination" means:

 

A determination by a health carrier or its designee utilization review organization that, based upon the information provided, a request for a benefit under the health carrier's health benefit plan, upon application of any utilization review technique, does not meet the health carrier's requirements for medical necessity, appropriateness, health care setting, level of care, or effectiveness or is determined to be experimental or investigational, and the requested benefit is therefore denied, reduced or terminated, or payment is not provided or made, in whole or part, for the benefit;

 

The denial, reduction or termination of, or failure to provide or make payment, in whole or in part, for, a benefit based on a determination by a health carrier or its designee utilization review organization that a preexisting condition was present before the effective date of coverage; or

 

A rescission of coverage determination, which does not include a cancellation or discontinuance of coverage that is attributable to a failure to timely pay required premiums or contributions towards the cost of coverage.

 

"Authorized Representative" means:

 

A person to whom a covered person has given express written consent to represent the covered person for purposes of the Act;

 

A person authorized by law to provide substituted consent for a covered person;

 

A family member of the covered person or the covered person's treating health care professional when the covered person is unable to provide consent;

 

A health care provider when the covered person's health benefit plan requires that a request for a benefit under the plan be initiated by the health care provider; or

 

In the case of an urgent care request, a health care provider with knowledge of the covered person's medical condition.

 

"Best Evidence" means evidence based on:

 

Randomized clinical trials;

 

If randomized clinical trials are not available, then cohort studies or case-control studies;

 

If the prior two items are not available, then case-series; or

 

If the prior three items are not available, then expert opinion.

 

"Case-control Study" means a retrospective evaluation of two groups of patients with different outcomes to determine which specific interventions the patients received.

 

"Case-series" means an evaluation of a series of patients with a particular outcome, without the use of a control group.

 

"Clinical Review Criteria" means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

 

"Cohort Study" means a prospective evaluation of 2 groups of patients with only one group of patients receiving specific intervention.

 

"Code" means the Illinois Insurance Code [215 ILCS 5].

 

"Concurrent Review" means a review conducted during a patient's stay or course of treatment in a facility, the office of a health care professional, or other inpatient or outpatient health care setting.

 

"Covered Benefits" or "Benefits" means those health care services to which a covered person is entitled under the terms of a health benefit plan.

 

"Covered Person" means a policyholder, subscriber, enrollee, or other individual participating in a health benefit plan.

 

"Director" means the Director of the Illinois Department of Insurance.

 

"Emergency Medical Condition" means a medical condition manifesting itself by acute symptoms of sufficient severity, including, but not limited to, severe pain, such that a prudent layperson who possesses an average knowledge of health and medicine could reasonably expect the absence of immediate medical attention to result in:

 

placing the health of the individual or, with respect to a pregnant woman, the health of the woman or her unborn child, in serious jeopardy;

 

serious impairment to bodily functions; or

 

serious dysfunction of any bodily organ or part.

 

"Evidence-based Standard" means the conscientious, explicit and judicious use of the current best evidence based on an overall systematic review of the research in making decisions about the care of individual patients.

 

"Expert Opinion" means a belief or an interpretation by specialists with experience in a specific area about the scientific evidence pertaining to a particular service, intervention, or therapy.

 

"Facility" means an institution providing health care services or a health care setting.

 

"Final Adverse Determination" means an adverse determination involving a covered benefit that has been upheld by a health carrier, or its designee utilization review organization, at the completion of the health carrier's internal grievance process procedures as set forth by the Managed Care Reform and Patient Rights Act [215 ILCS 134].

 

"Health Benefit Plan" means a policy, contract, certificate, plan, or agreement offered or issued by a health carrier to provide, deliver, arrange for, pay for, or reimburse any of the costs of health care services.

 

"Health Care Provider" or "Provider" means a physician, hospital facility, or other health care practitioner licensed, accredited, or certified to perform specified health care services consistent with State law, responsible for recommending health care services on behalf of a covered person.

 

"Health Care Services" means services for the diagnosis, prevention, treatment, cure, or relief of a health condition, illness, injury, or disease.

 

"Health Carrier" means an entity subject to the insurance laws and regulations of this State, or subject to the jurisdiction of the Director, that contracts or offers to contract to provide, deliver, arrange for, pay for, or reimburse any of the costs of health care services, including a sickness and accident insurance company, a health maintenance organization, or any other entity providing a plan of health insurance, health benefits, or health care services. "Health carrier" also means Limited Health Service Organizations (LHSO) and Voluntary Health Service Plans.

