3 Alaska Admin. Code § 28.962

Current through October 17, 2024

Section 3 AAC 28.962 - External review of experimental or investigational treatment adverse determinations

(a) A covered person or the covered person's authorized representative may file a request with the director for an external review not later than 180 days after receipt of a health care insurer's notice of adverse determination or final adverse determination that involves a denial of coverage based on a determination that the health care service or treatment recommended or requested is experimental or investigational. The director will extend the 180-day time period for filing the request if the

(1) covered person or the covered person's authorized representative files a written request with the director seeking an extension; and

(2) the written request for the extension sets out one or more justifications for the extension that a prudent person would consider to be a fair and reasonable basis for allowing the extension; the covered person or the covered person's authorized representative does not need to file the request for an extension under this subsection within the 180-day filing period.

(b) A covered person or the covered person's authorized representative may make an oral or written request to the director for an expedited external review of a health care insurer's adverse determination or final adverse determination if the covered person's treating physician certifies, in writing, that the recommended or requested health care service or treatment that is the subject of the request would be significantly less effective if not promptly initiated.

(c) Upon receipt of a request for an expedited external review, the director will immediately notify the health care insurer of the request.

(d) immediately upon receipt of notice of a request for an expedited external review under (c) of this section, a health care insurer shall determine whether the request is eligible for external review under (i) of this section. If the health care insurer determines that the request is not eligible for external review, that health care insurer shall immediately issue a notice of initial determination in writing informing the covered person or the covered person's authorized representative, and also informing the director, of that determination and the reasons the request is not eligible for review. The notice must include a statement that the covered person or the covered person's authorized representative may appeal the health care insurer's initial determination of ineligibility to the director.

(e) Notwithstanding a health care insurer's initial determination that a request is not eligible, the director may determine the request is eligible for external review under (i) of this section and refer the request for external review. The director will make the determination

(1) under the terms of the covered person's health care insurance policy; and

(2) subject to all applicable provisions under 3 AAC 28.950 - 3 A AC 28.982.

(f) Upon receipt of the notice of initial determination from a health care insurer that a request is eligible for expedited external review or upon a determination by the director that a request is eligible for expedited external review, the director will immediately

(1) assign an independent review organization, in the manner set out in 3 AAC 28.958(i)(l), to conduct the expedited external review; and

(2) notify the health care insurer and notify the covered person or the covered person's authorized representative of the name of the assigned independent review organization.

(g) upon receiving notice under (f)(2) of this section, a health care insurer or the health care insurer's designee utilization review organization shall immediately provide or transmit, by electronic mail, telephone, facsimile transmission, or other available expeditious method, all necessary documents and information considered in making the adverse determination or final adverse determination to the assigned independent revievv organization.

(h) Except for a request for an expedited external review under (b) of this section, not later than one working day after receipt of a request for external review under (a) of this section, the director shall send written notice of the request to the health care insurer.

(i) Not later than five working days after receipt of a notice under (h) of this section, a health care insurer shall complete a preliminary review of the external review request to determine whether

(1) the individual is or was a covered person under the health care insurance policy when the health care service or treatment was recommended or requested or, if the request concerns a retrospective review, was a covered person in the health care insurance policy when 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 meets the following conditions:

(A) is a covered benefit under the covered person's health care insurance policy except for the health care insurer's determination that the service or treatment is experimental or investigational for a particular medical condition;

(B) is not explicitly listed as an excluded benefit under the covered person's health care insurance policy with the health care insurer;

(3) the covered person's treating physician has certified that one of the following situations is applicable:

(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; or

(C) there is no available standard health care service or treatment covered by the health care insurer that Is more beneficial than the recommended or requested health care service or treatment sought;

(4) the covered person's treating physician has certified in writing that the

(A) recommended or requested health care service or treatment that is the subject of the adverse determination or the final adverse determination is likely to be more beneficial to the covered person, in the physician's opinion, than other available standard health care services or treatments; or

(B) physician 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 scientifically valid studies using accepted protocols demonstrate the health care service or treatment recommended or requested that is the subject of the adverse determination or final adverse determination is likely to be more beneficial to the covered person than other available standard health care services or treatments;

(5) the covered person or the covered person's authorized representative has exhausted the health care insurer's internal grievance process under 3 AAC 28.930 - 3 AAC 28.938, unless the covered person or the covered person's authorized representative is not required to exhaust the health care insurer's internal grievance process under 3 AAC 28.956; and

(6) the covered person or the covered person's authorized representative has provided the information and forms required to process an external review request, including the release form under 3 AAC 28.952(f).

