3901-8-04 Accreditation of independent review organizations.

(A) Purpose

The purpose of this rule is to govern the accreditation of independent review organizations and to govern the assignment of independent review organizations that conduct external reviews.

(B) Authority

This rule is issued pursuant to the authority vested in the superintendent under sections 3901.011, 3901.04, 3901.041, 3901.19 to 3901.26 and 3901.80 of the Revised Code.

(1) Except as otherwise provided, this rule shall apply to:

(a) Health insuring corporations, insurers and public employee benefit plans; and

(b) Independent review organizations seeking accreditation or accredited by the superintendent to conduct external reviews on behalf of health insuring corporations, insurers, and public employee benefit plans on or after May 1, 2000.

(2) This rule shall not apply to:

(a) Health insuring corporations that do not provide basic health care services or do not provide either, directly or indirectly, utilization review services in connection with their policies, contracts, and agreements;

(b) Coverage provided by health insuring corporations to beneficiaries enrolled in medicare programs operated under Title XVIII of the Social Security Act, 49 stat. 620 (1935), 42 U.S.C. Section 301, as amended;

(c) Coverage provided by health insuring corporations to recipients of assistance under the medicaid program operated pursuant to Chapter 5111. of the Revised Code;

(d) Any individual or group policy of sickness and accident insurance covering only accident, credit, dental, disability income, long-term care, hospital indemnity of one hundred dollars per day or less or subject to section 3923.37 of the Revised Code, medicare supplement, medicare, tricare, specified disease or vision care;

(e) Public employee benefit plans covering only accident, credit, dental, disability income, long-term care, hospital indemnity, medicare supplement, medicare, tricare, specified disease or vision care;

(f) Coverage issued as a supplement to liability insurance;

(g) Insurance arising out of worker’s compensation or similar law;

(h) Automobile medical payment insurance; or

(i) Insurance under which benefits are payable with or without regard to fault and which is statutorily required to be contained in any liability insurance policy or equivalent self-insurance.

(D) Definitions For purposes of this rule, the terms have the same meanings as those in sections 1751.77, 3923.65 and 3923.75 of the Revised Code.

(E) General information

(1) Each applicant for accreditation shall apply on a form prescribed by the superintendent and submit it, and the information set forth in paragraphs (E)(3) and (E)(4) of this rule to the superintendent for review.

(2) Notwithstanding paragraph (E)(1) of this rule, each applicant for accreditation that has received accreditation by a national organization that accredits organizations providing expert reviews and related services shall verify their national accreditation and certify compliance with relevant Ohio law on a form prescribed by the superintendent and submit it to the superintendent in lieu of both the form in paragraph (E)(1) of this rule and the information set forth in paragraphs (E)(3) and (E)(4) of this rule.

(3) The independent review organization shall provide to the superintendent a certified statement from an officer of the independent review organization that the independent review organization is not and will not be operated by a national, state, or local trade association of health benefit plans or health care providers.

(4) The independent review organization shall provide to the superintendent:

(a) A description of the areas of expertise available from the independent review organization and the number of clinical peers with expertise in each area, included subspecialties;

(b) A description of the methods of recruiting and selecting impartial clinical peers and matching the clinical peers to specific cases;

(c) A description of the policies and procedures for orientation and training of the clinical peers who perform external reviews;

(d) A description of the procedures employed to ensure that clinical peers conducting external reviews meet all of the requirements in paragraph (F) of this rule;

(e) A description of the procedures for requesting additional information needed to conduct the external review;

(f) A description of the procedures for notifying the following parties when the independent review organization is not required to make a determination because it has not received requested information that it or its clinical peer considers necessary to complete the review:

(i) The health insuring corporation, insurer, or public employee benefit plan;

(ii) The enrollee, insured, plan member, or any authorized person acting on their behalf;

(iii) The superintendent; and

(iv) When applicable, the provider or health care facility the initiated the review; and

(g) A description of the policies and procedure employed to protect the confidentiality of individual medical and treatment records and personal information in accordance with state and federal laws;

