(a) To be approved under 23 CAR § 117-111 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 this part that include, at a minimum:

1. (1) A quality assurance mechanism in place that ensures:

   1. (A) That external reviews are conducted within the specified time frames and required notices are provided in a timely manner;
   2. (B) The selection of qualified and impartial clinical reviewers to conduct external reviews on behalf of the independent review organization 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;
   3. (C) The confidentiality of medical and treatment records and clinical review criteria; and
   4. (D) That any person employed by or under contract with the independent review organization adheres to the requirements of this part;
2. (2) A toll-free telephone service to receive information on a twenty-four-hours-a-day, seven-days-a-week basis related to external reviews that is capable of accepting, recording, or providing appropriate instruction to incoming telephone callers during other than normal business hours; and
3. (3) Agree to maintain and provide to the Insurance Commissioner the information set out in 23 CAR § 117-114.

(b) All clinical reviewers assigned by an independent review organization to conduct external reviews shall be physicians or other appropriate healthcare providers who meet the following minimum qualifications:

1. (1) Be an expert in the treatment of the covered person’s medical condition that is the subject of the external review;
2. (2) Be knowledgeable about the recommended healthcare service or treatment through recent or current actual clinical experience treating patients with the same or similar medical condition of the covered person;
3. (3) Hold a nonrestricted license in a state of the United States and, for physicians, a current certification by a recognized United States medical specialty board in the area or areas appropriate to the subject of the external review; and

4. (4) 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:

   1. (A) Physical, mental, or professional competence; or
   2. (B) Moral character.

(c) In addition to the requirements set forth in subsection (a) of this section, 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:

1. (1) Health benefit plan;
2. (2) National, state, or local trade association of health benefit plans; or
3. (3) National, state, or local trade association of healthcare providers.

(d)

1. (1) In addition to the requirements set forth in subsections (a), (b), and (c) of this section, to be approved pursuant to 23 CAR § 117-111 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 independent organization to conduct the external review may have a material professional, familial, or financial conflict of interest with any of the following:

   1. (A) The health carrier that is the subject of the external review;
   2. (B) The covered person whose treatment is the subject of the external review or the covered person’s authorized representative;
   3. (C) Any officer, director, or management employee of the health carrier that is the subject of the external review;
   4. (D) The healthcare provider, the healthcare provider’s medical group, or independent practice association recommending the healthcare service or treatment that is the subject of the external review;
   5. (E) The facility at which the recommended healthcare service or treatment would be provided; or
   6. (F) 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.
2. (2) In determining whether an independent review organization or a clinical reviewer of the independent review organization has a material professional, familial, or financial conflict of interest for purposes of subdivision (d)(1) of this section, the commissioner shall take into consideration situations where the independent review organization to be assigned to conduct an external review of a specified case or a clinical reviewer to be assigned by the independent review organization to conduct an external review of a specified case may have an apparent professional, familial, or financial relationship or connection with a person described in subdivision (d)(1) of this section, but that the characteristics of that relationship or connection are such that they are not a material professional, familial, or financial conflict of interest that results in the disapproval of the independent review organization or the clinical reviewer from conducting the external review.

(e)

1. (1) An independent review organization that is accredited by a nationally recognized private accrediting entity that has independent review accreditation standards that the commissioner has determined are equivalent to or exceed the minimum qualifications of this section shall be presumed in compliance with this section to be eligible for approval under 23 CAR § 117-111.

2. (2)

   1. (A) The commissioner shall initially review and periodically review the independent review organization accreditation standards of a nationally recognized private accrediting entity to determine whether the entity’s standards are, and continue to be, equivalent to or exceed the minimum qualifications established under this section.
   2. (B) The commissioner may accept a review conducted by the NAIC for the purpose of the determination under this subdivision (e)(2).

3. (3)

   1. (A) Upon request, a nationally recognized private accrediting entity shall make its current independent review organization accreditation standards available to the commissioner or the NAIC in order for the commissioner to determine if the entity’s standards are equivalent to or exceed the minimum qualifications established under this section.
   2. (B) The commissioner may exclude any private accrediting entity that is not reviewed by the NAIC.

(f)

1. (1) An independent review organization shall be unbiased.
2. (2) An independent review organization shall establish and maintain written procedures to ensure that it is unbiased, in addition to any other procedures required under this section.