2023 Hawaii Revised Statutes › Title 24. Insurance › 432E. Patients' Bill of Rights and Responsibilities Act › 432E-36 External review of experimental or investigational treatment adverse determinations.

§432E-36 External review of experimental or investigational treatment adverse determinations.
(a) An enrollee or an enrollee's appointed representative may file a request for an external review with the commissioner within one hundred thirty days of receipt of notice of an adverse action that involves a denial of coverage based on a determination that the health care service or treatment recommended or requested is experimental or investigational.
(b) An enrollee or the enrollee's appointed representative may make an oral request for an expedited external review of the adverse action if the enrollee's treating physician or advanced practice registered nurse certifies, in writing, that the health care service or treatment that is the subject of the request would be significantly less effective if not promptly initiated. A written request for an expedited external review pursuant to this subsection shall include, and oral request shall be promptly followed by, a certification signed by the enrollee's treating physician or treating advanced practice registered nurse and the authorization for release and disclosures required by section 432E-33. Upon receipt of all items required by this subsection, the commissioner shall immediately notify the health carrier.
(c) Upon notice of the request for expedited external review, the health carrier shall immediately determine whether the request meets the requirements of subsection (b). The health carrier shall immediately notify the commissioner, the enrollee, and the enrollee's appointed representative of its eligibility determination.
Notice of eligibility for expedited external review pursuant to this subsection shall include a statement informing the enrollee and, if applicable, the enrollee's appointed representative that a health carrier's initial determination that the external review request is ineligible for review may be appealed to the commissioner.
(d) Upon receipt of a request for appeal pursuant to subsection (c), the commissioner shall review the request for external review submitted by the enrollee pursuant to subsection (a), determine whether an enrollee is eligible for external review and, if eligible, shall refer the enrollee to external review. The commissioner's determination of eligibility for external review shall be made in accordance with the terms of the enrollee's health benefit plan and all applicable provisions of this part. If an enrollee is not eligible for external review, the commissioner shall notify the enrollee, the enrollee's appointed representative, and the health carrier of the reason for ineligibility within three business days.
(e) Upon receipt of the notice pursuant to subsection (a) or a determination of the commissioner pursuant to subsection (d) that the enrollee meets the eligibility requirements for expedited external review, the commissioner shall immediately randomly assign an independent review organization to conduct the expedited external review from the list of approved independent review organizations qualified to conduct the external review, based on the nature of the health care service that is the subject of the adverse action and other factors determined by the commissioner including conflicts of interest pursuant to section 432E-43, compiled and maintained by the commissioner to conduct the external review and immediately notify the health carrier of the name of the assigned independent review organization.
(f) Upon receipt of the notice from the commissioner of the name of the independent review organization assigned to conduct the expedited external review, the health carrier or its designee utilization review organization shall provide or transmit all documents and information it considered in making the adverse action that is the subject of the expedited external review to the assigned independent review organization electronically or by telephone, facsimile, or any other available expeditious method.
(g) Except for a request for an expedited external review made pursuant to subsection (b), within three business days after the date of receipt of the request, the commissioner shall notify the health carrier that the enrollee has requested an expedited external review pursuant to this section. Within five business days following the date of receipt of notice, the health carrier shall determine whether:
(1) The individual is or was an enrollee in the health benefit plan at the time the health care service or treatment was recommended or requested or, in the case of a retrospective review, was an enrollee in the health benefit plan at the time the health care service or treatment was provided;
(2) The recommended or requested health care service or treatment that is the subject of the adverse action:
(A) Would be a covered benefit under the enrollee's health benefit plan but for the health carrier's determination that the service or treatment is experimental or investigational for the enrollee's particular medical condition; and
(B) Is not explicitly listed as an excluded benefit under the enrollee's health benefit plan;
(3) The enrollee's treating physician or treating advanced practice registered nurse has certified in writing that:
(A) Standard health care services or treatments have not been effective in improving the condition of the enrollee;
(B) Standard health care services or treatments are not medically appropriate for the enrollee; or
(C) There is no available standard health care service or treatment covered by the health carrier that is more beneficial than the health care service or treatment that is the subject of the adverse action;
(4) The enrollee's treating physician or treating advanced practice registered nurse:
(A) Has recommended a health care service or treatment that the physician or advanced practice registered nurse certifies, in writing, is likely to be more beneficial to the enrollee, in the physician's or advanced practice registered nurse's opinion, than any available standard health care services or treatments; or
(B) Who is a licensed, board certified or board eligible physician qualified to practice in the area of medicine appropriate to treat the enrollee's condition, or who is an advanced practice registered nurse qualified to treat the enrollee's condition, has certified in writing that scientifically valid studies using accepted protocols demonstrate that the health care service or treatment that is the subject of the adverse action is likely to be more beneficial to the enrollee than any available standard health care services or treatments;
(5) The enrollee has exhausted the health carrier's internal appeals process or the enrollee is not required to exhaust the health carrier's internal appeals process pursuant to section 432E-33(b); and
(6) The enrollee has provided all the information and forms required by the commissioner that are necessary to process an external review, including the release form and disclosure of conflict of interest information as provided under section 432E-33(a).