 

"Health Information" means information or data, whether oral or recorded in any form or medium, and personal facts or information about events or relationships that relate to:

 

The past, present, or future physical, mental, or behavioral health or condition of an individual or a member of the individual's family;

 

The provision of health care services to an individual; or

 

Payment for the provision of health care services to an individual.

 

"Independent Review Organization" or "IRO" means an entity that conducts independent external reviews of adverse determinations and final adverse determinations.

 

"Medical Necessity" means health care services and supplies provided by a health care provider, appropriate to the evaluation and treatment of a disease, condition, illness or injury and consistent with the applicable standard of care, including the evaluation of experimental and/or investigational services, procedures, drugs or devices.

 

"Medical or Scientific Evidence" means evidence found in the following sources:

 

Peer-reviewed scientific studies published in or accepted for publication by medical journals that meet nationally recognized requirements for scientific manuscripts and that submit most of their published articles for review by experts who are not part of the editorial staff;

 

Peer-reviewed medical literature, including literature relating to therapies reviewed and approved by a qualified institutional review board, biomedical compendia, and other medical literature that meets the criteria of the National Institutes of Health's Library of Medicine for indexing in Index Medicus (Medline) and Elsevier Science Ltd. for indexing in Excerpta Medicus (EMBASE);

 

Medical journals recognized by the Secretary of Health and Human Services under section 1861(t)(2) of the federal Social Security Act (42 USC 1861(t)(2));

 

The following standard reference compendia:

 

The American Hospital Formulary Service Drug Information;

 

Drug Facts and Comparisons;

 

The American Dental Association Accepted Dental Therapeutics; and

 

The United States Pharmacopoeia Drug Information;

 

Findings, studies, or research conducted by or under the auspices of federal government agencies and nationally recognized federal research institutes, including:

 

The federal Agency for Healthcare Research and Quality;

 

The National Institutes of Health;

 

The National Cancer Institute;

 

The National Academy of Sciences;

 

The Centers for Medicare & Medicaid Services;

 

The federal Food and Drug Administration; and

 

Any national board recognized by the National Institutes of Health for the purpose of evaluating the medical value of health care services; or

 

Any other medical or scientific evidence that is comparable to the sources listed in this definition.

 

Medical necessity determinations for substance use disorders shall be made in accordance with appropriate patient placement criteria established by the American Society of Addiction Medicine [215 ILCS 5/370c(b)(3)].

 

"Member" means a covered person as defined by this Part.

 

"Person" means an individual, a corporation, a partnership, an association, a joint venture, a joint stock company, a trust, an unincorporated organization, any similar entity, or any combination of the foregoing.

 

"Prospective Review" means a review conducted prior to an admission or the provision of a health care service or a course of treatment in accordance with a health carrier's requirement that the health care service or course of treatment, in whole or in part, be approved prior to its provision.

 

"Protected Health Information" means health information that identifies an individual who is the subject of the information, or with respect to which there is a reasonable basis to believe that the information could be used to identify an individual.

 

"Randomized Clinical Trial" means a controlled, prospective study of patients that have been randomized into an experimental group and a control group at the beginning of the study with only the experimental group of patients receiving a specific intervention, which includes study of the groups for variables and anticipated outcomes over time.

 

"Retrospective Review" means any review of a request for a benefit that is not a concurrent or prospective review request. "Retrospective Review" does not include the review of a claim that is limited to veracity of documentation or accuracy of coding.

 

"Utilization Review" means the evaluation of the medical necessity, appropriateness, and efficiency of the use of health care services, procedures, and facilities.

 

"Utilization Review Organization" means a utilization review program as defined in the Managed Care Reform and Patient Rights Act.

 

(Source:  Amended at 39 Ill. Reg. 4077, effective September 1, 2015)

 

Section 4530.40  Health Carrier Obligations 

 

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;

 

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

320 W. Washington Street

Springfield IL 62767

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 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

320 West Washington Street

Springfield IL  62767

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

320 West Washington Street

Springfield IL  62767

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. 

 

(Source:  Amended at 42 Ill. Reg. 20426, effective November 1, 2018)

 

Section 4530.50  Independent Review Organization Obligations 

 

a)         An independent review organization may not conduct external independent reviews of adverse determinations for persons subject to Section 15 of the Act unless the independent review organization has first registered with the Director. An application for registration shall be in the format set forth in Appendix C.

