Section 22:2438 - External review of experimental or investigational treatment adverse determinationsA.(1) Within four months after the date of receipt of a notice of an adverse determination or final adverse determination pursuant to R.S. 22:2433 that involves a denial of coverage based on a determination that the health care service or treatment recommended or requested is experimental or investigational, a covered person or his authorized representative may file a request for a standard and an expedited external review with the health insurance issuer, regardless of the claim amount.(2)(a) A covered person or his authorized representative may make an oral request to the health insurance issuer for an expedited external review of the adverse determination or final adverse determination pursuant to Paragraph (1) of this Subsection if the covered person's treating physician certifies, in writing, that any delay in appealing the adverse determination may pose an imminent and serious threat to the covered person's health, including but not limited to severe pain, potential loss of life, limb, or major bodily function, or the immediate and serious deterioration of the health of the covered person.(b)(i) Upon notice of the request for an expedited external review, the health insurance issuer shall immediately determine whether the request meets the reviewability requirements of Subsection B of this Section. The health insurance issuer shall immediately notify the covered person and, if applicable, his authorized representative of its eligibility determination.(ii) The commissioner may specify the form and method for the health insurance issuer's notice of initial determination pursuant to Item (i) of this Subparagraph and any supporting information to be included in the notice.(iii) The notice of initial determination under Item (i) of this Subparagraph shall include a statement informing the covered person and, if applicable, his authorized representative that a health insurance issuer's initial determination that the expedited external review request is ineligible for review may be appealed to the commissioner.(c)(i) If the covered person or his authorized representative makes a written request to the commissioner of insurance after receipt of the denial of an expedited external review, the commissioner may determine that a request is eligible for an expedited external review pursuant to Subsection B of this Section, notwithstanding a health insurance issuer's initial determination the request is ineligible, and require that it be referred for an expedited external review.(ii) In making a determination pursuant to Item (i) of this Subparagraph, the commissioner's decision shall be made in accordance with all applicable provisions of this Part.(iii) The commissioner shall immediately notify the health insurance issuer and the covered person or his authorized representative of its determination concerning the eligibility of the request. Following receipt of the commissioner's determination that a request is eligible for an expedited external review, a health insurance issuer shall immediately comply with Subparagraph (d) of this Paragraph.(d) Immediately upon the health insurance issuer's determination that a request is eligible for an expedited external review or upon the determination by the commissioner that a request is eligible for an expedited external review, the health insurance issuer shall submit a request for assignment of an independent review organization through the Department of Insurance's website. Upon receipt of the notice that the expedited external review request meets the reviewability requirements of Subsection B of this Section, the commissioner shall immediately randomly assign an independent review organization to review the expedited request from the list of approved independent review organizations compiled and maintained by him pursuant to R.S. 22:2440 and notify the health insurance issuer and the covered person or his authorized representative of the name and contact information of the assigned independent review organization.(e) At the time that the health insurance issuer receives the notice of the assigned independent review organization pursuant to Subparagraph (d) of this Paragraph, the health insurance issuer 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 electronically, by telephone or facsimile, or any other available expeditious method.B. Within five business days following the date of receipt of the standard external review request, the health insurance issuer shall conduct and complete a preliminary review of the request to determine whether each of the following conditions have been met: (1) The individual is or was a covered person 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 a covered person 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 determination or final adverse determination is not explicitly listed as an excluded benefit under the covered person's health benefit plan with the health insurance issuer.(3) The covered person's treating physician has certified that one of the following situations exists: (a) Standard health care services or treatments have not been effective in improving the condition of the covered person.(b) Standard health care services or treatments are not medically appropriate for the covered person.(c) There is no available standard health care service or treatment covered by the health insurance issuer that is more beneficial than the recommended or requested health care service or treatment.(4) The covered person's treating physician either:(a) Has recommended a health care 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 health care services or treatments.(b) 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 and has certified, in writing, that scientifically valid studies using accepted protocols demonstrate that the health care 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 health care services or treatments.(5) The covered person has exhausted the health insurance issuer's internal claims and appeals process provided pursuant to R.S. 22:2401, unless the covered person is not required to exhaust the health insurance issuer's internal claims and appeals process pursuant to R.S. 22:2435.(6) The covered person has provided all the information and forms required by the commissioner that are necessary to process a standard external review, including the authorization form provided pursuant to R.S. 22:2433(B).C.(1) Within five business days after the completion of the preliminary review, the health insurance issuer shall notify the covered person and, if applicable, his authorized representative in writing whether each of the following conditions have been met: (a) The request is complete.(b) The request is eligible for a standard external review.(2) If the request: (a) Is not complete, the health insurance issuer shall inform the covered person and, if applicable, his authorized representative in writing and specify in the notice what information or materials are needed to make the request complete.(b) Is not eligible for a standard external review, the health insurance issuer shall inform the covered person and his authorized representative, if applicable, in writing and include in the notice the reasons for its ineligibility.