836-053-1325 Procedures for Conducting External Reviews (1) An independent review organization is subject to the following decision-making standards and procedures: (a) The independent review process is intended to be neutral and independent of influence by any affected party or by state government. The Director of the Department of Consumer and Business Services may conduct investigations as authorized by law but has no involvement in the disposition of specific cases. (b) Independent review is a document review process. An enrollee, a health plan or an attending provider may not participate in or attend an independent review in person or obtain reconsideration of a decision by an independent review organization. (c) An independent review organization shall present cases to medical reviewers in a way that maximizes the likelihood of a clear, unambiguous decision. This may involve stating or restating the questions for review in a clear and precise manner that encourages yes or no answers. (d) An independent review organization may uphold an adverse determination if the patient or any provider refuses or fails to provide in a timely manner relevant medical records that are available and have been requested pursuant to ORS 743B.256. Pursuant to ORS 743B.252, an independent review organization may overturn an adverse determination if the insurer refuses or fails to provide in a timely manner relevant medical records that are available and have been requested. (e) An independent review organization must maintain written policies and procedures covering all aspects of review. (2) Once the director refers a dispute, the independent review organization must proceed to a final decision in accordance with the procedural requirements of ORS 743B.252 and 743B.256 and OAR 836-053-1300 to 836-053-1365 unless requested otherwise by both the insurer and the enrollee. (3) An independent review organization must decide whether or not the dispute pertains to an adverse benefit determination as described in ORS 743B.252(1). If the dispute is covered, it is eligible for external review. An independent review organization must also decide whether the dispute concerns a covered benefit in the health benefit plan. If the dispute concerns a non-covered benefit, the dispute does not qualify for external review. (4) An independent review organization is subject to the following standards with respect to information to be considered for reviews: (a) An independent review organization must request as necessary and must accept and consider the following information as relevant to a case referred: (A) Medical records and other materials that the insurer is required to submit to the independent review organization under ORS 743B.252(3), including information identified in that section that is initially missing or incomplete as submitted by the insurer. (B) For cases in which the insurer's decision addressed whether a course or plan of treatment was medically necessary: (i) A copy of the definition of medical necessity from the relevant health insurance policy; (ii) An explanation of how the insurer's decision conformed to the definition of medical necessity; and (iii) An explanation of how the insurer's decision conformed to the requirement that the definition of medical necessity be uniformly applied. (C) For cases in which the insurer's decision addressed whether a course or plan of treatment was experimental or investigational: (i) A copy of the definition of experimental or investigational from the relevant health insurance policy; (ii) An explanation of how the insurer's decision conformed to that definition of experimental or investigational; and (iii) An explanation of how the insurer's decision conformed to the requirement that the definition of experimental or investigational be uniformly applied. (D) Other medical, scientific and cost-effectiveness evidence, as described in section (5) of this rule, that is relevant to the case. (b) After referral of a case, an independent review organization must accept additional information from the enrollee, the insurer or a provider acting on behalf of the enrollee at the enrollee's request if the information is submitted within five business days of the independent review organization after the enrollee’s receipt of notification of the appointment of the independent review organization or, in the case of an expedited referral, within 24 hours. The additional information must be related to the case and relevant to statutory criteria contained in ORS 743B.252. (c) An independent review organization must ensure the confidentiality of medical records and other personal health information received for use in reviews, in accordance with applicable federal and state laws. (5) If a course or plan of treatment is determined to be subject to independent review, a determination of whether the adverse decision of an insurer should be upheld or not must be based upon expert clinical judgment, after consideration of relevant medical, scientific and cost-effectiveness evidence and medical standards of practice in the United States. As used in this section: (a) "Medical, scientific, and cost-effectiveness evidence" means published evidence on results of clinical practice of any health profession that complies with one or more of the following requirements: (A) 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; (B) Peer-reviewed literature, biomedical compendia, and other medical literature that meet the criteria of the National Institute of Health's National Library of Medicine for indexing in Index Medicus, Excerpta Medica, Embase, Medline, Medical Literature Analysis and Retrieval System or Health Services Technology Assessment Texts; (C) Medical journals recognized by the Secretary of Health and Human Services, under Section 1861(t)(2) of the Social Security Act; (D) The American Hospital Formulary Service-Drug Information, the American Medical Association Drug Evaluation, the American Dental Association Accepted Dental Therapeutics, and the United States Pharmacopoeia-Drug Information; (E) Findings, studies or research conducted by or under the auspices of a federal government agency or a nationally recognized federal research institute, including the Federal Agency for Healthcare Research and Quality, National Institutes of Health, National Cancer Institute, National Academy of Sciences, Center for Medicaid and Medicare Services, Congressional Office of Technology Assessment, and any national board recognized by the National Institutes of Health for the purpose of evaluating the medical value of health services; (F) Clinical practice guidelines that meet Institute of Medicine criteria; or (G) In conjunction with other evidence, peer-reviewed abstracts accepted for presentation at major scientific or clinical meetings. (b) Medical standards of practice include the standards appropriately applied to physicians or other providers or health care professionals, as pertinent to the case. (6) The following standards govern the assignment by an independent review organization of appropriate medical reviewers to a case: (a) A medical reviewer assigned to a case must comply with the conflict of interest provisions in OAR 836-053-1320. (b) An independent review organization shall assign one or more medical reviewers to each case as necessary to meet the requirements of this subsection. The medical reviewer assigned to a case, or the medical reviewers assigned to a case together, must meet each of the following