 

b)         An independent review organization must secure and maintain a current certificate of accreditation by the American Accreditation Healthcare Commission (URAC) under applicable standards for Independent Review Organizations.

 

c)         Each independent review organization shall provide a written notice as set forth in Appendix A and Appendix B, explaining its decision to uphold or reverse adverse or final adverse determinations to the health carrier, the covered person, and, if applicable, the covered person's authorized representative.

 

d)         Each independent review organization shall maintain written records in the aggregate, by state, and by health carrier on all requests for external review for which it conducted an external review during a calendar year and submit, electronically, a report in the format specified by the Director by March 1 of each year. The independent review organization shall retain the written records required under the Act for at least three years.

 

(Source:  Amended at 39 Ill. Reg. 12577, effective September 1, 2015)

 

Section 4530.60  Registration of Independent Review Organizations

 

a)         On or after July 1, 2010, an independent review organization may not conduct external reviews for persons subject to Section 15 of the Act unless the independent review organization has registered with the Director. An application for registration shall be in the format set forth in Appendix C and must be signed by an officer or director of the independent review organization. Initial registration applications shall be deemed approved unless the Director finds an application to be noncompliant with either the standards set forth in Section 55 of the Act or this Part.

 

b)         An independent review organization must register with the Director every 2 years. A fee of $1,000 must be submitted with each application or renewal. If the Director determines that there are no acceptable nationally recognized private accrediting entities providing independent review organization accreditation, he or she may then approve independent review organizations that are not accredited by a nationally recognized private accrediting entity, in which case the fee for each application or renewal shall be $1,500.

 

c)         Any material changes in the information filed pursuant to this Part shall be filed with the Director within 30 days after the change. Loss of accreditation status will require re-registration and payment of the appropriate fee pursuant to subsection (b).

 

d)         Renewals and Appeals

 

1)         A registered independent review organization may continue to operate, if a renewal application as specified in Appendix D and fee have been filed 30 days prior to the renewal date, until the renewal is denied or issued by the Director.

 

2)         If the renewal application and fee are not received prior to the renewal date, the registration will automatically expire and the independent review organization must re-register and pay a fee pursuant to subsection (b).

 

3)         If an application for registration or renewal is denied under this Part, the applicant may appeal the denial by requesting a hearing under the terms of Article 10 of the Illinois Administrative Procedure Act [5 ILCS 100/Art. 10] and 50 Ill. Adm. Code 2402. A petition for hearing must be postmarked no later than 30 days from the date of initial denial. A hearing shall be scheduled within 45 days after the petition is filed with the Director. A decision by the Director shall be rendered within 60 days after the close of the hearing.

 

Section 4530.70  Operational Requirements

 

An independent review organization shall secure and maintain a current certificate of accreditation by the American Accreditation Healthcare Commission (URAC) under applicable standards for Independent Review Organizations except when the Director determines that there are no acceptable nationally recognized private accrediting entities providing independent review organization accreditation. Independent review decisions shall be issued pursuant to the Act.

 

Section 4530.80  Examination

 

a)         The Director or his or her designee may examine any applicant for registration or any registrant upon receipt of information that the applicant or registrant may be in violation of this Part, or any applicable provision of the Code, when he or she receives a complaint or when the applicant has a history of violations of the Code.

 

b)         Any independent review organization being examined shall provide to the Director or his or her designee convenient and free access, during reasonable hours at the organization's offices, to all books, records, documents and other papers relating to the independent review organization's business affairs.  The Director or designee shall not have access to beneficiary medical records protected under Sections 8-2101 through 8-2105 of the Code of Civil Procedure titled "Medical Studies" [735 ILCS 5/8-2101 through 8-2105].

 

c)         The Director or designee may administer oaths and thereafter examine any individual about the business of the independent review organization.

 

d)         The expenses of examination under this Section shall be assessed against the independent review organization being examined in accordance with Section 408(3) of the Code.

 

e)         The examiner designated by the Director shall make a written report if he or she alleges a violation of this Part, any applicable provisions of the Code or any other applicable Part of Title 50 of the Illinois Administrative Code.  The report shall be verified by the examiner. The report must be made to the Director within 45 days after the conclusion of the examination.