(h) A description of the procedures to ensure that no clinical peer or health care facility with which the clinical peer is affiliated shall have any prohibited affiliation as outlined in divion (d)(2) of sections 1751.84, 3923.67 and 3923.76 of the Revised Code;

(i) A description of the procedures to ensure that no conflict of interest exists among:

(i) The independent review organization and its clinical peers;

(ii) The independent review organization and the health insuring corporation, insurer, public employee benefit plan or any officer, director, or managerial employee of these entities; and

(iii) The independent review organization and the parties involved in the case under review;

(j) A description of the quality assurance program as outlined in paragraph (I)(3) of this rule;

(k) A description of the procedures that do the following:

(i) Ensure that appropriate systems are accessible twenty-four hours per day, seven days per week to receive a notice of selection for an external review;

(ii) Ensure that appropriate systems are available twenty four hours per day, seven days per week to respond to a notice of selection for an external review; and

(iii) Ensure that appropriate personnel are accessible not less than forty hours per week during normal business hours to discuss issues related to the external review;

(l) A description of the procedure for providing notification of the determinations to the health insuring corporation, insurer, or public employee benefit plan and the enrollee, insured, plan member, or any authorized person acting on their behalf, and when applicable, the provider or health care facility that initiated the review; and

(m) A description of the procedures to ensure that the independent review organization meets all of the requirements required in the Revised Code.

(F) Qualification of reviewers

(1) Each clinical peer assigned by an independent review organization to conduct external reviews shall:

(a) Have expertise in the treatment of the medical condition of the enrollee, insured, or plan member and clinical experience in the past three years with the service requested or recommended by the enrollee, insured, or plan member or the provider of the enrollee, insured or plan member;

(b) Hold a license that is not restricted in any manner by the state in which the clinical peer is licensed;

(c) Not have been disciplined or sanctioned by a hospital or government entity based on the quality of care provided by the clinical peer; and

(d) In the case of a physician, be certified by a nationally recognized medical specialty board in the area that is the subject of the review.

(G) Confidentiality requirements

(1) An independent review organization shall preserve the confidentiality of individual medical and treatment records and personal information. Personal information shall include, at a minimum:

(a) Name;

(b) Address;

(d) Social security number; and

(e) Financial information.

(2) An independent review organization may not disclose or publish individual medical and treatment records and personal information or other confidential information about a patient without the prior written consent of the patient or as otherwise required by law. An independent review organization may provide confidential information to a third party under contract or affiliated with the independent review organization for the sole purpose of performing the external review. Information provided to such third parties shall remain confidential.

(3) The independent review organization shall maintain policies and procedures to protect the confidentiality of individual medical and treatment records and personal information in accordance with state and federal laws.

(4) An independent review organization shall preserve the confidentiality of proprietary information of the health insuring corporation, insurer, or public employee benefit plan and shall not disclose such information without the prior written consent of the company or as otherwise required by law.

(H) Conflicts of interest

(1) The independent review organization shall maintain policies and procedures ensuring that no clinical peer or health care facility with which the clinical peer is affiliated shall have any prohibited affiliation as outlined in division (d)(2) of sections 1751.84, 3923.67 and 3923.76 of the Revised Code.

(2) The independent review organization shall maintain procedures to ensure that no conflict of interest exists among:

(a) The independent review organization and its clinical peers;

(b) The independent review organization and the health insuring corporation, insurer, public employee benefit plan or any officer, director, or managerial employee of these entities; and

(I) Administrative and operational policies and procedures

(1) The independent review organization shall retain the services of a physician currently licensed and in good standing to practice medicine by a state licensing agency in the United States to provide medical oversight of the external review process.

(2) The independent review organization shall provide notice of the determination to the health insuring corporation, insurer, or public employee benefit plan and the enrollee, insured, plan member, or any authorized person acting on their behalf, and, when applicable, the provider or health care facility that initiated the review within the time frames and in the manner set forth below:

(a) Except as provided in paragraph (I)(2)(b) of this rule, written notice shall be given within one business day of making the determination. At no time shall notice be received beyond the thirty day time period required by law.

