23 CAR § 117-109. External review of experimental or investigational treatment adverse determinations

(a)(1) Within four (4) months after the date of receipt of a notice of an adverse determination or final adverse determination pursuant to 23 CAR § 117-104 that involves a denial of coverage based on a determination that the healthcare service or treatment recommended or requested is experimental or investigational, a covered person or the covered person’s authorized representative may file a request for external review with the Insurance Commissioner. (2)(A) A covered person or the covered person’s authorized representative may make an oral request for an expedited external review of the adverse determination or final adverse determination pursuant to subdivision (a)(1) of this section if the covered person’s treating physician certifies, in writing, that the recommended or requested healthcare service or treatment that is the subject of the request would be significantly less effective if not promptly initiated. (B) Upon receipt of a request for an expedited external review, the commissioner immediately shall notify the health carrier. (C)(i)(a) Upon notice of the request for expedited external review, the health carrier immediately shall determine whether the request meets the reviewability requirements under subsection (b) of this section. (b) The health carrier shall immediately notify the commissioner, the covered person, and, if applicable, the covered person’s authorized representative of its eligibility determination. (ii) The commissioner may specify the form for the health carrier’s notice of initial determination under subdivision (a)(2)(C)(i) of this section and any supporting information to be included in the notice by bulletin, directive, or other publication to health carriers. (iii) The notice of initial determination under subdivision (a)(2)(C)(i) of this section 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. (D)(i) The commissioner may: (a) Determine that a request is eligible for external review under subdivision (b)(2) of this section notwithstanding a health carrier’s initial determination the request is ineligible; and (b) Require that it be referred for external review. (ii) In making a determination under subdivision (a)(2)(D)(i) of this section, the commissioner’s decision shall be: (a) Made in accordance with the terms of the covered person’s health benefit plan; and (b) Subject to all applicable provisions of this part. (E) Upon receipt of the notice that the expedited external review request meets the reviewability requirements of subdivision (b)(2) of this section, the commissioner immediately shall: (i) Assign an independent review organization to review the expedited request from the list of approved independent review organizations compiled and maintained by the commissioner pursuant to 23 CAR § 117-111; and (ii) Notify the health carrier of the name of the assigned independent review organization. (F) At the time the health carrier receives the notice of the assigned independent review organization pursuant to subdivision (a)(2)(E) of this section, the health carrier or its designee utilization review organization shall provide or transmit all necessary documents and information considered in making the adverse determination or final adverse determination to the assigned independent review organization: (i) Electronically; (ii) By telephone or facsimile; or (iii) By any other available expeditious method. (b)(1) Except for a request for an expedited external review made pursuant to subdivision (a)(2) of this section, within one (1) business day after the date of receipt of the request, the commissioner receives a request for an external review, the commissioner shall notify the health carrier. (2) Within five (5) business days following the date of receipt of the notice sent pursuant to subdivision (b)(1) of this section, the health carrier shall conduct and complete a preliminary review of the request to determine whether the: (A) Individual is or was a covered person in the health benefit plan at the time the healthcare service or treatment was recommended or requested or, in the case of a retrospective review, was a covered person in the health benefit plan at the time the healthcare service or treatment was provided; (B) Recommended or requested healthcare service or treatment that is the subject of the adverse determination or final adverse determination: (i) Is a covered benefit under the covered person’s health benefit plan except for the health carrier’s determination that the service or treatment is experimental or investigational for a particular medical condition; and (ii) Is not explicitly listed as an excluded benefit under the covered person’s health benefit plan with the health carrier; (C) Covered person’s treating physician has certified that one (1) of the following situations is applicable: (i) Standard healthcare services or treatments have not been effective in improving the condition of the covered person; (ii) Standard healthcare services or treatments are not medically appropriate for the covered person; or (iii) There is no available standard healthcare service or treatment covered by the health carrier that is more beneficial than the recommended or requested healthcare service or treatment described in subdivision (b)(2)(D) of this section; (D) Covered person’s treating physician: (i) Has recommended a healthcare service or treatment that the physician certifies, in writing, is likely to be more beneficial to the covered person, in the physician’s opinion, than any available standard healthcare services or treatments; or (ii) Who is a licensed, board-certified or board-eligible physician qualified to practice in the area of medicine appropriate to treat the covered person’s condition, has certified in writing that scientifically valid