W. Va. Code R. § 114-97-11

Current through Register Vol. XLI, No. 50, December 13, 2024

Section 114-97-11 - Minimum Qualifications for IROs

11.1. To be approved under section 10 to conduct external reviews, an IRO 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 rule that include, at a minimum:

11.1.a. A quality assurance mechanism in place that:

11.1.a.1. Ensures that external reviews are conducted within the specified time frames and required notices are provided in a timely manner;

11.1.a.2. Ensures the selection of qualified and impartial clinical reviewers to conduct external reviews on behalf of the IRO and suitable matching of reviewers to specific cases that the IRO employs or contracts with an adequate number of clinical reviewers to meet this objective;

11.1.a.3. Ensures the confidentiality of medical and treatment records and clinical review criteria; and

11.1.a.4. Ensures that any person employed by or under contract with the IRO adheres to the requirements of this rule;

11.1.b. A toll-free telephone service to receive information on a 24-hour-day, 7-day-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

11.1.c. Agree to maintain and provide to the Commissioner the information set out in section 13.

11.2. All clinical reviewers assigned by an IRO to conduct external reviews shall be physicians or other appropriate health care providers who meet the following minimum qualifications:

11.2.a. Be an expert in the treatment of the covered person's medical condition that is the subject of the external review;

11.2.b. 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 of the covered person;

11.2.c. 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

11.2.d. 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.

11.3. In addition to the requirements set forth in subsection 11.1, an IRO may not own or control, be a subsidiary of or in anyway 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.

11.4.Conflicts.

11.4.a. In addition to the requirements set forth in subsections 11.1, 11.2 and 11.3, to be approved pursuant to section 10 to conduct an external review of a specified case, neither the IRO 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 with any of the following:

11.4.a.1. The issuer that is the subject of the external review;

11.4.a.2. The covered person whose treatment is the subject of the external review, any known close relative of the covered person or the covered person's representative;

11.4.a.3. Any officer, director or management employee of the issuer that is the subject of the external review;

11.4.a.4. Any administrator, fiduciary, employee or sponsor of an employee welfare benefit plan as defined in 29 U.S.C. 1002(1), if any, under which the covered person's request for external review arises;

11.4.a.5. A trade association of group health plans or issuers, or a trade association of health care providers;

11.4.a.6. 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;

11.4.a.7. The facility at which the recommended health care service or treatment would be provided; or

11.4.a.8. 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.

11.4.b. In determining whether an IRO or a clinical reviewer of the IRO has a material professional, familial or financial conflict of interest for purposes of subdivision 11.4.a, the Commissioner may disregard the mere appearance of a conflict of interest.

11.5. An IRO 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 section 10.

11.5.a. The Commissioner shall initially review and periodically review the IRO 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. The Commissioner may accept a review conducted by the NAIC for the purpose of the determination under this paragraph.

11.5.b. Upon request, a nationally recognized private accrediting entity shall make its current IRO 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. The Commissioner may exclude any private accrediting entity that is not reviewed by the NAIC.

11.6. An IRO 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.

W. Va. Code R. § 114-97-11