(b) In the case of an expedited external review, the independent review organization shall make a good faith effort to provide notice of the determination on the same day, and shall provide written notice that is received within one day of the determination. At no time shall notice be received beyond the seven day time period required by law.

(c) Each written notice of the determination shall contain the information required by division (D)(9)(b) of sections 1751.84, 3923.67 and 3923.76, and division (C)(9) of sections 1751.85, 3923.68, and 3923.77 of the Revised Code.

(3) The independent review organization shall establish a quality assurance program that:

(a) Ensures that external reviews are conducted within the time frames specified in this rule and in sections 1751.84, 1751.85, 3923.67, 3923.68, 3923.76. and 3923.77 of the Revised Code;

(b) Ensures the selection of qualified and impartial clinical peer reviewers, as required by section 3901.81 of the Revised Code, to conduct external reviews on behalf of the independent review organization;

(c) Ensures the reviewers assigned to specific cases meet the qualifications as identified by section 3901.81 of the Revised Code;

(d) Ensures the confidentiality of individual medical and treatment records and personal information by the independent review organization and the clinical peer;

(e) Ensures that any person involved in the external review process adheres to the relevant provisions of Ohio law;

(f) Ensures that the external reviews and determinations provided by the clinical peers are based on sound clinical evidence and take into consideration the information identified in section 1751.84, 3923.67, or 3923.76 of the Revised Code; and

(g) Ensures that external reviews and determinations are clear and monitored by the independent review organization for quality on an ongoing basis.

(4) The independent review organization shall:

(a) Ensure that appropriate systems are accessible twenty-four hours per day, seven days per week to receive notice of selection for an external review;

(b) Ensure that appropriate systems are available twenty-four hours per day, seven days per week to respond to a notice of selection for an external review; and

(c) Ensure that appropriate personnel are accessible not less that forty hours per week during normal business hours to discuss issued related to the external review.

(5) The independent review organization shall notify the health insuring corporation, insurer, or public employee benefit plan and the enrollee, insured, plan member, or any other authorized person acting on their behalf, and, when applicable, the provider or health care facility that initiated the review of the determinations.

(6) The independent review organization shall, within three business days of its determination, submit to the superintendent, in writing, the following:

(a) Whether the determination is an affirmation or reversal of the adverse determination or an affirmation in part or reversal in part;

(b) The time required to conduct the review;

(c) The costs associated with the external review, including the rates charged by the independent review organization to conduct the review; and

(d) The medical specialty or type of provider used to conduct the review.

(J) Reporting requirements Each accredited independent review organization shall provide to the superintendent the information required by section 3901.82 of the Revised Code no later than June first of each calendar year beginning in 2001.

(K) Application examinations

The superintendent or designee may conduct onsite or offsite qualifying examinations of independent review organizations pursuant to sections 3901.011 and 3901.04 of the Revised Code at the expense of the independent review organization. All documents shall be available for inspection at the time of any qualifying examination at the administrative offices of the independent review organization.

(L) Amendments

The independent review organization shall report to the superintendent any material changes in the information in the application or renewal, not later than the thirtieth day before the date on which the change takes effect. This would include notifying the superintendent immediately upon the occurrence of any change to the independent review organization’s accreditation to perform external reviews and related services by a national accrediting organization.

(M) Renewal and examinations

(1) Each accredited independent review organization shall annually apply for renewal of its accreditation not later than sixty days before the anniversary date of the issuance of the accreditation. Each accredited independent review organization shall include a certification that no material changes exist that have not already been filed with the superintendent. This would include the occurrence of any change to the independent review organization’s accreditation to perform external reviews and related services by a national accrediting organization.

(2) The superintendent or designee may conduct periodic examinations and random audits pursuant to sections 3901.011 and 3901.04 of the Revised Code once an independent review organization has been accredited, to verify compliance with the standards specified in this rule and the Revised Code. These examinations and audits shall be at the expense of the independent review organization. All documents shall be available for inspection at the time of any examination or audit at the administrative offices of the independent review organization. Independent review organizations shall maintain all records concerning external reviews for at least three years after conclusion of each external review.

