of this Regulation; and

of this Regulation; and f. The covered person has provided all the information and forms required by the Commissioner that are necessary to process an external review, including the release form provided under Rule 15.04(B) of this Regulation. C. 1. Within one (1) business day after completion of the preliminary review, the health carrier shall notify the Commissioner and the covered person and, if applicable, the covered person’s authorized representative in writing whether: a. The request is complete; and b. The request is eligible for external review. 2. If the request: a. Is not complete, the health carrier shall inform in writing the Commissioner and the covered person and, if applicable, the covered person’s authorized representative and include in the notice what information or materials are needed to make the request complete; or b. Is not eligible for external review, the health carrier shall inform the covered person, the covered person’s authorized representative, if applicable, and the Commissioner in writing and include in the notice the reasons for its ineligibility. 3. a. The Commissioner may specify the form for the health carrier’s notice of initial determination under paragraph (2) and any supporting information to be included in the notice. b. The notice of initial determination provided under paragraph (2) shall include a statement informing the covered person and, if applicable, the covered person’s authorized representative that a health carrier’s initial determination that the external review request is ineligible for review may be appealed to the Commissioner. 4. a. The Commissioner may determine that a request is eligible for external review under subsection B(2) notwithstanding a health carrier’s initial determination that the request is ineligible and require that it be referred for external review. b. In making a determination under subparagraph (a) of this paragraph, the Commissioner’s decision shall be made in accordance with the terms of the covered person’s health benefit plan and shall be subject to all applicable provisions of this Regulation. 5. Whenever a request for external review is determined eligible for external review, the health carrier shall notify the Commissioner and the covered person and, if applicable, the covered person’s authorized representative. D. 1. Within one (1) business day after the receipt of the notice from the health carrier that the external review request is eligible for external review pursuant to subsection A(2)(d) or subsection C(5), the Commissioner shall: a. Assign an independent review organization to conduct the external review from the list of approved independent review organizations compiled and maintained by the Commissioner pursuant to Rule 15.11 of this Regulation and notify the health carrier of the name of the assigned independent review organization; and b. Notify in writing the covered person and, if applicable, the covered person’s authorized representative of the request’s eligibility and acceptance for external review. 2. The Commissioner shall include in the notice provided to the covered person and, if applicable, the covered person’s authorized representative a statement that the covered person or the covered person’s authorized representative may submit in writing to the assigned independent review organization within five (5) business days following the date of receipt of the notice provided pursuant to paragraph (1) additional information that the independent review organization shall consider when conducting the external review. The independent review organization is not required to, but may, accept and consider additional information submitted after five (5) business days. 3. Within one (1) business day after the receipt of the notice of assignment to conduct the external review pursuant to paragraph (1), the assigned independent review organization shall: a. Select one or more clinical reviewers, as it determines is appropriate, pursuant to paragraph (4) to conduct the external review; and b. Based on the opinion of the clinical reviewer, or opinions if more than one clinical reviewer has been selected to conduct the external review, make a decision to uphold or reverse the adverse determination or final adverse determination. 4. a. In selecting clinical reviewers pursuant to paragraph (3)(a), the assigned independent review organization shall select physicians or other health care professionals who meet the minimum qualifications described in Rule 15.12 of this Regulation and, through clinical experience in the past three (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. b. Neither the covered person, the covered person’s authorized representative, if applicable, nor the health carrier shall choose or control the choice of the physicians or other health care professionals to be selected to conduct the external review. 5. In accordance with subsection H, each clinical reviewer shall provide a written opinion to the assigned independent review organization on whether the recommended or requested health care service or treatment should be covered. 6. In reaching an opinion, clinical reviewers are not bound by any decisions or conclusions reached during the health carrier’s utilization review process or the health carrier’s internal grievance process. E. 1. Within five (5) business days after the date of receipt of the notice provided pursuant to subsection D(1), the health carrier or its designee utilization review organization shall provide to the assigned independent review organization, the documents and any information considered in making the adverse determination or the final adverse determination. 2. Except as provided in paragraph (3), failure by the health carrier or its designee utilization review organization to provide the documents and information within the time specified in paragraph (1) shall not delay the conduct of the external review. 3. a. If the health carrier or its designee utilization review organization has failed to provide the documents and information within the time specified in paragraph (1), the assigned independent review organization may terminate the external review and make a decision to reverse the adverse determination or final adverse determination. b. Immediately upon making the decision under subparagraph (a) of this paragraph, the independent review organization shall notify the covered person, the covered person’s authorized representative, if applicable, the health carrier, and the Commissioner. F. 1. Each clinical reviewer selected pursuant to subsection D shall review all of the information and documents received pursuant to subsection E and any other information submitted in writing by the covered person or the covered person’s authorized representative pursuant to subsection D(2). 2. Upon receipt of any information submitted by the covered person or the covered person’s authorized representative pursuant to subsection D(2), within one (1) business day after the receipt of the information, the assigned independent review organization shall forward the information to the health carrier. G. 1. Upon receipt of the information required to be forwarded pursuant to subsection F(2), the health carrier may reconsider its adverse determination or final adverse determination that is the subject of the external review. 2. Reconsideration by the health carrier of its adverse determination or final adverse determination pursuant to paragraph (1) shall not delay or terminate the external review. 3. The external review may terminated only if the health carrier decides, upon completion of its reconsideration, to reverse its adverse determination or final adverse determination and provide coverage or payment for the recommended or requested health care service or treatment that is the subject of the adverse determination or final adverse determination. 