studies using accepted protocols demonstrate that the healthcare service or treatment requested by the covered person that is the subject of the adverse determination or final adverse determination is likely to be more beneficial to the covered person than any available standard healthcare services or treatments; (E) Covered person has exhausted the health carrier’s internal appeal process unless the covered person is not required to exhaust the health carrier’s internal appeal process pursuant to 23 CAR § 117-106; and (F) 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 23 CAR § 117-104(b). (c)(1) Within one (1) business day after completion of the preliminary review, the health carrier shall notify the commissioner, 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: (i) Inform in writing the commissioner, the covered person, and, if applicable, the covered person’s authorized representative; and (ii) 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: (i) Inform the covered person, the covered person’s authorized representative, if applicable, and the commissioner in writing; and (ii) 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 subdivision (c)(2) of this section and any supporting information to be included in the notice by bulletin, directive, or other publication to health carriers. (B) The notice of initial determination provided under subdivision (c)(2) of this section 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: (i) Determine that a request is eligible for external review notwithstanding a health carrier’s initial determination that the request is ineligible; and (ii) Require that it be referred for external review. (B) In making a determination under subdivision (c)(4)(A) of this section, the commissioner’s decision shall be: (i) Made in accordance with the terms of the covered person’s health benefit plan; and (ii) Subject to all applicable provisions of this part. (5) Whenever a request for external review is determined eligible for external review, the health carrier shall notify: (A) The commissioner; (B) The covered person; and (C) 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 subdivision (a)(2)(D) or subdivision (c)(5) of this section, 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 23 CAR § 117-111 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)(A) 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 subdivision (d)(1) of this section additional information that the independent review organization shall consider when conducting the external review. (B) 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 subdivision (d)(1) of this section, the assigned independent review organization shall: (A) Select one (1) or more clinical reviewers, as it determines is appropriate, pursuant to subdivision (d)(4) of this section to conduct the external review; and (B) Based on the opinion of the clinical reviewer, or opinions if more than one (1) 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 subdivision (d)(3)(A) of this section, the assigned independent review organization shall select physicians or other healthcare professionals who: (i) Meet the minimum qualifications described in 23 CAR § 117-112; and (ii) Through clinical experience in the past three (3) years, are: (a) Experts in the treatment of the covered person’s condition; and (b) Knowledgeable about the recommended or requested healthcare 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 healthcare professionals to be selected to conduct the external review. (5) In accordance with subsection (h) of this section, each clinical reviewer shall provide a written opinion to the assigned independent review organization on whether the recommended or requested healthcare 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 procedure or the health carrier’s internal appeal procedure. (e)(1) Within five (5) business days after the date of receipt of the notice provided pursuant to subdivision (d)(1) of this section, 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 subdivision (e)(3) of this section, failure by the health carrier or its designee utilization review organization to provide the documents and information within the time specified in subdivision (e)(1) of this section 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 subdivision (e)(1) of this section, the assigned independent review organization may: (i) Terminate the external review; and (ii) Make a decision to reverse the adverse determination or final adverse determination. (B) Immediately upon making the decision under subdivision (e)(3)(A) of this section, the independent review organization shall notify the: (i) Covered person; (ii) Covered person’s authorized representative, if applicable; (iii) Health carrier; and (iv) Commissioner. (f)(1) Each clinical reviewer selected pursuant to subsection (d) of this section shall review: (A) All of the information and documents received pursuant to subsection (e) of this section; and (B) Any other information submitted in writing by the covered person or the covered person’s authorized representative pursuant to subdivision (d)(2) of this section. (2) Upon receipt of any information submitted by the covered person or the covered person’s authorized representative pursuant to subdivision (d)(2) of this section, 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 subdivision (f)(2) of this section, 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 subdivision (g)(1) of this section shall not delay or terminate the external review. (3) The external review may be 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 healthcare 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 subdivision (g)(3) of this section, 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 subdivision (g)(4)(A) of this section. (h)(1) Except as provided in subdivision (h)(3) of this