(j) Not later than one working day after completion of a preliminary review under (i) of this section, a health care insurer shall notify in writing the covered person or the covered person's authorized representative, and also shall notify in writing the director, whether the request is

(1) complete; and

(2) eligible for external review.

(k) If a health care insurer determines the request is not complete, the health care insurer shall notify in writing the covered person or the covered person's authorized representative, and also shall notify in writing the director,

(1) that the request is not complete; and

(2) what information or materials are needed to make the request complete.

(l) If a health care insurer determines a request is not eligible for external review, the health care insurer shall issue a notice of initial determination in writing informing the covered person or the covered person's authorized representative, and also informing the director, of that determination and the reasons Why the request is not eligible for external review. The notice must include a statement informing the covered person or the covered person's authorized representative that the health care insurer's initial determination of ineligibility may be appealed to the director.

(m) Notwithstanding a health care insurer's initial determination that a request is not eligible, the director may determine the request is eligible for external review under (i) of this section and refer the request for external review. The director will make the determination

(1) under the terms of the covered person's health care insurance policy; and

(2) subject to all applicable provisions under 3 AAC 28.950 - 3 AAC 28.982.

(n) A health care insurer shall notify the director and the covered person or the covered person's authorized representative if a request for external review is determined eligible for external review.

(o) Not later than one working day after receipt of the notice of initial determination from a health care insurer that a request for external review is eligible for external review or upon a determination by the director that a request is eligible for external review, the director will assign an independent review organization and issue the notification as provided under 3 AAC 28.958(i),

(p) Not later than one working day after receipt of a notice of assignment to conduct an external review under (o) of this section, an assigned independent review organization shall

(1) select one or more clinical reviewers, as the independent review organization determines is appropriate under (q) of this section, to conduct the external review; and

(2) based on the opinion of the clinical reviewer, or opinions if there is more than. one clinical reviewer, make a decision to uphold or reverse the adverse determination or final adverse determination.

(q) In selecting clinical reviewers, an assigned independent review organization shall select physicians or other health care professionals who

(1) meet the minimum qualifications described under 3 AAC 28.974; and

(2) through clinical experience in the past three years, arc experts in the treatment of the covered person's condition and knowledgeable about the recommended or requested health care service or treatment that is the subject of the adverse determination or the final adverse determination; a covered person, the covered person's authorized representative, or a health care insurer may not choose or control the choice of the clinical reviewers selected to conduct the external review.

(r) Each clinical reviewer selected shall

(1) review all information and documents received and other information submitted in writing by the covered person or the covered person's authorized representative;

(2) review all documents and other information received from the health care insurer under (s) of this section; and

(3) provide a written opinion to the assigned independent review organization regarding whether the recommended or requested health care service or treatment should be covered; in reaching an opinion, a clinical reviewer is not bound by the decision or conclusion reached during the health care insurer's utilization review or internal grievance processes.

(s) Not later than five working days after receipt of the notice of an assignment of an independent review organization, a health care insurer or the health care insurer's designee utilization review organization shall provide or transmit all necessary documents and information considered in making the adverse determination or the final adverse determination to the assigned independent review organization. Except under (t) of this section, failure by a health care insurer or health care insurer's designee utilization review organization to provide the documents and information during the time specified may not delay the conduct of the external review.

(t) If a health care insurer or health care insurer's designee utilization review organization fails to provide the documents and information during the time specified under (s) of this section, an assigned independent review organization may terminate the external review and make a decision to reverse the adverse determination or final adverse determination. Immediately after making a decision, the independent review organization shall notify the covered person or the covered person's authorized representative, and also shall notify the health care insurer and the director, of its decision.

(u) Not later than one working day after receipt of information and documents submitted by the covered person or the covered person's authorized representative, an assigned independent review organization shall forward the information and documents to the health care insurer.

(v) Upon receipt of the information and documents forwarded to the health care insurer under (u) of this section, the health care insurer may reconsider the adverse determination or final adverse determination that is the subject of the external review. The health care insurer's reconsideration of the adverse determination or final adverse determination may not delay or terminate the external review. The external review shall only be terminated if the health care insurer decides, upon completion of the reconsideration, to reverse the 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,

(w) Immediately after making a decision to reverse an adverse determination or final adverse determination, a health care insurer shall notify in writing the covered person or the covered person's authorized representative, and also shall notify in writing the assigned independent review organization and the director, of the health care insurer's decision. The assigned independent review organization shall terminate the external review upon receipt of notice of the health care insurer's decision to reverse the adverse determination or final adverse determination.