(3) The superintendent or designee shall have authority to investigate complaints regarding external reviews by enrollees, insureds, plan members, any authorized persons, health insuring corporations, insurers, public employee benefit plans, and providers or health care facilities that initiated the reviews.

(N) Experts

The superintendent may retain experts, at the expense of the independent review organization, to execute the powers granted to the superintendent including, but not limited to, periodic examinations and random audits.

(O) Termination

(1) An accredited independent review organization may request termination of its accreditation by notice to the superintendent at least thirty days prior to the effective date of the termination. No termination of an independent review organization under paragraph (O)(1) of this rule shall be effective until all pending external reviews assigned to that independent review organization have been completed.

(2) The superintendent may revoke accreditation immediately upon receipt of information, including, but not limited to, information filed under paragraph (M) of this rule if the information is such that the superintendent would not have accredited the independent review organization if that information had been part of the initial application.

(P) Prohibited practices

(1) An independent review organization shall not, with respect to external review activities, permit or provide compensation or anything of value to its employees, agents, or contractors that, directly or indirectly, encourages the affirmation or reversal of an adverse determination.

(2) An independent review organization shall not, with respect to external review activities, accept compensation, other than payment for the cost of the review, or anything of value from any party.

(3) No contract between an independent review organization and a health insuring corporation, insurer or public employee benefit plan shall contain any provisions that violate this rule or the Revised Code.

(4) An independent review organization shall not, with respect to external review activities, permit or provide compensation or anything of value to a health insuring corporation, insurer, or public employee benefit plan.

(5) Failure of an independent review organization, health insuring corporation, insurer or public employee benefit plan to comply with any provision of this rule or the Revised Code shall be an unfair and deceptive trade practice under sections 3901.19 to 3901.26 of the Revised Code.

(Q) The assignment process

(1) Upon receipt by the health insuring corporation, insurer or public employee benefit plan of a request for an external review subject to divisions (A), (B) and (C) of sections 1751.84, 3923.67, and 3923.76, and divisions (A) and (B) of sections 1751.85, 3923.68, and 3923.77(A) and (B) of the Revised Code, the health insuring corporation, insurer, or public employee benefit plan, shall notify the superintendent of the request for an external review. The notice shall be given on the same day health insuring corporation, insurer, or public employee benefit plan receives the request for an external review in the case of an expedited external review.

(2) The superintendent, upon receipt of a request from a health insuring corporation, insurer, or public employee benefit plan, shall randomly assign two accredited independent review organizations.

(3) The health insuring corporation, insurer, or public employee benefit plan shall, within one day of the superintendent’s assignment, select and notify one of the assigned independent review organizations to conduct the review.

(4) The prescribed thirty day and seven day time periods in which an independent review organization has to issue a written decision on a request for external review shall begin upon receipt by a health insuring corporation, insurer, or public employee benefit plan of the request for an external review by the enrollee, insured, plan member, or any authorized person acting on their behalf, or the provider or health care facility. In the case of an expedited external review, receipt includes a request made orally or electronically.

(R) Payment

The cost of an external review shall be borne by the health insuring corporation, insurer, or public employee benefit plan. No enrollee, insured or plan member shall be required to pay for any part of the cost of the review.

(S) Severability

If any paragraph, term, or provision of this rule is adjudged invalid for any reason, such judgment shall not affect, impair, or invalidate any other paragraph, term or provision of this rule, and the remaining paragraphs, terms and provisions shall continue in full force and effect.

Replaces: 3901-1-62

Effective: 12/31/2008

R.C. 119.032 review dates: 08/29/2013

Promulgated Under: 119.03

Statutory Authority: 3901.041, 3901.19 to 3901.22, 3901.80

Rule Amplifies: 3901.19 to 3901.22, 3901.80

Prior Effective Dates: 2/17/2000