section, within twenty (20) days after being selected in accordance with subsection (d) of this section to conduct the external review, each clinical reviewer shall provide an opinion to the assigned independent review organization pursuant to subsection (i) of this section on whether the recommended or requested healthcare service or treatment should be covered. (2) Except for an opinion provided pursuant to subdivision (h)(3) of this section, 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: (i) Recommended or requested healthcare service or treatment is more likely than not to be beneficial to the covered person than any available standard healthcare services or treatments; and (ii) Adverse risks of the recommended or requested healthcare service or treatment would not be substantially increased over those of available standard healthcare services or treatments; (C) A description and analysis of any medical or scientific evidence, as that term is defined in 23 CAR § 117-102(30), considered in reaching the opinion; (D) A description and analysis of any evidence-based standard, as that term is defined in 23 CAR § 117-102(19); and (E) Information on whether the reviewer’s rationale for the opinion is based on subdivision (i)(5)(A) or subdivision (i)(5)(B) of this section. (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 circumstance requires, but in no event more than five (5) calendar days after being selected in accordance with subsection (d) of this section. (B) If the opinion provided pursuant to subdivision (h)(3)(A) of this section 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 subdivision (h)(2) of this section. (i) In addition to the documents and information provided pursuant to subdivision (a)(2) or subsection (e) of this section, each clinical reviewer selected pursuant to subsection (d) of this section, 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) of this section: (1) The covered person’s pertinent medical records; (2) The attending physician or healthcare professional’s recommendation; (3) Consulting reports from appropriate healthcare professionals and other documents submitted by the: (A) Health carrier; (B) Covered person; (C) Covered person’s authorized representative; or (D) Covered person’s treating physician or healthcare 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 healthcare 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 healthcare service or treatment has been approved by the United States Food and Drug Administration, if applicable, for the condition; or (B) Medical or scientific evidence or evidence-based standards demonstrate that the: (i) Expected benefits of the recommended or requested healthcare service or treatment is more likely than not to be beneficial to the covered person than any available standard healthcare service or treatment; and (ii) Adverse risks of the recommended or requested healthcare service or treatment would not be substantially increased over those of available standard healthcare services or treatments. (j)(1)(A) Except as provided in subdivision (j)(1)(B) of this section, within twenty (20) days after the date it receives the opinion of each clinical reviewer pursuant to subsection (i) of this section, the assigned independent review organization, in accordance with subdivision (j)(2) of this section, 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 seventy-two (72) hours after the date it receives the opinion of each clinical reviewer pursuant to subsection (i) of this section, the assigned independent review organization, in accordance with subdivision (j)(2) of this section, shall: (a) Make a decision; and (b) Provide notice of the decision orally or in writing to the persons listed in subdivision (j)(1)(A) of this section. (ii) If the notice provided under subdivision (j)(1)(B)(i) of this section was not in writing, within forty-eight (48) hours after the date of providing that notice the assigned independent review organization shall: (a) Provide written confirmation of the decision to the persons listed in subdivision (j)(1)(A) of this section; and (b) Include the information set forth in subdivision (j)(3) of this section. (2)(A) If a majority of the clinical reviewers recommend that the recommended or requested healthcare 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 healthcare 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 healthcare 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 subdivision (j)(2)(A) or subdivision (j)(2)(B) of this section. (ii) The additional clinical reviewer selected under subdivision (j)(2)(C)(i) of this section shall use the same information to reach an opinion as the clinical reviewers who have already submitted their opinions pursuant to subsection (i) of this section. (iii) The selection of the additional clinical reviewer under this subdivision (j)(2)(C) 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) of this section. (3) The independent review organization shall include in the notice provided pursuant to subdivision (j)(1) of this section: (A) A general description of the reason for the request for external review; (B) The written opinion of each clinical reviewer, including the: (i) Recommendation of each clinical reviewer as to whether the recommended or requested healthcare service or treatment should be covered; and (ii) 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 subdivision (j)(1) of this section reversing the adverse determination or final adverse determination, the health carrier immediately shall approve coverage of the recommended or requested healthcare 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: (1) The nature of the healthcare service that is the subject of the adverse determination or final adverse determination; and (2) Other circumstances, including conflict of interest concerns pursuant to 23 CAR § 117-112(d).