(h) Within three business days after determining the enrollee's eligibility for external review pursuant to subsection (g), the health carrier shall notify the commissioner, the enrollee, and the enrollee's appointed representative in writing as to whether the request is complete and eligible for external review.
If the request is not complete, the health carrier shall inform the commissioner, the enrollee, and the enrollee's appointed representative in writing of the information or materials needed to complete the request.
If the enrollee is not eligible for external review pursuant to subsection (g), the health carrier shall inform the commissioner, the enrollee, and the enrollee's appointed representative in writing of the ineligibility and the reasons for ineligibility.
Notice of ineligibility pursuant to this subsection shall include a statement informing the enrollee and the enrollee's appointed representative that a health carrier's initial determination that the external review request is ineligible for review may be appealed to the commissioner by submitting a request to the commissioner.
If a request for external review is determined eligible for external review, the health carrier shall notify the commissioner and the enrollee and, if applicable, the enrollee's appointed representative.
(i) Upon receipt of a request for appeal pursuant to subsection (h), the commissioner shall review the request for external review submitted pursuant to subsection (a) and, if eligible, shall refer the enrollee for external review. The commissioner's determination of eligibility for expedited external review shall be made in accordance with the terms of the enrollee's health benefit plan and all applicable provisions of this part. If an enrollee is not eligible for external review, the commissioner shall notify the enrollee, the enrollee's appointed representative, and the health carrier of the reasons for ineligibility within three business days.
(j) When the commissioner receives notice pursuant to subsection (h) or makes a determination pursuant to subsection (i) that an enrollee is eligible for external review, within three business days after receipt of the notice or determination of eligibility, the commissioner shall:
(1) Randomly assign an independent review organization from the list of approved independent review organizations qualified to conduct the external review, based on the nature of the health care service that is the subject of the adverse action and other factors determined by the commissioner including conflicts of interest pursuant to section 432E-43, compiled and maintained by the [commissioner to] conduct the external review and notify the health carrier of the name of the assigned independent review organization; and
(2) Notify the enrollee and the enrollee's appointed representative, in writing, of the enrollee's eligibility and acceptance for external review.
(k) An enrollee or an enrollee's appointed representative may submit additional information in writing to the assigned independent review organization for consideration in its external review. The independent review organization shall consider information submitted within five business days following the date of the enrollee's receipt of the notice provided pursuant to subsection (j). The independent review organization may accept and consider additional information submitted by an enrollee after five business days.
(l) Within five business days after the date of receipt of notice pursuant to subsection (j), the health carrier or its designated utilization review organization shall provide to the assigned independent review organization all documents and information it considered in issuing the adverse action that is the subject of external review. Failure by the health carrier or its utilization review organization to provide the documents and information within five business days shall not delay the conduct of the external review; provided that the assigned independent review organization may terminate the external review and reverse the adverse action that is the subject of the external review. The independent review organization shall notify the enrollee, the enrollee's appointed representative, the health carrier, and the commissioner within three business days of the termination of an external review and reversal of an adverse action pursuant to this subsection.
(m) Within three business days after the receipt of the notice of assignment to conduct the external review pursuant to subsection (j), the assigned independent review organization shall:
(1) Select one or more clinical reviewers who each shall be a physician or other health care professional who meets the minimum qualifications described in section 432E-39 and, through clinical experience in the past three years, is an expert in the treatment of the enrollee's condition and knowledgeable about the recommended or requested health care service or treatment to conduct the external review; provided that neither the enrollee, the enrollee's appointed representative, 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; and
(2) Based on the written opinion of the clinical reviewer, or opinions if more than one clinical reviewer has been selected, to the assigned independent review organization on whether the recommended or requested health care service or treatment should be covered, make a determination to uphold or reverse the adverse action.
In reaching an opinion, the clinical reviewers are not bound by any decisions or conclusions reached during the health carrier's utilization review process or internal appeals process.