 

f)         The Director shall deliver a duplicate of the report to the independent review organization being examined using the address specified in the Department's records.  In that event, the IRO may request a hearing before the Director or designee within 30 days after receipt of the duplicate examination report.  The request shall be in writing and include the IRO's objections to the report.  The hearing shall be conducted in accordance with Sections 402 and 403 of the Code and 50 Ill. Adm. Code 2402.  The IRO's right to hearing is waived if the delivery of the report is refused, or the IRO does not timely request a hearing.  After hearing, or upon expiration of the time period during which an IRO may request a hearing and the IRO has not done so, the Director, upon finding noncompliance with the laws of this State or previous Order of the Director, may require the IRO to take corrective action. Any such Order shall be issued within 90 days after the report is filed, or, if there is a hearing, within 90 days after the conclusion of the hearing.  The Order shall be a final administrative decision of the Department subject to review under the Administrative Review Law [735 ILCS 5/Art. III].

 

Section 4530.90  Random Selection of IROs by Director

 

The assignment by the Director of an approved independent review organization to conduct an external review in accordance with the Act shall be done on a random basis among those independent review organizations approved by the Director.  Random selection shall be done on a computerized rotation basis; notwithstanding special circumstances in which an expedited review is requested and location of the independent review organization (time zones) may be taken into account to facilitate the review process.

 

(Source:  Added at 39 Ill. Reg. 4077, effective September 1, 2015)

 

Section 4530.APPENDIX A   IRO Notice of Decision Template – Non-Experimental and Investigational

 

 

 

[Independent Review Organization Letterhead]

 

 

 

Notice of Independent Review Decision

 

 

 

 

[Date of the Notice of the Decision]

 

 

Re:       IRO Case #:

[Name of Patient] 

 

 

[Name of IRO] has been certified, by the Illinois Department of Insurance (DOI) as an Independent Review Organization (IRO). The Illinois Department of Insurance has assigned this case to us for independent review in accordance with the Illinois Insurance Code and applicable regulations.

 

The IRO has performed an independent review of the proposed/rendered care to determine if the adverse determination was appropriate.  In the performance of the review, the IRO reviewed the medical records and documentation provided to the IRO by involved parties. 

IRO NOTICE OF DECISION TEMPLATE

 

This case was reviewed by a [Specialty of Reviewing Physician or Health Care Provider].  The reviewer has made a good faith effort to check for the existence of any potential conflicts of interest and has signed a certification stating that no known conflicts of interest exist between the reviewer and the patient, the patient's insurance carrier, the utilization review agent (URA), any of the treating physicians or health care providers who provided care to the patient, or the URA or insurance carrier health care providers who reviewed the case for a decision regarding medical necessity before referral to the IRO.  In addition, the reviewer has certified that the review was performed without bias for or against any party to the dispute.

 

As an officer of [Name of IRO] I certify that:

 

1.         there is no known conflict between the reviewer, the IRO and/or any officer/employee of the IRO with any person or entity that is a party to the dispute, and

 

2.         a copy of this IRO decision was sent to the covered person and, if applicable, his or her authorized representative on [Date].

 

 

Sincerely,

 

 

[Name of IRO Representative]

[Title]

IRO REVIEWER REPORT TEMPLATE

GENERAL

 

Date that the IRO Received the Assignment:  

 

Date of Review: 

 

Date of IRO's Decision: 

 

Time Period for which the Review Was Conducted: 

 

IRO Case #: 

 

A General Description of the Reason for the Request for External Review:

 

A Description of the Qualifications for Each Physician or Other Health Care Provider Who Reviewed the Decision:

 

Review Outcome:

 

Upon independent review the reviewer finds that the previous adverse determination/adverse determinations should be:

 

 Upheld                               (Agree)

 

 Overturned                        (Disagree)

 

 Partially Overturned          (Agree in part/Disagree in part)

 

Provide a description of the review outcome that clearly states whether or not medical necessity exists for each of the health care services in dispute.