4. a. Immediately upon making the decision to reverse its adverse determination or final adverse determination, as provided in paragraph (3), the health carrier shall notify the covered person, the covered person’s authorized representative if applicable, the assigned independent review organization, and the Commissioner in writing of its decision. b. The assigned independent review organization shall terminate the external review upon receipt of the notice from the health carrier sent pursuant to subparagraph (a) of this paragraph. H. 1. Except as provided in paragraph (3), within twenty (20) days after being selected in accordance with subsection D to conduct the external review, each clinical reviewer shall provide an opinion to the assigned independent review organization pursuant to subsection I on whether the recommended or requested health care service or treatment should be covered. 2. Except for an opinion provided pursuant to paragraph (3), each clinical reviewer’s opinion shall be in writing and include the following information: a. A description of the covered person’s medical condition; b. A description of the indicators relevant to determining whether there is sufficient evidence to demonstrate that the recommended or requested health care service or treatment is more likely than not to be 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; c. A description and analysis of any medical or scientific evidence, as that term is defined in Rule 15.02(DD) of this Regulation, considered in reaching the opinion; d. A description and analysis of any evidence-based standard, as that term is defined in Rule 15.02(S) of this Regulation; and e. Information on whether the reviewer’s rationale for the opinion is based on subsection I(5)(a) or (b). 3. a. For an expedited external review, each clinical reviewer shall provide an opinion orally or in writing to the assigned independent review organization as expeditiously as the covered person’s medical condition or circumstances requires, but in no event more than five (5) calendar days after being selected in accordance with subsection D. b. If the opinion provided pursuant to subparagraph (a) of this paragraph was not in writing, within forty-eight (48) hours following the date the opinion was provided, the clinical reviewer shall provide written confirmation of the opinion to the assigned independent review organization and include the information required under paragraph (2). I. In addition to the documents and information provided pursuant to subsection A(2) or subsection E, each clinical reviewer selected pursuant to subsection D, to the extent the information or documents are available and the reviewer considers appropriate, shall consider the following in reaching an opinion pursuant to subsection H: 1. The covered person’s pertinent medical records; 2. The attending physician or health care professional’s recommendation; 3. Consulting reports from appropriate health care professionals and other documents submitted by the health carrier, covered person, the covered person’s authorized representative, or the covered person’s treating physician or health care professional; 4. The terms of coverage under the covered person’s health benefit plan with the health carrier to ensure that, but for the health carrier’s determination that the recommended or requested health care service or treatment that is the subject of the opinion is experimental or investigational, the reviewer’s opinion is not contrary to the terms of coverage under the covered person’s health benefit plan with the health carrier; and 5. Whether: a. The recommended or requested health care service or treatment has been approved by the federal Food and Drug Administration, if applicable, for the condition; or b. 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 than not to be 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. J. 1. a. Except as provided in subparagraph (b) of this paragraph, within twenty (20) days after the date it receives the opinion of each clinical reviewer pursuant to subsection I, the assigned independent review organization, in accordance with paragraph (2), shall make a decision and provide written notice of the decision to: i. The covered person; ii. If applicable, the covered person’s authorized representative; iii. The health carrier; and iv. The Commissioner. b. i. For an expedited external review, within forty-eight (48) hours after the date it receives the opinion of each clinical reviewer pursuant to subsection I, the assigned independent review organization, in accordance with paragraph (2), shall make a decision and provide notice of the decision orally or in writing to the persons listed in subparagraph (a) of this paragraph. ii. If the notice provided under item (i) was not in writing, within forty-eight (48) hours after the date of providing that notice, the assigned independent review organization shall provide written confirmation of the decision to the persons listed in subparagraph (a) of this paragraph and include the information set forth in paragraph (3). 2. a. If a majority of the clinical reviewers recommend that the recommended or requested health care service or treatment should be covered, the independent review organization shall make a decision to reverse the health carrier’s adverse determination or final adverse determination. b. If a majority of the clinical reviewers recommend that the recommended or requested health care service or treatment should not be covered, the independent review organization shall make a decision to uphold the health carrier’s adverse determination or final adverse determination. c. i. If the clinical reviewers are evenly split as to whether the recommended or requested health care service or treatment should be covered, the independent review organization shall obtain the opinion of an additional clinical reviewer in order for the independent review organization to make a decision based on the opinions of a majority of the clinical reviewers pursuant to subparagraph (a) or (b) of this paragraph. ii. The additional clinical reviewer selected under item (i) shall use the same information to reach an opinion as the clinical reviewers who have already submitted their opinions pursuant to subsection I. iii. The selection of the additional clinical reviewer under this subparagraph shall not extend the time within which the assigned independent review organization is required to make a decision based on the opinions of the clinical reviewers selected under subsection D pursuant to paragraph (1). 3. The independent review organization shall include in the notice provided pursuant to paragraph (1): a. A general description of the reason for the request for external review; b. The written opinion of each clinical reviewer, including the recommendation of each clinical reviewer as to whether the recommended or requested health care service or treatment should be covered and the rationale for the reviewer’s recommendation; c. The date the independent review organization was assigned by the Commissioner to conduct the external review; d. The date the external review was conducted; e. The date of its decision; f. The principal reason or reasons for its decision; and g. The rationale for its decision. 4. Upon receipt of a notice of a decision pursuant to paragraph (1) reversing the adverse determination or final adverse determination, the health carrier immediately shall approve coverage of the recommended or requested health care service or treatment that was the subject of the adverse determination or final adverse determination. K. The assignment by the Commissioner of an approved independent review organization to conduct an external review in accordance with this section shall be done on a random basis among those approved independent review organizations qualified to conduct the particular external review based on the nature of the health care service that is the subject of the adverse determination or final adverse determination and other circumstances, including conflict of interest concerns pursuant to Rule 15.12(D) of this Regulation.