(3)(a) The commissioner may specify the form and method for the health insurance issuer's notice of initial determination pursuant to Paragraph (2) of this Subsection and any supporting information to be included in the notice.(b) The notice of initial determination provided pursuant to Paragraph (2) of this Subsection shall include a statement informing the covered person and, if applicable, his authorized representative that a health insurance issuer's initial determination that the standard external review request is ineligible for review may be appealed to the commissioner.(4)(a) If the covered person or his authorized representative makes a written request to the commissioner of insurance after receipt of the denial of a standard external review, the commissioner may determine that a request is eligible for a standard external review under Subsection B of this Section, notwithstanding a health insurance issuer's initial determination that the request is ineligible, and require that it be referred for a standard external review.(b) In making a determination pursuant to Subparagraph (a) of this Paragraph, the commissioner's decision shall be made in accordance with all applicable provisions of this Part.(c) The commissioner shall notify the health insurance issuer and the covered person or his authorized representative of his determination concerning the eligibility of the request within five business days. Following receipt of the commissioner's determination that a request is eligible for a standard external review, the health insurance issuer shall comply with Subsection D of this Section.D.(1) A health insurance issuer shall notify the commissioner that a request is eligible for a standard external review pursuant to Subsection C of this Section by submitting a request for assignment of an independent review organization through the Department of Insurance's website. Upon notification, the commissioner shall do both of the following: (a) Randomly assign an independent review organization to conduct the standard external review from the list of approved independent review organizations compiled and maintained by the commissioner pursuant to R.S. 22:2440 and notify the health insurance issuer of the name of the assigned independent review organization.(b) Within one business day, notify in writing the covered person and, if applicable, his authorized representative of the request's eligibility and acceptance for a standard external review and the identity of and contact information for the assigned independent review organization.(2) The commissioner shall include a statement in the notice provided to the covered person and, if applicable, his authorized representative that the covered person or his authorized representative may submit in writing to the assigned independent review organization, within five business days following the date of receipt of the notice provided pursuant to Paragraph (1) of this Subsection, additional information that the independent review organization shall consider when conducting the standard external review. The independent review organization shall be authorized but not required to accept and consider additional information submitted after five business days. Within one business day after the receipt of the notice of assignment to conduct the standard external review pursuant to Paragraph (1) of this Subsection, the assigned independent review organization shall follow the clinical peer process provided for in Paragraph (3) of this Subsection.(3) For both a standard and an expedited external review, the assigned independent review organization shall do both of the following:(a) Select one or more clinical peers, as it determines is appropriate, pursuant to Paragraph (4) of this Subsection, to conduct the standard or expedited external review.(b) Based on the opinion of the clinical peer, or opinions if more than one clinical peer has been selected to conduct the standard or expedited external review, make a decision to uphold or reverse the adverse determination or final adverse determination.(4)(a) In selecting clinical peers pursuant to Subparagraph (3)(a) of this Subsection, the assigned independent review organization shall select physicians or other health care professionals who meet the minimum qualifications of R.S. 22:2441 and, through clinical experience in the past three 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) The covered person, his authorized representative, if applicable, or the health insurance issuer shall not choose or control the choice of the physicians or other health care professionals to be selected to conduct the standard external review or the expedited external review.(5) In accordance with Subsection H of this Section, each clinical peer 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 peers shall not be bound by any decisions or conclusions reached during the health insurance issuer's utilization review process or the health insurance issuer's internal claims and appeals process provided pursuant to R.S. 22:2401.E.(1) Within five business days after the date of receipt of the notice provided pursuant to Paragraph (D)(1) of this Section, the health insurance issuer or its designee utilization review organization shall provide the documents and any information considered in making the adverse determination or the final adverse determination to the assigned independent review organization.(2) Except as provided in Paragraph (3) of this Subsection, failure by the health insurance issuer or its designee utilization review organization to provide the documents and information within the time frame specified in Paragraph (1) of this Subsection shall not delay the conduct of the standard external review or the expedited external review.(3)(a) If the health insurance issuer or its designee utilization review organization has failed to provide the documents and information within the time frame specified in Paragraph (1) of this Subsection, the assigned independent review organization may terminate the standard external review or the expedited 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, his authorized representative, if applicable, the health insurance issuer, and the commissioner.F.(1) For a standard or an expedited external review, each clinical peer selected pursuant to Subsection D of this Section shall review all of the information and documents received pursuant to Subsection E of this Section and any other information submitted in writing by the covered person or his authorized representative pursuant to Paragraph (D)(2) of this Section.(2) Within one business day after receipt of any information submitted by the covered person or his authorized representative pursuant to Paragraph (D)(2) of this Section, the assigned independent review organization shall forward the information to the health insurance issuer.G.(1) Upon receipt of the information required to be forwarded pursuant to Paragraph (F)(2) of this Section, the health insurance issuer may reconsider its adverse determination or final adverse determination that is the subject of the standard or the expedited external review.(2) Reconsideration by the health insurance issuer of its adverse determination or final adverse determination pursuant to Paragraph (1) of this Subsection shall not delay or terminate the standard or the expedited external review.