 

Information Provided to the IRO for Review:

 

 

Description of the Covered Person's History (Summary):

 

 

Principal Reason or Reasons for its Decision, Including Clinical Basis, Findings and Conclusions Used to Support the Decision:

 

 

Rationale for Decision:

 

 

A Description and the Source of the Screening Criteria or Other Clinical Basis Used to Make the Decision:

 

        Peer-reviewed scientific studies published in or accepted for publication by medical journals that meet nationally recognized requirements for scientific manuscripts and that submit most of their published articles for review by experts who are not part of the editorial staff;

 

        Peer-reviewed medical literature, including literature relating to therapies reviewed and approved by a qualified institutional review board, biomedical compendia, and other medical literature that meets the criteria of the National Institutes of Health's Library of Medicine for indexing in Index Medicus (Medline) and Elsevier Science Ltd. for indexing in Excerpta Medicus (EMBASE);

 

        Medical journals recognized by the Secretary of Health and Human Services under section 1861(t)(2) of the federal Social Security Act;

 

        The following standard reference compendia: 

 

a.         The American Hospital Formulary Service Drug Information;

b.         Drug Facts and Comparisons;

c.         The American Dental Association Accepted Dental Therapeutics; and

d.         The United States Pharmacopoeia Drug Information;

 

        Findings, studies, or research conducted by or under the auspices of federal government agencies and nationally recognized federal research institutes, including:

 

a.         The federal Agency for Healthcare Research and Quality;

b.         The National Institutes of Health;

c.         The National Cancer Institute;

d.         The National Academy of Sciences;

e.         The Centers for Medicare & Medicaid Services;

f.          The federal Food and Drug Administration; and

g.         Any national board recognized by the National Institutes of Health for the purpose of evaluating the medical value of health care services; or

 

        Any other medical or scientific evidence that is comparable to the sources listed above (Provide a Description).

 

Medical necessity determinations for substance use disorders shall be made in accordance with appropriate patient placement criteria established by the American Society of Addiction Medicine pursuant to Section 370(b)(3) of the Illinois Insurance Code [215 ILCS 5].

 

(Source:  Amended at 39 Ill. Reg. 4077, effective September 1, 2015)

 

Section 4530.APPENDIX B   IRO Notice of Decision Template – Experimental and Investigational

 

 

[Independent Review Organization Letterhead]

 

 

Notice of Independent Review Decision

 

 

[Date of the Notice of the Decision]

 

 

RE:      IRO Case #:

[Name of Patient] 

 

 

[Name of IRO] has been certified, by the Illinois Department of Insurance (DOI) as an Independent Review Organization (IRO).  Illinois Department of Insurance has assigned this case to us for independent review in accordance with the Illinois Insurance Code and applicable regulations.

 

The IRO has performed an independent review of the proposed/rendered care to determine if the adverse determination was appropriate.  In the performance of the review, the IRO reviewed the medical records and documentation provided to the IRO by involved parties. 

IRO NOTICE OF DECISION TEMPLATE

 

This case was reviewed by a [Specialty of Reviewing Physician or Health Care Provider].  The reviewer has made a good faith effort to check for the existence of any potential conflicts of interest and has signed a certification stating that no known conflicts of interest exist between the reviewer and the patient, the patient's insurance carrier, the utilization review agent (URA), any of the treating physicians or health care providers who provided care to the patient, or the URA or insurance carrier health care providers who reviewed the case for a decision regarding medical necessity before referral to the IRO.  In addition, the reviewer has certified that the review was performed without bias for or against any party to the dispute.

 

As an officer of [Name of IRO] I certify that:

 

1.         there is no known conflict between the reviewer, the IRO and/or any officer/employee of the IRO with any person or entity that is a party to the dispute, and

 

2.         a copy of this IRO decision was sent to all of the parties via U.S. Postal Service or otherwise transmitted in the manner indicated above on [Date].

 

 

Sincerely,

 

 

[Name of IRO Representative]

[Title]

IRO REVIEWER REPORT TEMPLATE

EXPERIMENTAL OR INVESTIGATIONAL

 

Date that the IRO Received the Assignment:  

 

Date of Review: 

 

Date of IRO's Decision: 

 

Time Period for which the Review Was Conducted: 

 

IRO Case #: 

 

A General Description of the Reason for the Request for External Review:

 

 

A Description of the Qualifications for Each Physician or Other Health Care Provider Who Reviewed the Decision:

 

 

Review Outcome:

 

Upon independent review the reviewer finds that the previous adverse determination/adverse determinations should be:

 

 Upheld                               (Agree)

 

 Overturned                        (Disagree)

 

 Partially Overturned          (Agree in part/Disagree in part)

 

Provide a description of the review outcome that clearly states whether or not medical necessity exists for each of the health care services in dispute.