(x) Except under (y) of this section, not later than 20 days after being selected to conduct an external review, each clinical reviewer shall provide an opinion to the assigned independent review organization regarding whether the recommended or requested health care service or treatment should be covered under this section, Each clinical reviewer's opinion must be in writing and include

(1) a description of the covered person'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 likely to be more beneficial to the covered person than other available standard health care services or treatments and that 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 medical or scientific evidence considered in reaching the opinion;

(4) a description and analysis of applicable evidence-based standards, if any; and

(5) information on whether the reviewer's rationale for the opinion is based on a factor described in (z)(5)(A) or (B) of this section,

(y) 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 persons medical condition or circumstances require, but not later than five working days after being selected as a clinical reviewer under (p) of this section. If the opinion provided is not in writing, not later than 48 hours after the opinion is provided, the clinical reviewer shall provide written confirmation of the opinion to the assigned independent review organization and include all required information in support of the opinion.

(z) In addition to the documents and information provided under (g) and (s) of this section, each clinical reviewer selected shall, to the extent the information or documents are available and the reviewer considers them appropriate, consider the following in reaching an opinion:

(1) the covered person's pertinent medical records;

(2) the attending physician or health care professional's recommendation or request;

(3) consulting reports from appropriate health care professionals and other documents submitted by the health care insurer, the covered person, the covered person's authorized representative, or the covered person's treating physician or other health care professional;

(4) the terms of coverage under the covered person's health care insurance policy with the health care insurer to ensure that, but for the health care insurer'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 care insurance policy with the health care insurer;

(5) whether either of the following factors is applicable:

(A) the recommended or requested health care service or treatment is approved by the United States Food and Drug Administration, if applicable, for the condition;

(B) medical or scientific evidence or evidence-based standards demonstrate that

(i) the expected benefits of the recommended or requested health care service or treatment are likely to be more beneficial to the covered person than other available standard health care services or treatments; and

(ii) 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.

(aa) Except under (bb) of this section, not later than 20 days after receipt of the opinion of each clinical reviewer, an assigned independent review organization shall

(1) make a decision based on the opinions of the clinical reviewer or reviewers, to uphold or reverse the adverse determination or final adverse determination of a health care insurer; and

(2) provide written notice of the decision to the covered person or the covered person's representative, and also to the health care insurer and the director.

(bb) For an expedited external review, not later than 48 hours after receipt of the opinion of each clinical reviewer, an assigned independent review organization shall

(1) make a decision based on the opinions of the clinical reviewer or reviewers, to uphold or reverse or the adverse determination or final adverse determination of a health care insurer; and

(2) notify the covered person or the covered person's authorized representative, and also notify the health care insurer and the director, of the decision.

(cc) If a notice provided under (bb) of this section is not in writing, not later than 48 hours after providing notice, an assigned independent review organization shall provide written confirmation of the decision to the covered person or the covered person's authorized representative, and also to the health care insurer and the director.

(dd) 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 a health care insurer's adverse determination or final adverse determination.

(ee) 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 a health care insurer's adverse determination or final adverse determination.

(ff) 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 for the independent review organization to make a decision based on the opinions of a majority of the clinical reviewers. The additional clinical reviewer selected shall use the same information to reach an opinion as the clinical reviewers who have already submitted their opinions. The selection of an additional clinical reviewer under this section may 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 for the external review.

(gg) An independent review organization's notice of decision must include

(1) a general description of the reason for the request for external review;

(2) the written opinion of each clinical reviewer which must include

(A) a description of the qualifications of the clinical reviewer;

(B) the recommendation of the clinical reviewer as to whether the recommended or requested health care service or treatment should be covered; and

(C) the rationale for the reviewer's recommendation;

(3) the date the in dependent review organization received the assignment from the director to conduct the external review;

(4) the date the external review was conducted;

(5) the date of the independent review organization's decision;

(6) each principal reason for the decision, including what applicable evidence-based standards, if any, were a basis for the decision;

(7) the rationale for the decision;

(8) references to the evidence or documentation, including evidence-based standards, considered in reaching the decision; and

(9) the professional licenses held by each reviewer.

(hh) Upon receipt of notice under (bb) of this section of a decision of the independent review organization reversing an adverse determination or final adverse determination of a health care insurer, a health care insurer shall immediately approve the coverage of the recommended or requested health care service or treatment that was the subject of the adverse determination or final adverse determination.

3 AAC 28.962

Eff. 3/15/2018,Register 225, April 2018

Authority:AS 21.06.090

AS 21.07.005