Each clinical reviewer selected pursuant to this subsection shall review all of the information and documents received pursuant to subsection (l) and any other information submitted in writing by the enrollee or the enrollee's authorized representative pursuant to this subsection.
(n) The assigned independent review organization, within one business day of receipt by the independent review organization, shall forward all information received from the enrollee pursuant to subsection (k) to the health carrier. Upon receipt of information forwarded to it pursuant to this subsection, a health carrier may reconsider the adverse action that is the subject of the external review; provided that reconsideration by the health carrier shall not delay or terminate an external review unless the health carrier reverses its adverse action and provides coverage or payment for the health care service that is the subject of the adverse action. The health carrier shall notify the enrollee, the enrollee's appointed representative, the assigned independent review organization, and the commissioner in writing of its decision to reverse its adverse action and within three business days of making its decision to reverse the adverse action and provide coverage. The assigned independent review organization shall terminate its external review upon receipt of notice pursuant to this subsection from the health carrier.
(o) Except as provided in subsection (p), within twenty days after being selected to conduct the external review, a clinical reviewer shall provide an opinion to the assigned independent review organization pursuant to subsection (q) regarding whether the recommended or requested health care service or treatment subject to an appeal pursuant to this section shall be covered.
The clinical [reviewer's] opinion shall be in writing and shall include:
(1) A description of the enrollee's medical condition;
(2) 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 more beneficial to the enrollee than any available standard health care services or treatments and whether 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;
(3) A description and analysis of any medical or scientific evidence, as that term is defined in section 432E-1.4, considered in reaching the opinion;
(4) A description and analysis of any medical necessity criteria defined in section 432E-1; and
(5) Information on whether the reviewer's rationale for the opinion is based on approval of the health care service or treatment by the federal Food and Drug Administration for the condition or medical or scientific evidence or evidence-based standards that demonstrate that the expected benefits of the recommended or requested health care service or treatment is likely to be more beneficial to the enrollee 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.
(p) Notwithstanding the requirements of subsection (o), in an expedited external review, the clinical reviewer shall provide an opinion orally or in writing to the assigned independent review organization as expeditiously as the enrollee's medical condition or circumstances require, but in no event more than five calendar days after being selected in accordance with subsection (m).
If the opinion provided pursuant to this subsection was not in writing, within forty-eight 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 subsection (o).
(q) In addition to the documents and information provided pursuant to subsection (b) or (l), a clinical reviewer may consider the following in reaching an opinion pursuant to subsection (o):
(1) The enrollee's pertinent medical records;
(2) The attending physician's or health care professional's recommendation;
(3) Consulting reports from appropriate health care professionals and other documents submitted by the health carrier, enrollee, the enrollee's appointed representative, or the enrollee's treating physician or health care professional; and
(4) Whether:
(A) The recommended 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 enrollee 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;
provided that the independent review organization's decision shall not contradict the terms of the enrollee's health benefit plan or the provisions of this chapter.
(r) Except as provided in subsection (s), within twenty days after the date it receives the opinion of the clinical reviewer pursuant to subsection (o), the assigned independent review organization, in accordance with subsection (t), shall determine whether the health care service at issue in an external review pursuant to this section shall be a covered benefit and shall notify the enrollee, the enrollee's appointed representative, the health carrier, and the commissioner of its determination. The independent review organization shall include in the notice of its decision:
(1) A general description of the reason for the request for external review;
(2) 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;
(3) The date the independent review organization was assigned by the commissioner to conduct the external [review];
(4) The date the external review was conducted;
(5) The date the decision was issued;
(6) The principal reason or reasons for its decision; and
(7) The rationale for its decision.
Upon receipt of a notice of a decision reversing the adverse action, the health carrier immediately shall approve coverage of the recommended or requested health care service or treatment that was the subject of the adverse action.
(s) For an expedited external review, within forty-eight hours after the date it receives the opinion of each clinical reviewer, the assigned independent review organization, in accordance with subsection (t), shall make a decision and provide notice of the decision orally or in writing to the enrollee, the enrollee's appointed representative, the health carrier, and the commissioner.
If the notice provided was not in writing, within forty-eight hours after the date of providing that notice, the assigned independent review organization shall provide written confirmation of the decision to the enrollee, the enrollee's appointed representative, the health carrier, and the commissioner.
(t) If a majority of the clinical reviewers recommends 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.
If a majority of the clinical reviewers recommends 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.
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. The additional clinical reviewer shall use the same information to reach an opinion as the clinical reviewers who have already submitted their opinions. The selection of the additional clinical reviewer 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. [L 2011, c 230, pt of §2; am L 2014, c 45, §12; am L 2015, c 63, §19]