(3) The standard or the expedited external review may terminate only if the health insurance issuer 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) For a standard or an expedited review, immediately upon making the decision to reverse its adverse determination or final adverse determination, as provided in Paragraph (3) of this Subsection, the health insurance issuer shall notify the covered person, his 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 standard or the expedited external review upon receipt of the notice from the health insurance issuer sent pursuant to Subparagraph (a) of this Paragraph.H.(1) Except as provided in Paragraph (3) of this Subsection, within twenty days after being selected in accordance with Subsection D of this Section to conduct the standard external review, each clinical peer shall provide an opinion to the assigned independent review organization pursuant to Subsection I of this Section regarding whether the recommended or requested health care service or treatment should be covered.(2) Except for an opinion provided pursuant to Paragraph (3) of this Subsection, each clinical peer's opinion for a standard review 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 more beneficial to the covered person 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.(c) A description and analysis of any medical or scientific evidence considered in reaching the opinion.(d) A description and analysis of any evidence-based standard.(e) Information on whether the peer's rationale for the opinion is based on the provisions of Subparagraph (I)(5)(a) or (b) of this Section.(3)(a) For an expedited external review, each clinical peer shall provide an opinion orally or in writing containing the information outlined in Paragraph (2) of this Subsection 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 days after being selected in accordance with Subsection D of this Section.(b) If the opinion provided pursuant to Subparagraph (a) of this Paragraph was not in writing, within forty-eight hours following the date that the opinion was provided, the clinical peer shall provide written confirmation of the opinion to the assigned independent review organization and include the information required under Paragraph (2) of this Subsection.I. In addition to the documents and information provided pursuant to Paragraph (A)(2) of this Section or Subsection E of this Section, each clinical peer selected to conduct a standard or an expedited review pursuant to Subsection D of this Section, to the extent the information or documents are available and the peer 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's or health care professional's recommendation.(3) Consulting reports from appropriate health care professionals and other documents submitted by the health insurance issuer, covered person, his authorized representative, or his treating physician or health care professional.(4) The terms of coverage under the covered person's health benefit plan with the health insurance issuer to ensure that, but for the health insurance issuer's determination that the recommended or requested health care service or treatment that is the subject of the opinion is experimental or investigational, the peer's opinion is not contrary to the terms of coverage under the covered person's health benefit plan with the health insurance issuer.(5) Either of the following:(a) Whether the recommended or requested health care service or treatment has been approved by the federal Food and Drug Administration, if applicable, for the condition.(b) Whether 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 more beneficial to the covered person than any available standard health care service or treatment 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.J.(1)(a) Except as provided in Subparagraph (b) of this Paragraph, within twenty days after the date it receives the opinion of each clinical peer made pursuant to Subsection I of this Section, the assigned independent review organization in a standard external review, in accordance with Paragraph (2) of this Subsection, shall make a decision and provide written notice of the decision to:(ii) If applicable, his authorized representative.(iii) The health insurance issuer.(b)(i) For an expedited external review, within forty-eight hours after the date it receives the opinion of each clinical peer pursuant to Subsection I of this Section, the assigned independent review organization, in accordance with Paragraph (2) of this Subsection, shall make a decision and provide notice of the decision orally or in writing to the persons specified in Subparagraph (a) of this Paragraph.(ii) If the notice provided under Item (i) of this Subparagraph 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 persons specified in Subparagraph (a) of this Paragraph and include the information provided for in Paragraph (3) of this Subsection. (2)(a) For a standard or an expedited review, if a majority of the clinical peers 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 insurance issuer's adverse determination or final adverse determination.(b) For a standard or an expedited external review, if a majority of the clinical peers 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 insurance issuer's adverse determination or final adverse determination.(c)(i) For a standard or an expedited external review, if the clinical peers 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 peer in order for the independent review organization to make a decision based on the opinions of a majority of the clinical peers made pursuant to Subparagraph (a) or (b) of this Paragraph.(ii) The additional clinical peer selected under Item (i) of this Subparagraph shall use the same information to reach an opinion as the clinical peers who have already submitted their opinions pursuant to Subsection I of this Section.(iii) The selection of the additional clinical peer under Item (i) of 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 peers selected under Subsection D of this Section pursuant to Paragraph (1) of this Subsection.(3) For a standard or an expedited appeal, the independent review organization shall include in the notice provided pursuant to Paragraph (1) of this Subsection: (a) A general description of the reason for the request for external review.(b) The written opinion of each clinical peer, including the recommendation of each clinical peer as to whether the recommended or requested health care service or treatment should be covered and the rationale for the peer's recommendation.(c) The date that the independent review organization was assigned by the commissioner to conduct the external review.(d) The date that the external review was conducted.(e) The date of its decision.(f) The principal reason or reasons for its decision.(g) The rationale for its decision.(4) For a standard or an expedited external review, upon receipt of a notice of a decision pursuant to Paragraph (1) of this Subsection reversing the adverse determination or final adverse determination, the health insurance issuer shall immediately approve coverage and payment 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 R.S. 22:2441(D). Acts 2013, No. 326, §1, eff. Jan. 1, 2015.Added by Acts 2013, No. 326,s. 1, eff. 1/1/2015.