requirements: (A) Have expertise to address each of the issues that are the source of the dispute. (B) Be a clinical peer. For purposes of this paragraph, a clinical peer is a physician or other medical reviewer who is in the same or similar specialty that typically manages the medical condition, procedures or treatment under review. Generally, as a peer in a similar specialty, the individual must be in the same profession and the same licensure category as the attending provider. In a profession that has organized, board-certified specialties, a clinical peer generally will be in the same formal specialty. (C) Have the ability to evaluate alternatives to the proposed treatment. (c) Each independent review organization must have a policy specifying the methodology for determining the number and qualifications of medical reviewers to be assigned to each case. The number of reviewers shall be governed by the following requirements: (A) The number of reviewers must reflect the complexity of the case and the goal of avoiding unnecessary cost. (B) The independent review organization may consider, but shall not be bound by, recommendations regarding complexity from the insurer or attending provider. (C) The independent review organization shall consider situations such as review of experimental and investigational treatments that may benefit from an expanded panel. (7) An independent review organization shall notify the enrollee and the insurer of its decision on the enrollee's case and provide documentation and reasons for the , decision including the clinical basis for the decision unless the decision is wholly based on application of coverage provisions. (a) Documentation of the basis for the decision shall include references to supporting evidence, and if applicable, the reasons for any interpretation regarding the application of health benefit plan coverage provisions, but shall not recommend a course of treatment or otherwise engage in the practice of medicine. (b) If the decision overrides the health benefit plan's standards governing the coverage issues that are subject to independent review, the reasons shall document why the health benefit plan's standards are unreasonable or inconsistent with sound, evidence-based medical practice. (c) The written report shall include the qualifications of each medical reviewer but shall not disclose the identity of the reviewer. (d) Notification of the decision shall be provided initially by phone, e-mail or fax, followed by a written report by mail. In the case of expedited reviews, the initial notification shall be immediate and by phone, followed by a written report. (8) An independent review organization’s decision shall be final unless, within seven business days of an enrollee’s receipt of the written report of the independent review organization’s decision, the enrollee submits information to the director that the independent review organization failed to materially comply with the procedural requirements of ORS 743B.253 or 743B.256 or OAR 836-053-1300 to 836-053-1365. If the enrollee is satisfied with the independent review organization’s decision, the enrollee may notify the independent review organization and insurer by electronic mail, fax or telephone, followed by a written notice, stating that the enrollee waives the seven business days before the independent review organization decision is final. (9) The director shall review the information submitted by the enrollee and, within seven business days, make a written determination whether: (a) The director is reasonably satisfied that the independent review organization failed to materially comply with the procedural requirements of ORS 743B.253 or 743B.256 or OAR 836-053-1300 to 836-053-1365; and (b) The independent review organization’s failure to materially comply with the procedural requirements of ORS 743B.253 or 743B.256 or OAR 836-053-1300 to 836-053-1365 materially affected the independent review organization’s decision. (10) The director shall send a written notification of the determination to the enrollee and the independent review organization. The independent review organization’s decision will be final if the director is reasonably satisfied that the independent review organization complied with the procedural requirements in ORS 743B.253 or 743B.256 or OAR 836-053-1300 to 836-053-1365. (11) If an independent review organization failed to materially comply with the procedural requirements in ORS 743B.253 or 743B.256 or OAR 836-053-1300 to 836-053-1365, the independent review organization shall correct the failure to materially comply by conducting a new external review, at the independent review organization’s cost, and issuing a new decision within ten business days. (a) Within 24 hours of receipt of the written notification from the director described in section (10) of this rule, the independent review organization shall: (A) Notify the enrollee and the insurer via electronic mail, fax or telephone that the independent review organization will be conducting a new external review, and (B) Request from the enrollee or the insurer via electronic mail or fax any information not already provided to the independent review organization that is necessary to correct the material failure to comply with the procedural requirements of ORS 743B.253, or 743B.256 or OAR 836-053-1330 to 836-053-1365. (12) The enrollee or insurer must provide to the independent review organization any requested information in section (11) of this rule within 48 hours after receipt of the request. (13) Notification of the independent review organization’s new decision shall be provided to the enrollee and insurer initially via electronic mail, fax or telephone, followed by a written report by mail. (14) For the purposes of sections (8) to (13) of this rule, “procedural requirements” does not include requirements related to the exercising of medical judgment or decision making by the independent review organization. (15) The independent review organization’s decision based on the new external review shall be final as of the date of the decision. (16) Except as provided in this section, an independent review organization shall not disclose the identity of a medical reviewer unless otherwise required by state or federal law. The director shall not require reviewers' identities as part of the contracting process but may examine identified information about reviewers as part of enforcement activities. The identity of the medical director of an independent review organization shall be disclosed upon request of any person. (17) An independent review organization shall promptly report to the director any attempt by any party, including a state agency, to interfere with the carrying out of the independent review organization’s duties under ORS 743B.253 or 743B.256 or OAR 836-053-1300 to 836-053-1365. (18) An independent review organization must maintain business hours, methods of contact (including telephone contact), procedures for after-hours requests and other relevant procedures to ensure timely availability to conduct expedited as well as regular reviews. Statutory/Other Authority: ORS 731.244 & ORS 743B.253 Statutes/Other Implemented: ORS 743B.253, ORS 743B.252 & ORS 743B.256 History: ID 19-2018, minor correction filed 08/21/2018, effective 08/21/2018 ID 12-2013, f. 12-31-13, cert. ef. 1-1-14 ID 13-2006, f. 7-14-06 cert. ef. 1-1-07 ID 19-2002, f. 9-27-02, cert. ef. 9-28-02 ID 10-2002(Temp), f. & cert. ef. 4-5-02 thru 9-27-02