 

Information Provided to the IRO for Review:

 

 

Description of the Covered Person's History (Summary):

 

 

 

Principal Reason or Reasons for its Decision Including Clinical Basis, Findings and Conclusions Used to Support the Decision:

 

 

Rationale for Decision:

 

 

A Description and the Source of the Screening Criteria or Other Clinical Basis Used to Make the Decision:

 

        Peer-reviewed scientific studies published in or accepted for publication by medical journals that meet nationally recognized requirements for scientific manuscripts and that submit most of their published articles for review by experts who are not part of the editorial staff;

 

        Peer-reviewed medical literature, including literature relating to therapies reviewed and approved by a qualified institutional review board, biomedical compendia, and other medical literature that meets the criteria of the National Institutes of Health's Library of Medicine for indexing in Index Medicus (Medline) and Elsevier Science Ltd. for indexing in Excerpta Medicus (EMBASE);

 

        Medical journals recognized by the Secretary of Health and Human Services under section 1861(t)(2) of the federal Social Security Act;

 

        The following standard reference compendia: 

 

a.         The American Hospital Formulary Service Drug Information;

b.         Drug Facts and Comparisons;

c.         The American Dental Association Accepted Dental Therapeutics; and

d.         The United States Pharmacopoeia Drug Information;

 

        Findings, studies, or research conducted by or under the auspices of federal government agencies and nationally recognized federal research institutes, including:

 

a.         The federal Agency for Healthcare Research and Quality;

b.         The National Institutes of Health;

c.         The National Cancer Institute;

d.         The National Academy of Sciences;

e.         The Centers for Medicare & Medicaid Services;

f.          The federal Food and Drug Administration; and

g.         Any national board recognized by the National Institutes of Health for the purpose of evaluating the medical value of health care services; or

 

        Any other medical or scientific evidence that is comparable to the sources listed above (Provide a Description).

 

Medical necessity determinations for substance use disorders shall be made in accordance with appropriate patient placement criteria established by the American Society of Addiction Medicine pursuant to Section 370(b)(3) of the Illinois Insurance Code [215 ILCS 5].

 

Description of the Covered Person's Medical Condition:

 

 

Description of the Indicators Relevant to Whether There Is Sufficient Evidence to Demonstrate That the Recommended or Requested Health Care Service or Treatment Is More Likely To Be More Beneficial to the Covered Person Than Any Available Standard Health Care Services or Treatments and the Adverse Risks of the Recommended or Requested Health Care Service or Treatment Would Not Be Substantially Increased Over Those of Available Standard Health Care Services or Treatments:

 

 

Description and Analysis of Any Medical or Scientific Evidence Considered in Reaching the Opinion:

 

 

Description and Analysis of Any Evidence-based Standards:

 

 

Whether the Recommended or Requested Health Care Service or Treatment Has Been Approved by the Federal Food and Drug Administration for the Condition:

 

 

Whether Medical or Scientific Evidence or Evidence-based Standards Demonstrate That the Expected Benefits of the Recommended or Requested Health Care Service or Treatment Is More Likely To Be More Beneficial to the Covered Person Than Any Available Standard Health Care Service or Treatment and the Adverse Risks of the Recommended or Requested Health Care Service or Treatment Would Not Be Substantially Increased Over Those of Available Standard Health Care Services or Treatments:

 

 

The Written Opinion of the Clinical Reviewer, Including the Reviewer's Recommendation as to Whether the Recommended or Requested Health Care Service or Treatment Should Be Covered and the Rationale for the Reviewer's Recommendation:

 

(Source:  Amended at 39 Ill. Reg. 4077, effective September 1, 2015)

 

 

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 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;

 

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.

 

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.

 

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

320 West Washington Street

Springfield IL 62767-0001

(217) 558-2309

 

(Source:  Amended at 43 Ill. Reg. 11502, effective September 24, 2019)

 

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 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

320 West Washington Street

Springfield IL 62767-0001

(217) 558-2309

 

(Source:  Amended at 39 Ill. Reg. 4077, effective September 1, 2015)

 

 

Section 4530.APPENDIX E   Illinois or NAIC Biographical Affidavit (Repealed)

 

(Source:  Repealed at 43 Ill. Reg. 11502, effective September 24, 2019)